chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: FLUA3
Symptoms: Balance disorder, Dizziness, Nausea
Clinical narrative: This spontaneous case, initially received from a pharmacist on 25-Sep-2018, concerns a 66-year-old, elderly male patient. The patient had no relevant medical history and had not received any concomitant medications. On 19-Sep-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250789, expiry date: 30-Apr-2019]. On the same day, after vaccination, the patient experienced nausea, dizziness and almost fell down. The patient had recovered from the events. The reporter assessed this case as non-serious. Follow-up received from the pharmacist on 20-Nov-2018: The route of administration of the vaccine was confirmed to be intramuscular. The outcome of the events was changed from not recovered to recovered in the event tab. Narrative was amended accordingly.
Sex: F
Vaccine: FLUX
Symptoms: Ankylosing spondylitis, Arthralgia, Back pain, Condition aggravated, Musculoskeletal pain
Clinical narrative: This is a spontaneous case, initially received from other non-health care professional on 08-Oct-2018, concerning an adult female patient of unknown age. The patient's current condition included ankylosing spondylitis. On an unspecified date, the patient was administered with Influenza vaccine [dose, route of administration, anatomical location, batch number, expiry date: not reported). On an unspecified date, the patient was administered with co-suspect drug COSENTYX (dose: 300 mg, route of administration: subcutaneous, anatomical location: not reported, batch number: not reported, expiry date: not reported). On an unspecified date (reported as today), after administration of vaccine, the patient had lost 52 pounds and 14 inches from her waist. The patient had experienced a lot of pain in shoulder blades and her back pain and knee pain was minimized. The patient had also experienced flares in an occasional manner. It was stated by the patient that, medication weared of around the third week. Since May 2018, the patient was on ketogenic diet and it had helped her in reducing the inflammation as well as the patient hands and feet did not swell as much as before. It was reported by the patient that, she started keto diet around the same time as that of when started COSENTYX and the patient was not sure which made the most effect on weight loss. The patient reported that, she had a flare up of ankylosing spondylitis, two days after getting vaccinated. The outcome of the events was unknown. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Waist circumference decreased, Weight decreased
Clinical narrative: This is a spontaneous case, initially received from other non-health care professional on 08-Oct-2018, concerning an adult female patient of unknown age. The patient's current condition included ankylosing spondylitis. On an unspecified date, the patient was administered with Influenza vaccine [dose, route of administration, anatomical location, batch number, expiry date: not reported). On an unspecified date, the patient was administered with co-suspect drug COSENTYX (dose: 300 mg, route of administration: subcutaneous, anatomical location: not reported, batch number: not reported, expiry date: not reported). On an unspecified date (reported as today), after administration of vaccine, the patient had lost 52 pounds and 14 inches from her waist. The patient had experienced a lot of pain in shoulder blades and her back pain and knee pain was minimized. The patient had also experienced flares in an occasional manner. It was stated by the patient that, medication weared of around the third week. Since May 2018, the patient was on ketogenic diet and it had helped her in reducing the inflammation as well as the patient hands and feet did not swell as much as before. It was reported by the patient that, she started keto diet around the same time as that of when started COSENTYX and the patient was not sure which made the most effect on weight loss. The patient reported that, she had a flare up of ankylosing spondylitis, two days after getting vaccinated. The outcome of the events was unknown. The reporter assessed this case as non-serious.
Age: 55.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This is a spontaneous case, initially received from pharmacist on 29-Oct-2018, concerning a 55-year-old, adult, male patient. The patient had no relevant medical history and concomitant medications. On 29-Oct-2018, the patient (less than 65 years) was administered FLUAD (TIV) dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, expiry date: 30-Jun-2019 and batch number: 250804) (explicitly coded as inappropriate age at vaccine administration). At the time of the report, no adverse events were 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 spontaneous case, initially received from other non-health professional (consumer) on 19-Oct-2018, concerns a male patient of unspecified age (under age 65 years as reported). The patient's current condition included asthma (reported as medical history). The patient's concomitant medication included montelukast. On an unspecified date (couple of weeks ago as reported), the patient (under 65 years of age) was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250798 and expiry date: 31-May-2018] (explicitly coded as inappropriate age at vaccine administration). The patient had not experienced any adverse events after the vaccination. The reporter assessed the case as non-serious. This case was linked to 201804741 due to same reporter. Follow-up received from other non-health professional on 20-Nov-2018: The batch number: 250798 and expiry date: 31-May-2018 were added in product tab. It was confirmed that, patient had not experienced any adverse events after the vaccination. The narrative was amended accordingly.
