chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous case, initially received on 16-Oct-2017, by other health professional, concerning a 4-year-old, child male patient. The patient's medical history and concomitant medications were not reported. On 16-Oct-2017, the patient (under 4 years of age) received AFLURIA TIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: XF32708, expiry date: 30-Jun-2018) (explicitly coded as inappropriate age at vaccination administration). The patient did not experience any adverse events after vaccination (explicitly coded as no adverse event). The outcome of the event was not reported. The reporter considered this case as non-serious. Follow-up report received on 20-Oct-2017: It was reported that, the patient did not experience any adverse events. Amended narrative accordingly. Non-significant case correction received with IRD 16-Oct-2017: Added "special case with No AE" in general tab. Batch number was added in the field. Updated expiry date from Jun-2018 to 30-Jun-2018. The narrative was amended accordingly.
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial spontaneous case, was received on 12-Oct-2017, by a pharmacist, concerning a female patient of unspecified age. The patient's medical history and concomitant medications were reported. On 10-Oct-2017, the patient received AFLURIA QUADRIVALENT after a temperature excursion (dose: 0.5 ml route of administration: intramuscular, anatomical location: deltoid (assumed by the pharmacist), batch number and expiry date were not reporter) as active immunization. The patient received the vaccine after a temperature excursion (explicitly coded as drug administration error and product storage error). It was reported that, the patient did not develop any adverse event after vaccination (the patient did not call or any adverse events were reported). Pharmacist doesn't have much information about the patient, stated that the patient has already been discharged. The outcome of the events was not reported. The reporter considered this case as non-serious. Significant case correction received with IRD 12-OCT-2017: Additional event "product storage error" was added and narrative amended accordingly.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Liquid product physical issue, No adverse event
Clinical narrative: This initial spontaneous case, was received from pharmacist on 06-Oct-2017, concerning a 61-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 28-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, batch number: 01044621A, expiry date: 30-Jun-2018, route of administration: intramuscular, anatomical location: deltoid). The patient received the vaccine, which had floating particulate matter in the vial after refrigeration (explicitly coded as poor-quality vaccine administered). It was reported that, the product had very fine white particles, which looked foggy and did not suspended in the solution (explicitly coded as particle present in liquid product). The patient did not experience any adverse event after the vaccination. The reporter stated that, product was always stored in the refrigerator within the recommended storage conditions. As per the PTC (product technical complaint) (PTC reference number: PR436457) investigation performed, it was concluded that, the particulate matter in the returned complaint sample was confirmed to be consistent with the appearance of Influenza Virus Vaccine; it contained protein typical to that of influenza virus with no atypical structures. As there was no safety issue associated with the batch (01044621A), the final severity for the PTC was re-assessed as low. Retention sample description testing was also performed and confirmed the AFLURIA vials were satisfactory. Manufacturing and Filling investigations were not able to determine a causal link to the reported particulate matter observed by the consumer. This investigation confirmed all manufacturing processes were performed as per registered procedures and test requirements. The Quality attribute review had demonstrated that, the filled lot and associated Bulk and Monovalent Pooled Harvest lots were within statistically derived process control limits and specification. Trending of the PTC event was performed and determined that, the complaint report was not part of an emerging trend for the lot or complaint type. A Safety Assessment completed by the clinical safety physician determined no safety issue has been identified for lot 01044621A. This complaint was not considered indicative of a quality issue for the batch and lot 01044621A was considered suitable for continued use in the market. The reporter assessed the events as non-serious. Non-significant follow-up received on 14-Nov-2017: Updated PTC Reference Number: PR436457. The narrative was amended accordingly. Follow up received on 06-Dec-2017: The PTC investigations results were updated. The narrative was amended accordingly.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Liquid product physical issue, No adverse event
Clinical narrative: This initial spontaneous case, was received on 06-Oct-2017, concerning a 72-year-old elderly female patient. The patient's medical history included diabetes (since an unspecified date). On 28-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 01044621A and expiry date: 30-Jun-2018). The patient received the vaccine, which had floating particulate matter in the vial after refrigeration (explicitly coded as poor quality vaccine administered). It was reported that, the product had very fine white particles, which looked foggy and did not suspended in the solution (explicitly coded as particle present in liquid product). The patient did not experienced any adverse event after the vaccination. The reporter stated that, product was always stored in the refrigerator within the recommended storage conditions. As per the PTC (product technical complaint) (PTC reference number: PR 436457) investigation performed, it was concluded that, the particulate matter in the returned complaint sample was confirmed to be consistent with the appearance of Influenza Virus Vaccine; it contained protein typical to that of influenza virus with no atypical structures. As there was no safety issue associated with the batch (01044621A), the final severity for the PTC was re-assessed as low. Retention sample description testing was also performed and confirmed the AFLURIA vials were satisfactory. Manufacturing and Filling investigation were not able to determine a causal link to the reported particulate matter observed by the customer. This investigation confirmed all manufacturing processes were performed as per registered procedures and test requirements. The Quality attribute review had demonstrated that, the filled lot and associated Bulk and Monovalent Pooled Harvest lots were within statistically derived process control limits and specification. Trending of the PTC event was performed and determined that, the complaint report was not part of an emerging trend for the lot or complaint type. A Safety Assessment completed by the clinical safety physician determined no safety issue has been identified for lot 01044621A. This complaint was not considered indicative of a quality issue for the batch and lot 01044621A was considered suitable for continued use in the market. The reporter assessed the events as no-serious. Non-significant follow-up received on 14-Nov-2017: Updated PTC Reference Number: PR436457. The narrative was amended accordingly. Follow up received on 06-Dec-2017: The PTC investigations result were updated. The narrative was amended accordingly.
