chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 03-year-old, male child patient. On 08-Oct-2018, the patient (underage of 4 years) was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230 and expiry date: 31-May-2019) (explicitly coded as inappropriate age at vaccination). No adverse were reported after administration of the vaccine. This case 201804694 was cross-linked with original cases 201804369 due to the same reporter. Follow-up report received from the reporter on 12-Nov-2018: The reporter confirmed that the patient had not received partial dose of suspect vaccine. Hence, the event under-dose was deleted. The narrative was amended accordingly.
Age: 43.0
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 43-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: 201804672 was cross-linked to the source case: 201804657 reported by the same reporter.
Age: 33.0
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 33-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 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 events were reported. The reporter assessed this case as non-serious. This case 201804538 was cross-linked to the case 201804533 reported by the same reporter.
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Insomnia, Myalgia, Pyrexia
Clinical narrative: This spontaneous case initially received from other non-health professional (consumer) on 17-Oct-2018, concerning a adult female patient of an unspecified age. On 09-Oct-2018, the patient was administered FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported). On the same day, the patient experienced low fever, headache, pain and sore in the muscles and lot of trouble in sleeping during night. The patient administered painkillers (medication unspecified) as the treatment medication as the patient still had fever. At the time of report, the patient had not recovered from the event fever and the outcome of the events headache, muscle pain and insomnia were not reported. The reporter assessed this case as non-serious.
Age: 58.0
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 58-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, batch number: 252235, expiry date: 30-Jun-2019, route of administration and anatomical location: not reported]. At the time of this report, no adverse events were reported. This case: 201804683 was cross-linked to the source case: 201804657 reported by the same reporter.
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect dose administered, No adverse event, Product quality issue, Syringe issue
Clinical narrative: This spontaneous case, initially received from other health professional (combinedly processed with follow-up) on 17-Oct-2018, concerns a female patient of unspecified age. The patient had no medical history and concomitant medications. It was reported that the plunger got stucked and was not moved even with a lot pressure applied. On 12-Oct-2018, the patient was administered partial dose of FLUCELVAX QIVc [dose: half dose (0.5 ml as reported), route of administration: intramuscular, anatomical location: deltoid, batch number: 252656 and expiry date: 31-May-2019], with a pre-filled syringe (PFS) with plunger issue. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding PTC reference number was (PTC number: 1034396). No adverse events were reported after the vaccine administration. The reporter assessed the case as non-serious. Non-significant follow-up received from the other health professional on 17-Nov-2018: The reporter confirmed that the patient did not experienced any adverse event after the vaccine administration and did not have any further information to provide about the patient or the case. No changes were made in the narrative.
Age: 32.0
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 32-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]. The patient had not experienced any adverse events after the vaccination. This case 201804685 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: 19.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Hyperhidrosis, Hypoaesthesia, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous case, initially received from other non-health professional on 15-Oct-2018, concerns a 19-year-old, adult female patient. On 08-Oct-2018, around 8 pm, the patient was administered FLUCELVAX QIVc (dose, route of administration, anatomical location, batch number and expiry date: not reported). On 09-Oct-2018, around 1:30 am in morning, after vaccination, the patient was pale with white lips, was sweating, could not feel legs and could not close her hands. Those symptoms lasted for about 20 minutes. The patient also complained of pelvic pain. On the same day, the patient's arms and legs were sore. On 12-Oct-2018, reported as Friday, the patient had no other symptoms. On 14-Oct-2018, reported as Sunday, the patient was weak and pinky was tingling. After a week, the aching was still prevailing. At the time of this report, the outcome of the events pelvic pain, weakness and tingling was not reported. The patient had not recovered from the pain in extremities. The patient had recovered from the other events.