Age: 46.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from a pharmacist on 29-Oct-2018 concerns a 46-year-old, adult, male patient. The patient had no relevant medical history. The patient's concomitant medications were reported to be unknown. On 24-Oct-2018, the patient under age of 65 years was accidentally administered FLUAD TIV [dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number: 250798, expiry date: 31-May-2019] (explicitly coded as inappropriate age at vaccine administration). No adverse event was reported. The reporter assessed the event as non-serious. This case (201805051) was cross-linked to the source case: 201805049 reported by the same reporter.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case initially received from pharmacist on 24-Oct-2018, concerning a 71-year-old, elderly, female patient. The patient had no relevant medical history. The patient's concomitant medications included Lisinopril and Hydrochlorothiazide, Levothyroxine and aspirin. On an unspecified date, the vaccine was out of the refrigerator for 2 hours and maximum temperature of 70 Fahrenheit was reached, which was considered as first excursion (explicitly coded as incorrect product storage). On 24-Oct-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250802 and expiry date: 30-Jun-2019) which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported after the vaccine administration. The reporter assessed this case as non-serious.
Age: 46.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This non-serious spontaneous case, initially received from pharmacist on 24-Oct-2018, concerns a 46-year-old, adult male patient. On 24-Oct-2018, the patient (under age of 65 years) was administered FLUAD (TIV) [batch number: 250798, expiry date: 31-May-2019, dose, route of administration and anatomical location: not reported] (explicitly coded as inappropriate age at vaccine administration). At the time of this report, no adverse event was reported. Non-significant follow-up received from the pharmacist on 21-Nov-2018: The pharmacist states that, the patient didn't report any additional information since the original report. Hence no changes were made in the narrative.
Age: 76.0
Sex: F
Vaccine: FLUA3
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injected limb mobility decreased, Injection site reaction, Loss of personal independence in daily activities
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) on 25-Oct-2018, concerns a 76-year-old, elderly, female patient. On 28-Sep-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, anatomical location: right arm, route of administration, batch number and expiry date: not reported]. On the same day after the vaccination, the patient experienced that needle hit the bone and was kept in her arm longer than usual. The patient's right arm got hurt immediately after the administration and got worse later the same night. The patient was not able to lift her arm as her arm completely went numb and could not lift her clothes off. The patient also reported that numbness eventually went away and was not as painful as before. The patient did not take any treatment measures associated with the event. At the time of report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 76.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain in extremity, Skeletal injury
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) on 25-Oct-2018, concerns a 76-year-old, elderly, female patient. On 28-Sep-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, anatomical location: right arm, route of administration, batch number and expiry date: not reported]. On the same day after the vaccination, the patient experienced that needle hit the bone and was kept in her arm longer than usual. The patient's right arm got hurt immediately after the administration and got worse later the same night. The patient was not able to lift her arm as her arm completely went numb and could not lift her clothes off. The patient also reported that numbness eventually went away and was not as painful as before. The patient did not take any treatment measures associated with the event. At the time of report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 79.0
Sex: F
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a spontaneous case, initially received on 24-Sep-2018, reported by other health professional (nurse), concerning a 79-year-old, elderly, female patient. The patient's historical conditions included: hypertension, cerebrovascular accident, arterial aneurysm, post-menopausal osteoporosis, mitral valve prolapse, lumbar spinal stenosis, major depression, osteoarthritis of the knee and prolapse of uterus mucosa. The patient's current condition was hyperlipidaemia (reported as medical history). The concomitant medication included: LIPITOR for an unknown indication. Since an unspecified date (reported as Saturday, 1 o'clock until this morning at 7 o'clock), the suspect vaccine FLUAD TIV underwent temperature excursion for 42 hours (explicitly coded as incorrect product storage). The average room temperature was reported to be 72-degree Fahrenheit. On 24-Sep-2018, the patient was administered FLUAD TIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch no: 250791 and expiry date: 30-Apr-2019) which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse events after the vaccination. The reporter assessed the case as non-serious.
