chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUA3
Symptoms: Exposure via skin contact, Syringe issue
Clinical narrative: This non-serious initial spontaneous case, was received from other-non- health professional, concerns a patient of unspecified age and gender. This was a quality complaint report (number: 1025284). At the time of this report, it was not clear whether the dose was administered as the information currently reported was conflicting. On 16-Oct-2017, the patient was possibly administered with FLUAD (batch no. 179403, expiry date: Jun-2018, dose, route of administration and anatomical location: not reported). While administration, the fluid came out from the base of the hub of the needle (not where the needle was screwed in) which was explicitly coded as syringe leak. It was reported that, the leak was underside of the luer lock assembly. When the plunger was being pushed to administer the injection, the fluid came out and ran down the patient's arm. As per the reporter, the dose was not administered and there were no any signs of damage on the syringe. The reporter did not provide the seriousness assessment. Non-significant case correct received 18-Oct-2017 and 02-Dec-2017: number (1025284) was added. Amended narrative accordingly.
Sex: F
Vaccine: FLUX
Symptoms: Cutaneous symptom, Flushing
Clinical narrative: This initial non-serious spontaneous case was received a pharmacist on 20-Oct-2017, concerning an elderly female patient of unspecified age (reported as in 40's). On an unspecified date in 2015, the patient received influenza vaccine (dose, route of administration, anatomical location, batch number:173906 (as reported), expiry date, trade name, manufacturer: not reported). On the same day (within 24 hours), after vaccination, the patient had reactions such as flushing and non-specific skin symptoms. It was reported that the patient had recovered from the events within 24 hours.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Fatigue, Feeling abnormal, Influenza like illness, Malaise
Clinical narrative: This non-serious initial spontaneous case, was received on 19-Oct-2017 from other non-health professional and concerns a 65-year-old, adult, male patient. On an unspecified (reported as mid-December), the patient was administered with influenza virus vaccine polyvalent (dose, batch number, route of administration, anatomical location, expiry date, trade name and manufacture: not reported). On unspecified date, (reported as early January) after the administration of vaccine, the patient was sick and experienced chills, fatigue, fever and he felt bad for a few days. It was reported that, the patient self-diagnosed the flu and he was not 100 percent sure that it was flu. The outcome of the event was not reported.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: This non-serious initial spontaneous case, was received on 19-Oct-2017 from other non-health professional and concerns a 65-year-old, adult, male patient. On an unspecified (reported as mid-December), the patient was administered with influenza virus vaccine polyvalent (dose, batch number, route of administration, anatomical location, expiry date, trade name and manufacture: not reported). On unspecified date, (reported as early January) after the administration of vaccine, the patient was sick and experienced chills, fatigue, fever and he felt bad for a few days. It was reported that, the patient self-diagnosed the flu and he was not 100 percent sure that it was flu. The outcome of the event was not reported.
Age: 5.0
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This initial spontaneous case, was received from other-non health professional on 20-Oct-2017, concerns 5-year-old male patient. This was 01st out of 03 reports. On 18-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml, batch no: 179403, expiry date: Jun-2018, route of administration and anatomical location: not reported). On 18-Oct-2017, 5-year-old male patient was administered with FLUAD which was explicitly coded as inappropriate age at vaccine administration. The reporter assessed this report as non-serious.
Age: 32.0
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This initial spontaneous case, received on 20-Oct-2017, reported by other non-health professional and concerning a 32-year-old male patient. Patient's medical history and concomitant medications was not reported. On 18-Oct-2017, the patient received FLUAD (dose: 0.5 ml, route of administration, anatomical location, batch number: 179403, expiry date: Jun-2018). It was reported that 32-year-old male patient received FLUAD (explicitly coded as inappropriate age at vaccine administration). No other symptoms were experienced by the patient so far. Outcome of the event was not reported. The reporter assessed this case non-serious.
Age: 32.0
Sex: F
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This initial spontaneous case, was received from other non-health professional on 20-Oct-2017, concerns a 32-year-old, adult female patient. On 18-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml, batch no: 179403, expiry date: Jun-2018, route of administration and anatomical location: not reported). On 18-Oct-2017, 32-year-old, adult female patient was administered with FLUAD (explicitly considered as inappropriate age at vaccine administration). The reporter assessed this report as non-serious.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Pain in extremity
Clinical narrative: Starting the day after the vaccination, the patient developed a large bruise at the injection site, bigger than the size of a softball. The patient experience some soreness in the arm for a few days. The bruise was still sore when pressure was applied as of 1/8/18.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Hyperhidrosis, Hypoacusis, Nausea, Tremor, Vision blurred
Clinical narrative: Temporary hearing impairment, blurred vision, nausea, diaphoresis, shaking that was brought on within 30 seconds of immunization. Patient began to feel better within 2-3 minutes of sitting upright. Symptoms were fully resolved after 10 minutes. No treatment was administered.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Achy, swelling and tenderness at the site - No redness and no fever. Muscle aches and fatigue worsening and continue.
