chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: M
Vaccine: FLUN4
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: A report has been received from a Health Professional concerning a 10 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. FLUMIST quadrivalent was administered to a patient but the patient moved and turned their head as the dose was being administered and only half the dose was able to be administered into one nostril which started on 27-Sep-2013. The outcome of the event of only half the dose was administered into one nostril is unknown. The report was considered to be non-serious, by the reporter.
Age: 70.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a patient, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST (intranasal) started on an unknown date. The patient experienced inadvertent administration to a 70 year old. The outcome of the event of inadvertent administration to a 70 year old is unknown. The report was considered to be non-serious.
Age: 15.0
Sex: F
Vaccine: FLUN4
Symptoms: Incorrect dose administered
Clinical narrative: A report has been received from a Physician concerning a 15 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 03-Sep-2013. The reporter said that a 15 year old female received FLUMIST on 03-Sep-2013 and then by mistake again on 26-Sep-2013. The outcome of the event of 15 yo patient received two doses of FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
Age: 50.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administration error, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a 50 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 26-Sep-2013. Lab manager reported that they have inadvertently given FLUMIST quadrivalent to a 50 year old employee of clinic. She had not reported any adverse effects. FLUMIST quadrivalent (intranasal) was discontinued on 26-Sep-2013. The outcome of the event of inadvertently gave FLUMIST quadrivalent to a 50 year old patient is unknown. The report was considered to be non-serious.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A report has been received from a Health Professional concerning a 7 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). The patient's concurrent disease(s) included asthma. Concomitant medications included fluticasone propionate and salbutamol. FLUMIST quadrivalent (intranasal) started on 25-Sep-2013. It was reported that FLUMIST quadrivalent was given unintentionally to a patient with asthma. Patient was not reporting any symptoms. FLUMIST quadrivalent (intranasal) was discontinued on 25-Sep-2013. The outcome of the event of given unintentionally to a patient with asthma is unknown. The report was considered to be non-serious.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Rash erythematous
Clinical narrative: A report has been received from a Health Professional concerning a 6 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 18-Sep-2013. The patient experienced red raised rash which started on 18-Sep-2013. The patient recovered from the event of red raised rash on an unspecified date. The report was considered to be non-serious.
Age: 0.82
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A consumer report has been received. The report concerns a 9 month old, Male consumer, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The patient's mother reported that her baby given FLUMIST QUADRIVALENT instead of the flu shot to 10 month old which started on 25-Sep-2013. The outcome of the event GIVEN FLUMIST QUADRIVALENT INSTEAD OF THE FLU SHOT TO 10 MONTH OLD is unknown. The report was considered to be non-serious.
Age: 53.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Pharmacist concerning a 53 year old, Female subject, who had been receiving FLUMIST. FLUMIST started on 10-Sep-2013. It was reported they inadvertently administered FLUMIST to a patient over 49 on 10-Sep-2013. The outcome of the event of inadvertently administered FLUMIST to a patient over 49 is unknown. The report was considered to be non-serious.
Age: 53.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 53 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 10-Sep-2013. It was reported that the patient had inadvertently administered FLUMIST to a patient over 49 which started on 10-Sep-2013. The outcome of the event of inadvertently administered FLUMIST to a patient over 49 is unknown. The report was considered to be non-serious.
Age: 52.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 52 year old, male subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 10-Sep-2013. Tlt was reported that the patient had inadvertently administered FLUMIST to a patient over 49 which started on 10-Sep-2013. The outcome of the event of inadvertently administered FLUMIST to a patient over 49 is unknown. The report was considered to be non-serious.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Accidental exposure to product
Clinical narrative: A report has been received from a Health Professional concerning a 7 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. It was reported that while administering FLUMIST quadrivalent, the child moved their head the second half of the dose was sprayed into the eye which started on 10-Oct-2013. The outcome of the event of second half of the dose was sprayed into the eye is unknown. The report was considered to be non-serious.