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: This non-serious initial spontaneous case, was received on 26-Sep-2017 from other health professional, concerning a female patient of unspecified age. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with AFLURIA QUADRIVALENT (dose, batch number, expiry date, route of administration: not reported, anatomical location: deltoid). It was reported that, the patient developed pain after taking a vaccine in the deltoid muscle. The patient experienced pain after taking the vaccine given either in the deltoid muscle or in the thigh. The outcome of the events was not reported. The reporter assessed the events as non-serious.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, initially received on 06-OCT-2017, reported by other health professional and concerns a 47-year-old adult male patient. Patient's medical history and concomitant medications were not reported. On 06-Oct-2017, the patient received AFLURIA QUADRIVALENT was in the refrigerator and the refrigerator temperature was 37 to 35 degrees with the lowest being at 12 degrees for 1 minute. (explicitly coded as incorrect product storage) (dose: 0.5 ml, batch number: XF33308, route of administration: intramuscular, anatomical location: left deltoid). Not sure if it was the probe that has the problem or the refrigerator. Patient received vaccine that underwent temperature excursion (explicitly coded as drug administration error). No adverse event was reported. The outcome of the events was not reported. The reporter assessed this case as non-serious. Follow-up received on 18-Oct-2017: Added vaccine administration details (route of administration: intramuscular, anatomical location: left deltoid). No adverse event was reported. Narrative amended accordingly. Insignificant case correction received 06-Oct-2017: the description coded for 'incorrect product storage was incorrectly taken as 'AFLURIA QUADRIVALENT was in the refrigerator and the refrigerator went from 37 to 35 with the lowest being at 12 degrees for 1 minute/Patient received vaccine that underwent temperature excursion' was changed to 'AFLURIA QUADRIVALENT was in the refrigerator and the refrigerator went from 37 to 35 with the lowest being at 12 degrees for 1 minute/ [Patient received] vaccine that underwent temperature excursion. The description coded for 'drug administration error' was incorrectly taken as '[AFLURIA QUADRIVALENT was in the refrigerator and the refrigerator went from 37 to 35 with the lowest being 12 degrees for 1 minute] / Patient received vaccine that underwent temperature excursion'. Was changed to / Patient received vaccine that underwent temperature excursion.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial spontaneous case, initially received on 06-OCT-2017, reported by other health professional and concerns a 19-year-old female patient. Patient's medical history and concomitant medications were not reported. On 06-Oct-2017, the patient received AFLURIA QUADRIVALENT, which was in the refrigerator and the refrigerator temperature was 37 to 35 degrees with the lowest being at 12 degrees for 1 minute (dose: 0.5 ml, batch number: XF33308, route of administration: intramuscular, anatomical location: left deltoid). Not sure if it was the probe that has the problem or the refrigerator. Patient received vaccine that underwent temperature excursion. It was reported that, the patient did not experience any adverse event after the administration of the vaccine. The reporter assessed this case as non-serious. Follow up report received on 17-Oct-2017: The route of administration (intramuscular), anatomical location (left deltoid) were updated. It was reported that, the patient did not experience any adverse event after the administration of the vaccine. The narrative was amended accordingly. Insignificant case correction received with IRD 06-OCT-2017: The description as reported for the event drug administration error was changed from "AFLURIA QUADRIVALENT was in the refrigerator and the refrigerator went from 37 to 35 with the lowest being at 12 degrees for 1 minute/Patient received vaccine that underwent temperature excursion" to "patient received vaccine that underwent temperature excursion". The description as reported for event product storage error was changed from AFLURIA QUADRIVALENT was in the refrigerator and the refrigerator went from 37 to 35 with the lowest being at 12 degrees for 1 minute/Patient received vaccine that underwent temperature excursion "to" AFLURIA QUADRIVALENT was in the refrigerator and the refrigerator went from 37 to 35 with the lowest being at 12 degrees for 1 minute/[Patient received vaccine] that underwent temperature excursion".