Age: 68.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This non-serious initial spontaneous case, was received from pharmacist on 13-Oct-2017, concerning a 68-year-old male patient. The patient's medical history included insomnia (on an unspecified date), arrhythmia (on an unspecified date) and HTN (hypertension, on an unspecified date). The patient's concomitant medications included amlodipine, tramadol, losartan/hydrochlorothiazide, temazepam and sotalol. On 11-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml, batch number: 179402, route of administration: intramuscular, anatomical location: left deltoid, expiry date: Jun-2018). On 12-Oct-2017, after 1 day of vaccination, the patient had dark redness, which was 3 inches in diameter and warmth around the injection site. No treatment was taken for the events. The patient was recovered from the events within 2 to 5 days. Follow up report received on 23-Oct-2017: The outcome of the event from not recovered to recovered within 2 to 5 days was updated. The narrative was amended accordingly.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient stated the only symptom she had was the night after having the injection was arm pain at the site. She took TYLENOL and it relieved the pain. Nothing else has been reported.
Sex: U
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This initial non-serious spontaneous case, was received on 26-Sep-2017, from pharmacist and concerning a patient of an unspecified gender and age (reported as below 65 years). The patient's medical history and concomitant medications were not reported. On 06-Sep-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: intramuscular, batch number (reported as 178502), expiry date, anatomical location not reported) which was characterized as inappropriate age at vaccination. As FLUAD was indicated in individuals 5 years of age and older. It was reported that the patient had no issues after vaccination. The outcome of the events was not reported. The reporter considered this case as non-serious.
Sex: U
Vaccine: FLUX
Symptoms: Dyspnoea
Clinical narrative: This initial non-serious spontaneous case, was received on 26-Sep-2017, reported by other health professional concerning a patient of unspecified age and gender. Patient's medical history was not reported. On an unspecified date in "fall 2009" (as reported), the patient received INN (dose: one dose (as reported), route of administration, batch number expiry date and indication: not reported). On unspecified date, after administration of INN, the patient developed shortness of breath, No further information was provided. The outcome of the event was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: This initial non-serious spontaneous case, was received on 25-Sep-2017, reported by other non-health professional concerning a female patient of unspecified age. Patient's medical history was not reported. On an unspecified date, the patient received INN Flu Vaccine (dose, route of administration, batch number, expiry date, trade name, manufacturer name: not reported). On an unspecified date, after administration of INN Flu Vaccine, it was reported that the consumer's sister (patient) and her son received an unspecified flu vaccine (as reported) that caused them to become sick. It was unknown when they had become sick. No furher elaboration regarding what sick meant was provided. The outcome of the event was not reported.
Age: 4.0
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This initial non-serious spontaneous case, was received on 05-Oct-2017, from other non-health professional (consumer), concerning a 04-year-old male child. The patient's concomitant medications and medical history was not provided. On an unspecified date, the patient was administered with FLUAD (dose, route of administration, anatomical location, batch number, expiry date: not reported). It was reported that FLUAD which should be administered for people above 65 years old, was given to a 4-year-old child (explicitly coded as inappropriate age at vaccine administration). The reporter considered this event as non-serious.
Age: 58.0
Sex: F
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This non-serious initial spontaneous case was received from Other Health Professional on 13-Sep-2017, concerns a 58-year-old adult female patient. The patient's current condition included: hypertension and hypothyroid, concomitant medication included: ROBAXIN and loratadine for unknown indication. On 13-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, lot number: 178501 (as reported), expiry date: April-2018, route of administration, anatomical location: not reported). It was reported that the FLUAD was administered to the patient under age 65 and no adverse effects were noted. The patient did not receive any treatment associated with event. The outcome of the event was not reported. The reporter assessed the event as non-serious.