Age: 69.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Syringe issue, Underdose, Wrong technique in product usage process
Clinical narrative: This spontaneous case, initially received from a pharmacist on 23-Oct-2018, concerns a 69-year-old, elderly male patient. It was reported that during administration of the vaccine, since the pharmacist did not fasten the needle tip correctly (explicitly coded as wrong technique in product usage process), part of the vaccine leaked out of the syringe between the needle tip and the place where the needle fastens onto the pre-filled syringe (explicitly coded as product leakage). On 10-Oct-2018, the patient was administered an incomplete dose of FLUAD TIV [dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250783 and expiry date: 30-Apr-2019] (explicitly coded as incomplete dose administered). No adverse reactions reported after administration of the vaccine. The reporter assessed this case as non-serious. Follow up report received from the pharmacist on 19-Nov-2018: The gender (male) of the patient was added. The dose (0.5ml), anatomical location (deltoid), batch number (250783) and expiry date (30-Apr-2019) were updated. The narrative was amended accordingly.
Age: 50.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received on 20-Sep-2018, reported by a pharmacist and concerns a 50-year-old, adult, male patient. The patient had no medical history and did not receive any concomitant medications. On 20-Sep-2018, the patient (under 65 years of age) was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number and expiry date: not reported] (explicitly coded as inappropriate age at vaccine administration). No adverse event was reported. The reporter assessed the case as non-serious. Non-significant follow-up received from the reporter on 09-Nov-2018: It was confirmed that the patient did not experience any adverse event.
Age: 80.0
Sex: M
Vaccine: FLUA3
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: This spontaneous case, initially received on 20-Sep-2018 (initial and follow-up combinedly processed) from other health professional (pharmacist), concerns an 80-year-old, elderly, male patient. On 19-Sep-2018, the patient was administered FLUAD (TIV) [dose: less than 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250787 and expiry date: 30-Apr-2019]. During administration, while the plunger was normally pressed, the medication leaked out between the needle and the barrel of the syringe (reported as locker device) (explicitly coded as syringe issue), and hence the patient received only partial dose of vaccine (explicitly coded as incomplete dose administered). The threading between the two was not secured. It began to leak, and majority of the vaccine ran onto the patient's arm (explicitly coded as exposure via skin contact). BD Safety Glide Needle was used. There were no signs of damage on the syringe. The needle appeared to be tightly attached. It was reported that the reporter always tightened the needles before administration. The syringe was stored in the original packaging before use. The health care professional was not exposed to the vaccine. This case was associated with product technical complaint (PTC) and the corresponding reference number was 1033424. No adverse event was reported. The reporter assessed the case as non-serious. Update received on 02-Nov-2018: Non-significant case correction (20-Sep-2018): The narrative was amended accordingly. Update received on 11-Nov-2018: Non-significant case correction (20-Sep-2018): The term 'QA reference number' was changed to 'PTC reference number' in the notes section of the additional information tab.
Sex: F
Vaccine: FLUX
Symptoms: Feeling hot, Throat tightness
Clinical narrative: This spontaneous case, initially received on 24-Oct-2018, reported by other non-healthcare professional (consumer), concerns a female patient of an unspecified age. On an unspecified date in 2017 (reported as last year), the patient was administered Influenza vaccine [dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported]. On an unspecified date in 2017, right after the vaccination, the patient experienced tightness in throat and had a very warm feeling that extended from her neck to her face. The patient told the pharmacist about it, and he instructed her to sit down in the waiting area. It was reported that the symptoms went away after sitting in the waiting area for several minutes (recovered). The patient had not taken any treatment measured for the events. The reporter assessed this case as non-serious. This case was considered as lost to follow up as the reporter did not provide consent for follow up.
