chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Injection site induration, Paraesthesia, Pruritus
Clinical narrative: Night of administration and info next day approx 1/2 to 1 inch below injection site got hard. Redness, burning, tingling, "unbearable" itching, and extreme swelling. Swelling around 3x normal. This reaction spreading down to elbow. Symptoms lasting around 4 days. Treatment with ice and promethazine.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Night of administration and info next day approx 1/2 to 1 inch below injection site got hard. Redness, burning, tingling, "unbearable" itching, and extreme swelling. Swelling around 3x normal. This reaction spreading down to elbow. Symptoms lasting around 4 days. Treatment with ice and promethazine.
Age: 79.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen area on arm where flu vaccine was administered - slightly red.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Rash
Clinical narrative: Patient stated that her arm is swollen (4x4 inch area) and that she has a rash.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site anaesthesia, Injection site reaction, Paraesthesia
Clinical narrative: Patient experienced numbness and tingling down left arm, from injection site to fingers. No swelling or redness at injection site. Patient has tried heating pad, MOTRIN, and cold pack with no change.
Age: 51.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Burning sensation, Erythema, Pruritus
Clinical narrative: Pt developed large area of redness covering most of triceps c/o itching and burning.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Pain, Rash generalised, Skin warm, Tenderness
Clinical narrative: Patient presented to the pharmacy with a swollen arm that was warm and tender to touch. Also complained of a rash all over body. Also had pain.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Myalgia, Pyrexia, Rash
Clinical narrative: Pt developed increasing fever and myalgias and rash below injection site. On the 4th day pt went to doctor's office.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Chills, Headache, Hyperhidrosis, Pain
Clinical narrative: Pt developed increasing fever and myalgias and rash below injection site. On the 4th day pt went to doctor's office.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Pt developed increasing fever and myalgias and rash below injection site. On the 4th day pt went to doctor's office.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Myalgia, Pyrexia, Rash
Clinical narrative: Fever, headache, chills, sweats, cellulitis (L) arm, body aches.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Chills, Headache, Hyperhidrosis, Pain
Clinical narrative: Fever, headache, chills, sweats, cellulitis (L) arm, body aches.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Fever, headache, chills, sweats, cellulitis (L) arm, body aches.
Age: 3.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: VIIth nerve paralysis
Clinical narrative: (L) sided facial nerve palsy. Treated with 5 days prednisolone.
Age: 13.0
Sex: M
Vaccine: FLUN4, HPV4
Symptoms: Syncope
Clinical narrative: Patient given GARDASIL in Lt deltoid while sitting on exam table next to mother, mother stated he fainted after immunization while nurse was out of the room. Lasted approximately 15 sec. Patient able to go home from clinic in 15 minutes.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Fever, redness, swellng. Redness on bicep and tricep ara only, from shoulder to elwo. Painful x2 days.
Age: 57.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site nodule
Clinical narrative: Injection site nodule on right arm.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Influenza like illness, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: A report has been received from a Physician concerning a 4 year old, female patient. The relevant history and concomitant drugs of patient were not reported. The patient had been receiving nasal FLUMIST which was started on 22-Jan-2013. The physician reported that the patient had flu-like symptoms on 24-Jan-2013. The symptoms included body ache, fever, congestion and cough. At the time of reporting, the event of flu-like symptoms was continuing. The reporter considered the event of flu-like symptoms to be non-serious.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Vaccine given 09/18/13 - started with redness, swelling at injection site Thursday - worse by next day Friday 9/20/13 - doctor evaluated - diagnosed secondary cellulitis and prescribed Augmentin for 10 days.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site cellulitis, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (L) deltoid area was swollen, hot to touch and painful. MD prescribed antibiotics for cellulitis.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Emp presented to employee health c/o rash and itching of face that started 15 min after administration.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Erythema, Night sweats, Pyrexia, Tenderness
Clinical narrative: Rt arm warm, red, tender. Night sweats. Fever. Started 09/19/13 - received injection 9/17/13. Seen in office 09/20/13. Started on doxycycline 100 mg bid x 14 days.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Rt arm warm, red, tender. Night sweats. Fever. Started 09/19/13 - received injection 9/17/13. Seen in office 09/20/13. Started on doxycycline 100 mg bid x 14 days.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Dizziness, Electrocardiogram normal, Syncope