Age: 28.0
Sex: F
Vaccine: FLUN4
Symptoms: Local swelling, Nasal congestion, Sneezing
Clinical narrative: A report has been received from a Health Professional concerning a 28 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT, 0.2 Millilitres, Monthly. FLUMIST QUADRIVALENT started on 07-Oct-2013. The patient experienced woke up with swollen left hand which started on 11-Oct-2013 and repeated sneezing and nasal stuffiness which started on 08-Oct-2013. The patient recovered from the event of woke up with swollen left hand on 14-Oct-2013 and the patient recovered from the event of repeated sneezing and nasal stuffiness on 09-Oct-2013. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune 23-Oct-2013 from the health professional: New non-serious event of nasal stuffiness added. Dose of suspect drug FLUMIST QUADRIVALENT added. Stop date of event of repeated sneezing added and outcome changed from unknown to recovered. Stop date of event of woke up with swollen left hand added and outcome changed from unknown to recovered.
Age: 0.51
Sex: F
Vaccine: FLUN4
Symptoms: Bronchial hyperreactivity, Bronchiolitis, Cough, Drug administered to patient of inappropriate age, Respiratory tract congestion
Clinical narrative: A report has been received from a health professional (LPN), concerning a 6 month old female patient. No relevant history, concomitant disease or concomitant medications of the patient were reported. The 6 month old patient had received nasal FLUMIST QUADRIVALENT (Intranasal), administered on 23-Aug-2013. It was reported that the patient had symptoms of cough and congestion on 25-Sep-2013. She was diagnosed with bronchiolitis and reactive airway on 03-Oct-2013. Action taken with FLUMIST QUADRIVALENT was not applicable. The patient recovered from the events of bronchiolitis and reactive airway on 10-Oct-2013 and the outcome of the event of inadvertently gave FLUMIST QUADRIVALENT to a 6 month old was unknown. The reporter assessed the event of inadvertently gave FLUMIST QUADRIVALENT to a 6 month old to be non-serious. The events of bronchiolitis and reactive airway have been identified by the company physician from the source documents and added as adverse events and considered them as non-serious.
Age: 0.6
Sex: U
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 7 month old, subject of unknown gender, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 10-Oct-2013. The outcome of the event of we inadvertently gave FLUMIST quadrivalent to a 7 month old is unknown. The reporter considered the event to be non-serious.
Age: 53.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Pharmacist concerning a 53 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 06-Oct-2013. The patient experienced 53 year old patient received FLUMIST on 06-Oct-2013. The outcome of the event of 53 year old patient received FLUMIST is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning an Adult, subject of unknown gender, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. The health professional reported that the had two patients that received FLUMIST quadrivalent who are over the recommended age of 49 by mistake which started on 09-Oct-2013. No symptoms reported. The outcome of the event of patient over 49 years old received FLUMIST is unknown. The report was considered to be non-serious.
Age: 11.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning an 11 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST started on 03-Dec-2013. The patient was inadvertently given an expired dose of FLUMIST which started on 03-Dec-2013. The outcome of the event of inadvertently gave an expired dose of FLUMIST is unknown. The report was considered to be non-serious.
Age: 11.0
Sex: M
Vaccine: FLUN4, MNQ, TDAP
Symptoms: Ear infection, Ear pain, VIIth nerve paralysis
Clinical narrative: A report had been received from a Health Professional concerning an 11 years old, male patient. The relevant history and concomitant drugs of the patient were not reported. The patient had received nasal FLUMIST QUADRIVALENT of batch number BH2124 on 16-Sep-2013. The patient also received Tdap and MCV4 vaccines on that day. The nurse reported that the patient had right ear pain on 01-Oct-2013. The patient was diagnosed with right ear infection on 01-Oct-2013. The patient was started on CIPRODEX drops - four drops to right ear two times a day. The patient started to experience a symptom of Bell's palsy (right sided facial drooping) on 07-Oct-2013. Patient was seen in office on 08-Oct-2013. Doctor started him on ZITHROMAX 250 mg-two tablet, the first day, then one tablet for four days, Prednisone 20 mg tablet two tablet for seven days, one and half tablet for two days, then one tablet for two days then half tablet for two days and then one fourth tablet for two days. At the time of reporting, the event of patient's right sided droop had not improved. The outcome of the event of right ear infection was unknown. The reporter considered the events of right ear infection and right sided facial droop to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 09-Oct-2013 from health professional: Event verbatim and coding for event of right sided facial droop/Bell's palsy was updated. Reporter's type patient was added. Reporter's and patient's details were updated. Concomitant drugs were added. Narrative was amended. Corrected report 20-Oct-2013: Manufacturer for suspect vaccine was added.
