chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUC4
Symptoms: Influenza like illness, Malaise, Pain, Swelling
Clinical narrative: This is a spontaneous case, reported by other non-health professional (consumer) on 22-Oct-2018, concerns a female patient of unspecified age. The patient's current condition included egg allergy. It was reported that, the patient had a bad egg-allergy, she could not eat cooked egg, but only in small amounts (for e.g. she could not eat angel cake or cheese cake because it had too much egg in it and if she ate egg that was barely cooked her throat stared to close). On 29-Dec-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195244 and expiry date: 30-Jun-2018]. On the same day, after vaccination, the patient developed flu-like symptoms which included sickness and body aches. Additionally, the patient experienced localized swelling. It was reported that, the patient's symptoms were not severe. The patient believed that, these were the normal adverse reactions from the vaccine rather than the egg allergy. On 31-Dec-2017, the patient had recovered from the events flu like symptoms and localized swelling. The reporter assessed this case as non-serious and considered the causality of the events as related to the suspect vaccine. Follow-up report received on 05-Nov-2018: The suspect product was changed from 'INN Flu Vaccine Seasonal' to 'FLUCELVAX QIV'. Added vaccination date as 29-Dec-2017, batch number as 195244 and expiry date as 30-Jun-2018 in the product tab. The new events 'localized swelling' and 'body aches' were added in event tab. The onset date of the event 'flu symptoms' was updated as 29-Dec-2017. The narrative was amended accordingly. Follow-up received from the reporter on 27-Nov-2018: The case was downgraded from serious to non-serious. The reporter confirmed that, she experienced flu like symptoms and onset date of the event was 29-Dec-2017. The LLT for the event flu symptoms was changed to flu-like symptoms. The narrative was amended accordingly.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case, initially received from a physician on 18-Oct-2018, concerns a 51-year-old, adult female patient. The patient's medical history and concomitant medications were not available. On 11-Oct-2018, the patient was administered an expired vaccine FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195220 and expiry date: 30-Apr-2018). It was planned to revaccinate the patent. At the time of this report, no adverse events were noted after administration of the vaccine. The reporter assessed this case as non-serious. Non-significant follow up received from the reporter on 02-Nov-2018: The reporter confirmed that, the patient had not experienced any adverse events after vaccination. No changes were made in narrative.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This non-serious spontaneous case, initially received from other health professional on 19-Oct-2018 concerns a 26-year-old, adult, female patient. The patient did not have any medical history and did not take any concomitant medications at the time of vaccination. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, dose: 1.5 ml, batch number: 252235 and expiry date: 30-Jun-2019]. At the time of this report, no adverse reaction was reported. This case: 201804663 was cross-linked to the original case: 201804657 reported by the same reporter.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Incorrect dose administered, Injection site pain, Malaise, Muscle tightness
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 52-year-old, adult female patient. The patient had no relevant medical history and had not received any concomitant medications. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 1.5 ml instead of 0.5 ml (explicitly coded as overdose), route of administration: intramuscular, anatomical location: right deltoid, batch number: 252235, expiry date: 30-Jun-2019). On the same day, after vaccination, the patient felt under the weather (ill feeling). On 10-Oct-2018, 1 day after vaccination, the patient had a pounding headache. On 15-Oct-2018, the patient called back the nurse and stated that she was feeling better but still had some tension on her neck (neck pain) and soreness at the injection site. It was reported that the health care professional (HCP) followed up with the patient. At the time of this report, the patient was recovering from the events ill-feeling and pounding headache. The patient had not recovered from the events neck pain and injection site pain. This case 201804660 was cross-linked with the original case 201804657 due to the same reporter. Significant case amendment (19-Oct-2018): The event 'extra dose administered' was recoded to 'overdose'. The introductory statement in case comment was modified to 'A 52-year-old female patient experienced ill feeling, on the same day after receipt of FLUCELVAX QIVc of dose 1.5 ml instead of 0.5ml (coded as overdose). The patient also experienced pounding headache, 1 day post vaccination and neck pain, injection site pain, unspecified period after vaccination.' The narrative and case comment were amended accordingly.