Sex: U
Vaccine: FLUX
Symptoms: Product storage error
Clinical narrative: This initial non-serious spontaneous case, received from a pharmacist on 28-Aug-2017. Patient's medical history and concomitant medications were not reported. On 28-Aug-2017, the patient received FLUCELVAX QIV (batch number: 195123, expiry date: Mar-2018) (not sure whether the patient received FLUCELVAX or FLUAD, MF59, batch number: 2J2EC (as reported), expiry date: May-2018) (dose: 0.5 ml, route of administration and anatomical location was not reported). It was reported that FLUAD (Influenza Vaccine, Adjuvanted) is to be stored protected from light and refrigerated between 36 degrees F and 46 F (2 degrees C and 8 degrees C) as stated in the approved product label and must not be freeze. It was reported by the pharmacist that, the refrigerator reached 8F over the night and wanted to know, if they can still administer the vaccines (FLUCELVAX and FLUAD) characterized by incorrect product storage. The pharmacist thought that, the vaccine might have been administered to a single patient characterized by drug administration error, but does not want to provide the information because she was not sure. It was stated by the pharmacist that, even though the vaccines were subjected to a temperature of 8F for 12 hours (temperature excursion below recommended temperature), the vaccines were not frozen. The outcome of the events were not reported.
Sex: M
Vaccine: FLUA3
Symptoms: Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 18-Sep-2017, reported by other health professional. Patient's medical history was not reported. On an unspecified date, a patient received FLUAD (TIV) (batch number: 178623, expiry date: Apr-2018, dose, route of administration and anatomical location was not reported), which reached 1.4 C F (as reported) for about 6 hours (reported as first time excursion and vaccine was not frozen) (explicitly coded as drug administration error). Outcome of the events were not reported.
Sex: F
Vaccine: FLUA3
Symptoms: Abnormal behaviour, Depression, Feeling abnormal
Clinical narrative: This non-serious initial spontaneous case was received on 15-Sep-2017 from other health professional and concerns a female patient of unspecified age. On an unspecified date, the patient was administered with FLUAD (TIV) (dose, route of administration, anatomical location, batch number, expiry date was not reported). On an unspecified date, 2 days after administration of FLUAD, the patient was out of character and was with depression with out of sorts. The outcome of the events was not reported.
Age: 34.0
Sex: M
Vaccine: FLUA3
Symptoms: Asthenia, Drug administered to patient of inappropriate age, Fatigue, Wrong drug administered
Clinical narrative: This non-serious initial spontaneous case, was received on 12-Sep-2017, from pharmacist, concerning a 34-year-old male patient. The patient had no relevant medical history. The patient's concomitant medication included ADDERALL for an unknown indication. On 08-Sep-2017, the patient was administered with FLUAD TIV (dose: 0.5 ml, batch number: (reported as 178602), expiry date: Apr-2018, route of administration, anatomical location: not reported). It was reported that FLUAD TIV was administered to a 34-year-old patient (explicitly coded as inappropriate age at vaccine administration). Reporter stated that, the patient was administered FLUAD instead of FLUCELVAX (wrong vial of the product was selected). On an unspecified date, the patient experienced fatigue and mild weakness. The outcome of events was not reported. Follow up report received on 02-Nov-2017: It was reported that, wrong vial of the product was selected and that was administered. The event fatigue and mild weakness was added. The narrative was amended accordingly.
Age: 32.0
Sex: F
Vaccine: FLUA3
Symptoms: Adverse event, Drug administered to patient of inappropriate age, Exposure during pregnancy
Clinical narrative: This non-serious initial spontaneous case, was received on 30-Aug-2017 from a pharmacist, concernng a 32-year-old adult female pregnant patient. The patient's medical history, concomitant medications and the contraceptive use were not reported. On 11-Aug-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, batch number: 1785503 (as reported), expiry date: Apr-2018, route of administration: intramuscular, anatomical location: not reported), explicitly coded as Vaccine exposure during pregnancy. It was reported that the patient was 39 weeks pregnant at the time of this report. The reporter stated that, adverse event had been reported in pregnant woman and in foetus. The outcome of the event was not reported. The reporter assessed the event as non-serious.
Sex: M
Vaccine: FLUX
Symptoms: Underdose
Clinical narrative: This non-serious initial spontaneous case, was received from pharmacist on 07-SEP-2017, concerning a male patient of an unspecified age. On an unspecified date, the patient was administered with influenza vaccine (dose: batch number, manufacturer, trade name, route of administration, anatomical location: not reported). On an unspecified date, the patient reported that, he did not get the full dose of the vaccine because nurse administered the vaccine very fast, which looked that vaccine was not injected. The patient felt that, the vaccine came out of his arm and he did not feel his arm sore. At the time of this report, the outcome of the events was not reported.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left arm became swollen and red. Redness extended from her upper arm to several inches below her elbow.
Sex: F
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This initial spontaneous case received from a consumer on 22-Aug-2017, concerning a 48-year-old female patient. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient received FLUAD (TIV) (dose: 0.5ml, route of administration, anatomical location, batch number, expiry date: not reported). It was reported that, the FLUAD vaccine was given to 48-year-old female patient. The outcome of the event were not reported.