Age: 19.0
Sex: F
Vaccine: FLUC4
Symptoms: Pallor, Paraesthesia, Pelvic pain
Clinical narrative: This spontaneous case, initially received from other non-health professional on 15-Oct-2018, concerns a 19-year-old, adult female patient. On 08-Oct-2018, around 8 pm, the patient was administered FLUCELVAX QIVc (dose, route of administration, anatomical location, batch number and expiry date: not reported). On 09-Oct-2018, around 1:30 am in morning, after vaccination, the patient was pale with white lips, was sweating, could not feel legs and could not close her hands. Those symptoms lasted for about 20 minutes. The patient also complained of pelvic pain. On the same day, the patient's arms and legs were sore. On 12-Oct-2018, reported as Friday, the patient had no other symptoms. On 14-Oct-2018, reported as Sunday, the patient was weak and pinky was tingling. After a week, the aching was still prevailing. At the time of this report, the outcome of the events pelvic pain, weakness and tingling was not reported. The patient had not recovered from the pain in extremities. The patient had recovered from the other events.
Age: 3.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This non-serious, spontaneous case, initially received from other health professional (nurse) on 08-Oct-2018, concerns a 03-year-old, female child patient. On 08-Oct-2018, the patient (under age of 4 years) was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230 and expiry date: 31-May-2019] (explicitly coded as inappropriate age at vaccine administration). At the time of this report, no adverse events were reported. This case was linked to original case 201804369 and 201804369 due to the same reporter. Follow-up report received from the reporter o 12-Nov-2018: The reporter confirmed that the patient had not received partial dose of suspect vaccine. Hence, the event under-dose was deleted. The narrative was amended accordingly.
Age: 3.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This non-serious, spontaneous case, initially received from other health professional (nurse) on 08-Oct-2018, concerns a 03-year-old, male child patient. On 08-Oct-2018, the patient (less than 4 years of age) was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230 and expiry date: 31-May-2019]. At the time of this report, no adverse events were reported. This case was linked to case 201804369 and 201804369 due to the same reporter. Follow-up report received from the reporter on 12-Nov-2018: The reporter confirmed that the patient had not received partial dose of suspect vaccine. Hence, the event under-dose was deleted. The narrative was amended accordingly.
Age: 39.0
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 39-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 (explicitly coded as overdose), 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 events were reported after administration of the vaccine. This case 201804671 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: 3.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This non-serious, spontaneous case, initially received from other health professional (nurse) on 08-Oct-2018, concerns a 03-year-old, male child patient. On 08-Oct-2018, the patient (less than 4 years of age) was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230 and expiry date: 31-May-2019] (explicitly coded as inappropriate age at vaccine administration). At the time of this report, no adverse events were reported. This case 201804696 was linked to the source case 201804369 due to the same reporter. Follow-up report received from the reporter on 12-Nov-2018: The reporter confirmed that the patient had not received partial dose of suspect vaccine. Hence, the event under-dose was deleted. The narrative was amended accordingly.
Age: 3.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 03-year-old, female child patient. On 08-Oct-2018, the patient (under 4 years of age) was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230 and expiry date: 31-May-2019). No adverse events were reported after administration of the vaccine. This case 201804693 was cross-linked with original case 201804691 due to the same reporter. Follow-up report received from the reporter on 12-Nov-2018: The reporter confirmed that the patient had not received partial dose of suspect vaccine. Hence, the event under-dose was deleted. The narrative was 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 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 201804690 was linked to the source case 201804657 due to the same reporter.
Age: 33.0
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 33-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] (explicitly coded as extra dose administration). At the time of this report, no adverse events were reported. This case: 201804688 was cross-linked to the source case: 201804657 reported by the same reporter.
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, concerns 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, expiry date: 30-Jun-2019]. At the time of this report, no adverse events were reported. This case 201804687 was linked to the source case 201804657 due to the same reporter.
Sex: M
Vaccine: FLUC4
Symptoms: Headache, Incorrect dose administered, Pain, Pain in extremity, Pyrexia
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a male patient of an unspecified age. 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 11-Oct-2018, 2 days after vaccination, the patient complained of a bad headache and sore arm. On 15-Oct-2018, the patient texted the reporter and stated that he was at home with complaints of body aches and fever. On 17-Oct-2018, the reporter followed up the patient. The patient stated that, he planned to get a message therapy due to his body fever and aches. At the time of this report, the patient had not recovered from the events body pains and fever. The outcome of the events painful arm and headache was not reported. This case 201804686 was cross-linked to the source case: 201804657 reported by the same reporter.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a spontaneous case initially received from other health care professional (nurse) on 19-Oct-2018, concerning a 33-year-0ld, adult, female patient. On an unspecified date, it was reported that, the fridge had never gone out of range between 2 and 8 degrees for 10 months. On 15-Oct-2018, at 8:23 AM, the tracker thermometer cloud was disconnected until 17-Oct-2018 at 9:34 AM and they did not have any temperature recordings between that time, which was considered possible temperature excursion. On 16-Oct-2018, the patient was administered FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 272676, expiry date: not reported] which underwent possible temperature excursion. At this time of report, no adverse event was reported after the vaccine administration. The reporter assessed this case as non-serious.