Age: 55.0
Sex: M
Vaccine: FLUA3
Symptoms: Dizziness, Nausea, Urticaria
Clinical narrative: This spontaneous case, initially received from other health professional (pharmacist) on 05-Oct-2018, concerns a 55-year-old, adult male patient. The patient's medical history was not reported. The concomitant medications included CYMBALTA, celecoxib and glimepiride. It was reported that the patient might take losartan (reported as: losartan was not guaranteed). On 28-Sep-2018, in afternoon, the patient (less than 65 years of age) was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250792 and expiry date: 30-Apr-2019] (explicitly coded as drug administration error). It was reported that the patient experienced several adverse effects after the administration of suspect vaccine. On 30-Sep-2018, at night, the patient woke up dizzy, with extreme nausea and dry hives, but did not vomit. The events happened again on 02-Oct-2018 during the day. It was reported that the events stopped and then came back. On 03-Oct-2018 the patient felt ok but on 04-Oct-2018, the events happened again during the day and overnight. The patient did not know if the effects were correlated with the vaccine administration, because they had started only 2 days after receiving the flu shot. The patient had an appointment with the physician at 4 PM (reported as: today). At the time of report, the outcome of the events was not reported. The reporter assessed the case as non-serious. Non-significant follow-up received from a pharmacist on 25-Oct-2018: No new information obtained. It was reported that the primary reporter (pharmacist) no longer works in the pharmacy. Hence, they do not have further information on the patient and adverse event to provide.
Age: 89.0
Sex: F
Vaccine: FLUA3
Symptoms: Epistaxis, Vomiting
Clinical narrative: This spontaneous case, initially received from other non-health professional on 19-Oct-2018, concerns an 89-year-old, elderly female patient. The patient's current conditions included urinary incontinence and chronic obstructive pulmonary disease (COPD). The concomitant medications included ADVIL, MYRBETRIQ, SYMBICORT and oxygen. On 18-Oct-2018, in the afternoon the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250805 and expiry date: 30-Jun-2019]. On the same day, in the evening after going to bed, the patient got up and vomited the entire dinner which she had earlier. While vomiting, the patient had a terrific or horrendous nose bleed. The patient said that she normally takes this dinner which was 2.5 ounces of rib steak, half of a potato, and fresh asparagus and an ice cream cone and did nothing differently. No treatment measure was taken. On the same day, the patient had recovered from the event. The reporter had assessed the case as non-serious and the causality as related (had an adverse reaction to a flu vaccine).
Age: 69.0
Sex: M
Vaccine: FLUA3
Symptoms: Exposure via skin contact, Injection site extravasation, No adverse event
Clinical narrative: This spontaneous case, initially received from pharmacist on 24-Oct-2018, concerns a 69-year-old, elderly male patient. The patient had no medical history and concomitant medications. On 10-Oct-2018, the patient was administered the partial dose FLUAD (TIV) [dose: less than 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250783 and expiry date: 30-Apr-2019] (explicitly coded as incomplete dose administered). It was reported that the patient did not receive full dose because the vaccine came out and the patient's arm got exposed to some vaccine (explicitly coded as exposure via skin contact). On 09-Nov-2018, the patient was revaccinated with unspecified vaccine (dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) (explicitly coded as drug administration error). No adverse events were experienced after vaccination and no treatment measures were required. The reporter assessed this case as non-serious. Follow-up report received from the pharmacist on 21-Nov-2018: It was reported that, the patient was revaccinated with unspecified vaccine. The event (drug administration error) was added in the event tab. Reporter confirmed that, some of the vaccine contacted the patient's arm but had no reactions. Narrative was amended accordingly.
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) on 19-Oct-2018, concerns a male patient of unspecified age (under 65 years as reported). On an unspecified date (couple of weeks ago as reported), the patient (under 65 years of age) was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250798 and expiry date: 31-May-2018] (explicitly coded as inappropriate age at vaccine administration). The patient had not experienced any adverse events after the vaccination. The reporter assessed the case as non-serious. Follow-up received from other non-health professional on 20-Nov-2018: The batch number: 250798 and expiry date: 31-May-2018 were added in product tab. It was confirmed that, patient had not experienced any adverse events after the vaccination. The narrative was amended accordingly.