Sex: U
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This non-serious initial spontaneous case, was received on 27-Sep-2017 from other health professional, concerning a patient of unspecified gender. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with FLUAD (TIV) (dose, batch number, expiry date, route of administration, anatomical location: not reported), explicitly coded as inappropriate age at vaccine administration. The outcome of the events was not reported. The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Malaise
Clinical narrative: This initial non-serious spontaneous case, was received on 27-Sep-2017, reported by a pharmacist concerning an elderly, female patient of unspecified age. Patient's medical history was not reported. As reported, no vaccine was administered to any patient who had egg allergies. On an unspecified date (five years ago (as reported) from the time of this report), the patient received influenza virus vaccine polyvalent (dose, route of administration, anatomical site, batch number and expiry date: not reported). On an unspecified date (five years ago (as reported)), after administration of egg-derived flu vaccine, the patient did not feel well (as per the reporter, it was stomach ache). Outcome of the event was not reported. This report was considered as non-serious. Non-significant follow-up received on 10-Oct-2017: It was reported that, pharmacist does not have an idea about dose, route, anatomical site of suspect vaccine, whether patient experienced stomach pain after administration or any other events and outcome of the events as it was five was five ago. Significant case correction received 27-Sep-2017: "The patient did not feel well after taking an egg-derived Flu vaccine 5 years ago" was coded as 'feeling unwell' as a symptom for the event stomach ache. Amended narrative accordingly.
Age: 26.0
Sex: F
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This non-serious initial spontaneous case, was received on 29-Aug-2017 from a pharmacist, concerning a 26-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 28-Aug-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, batch number: 178601 (as reported), expiry date: Apr-2018, route of administration, anatomical location: not reported), explicitly coded as inappropriate age at vaccine administration. It was reported that, no adverse effects were noted. The outcome of the events was not reported. The reporter assessed the events as non-serious.
Age: 62.0
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This non-serious initial spontaneous case, was received from physician on 11-Oct-2017, concerning a 62-year-old male patient. The patient's medical history included BPH (benign prostatic hyperplasia), thalassemia minor and meningioma since an unspecified date. The patient's concomitant medications included finasteride, RAPAFLO, fish oil, Multi vitamin and glucosamine for an unknown indication. On 11-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, batch number: 178502 (as reported), expiry date: 30-Apr-2018, route of administration: intramuscular, anatomical location: deltoid). It was reported that, the patient received the vaccine under the age of 65-year-old, which was considered as inappropriate age at vaccine administration and no adverse event was experienced by the patient. The reporter assessed the events as non-serious.
Age: 40.0
Sex: F
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This initial spontaneous case, was received from other health professional (pharmacist) on 05-Oct-2017, concerning a 40-year-old, adult, female patient. The patient had no medical history. The patient's concomitant medications were not reported. On 05-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, batch number, expiry date, and anatomical location: not reported). The vaccine was administered to the patient under age of 65-year-old (explicitly coded as inappropriate age at vaccine administration). It was reported that, no adverse effects were experienced by the patient. The reporter assessed the events as non-serious. Follow-up received on 08-Nov-2017: Added patient's age (40-year-old). Narrative amended accordingly.
Age: 84.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Pain in extremity
Clinical narrative: This initial spontaneous case, was received from other non-health professional (consumer) on 30-Sep-2017, concerning an 84-year-old female patient. The patient's medical history and concomitant medications were not reported. On 25-Sep-2017, the patient was administered with INN Flu Vaccine (dose: 0.5 ml, batch number, manufacturer, trade name, route of administration, anatomical location and expiry date: not reported). On the same day, after vaccination, the patient experienced leg and lower back pain, which were lasted for 5 days. At the time of this report, the outcome of the event was recovered. The reporter assessed the event as non-serious. Significant case correction received with IRD 30-Sep-2017: The company causality was changed from unassessable to related. Listedness was corrected.
Sex: F
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This non-serious initial spontaneous case was received from a Pharmacist on 26-Sep-2017, concerning a female patient age less than 65 years (as reported). On 06-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, batch number (as reported 178502), anatomical location, expiry date: not reported). It was reported that FLUAD was indicated individuals 65 years of age and older. No issues were reported since administration. The outcome of the event was not reported. The reporter assessed the event as non-serious.