Age: 34.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site discolouration, Pain, Swelling
Clinical narrative: This spontaneous case, initially received from physician on 16-Oct-2018, concerning a 34-year-old, adult, male patient. The patient had no medical history and concomitant FLUCELVAX (QIVc) (dose: 0.5 ml, batch number: 252234, anatomical location: deltoid, expiry date: 30-Jun-2019 and route of administration: intramuscular). On or before 15-Oct-2018 (as reported by the physician), after vaccination, the patient developed a discoloration on his arm that has not resolved in several days. It looks dark (brownish colour), size 2-3 quarters and it's spread out in an irregular shape from the injection site. The physician also reported some pain and swelling. The patient did not receive any treatment till the date of the report. At the time of the report, the patient had not recovered from the events. The reporter assessed the event as non-serious.
Age: 63.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Headache, Retching, Vaccination complication
Clinical narrative: This spontaneous case, initially received on 15-Oct-2018, reported by a non-healthcare professional concerns a 63-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 12-Oct-2018, at 3 PM, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency: unknown), route of administration: intramuscular, anatomical location, batch number and expiry date: not reported]. It was reported that the patient was okay on the weekend. On 15-Oct-2018, in the morning, 3 days after vaccination, the patient developed a reaction to the vaccine and felt dizzy, so he went back to bed. Later, on the same day, the patient experienced dry heaving when he went to work. It was reported that the patient also experienced a headache and dizziness, but no fever. The dizziness at the time of the call had subsided. The patient did not receive any treatment associated with the event. At the time of this report, the patient had recovered from the event dizziness. The outcome of the event dry heaving and headache was not reported. The reporter assessed this case as non-serious.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous case, initially received on 17-Oct-2018 from pharmacist, concerns a 54-year-old, adult, female patient. On 15-Oct-2018, while administrating the vaccine, the syringe was leaked at the needle point and the patient received partial dose of FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid batch number: 252229, expiry date: 31-May-2019) (explicitly coded as needle issue and incomplete dose administered). It was reported that a lot of vaccine was lost while administration of vaccine. The patient did not experience any adverse event after vaccination. The reporter assessed this case as non-serious.
Age: 51.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received (combinedly processed with follow-up) from a pharmacist on 15-Oct-2018, concerns a 51-year-old, adult, male 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 14-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: not reported] which underwent temperature excursion and administered the vaccine. The patient did not experience any adverse events after the vaccination. The reporter assessed this case as non-serious. This case 201804552 was cross-linked with the original case 201804533 due to the same reporter.
Age: 52.0
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 52-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 (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 201804550 was cross-linked to source case: 201804533 due to 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 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 events were reported. The reporter assessed this case as non-serious. This case 201804549 was cross-linked to the case 201804533 reported by the 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 15-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 201805483 was cross linked to the original case 201804863 due to same reporter.
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error, Vaccination error
Clinical narrative: This 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 underwent first temperature excursion with Tmax 8.2 degree centigrade for 4 minutes. On 22-Oct-2018, vaccine underwent second temperature excursion with Tmax 9.8 degree centigrade for 23 minutes (explicitly coded as incorrect product storage). On an unspecified date, two temperature excursions were identified after an audit. On 29-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 (explicitly coded as drug administration error). The patient did not experience any adverse events after administration. This case is linked to (201805262) due to same reporter.