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Rash generalised
Clinical narrative: This initial spontaneous case, was received from other health professional (nurse) on 27-Sep-2017, concerning a 56-year-old adult male patient. The patient's medical history and concomitant medications were not reported. On 19-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, batch number: 00444611A, expiry date: Jun-2018, route of administration: intramuscular, anatomical location: deltoid). On the same day, after 12 hours of vaccination, the patient developed rash all over the body. No treatment was taken by the patient for the event. It was assumed that, there were no further issues with the patient. At the time of this report, the outcome of the event was not reported. The reporter assessed the event as non-serious and considered the causality of the event as related. Follow up received on 07-Nov-2017: The route of administration (intramuscular) and anatomical location (deltoid) of the vaccine were updated. It was assumed that, there were no further issues with the patient. The narrative was amended accordingly.
Sex: U
Vaccine: FLU4
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: This initial spontaneous case, received on 27-Oct-2017 was reported by other health professional and concerns a patient of unspecified age and gender. On 25-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose:0.5ml, route of administration: intramuscular, anatomical location: right deltoid, batch number:00844621A, expiry date: 30-Jun-2018). On 25-Oct-2017, while injecting vaccine the hub of the needle separated from the syringe and the patient received roughly half a dose. It was confirmed that there were no problems or defects with the product. It was reported that, the patient had no experienced any adverse events. Reporter stated that, the patient is doing good. The reporter assessed this case as non-serious.
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: This non-serious initial spontaneous case, was received on 01-NOV-2017, from a Pharmacist, concerning a patient of unspecified age and gender. On 31-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported). It was reported that pharmacy temperature was 70-degree F. Multi dose vial (MDV) was left out on the pharmacy counter for 1 hour and 20 minutes. Hence first temperature excursion occurred and was administered to the patient. It was reported that MDV had been used that morning (as reported), that was left out, administered to the patient and was finally discarded.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This non-serious initial spontaneous case, was received from other-health professional (nurse), concerns a 4-year-old child of unspecified gender. On 31-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch no: 00144621A and expiry date: 31-May-2018). On 31-Oct-2017, 4-year-old child was vaccinated with AFLURIA QUADRIVALENT which was explicitly coded as inappropriate age at vaccine administration. It was reported that the patient did not experience any adverse reactions. The reporter did not provide the seriousness assessment.
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Diarrhoea, Dizziness, Fatigue, Injected limb mobility decreased
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 05-Oct-2017, concerning a female patient of an unspecified age. The patient's historical vaccine included unspecified flu vaccine without any adverse effects. The patient's concomitant medications were not reported. On 04-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, batch number: 01344611A, anatomical location: deltoid muscle of upper arm, route of administration: intramuscular, expiry date: not reported). On the same day, after vaccination, the patient could not move her injected hand or arm as hand was very sore. The patient also experienced fatigue, light-headedness, joint pain, muscle pain, diarrhea and was treated with Probiotic. It was reported that, patient would consult with HCP (health care professional) on TYLENOL and ibuprofen. 04-Oct-2017, the patient was recovered from the events. The reporter assessed the report as non-serious. Significant case correction received with IRD 05-Oct-2017: The route of administration of the vaccine was added as intramuscular. The listedness of the event fatigue and diarrhea were corrected. Non-significant case correction received with IRD 05-Oct-2017: Batch number (01344611A) was added on the screen. The narrative was amended accordingly. Significant case correction received with IRD 05-Oct-2017: The treatment received as "yes" was removed for all the events except diarrhea.