Clinical narrative: Patient received vaccination and became lightheaded. She was sat down on a stool and ended up fainting. She was out for a few seconds and then came to and seemed to be ok.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site anaesthesia, Injection site pain, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: R.N. was unable to locate deltoid properly - flu vaccine erroneously given in left shoulder joint. Within 1/2 hr. patient developed warmth, numbness and pain at injection site and warmth, stiffness in left face and axillary area.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: R.N. was unable to locate deltoid properly - flu vaccine erroneously given in left shoulder joint. Within 1/2 hr. patient developed warmth, numbness and pain at injection site and warmth, stiffness in left face and axillary area.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Pt has had a rash for 2 days - noticed on (R) leg - went to ER and BACTRIM for prescription did not take. Took Aspirin 8/25/13 - Rash is red. Rash where vaccine given 1.5 cm centered by 3 cm.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Asthenia, Cold sweat, Heart rate decreased, Muscle twitching, Posture abnormal
Clinical narrative: 5 minutes after shot felt weak -> brief syncope with pulse 48 pulse, clammy, twitches a few times, slumped in chair (we have all new patients wait 15 minutes before going home). Taken back to room, lied down, later some fluid given. BP ok. Went home about 30-40 min later and doing well exam WNL.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: 5 minutes after shot felt weak -> brief syncope with pulse 48 pulse, clammy, twitches a few times, slumped in chair (we have all new patients wait 15 minutes before going home). Taken back to room, lied down, later some fluid given. BP ok. Went home about 30-40 min later and doing well exam WNL.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 2 year old, Female subject, who had been receiving Nasal FLUMIST.  FLUMIST started on 11-JAN-2013. The reporter stated that expired FLUMIST was administered to the patient which started on 11-JAN-2013. The outcome of the event of EXPIRED FLUMIST ADMINISTERED is unknown. The report was concerning to be non-serious.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Wife showed me picture on phone of her husband's arm. Appeared to have rash.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Local swelling
Clinical narrative: Patient's arm swelled significantly at injection site. Veins in hands also swelled. Injection site bulged. Patient said they felt OK just swelling was alarming.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 2 year old, Female subject, who has been receiving nasal FLUMIST. FLUMIST started on an unknown date. Med Assist reported that we have a patient who received expired FLUMIST on 07-Feb-2013. The outcome of the event of RECEIVED EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Paraesthesia, Respiration abnormal
Clinical narrative: Patient complained of being dizzy, lightheaded, tingling sensation all over, and having to concentrate on breathing. The patient waited in the store for 15 minutes and felt fine afterwards. The next day, the patient reported shortness of breath and difficulty breathing while running only. No treatment given. patient experiencing symptoms while running only No symptoms while performing normal activity.
Age: 27.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Erythema, Nodule, Pyrexia
Clinical narrative: Large red mark on arm with knot and low grade fever.
Age: 14.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Dizziness, Headache, Hypotonia, Pallor
Clinical narrative: Received flu and GARDASIL vaccine, 1-2 min after said "I have a headache", then reported being dizzy. 1 minute later, turned pale and limp (was sitting). Returned to supine position, check HR (HRR) and came to after 1-2 minutes. Laid down for 15-15 minutes, was able to tolerate and return to baseline.
Age: 1.3
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Blood culture, Body temperature increased, Convulsion, Differential white blood cell count, Full blood count
Clinical narrative: Put pt to bed about 7:30pm, woke with seizure at 10:00pm, temp 102.5 then called 911. Temp 104.5 upon arrival at facility. Labs done, ROCEPHIN given.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report was received from a health professional, concerning a 3 year old female patient. The patient's medical history, concurrent diseases and concomitant medications were not provided. On 07-Feb-2013, the patient was received nasal FLUMIST, but the vaccine was expired on 04-Feb-2013. At the time of reporting, the outcome of the event of gave expired FLUMIST was unknown. The report was considered to be non-serious by the reporter.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Soft tissue swelling to upper L arm where VAR vaccine given 9/5/13. Ibuprofen and cold packs advised.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A registered nurse reported that they administered expired FLUMIST to one patient which started on 05-Feb-2013. The outcome of the event of ADMINISTRATION OF EXPIRED FLUMIST is unknown. The report was considered to be non-serious. Summary of follow-up information received 12-Mar-2013 from Health professional: Dosing regiment lot number and expiry date added for suspect drug.
Age: 1.1
Sex: F
Vaccine: FLUN3
Symptoms: Ear infection, Influenza
Clinical narrative: A report has been received from physician concerning a 2 years old female patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. Patient had been receiving nasal FLUMIST given on 05-Sep-2012. The patient experienced Influenza A, Influenza B, and ear infection which started on 31-Dec-2012. The outcome of all the events were unknown. The reporter considered all of the events to be non-serious.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a series of unidentifiable patients of unknown gender, who have been receiving Nasal FLUMIST. FLUMIST was administered during Jan-2013. The patients were ADMINISTERED EXPIRED FLUMIST during Jan-2013. Lot number unknown, expiration date 14-Jan-2013. The outcome of the event of unknown. The report was considered to be EXPIRED FLUMIST ADMINISTERED is  non-serious by the reporter.