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error, Vaccination 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: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error, Vaccination error
Clinical narrative: This is a 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 25-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: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error, Vaccination error
Clinical narrative: This 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 Tmax 8.2 degree Centigrade for 4 minutes. On 22-Oct-2018, vaccine underwent second temperature excursion with Tmax 9.8 degree Centigrade for 23 minutes. On an unspecified date, two temperature excursions were identified after an audit. On 24-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 events after administration. This case is linked to (201805262) 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 23-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: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other health professional on 10-Oct-2018, concerns a female patient of unspecified age. It was reported that, the reporter checked the temperature of the vaccine every morning at 7:00 am and it was found within the range 38-Fahrenheit. On an unspecified date, the fridge was left ajar and the multi-dose vial (MDV) of vaccine underwent first time temperature excursion. It was reported that, the excursion had occurred between 7:45 am and 1:37 pm for 6 hours. On 10-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252231 and expiry date: 31-May-2019) that underwent temperature excursion. At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; doses of improperly stored given PROQUAD and VARIVAX were administrated; This spontaneous report was received from a nurse regarding a 4-year patient of an unknown gender. The patient's concurrent conditions and medical history were not provided.  On 14-JAN-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) (route of administration and dose were not reported) for prophylaxis (lots # and expiration dates: R020676, 15-JAN-2020; R020816, 16-JAN-2020; R020677, 15-JAN-2020; R020814, 16-JAN-2020), however, it was unknown which specific lots the patient received. A sterile diluent was used to reconstitute the vaccines was properly stored.   No adverse effects were reported. The vaccines were exposure to a temperature excursion of 9°C to 25°C (9.2°C) during 2 hours which was called by a data logger. There was not previous temperature excursion.  This is one of the several reports received from the same reporter.; Sender's Comments:  009507513-1901USA005742: 009507513-1901USA005741: 009507513-1901USA005740: 009507513-1901USA005743: 009507513-1901USA005739:
Age: 50.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Rash
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 05-Mar-2018 by Seqirus from VAERS (VAERS ID: 690835), concerns a 50-year-old, adult female patient. On 18-Nov-2015, the patient was administered with FLUCELVAX (TIV) (dose: 0.5 ml (reported as 3 doses), route of administration: intramuscular, anatomical location: left arm, batch number: 174279, expiry date: not reported) and PNEUMOVAX (dose: 2 (as reported), route of administration: unknown, anatomical location: left arm, batch number: L017265, expiry date: not reported). On the same day after vaccination, the patient developed rash. The outcome of the event was unknown. The reporter assessed the case as non-serious.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Paraesthesia
Clinical narrative: This spontaneous case, reported by other non-health professional (consumer) to VAERS and initially retrieved on 19-May-2018 by Seqirus from VAERS (VAERS ID: 695409), concerns a 36-year-old, adult, female patient. The patient had no historical condition and current illness. The patient's allergies were not reported. The patient did not receive any concomitant medications. On 31-Dec-2016, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml [reported as 1], route of administration: intramuscular, anatomical location: left arm, batch number: 185285 and expiry date: not reported). It was reported that, at the time of vaccination, the patient was not sick. On 26-Jan-2017, after 26 days of vaccination, the patient experienced tingling in her toes. At the time of this report, that patient had not yet recovered from the event. The reporter assessed the event as non-serious.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Nausea
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 19-May-2018 by Seqirus from VAERS (VAERS ID: 707137), concerns a 30-year-old, adult, female patient. The patient had no known allergies. The concomitant medications included Lisinopril. On 07-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195214 and expiry date: not reported). On the same day (07-Aug-2017) after vaccination, the patient experienced nausea and headache. At the time of this report, the outcome of the event was unknown. The reporter assessed the events as non-serious.
Age: 19.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 19-May-2018 by Seqirus from VAERS (VAERS ID: 708915), concerns a 19-year-old, adult, female patient. The patient's relevant medical history, current condition and concomitant medications were not reported. On 15-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195220 and expiry date: not reported). On 16-Aug-2017, 1 day after vaccination, the patient developed hives all over the body. At the time of this report, the outcome of the event (hives) was unknown. The reporter assessed the event as non-serious.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 19-May-2018 by Seqirus from VAERS (VAERS ID: 708943), concerns a 56-year-old, adult, female patient. The patient had no current condition and lab test performed. The patient was allergic to Penicillin. On 12-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195214 and expiry date: not reported). On the same day evening after vaccination, the patient experienced itching, swelling, and redness at injection site. The events were persistent even after 2 days. At the time of this report, the outcome of the events was unknown. The reporter assessed the event as non-serious. Update 03-Jul-2018: Non-significant case correction was performed with IRD 19-May-2018: The sentence in narrative was changed from 'the events persistent after 2 days' to 'the events were persistent even after 2 days'. A sentence in case comment was reframed from 'as the events occurred at the injection site, the causality of the events is assessed as related' to 'considering the plausible temporal relationship between vaccination to event onset and the events occurred at the injection site, the causality of the events is assessed as related'. Case comment and narrative was amended accordingly.