Age: 7.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site urticaria, Pain, Pyrexia
Clinical narrative: This spontaneous case, initially received on 12-Oct-2018, reported by other non-healthcare professional, concerning a 07-year-old, female child patient. The patient's current condition included metal sensitivities. On an unspecified date in Oct-2017 (reported as late Oct-2017), the patient was administered influenza vaccine (dose, frequency, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported). Within 24 hours after vaccination, the patient developed reactions at the injection site with red welts for 1-3 weeks. On an unspecified date after vaccination, the patient experienced fever and aching all over, for a couple of weeks (reported as 1-3 weeks), as a reaction to the vaccine. According to the patient's primary care physician (PCP), the reactions were either due to the mercury or the sorbitol contained in the vaccine and the reporter thought that it was due to the preservatives in the multidose vial (MDV) (related). At the time of this report, the patient had recovered from injection site reactions. The outcome of the events fever and generalised aching lasted for 1-3 weeks and then resolved. The reporter considered the events as related (side effects) to the suspect vaccine. This case is linked to the case 201804491 owing to the same reporter. Follow-up received on 02-Nov-2018 from other non-health professional: Age of the patient was added in the patient tab. Current condition 'metal sensitivity' was added under other relevant history in patient tab. Vaccination date 'Oct-2017' was added in the product tab. Events 'injection site reaction', 'injection site erythema' and 'injection site urticaria' was added in the event tab. Narrative and case comment was amended accordingly. Follow-up received from the reporter on 15-Nov-2018: The verbatim 'body aches' was added to the event 'generalized aching'. The outcome of the events generalised aching and fever was updated from 'not reported' to 'resolved'. The narrative was amended accordingly.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site extravasation, Underdose
Clinical narrative: This is a spontaneous case, initially received on 16-Oct-2018, reported by other health professional, concerning a 69-year-old, elderly, female patient. The patient had no medical history and concomitant medications at the time of vaccination. The patient's current condition included anaemia. On 16-Oct-2018, the patient was administered FLUAD TIV (dose: reported as 5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250790 and expiry date: 30-Apr-2019). The patient received was administered partial dose of FLUAD (explicitly coded as underdose). As the medicine leaked out of the injection site (reported as 2 or 3 drops came out) (explicitly coded as injection site extravasation). It was reported that on the same day the patient was re-vaccinated with FLUAD (dose: 0.5 ml, route: intramuscular, anatomical location: deltoid) in the opposite arm (explicitly coded as drug administration error). The patient had not complained about any side effects or adverse reactions after vaccination. The reporter assessed the case as non-serious. Follow-up received from the other health professional on 21-Nov-2018: The reporter confirmed that the patient was re-vaccinated with FLUAD on the same day (16-Oct-2018) in the opposite arm. Added new dosage regimen for FLUAD (dose: 0.5 ml, route: intramuscular, anatomical location: deltoid) in the product tab. Added new event drug administration error in the event tab. The patient had not reported any adverse reactions after vaccination. Added reference number (Med Info Number: SEQ18-06799) in the additional information tab. The narrative was amended accordingly.
Age: 81.0
Sex: F
Vaccine: FLUA3
Symptoms: Syringe issue, Underdose, Wrong technique in product usage process
Clinical narrative: This spontaneous case, initially received from the other-health professional on 23-Oct-2018, concerns an 81-year-old, elderly male patient. The patient did not have any medical history. The patient did not administer any concomitant medications. On 23-Oct-2018, the patient was administered inadequate dose of FLUAD (TIV) [route of administration: intramuscular, anatomical location: deltoid, batch number: 250801 and expiry date: 30-Jun-2019] (explicitly coded as incomplete dose administered). On the same day of vaccination, the liquid came out of the syringe as the needle was not attached properly (explicitly coded as syringe leakage and wrong technique in product usage process). The reporter assessed this case as non-serious.
Age: 63.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from pharmacist on 12-Oct-2018, concerns a 63-year-old, adult male patient. On 12-Oct-2018, the patient (under 65-year-old) was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250796 and expiry date: 31-May-2019] (coded as inappropriate age at vaccine administration). No adverse effects were noted. The reporter assessed the case as non-serious.
Age: 74.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received on 15-Oct-2018 from pharmacist, concerning a 74-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 FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 250783, expiry date: 30-Apr-2019] which underwent temperature excursion. The patient did not experience any adverse events after the vaccination. The reporter assessed the case as non-serious. This case: 201804513 was cross-linked to the case: 201804514 reported by the same reporter. Non-significant follow-up received from reporter on 17-Nov-2018: The reporter confirmed that the patient did not experience any adverse event. No changes were made in the narrative.
