chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from the other health professional (nurse) on 07-Nov-2018, concerns a 42-year-old, adult male patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 252227 and expiry date: 31-May-2019) which underwent temperature excursion. The patient experienced no adverse event after the vaccination. This case (201805345) was cross-linked to the source case 201805327 reported by the same reporter. The reporter assessed this case as non-serious. Follow-up received from the nurse on 28-Nov-2018: Age of the patient was added in the patient tab. Route of administration and anatomical location was added in the product tab. It was reported that the patient had not experienced any adverse event after the vaccination. Narrative and case comment were amended accordingly.
Age: 77.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 77-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius. On 19-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805441 was crossed linked to original case 201804863 due to same reporter.
Age: 66.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 66-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius. On 22-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number; 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805437 was crossed linked to original cases 201804863 due to same reporter.
Age: 20.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received on 07-Nov-2018, from other health professional (nurse), concerns a 20-year-old, adult, female patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, batch number: 252227, expiry date: 31-May-2019, route of administration: intramuscular and anatomical location: left deltoid) which underwent temperature excursion. The patient did not experience any adverse reactions after the vaccination. The reporter assessed this case as non-serious. This case (201805348) was cross-linked to the source case 201805327 due to same reporter. Follow-up report received from other health profession on 28-Nov-2018: The patient's age (20-year-old) was added. The route of administration (intramuscular) and anatomical location (left deltoid) of suspect vaccine were added in the product tab. The reporter confirmed that, the patient did not experience any adverse reactions. The narrative and case comment were amended accordingly.
Sex: M
Vaccine: FLUC4
Symptoms: Incorrect route of product administration, Product administered at inappropriate site, Skin discolouration, Wrong product administered
Clinical narrative: This is a non-serious spontaneous case, initially received from other health professional on 13-Nov-2018, concerning a male patient of an unspecified age. On 10-Nov-2018, the patient was administered FLUCELVAX QIVc (dose: 0.1 ml, route of administration: subdermal, anatomical location forearm, batch number: 252227 and expiry date: 31-May-2019). It was reported that the patient was accidently administered FLUCELVAX QIVc instead of tuberculin injection. On the same day after vaccination, the patient developed a discoloration. The outcome of the event was not reported. The reporter assessed this case as non-serious.
Sex: M
Vaccine: FLUC4
Symptoms: Device leakage, Product closure issue, Wrong technique in product usage process
Clinical narrative: This is a spontaneous case, initially received from other non-health professional on 14-Nov-2018, concerning a male patient of unspecified age. It was reported that, whenever the flu vaccine was withdrawn, the vaccine leaked out from the rubber stopper. As the secured lock was popped off the vial the rubber stopper was dented in and off a little. It was reported that, when the nurses removed the hard cap and stuck the needle in the middle, there was a corner on the top where the rubber stopper was dented in causing a hole where the medication leaked. On 03-Oct-2018, 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] from a leaked vial. There were only 5 doses left out of the 10 doses in the vial. It was reported that sample vials were available in which they had one opened vial and 46 left. The package was not damaged, but the rubber stopper was damaged. From the withdrawal of first vaccine, the leakage was observed. The needle used was 25-gauge needle and the syringe were 3 ml syringe. The user had added air to the vial from the syringe. At the time of this report, no adverse event was reported. This case is linked to case 201805390 (same reporter). This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding product technical complaint (PTC) reference number was 1034101. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 252234 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process. A follow-up revealed the complainant was adding air to the vial prior to extracting doses and was inverting the vial when withdrawing the needle from the stopper. It is known that the addition of air to the vial can over pressurize the vial and cause leaking. In addition, inverting the vial while trying to extract a dosage can increase the potential for the vial to leak. The root cause for this investigation was found to be User-Improper Handling. The reporter assessed the case as non-serious. Follow up report received from QA department on 19-Nov-2018: The QA investigation report stated that, the root cause for the leaking FLUCELVAX MDV of Batch 252334 was due to user or improper handling. Added new event (wrong technique in product usage process) in event tab. The narrative was amended accordingly.
Age: 43.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 43-year-old, adult patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 16-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805460 was crossed linked to original cases 201804863 due to same reporter.