Age: 35.0
Sex: M
Vaccine: FLUC4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 35-year-old, adult male patient. The patient had no relevant medical history. The patient was not taking any medication at the time of vaccination. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml instead of 0.5 ml (explicitly coded as overdose), route of administration: intramuscular, anatomical location: right deltoid, batch number: 252235, expiry date: 30-Jun-2019]. At the time of this report, no adverse events were reported. This case was linked to case 201804657 (same reporter). Significant case amendment (19-Oct-2018): The description to be coded for the verbatim 'Received 1.5 ml dose instead of 0.5 ml' was changed form 'Extra dose administered' to 'Overdose'. The narrative and case comment were amended accordingly.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 54-year-old, adult, female patient. The patient had no relevant medical history. The patient was not taking any medication at the time of vaccination. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235, expiry date: 30-Jun-2019]. At the time of this report, no adverse events were reported. This case 201804659 was linked to the source case 201804657 due to the same reporter.
Age: 62.0
Sex: M
Vaccine: FLUC4
Symptoms: Generalised erythema
Clinical narrative: This non-serious spontaneous case, initially received from non-other health professional (consumer) on 12-Oct-2018 (combinedly processed with follow up received on 17-Oct-2018), concerns a 62-year-old, adult male patient. The patient's historical vaccine FLUCELVAX (batch number: 195227 and administered in 2017). The patient's historical procedure included thyroid removal (thyroidectomy). The patient's concomitant medication included SYNTHROID for an unknown indication.  On 10-Oct-2018, at 7:45 am, the patient was administered FLUCELVAX QIV [dose: single dose, batch number 252676, route of administration, anatomical location and expiry date: not reported). On the same day, after vaccination, in evening between 9:30 to 10:30 pm, the patient noticed (redness) on the upper arm and by the time he took shower, it spread to upper quadrant of his body. It was like glowing red over the patient's body. On 12-Oct-2018, the patient had recovered from the event. The reporter considered the causality of the event as not related to the suspect vaccine. Non-significant follow-up report received from reporter on 19-Nov-2018: The reporter's wife confirmed that the patient was feeling better at the time of the report and no new information was available. No changes were done in the narrative.
Age: 53.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a spontaneous case, received on 15-Oct-2018 from a pharmacist (Initial and follow-up 1 combinedly processed), concerns a 53-year-old, adult, male patient. On an unspecified date, FLUCELVAX QIVc was stored at a maximum temperature of 56 F for 8 hours following a power outage. On 14-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252268 and expiry date: 30-Jun-2019) which was stored inappropriately. At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious. This case 201804542 was cross-linked to source case: 201804533 due to same reporter.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, received from a pharmacist on 15-Oct-2018, (initial and follow-up 1 combinedly processed) concerns a 33-Year-old, adult female patient. On an unspecified date, FLUCELVAX QIVc was stored at a maximum temperature of 56 F for 8 hours following a power outage (explicitly coded as incorrect product storage). On 13-Oct-2018, the patient was administered FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 30-Jun-2019) which was stored inappropriately (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious. This case 201804538 was cross-linked to source case: 201804533 due to same reporter.
Age: 46.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 15-Oct-2018, (initial and follow up 1 combinedly processed) concerns a 46-year-old, adult male patient. On an unspecified date, FLUCELVAX QIVc was stored at a maximum temperature of 56F for 8 hours following a power outage. On 13-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 30-Jun-2019) which was stored inappropriately. At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious. This case 201804537 was cross-linked to source case: 201804533 due to same reporter.
