chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: U
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 73-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD TIV vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 15-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805484 was crossed linked to original case 201804863 due to same reporter.
Age: 76.0
Sex: U
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 76-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 23-Oct-2018, the patient was administered FLUAD (TIV), [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805418 was crossed linked to original case 201804863 due to same reporter.
Age: 84.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 84-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 23-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250802, expiry date: 30-Jun-2019 and dose: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805415 was crossed linked to original cases 201804863 due to same reporter.
Age: 74.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 74-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 10-Oct-2018, the patient was administered FLUAD (TIV) which underwent temperature excursion [route of administration: intramuscular, anatomical location: left deltoid, batch: 250802, expiry date: 30-Jun-2019 and dose: not reported] (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805508 was crossed linked to original case 201804863 due to same reporter.
Age: 67.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 67-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree celsius (explicitly coded as incorrect product storage). On 12-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apt-2019 and dose: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805489 was crossed linked to original cases 201804863 due to same reporter.
Age: 54.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 54-year-old, adult patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 10-Oct-2018, the patient was administered FLUAD (TIV) which underwent temperature excursion [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250802, expiry date: 30-Jun-2019 and dose: not reported] which underwent temperature excursion. The reported batch number (250802), dose not match FLUCELVAX QIV batch numbers, however, the batch number was mapped to FLUAD (TIV). Hence, the suspect vaccine was coded as FLUAD (TIV). At the time of this report, no adverse event was reported. This case 201805504 was crossed linked to original case 201804863 due to same reporter.
Age: 83.0
Sex: U
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns an 83-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 11-Oct-2018, the patient was administered FLUAD (TIV), [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805494 was crossed linked to original case 201804863 due to same reporter.
Age: 67.0
Sex: U
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 67-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD TIV vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 23-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250802, expiry date: 30-Jun-2019 and dose: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805409 was crossed linked to original case 201804863 due to same reporter.
Age: 71.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 71-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD TIV vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 23-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: right deltoid, batch number: 250802, expiry date: 30-Jun-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805414 was crossed linked to original case 201804863 due to same reporter.
Age: 77.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 77-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 22-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250802, expiry date: 30-Jun-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805425 was crossed linked to original cases 201804863 due to same reporter.
Age: 71.0
Sex: U
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 71-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 11-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805498 was crossed linked to original cases 201804863 due to same reporter.
Age: 69.0
Sex: U
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 69-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD TIV vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 23-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250802, expiry date: 30-Jun-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805417 was crossed linked to original case 201804863 due to same reporter.
Age: 75.0
Sex: U
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 75-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD TIV vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 11-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805499 was crossed linked to original case 201804863 due to same reporter.
Age: 71.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 71-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 23-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805423 was crossed linked to original cases 201804863 due to same reporter.
Age: 68.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 68-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 22-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805431 was crossed linked to original cases 201804863 due to same reporter.
Age: 75.0
Sex: U
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 75-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD TIV vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 10-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250802, expiry date: 30-Jun-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805507 was crossed linked to original case 201804863 due to same reporter.
Age: 59.0
Sex: F
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from a pharmacist on 08-Nov-2018, concerns a 59-year-old, adult female patient. The patient had no historical conditions and did not received any concomitant medications. On 08-Nov-2018, the patient (under age of 65 years) was administered FLUAD TIV [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250783 and expiry date: 30-Apr-2019]. At the time of this report, no adverse events were reported after vaccine administration. The reporter assessed this case as non-serious.
Age: 68.0
Sex: U
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 68-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD TIV vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 23-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805413 was crossed linked to original case 201804863 due to same reporter.
Age: 71.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 71-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 22-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: right deltoid, batch number: 250802, expiry date: 30-Jun-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805434 was crossed linked to original case 201804863 due to same reporter.
Age: 75.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 75-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 12-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: right deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805485 was crossed linked to original cases 201804863 due to same reporter.