Sex: M
Vaccine: FLUC4
Symptoms: Device leakage, Product closure issue, Wrong technique in product usage process
Clinical narrative: This is a spontaneous case, initially received from other non-health professional on 14-Nov-2018, concerning a male patient of unspecified age. It was reported that, whenever the flu vaccine was withdrawn, the vaccine leaked out from the rubber stopper. As the secured lock was popped off the vial the rubber stopper was dented in and off a little. It was reported that, when the nurses removed the hard cap and stuck the needle in the middle, there was a corner on the top where the rubber stopper was dented in causing a hole where the medication leaked. On 04-Oct-2018, 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] from a leaking vial. There were only 5 doses left out of the 10 doses in the vial. It was reported that sample vials were available in which they had one opened vial and 46 left. The package was not damaged, but the rubber stopper was damaged. From the withdrawal of first vaccine, the leakage was observed. The needle used was 25-gauge needle and the syringe were 3 ml syringe. The user had added air to the vial from the syringe. At the time of this report, no adverse event was reported. This case is linked to case 201805389 due to same reporter. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding product technical complaint (PTC) reference number was 1034101. Based on the QA Investigation report, it was concluded that FLUCELVAX Batch 252234 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process. A known trend was identified for the FLUCELVAX batches from the 2018/2019 FLUCELVAX commercial season for vials leaking at the stopper during dosing. A review revealed that the complainant was adding air to the vial prior to extracting doses and was inverting the vial when withdrawing the needle from the stopper. It is known that the addition of air to the vial can over pressurize the vial and cause leaking. In addition, inverting the vial while trying to extract a dosage can increase the potential for the vial to leak. The root cause for this investigation was found to be user-improper handling. The reporter assessed the case as non-serious. Follow up report received from QA department on 19-Nov-2018: The QA investigation report stated that, the root cause for the leaking FLUCELVAX MDV of Batch 252234 was due to user or improper handling. Added new event (wrong technique in product usage process) in event tab. The narrative and the case comment were amended accordingly.
Age: 64.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 64-year-old, adult patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 23-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805420 was crossed linked to original case 201804863 due to same reporter.
Age: 67.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 67-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius. On 23-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805421 was crossed linked to original case 201804863 due to same reporter.
Age: 67.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 67-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 23-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805424 was crossed linked to original cases 201804863 due to same reporter.
Age: 74.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 74-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 22-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805428 was crossed linked to original case 201804863 due to same reporter.
Age: 65.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 65-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 17-Oct-2018, the patient was administered FLUCELVAX QIVc [[route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805459 was crossed linked to original cases 201804863 due to same reporter.
Age: 67.0
Sex: U
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 67-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius. On 10-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805505 was crossed linked to original cases 201804863 due to same reporter.
Age: 74.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 74-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 10-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805503 was crossed linked to the original case 201804863 due to same reporter.
Age: 71.0
Sex: U
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 71-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 17-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: right deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805458 was crossed linked to the original case 201804863 due to same reporter.
Age: 68.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 68-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius. On 22-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: right deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805427 was crossed linked to original case 201804863 due to same reporter.
Age: 68.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 68-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 22-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805430 was crossed linked to original case 201804863 due to same reporter.
Age: 76.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 76-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius. On 18-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. At the time of this report, no adverse event was reported. This case 201805443 was crossed linked to the original cases 201804863 due to same reporter.
Age: 78.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 78-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 17-Oct-2018, the patient was administered FLUCELVAX QIVc which underwent temperature excursion [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported]. At the time of this report, no adverse event was reported. This case 201805453 was crossed linked to original case 201804863 due to same reporter.
Age: 79.0
Sex: U
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 79-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius. On 17-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: right deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805457 was crossed linked to original cases 201804863 due to same reporter.
Age: 65.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 65-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 16-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805464 was crossed linked to original cases 201804863 due to same reporter.
Age: 81.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns an 81-year-old, elderly patient of unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 11-Oct-2018, the patient was administered FLUCELVAX QIVc (route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported) which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805495 was crossed linked to original cases 201804863 due to same reporter.
Age: 60.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 60-year-old, adult patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius. On 11-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805497 was crossed linked to original cases 201804863 due to same reporter.