Age: 34.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, received from a pharmacist on 15-Oct-2018, (initial and follow-up 1 combinedly processed), concerns a 34-year-old, adult male patient. On an unspecified date, FLUCELVAX QIVc was stored at a maximum temperature of 56 F for 8 hours following a power outage. On 14-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 30-Jun-2019) which underwent temperature excursion. No adverse event was reported. The reporter assessed the case as non-serious. This case 201804535 was cross linked to the case 201804533 (original case) reported by the same reporter.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received on 15-Oct-2018 from a pharmacist (initial and follow up 1 combinedly processed) concerns a 46-year-old, adult female patient. On an unspecified date, FLUCELVAX QIVc was stored at a maximum temperature of 56F for 8 hours following a power outage. On 14-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 30-Jun-2019] which was stored inappropriately. At the time of this report, no adverse event was reported. The reporter assessed this case as non-serious. This case 201804548 was cross-linked to source case: 201804533 due to the same reporter. Non-significant case amendment (15-Oct-2018): The sentence 'On 14-Oct-2018, the patient was administered' was added in the product description in narrative.
Age: 47.0
Sex: M
Vaccine: FLUC4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 47-year-old, adult, male patient. The patient had no relevant medical history and did not take any concomitant medications at the time of vaccination. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235, expiry date: 30-Jun-2019]. At the time of this report, no adverse events were reported. This case: 201804681 was cross-linked to the case 201804657 reported by the same reporter.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, received from a pharmacist on 15-Oct-2018, (initial and follow-up 1 combinedly processed), concerns a 47-year-old, adult female patient. On an unspecified date, FLUCELVAX QIVc was stored at a maximum temperature of 56F for 8 hours following a power outage. On 14-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 30-Jun-2019) which was stored inappropriately. No adverse event was reported. The reporter assessed this case as non-serious. This case 201804547 was cross-linked to the case 201804533 reported by the same reporter.
Age: 33.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 15-Oct-2018, (initial and follow-up 1 combinedly processed) concerns a 33-year-old, adult male patient. On an unspecified date, FLUCELVAX QIVc was stored at a maximum temperature of 56 F for 8 hours following a power outage (explicitly coded as incorrect product storage). On 14-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 30-Jun-2019) which was stored inappropriately (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious. This case 201804546 was cross-linked with the original case 201804533 due to the same reporter.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, received on 15-Oct-2018 from a pharmacist (initial and follow-up 1 combinedly processed), concerns a 34-year-old, adult female patient. On an unspecified date, FLUCELVAX QIVc was stored at a maximum temperature of 56F for 8 hours following a power outage. On 14-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 30-Jun-2019) which was stored inappropriately. At the time of this report, no adverse event was reported. The reporter assessed this case as non-serious. This case 201804545 was linked to source case 201804533 due to same reporter.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, received from a pharmacist on 15-Oct-2018, (initial and follow-up 1 combinedly processed), concerns a 56-year-old, adult female patient. On an unspecified date, FLUCELVAX QIVc was stored at a maximum temperature of 56 F for 8 hours following a power outage (explicitly coded as incorrect product storage). On 14-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 30-Jun-2019) which underwent temperature excursion (coded as drug administration error). No adverse event was reported. The reporter assessed the case as non-serious. This case 201804544 was cross-linked to the case 201804533 (original case) reported by the same reporter.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This spontaneous case, initial and follow-up (combinedly processed) received from a pharmacist on 15-Oct-2018, concerns a 48-year-old, adult female patient. It was reported that, the vaccine reached the maximum temperature of 56 Fahrenheit and was out of the recommended storage conditions for 8 hours. It was the first excursion. On 13-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: not reported) after being subjected to temperatures above 46 Fahrenheit. The reporter assessed this case as non-serious. This case 201804543 was cross-linked with the original case 201804533 due to the same reporter.