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Pain in extremity
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 19-May-2018 by Seqirus from VAERS (VAERS ID: 710845), concerning a 62-year-old, adult, female patient. The patient's medical history was unknown and the patient had no known allergies. The concomitant medication included COUMADIN for an unknown indication (on an unspecified date). On 28-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (1 as reported), route of administration: intramuscular, anatomical location: left arm, batch number: 195213: and expiry date: not reported). On 29-Aug-2017, after 1 day of vaccination, the patient experienced swelling, redness, soreness at the injection site which was radiating down the arm for about 5 inches. The patient was advised to apply ice to the affected area every hour for 10-15 minutes and recommended to take TYLENOL as needed. At the time of this report, the patient had not recovered from the events (injection site redness, injection site swelling and injection site pain). The reporter assessed this case as non-serious.
Age: 66.0
Sex: F
Vaccine: FLUC4, HEPA, TYP
Symptoms: Pruritus, Urticaria
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 19-May-2018 by Seqirus from VAERS (VAERS ID: 710897), concerning a 66-year-old, elderly, female patient. The patient's historical condition was not reported. Current condition included: Hashimoto's disease. The patient had no known allergies and no concomitant medication was administered. On 19-AUG-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195228 (reported as 175228), expiry date: not reported). The patient also received non-company suspect drug Hepatitis A (dose: 1 DF, route of administration: intramuscular, anatomical location: right arm, batch number: MP3Y2, expiry date: not reported) and Typhoid Vaccine (dose: 1 DF, route of administration: intramuscular, anatomical location: right arm, batch number: M00831, expiry date: not reported). On 20-Aug-2017, one day after vaccination, the patient complained of itchy hives on elbow, buttock, breast, leg and foot. Injection sites were clear and no other complaint she reported. On 21-Aug-2017, the patient was followed-up, reported that there was 90 percent improvement on the sites. On 23-Aug-2017, the patient called and reported that, everything was improved (recovered) without any problem. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Headache, Injection site erythema
Clinical narrative: This spontaneous case, reported by other healthcare professional (other) to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 711255), concerns a 74-year-old, elderly, female patient. The patient had no current illness. The patient's historical condition and concomitant medications were not reported. On 29-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml [reported as 1], route of administration: intramuscular, anatomical location: right arm, batch number: 195217, expiry date: not reported) and PNEUMOVAX (dose: [reported as 2], route of administration: intramuscular, anatomical location: left arm, batch number: N011490, expiry date: not reported). On 30-Aug-2017, 1 day after vaccination, the patient experienced headache and erythema on right arm which extended down to antecubital region, circumventing entire upper arm. On an unspecified date, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 82.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Initial information received on 15-Jan-2019 regarding an unsolicited valid serious case received from a pharmacist. This case involves an 82 years old female patient who experienced good size red warm spot, sore and swelling on arm, redness about 4x4 inches in size and itching, while she received vaccines FLUZONE HIGH DOSE and PREVNAR 13. The patient's past vaccination(s) included pneumococcal vaccine (Pneumonia shot years ago) and FLUZONE HIGH DOSE last year. The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Hypertension with Diagnosed a long time ago. Concomitant medications included DILTIAZEM for Blood pressure measurement; and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication. On 24-Aug-2017, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot U1808AB, expiry date: Feb-2018 via intramuscular route in the left deltoid. On 24-Aug-2017, the patient received a 0.5ml dose of suspect PREVNAR 13 not produced by Sanofi Pasteur lot R28320, expiry date: Feb-2018 via unknown route in the right deltoid. On an unknown date, the patient developed a serious good size red warm spot, sore and swelling on arm, redness about 4x4 inches in size (inflammation), following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and PREVNAR 13. This event was assessed as medically significant. On 30-Aug-2017, the patient developed a serious itching (pruritus), 6 days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and PREVNAR 13. This event was assessed as medically significant. Other relevant tests were not reported. Final diagnosis was