Sex: U
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning an Adult, subject of unknown gender, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 09-Oct-2013. It was reported that on 09-Oct-2013 patient over 49 years old received FLUMIST. FLUMIST quadrivalent (intranasal) was discontinued on 09-Oct-2013. The outcome of the event of patient over 49 years old received FLUMIST is unknown. The report was considered to be non-serious.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a 7 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. The health professional reported that she inadvertently gave FLUMIST quadrivalent to a person with asthma on 27-Nov-2013. No symptoms were reported at that time. The outcome of the event of administered FLUMIST quadrivalent to an asthmatic is unknown. The report was considered to be non-serious.
Age: 1.56
Sex: F
Vaccine: FLUN4
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 patient, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. The nurse reported that they inadvertently administered FLUMIST quadrivalent which started on 04-Oct-2013. The outcome of the event of we inadvertently administered FLUMIST quadrivalent is unknown. The report was considered to be non-serious.
Age: 30.0
Sex: F
Vaccine: FLUN4
Symptoms: Influenza A virus test positive
Clinical narrative: A report has been received from a Health Professional concerning a 30 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. The patient experienced positive influenza A. The patient recovered from the event of tested positive for influenza A on an unspecified date. The report was considered to be non-serious.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date, unspecified number of patients were vaccinated with ROTATEQ (lot # unspecified) (dose, frequency and route were not reported) which were exposed to -1.5C for 48 hours. Each excursion lasted for 12 hours and occurred on November 8, 9, 10 and 16. ROTATEQ supported. No adverse effects were reported. No concomitant medications were reported. Follow up information as received from the pharmacist refers to an unspecified number of patients were vaccinated with ROTATEQ (lot# unspecified) (dose, frequency and route were not reported) which were exposed to temperature range:-0.7C Time frame: 15 minutes Temperature Range:-0.5C Time frame: 15 minutes. No adverse effects were reported. No concomitant medications were reported. No adverse events or Product quality issue (PQC) were reported. This case is linked to case # 1401USA000286, 1401USA000288, 1312USA011848, 1402USA010746 and 1402USA010747 (same reporter link). Additional information is not expected.
Age: 36.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Pharmacist concerning, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 28-Sep-2013. It was reported that consumer was administered FLUMIST to a pregnant female two to three weeks ago who was 28 to 30 weeks pregnant. Patient was 7 and half month pregnant. The outcome of the event of Administered FLUMIST to a pregnant female is unknown. The consumer was in third trimester and pregnancy result was unknown. The report was considered to be non-serious by the reporter. Follow-up of insignificant to be non-serious by the reporter. Follow-up of insignificant information received by MedImmune 02-Nov-2013 from pharmacist: drug start date added.
Age: 10.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Pharmacist concerning a 10 year old, Male subject, who had been receiving FLUMIST, (intranasal). FLUMIST started on 29-Nov-2013. The patient experienced expired FLUMIST which started on 29-Nov-2013. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious by the reporter.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date, unspecified number of patients were vaccinated with VAQTA (lot# unspecified) (dose, frequency and route were not reported) which were exposed to temperature range:-0.7C Time frame: 15 minutes Temperature Range:-0.5C Time frame: 15 minutes. No adverse effects were reported. No concomitant medications were reported. No adverse events or Product quality issue (PQC) were reported. This case is linked to case # 1401USA000286, 1401USA000288, 1402USA010744, 1402USA010745, 1402USA010746 and 1312USA011848 (same reporter link). Additional information is not expected.