Age: 45.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, received from a pharmacist on 15-Oct-2018, (initial and follow-up 1 combinedly processed), concerns a 45-year-old, adult male patient. On an unspecified date, FLUCELVAX QIVc was stored at a maximum temperature of 56 F for 8 hours following a power outage. On 13-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 30-Jun-2019) which underwent temperature excursion. At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious. This case 201804541 was cross linked to the case 201804533 (original case) reported by the same reporter.
Age: 37.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, received on 15-Oct-2018 from a pharmacist (initial and follow-up 1 combinedly processed), concerns a 37-year-old, adult male patient. On an unspecified date, FLUCELVAX QIVc vaccine reached maximum temperature of 56 Fahrenheit and was out of the recommended storage conditions for 8 hours, which was reported to be the first excursion. On 13-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 30-Jun-2019] which was stored inappropriately. At the time of this report, no adverse events were reported. The reporter assessed this case as non-serious. This case 201804540 was cross-linked to source case: 201804533 due to same reporter.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 15-Oct-2018 and follow up received (initial and follow-up 1 combinedly processed), concerns a 38-year-old, adult female patient. On an unspecified date, FLUCELVAX QIVc was stored at a maximum temperature of 56F for 8 hours following a power outage. On 14-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 30-Jun-2019) which was stored inappropriately. At the time of this report, no adverse event was reported. The reporter assessed this case as non-serious. This case 201804539 was cross-linked to source case: 201804533 due to same reporter.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerning a 48-year-old, adult, female patient. The patient had no relevant medical history. The patient did not receive any concomitant medications. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 1.5 ml instead of 0.5 ml, batch number: 252235, expiry date: 30-Jun-2019, route of administration and anatomical location: not reported). At the time of the report, no adverse event was reported. This case 201804658 was cross-linked with the original case 201804657 due to the same reporter. Significant case amendment (19-Oct-2018): Description to be Coded was changed from 'extra dose administered' to 'overdose' for the event verbatim "Received 1.5 ml dose instead of 0.5 ml". Narrative and case comment was amended accordingly.
Age: 1.75
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from other health professional on 12-Oct-2018, concerns a 21-month-old, infant male patient. The patient had no historical condition. The patient did not receive any concomitant medication. On 12-Oct-2018, the infant patient was administered FLUCELVAX QIVc (dose: 0.5 ml, batch number: 252656, expiry date: 31-May-2019, route of administration and anatomical location: not reported). No adverse event was reported. The reporter assessed the case as non-serious. The reporter did not provide consent to follow-up. Hence, this case is considered as lost to follow-up.
Age: 53.0
Sex: M
Vaccine: FLUC4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 53-year-old, adult male patient. The patient had no relevant medical history. The patient did not receive any concomitant medications. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml instead of 0.5 ml (explicitly coded as overdose), route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235 and expiry date: 30-Jun-2019]. The patient did not experience any adverse events after administration of the vaccine. This case 201804662 was cross-linked with the original case 201804657 due to the same reporter. Significant case amendment (19-Oct-2018): The event coding for the verbatim 'Received 1.5 ml dose instead of 0.5 ml' was changed form 'Extra dose administered' to 'Overdose'. The narrative and case comment was amended accordingly.