Age: 80.0
Sex: U
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns an 80-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 10-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2018 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805500 was crossed linked to original case 201804863 due to same reporter.
Age: 77.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 77-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius. On 10-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805501 was crossed linked to original cases 201804863 due to same reporter.
Age: 60.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 60-year-old, adult patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius. On 10-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: right deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805509 was crossed linked to original cases 201804863 due to same reporter.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 61-year-old, adult patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the firs time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 10-Oct-2018, the patient was administered FLUCELVAX QIVc [batch number: 252230, route of administration: intramuscular, anatomical location: left deltoid, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805510 was crossed linked to original case 201804863 due to same reporter.
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 14-Nov-2018, concerning a female patient of unspecified age. On an unspecified date, the FLUCELVAX QIVc vaccine underwent first temperature excursion with maximum temperature (Tmax) 8.2 degree Celsius for 4 minutes. On 22-Oct-2018, vaccine underwent second temperature excursion with Tmax 9.8 degree Celsius for 23 minutes. On an unspecified date, two temperature excursions were identified after an audit. On 26-Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 252672 and expiry date: 30-Jun-2019) which underwent temperature excursion. The patient did not experience any adverse effect after the vaccination. This case is linked to 201805262 (same reporter).
Sex: M
Vaccine: FLUC4
Symptoms: Erythema, Eye infection, Swelling, Vertigo
Clinical narrative: This spontaneous case, initially received from a physician on 15-Nov-2018, concerning a male patient of an unspecified age (reported as 40-50 years of age). On 12-Nov-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252683, expiry date: not reported). On the same day, after vaccination, the patient contracted an eye infection and experienced localized swelling, redness and vertigo. The physician had monitored the infection and said that the infection 'seems to be better'. The physician confirmed that no treatment measures were associated with the events. The outcome of the events was resolved on 15-Nov-2018. At the time of this report, the patient was well. The reporter assessed the case as non-serious and considered the causality of the events as related to the suspect product.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Tremor
Clinical narrative: Patient had severe chills and shaking which lasted almost 24 hours. Husband is a physician and gave her diazepam to treat the shaking. Patient did not have any reaction after 1st dose. Patient completely normal after 24 hours.
Age: 23.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Arthralgia, Asthenia, Hypotonia, Musculoskeletal pain, Myalgia
Clinical narrative: Severe muscle and joint pain, sharp shooting pain from back of shoulder to hand, weakness, muscle loss.
Age: 23.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Severe muscle and joint pain, sharp shooting pain from back of shoulder to hand, weakness, muscle loss.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Injection site movement impairment, Injection site pain, Injection site swelling, Sleep disorder
Clinical narrative: Pain, swelling of left thigh, not moving left leg, could not change position in lying, sleep disturbance.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Body temperature increased, Irritability
Clinical narrative: Fussy through the night and awoke with a 100 degree temperature (taken with digital thermometer underarm).
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Myalgia, Nausea, Pain, Paraesthesia
Clinical narrative: Low fever, body aches, muscular aches, stomach nausea, tingling in left hand.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Low fever, body aches, muscular aches, stomach nausea, tingling in left hand.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Pain, Tenderness
Clinical narrative: The morning after the second dose of SHINGRIX in my upper left arm, my left armpit swelled up and became very tender to the touch for about 4 days. Finally the swelling and pain abated, lasting about a week.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Blood test normal, Body temperature increased, Chest X-ray normal, Crying, Decreased appetite