Age: 62.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received on 20-Sep-2018, reported by a pharmacist and concerning a 62-year-old, adult male patient. The patient's medical history and concomitant medications were not available. On 20-Sep-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: 250786 and expiry date: 30-Apr-2019] (explicitly coded as inappropriate age at vaccine administration). It was reported that the patient did not experience any adverse effect after the vaccination. The reporter assessed the case as non-serious.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Rash, Rash erythematous
Clinical narrative: This spontaneous case, initially received from pharmacist on 15-OCT-2018, concerns a 62-year-old, adult, female patient. On 12-Sep-2018, the patient was administered FLUAD (TIV) [route of administration, anatomical location, dose, batch number and expiry date: not reported]. On an unspecified date in Sep-2018, one week after vaccination, the patient had a red rash on thighs, armpits and groin. On an unspecified date in Sep-2018 (reported as two weeks after), the patient had recovered from the event. The reporter assessed the case as non-serious. Follow-up received from the pharmacist on 16-Nov-2018: Start date of the suspect vaccine was changed from 12-Sep-2012 to 12-Sep-2018. The outcome of the event red rash was changed from not reported to recovered. Narrative was amended accordingly.
Age: 49.0
Sex: F
Vaccine: FLUA3
Symptoms: Headache, Musculoskeletal stiffness, Pain in extremity, Palpitations, Product administered to patient of inappropriate age
Clinical narrative: This is a spontaneous case initially received from other health professional (nurse) on 30-Oct-2018, concerning a 49-year-old, adult, female patient. The patient's concomitant medications were unknown. On 10-Oct-2018, the patient (who was under age of 65 years) was administered FLUAD (TIV) [dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250788, expiry date: not reported]. On the same day, after vaccination, the patient experienced headache at the night and felt pain and stiffness in her hand on the same arm. The patient also felt that, her heart was racing. The patient's treatment measures included ice pack on her arm. At the time of this report, the patient had notrecovered from the events pain in arm and heart racing and the outcome of the events headache and stiffness is not reported. The reporter assessed this case as non-serious.
Age: 73.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from a pharmacist on 12-Oct-2018, concerns a 73-year-old, elderly male patient. On an unspecified date, due to power off, the vaccine went below 28.4 F for about 6 hours (explicitly coded as incorrect product storage). On 12-Oct-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 250794 and expiry date: 30-Apr-2019] which underwent temperature excursion (explicitly coded as drug administration error). No adverse event was reported.
Age: 11.0
Sex: F
Vaccine: FLUX, HPV9, MNQ, TDAP
Symptoms: Rash erythematous, Rash macular
Clinical narrative: This spontaneous case, initially received from a physician via pharmaceutical manufacturer (Merck) on 23-Oct-2018, concerns a 11-year-old, child, female patient. The patient's current condition included seasonal allergies. The patient's historical drug included NASONEX for seasonal allergies. It was unknown if the patient was taking NASONEX when the vaccines were administered. On 11-Oct-2018, the patient was administered influenza vaccine (batch number: U1982AC (as reported), anatomical location: left arm, dose, route of administration, expiry date, trade name and manufacturer: not reported). On the same day, the patient was also administered non-company suspect vaccines MENACTRA (anatomical location: right arm, batch number: U5986AA, dose, route of administration and expiry date: not reported), ADACEL (anatomical location: left arm, batch number: C5519BA, dose, route of administration and expiry date; not reported). The patient also received GARDASIL 9 (route of administration: intramuscular, anatomical location: right arm, batch number: R008163, dose and expiry date: not reported). On the same day, within minutes after receiving the four vaccines, the patient experienced a systemic bilateral rash on upper part of the body during an office visit. The rash was described as a red, blotchy shirt (as reported). The patient was given BENADRYL in the office and emergency services were called. The patient's blood pressure, oxygen level and temperature were monitored, and the vitals were reported as good. It was reported that, the patient was recovering, so the patient's parents declined the use of emergency services. The patient was taken home, after about an hour of vaccination. The field representative stated that, the emergency services had been contacted as a precaution, but the event was not life threatening. The reporter assessed the case as non-serious.
Age: 15.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This is a spontaneous case, from other health professional (pharmacist) on 26-Oct-2018, concerns a 15-year-old, adolescent, male patient. The patient had no medical history and didn't receive any concomitant medications at the time of the vaccination. On 26-Oct-2018, the adolescent patient was inadvertently administered FLUAD (TIV) at inappropriate age [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250805 and expiry date: 31-May-2019] (explicitly considered as inappropriate age at vaccine administration). At the time of this report, no other adverse reactions were reported. The reporter assessed the case as non-serious. Follow-up received from pharmacist on 20-Nov-2018: The reporter confirmed that the patient did not experience any adverse event and the correct batch number (250805) was updated in the product tab. The narrative was amended accordingly.