Age: 63.0
Sex: M
Vaccine: FLUC4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This non-serious spontaneous case, initially received from other health professional on 19-Oct-2018 concerns a 63-year-old, adult, male patient. The patient did not have any medical history and did not take any concomitant medications at the time of vaccination. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc (route of administration: intramuscular, anatomical location: left deltoid, dose: 1.5 ml, batch number: 252235 and expiry date: 30-Jun-2019). At the time of this report, no adverse reaction was reported.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Migraine, Tachycardia
Clinical narrative: This is a spontaneous case, initially received on 17-Oct-2018, reported by other non-health professional, concerning a 50-year-old, adult female patient of weight 119 lbs and height 62 inches. The patient's historical vaccine included FLUCELVAX QIV which was tolerated in the past. On an unspecified date, the patient was administered FLUCELVAX QIV [dose, route of administration, anatomical location, batch number and expiry date: not reported].  On 17-Oct-2018, after vaccination, the patient experienced severe migraine and tachycardia. The patient was treated with MAXALT and MIDRIN. On 18-Oct-2018, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 1.17
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from other health professional on 19-Oct-2018, concerns a 1-year-old, infant male patient. The patient had no historical condition. The patient did not receive any concomitant medications. On 16-Oct-2018, the infant patient (under age of 4 years) was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left thigh, batch number: 252660 and expiry date: 31-May-2019). At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a spontaneous case, initially received from a pharmacies on 15-Oct-2018 (initial and follow-up 1 combinedly processed), concerning a 55-year-old, adult, female patient. On an unspecified date, FLUCELVAX QIVc was stored at a maximum temperature of 56 F for 8 hours following a power outage (explicitly coded as incorrect product storage). On 13-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668, expiry date: 30-Jun-2019) which underwent temperature excursion (explicitly coded as product administration error). No adverse event was reported. The reporter assessed this case as non-serious. Non-significant case amendment (15-Oct-2018): The term 'administration error' was replaced with 'product administration error' in narrative and ease comment.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Product storage error, Vaccination error
Clinical narrative: This spontaneous case, initially received from other health professional (nurse) on 22-Oct-2018, concerns a 30-year-old, adult female patient. The patient had no relevant medical history and had not received any concomitant medications. It was reported that, on an unspecified date, the vaccine underwent temperature excursion. On 22-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, anatomical location: deltoid, batch number: 252657 (reported as 2526577), expiry date: 30-Jun-2019 and route of administration: not reported] that underwent temperature excursion. The reporter assessed this case as non-serious.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous case, initially received from other health professional on 18-Oct-2018, concerning a 43-year-old, adult female patient. The patient had no medical history and did not receive any concomitant medications. On 18-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: subcutaneous, anatomical location: left upper arm, batch number: 252227 (reported as 25227) and expiry date: 31-May-2019). At the time of this report, the patient did not experience any adverse events. The reporter assessed the case as non-serious.
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This spontaneous case, initially received on 18-Oct-2018, reported by other healthcare professional (nurse), concerns a 22-year-old adult female patient. The patient did not receive any concomitant medications. On 15-Oct-2018 (Monday), the patient was administered FLUCELVAX QIVc [ dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252234 and expiry date: 30-Jun-2019]. On 16-Oct-2018 (Tuesday), 1 day after vaccination, the patient developed a red, warm and hard area at the injection site. The patient received ibuprofen, BENADRYL and put cold compresses. But treatment medications did not relieve the symptoms. It was reported that, the patient was not hospitalized. At the time of this report, the patient had not yet recovered from the events. The reporter assessed this case as non-serious.
Age: 1.42
Sex: U
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 19-Oct-2018, concerns a 17-month-old, infant of unspecified gender. On an unspecified date, the patient (less than 4 years) was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration, anatomical location, batch number and expiry date: not reported). At the time of this report, no adverse event was reported.
Age: 30.0
Sex: M
Vaccine: FLUC4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This is a spontaneous case, initially received from other health professional on 19-Oct-2018, concerning a 30-year-old, adult male patient. The patient had no relevant medical history. The patient was not taking any medication at the time of vaccination. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235 and expiry date: 30-Jun-2019]. It was reported that the health care professional (HCP) followed up with the patient. At the time of this report, no adverse events were reported. This case is linked to 201804657 owing to same reporter. Significant case amendment (19-Oct-2018): The description to be coded for the verbatim "Received 1.5 ml dose instead of 0.5 ml' was changed from 'Extra dose administered' to 'Overdose'. The narrative and case comment were amended accordingly.