Age: 1.84
Sex: M
Vaccine: DTAP, FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 1 year old, Male subject, Height: 34.0 IN; Weight: 26.0 LB, who had been receiving FLUMIST quadrivalent (intranasal). Concomitant medications included DTaP and paracetamol. Concomitant disease(s) included acute gastroenteritis. FLUMIST quadrivalent (intranasal) started on 06-Oct-2013. It was reported that consumer was inadvertently gave FLUMIST quadrivalent to a 22 month old child, that is FLUMIST was given to a before recommended age on 06-Oct-2013. FLUMIST quadrivalent (intranasal) was discontinued on 06-Oct-2013. The outcome of the event of inadvertently gave FLUMIST quadrivalent to a 22 month old child/FLUMIST given before recommended age is unknown. The report was considered to be non-serious.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: A spontaneous report has been received from a Physician concerning a 3 year old, male patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. The patient was administered nasal FLUMIST Quadrivalent on 26-Nov-2013 and experienced urticaria reaction in about twelve hours on 26-Nov-2013. Outcome of the reported event was unknown. The reporter considered the event to be non-serious by reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unkonwn age and gender. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date, unspecified number of patients were vaccinated with ZOSTAVAX (lot# unspecified) (dose, temperature ranging from -9C to -4.7C was reached and was supported by defrost cycle information. No adverse effects were reported. No concomitant medications were reported. This case is linked to case # 1401USA000286, 1401USA000288, 1402USA010744, 1402USA010745, 1312USA011848 and 1402USA010747 (same reporter link). Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: FLUN4
Symptoms: Incorrect dose administered
Clinical narrative: A report has been received from a Pharmacist concerning a 12 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The pharmacist reported that two doses of FLUMIST QUADRIVALENT were given inadvertently to a patient one week apart which started on 09-Oct-2013. The outcome of the event of two doses of FLUMIST QUADRIVALENT were given inadvertently to a patient one week apart is unknown. The report was considered to be non-serious.
Age: 29.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Erythema, Local swelling, Skin warm, Tenderness
Clinical narrative: Patient states after shot given at 11:30 am, at about 1:00 pm (L) arm became red and swollen. At 4:00 pm warm and sensitive to touch. No pain or itching noted as stated by patient. 2-20-14 seen at PCP for job physical and was advised to take BENADRYL. Patient states followed instruction given after shots and added BENADRYL advised by PCP. (Cold pack, MOTRIN, BENADRYL). Patient presented 2-21-14 for skin test reading and (L) arm observed with redness, swollen and warm to touch today. Patient states continue to take BENADRYL and MOTRIN and Dr. is prescribing an antibiotic to take. Patient advised to contact clinic if any other problem and contact PCP.
Age: 14.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 14 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 02-Dec-2013. The patient experienced administration of expired product which started on 02-Dec-2013. The outcome of the event of administration of expired product is unknown. The report was considered to be non-serious by the reporter.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Erythema, Hypoaesthesia, Joint swelling, Pain, Paraesthesia
Clinical narrative: A report has been received from a Health Professional concerning a 9 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST started on an unknown date. The patient experienced numbness in feet, tingling in hands and feet, swelling at joints, blurred vision, left knee swollen, numbness in hands, left knee red and hard to bend and shooting pain which started on 08-Oct-2013. The outcome of the event of numbness in feet, tingling in hands and feet, swelling at joints, blurred vision, left knee swollen, numbness in hands, left knee red and hard to bend and shooting pain is unknown. The report was considered to be non-serious.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Vision blurred
Clinical narrative: A report has been received from a Health Professional concerning a 9 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST started on an unknown date. The patient experienced numbness in feet, tingling in hands and feet, swelling at joints, blurred vision, left knee swollen, numbness in hands, left knee red and hard to bend and shooting pain which started on 08-Oct-2013. The outcome of the event of numbness in feet, tingling in hands and feet, swelling at joints, blurred vision, left knee swollen, numbness in hands, left knee red and hard to bend and shooting pain is unknown. The report was considered to be non-serious.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Headache, Laziness, Pyrexia, Somnolence
Clinical narrative: A report has been received from a Health Professional concerning an 8 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 01-Oct-2013. The patient experienced Fever, Acting sleepy, Lazy and Headache which started on 01-Oct-2013. The patient recovered from the event of Fever, Acting sleepy, Lazy and Headache on 04-Oct-2013. The report was considered to be non-serious. Summary of follow-up information received by MedImmune on 24-Oct-2013 from Health Professional: New reporter added. Details of the reporter administered by updated. County where administered updated. Lot number and expiration date of the suspect drug added. Corrected Report 15-Nov-2013: Stop date of all the events added.