Age: 1.63
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 1 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 29-Jan-2013. The reported stated that she gave FLUMIST to a 19 month old on 29-Jan-2013. The outcome of the event of GAVE FLUMIST TO A 19 MONTH OLD is unknown. The report was considered to be non-serious. Corrected report 15-Feb-2013: Details for the reporter type administered by are updated. The reporter's details updated.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 2 year old, Male subject who had been receiving Nasal FLUMIST. FLUMIST started on 24-Jan-2013. The patient experienced GAVE AN EXPIRED DOSE which started on 24-Jan-2013. The outcome of the event of GAVE AN EXPIRED DOSE is unknown. The patient was inadvertently gave an expired dose of FLUMIST. The report was considered to be non-serious. Follow-up of insignificant information received 12-March-2013: Reporter phone number updated.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza
Clinical narrative: A report has been received from a health professional concerning a 43 year old, female patient. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient started receiving a treatment with nasal FLUMIST. On 10-Dec-2012, the patient reported that she got flu B after receiving the FLUMIST. The patient recovered from the event of flu B after receiving FLUMIST on an unspecified date. The report was considered to be non-serious by reporter.
Age: 4.0
Sex: U
Vaccine: FLUN3
Symptoms: Incorrect storage of drug
Clinical narrative: A report has been received from a Pharmacist concerning a 4 year old, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. FLUMIST was inadvertently frozen overnight on January 18 for a maximum for 24 hours. The batch was not quarantined and instead, was later administered to a patient on 21-Jan-2013. Product was not expired. The outcome of the event of previously frozen FLUMIST administered is unknown. The report was considered to be non-serious.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Pharyngeal erythema, Pyrexia
Clinical narrative: A consumer report has been received. The report concerns a 9 year old, male patient. No relevant history or concomitant medications reported. The patient was receiving nasal FLUENZ, once/single administration for influenza vaccination) started on an unknown date. The patient experienced mild fever and redness of throat. He received therapy with Tonsipret. The patient recovered from the events of mild fever and redness of throat on an unspecified date. The report was considered to be non-serious by the company physician.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Nasal congestion, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: A consumer report has been received. The report concerns a 10 year old, female consumer, who had been receiving Nasal FLUMIST, 0.2 Millilitres, Once/Single administration. FLUMIST started on 06-Dec-2012. The patient experienced mild fever, mild sore throat, mild general weakness, mild stuffed up and mild runny nose which started on 09-Dec-2012. At the time of reporting, the event of fever, sore throat, general weakness, stuffed up and runny nose was ongoing. The report was considered to be non-serious.
Age: 13.0
Sex: M
Vaccine: FLUN3
Symptoms: Lip swelling
Clinical narrative: A consumer report has been received concerning a 13 year old male patient. The patient's concurrent disease included allergy to amoxicillin and patient history included reaction to sulfamethoxazole-trimethoprim -swelling of lips. Relevant history of patient included flu shot with no reaction. The patient received Nasal FLUMIST on 06-Dec-2012. On 06-Dec-2012 eight hours after FLUMIST the patient developed swelling of the lips. The patient recovered from the event of swelling of the lips on 07-Dec-2012. The report was considered to be non serious by reporter. Summary of follow-up information received by AstraZeneca/MedImmune on 29-Jan-2013 from consumer: outcome of the event added, event stop date added, narrative updated. Corrected report 04-Feb-2013: patient history corrected.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, Rhinorrhoea
Clinical narrative: A report has been received from a Physician concerning a 4 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST (Intranasal) started on 03-May-2013. It was reported that expired FLUMIST administered to patient which started on 03-May-2013 and experienced rhinorrhea. The outcome of the event of rhinorrhea and expired FLUMIST administered is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 08-May-2013 from physician: New non serious event of rhinorrhea added.