Age: 38.0
Sex: M
Vaccine: FLUC4
Symptoms: Incorrect dose administered, Pain, Pyrexia
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 38-year-old, adult male patient. The patient had no relevant medical history. The patient did not receive any concomitant medications. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 1.5 ml instead of 0.5 ml, batch number: 252235, expiry date: 30-Jun-2019, anatomical location and route of administration: not reported). On the same day, after vaccination, the patient experienced fever and body aches. On 11-Oct-2018, the patient had recovered from the events and he was fine. This case 201804666 was cross-linked with the original case 201804657 due to the same reporter. Significant case amendment (19-Oct-2018): The description to be coded for the verbatim Received 1.5 ml dose instead of 0.5 ml in the event tab was changed from extra dose administered to overdose. The narrative and case comment amended accordingly.
Age: 30.0
Sex: M
Vaccine: FLUC4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerning a 30-year-old, adult male patient. The patient had no relevant medical history. The patient did not receive any concomitant medications. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235 and expiry date: 30-Jun-2019]. At the time of this report, no adverse event was reported. This case 201804667 was cross-linked with the original case 201804657 due to the same reporter. Significant case amendment (19-Oct-2018): The event was corrected from 'extra dose administered' to 'overdose'. The narrative and case comment were amended accordingly.
Age: 32.0
Sex: M
Vaccine: FLUC4
Symptoms: Incorrect dose administered, Pain
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 32-year-old, adult male patient. The patient had no relevant medical history and had not received any concomitant medications. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235 and expiry date: 30-Jun-2019). On an unspecified date in Oct-2018, after vaccination, the patient experienced soreness. On 17-Oct-2018, the patient still had a bit soreness but was fine (recovering). This case 201804680 was cross-linked with the original case 201804657 due to the same reporter. Significant case amendment (19-Oct-2018): The description to be coded for the verbatim 'Received 1.5 ml dose instead of 0.5 ml' in the event tab was changed from extra dose administered to overdose. The narrative and case comment amended accordingly.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal pain upper, Injection site pain, Migraine
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 64-year-old, adult, female patient. The patient had no relevant medical history. The patient was not taking any medication at the time of vaccination. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235, expiry date: 30-Jun-2019]. On 10-Oct-2018, the patient had a migraine episode which might be due to the flu shot (as reported by reporter). On an unspecified date in Oct-2018, the patient also experienced stomach aches and injection site pain. On 15-Oct-2018, the patient was followed up via phone call. It was noted that the patient was much better. The stomach aches were resolved on an unspecified date. Upon the call, the patient confirmed that she only had injection site pain which was persistent at that moment of the call. At the time of this report, the event migraine was resolving, stomach ache had resolved but the event injection site pain had not resolved. This case (201804665) was linked to the source case 201804657 due to the same reporter.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 15-Oct-2018, (initial and follow-up 1 combinedly processed) concerns a 57-year-old, adult female patient. On an unspecified date, FLUCELVAX QIVc was stored at a maximum temperature of 56 F for 8 hours following a power outage. On 13-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 30-Jun-2019) which was stored inappropriately. At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious. This case 201804534 was cross-linked to source case: 201804533 due to same reporter.