Age: 62.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a 62 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT. FLUMIST QUARDIVALENT started on 10-Oct-2013. A nurse reported that on 10-Oct-2013, they inadvertently gave FLUMIST to a 62 year old. The patient had not reported any symptoms at the time of reporting. The outcome of the event of INADVERTENTLY GAVE FLUMIST TO A 62 YEAR OLD is unknown. The report was considered to be non-serious.
Age: 43.0
Sex: M
Vaccine: FLUN4
Symptoms: Headache
Clinical narrative: A report has been received from a Pharmacist concerning a 43 year old, male subject, who had been receiving FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started during Aug-2013. The patient experienced severe headache. At the time of reporting, the event of severe headache was ongoing. The report was considered to be non-serious.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a 7 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 04-Dec-2013. Registered Nurse reported that the patient received expired FLUMIST on 04-Dec-2013 and not reported any symptoms. The outcome of the event of patient received expired FLUMIST is unknown. The report was considered to be non-serious.
Age: 13.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 13 year old, male subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 04-Dec-2013. It was reported that the patient received expired FLUMIST on 04-Dec-2013. Not reported any symptoms. The outcome of the event of administration of expired dose is unknown. The report was considered to be non-serious.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: A report has been received from a physician via a medical assistant, concerning a 6 year old female patient. No relevant history, concomitant disease or concomitant medications of the patient were reported. Patient was a healthy child, no medical issues. The patient had received nasal FLUMIST quadrivalent, on 28-Sep-2013. It was reported that the patient contracted the flu on 19-Nov-2013 after being vaccinated with FLUMIST this season. Patient was treated with TAMIFLU. The outcome of the event of flu diagnosis after vaccination with FLUMIST was unknown. The reporter assessed the event to be non-serious.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Exposure via direct contact
Clinical narrative: A report has been received from a Health Professional concerning a 2 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 05-Dec-2013. The nurse reported that patient had gotten some FLUMIST in their eye which started on 05-Dec-2013. The outcome of the event of administration into eye is unknown. The report was considered to be non-serious.
Age: 2.0
Sex: F
Vaccine: FLUN4
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 FLUMIST quadrivalent (intranasal). FLUMSIT quadrivalent (intranasal) started on 04-Dec-2013. It was reported that four patients were inadvertently administered expired FLUMIST quadrivalent which started on 04-Dec-2013. The outcome of the event of inadvertently administered expired FLUMIST quadrivalent to four patients is unknown. The report was considered to be non-serious.
Age: 4.0
Sex: F
Vaccine: FLUN4
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 QUADRIVALENT (Intranasal). The patient's medical history included Constipation. The patient's concurrent disease(s) included Encopresis, Vesicoureteral reflux and Otitis media. Concomitant medications included Amoxicillin and Macrogol. FLUMIST QUADRIVALENT (Intranasal) started on 03-Dec-2013. The patient was inadvertently administered expired FLUMIST QUADRIVALENT on 03-Dec-2013. The outcome of the event of Inadvertently administered expired FLUMIST QUADRIVALENT to a patient is unknown. The report was considered to be non-serious.
Age: 17.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 17 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 04-Dec-2013. It was reported that four patients were inadvertently administered with expired FLUMIST QUADRIVALENT which started on 04-Dec-2013. The outcome of the event of inadvertently administered expired FLUMIST QUADRIVALENT to four patients is unknown. The report was considered to be non-serious.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning an 8 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 04-Dec-2013. It was reported that four patients were inadvertently administered expired FLUMIST quadrivalent which started on 04-Dec-2013. The outcome of the event of INADVERTENTLY ADMINISTERED EXPIRED FLUMIST QUADRIVLAENT is unknown. The report was considered to be non-serious.
Age: 32.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a pharmacist concerning a 32 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 29-Nov-2013. It was reported that two patient were administered expired FLUMIST on 29-Nov-2013. The outcome of the event of expired FLUMIST administered is unknown. The report was considered to be non-serious.