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Pain in extremity
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 05-Oct-2017, concerning a female patient of an unspecified age. The patient's historical vaccine included unspecified flu vaccine without any adverse effects. The patient's concomitant medications were not reported. On 04-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, batch number: 01344611A, anatomical location: deltoid muscle of upper arm, route of administration: intramuscular, expiry date: not reported). On the same day, after vaccination, the patient could not move her injected hand or arm as hand was very sore. The patient also experienced fatigue, light-headedness, joint pain, muscle pain, diarrhea and was treated with Probiotic. It was reported that, patient would consult with HCP (health care professional) on TYLENOL and ibuprofen. 04-Oct-2017, the patient was recovered from the events. The reporter assessed the report as non-serious. Significant case correction received with IRD 05-Oct-2017: The route of administration of the vaccine was added as intramuscular. The listedness of the event fatigue and diarrhea were corrected. Non-significant case correction received with IRD 05-Oct-2017: Batch number (01344611A) was added on the screen. The narrative was amended accordingly. Significant case correction received with IRD 05-Oct-2017: The treatment received as "yes" was removed for all the events except diarrhea.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous case, was initially received from Other Health Professional on 27-Sep-2017, concerning a 4-year-old female patient. On 14-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, batch number: 00644611A, expiry date: 30-Jun-2018, route of administration: intramuscular, anatomical location: right deltoid). It was reported that patient under 5 years received vaccine. The outcome of the event was not reported. The reporter assessed the event as non-serious. Follow-up report received on 13-Oct-2017: Route of administration and anatomical location was updated. Event no adverse event was added. Amended narrative accordingly. Non-significant case correction received on 13-Oct-2017: Follow-up report received on 13-Oct-2017 was added in the narrative. Non-significant case correction received with IRD 27-Sep-2017: Batch number (00644611A) was added on the screen and updated expiry date. The narrative was amended accordingly.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Liquid product physical issue
Clinical narrative: This spontaneous case, initially received from the pharmacist on 03-Nov-2017, concerning a 60-year-old adult female patient. It was reported that, the vaccine seems to be clear white looking with many very small fiber looking particles. Reported that, the product was agitated for 10-15 seconds, where some of the particles were dissolved after agitation. The vaccine was stored in temperature of 41 degrees, where no temperature excursions was noted. It was reported that particulate was found when it was preparing to administer. The PTC number was 452078. On an unspecified date, the patient was administered with AFLURIA QUADRIVALENT PFS (pre-filled syringe) with the presence of particular matter (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: XF33108 and expiry date: 30-Jun-2018).
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: This initial non-serious case, was received on 27-Sep-2017, from other health professional, concerning a 34-year-old, female, adult patient. The patient's medical history included first flu shot on an unspecified date and concomitant medications were not reported. On 19-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, batch number: 00444611A, expiry date: Jun-2018, route of administration, anatomical location: not reported). On 19-Sep-2017, 2.5 hours after vaccination, the patient complained of redness, itching on forearms and chest, noticeable hives. The patient recovered from the events on 20-Sep-2017. The reporter assessed the events as non-serious. Non-significant case correction received with IRD on 27-Sep-2017: The description as reported of the event was changed from "after receiving AFLURIA QUADRIVALENT patient complained of redness [and itching on forearms and chest and noticeable hives]" to "patient complained of redness [and itching on forearms and chest]" and "after receiving AFLURIA QUADRIVALENT' verbatim was removed from the description as reported from all the events.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site haemorrhage, Injection site mass, Injection site rash
Clinical narrative: This non-serious spontaneous case, was initially received from other health professional on 27-Sep-2017, concerning a 61-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 19-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, batch number: 00444611A, expiry date: 30-Jun-2018, route of administration: intramuscular, anatomical location: right deltoid). On the same day, immediately after vaccination, the patient developed redness, a little bleeding, lump and rash around injection site. The patient could elevate arm and swelling seemed to diminish. It was reported that, after 15 minutes swelling was reduced, leaving just a little rash around the injection site. On 19-Sep-2017, the patient recovered from the events. The reporter assessed the report as non-serious. Follow-up received on 13-Oct-17: The vaccine administration details were updated (route of administration: intramuscular and anatomical location: right deltoid). Narrative amended accordingly. Non-significant case correction received with IRD 27-Sep-2017: Batch number (00444611A) was added on the screen and updated expiry date. The narrative was amended accordingly.