Clinical narrative: Elevated temperature of 103.7 degrees under the arm, lethargy, unresponsive, loss of appetite, 1/24/2019 3:45- Mom notices baby becomes very fussy around 3:45 pm. Takes temp and it is 100.8 under the arm. Mom administers 1.25mL of infant Motrin Baby is extra sleepy and goes to bed around 6:00pm. Baby is fussy through the night 1/25/2019 12:00am- Mom wakes up to baby crying. Notices baby is extremely hot. Tries to administer 1.25mL of Motrin when baby starts convulsing and throwing up 12:04- Mom takes temperature under the arm and it reads 103.7 degrees 12:12am- Mom calls the on call nurse at the pediatrician office. While on the phone baby convulses two more times. 12:13- calls 911 12:38- Arrive at ER roughly 3:30am- admitted to hospital As of 9:35 am.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Influenza, Influenza virus test negative, Irritability, Lethargy, Seizure
Clinical narrative: Elevated temperature of 103.7 degrees under the arm, lethargy, unresponsive, loss of appetite, 1/24/2019 3:45- Mom notices baby becomes very fussy around 3:45 pm. Takes temp and it is 100.8 under the arm. Mom administers 1.25mL of infant Motrin Baby is extra sleepy and goes to bed around 6:00pm. Baby is fussy through the night 1/25/2019 12:00am- Mom wakes up to baby crying. Notices baby is extremely hot. Tries to administer 1.25mL of Motrin when baby starts convulsing and throwing up 12:04- Mom takes temperature under the arm and it reads 103.7 degrees 12:12am- Mom calls the on call nurse at the pediatrician office. While on the phone baby convulses two more times. 12:13- calls 911 12:38- Arrive at ER roughly 3:30am- admitted to hospital As of 9:35 am.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Skin warm, Somnolence, Unresponsive to stimuli, Urine analysis normal, Vomiting
Clinical narrative: Elevated temperature of 103.7 degrees under the arm, lethargy, unresponsive, loss of appetite, 1/24/2019 3:45- Mom notices baby becomes very fussy around 3:45 pm. Takes temp and it is 100.8 under the arm. Mom administers 1.25mL of infant Motrin Baby is extra sleepy and goes to bed around 6:00pm. Baby is fussy through the night 1/25/2019 12:00am- Mom wakes up to baby crying. Notices baby is extremely hot. Tries to administer 1.25mL of Motrin when baby starts convulsing and throwing up 12:04- Mom takes temperature under the arm and it reads 103.7 degrees 12:12am- Mom calls the on call nurse at the pediatrician office. While on the phone baby convulses two more times. 12:13- calls 911 12:38- Arrive at ER roughly 3:30am- admitted to hospital As of 9:35 am.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Bronchitis, Fatigue, Feeling abnormal, Headache, Injection site pain
Clinical narrative: I was a very healthy 59 year old man who is slim and in good shape 5'9" 162 lbs I worked out 3 times a week and did 2 sets of 15 pushups 3 times a week for the last 10 years. I have been on a downward trend since getting the first vaccine. Horrible pain in my right shoulder that radiates up towards my neck. Shooting nerve pains down my left leg and have felt extreme fatigue and have a dull headache every day. Shortly after getting the vaccine I got slight bronchitis. I also think the shot was administer too high I have severe pain in my right shoulder and have MRI scheduled on that. I have went from a guy that did 90 push ups a week to one that can't complete 1 push up due to the pain in my shoulder. I feel as though I have been poisoned.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Neck pain, Neuralgia
Clinical narrative: I was a very healthy 59 year old man who is slim and in good shape 5'9" 162 lbs I worked out 3 times a week and did 2 sets of 15 pushups 3 times a week for the last 10 years. I have been on a downward trend since getting the first vaccine. Horrible pain in my right shoulder that radiates up towards my neck. Shooting nerve pains down my left leg and have felt extreme fatigue and have a dull headache every day. Shortly after getting the vaccine I got slight bronchitis. I also think the shot was administer too high I have severe pain in my right shoulder and have MRI scheduled on that. I have went from a guy that did 90 push ups a week to one that can't complete 1 push up due to the pain in my shoulder. I feel as though I have been poisoned.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Nausea, Pain
Clinical narrative: Flu like symptoms, body ache, extreme tired worn out feeling, headache, nausea.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Unresponsive to stimuli