Age: 10.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 10 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 04-Dec-2013. The nurse reported that they accidentally administered expired FLUMIST which started on 04-Dec-2013. The outcome of the event of accidentally administered expired FLUMIST is unknown. The report was considered to be non-serious.
Age: 13.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a patient, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. Reporter reported that they inadvertently administered expired FLUMIST Quadrivalent to a patient. The outcome of the event of ADMINISTRATION OF EXPIRED DOSE is unknown. The report was considered to be non-serious.
Age: 34.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Pharmacist concerning a 34 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 29-Nov-2013. It was reported that two patients were administered expired FLUMIST QUADRIVALENT on 29-Nov-2013. The outcome of the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious.
Age: 11.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning an 11 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 29-Nov-2013. Reporter reported that they administered expired FLUMIST/one of my staff members accidentally administered expired FLUMIST which started on 29-Nov-2013. The outcome of the event of administered expired FLUMIST/one of my staff members accidentally administered expired FLUMIST is unknown. The report was considered to be non-serious.
Age: 16.0
Sex: M
Vaccine: FLUN4
Symptoms: Feeling abnormal, Herpes simplex serology negative, Nuclear magnetic resonance imaging brain normal, VIIth nerve paralysis, Varicella
Clinical narrative: A report had been received from a physician via medical representative. The report concerns a male patient. The patient's medical history and concomitant medications were not reported. The patient received treatment with nasal FLUMIST QUADRIVALENT on 24-Oct-2013. The patient had Bell's palsy. From 25-Oct-2013 he started feeling funny, but did not report to his mother till 26-Oct-2013. Patient was taken to the emergency room (ER) and had MRI of his brain with negative result. He was tested positive for varicella and negative for Herpes Simplex virus. At the ER they also suspected for Lyme's disease and the patient was given VALTREX and doxycycline. The doxycycline was discontinued after 6 days as they found that the patient did not have Lyme's disease. The patient was recovered from the events. The report was considered to be non-serious by reporter. Summary of follow-up information received by AstraZeneca/MedImmune 09-Dec-2013 from physician: patient's gender and birth date was reported, new non-serious event of varicella was reported, the patient recovered from the events, start date of the suspected product added, laboratory tests were performed and narrative updated.
Age: 16.0
Sex: M
Vaccine: FLUN4
Symptoms: Varicella virus test positive
Clinical narrative: A report had been received from a physician via medical representative. The report concerns a male patient. The patient's medical history and concomitant medications were not reported. The patient received treatment with nasal FLUMIST QUADRIVALENT on 24-Oct-2013. The patient had Bell's palsy. From 25-Oct-2013 he started feeling funny, but did not report to his mother till 26-Oct-2013. Patient was taken to the emergency room (ER) and had MRI of his brain with negative result. He was tested positive for varicella and negative for Herpes Simplex virus. At the ER they also suspected for Lyme's disease and the patient was given VALTREX and doxycycline. The doxycycline was discontinued after 6 days as they found that the patient did not have Lyme's disease. The patient was recovered from the events. The report was considered to be non-serious by reporter. Summary of follow-up information received by AstraZeneca/MedImmune 09-Dec-2013 from physician: patient's gender and birth date was reported, new non-serious event of varicella was reported, the patient recovered from the events, start date of the suspected product added, laboratory tests were performed and narrative updated.
Sex: U
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning, subject gender, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 02-Dec-2013. The patient was administered expired FLUMIST on 02-dec-2013. The outcome of the event of administered FLUMIST is unknown. The report was considered to be non-serious.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 3 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The reporter stated that patient inadvertently administered expired FLUMIST QUADRIVALENT to a patient which started on 06-Dec-2013. The outcome of the event of inadvertently administered expired FLUMIST QUADRIVALENT to a patient is unknown. The report was considered to be non-serious.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 6 year old, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 26-Nov-2013. It was reported that consumer was administered expired FLUMIST QUADRIVALENT which started on 26-Nov-2013. The outcome of the event of Expired FLUMIST QUADRIVALENT Administered is unknown. The report was considered to be non-serious.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Discomfort, Musculoskeletal pain, Pain
Clinical narrative: Ache up into shoulder for several weeks. Was extremely bothersome especially when using left arm for other activities - in snow shoveling/carrying groceries, etc. Pain/discomfort.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: A report has been received from a Health Professional concerning a 3 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 03-Aug-2013. The patient experienced diarrhea and fever 103 degrees which started on 17-Sep-2013. The outcome of the event of diarrhea and fever 103 degrees is unknown. The report was considered to be non-serious.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site papule
Clinical narrative: Scattered papules on bilat ant thighs, around presumptive sites of vax admin.