Sex: U
Vaccine: FLUN3
Symptoms: Nasal congestion, Rhinorrhoea
Clinical narrative: A report has been received from a Health Professional concerning four or five patients of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST (Intranasal) started on an unknown date. The patients experienced runny nose and congestion/stuffy nose. The patients recovered from the event of runny nose and congestion/stuffy nose on an unspecified date. The runny nose was considered to be non-serious by the reporter. The company physician captured congestion/stuffy nose together and assessed as non-serious.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 22-Jan-2013. The expired vaccine was administered on 22-Jan-2013 by a nurse in a public health clinic. The outcome of the event of expired FLUMIST administered is unknown. The report was considered to be non-serious.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 2 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST (Intranasal) started on an unknown date. It was reported that patient had administered with expired dose of FLUMIST on 20-Mar-2013. The outcome of the event of administered an expired dose of FLUMIST is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN3
Symptoms: Asthma
Clinical narrative: A report was received from a physician via medical representative concerning a child patient. The patient's medical history was reported as asthma. Concurrent diseases and concomitant medications were not reported. On an unknown date, the patient started receiving a treatment with nasal FLUMIST. The doctor gave FLUMIST to a patient who had a history of asthma. The patient had not wheezed in a couple of years, but after receiving the FLUMIST the patient had an incidence of asthma within a week. They were able to manage it in the office. He said that this happened last season. Action taken of FLUMIST was unknown. On an unspecified date, the patient recovered from the event of incidence of asthma. According to company physician the report was considered to be non-serious.
Sex: F
Vaccine: FLUN3
Symptoms: Influenza
Clinical narrative: A report has been received from a Health Professional concerning a child, female subject, who had been receiving Nasal FLUMIST. FLUMIST started during 2012. The patient experienced Influenza A which started on 14-Jan-2013. The patient recovered from the event. The report was considered to be non-serious by the reporter.
Sex: M
Vaccine: FLUN3
Symptoms: Influenza, Influenza B virus test positive
Clinical narrative: A report has been received from a health professional concerning a child male patient. Concomitant medications and medical history were not reported. During 2012 August or September the patient received nasal FLUMIST. It was reported that the patient experienced breakthrough infections of influenza and also tested positive for Flu B, on 20-Dec-2012. Action taken with FLUMIST was unknown. At the time of reporting the outcome of the event of breakthrough infections of influenza was unknown and the patient recovered from the event of influenza B on an unspecified date. The event of influenza B was considered to be non-serious by the reporter. The event of breakthrough infections of influenza has been identified by the company physician from the source documents and it was added as non-serious adverse event.
Sex: F
Vaccine: FLUN3
Symptoms: Influenza
Clinical narrative: A report has been received from a Health Professional concerning a Child, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced Influenza A which started on 21-Dec-2012. The patient recovered from the event of Influenza A on an unspecified date. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN3
Symptoms: Influenza
Clinical narrative: A report has been received from a Health Professional concerning a Child, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced Influenza A which started on 20-Dec-2012. The patient recovered from the event of Influenza A on an unspecified date. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN3
Symptoms: Accidental exposure to product
Clinical narrative: A report has been received from a Physician concerning a Child, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. Inadvertent inoculation in eye was reported. The outcome of the event of inadvertent inoculation in eye is unknown. The report was considered to be non-serious by the reporter.
Sex: U
Vaccine: FLUN3
Symptoms: Drug administered at inappropriate site
Clinical narrative: A report has been received from a Physician concerning a child, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. Immunization status after inadvertent inoculation in the eye and any consequences thereof. The outcome of the event of inadvertent inoculation in eye is unknown. The report was considered to be non-serious by the reporter.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza A virus test positive
Clinical narrative: A report has been received from a Health Professional concerning a 2 year old female patient. No medical history, concurrent diseases and concomitant medications were reported. On 16-Oct-2012, the patient received nasal FLUMIST. The patient's test was positive for influenza A on 15-Dec-2012. Patient was treated with TAMIFLU. The outcome of the event of tested positive for influenza A was recovered. The report was considered to be non-serious by the reporter. Summary of follow-up information received by AstraZeneca/MedImmune 24-Jan-2013 from Health Professional: Event outcome was updated from unknown to recovered. Patient reporter deleted. Reporter's details updated. Patient detail added. County of administration was added. Lab detail added. Corrected report 29-Jan-2013: Action taken corrected from Unknown to Not applicable. Associated case ID added.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza
Clinical narrative: A spontaneous report has been received from consumer concerning a 6 years old, female patient. The relevant history, concurrent diseases and concomitant medications were not reported. From unknown date the patient had been receiving nasal FLUMIST for unknown indication. During Dec 2012 the patient had experienced tough bout of flu. The action taken with FLUMIST was unknown. The outcome of the event of tough bout of flu was unknown. The event of tough bout of flu was considered to be non-serious by reporter.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza A virus test positive
Clinical narrative: A report has been received from a Health Professional. The report concerns a 7 years old female patient. No information regarding relevant medical history, concomitant disease was provided. Concomitant medication include cetirizine hydrochloride. On 03-Nov-2012, patient received nasal FLUMIST. The patient test was positive for influenza A on 16-Dec-2012. Patient was treated with TAMIFLU. Action taken with FLUMIST was Not applicable. The outcome of the event of tested positive for influenza A was recovered. The report was considered to be non-serious by the reporter. Summary of follow-up information received by AstraZeneca/MedImmune 24-Jan-2013 from Health Professional: New reporter added as Health Professional. Event outcome was updated from unknown to recovered. Concomitant drug was added. Patient details added. Reporter's details updated. County of administration was added. Corrected report 29-Jan-2013: Manufacturer name added. Associated case ID added. Lab details added. Corrected report on 01-Mar-2013: event coding changed, narrative updated.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza A virus test positive
Clinical narrative: A report has been received from a health professional concerning a 6 years old male patient. No medical history, concurrent disease or concomitant medication was provided. On 12-Dec-2012, the patient receiving nasal FLUMIST. The patient had positive test for influenza A on 12-Dec-2012. At the time of reporting, the outcome of the event of positive test for influenza A was unknown. The report was considered to be non-serious by the reporter.