Clinical narrative: PATIENT COMPLAINED OF HE WAS FEELING LIKE HE WAS GOING TO FAINT. HE WAS ASKED TO SIT ON THE FLOOR AND LIE DOWN. HIS BREATHING WAS NORMAL, THEN HE WILL NOT RESPOND TO HIS NAME WHEN CALLED FOR A FEW SECONDS. 911 AND EMS WAS ALERTED. IN 10 MINUTES THEY ARRIVED AND PATIENT HAD BEEN UP WAS TALKING FEELING LIKE HIMSELF, HE WAS OFFERED A BOTTLE OF WATER. AFTER ASSESSMENT FROM EMS HE DECIDED TO GO HOME AND REST FOR THE EVENING.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient came in last night to the pharmacy and speak to the other pharmacist. She said the right arm where she got the PNEUMOVAX vaccine was red and swollen. She went to the urgent care and got KEFLEX and BACTRIM but said the doctor was not certain it is an infection. Alen recommended to take her antibiotics and we would check in the next day with the patient. I called the patient twice today at 9am and 10am but had to leave a message for patient to call back.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Insomnia
Clinical narrative: PT COMPLAINED OF BAD PAIN IN LEFT ARM NEAR SHOULDER AND DOWN TO ELBOW. HE WAS GIVEN THE SHOT AROUND 6PM. PT DID NOT EVEN FEEL IT. THERE ALSO WAS NOT ANY BLOOD FROM THE INJECTION AND HE IS ON BLOOD THINNERS. HE LEFT THE PHARMACY PERFECTLY FINE. CALLED ME SATURDAY 9AM AND SAID FROM 9PM THE PREVIOUS NIGHT HE HAD PAIN IN HIS SHOULDER AND HAD DIFFICULTY SLEEPING.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Oropharyngeal pain
Clinical narrative: Patient started experiencing chest tightness last night on 1/25/2019 mostly exercise induced. Today she is experiencing sore throat and chest tightness. The symptoms are not worsening and slightly better.
Age: 56.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Cellulitis, Chills, Erythema, Hyperhidrosis, Injection site pain
Clinical narrative: Patient reports that she experienced muscle pain in the arm around the area where the vaccines were given later in the afternoon on 1-13-19. Later that evening she reports having a fever and chills, and by 3am the next morning woke with a high fever and sweating with redness and swelling in her arm. She went to see her PCP, the next day. She reports being diagnosed with cellulitis and given an injection and a course of oral clindamycin. The condition resolved completely by the time of reporting.
Age: 56.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Patient reports that she experienced muscle pain in the arm around the area where the vaccines were given later in the afternoon on 1-13-19. Later that evening she reports having a fever and chills, and by 3am the next morning woke with a high fever and sweating with redness and swelling in her arm. She went to see her PCP, the next day. She reports being diagnosed with cellulitis and given an injection and a course of oral clindamycin. The condition resolved completely by the time of reporting.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reports itching, swelling, and tenderness around injection site. She treated the reaction with an ice pack and acetaminophen. Upon reporting reaction to the pharmacy on 1/26/19, she says that the reaction has subsided but began within 24 hours of receiving the vaccine.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Pain
Clinical narrative: Pain at injection site and generalized malaise and body aches x 24 hrs.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Extreme redness and swellign to the underside of the arm.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Musculoskeletal pain, Periarthritis
Clinical narrative: Shoulder pain that lasted months, eventually diagnosed as frozen shoulder syndrome, still having pain now, doctor recommended physical therapy.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, CSF culture negative, CSF glucose decreased, CSF lymphocyte count normal, CSF neutrophil count increased
Clinical narrative: On 1/13, she developed low back pain.  8-9 days later, she woke up with bilateral leg numbness and tingling with weakness from hips to feet. She was admitted to the hospital where she had an MRI of her brain, complete spine that showed enhancement of the grey matter of the spinal cord in the optic radiations, brain stem, cervical-thoracic spinal cord. She was diagnosed with presumed acute flaccid myelitis. She received IVIG inpatient with improvement of symptoms.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: CSF protein increased, CSF red blood cell count positive, CSF white blood cell count increased, Hypoaesthesia, Hypotonia