Age: 70.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 70-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 12-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805490 was crossed linked to original case 201804863 due to same reporter.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Loss of personal independence in daily activities, Musculoskeletal disorder, Musculoskeletal pain, Pain in extremity
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) on 07-Nov-2018, concerns a 75-year-old, elderly female patient. On 16-Oct-2018, the patient was administered FLUAD TIV [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported]. On the same day within 15 minutes after vaccination, the patient stated that she had a reaction to the vaccine. The patient experienced a lot of pain in left arm, upper shoulder and biceps. It was reported that, in the first week of vaccination, her arm hurt so badly that she could not even lift anything and could not even put on her watch. The patient tried to take TYLENOL and MOTRIN but nothing helped it. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 77.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 77-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 23-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250802, expiry date: 30-Jun-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805416 was crossed linked to original cases 201804863 due to same reporter.
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Syringe issue
Clinical narrative: This spontaneous case, initially received from pharmacist (reporting on himself) on 01-Nov-2018, concerns a male patient of unspecified age. On 01-Nov-2018, during administration of FLUAD (TIV) (batch number: 250783), when the needle was put into the luer locking device which was secure, luer locking device on the barrel back sprayed on the reporter and the medicine was sprayed out. The needle on the luer lock and the luer piece came off. It was not a bad luer lock, but it just popped off the luer lock. The syringe was damaged near the luer lock. There were no signs of leakage. No adverse events were reported. This case: 201805410 is cross-linked to the case: 201805151 due to the same reporter. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding product technical complaint (PTC) reference number was 1034866. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous case, initially received from healthcare professional (physician) on 06-Nov-2018, concerns a female patient of unspecified age. The patient's medical history, allergies and concomitant medications were unknown to the reporter. On 30-Oct-2018, the patient was administered influenza vaccine, (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). The co-suspect included: PNEUMOVAX 23 [route of administration: unknown, anatomical location: arm, dose, batch number, and expiry date: not reported]. On an unspecified date, the patient developed redness and swelling from injection site to elbow in arm, where PNEUMOVAX 23 injection was administered. The reporter was unaware of whether the patient had performed any lab investigations and received any treatment. At the time of the report, the patient had not recovered from the events.
Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: Reached 11.6C/1st time excursion/vaccine was out for around 48 hours [Product storage error] Reached 11.6C/1st time excursion/vaccines were administered [Product storage error]  This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 76-year-old, elderly patient of an unspecified gender.   It was reported that, the Fluad (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage).   On 12-Oct-2018, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion (explicitly coded as drug administration error) for an unknown indication.  At the time of this report, no adverse event was reported.   This case 201805491 was crossed linked to original cases 201804863 due to same reporter.
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Chest pain
Clinical narrative: This spontaneous case, initially received from other health professional (pharmacist) on 07-Nov-2018, concerns a 74-year-old, elderly, female patient. On 22-Oct-2018, at 12 pm, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250806 and expiry date: 30-Jun-2019]. On the same day, few hours after vaccination, by 6 pm, the patient reported to the pharmacy with the symptom chest pain. At the time of the report, the outcome of the event was not reported. This reporter considered the case as non-serious.
Age: 69.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 69-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius (explicitly coded as incorrect product storage). On 12-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location, left deltoid, batch number: 250802, expiry date: 30-Jun-2019 and dose: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805492 was crossed linked to original cases 201804863 due to same reporter.
Age: 70.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 70-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius. On 11-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805496 was crossed linked to original cases 201804863 due to same reporter.
Age: 74.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 74-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 10-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250802, expiry date: 30-Jun-2019 and dose: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805506 was crossed linked to original cases 201804863 due to same reporter.