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza A virus test positive
Clinical narrative: A report has been received from a Health Professional concerning a 12 year old, male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 27-Oct-2012. The patient experienced tested positive for influenza A which started on 11-Dec-2012. The outcome of the event of tested positive for influenza A is unknown. The report was considered to be non-serious. Follow-up of significant information received AstraZeneca/MedImmune 09-Jan-2013: patient identifiers, drug and adverse event start date added. Lot numbers added. Initial and follow-up information processed together.
Age: 14.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza B virus test positive
Clinical narrative: A report has been received from a health professional concerning a 14 year old, male patient. No medical history, concurrent disease or concomitant medication was provided. On 24-Oct-2012, the patient receiving nasal FLUMIST. The patient had positive test for influenza B on 03-Jan-2013. At the time of reporting, the outcome of the event of positive test for influenza B was unknown. The report was considered to be non-serious by the reporter.
Age: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Diarrhoea, Gastrointestinal disorder, Malaise, Pyrexia, Vomiting
Clinical narrative: A consumer report has been received. The report concerns a 12 year old, Female consumer, who had been receiving Nasal FLUMIST. FLUMIST started on 16-Oct-2012. The patient experienced fever, GI symptoms, vomiting, diarrhea and feeling ill which started on 06-Jan-2013. The patient recovered from the event of fever, GI symptoms, vomiting, diarrhea and feeling ill on 10-Jan-2013. The report was considered to be non-serious by the reporter. Summary of follow-up information received by AstraZeneca/MedImmune on 07-Mar-2013 from consumer: event of Influenza B deleted, events of fever, GI symptoms, vomiting, diarrhea and feeling ill added. New reporter added, event stop dates and outcomes added. Narrative updated.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza A virus test positive
Clinical narrative: A report has been received from a Health Professional concerning a 7 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 21-Nov-2012. The patient experienced positive influenza A test which started on 02-Jan-2013. The outcome of the event of positive influenza A test is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune 09-Jan-2013: patient details, adverse event start date, drug start date, lot number, exp date added.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza
Clinical narrative: A report has been received from consumer, concerning a 15 year old, female patient (one of two sisters). The patient's medical history and concomitant medications were not reported. On 16-Oct-2012, the patient received FLUMIST. On 06-Jan-2013, the patient and her sister, were both diagnosed with Influenza B. On 10-Jan-2013, the patient returned to school and was recovered. The report was considered to be non-serious by reporter. Summary of follow-up information received by AstraZeneca/MedImmune from consumer on 07-Mar-2013: event stop date entered, outcome changed from unknown to recovered. Corrected report 18-Mar-2013: third reporter, type other, entered.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Erythema multiforme, Rash
Clinical narrative: FLUMIST admin 9/12/13. Rash noted 9/17/13. Seen 9/19/13 and 9/20/13. On 9/20/13 diagnosed as erythema multiforme. No known illness, no fever.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain, Abdominal pain upper
Clinical narrative: A report has been received from a Health Professional concerning a 7 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 17-Jan-2013. The patient experienced abdominal pain which started 06-Feb-2013 and stomach aches which started on 18-Jan-2013. The outcome of the event of stomach aches and abdominal pain is unknown. The report was considered to be non-serious by the reporter. Summary of follow-up information received by AstraZeneca/MedImmune 09-Apr-2013 from Health Professional: new event of abdominal pain added, new reporter of health professional added, therefore case was medically confirmed, narrative updated.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical technologist refers to a patient of unknown age and gender. On 05-SEP-2013 the patient was vaccinated with a dose of M-M-R II  lot # 1293A that had expired 09-AUG-2013 (dose and route not provided). No adverse effect was reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MMRV
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse practitioner, concerning an 18 year old female patient with none pertinent medical history or drug reaction allergies. On 21-AUG-2013 the patient was vaccinated with a dose of GARDASIL (Lot #, dose and route not reported). Other suspect therapies included PROQUAD (Merck) given the same day (Lot #, dose and route not reported). Concomitant therapies included prenatal vitamins. The patient became pregnant with LMP of 09-JUL-2013 and EDD of 15-APR-2014. Initial exposure to GARDASIL was at 6 week(s). The outcome of a patient received GARDASIL and PROQUAD while pregnant was unknown. Laboratory diagnostic studies were not performed and no treatment was given for the adverse event. The patient was seen for routine prenatal care on 03-SEP-2013. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Confusional state, Fall, Impaired driving ability