Age: 41.0
Sex: M
Vaccine: FLUC4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 41-year-old, adult male patient. The patient had no relevant medical history. The patient was not taking any concomitant medication at the time of vaccination. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235, expiry date: 30-Jun-2019]. At the time of this report, no adverse events were reported. This case was linked to original case 201804657 due to same reporter. Significant case amendment (19-Oct-2018): The description to be coded for the verbatim 'Received 1.5 ml dose instead of 0.5 ml' was changed from 'Extra dose administered' to 'Overdose'. The causality rationale was changed from 'The company assessed the causality of the event as not related to the suspect vaccine, considering the event as incidental in nature' to 'The company assessed the causality of the event as not related to the suspect vaccine, considering the event as accidental nature (medication error)'. The narrative and case comment was amended accordingly.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 60-year-old, adult, female patient. The patient had no relevant medical history and did not take any concomitant medications at the time of vaccination. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235, expiry date: 30-Jun-2019]. At the time of this report, no adverse events were reported. This case 201804677 was linked to the source case 201804657 due to the same reporter.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Dry eye, Incorrect dose administered, Influenza like illness, Pain
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 33-year-old, adult, female patient. The patient had no relevant medical history and did not take any concomitant medications at the time of vaccination. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235, expiry date: 30-Jun-2019]. On 10-Oct-2018, one day after vaccination, the patient felt like she was getting the flu. In addition, the patient experienced body aches and dry eyes. At the time of this report, the patient was recovering from the events. This case 201804678 was cross-linked to the source case: 201804657 reported by the same reporter.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect dose administered, Malaise, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: This is a spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerning a 45-year-old, adult, female patient. The patient had no relevant medical history and concomitant medications. On 09-Oct-2018, the patient was administered with FLUCELVAX QIV (dose: 1.5 ml, route of administration: not reported, anatomical location: left deltoid, batch number: 252235, expiry date: 30-Jun-2019) also the patient received 1.5 ml instead of 0.5 ml. On 10-Oct-2018, 1 day after vaccination, it was stated that, the patient was not feeling well, and she had a feeling that, she was going to get sick. The patient also stated that, her arm was about 1 inch swollen, warm and was a bit sore. It was also stated by the patient that, on 15-Oct-2018 her arm was still a bit warm and was swollen. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious. This case was linked to case 201804657 due to same reporter. Significant case amendment (19-Oct-2018): The description to be coded for the verbatim 'Received 1.5 ml dose instead of 0.5 ml' was changed from 'Extra dose administered' to 'Overdose'. The narrative and case comment were amended accordingly.
Age: 49.0
Sex: M
Vaccine: FLUC4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 49-year-old, adult, male patient. The patient had no relevant medical history and did not take any concomitant medications at the time of vaccination. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235, expiry date: 30-Jun-2019]. At the time of this report, no adverse events were reported. This case: 201804674 was cross-linked to the case: 201804657 reported by the same reporter.
Age: 36.0
Sex: M
Vaccine: FLUC4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 36-year-old, adult, male patient. The patient had no relevant medical history. The patient was not taking any medication at the time of vaccination. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235, expiry date: 30-Jun-2019]. At the time of this report, no adverse events were reported (reported as no problems). This case: 201804665 was cross-linked to the source case: 201804657 reported by the same reporter.
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect dose administered, Pyrexia
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a female patient of unspecified age. The patient had no relevant medical history. The patient was not taking any medication at the time of vaccination. On 09-Oct-2018, the patient was administered FLUCELVAX QIVC [dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235, expiry date: 30-Jun-2019]. On the same day, after vaccination, the patient developed fever. The patient was reported to have been feeling better on the day, she was followed up by her healthcare professional (11-Oct-2018). On the following follow up (on 15-Oct-2018), the patient stated that she had no problems. At the time of this report, the patient was recovering from the event. This case was linked to original case 201804657 due to same reporter. Significant case amendment (19-Oct-2018): Description to be Coded was changed from 'extra dose administered' to 'overdose' for the event verbatim: "Received 1.5 ml dose instead of 0.5 ml". Narrative and case comment were amended accordingly.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Fatigue, Incorrect dose administered, Inflammation, Malaise, Pain