Age: 64.0
Sex: F
Vaccine: RAB
Symptoms: Candida infection, Diarrhoea, Pruritus, Rash generalised
Clinical narrative: 08/05/2017 seen in ED for cat bite obtained on 8/4/17. Bite to right middle finger and scratch to right palm and left fingers. Vaccine given 8/5/17 as well as ABX and tetanus (Tdap). Clindamycin PO QID x 1 week and rabies vaccine day 3, 7, 14 needed. 08/08/2017 - rabies shot (day 3). 08/12/2017 - rabies vaccine (day 7; rash under breast noted. DIFLUCAN PO x 1. 08/14/2017 - rash all over body x 2 days and diarrhea x 1 week.given DIFLUCAN for candidiasis; started having diffuse rash on Saturday, itching and intermittent diarrhea. 08/15/2017 rash is spreading since in ER on Saturday for injection. Pt reports needing more clobetasol. Pt seen in ER Saturday and yesterday for rash after receiving rabies vaccine. Final vaccination to be given on 8/19/17. Derm consulted.
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: Immunisation, No adverse event, Syringe issue, Underdose
Clinical narrative: This non-serious initial spontaneous case, was received from a pharmacist on 28-Sep-2017, concerning a 73-year-old, elderly, female patient. On 28-Sep-2017, the patient was administered with FLUAD (TIV) (batch number: 179002, expiry date: May-2018, dose: less than 0.5 ml (as reported), route of administration: intramuscular, anatomical location: deltoid). It was reported that, as the intern tried to screw the needle, to administer the vaccine after letting out the air and began to inject the vaccine, all leaked out from around the needle itself (explicitly coded to syringe issue). Partial dose of the flu vaccine was administered to the patient (explicitly coded to incomplete dose administered) and no adverse event was experienced by the patient after the administration of partial dose of the vaccine. However, the patient was re-vaccinated, as she was previously vaccinated with a partial dose of the flu vaccine. It was stated in the PTC (product technical complaint) report that, no damage was observed in package condition, stored in the original box until usage, the leakage was around the needle (25-gauge 1 inch, syringe type: Luer lock), however the needle was attached tightly. No signs of damage were seen. It was reported that, the defect occurred prior to administration. The outcome of the events was not reported. The reporter assessed the events as non-serious. Follow-up report received from the reporter on 04-Oct-2017 (PTC number: 1024854): PTC report received and updated. Amended narrative accordingly. Follow up report received on 05-Oct-2017: The route of administration (intramuscular), anatomical location (deltoid) of the vaccine were updated. It was reported that, no adverse event was experienced by the patient after the administration of partial dose of the vaccine. Non-significant follow up report received on 18-Oct-2017: Batch number (179002) was updated. Amended accordingly.
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This non-serious initial spontaneous case, was received from a Pharmacist on 26-Sep-2017, concerning a patient of unspecified gender with age less than 65 years (as reported). On 06-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, batch number (as reported 178502), anatomical location, expiry date: not reported). It was reported that FLUAD was indicated for patients 65 years and older (explicitly coded to inappropriate age at vaccine administration). No issues were reported since administration. The outcome of the event was not reported. The reporter assessed the event as non-serious.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Musculoskeletal stiffness
Clinical narrative: This initial spontaneous case, was received on 10-Oct-2017, by other non-health professional, concerning a 56-year-old female patient. The patient's historical drug included influenza vaccine. The patient's concomitant medications were not reported. On multiple seasons (including 2016), the patient received INN flu vaccine, (dose, route of administration, anatomical location, batch number, expiry date was not reported). It was reported that, over multiple seasons including Fall 2016, after vaccination, the patient had stiff arm routinely and often felt tired for a few days after getting the shot. It was reported that, the patient recovered from the events several days after vaccine administration. The reporter provided the causality of the events as related to the suspect vaccine. The reporter assessed the event as non-serious.
Sex: M
Vaccine: FLUX
Symptoms: Expired product administered
Clinical narrative: This initial non-serious spontaneous case was received on 04-Oct-2017, from a nurse, concerning a patient of unspecified age and gender. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). It was reported that the patient was injected with last year's flu shot. The nurse enquired the duration after which the patient can receive the next dose. The reporter was unable to assess the seriousness of the event.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial spontaneous case, was received on 02-Oct-2017, from a pharmacist, concerning a 70-year-old elderly female patient. The patient's current conditions included: CVA (cerebrovascular accident), memory changes, diabetes, hypertension, hypothyroidism, osteoarthritis, dementia and Urge Incontinence. Concomitant medications included: acetaminophen, albuterol sulfate nebulize solution, PROAIR inhaler, amlodipine, ASA, atorvastatin, citalopram, vitamin B 12, VOLTAREN Gel, donepezil, fexofenadine, fluticasone, levothyroxine, TRADJENTA, losartan, meclizine, NAMENDA, MYRBETRIQ, multivitamin, Vision Plus Lutein vitamin, ALEVE, Omeprazole, Promethazine with codeine, OCUVITE and vitamin B complex for unknown indications. On 02-Oct-2017, the patient was administered with the FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 178701, expiry date: Apr-2018). It was reported that the patient was administered with the PFS vaccine that was stored in 54 F up to 120 hours excursion time (explicitly coded as incorrect product storage and drug administration error). No adverse events were reported. The reporter assessed the event as non-serious. Non-significant case correction received 02-OCT-2017: The verbatim of the event drug administration error "Up to 120 hour excursion time, max temp reached of 54F. 2 doses administered" was corrected.