Clinical narrative: Pt fell 3 times, confusion, unable to operate car.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacy intern refers to an approximately 70 year old (reported as above 70 years old) male patient with no drug reaction/allergies. On 11-SEP-2013 the patient was vaccinated with ZOSTAVAX, subcutaneous in the right arm (lot number not provided). The pharmacist got about 0.1 ml into the patient's arm when the injection site burned, looked like a bug bite and it was hart to the touch. The patient did not receive the remainder of the dose of ZOSTAVAX. No treatment was given for the adverse event. No lab diagnostic tests were performed. The patient sought medical attention as he was in the pharmacy. The outcome of the events was unknown. The action taken was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Inflammation, Pruritus
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to a 60 year old female patient. Medical history and drug allergies/reactions were not reported. On 19-AUG-2013 the patient was vaccinated with ZOSTAVAX (dose, route and lot were not reported) to prevent shingles. No concomitant medication was reported. On 01-SEP-2013, the patient applied an unspecified lotion to her bilateral arms and legs. On 02-SEP-2013, the patient noted itchy, inflamed blisters to her bilateral arms and legs. On 04-SEP-2013, the inflamed, itchy blisters were not improving; the patient went to an unspecified urgent care facility to have them evaluated. The unspecified practitioner at the unspecified urgent care facility stated that he/she felt the blisters were caused by the unspecified lotion and prescribed an unspecified antihistamine and topical cortisone lotion to manage the symptoms. On 06-SEP-2013, the blisters were not improving while using the prescribed treatment ordered by the unspecified practitioner, so the patient decided to consult her physician (reporter) who stated to the patient that she felt it was a case of shingles and prescribed a 5 day regiment of prednisone (manufacturer unknown) starting dose of 40 mg per day (on 06-SEP-2013) and weaning the dose down by an unspecified amount for the rest of the 5 day course. On 13-SEP-2013, the patient called the physician (reporter) to report she noted the blisters on her torso. None lab diagnostics studies were performed. At the time of the report, the patient was improving with the blisters starting to resolve. Additional information is not expected.
Sex: F
Vaccine: FLUN3
Symptoms: Foetal exposure during pregnancy, Gastrooesophageal reflux disease, Premature baby
Clinical narrative: A consumer report has been received. The report concerns a female patient. The patient's mother stated that she received nasal FLUMIST on 03-Oct-2012 when she was 19 weeks pregnant. The baby was born 3.5 weeks early. The baby expected delivery date was 24-Feb-2013. It was reported that besides reflux, acid reflux so far everything was okay. No indications besides her being born a few weeks early that anything was amiss. The outcome of the event of born 3.5 weeks early and acid reflux was unknown. The event of born 3.5 weeks early was assessed as non-serious by the reporter. The event of acid reflux had been identified by the company physician from the source documents and added as non-serious adverse event.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Rash, Urticaria
Clinical narrative: A report has been received from a physician via medical representative concerning an 8 year old, female patient. The patient's concomitant diseases included mild upper respiratory (viral) symptoms at the time of the vaccine. Concomitant medications were none. On 19-Feb-2013 the patient received nasal FLUMIST. She received previously FLUMIST, without any adverse event. The patient experienced severe rash which started on 24-Feb-2013 and urticaria. Her rash appeared firstly on her abdomen and lower back. The patient responded to BENADRYL, but the rash reappeared on her shoulders and face. She was treated with BENADRYL again. The action taken of FLUMIST was not applicable. The patient recovered from the event of rash on 26-Feb-2013 and the outcome of the event of urticaria was unknown. The event of rash was considered to be non-serious by the reporter. The event of urticaria was considered to be non-serious by company physician. The event of urticaria have been identified by the company physician from the source document and added as adverse event. Summary of follow-up information received by AstraZeneca/MedImmune 06-May-2013: Patient initials corrected. The event as reported term of Rash over her back changed to Rash. Event onset- and stop date was provided. (From 24-Feb-2013 to 26-Feb-2013). Start date of FLUMIST completed as 19-Feb-2013. Lot number was provided. Concomitant disease added as mild upper respiratory (viral) symptoms at the time of the vaccine.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Vaccination site pain
Clinical narrative: A report has been received from a Health Professional concerning an 8 year old, male subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced BURNING IN NOSTRIL. The outcome of the event of BURNING IN NOSTRIL is unknown. The report was considered to be non-serious by the reporter.