Clinical narrative: This is a non-serious spontaneous case, initially received from other healthcare professional (nurse) on 19-Oct-2018 and concerns a 38-year-old, adult, female patient. The patient had no relevant medical history and had not received any medication at the time of vaccination. On 09-Oct-2018, the patient was administered 1.5 ml dose instead of 0.5 ml FLUCELVAX QIVc (dose: 1.5 ml, batch number: 252235, expiry date: 20-Jun-2019, route of administration and anatomical location: not reported] (explicitly coded as overdose). On the next day after vaccination, the patient went home early because she wasn't feeling well, and she fell asleep because she was feeling tired and achy. On 11-Oct-2018, 2 days after vaccination, the patient's arm was super "extremely" inflamed, sore and she thinks she might have a different type of reaction. On 12-Oct-2018, 3 days after the vaccination, the patient ended up going to the urgent care because she had a rash. It was reported that, her arm was feverish and warm at that time. The doctor advised the patient to take BENADRYL and mentioned that there was no sign of infection, it was just a reaction on the vaccine. On 15-Oct-2018, the patient reported that, the arm was not bruised, not warm and she was no longer in pain, hence recovered from the events pain in extremity, pain and warm skin. The outcome of the event (inflammation, malaise, rash and fatigue) was not reported.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity, Rash, Skin warm, Somnolence
Clinical narrative: This is a non-serious spontaneous case, initially received from other healthcare professional (nurse) on 19-Oct-2018 and concerns a 38-year-old, adult, female patient. The patient had no relevant medical history and had not received any medication at the time of vaccination. On 09-Oct-2018, the patient was administered 1.5 ml dose instead of 0.5 ml FLUCELVAX QIVc (dose: 1.5 ml, batch number: 252235, expiry date: 20-Jun-2019, route of administration and anatomical location: not reported] (explicitly coded as overdose). On the next day after vaccination, the patient went home early because she wasn't feeling well, and she fell asleep because she was feeling tired and achy. On 11-Oct-2018, 2 days after vaccination, the patient's arm was super "extremely" inflamed, sore and she thinks she might have a different type of reaction. On 12-Oct-2018, 3 days after the vaccination, the patient ended up going to the urgent care because she had a rash. It was reported that, her arm was feverish and warm at that time. The doctor advised the patient to take BENADRYL and mentioned that there was no sign of infection, it was just a reaction on the vaccine. On 15-Oct-2018, the patient reported that, the arm was not bruised, not warm and she was no longer in pain, hence recovered from the events pain in extremity, pain and warm skin. The outcome of the event (inflammation, malaise, rash and fatigue) was not reported.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 56-year-old, adult female patient. The patient had no relevant medical history and did not receive any concomitant medications. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235, expiry date: 30-Jun-2019). No adverse events reported after administration of the vaccine. This case 201804689 was cross-linked with the original case 201804657 due to the same reporter. Significant case amendment (19-Oct-2018): The lower level term of the event (received 1.5 ml dose instead of 0.5 ml) was corrected from extra dose administered to overdose in the event tab. The narrative and case comment were amended accordingly.
Age: 6.0
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case, initially received on 26-Oct-2018, reported by other healthcare professional (nurse) concerns 6-year-old, child female patient. The patient had no relevant medical history. The patient was not taking any concomitant medication at the time of vaccination. On 26-Oct-2018, the patient was administered expired vaccine FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left thigh, batch number: 195245 and expiry date: 18-Jun-2018]. At the time of this report, no adverse event was reported after the vaccine administration. The reporter assessed this case as non-serious.
Age: 1.75
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from other health professional (nurse) on 17-Oct-2018, concerns a 21-month-old, infant, male patient. The patient had no relevant medical history. The patient did not receive any concomitant medication. On 17-Oct-2018, the patient (under age of 4 years) was administered FLUCELVAX QIVc (dose: 0.5 ml, batch number: 252232, expiry date: 31-May-2019, route of administration: intramuscular, anatomical location: thigh). No adverse event or adverse reaction was reported. The reporter assessed the event as non-serious.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 46-year-old, adult, female patient. The patient had no relevant medical history and concomitant medications. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml, anatomical location: left deltoid, batch number: 252235, expiry date: 30-Jun-2019, route of administration: intramuscular]. At the time of this report, no adverse events were reported. This case 201804664 was cross-linked to the source case 201804657 due to the same reporter. The reporter assessed the case as non-serious.