Age: 67.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site discomfort, Myalgia, Pain
Clinical narrative: This spontaneous case, initially received from the pharmacist on 22-Oct-2018, concerns a 67-year-old, elderly male patient. The patient did not have any medical history. The patient did not administer any concomitant medications. On 27-Sep-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250780 and expiry date: not reported]. On the same day after vaccination, the patient had discomfort at injection site for three to four days and still had muscle pain. On an unspecified date, the discomfort had worsened, and it still hurt constantly when the patient lifted his arm. The patient when pressed (arm) it hurt more. The patient did not administer any treatment medication for the event. On an unknown date (reported as 3 to 4 days after) the patient had recovered from the event injection site discomfort and had not recovered from the other events. The reporter assessed this case as non-serious. Significant case amendment (22-Oct-2018): The event 'condition worsened' was deleted from the event tab. No changes were made in narrative.
Sex: M
Vaccine: FLUX
Symptoms: Condition aggravated, Vertigo
Clinical narrative: This spontaneous case, initially received from other health professional (nurse) on 10-Oct-2018, concerns a male patient of an unspecified age. The patient's historical drug included flu vaccine for an unknown indication and developed symptoms of vertigo after vaccination. On an unspecified date, the patient was administered Influenza vaccine (dose, route of administration, anatomical location, batch number, manufacturer, trade name and expiry date: not reported). On an unspecified date, after vaccination, the patient developed symptoms of vertigo. At the time of this report, the outcome of the event was not reported. Non-significant follow up report received on 19-Nov-2018: No new information received. hence, no changes were made in narrative.
Age: 58.0
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 29-Oct 2018 concerns a 58-year-old, adult, female patient. The patient had no relevant medical history. The patient's concomitant medications were unknown. On 24-Oct-2018, the patient (under age of 65 year) was administered FLUAD TIV [dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number: 250798, expiry date: 31-May-2019]. No adverse event or adverse reaction was reported. The reporter assessed the event as non-serious. This case (201805052) was linked to the source case: 201805049 due to the same reporter.
Age: 83.0
Sex: F
Vaccine: FLUA3
Symptoms: Headache, Inappropriate schedule of product administration, Myalgia, Wrong product administered
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) on 30-Oct-2018, concerning an 83-year-old, elderly, female patient. The patient's current conditions included hypothyroidism, hypertension and hyperlipidaemia. The patient's concomitant medications included SYNTHROID, atenolol, LIPITOR, NORVASC, MVI and PRILOSEC. On 12-Sep-2018, the patient received first dose of FLUAD. On 25-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). It was reported that, the patient received second dose of FLUAD instead of the planned shingles vaccine (explicitly coded as wrong vaccine administered and inappropriate schedule of vaccine administered). On 26-Oct-2018, the patient experienced bad headache and muscle aches. The patient was treated with TYLENOL (as needed [prn]) and was monitored. The patient did not go to hospital, emergency room or after-hours clinic. It was reported that the patient saw her doctor and spoke with several other doctors regarding the events. On 30-Oct-2018, the patient had recovered from the event headache (resolved after 4 days) and on an unspecified date in 2018, the patient recovered from muscle aches (lasted for few more days). The reporter assessed the case as non-serious. Follow up received from other non-health professional (consumer) on 14-Nov-2018: The start date of the event headache was changed from 27-Oct-2018 to 26-Oct-2018. The start date of the event muscle aches was changed to Oct-2018 in the event tab. The patient saw her doctor and spoke with several other doctors regarding the events. The patient did not go to hospital, emergency room or after-hours clinic. It was reported that the patient had a bad head ache which resolved after 4 days and the muscle aches lasted for few more days. Hence, the stop date and duration of the event muscle aches was deleted from the event tab. The patient had completely recovered from the events. The narrative and case comment were amended accordingly.
Age: 47.0
Sex: F
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This non-serious spontaneous case, initially received from other health professional on 11-Oct-2018, concerns a 47-year-old, adult female patient. On an unspecified date, the patient (under 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, the patient did not experience any adverse events. This case was considered as lost to follow up as the reporter did not provide consent for follow up.