Age: 41.0
Sex: F
Vaccine: FLUN3
Symptoms: Lacrimation increased, Nasal congestion
Clinical narrative: A report has been received from a Pharmacist concerning a 41 year old, Female subject, who had been receiving Nasal FLUMIST, 0.2 Millilitres, Unknown. FLUMIST started on an unknown date. The patient experienced severe watery eyes and severe nasal congestion which started on 10-Jan-2013. At the time of reporting, the event of watery eyes and nasal congestion was ongoing. The report was considered to be non-serious by the reporter.
Age: 14.0
Sex: M
Vaccine: FLUN3
Symptoms: Antinuclear antibody increased, Autoimmune disorder, Iritis, Uveitis
Clinical narrative: A consumer report has been received. The report concerns a 14 year old male patient. The patient was diabetic. The patient started to receive Nasal FLUMIST during Nov-2012. The patient started to experience autoimmune issues including iritis, uveitis and ANA > 600 since 01-Feb-2013. At the time of reporting, the event of autoimmune issues was ongoing and the outcome of the event of iritis, uveitis and ANA > 600 was unknown. The report was considered to be non-serious by a company physician.
Sex: F
Vaccine: FLUN3
Symptoms: Influenza, Influenza B virus test positive
Clinical narrative: A report has been received from a health professional via medical representative concerning a female patient between the age of 20-30 years. The patient's concomitant diseases and concomitant medications were unknown. On an unknown date the patient started receiving nasal FLUMIST. During Jan-2013 the patient experienced Influenza B. The action taken of FLUMIST was unknown. The patient recovered from the event on an unspecified date. The report was considered to be non-serious by the reporter.
Sex: M
Vaccine: FLUN3
Symptoms: Chills, Cough, Headache, Influenza like illness, Oropharyngeal pain
Clinical narrative: A report has been received from a Health Professional (Registered Nurse) concerning a male patient. The relevant history, concurrent diseases and concomitant medications of patient were not reported. The patient had been receiving FLUMIST which was started on 09-OCT-2012. It was reported that patient experienced flu-like symptoms, cough, sore throat, chills, fever, headache and body ache which started during Dec-2012. It was too late for him to be treated with TAMIFLU, so the patient was treated symptomatically with TYLENOL, fluids and rest. Action taken with FLUMIST was not applicable. Outcome of all the reported events was unknown. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN3
Symptoms: Pain, Pyrexia
Clinical narrative: A report has been received from a Health Professional (Registered Nurse) concerning a male patient. The relevant history, concurrent diseases and concomitant medications of patient were not reported. The patient had been receiving FLUMIST which was started on 09-OCT-2012. It was reported that patient experienced flu-like symptoms, cough, sore throat, chills, fever, headache and body ache which started during Dec-2012. It was too late for him to be treated with TAMIFLU, so the patient was treated symptomatically with TYLENOL, fluids and rest. Action taken with FLUMIST was not applicable. Outcome of all the reported events was unknown. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN3, MNQ, VARCEL
Symptoms: Expired drug administered, Syncope
Clinical narrative: A report has been received from a Health Professional concerning, Male subject, who had been receiving Nasal FLUMIST, Unknown MENACTRA and Unknown Varicella. FLUMIST started on 25-Feb-2013, MENACTRA started on an unknown date and Varicella virus vaccine started on an unknown date. The reporter stated that dose of expired FLUMIST was administered which started on 25-Feb-2013 and syncope. The outcome of the event of syncope and administered a dose of expired FLUMIST is unknown. The report was considered to be non-serious.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Rash, Rhinorrhoea
Clinical narrative: A report has been received from a Health Professional concerning a 7 year old, female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 16-Oct-2012. The patient experienced BUMPS THAT LOOKED LIKE IMPETIGO and RUNNY NOSE which started on 16-Oct-2012. The patient recovered from the event of BUMPS THAT LOOKED LIKE IMPETIGO on an unspecified date and the outcome of the event of RUNNY NOSE is unknown. The report was considered to be non-serious.