Age: 35.0
Sex: F
Vaccine: FLUN4
Symptoms: Incorrect dose administered
Clinical narrative: A report has been received from a Pharmacist concerning a 35 year old, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT 0.2 Milliliters (frequency not reported). FLUMIST QUADRIVALENT started on an unknown date. The pharmacist reported that entire dose went in one nostril of patient which started on 23-Sep-2013 and she did not feel anything go into each nostril. The outcome of the event of ENTIRE DOSE WENT IN ONE NOSTRIL and DIDN'T FEEL ANYTHING GO INTO EACH NOSTRIL is unknown. The report was considered to be non-serious.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: A report has been received from a Health Professional concerning a 2 year old, male subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. The reporter stated patient received FLUMIST on 28-sep-2013 and moved while the second half was being dispensed. T went all over his fence instead of his nose and was squirming. The outcome of the event of squirming, partial dose of FLUMIST and FLUMIST sprayed in face is unknown. The report ws considered to be non-serious.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising
Clinical narrative: Large bruise to the area around where shot was given.
Age: 31.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injected limb mobility decreased, Middle insomnia, Pain
Clinical narrative: Patient has been experiencing "excruciating pain" "waking up most nights in agony". Patient not able to fully use his left arm. Patient has been seen primary care physician and was prescribed prednisone and cephalexin.
Age: 56.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A consumer report has been received. The report concerns a 56 year old, female consumer, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 25-Sep-2013. It was reported that a 56 years old patient received FLUMIST QUADRIVALENT which started on 25-Sep-2013. FLUMIST QUADRIVALENT was discontinued on 25-Sep-2013. The outcome of the event of I received FLUMIST QUADRIVALENT and I am 56 years old is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A report has been received from a Pharmacist concerning a child, subject of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 16-Sep-2013. The patient received given full dose of FLUMIST into one nostril on 16-Sep-2013. The outcome of the event of given full dose of FLUMIST into one nostril is unknown. The report was considered to be non-serious.
Age: 74.0
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea, Headache, Swelling face, Vomiting
Clinical narrative: 2nd dose - swelling in face. 3rd dose - vomiting/diarrhea HA x 1 1/2d No issue after 1st dose. Did not take 4th dose.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Injection site on (R) deltoid was warm, with erythema.
Age: 23.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Dizziness, Vomiting
Clinical narrative: Patient stated he felt really dizzy and that it would happen in "spells" also stated that he vomited on the day he received the vaccines. He states he still feels dizzy today. (02-24-14).
Sex: F
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A report has been received from a pharmacist concerning an adult, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST(Intranasal) started on 16-Sep-2013. It was reported by the pharmacist that she and her children were administered with full dose of FLUMIST into one nostril which started on 16-Sep-2013. The outcome of the event of given full dose of FLUMIST into one nostril is unknown. The report was considered to be non-serious.
Age: 26.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A consumer report has been received. The report concerns a 26 year old, female consumer, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The reporter reported that she received FLUMIST QUADRIVALENT last week and found out she was pregnant last night which started on 22-Sep-2013. The outcome of the event of received FLUMIST QUADRIVALENT last week and found out she was pregnant last night is unknown. The report was considered to be non-serious.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Hyperhidrosis, Nausea, Pallor, Syncope
Clinical narrative: Fainting/mild syncope. Pale, sweaty and nausea - patient laid on table to help with the episode.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Onset of headache approximately 5 min after (2-21-14 approximately 4:00 pm) vaccination and still ongoing on (02/24/14). Patient is currently on Excedrin for HA.