Age: 63.0
Sex: F
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 63-year-old, adult female patient. The patient had no medical history and had not received any concomitant medications. On 28-Sep-2018, the patient (under age of 65 years) was administered FLUAD TIV [dose: 0.5 ml, route of administration: intramuscular, batch number: 250798, expiry date: 31-May-2019 and anatomical location: not reported] (explicitly coded as inappropriate age at vaccine administration). The patient had no adverse reactions after administration of the vaccine. The reporter assessed this case as non-serious.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous case, initially received from other non-health professional on 23-Oct-2018, concerns a 66-year-old, elderly female patient. The patient's current condition included low thyroid levels. The concomitant medication included SYNTHROID for an unknown indication. On 03-Oct-2018, the patient was administered FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250979 and expiry date: 31-May-2019). On the same day, after vaccination, the patient experienced soreness in her arms for more than 24 hours. The patient could not lift her arm to shoulder height. It was reported that 3 weeks after vaccination, the arm was still sore. It was not excruciating but was uncomfortable to sleep and difficult to get the right position to sleep. The patient used hot packing at night and TYLENOL and ibuprofen alternated as a treatment which helped her a little but didn't resolve completely (recovering). The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional via Merck on 23-Oct-2018, concerns an elderly female patient of an unspecified age. On an unspecified date, the patient was administered Influenza vaccine (dose, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported). On an unspecified date, after vaccination, the patient complained of sore arm. At the time of this report, the patient had not recovered from the event (reported as still sore). This case: 201804840 was cross-linked to the case: 201804841 (same reporter).
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Headache, Lymphadenopathy, Pain in extremity
Clinical narrative: This is a spontaneous case, initially received from other non-health professional on 18-Oct-2018, concerning a 65-year-old, elderly female patient. The patient received an unspecified flu vaccine and had not experienced any adverse reactions in the past. On 16-Oct-2018, the patient was administered FLUAD TIV [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 250794 and expiry date: 30-Apr-2019]. On the same day after vaccination, the patient experienced extreme soreness in her arm. After 1 hour or several hours, the arm soreness diminished. On 17-Oct-2018 (reported as following day), the patient experienced headache which lasted for 12 hours. The patient also noticed a swollen lymph node under her right arm. On an unspecified date in Oct-2018, the patient experienced pain from the bottom to the top of her head. It was reported that the patient had scheduled a medical appointment on an unspecified date. It was the first time that the patient received FLUAD, but she used to receive flu vaccines before and that was the first time the patient had a reaction after receiving the flu shot. The outcome of the event headache was recovered on an unspecified date in Oct-2018. The outcome of the event arm soreness was recovering and the outcome of other events general body pain and swollen lymph nodes was not reported. The reporter assessed this case as non-serious and the events related to the suspect vaccine.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Lower respiratory tract infection, Nasopharyngitis
Clinical narrative: This spontaneous case, initially received on 23-Oct-2018 reported by other non-health professional and concerns a 37-year-old, adult female patient. The patient's current condition included multiple sclerosis (MS as reported) (since an unspecified date). On unspecified date in Feb-2018, the patient was administered non-company suspect product GILENYA (dose: 0.5 mg, frequency: once daily and route of administration: oral). On an unspecified date in 2018 (reported as last week), the patient was administered Influenza vaccine [dose, route of administration, anatomical location, batch number, expiry date, manufacturer and trade name: not reported]. It was reported that, since vaccination, the patient experienced cold. On an unspecified date in 2018, the cold was moved in to the chest. At the time of this report, the patient had not recovered from cold and the outcome of the event (chest cold) was not reported. The reporter assessed this case as non-serious.
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This non-serious, spontaneous case, initially received on 20-Oct-2018, reported by a pharmacist, concerns an adult of an unspecified age and gender. On an unspecified date, the patient (under the age of 65 years) was administered FLUAD (TIV) [dose, route of administration, anatomical location, batch number and expiry date: not reported] (explicitly coded as inappropriate age at vaccine administration). At the time of this report, no adverse events were reported. This case was considered as lost to follow since the reporter has not given consent to provide further information.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: This spontaneous case, initially received from other non-health professional on 25-Oct-2018, concerns a female patient of an unspecified age. On an unspecified date (reported as in the 90s), the patient was administered Influenza vaccine, (dose, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported). On an unspecified date, after vaccination, the patient got sick. The patient reported that, the vaccine had 'swine flu' in it. At the time of this report, the outcome of the event was not reported.