Sex: U
Vaccine: FLUA3
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This non-serious initial spontaneous case, was received from other health professional on 27-Sep-2017, concerning a patient of unspecified age and gender. On an unspecified date, the patient was administered with FLUAD (TIV) (batch number: 179002, expiry date: unspecified date in May 2018, dose, route of administration and anatomical location: not reported). It was reported that, syringe (Luer lock) was checked for bubbles, and was injected at the patient's arm which was cleansed with alcohol swab as the plunger was pushed into the arm. The vaccine was spewed out, while the needle was still in-patient arm (explicitly coded as incomplete dose administered). It was reported that, 1 syringe was used where only half of the dose was injected, during use of the vaccine, they found that the defect was in between connection of needle and syringe. The reporter stated that, the patient had not experienced any adverse event. It was reported that, no signs of damage were seen on the syringe and needle, and the needle appeared to be tightly attached. The leaking was seen in the connection between the needle and syringe. It was reported that, the needle 25 gauge/1 inch was used. It was reported that, they didn't try to administer the vaccine with another needle as the needle was already in the patient's arm. This report was associated with PTC reference Number: 1024790. At the time of this report, the outcome of the events was not reported. Follow-up received on 10-Oct-2017: The reporter stated that, the PTC (product technical complaint) was reported without an adverse event. Narrative amended accordingly. Non-significant follow-up received on 18-Oct-2017: Batch number was updated. Amended accordingly. Non-significant case correction received on 27-Sep-2017: The PTC reference Number: 1024790 was amended in narrative.
Age: 38.0
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This non-serious initial spontaneous case, was received from other health professional (nurse) on 27-Sep-2017, concerning a 38-year-old adult male patient. The patient's medical history and concomitant medications were not reported. On 20-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, batch number: 18703 (as reported), expiry date: Apr-2018, route of administration and anatomical location: not reported). The patient received the vaccine under 65 years of age, which was considered as inappropriate age at vaccine administration. It was reported that, no reactions were occurred after administration of vaccine. The reporter assessed the report as non-serious. Significant case correction received on 27-Sep-2017: The event was changed from no reactions to no AE (adverse event). The narrative was amended accordingly.
Age: 78.0
Sex: F
Vaccine: FLUA3
Symptoms: Needle issue, No adverse event, Syringe issue, Underdose
Clinical narrative: This non-serious initial spontaneous case, was received from a Pharmacist on 02-Oct-2017, concerning a 78-year-old female patient. The patient's medical history included: allergic to CIPRO. On 02-Oct-2017, the patient was administered with FLUAD (TIV) (dose: less than 0.5 ml, route of administration: Intramuscular, anatomical location: right deltoid, batch number: 179203, expiry date: Jun-2018) (explicitly coded to incomplete dose administered). It was reported that the vaccine squirted out from the orange part while trying to retract the needle like a faulty tip (explicitly coded to needle issue) but no adverse event was experienced by the patient. PTC (Product Technical complaint) report was received where the complaint refers to a syringe, which leaked during administration and resulted in a partial dose being administered. PTC Reference Number: 1024960 was initiated for leaking syringe during administration for FLUAD batch number: 179203. The defect was discovered during the use of the vaccine. Partial dose was administered. It was reported that the complaint sample was already was disposed. The orange button where pressed to retract the needle was the location of the leak and the needle appeared tightly attached. It was reported that, there were no signs of damage on the syringe. The reporter assessed the report as non-serious. PTC report was received on 02-Oct-2017 and updated the information. Non-significant follow-up received on 18-Oct-2017: Batch number was added in the screen. The narrative was amended accordingly.
Age: 9.0
Sex: F
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, Headache
Clinical narrative: This non-serious initial spontaneous case, was received on 21-Sep-2017 from other health professional (nurse) concerning a 09-year-old female child. The patient's medical history and concomitant medications were not reported. On 19-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, batch number: 179002 (as reported), expiry date: May 2018, anatomical location: not reported). FLUAD vaccine was administered to the patient of 9 years (age less than 65 years) (explicitly coded as inappropriate age at vaccine administration) and the patient experienced headache. At the time of the report, the outcome of the event was not reported. The reporter assessed the event as non-serious. Follow up report received on 28-Sep-2017: The new event (headache) was coded and route of administration of the vaccine (intramuscular) were updated. It was reported that, the patient experienced headache after the vaccination. The narrative was amended accordingly.