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: This non-serious spontaneous case, was initially received from other health professional on 27-Sep-2017, concerning a 61-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 19-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, batch number: 00444611A, expiry date: 30-Jun-2018, route of administration: intramuscular, anatomical location: right deltoid). On the same day, immediately after vaccination, the patient developed redness, a little bleeding, lump and rash around injection site. The patient could elevate arm and swelling seemed to diminish. It was reported that, after 15 minutes swelling was reduced, leaving just a little rash around the injection site. On 19-Sep-2017, the patient recovered from the events. The reporter assessed the report as non-serious. Follow-up received on 13-Oct-17: The vaccine administration details were updated (route of administration: intramuscular and anatomical location: right deltoid). Narrative amended accordingly. Non-significant case correction received with IRD 27-Sep-2017: Batch number (00444611A) was added on the screen and updated expiry date. The narrative was amended accordingly.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Impaired work ability, Myalgia, Tremor
Clinical narrative: This is a spontaneous case, initially received from a nurse on 07-Nov-2017, concerning a 48-year-old, adult female patient. The patient did not have any medical history. The patient received unspecified vaccines in past and did not have any allergy. The patient did not receive any concomitant medication. On 27-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose :0.5ml route of administration: intramuscular, anatomical location: right deltoid, batch number: 00644611A and expiry date: 31-Mar-2018). On the same day, 12 hrs after the administration of vaccination, the patient started to have muscle ache, chills and headache. When she woke up she was shaking uncontrollably. The patient did not seek treatment but called her NP niece who said that, she had a reaction to the component and took 2 days off work. She saw her doctor who stated she was well. On 02-Oct-2017, the events (tremor, myalgia, and chills) were resolved, and had slight headache (not recovered). The reporter assessed the case as non-serious. Follow up received on 04-Dec-2017, The stop date for the events (tremor, myalgia, chills) was added. The narrative was amended accordingly. Non-significant case correction received with IRD 07-Nov-2017: The expiry date of the suspect vaccine was changed from Mar-2018 to 31-Mar-2018. The narrative was amended accordingly.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination complication
Clinical narrative: This is a spontaneous case, initially received from a nurse on 07-Nov-2017, concerning a 48-year-old, adult female patient. The patient did not have any medical history. The patient received unspecified vaccines in past and did not have any allergy. The patient did not receive any concomitant medication. On 27-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose :0.5ml route of administration: intramuscular, anatomical location: right deltoid, batch number: 00644611A and expiry date: 31-Mar-2018). On the same day, 12 hrs after the administration of vaccination, the patient started to have muscle ache, chills and headache. When she woke up she was shaking uncontrollably. The patient did not seek treatment but called her NP niece who said that, she had a reaction to the component and took 2 days off work. She saw her doctor who stated she was well. On 02-Oct-2017, the events (tremor, myalgia, and chills) were resolved, and had slight headache (not recovered). The reporter assessed the case as non-serious. Follow up received on 04-Dec-2017, The stop date for the events (tremor, myalgia, chills) was added. The narrative was amended accordingly. Non-significant case correction received with IRD 07-Nov-2017: The expiry date of the suspect vaccine was changed from Mar-2018 to 31-Mar-2018. The narrative was amended accordingly.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: This initial non-serious case, was received on 19-Sep-2017, from consumer, concerning a 29-year-old, adult female pregnant patient (16 weeks gestation period). The historical medication included unspecified allergy medication and unspecified oral contraceptives in past, prior to pregnancy. The paternal historical condition included acid reflux and unspecified medication for the same was taken prior to the conception. The current condition included allergy and concomitant medication included prenatal vitamins. The patient's last menstrual period was reported as 23-May-2017. The patient's medical and medication history relevant to pregnancy was not reported. On 15-Sep-2017, the patient (at 16 weeks gestation period) was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, batch number: 00144621A, expiry date: 31-May-2018, route of administration, anatomical location) (explicitly coded as vaccine exposure during pregnancy). The outcome of the event was not reported. The estimated date of pregnancy was reported as 07-Mar-2018. Non-significant case correction received 19-Sep-2017: Batch number was updated in the screen. Narrative was amended accordingly.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: This spontaneous report, initially received on 27-Sep-2017, from a pharmacist, concerns a 63-year-old adult female patient. The patient's medical and concomitant medications were not reported. On 12-Sep-2017, the patient was administered with the AFLURIA QUADRIVALENT (dose: 0.5 ml, batch number: XF30506, expiry date: 29-Jun-2018, route of administration: intramuscular, anatomical location: deltoid. On 15-Sep-2017, after 4 days of vaccination, the patient had headaches, nausea, chills, fever and sweats. It was reported that, the patient was recovered from the events prior to 27-Sep-2017. The reporter considered the events as non-serious. Follow up received on 02-Nov-2017: The route of administration (intramuscular) and anatomical location (deltoid) were updated. It was reported that, the patient was recovered from the events prior to 27-Sep-2017. The narrative was amended accordingly. Significant case correction received 27-SEP-2017: SOC (system organ class) of the event sweating was changed to 'general disorders and administration site conditions' from 'skin and subcutaneous tissue disorders'.