Age: 33.0
Sex: M
Vaccine: FLUN3
Symptoms: Body temperature increased, Chills, Headache, Pain
Clinical narrative: A report has been received from a Health Professional concerning a 33 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 14-Feb-2013. The patient experienced 103 degrees F temperature, chills, body aches and headache which started on 14-Feb-2013. At the time of reporting, the event of 103 degrees F temperature and chills was improving and at the time of reporting, the event of body aches and headache was ongoing. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN3
Symptoms: Influenza like illness
Clinical narrative: A report was received from a physician concerning a male patient. The patient's medical history, concurrent diseases and concomitant medications were not reported. On an unknown date, the patient started receiving a treatment with nasal FLUMIST. On an unspecified date the patient developed influenza like illness. Action taken on FLUMIST was unknown. At the time of reporting the outcome of the event of influenza like illness was unknown. According to the reporter the report was considered to be non-serious.
Age: 10.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Cough, Nasal congestion, Ocular hyperaemia, Oropharyngeal pain, Pyrexia
Clinical narrative: A report has been received from a Physician concerning a 10 year old, female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 05-Dec-2012. The patient experienced LOW GRADE FEVER, SORE THROAT, REDDENED EYES, COUGH and STUFFY NOSE which started on 08-Dec-2012. The patient recovered from the event of LOW GRADE FEVER/FEVER on 14-Dec-2012 and the patient recovered from the event of SORE THROAT, REDDENED EYES, COUGH and STUFFY NOSE during Dec-2012. The report was considered to be non-serious.
Age: 10.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Cough, Nasal congestion, Ocular hyperaemia, Oropharyngeal pain, Pyrexia
Clinical narrative: A report has been received from a Physician concerning a 10 year old, Female subject, who had been receiving Nasal FLUMIST. The patient's concurrent disease(s) included peanut allergy, seasonal allergy and intermittent asthma. Concomitant medications included Salbutamol and Montelukast. FLUMIST started on 05-Dec-2012. The patient experienced low grade fever, sore throat, cough, red eye and stuffy nose which started on 10-Dec-2012. The patient recovered from the event of low grade fever, sore throat, cough, red eye and stuffy nose during Dec-2012. The report was considered to be non-serious by the company physician.
Age: 4.0
Sex: U
Vaccine: FLUN3
Symptoms: Influenza A virus test positive
Clinical narrative: A report has been received from a Health Professional concerning a patient, subject of unknown gender, who had been receiving FLUMIST. FLUMIST started on 11-Sep-2012. The patient experienced tested positive for flu A. The patient recovered from the event of tested positive for flu A on an unspecified date. The report was considered to be non-serious.
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Influenza, Pain, Pyrexia
Clinical narrative: A consumer report has been received. The report concerns an 11 year old, male patient. No concomitant medication or relevant medical history has been reported. The patient received FLUMIST on Sep or Oct-2012. The patient's mother reported concerning her child, who received FLUMIST sometime during Sep or Oct-2012, and experienced flu on 17-Jan-2013. Child experienced fever 101.5 degrees F, cough, and achiness. Pediatrician did not test for influenza. At the time of reporting the child was feeling better and temp was 99.6 degrees F. At the time of reporting, the event of flu was improving. The report was considered to be non-serious by the reporter.
Age: 78.0
Sex: M
Vaccine: FLUN3
Symptoms: Headache
Clinical narrative: This case received from Regulatory Authority via a consumer concerning a 78 year old, male subject, who had been receiving nasal influenza and INDACATEROL, 150.0 micrograms, every day for COPD. The patient's medical history included asthma and intervertebral disc prolapse. Concomitant medications included unspecified and oxycodone hydrochloride for back pain. Influenza virus vaccine started during 2012 and INDACATEROL started on 09-Nov-2012 for COPD. The patient experienced severe headache which started on 13-Nov-2012 and ONBREZ used to treat suspected COPD, with underlying condition asthma. At the time of reporting, the event of severe headache was improving and the outcome of the event of ONBREZ used to treat suspected COPD, with underlying condition asthma is unknown. The report was considered to be non-serious. Corrected report 03-May-2013: Initial unit was changed from AstraZeneca to MedImmune and key ingredient was also changed from influenza virus vaccine polyvalent to FLUMIST.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Influenza A virus test positive, Pyrexia
Clinical narrative: A report has been received from a Health Professional, concerning a 10 year old male patient. No medical history, concurrent diseases and concomitant medications were reported. On 11-Jan-2013, the patient received FLUMIST. Dosing and frequency were not reported. On 14-Jan-2013, this patient was tested positive for influenza A and the patient also presented with fever and cough. The outcome of the events of tested positive for flu A, cough and fever were unknown. The event of tested positive for flu A was considered to be non-serious by the reporter. The events of fever and cough was considered to be non-serious by the company physician.