Clinical narrative: On 1/13, she developed low back pain.  8-9 days later, she woke up with bilateral leg numbness and tingling with weakness from hips to feet. She was admitted to the hospital where she had an MRI of her brain, complete spine that showed enhancement of the grey matter of the spinal cord in the optic radiations, brain stem, cervical-thoracic spinal cord. She was diagnosed with presumed acute flaccid myelitis. She received IVIG inpatient with improvement of symptoms.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Immunoglobulin therapy, Muscular weakness, Myelitis, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: On 1/13, she developed low back pain.  8-9 days later, she woke up with bilateral leg numbness and tingling with weakness from hips to feet. She was admitted to the hospital where she had an MRI of her brain, complete spine that showed enhancement of the grey matter of the spinal cord in the optic radiations, brain stem, cervical-thoracic spinal cord. She was diagnosed with presumed acute flaccid myelitis. She received IVIG inpatient with improvement of symptoms.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging thoracic abnormal, Paraesthesia
Clinical narrative: On 1/13, she developed low back pain.  8-9 days later, she woke up with bilateral leg numbness and tingling with weakness from hips to feet. She was admitted to the hospital where she had an MRI of her brain, complete spine that showed enhancement of the grey matter of the spinal cord in the optic radiations, brain stem, cervical-thoracic spinal cord. She was diagnosed with presumed acute flaccid myelitis. She received IVIG inpatient with improvement of symptoms.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: Day #1: Fever 102.5, rigors, headache, malaise. Day #2: Fever 100.2, malaise, fatigue, headache.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Fatigue, muscle pain, and pounding headache.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Extreme soreness at injection site lasting over 2 weeks. Pt states used NORCO to help pain.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Decreased appetite, Diarrhoea, Discomfort, Irritability, Vomiting
Clinical narrative: Vomiting x2, diarrhea x5, irritability and loss of appetite over 5 days post injection. Side effects ongoing at time of report. Behavior normal outside of discomfort.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Anaphylactic reaction, Blood pressure decreased, Chest discomfort, Electrocardiogram, Flushing
Clinical narrative: Within 20 minutes I had a severe anaphylactic reaction blood pressure dropping, pulse rapid, flushing of the face and was unresponsive, EPIPEN was injected in left thigh and transported by ambulance to ER. Given steroids, BENADRYL, monitored. Sent home, next day tightness in chest, fullness in that and flushing presented again, went back to ER given BENADRYL and steroids, given prescription for prednisone 3 times a day for 5 days and BENADRYL 50 mg every 6hours for 2 days. Still awaiting final outcome.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Heart rate increased, Troponin, Unresponsive to stimuli
Clinical narrative: Within 20 minutes I had a severe anaphylactic reaction blood pressure dropping, pulse rapid, flushing of the face and was unresponsive, EPIPEN was injected in left thigh and transported by ambulance to ER. Given steroids, BENADRYL, monitored. Sent home, next day tightness in chest, fullness in that and flushing presented again, went back to ER given BENADRYL and steroids, given prescription for prednisone 3 times a day for 5 days and BENADRYL 50 mg every 6hours for 2 days. Still awaiting final outcome.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain, Arthralgia
Clinical narrative: Severe joint pain and gastrointestinal upset (like an IBS attack). Joint pain lasted for two weeks, abdominal pain is still going on.
Sex: U
Vaccine: HEP
Symptoms: Blood gases, Blood test, Body temperature increased, Brain hypoxia, Brain injury
Clinical narrative: She was born a beautiful and perfectly healthy baby. She did receive her vitamin K shot being I had been on blood thinners for clotting. She suffered a bit from jaundice but at 4 days old she received her hep b. Her temp stayed lower than normal which they kept saying was normal being born at 36.5 weeks GA. At her 2 week check up she was found to be doing well and her temp had come up to 99.0 degrees. Well we took her home to have her temp spike within 8 hrs of her check up to 101.7. I thought it was my thermometer so I tried a bath, skin to skin and a tad bit of TYLENOL trying to help her. It came down to 99.8 which was better for me so we went to sleep for 3 hrs. When I retook it at 4am on December 14th, it was 101.4 so we took her to the ER. They did a lot of blood work and tried to get a lumbar puncture that ended as a failed try. They transferred us to another hospital where she started having respiratory issues and they ended up transferring us yet again. This time to another hospital's PICU. By the 15th she had crashed into a full cardiac/respiratory arrest which ended in her being intubated. They kept her intubated for 3.5 days until the morning of the 18th and they ended up bagging her within 5 minutes of extubated. Within the 7 days we were there, she was bagged 7 more times. Her last MRI showed her to have brain damage due to cerebral hypoxia, fluid on the brain, a collection on her spine as well as an abnormal 24 hr EEG.