itching and good size red warm spot, sore and swelling on arm, redness about 4x4 inches in size. It was not reported if the patient received a corrective treatment. On an unknown date, the patient was recovered form itching. The patient outcome was not reported for inflammation. The reporter assessed the causal relationship with suspect vaccine PREVNAR 13 as related with the events. List of documents held by sender: none.; Sender's Comments: This case concerns a 82 years old female patient who developed inflammation around the injection site and itching after vaccination with FLUZONE HIGH DOSE AND PREVNAR 13. The time to onset is unknown. Moreover, patient's medical condition at the time of vaccination was ongoing hypertension and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Urticaria
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 712111), concerns a 42-year-old, adult, female patient. The patient had no historical conditions and current illness. The patient had been allergic to penicillin. The patient did not receive any concomitant medications. On 23-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml [reported as 1], route of administration: intramuscular, anatomical location: left arm, batch number: 195210A and expiry date: not reported). On the same day, after vaccination, at around 4:30 pm, the patient developed hives on face along with a headache and then hives spread to body. It was reported that, patient took bath and applied steroids (unspecified) topically. The patient received BENADRYL and within 3 hours symptoms had resolved. The reporter assessed the case as non-serious.
Age: 53.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 713439), concerns a 53-year-old adult female patient. The patient's current conditions included allergic to macrolides and quinolones. The patient, concomitant medications were not reported. On 13-Sep-2017, the patient received FLUCELVAX QIV [dose: 0.5 ml (reported as unk), route of administration: intramuscular, anatomical location: right arm, batch number: 195225A and expiry date: not reported]. On the same day, the patient also received non-company suspect ZOSTAVAX (dose: unk as reported, route of administration: subcutaneous, anatomical location: left arm, batch number: M038863 and expiry date: not reported). On 16-Sep-2017, 04 days, after vaccination, the patient complained of reddening which spread in the area where she received the vaccine. The patient was prescribed with doxycycline (100 mg tabs twice a day for 10 days). The following day, the patient visited the emergency room as she felt that the condition was not improving. It was reported that, the patient was given BACTRIM DS generic (one tablet, every 12 hours for 10 days) and BENADRYL OTC. At the time of report, the outcome of the event (injection site erythema) was unknown. The reporter assessed this case as non-serious. Update 03-Jul-2018: Non-significant case correction received 11-Jun-2018: The co-suspect vaccine (ZOSTAVAX) was captured in case comment.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Nausea
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 713658), concerns a 57-year-old, adult, female patient. The patient's current conditions included anxiety attacks, back pain due to herniated discs and allergy to scallops (since an unspecified date). The concomitant medications included gabapentin, LIPITOR, ZOLOFT, amlodipine besylate, hydrochlorothiazide, ZANTAC and fish oil. On 19-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml [reported as 1st dose], route of administration: intramuscular, anatomical location: left arm, natation drug code [NDC]: 70461-0201-01, batch number and expiry date: not reported). On the same day (19-Sep-2017), after vaccination, the patient experienced nausea and joint pain. The patient treated with dimenhydrinate two tablets (50 mg) for nausea and ibuprofen (400 mg) for joint pain. On 20-Sep-2017 (reported as by morning), the patient had recovered from the events (joint pain and nausea). The reporter assessed the case as non-serious.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Induration
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 713728), concerns a 34-year-old, adult female patient. The patient had no relevant medical history. The patient was allergic to thiomersal. Concomitant medication included: LORYNA. On 19-Sep-2017, the patient was administered FLUCELVAX QIV (dose: 0.5 ml, frequency: 1, route of administration: intramuscular, anatomical location: left arm, batch number: 195230, expiry date: not reported). On the same day, after vaccination, the patient experienced induration, approximately 4cm x 3 cm in area. The patient was treated with ice pack (as needed). The patient made an office visit and was monitored. At the time of this report, the outcome of the event was unknown. The reporter assessed the case as non-serious. Update 01-Aug-2018: significant case correction received 11-Jun-2018: Added thiomersal allergy in patient tab and corrected verbatim.