Age: 45.0
Sex: M
Vaccine: FLUN4
Symptoms: Incorrect dose administered
Clinical narrative: A consumer report has been received. The concerns a 45 year old, Male consumer, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. The patient reported that the first half of dose dripped out of nose a little bit which started on 17-OCT-2013. The outcome of the first half of dose dripped out of nose a little bit is unknown. The report was considered to be non-serious.
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 6 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 02-Dec-2013. The Medical assistant reported that six patients received FLUMIST QUAD that expired on 25-Nov-2013 which started on 02-Dec-2013. Not reporting any symptoms. The outcome of the event of administration of expired product is unknown. The report was considered to be non-serious by reporter.
Age: 0.71
Sex: F
Vaccine: FLUN4
Symptoms: Sneezing
Clinical narrative: A report has been received from a physician concerning an 8 month old other, female subject, Height 57.5 inches; Weight: 82.0 pounds, who had been receiving FLUMIST (Intranasal), 0.5 mg/ml, once for flu. FLUMIST (Intranasal) started on 23-Sep-2013 for flu. The patient experienced sneezing/sneezes ten times after spray which started on 23-Sep-2013. FLUMIST (Intranasal) was discontinued on 23-Sep-2013. The outcome of the event of sneezing/sneezes ten times after spray is unknown. The report was considered to be non-serious.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 7 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 03-Dec-2013. The Health professional reported that she inadvertently given an expired dose of FLUMIST to the patient on 03-Dec-2013. The outcome of the event of inadvertently gave an expired dose of FLUMIST is unknown. The report was considered to be non-serious.
Age: 25.0
Sex: F
Vaccine: FLUN3
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Health Professional concerning a 25 years old female patient. The patient's medical history and concomitant medications were not reported. On 02-Oct-2012, the patient FLUMIST (Intranasal). The patient was pregnant at the time she received vaccine. Upon follow-up patient stated she had her baby girl delivered with weight: 6 pounds and 8 ounces, length: 20 inches and she was a healthy baby with no medication use or health issues. At the time of reporting the outcome of the event was unknown. The report was considered to be non-serious by company physician. Corrected report: Drug start and stop date, Event start date as 02-Oct-2012 added. Age at onset calculated. Summary of follow-up information received by AstraZeneca/MedImmune from registered nurse on 23-Oct-2012: Patient contact details added. Corrected report 19-Nov-2012: The event of administration to newly pregnant female has become a KUR term: therefore the case has been updated accordingly. Summary of follow-up information received by AstraZeneca/MedImmune 26-Jul-2013 from consumer: pregnancy and date, result added.
Age: 1.37
Sex: M
Vaccine: FLUX
Symptoms: Drug administered to patient of inappropriate age, Gastroenteritis, Vomiting
Clinical narrative: A solicited consumer report has been received via Abbvie. The report concerns a 1 year old male patient whose weight: 9.1 kilograms. Medical history, concurrent diseases and concomitant medications of the patient were not provided. During Oct-2013, intramuscular SYNAGIS was started for intra-atrial communication. Dosing and frequency were not provided. On 29-Oct-2013, the baby's father reported that after having administered the unknown influenza virus vaccine was administered. During Nov-2013, the patient experienced gastroenteritis and vomiting. The baby's father associated the vomiting more to the flu vaccine than to the SYNAGIS. In fact, the baby's mother had also administered the flu vaccine and also had suffered from vomiting. The paediatrician prescribed the baby oral fluids and he told that it was a gastroenteritis. The patient was treated with oral fluids. The patient recovered after few days from the event of gastroenteritis and vomiting. The outcome of the event of flu vaccine given outside the approved age was unknown. Lot number information was not provided. The events of gastroenteritis and vomiting were assessed as non-serious. The event of flu vaccine given outside of approved age was identified from the source document and considered to be non-serious by the company physician. The reporter considered that there was no causality between the events of gastroenteritis and vomiting and the suspected drug of SYNAGIS. The company physician considered that there was no causality between the events of gastroenteritis, vomiting and flu vaccine given outside of approved age and the suspected drug of flu vaccine (unknown). Corrected report 11-Dec-2013: Case was suppressed as non-valid.