Age: 37.0
Sex: M
Vaccine: FLUX
Symptoms: Reaction to excipient, Vaccination site bruising, Vaccination site discolouration
Clinical narrative: The initial spontaneous case, received on 12-Oct-2017 reported by other health professional (nurse), concerning a 37-year-old, adult, male patient. On an unspecified date, the patient was administered with influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported. On the same day after vaccination at night, the patient experienced extensive bruising which seemed to be blue and black colored whole upper arm where vaccine was administered. The patient stated that, bruise had not caused any hurt and there were no other systemic reactions were reported by the patient. The outcome of the event was not reported. The reporter assessed this case as non-serious. Significant case correction received 12-OCT-2017: Event 'reaction to drug excipient' was added. Reporter Causality was changed from not reported to related.
Sex: F
Vaccine: FLUX
Symptoms: Dry skin, Rash
Clinical narrative: This spontaneous case, was received from other non-health professional on 27-Sep-2017, concerning a female patient of an unspecified age. It was stated that, the patient stayed away from the flu shots for the last 3 years. In the first 2 years, the patient could sustain herself, but in the last year she caught the flu which was bad so, the patient went to pharmacy, and the pharmacist gave her the NDC for the vaccine. On an unspecified date, the patient was administered with INN Flu Vaccine (route of administration, anatomical location, dose, trade name, batch number, manufacturer: not reported). On an unspecified date, after receiving the vaccine, the patient experienced severe breakouts. It was reported that, the patient wanted to vaccinate her with the FLUCELVAX, as it protected her from the flu, but still the patient did not know if she was going to take the vaccine. It was reported that, the patient did not experience any breakouts whenever she was not vaccinated with the flu shot. Outcome of the event was not reported. The reporter assessed the report as non-serious. Significant correction received with IRD 27-Sep-2017: The event coding was updated from no adverse event NOS to dry skin aggravated, prior history was checked yes, the reporter causality was updated from not reported to related and the company causality was updated from not related to related.
Age: 72.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 02-Oct-2017, from a pharmacist, concerning a of 72-year-old elderly male patient. The patient's current conditions included diabetes, HTN (hypertension), ulcerative colitis, osteoarthritis from unspecified dates and the concomitant medications taken were PROAIR, amlodipine, ASA, Calcium w/Vitamin D, Clonidine, FLONASE, Glipizide, Glucosamine, LEVEMIR, HUMALOG, Metformin ER, Multi vitamin, BENECAR HCT, Sulfafalazine, Triamterene HCTZ for unknown indications. On 02-Oct-2017, the patient was administered with the FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 178701, expiry date: Apr-2018). It was reported that the patient was administered with the PFS vaccine that was stored in 54 F up to 120 hours excursion time. No adverse events were reported. The reporter assessed the event as non-serious. Non-significant case correction received with IRD on 02-Oct-2017: corrected verbatim of the event drug administration error from 2 doses administered/2 vaccines administered to up to 120 hour excursion time, max temp reached of 54F. 2 doses administered/2 vaccines administered.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Abdominal pain upper, Feeling of body temperature change, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous case, received from pharmacist on 03-Oct-2017, concerning a 70-year-old elderly female patient. It was reported that, the patient was allergic to latex since an unspecified date. On 29-Sep-2017, the patient was vaccinated with FLUAD (dose: 0.5ml, route of administration: intramuscular, anatomical location: left deltoid, lot no: 178323 (as reported) and expiry date: April 2018). On 30-Sep-2017, 1 day after vaccination, the patient felt hot and cold, her stomach was upset and swelling was seen below the shot. It looked like someone grabbed her under the shot (injection area). It was reported that, the patient experienced soreness at injection area. The subject was treated with BENADRYL (12.5mg), one single dose. At the time of this report, the patient had not yet recovered from events. The reporter assessed the reports as non-serious. Follow-up received on 16-Oct-2017: Event onset date were updated to 30-Sep-2017 from 29-Sep-2017 and narrative was amended accordingly. Non significant case correction done 03-Oct-2017: Reported events verbatims were corrected.