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Hypoaesthesia eye, Paraesthesia
Clinical narrative: This spontaneous case, initially received from the nurse on 07-Nov-2017, concerning an unspecified male patient of an unknown age. The patient was not allergic to any of the vaccine's components and was healthy on the date of the vaccine administration. The patient's concomitant medication was not reported. On 02-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 00444611A, expiry date: 13-Jun-2018). On the same day of vaccination 10 min after vaccination, the patient experienced numbness and tingling effect in left hand, chest and on eyes. At the time of this report, the outcome of events not reported. The reporter assessed this case as non-serious. Non-significant follow-up received on 11-Dec-2017: No new information was available. Hence, no updates were made to the narrative.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial spontaneous case, was received from nurse on 09-Nov-2017, concerns a 51-year-old adult female patient. The patient's medical history included low thyroid, anxiety, depression and concomitant medications included SYNTHROID, vitamins and KLONOPIN for an unknown indication. On 01-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch no: XF31407 and expiry date: 30-Jun-2018), which underwent at least one temperature excursion and there was no event occurred after administration of vaccine. It was reported that, vaccine reached to 34.29-degree F and returned to recommended storage range (36-46 degree F, as reported) and vaccine did not freeze. The reporter assessed the case as non-serious. Follow up report received on 30-Nov-2017: The concomitant medication (KLONOPIN) was updated. The narrative was amended accordingly.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Product storage error
Clinical narrative: This non-serious spontaneous case, was initially received on 27-Sep-2017 from other health professional (pharmacist), concerning a 20-year-old, adult, female pregnant patient. On 27-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, batch number: XF31007, expiry date: 30-Jun-2018, route of administration, anatomical location: not reported). The patient was administered with vaccine which was stored at 53F, approximately less than 23 hours, instead of storing at 36-46F which was considered as drug administration error. This vaccine was administered when the patient was pregnant which was considered as vaccine exposure during pregnancy. The outcome of the events was not reported. The reporter assessed the report as non-serious. Non-significant case correction received with IRD 27-Sep-2017: Batch number (XF31007) was added on the screen. The narrative was amended accordingly.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 32 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other health professional (nurse) on 09-Nov-2017, concerns a 58-year-old adult male patient. The patient's medical history includes BPH (benign prostatic hyperplasia), GERD (gastro esophageal reflux disease), high cholesterol and myalgia. The patient's concomitant medications included pravastatin, omeprazole and WELLBUTRIN. On 02-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch no: XF31407 and expiry date: 30-Jun-2018), which underwent at least one temperature excursion (explicitly coded as incorrect product  storage  and drug administration error). It was reported that, patient had not experienced any adverse event after the administration of the vaccine. The reporter assessed the events as non-serious. Non-significant follow up received on 11-Dec-2017: No new information received. Significant case correction received 09-Nov-2017: The event "No adverse event" was deleted. Added classification as "Special case with No AE" in relevant field.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 42 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of drug administration, Wrong drug administered
Clinical narrative: This spontaneous case, was received from other health professional (pharmacist) on 26-Sep-2017, concerning a male patient of an unspecified age. The patient's medical history was not reported. The patient's concomitant medications included CYMBALTA, folic acid, LIPITOR, LOPRESSOR, PAMELOR, PAXIL, PLAVIX, PARLODEL, PROTONIX; vitamin C; ULTRAM, VALIUM and ZOFRAN. It was reported that, the patient was already in hospital for an unspecified reason. On 26-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: subcutaneous, batch number: 00144621A (as reported), expiry date: Jun-2018 and anatomical location: not reported). The nurse intended to do PPD (purified protein derivative) test on the patient, but given him the vaccine subcutaneously, which was considered as inappropriate route of vaccination. The reporter assessed the event as non-serious. Significant case correction received 26-Sep-2017: The event verbatim was corrected. the event 'wrong vaccine administered' was added.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial spontaneous case, was received from other health professional (nurse) on 09-Nov-2017, concerning a 59-year-old adult male patient. The patient's medical history included BPH (benign prostatic hyperplasia), high blood pressure and diabetes mellitus (since an unspecified dates). The patient's concomitant medications included amlodipine, atenolol and FARXIGA for an unknown indication. On 01-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: XF31407, expiry date: 30-Jun-2018). The patient received the vaccine, which underwent at least one temperature excursion and he did not experience any adverse event after the administration of the vaccine. The reporter assessed the events as non-serious.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This case refers to 35th out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Sex: F