Age: 81.0
Sex: F
Vaccine: FLU4, FLUA3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This is a spontaneous case, initially received from a pharmacist (the initial and follow-up received on 26-Oct-2018 are being processed together) on 15-Oct-2018, concerns an 81-year-old, elderly female patient. It was reported that, the patient had no chronic medical illness. On 15-Oct-2018, the patient was administered high dose of FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250805 and expiry date: 30-Jun-2019] and the patient accidentally received non-company suspect product FLUZONE [dose, route of administration, anatomical location, batch number and expiry date: not reported]. The patient had no complaints or side effects after the vaccination. The reporter assessed the case as non-serious. Follow-up received from a pharmacist on 20-Nov-2018: The patient had no chronic medical illness. The reporter confirmed that, the FLUAD dose given was 0.5 ml. The reporter also confirmed that, the patient had no complaints or side effects after the vaccination. Upon internal review, it was realized that, the event coding was incorrectly done for the event. Hence, the event coding was changed from 'extra dose administered' to 'overdose'. The narrative was amended accordingly.
Age: 83.0
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 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. On 24-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.
Age: 33.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from a pharmacist on 18-Oct-2018, concerns a 33-year-old, adult male patient. The patient's current condition included autism (reported as medical history). The patient's concomitant medication included ZOLOFT. On 17-Oct-2018, the patient (under age of 65 years) was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 250788 and expiry date: 30-Apr-2019] (explicitly coded as inappropriate age at vaccine administration). At the time of this report, no adverse event was reported after the vaccination. The reporter assessed this case as non-serious. Non-significant follow-up received from the pharmacist on 13-Nov-2018: The reporter confirmed that autism was ongoing at the time of vaccination and no adverse events were noted after the vaccination. No changes were made in the narrative.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Nasopharyngitis
Clinical narrative: This spontaneous case, initially received from other non-health professional on 27-Oct-2018, concerns a 67-year-old elderly female patient. The patient's current conditions included Crohn's disease, diabetes and kidney cancer (reported as medical history). The concomitant medications included VOTRIENT, ENTYVIO, Cyanocobalamin, FERATE, Flax Seed Oil, Furosemide, Ginger root, Glipizide, Glucosamine, Lisinopril, Melatonin, Metformin HCL, Metoprolol, Nifedipine, Probiotics, Simvastatin, Turmeric, Vitamin D3. On an unspecified date in Oct-2018 (reported as last week), the patient was administered Influenza vaccine (batch number: 8ZP9087 (as reported), dose, route of administration, anatomical location, trade name, manufacturer and expiry date: not reported). On 23-Oct-2018 after vaccination, the patient experienced cold symptoms which lasted for about four days. At the time of this report, the patient had recovered from the event. The reporter assessed the case as non-serious.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site pain, Mobility decreased, Neuralgia
Clinical narrative: This is a spontaneous case, initially received from other non-health professional on 16-Oct-2018, concerning a 66-year-old, elderly, female patient. The patient's current conditions included unspecified gastrointestinal disorder, hypertension, reflux and atrial fibrillation. The patient's concomitant medications included XARELTO, NORVASC and NEXIUM. On 25-Oct-2018, the patient was administered FLUAD (TIV), dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm [deltoid], NDC: 70461-0018-03, batch number and expiry date: not reported). On the same day, immediately after vaccination, the patient experienced sharp pain going from injection site down into her arm to her wrist. The patient stated it was in the nerve. As the night progressed, it became harder for the patient to lift her arm. It subsided and came back and worsened. It was reported that the pain did not stop and kept hurting. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous case, initially received from other non-health professional on 16-Oct-2018, concerning a 66-year-old, elderly, female patient. The patient's current conditions included unspecified gastrointestinal disorder, hypertension, reflux and atrial fibrillation. The patient's concomitant medications included XARELTO, NORVASC and NEXIUM. On 25-Oct-2018, the patient was administered FLUAD (TIV), dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm [deltoid], NDC: 70461-0018-03, batch number and expiry date: not reported). On the same day, immediately after vaccination, the patient experienced sharp pain going from injection site down into her arm to her wrist. The patient stated it was in the nerve. As the night progressed, it became harder for the patient to lift her arm. It subsided and came back and worsened. It was reported that the pain did not stop and kept hurting. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.