Age: 12.0
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, Injection site pain
Clinical narrative: This initial spontaneous case, was received on 21-Sep-2017, from a nurse, concerning a 12-year-old male adolescent patient. The patient's medical history and concomitant medications were not reported. On 19-Sep-2017, the patient was administered with FLUAD (dose: 0.5 ml, batch number: 179002 (as reported), expiry date: May-2018, route of administration: intramuscular, anatomical location: not reported). On the same day, FLUAD was administered to the patient of 12 years age (aged less than 65 years) (explicitly coded as inappropriate age at vaccine administration) and had sore at the site of injection. The treatment measures were not reported. At the time of the report, the outcome of the event injection site pain was recovered on the same day and for the event inappropriate age at vaccine administration was not reported. The reporter assessed the event as non-serious. Follow-up report received on 28-Sep-2017: Event pain at injection site was added. Route of administration was updated as intramuscular. Amended narrative accordingly. Follow up report received on 13-Oct-2017: The outcome of the event injection site pain was changed from not reported to recovered. The start date was updated for the event injection site pain. The narrative was amended accordingly. Non-significant case correction received on 13-Oct-2017: Narrative changes were amended.
Age: 75.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product quality issue, Syringe issue, Underdose
Clinical narrative: This non-serious initial spontaneous case, was received from a Pharmacist on 06-Oct-2017, concerning a 75-year-old male patient. This was a quality complaint report (PTC number: 1025081). On 06-Oct-2017, the patient was administered FLUAD (TIV) (dose: less than 0.5 ml, batch number: 178302A, expiry date: Apr-2018, route of administration, anatomical location: not reported) (explicitly coded to Incomplete dose administered). It was reported that the patient received partial dose due to leakage of syringe (explicitly coded to drug administration error and syringe issue). It was reported that, no adverse event was experienced by the patient. It was reported that the dose leaked out of the syringe of 25-gauge 1 inch during the use. Hence partial dose was administered. The location of the leak was needle/syringe connector with no signs of damage on the syringe. E-Z pointe needle, retractable needle technology was used. The reporter assessed the report as non-serious. Follow up report received on 16-Oct-2017: It was reported that, no adverse event was experienced by the patient. Non-significant follow up report received on 18-Oct-2017: Added batch number in the screen. The narrative was amended accordingly. Non-significant case correction received with IRD 07-Oct-2017 CRD 02-Dec-2017: PTC number (1025081) was added. Amended narrative accordingly.
Age: 76.0
Sex: F
Vaccine: FLUA3
Symptoms: Gait disturbance, Myalgia, Pain
Clinical narrative: This initial spontaneous case, was received on 13-Oct-2017 from pharmacist, concerning a 76-year-old, elderly, female patient. The patient's current conditions included UTI (urinary tract infection) infection (since an unspecified date) and fibromyalgia (on an unspecified date). The patient's concomitant medications included Divalproex, levothyroxine, hydrochlorothiazide, pravastatin, ropinirole, duloxetine, enalapril, uvathim, pantoprazole and cephalexin (for UTI infection). On 12-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml, anatomical location: right deltoid, batch number: (reported as 179203), expiry date: on an unspecified date in Jun-2018, route of administration: intramuscular). On the same day, after 2 hours of vaccination, the patient experienced total body pains and at the night she had crawl to go to washroom. It was reported that the events were persistent until the next day. The patient had not experienced rash but she had systemic and massive muscle pain. It was reported that, the patient had not taken any treatment medication besides her normal medicine routine. The outcome of the event reported as recovered. The reporter assessed this case as non-serious. Follow up report received on 24-Oct-2017: The fibromyalgia was updated from historical condition to current condition. The route of administration (intramuscular) was added. The outcome of the event was updated from not recovered to recovered. It was reported that, the patient had not taken any treatment medication besides her normal medicine routine. The narrative was amended accordingly.
Age: 67.0
Sex: M
Vaccine: FLUA3
Symptoms: Blood glucose increased, Condition aggravated
Clinical narrative: This initial spontaneous case, was received from other health professional on 18-Oct-2017, concerning a 67-year-old, elderly, male patient. The patient's historical condition included cholesterol and gout (unspecified dates). The patient's current condition included diabetes (since an unspecified date), high blood pressure (since an unspecified date). The patient's concomitant medications included JANUVIA, BENICAR HCT, glimepiride, metformin, simvastatin and allopurinol for unknown indications. On 28-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 178302A, expiry date: not reported). On 29-Sep-2017, next day after vaccination, the patient's blood sugar level had raised up to 200 mg/dl. The patient's blood sugar level had raised up to 300 mg/dl for about next 3 weeks. The patient was treated with extra tablets of glimepiride for several days. It was reported that, the patient's regular range of blood level would be between 120 mg/dl and 160 mg/dl, but after vaccination the values were quite high than 320 mg/dl. On an unspecified date, the patient's blood sugar reduced to 200 mg/dl (not normal) and he had not experienced this condition before vaccination. The patient had not recovered from the event. The reporter assessed this case as non-serious. Follow-up received on 03-Nov-2017: Gout was changed from current condition to historical condition. The start date was confirmed as 29-Sep-2017. It was reported that the blood sugar was not yet under control. Narrative amended accordingly.