Vaccine: FLU4
Symptoms: Dysphonia, Fatigue, Immediate post-injection reaction, Loss of consciousness, Nausea
Clinical narrative: This initial spontaneous case was received on 26-Sep-2017, from other health professional, concerning a female patient of unspecified age. The patient's medical history and concomitant medications were not provided. On 26-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 01144621A, expiry date: 30-Jun-2018). On the same day, immediately after the injection the patient experienced nausea and passing out (as reported). The patient was also very tired and heard herself talking and recognized the change of voice. No treatment was taken for the events. The patient recovered from the events after 3 to 5 minutes (as reported), on the same day. The reporter considered the report as non-serious. Follow-up received from the reporter on 16-Oct-2017: The start date of the vaccination and event onset date were updated. Narrative amended accordingly. Follow-up received from the reporter on 08-Nov-2017: Added route of administration and anatomical location. The narrative was amended accordingly.
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Loss of consciousness, Nausea
Clinical narrative: This spontaneous case, was initially received on 26-Sep-2017, from other health professional, concerning a female patient of unspecified age. On 26-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, batch number: 01144621A, expiry date: 30-Jun-2018, route of administration, anatomical location: not reported). It was reported that, immediately after the injection the patient experienced nausea and passing out (as reported). No treatment was taken for the events. On the same day, the patient recovered from the events after a few minutes (as reported). The reporter considered the report as non-serious. Non-significant case correction received with IRD 26-Sep-2017: Batch no. (01144621A) was captured in the case form and narrative was amended accordingly.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial spontaneous case, was received from other health professional (nurse) on 09-Nov-2017, concerns a 46-year-old adult female patient. The patient's medical history includes anxiety, depression, GERD (gastro esophageal reflux disease), high cholesterol, rheumatoid arthritis and concomitant medications included BUMEX, COREG, losartan, methotrexate, PROTONIX, PLAQUENIL, spironolactone, WELLBUTRIN and Trazodone. On 02-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch no: XF31407 and expiry date: 30-Jun-2018) which underwent at least one temperature excursion (explicitly coded as incorrect product storage and drug administration error). It was reported that, vaccine reached to 34.29-degree F and returned to recommended storage range (36-46-degree F, as reported). It was reported that the vaccine did not freeze. It was reported that there was no event after administration of vaccine. The reporter assessed the case as non-serious. Follow up received on 11-Dec-2017: The patient's initial was updated.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 34 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial spontaneous case, was received from nurse on 09-Nov-2017, concerning a 26-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 30-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: XF32508, expiry date: 30-Jun-2018). It was reported that, the patient received the vaccine following one temperature excursion (explicitly coded as incorrect product storage and drug administration error) and patient had not experienced any adverse event after the administration of the vaccine. The reporter assessed the events as non-serious.
Sex: U
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Rash, Swelling
Clinical narrative: This non-serious spontaneous case, was initially received from other healthcare professional (nurse) on 22-Sep-2017, concerns a patient of unspecified age and gender. On an unspecified date, the patient was administered with AFLURIA QUADRIVALENT (lot number: 644623A (as reported), expiry date: 30-Jun-2018, dose, route of administration, anatomical location: not reported). On an unspecified date, the patient developed six-inch circle that looked like cellulitis. it was reported that, the patient was immunocompromised, had developed raised, bumpy, very red, circular area that was about 5 to 6 inches in diameter and looked like cellulitis. The patient's reaction had persisted for the past 6 days. The outcome of the event was not reported. Non-significant case correction received 22-Sep-2017: Batch number was updated on the screen. Narrative was amended accordingly.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This refers 33rd out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.