Age: 65.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a spontaneous case, initially received from a pharmacist on 15-Oct-2018, concerning a 65-year-old, elderly, male patient. The patient had no relevant medical history and concomitant medications. On an unspecified date, vaccines suffered two temperature excursions. In the first case, the maximum temperature was 48.4 Fahrenheit and was out of range for 3 hours. In the second case, the maximum temperature was 46.4 Fahrenheit (which was 8-degree Celsius) for 3 hours. On 13-Oct-2018, the patient was administered intramuscularly FLUAD (TIV) [dose: 0.5 ml, anatomical location: left deltoid, batch number: 250783, expiry date: 30-Apr-2019] which underwent temperature excursion. At the time of this report, no adverse events were reported. This case is linked to 201804513 due to same reporter. The reporter assessed the case as non-serious. Non-significant follow-up received from the pharmacist on 17-Nov-2018: The reporter confirmed that no adverse events were reported after vaccination administration. No changes were made in the narrative.
Age: 74.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 74-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUAD (TIV) vaccine exposed to temperatures in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 12-Sep-2018, the patient was administered FLUAD TIV [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804095 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Info number (SEQ18-04086) was updated in the additional information tab. No changes were made in the narrative.
Age: 71.0
Sex: U
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 71-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUAD (TIV) vaccine exposed to temperatures in the range of 47F to 50.9F. On 13-Sep-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case (201804098) was cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Med info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Age: 69.0
Sex: U
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 69-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUAD (TIV) vaccine exposed to temperatures in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 12-Sep-2018, the patient was administered FLUAD TIV [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804097 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Age: 69.0
Sex: U
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerns a 69-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUAD (TIV) vaccine exposed to temperatures in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 13-Sep-2018, the patient was administered FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804105 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Age: 75.0
Sex: U
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 75-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUAD (TIV) vaccine exposed to temperatures in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 15-Sep-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804111 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from reporter on 14-Nov-2018: The info number (SEQ18-02667) was added in additional information tab. No new information was received. Hence, no changes were done in the narrative.
Age: 68.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 68-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUAD (TIV) vaccine exposed to temperatures in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 07-Sep-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804082 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Age: 65.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 65-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUAD (TIV) vaccine exposed to temperatures in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 11-Sep-2018, the patient was administered FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed this case as non-serious. This case 201804090 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Age: 68.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 68-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUAD (TIV) vaccine exposed to temperatures in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 06-Sep-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804078 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Age: 1.67
Sex: M
Vaccine: FLUX
Symptoms: Chills, Cough, Fatigue, Headache, Myalgia
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) on 24-Oct-2018, concerns a 1-year-old, male infant patient. The patient's historical conditions included heart murmur, stomach/intestines intersection and the patient had visited emergency room. On 15-Oct-2018, the patient was administered Influenza vaccine (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number, expiry date, manufacturer and trade name: not reported). On an unspecified date in Oct-2018, after vaccination, the patient experienced fever, chills, sore throat, muscle aches, fatigue, cough, headache, runny nose and stuffy nose. The patient received MOTRIN. At the time of this report, the patient had not recovered from the event. The reporter assessed the case as non-serious. This case 201804858 was cross-linked to case 201804857 due to the same reporter.
Age: 1.67
Sex: M
Vaccine: FLUX
Symptoms: Nasal congestion, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) on 24-Oct-2018, concerns a 1-year-old, male infant patient. The patient's historical conditions included heart murmur, stomach/intestines intersection and the patient had visited emergency room. On 15-Oct-2018, the patient was administered Influenza vaccine (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number, expiry date, manufacturer and trade name: not reported). On an unspecified date in Oct-2018, after vaccination, the patient experienced fever, chills, sore throat, muscle aches, fatigue, cough, headache, runny nose and stuffy nose. The patient received MOTRIN. At the time of this report, the patient had not recovered from the event. The reporter assessed the case as non-serious. This case 201804858 was cross-linked to case 201804857 due to the same reporter.
Age: 69.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 69-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUAD (TIV) vaccine exposed to temperatures in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 11-Sep-2018, the patient was administered FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed this case as non-serious. This case 201804091 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Number (SEQ18-04086) was updated in the additional information tab. No changes were made to the narrative.
Age: 68.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 68-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUAD (TIV) vaccine exposed to temperatures in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 05-Sep-2018, the patient was administered FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Med info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.