chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 718099), concerns a 64-year-old, adult male patient. The patient had no known drug allergies [NKDA as reported]. The patient's concomitant medications were unknown. On 15-Sep-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, frequency reported as 1, route of administration: unknown, anatomical location: left arm, batch number: 195213 and expiry date: not reported] and administered non-company suspect product ZOSTAVAX [dose: unknown, route of administration: subcutaneous, anatomical location: right arm, batch number: N020942 and expiry date: not reported]. On 16-Sep-2017, one day after vaccination, the patient developed a red, painful, golf ball size bump on the right arm. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious. Update on 29-Aug-2018: Significant case correction was performed 16-Aug-2018: The rationale in the case comment was modified as 'as the events occurred in right arm where co-suspect was administered, the company assessed the causality as not related to suspect vaccine'. Upon internal review it was realized that, Listedness of the event erythema was wrongly captured as unlisted in Core labelling document. Hence, it was corrected as listed. The event swelling was unlisted in Core and Agency. Hence, it was corrected as Listed in both the labelling documents.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Limb discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 718101), concerns a 54-year-old, adult female patient. The patient did not have any current illness. On 27-Sep-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, anatomical location: left arm, batch number: 195128 [reported as L95128], route of administration: unknown and expiry date: not reported). On 28-Sep-2017, 1 day after vaccination, the patient experienced pain and heaviness in arm and developed swollen hand. It was reported that, the patient visited emergency room and physician office. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious. Update 29-Aug-2018: Non-significant case correction performed with IRD 16-Aug-2018: The case comment was changed from 'the causality of the event is assessed as related, considering that, the events occurred on the vaccinated arm' to 'the company assessed the causality as related due to plausible temporal relationship between suspect vaccine and the reported events'. No changes were made in the narrative.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site bruising
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 718141), concerns a 52-year-old, adult female patient. On 06-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency: unknown, route of administration: intramuscular, anatomical location: left arm, batch number: 195128 and expiry date: not reported). On the same day, soon after vaccination, the patient developed a large bruise of 2 inches at the injection site. At the time of this report, the outcome of the event was unknown. The reporter assessed the case as non-serious. Update 29-Aug-2018: Non-significant case correction performed 16-Aug-2018: The rationale of the case comment was modified from "The causality of the event is assessed as related as the events occurred at the injection site" to "The company assessed the causality as related, due to plausible temporal relationship between vaccination and the reported events".
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Syncope
Clinical narrative: This is a spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 718154), concerns a 24-year-old, adult female patient. On 05-Oct-2017, the patient received suspect vaccine FLUCELVAX QIV [dose: 0.5ml (1 as reported), route of administration: intramuscular, anatomical location: left arm, batch number: 195226A (reported as 1026-17-195226A)]. On the same day, after vaccination, the patient stood talking to staff for several minutes. The patient fainted and stood right back up. The patient said that, she was just looking for something and fainted for second time. The patient was assessed by the clinical team and released within half an hour (reported 1/2 hour). It was reported that, the patient had attributed the event to the needle and was not concerned about the situation. Prior to injection, the patient did not have any issues with needles. On an unspecified date, the patient visited the physician's office. At the time of report, the patient had recovered from the event syncope. The reporter assessed the case as non-serious.
Age: 76.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Headache, Influenza like illness, Injection site swelling, Pruritus
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2017 by Seqirus from VAERS (VAERS ID: 718176), concerns a 76-year-old, elderly female patient.  The patient's historical condition included high blood pressure. The patient had no current condition and allergies. The patient did not receive any concomitant medication. On 04-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195240 and expiry date: not reported) non-company co-suspect vaccine, PNEUMOVAX (dose: frequency reported as 2, route of administration: intramuscular, anatomical location: left arm, batch number: N003997, dose and expiry date: not reported). Both the vaccines were given in the same arm. On the same day, after vaccination, the patient developed itching that was limited to the immunized arm and swelling limited to area 3 to 4 inches above the injection site and down to the elbow. The patient also experienced flu like symptoms and headache. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Erythema, Feeling hot, Flushing, Palpitations
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 718211), concerns a 27-year-old, adult, female patient. The patient's concomitant medication included LEXAPRO. The patient had drug allergy with LEVAQUIN. On 06-Oct-2017, the patient was administered FLUCELVAX (QIVc) [dose: 0.5 ml (frequency reported as unknown), route of administration: intramuscular, anatomical location: right arm, batch number: 195220, expiry date: not reported]. On the same day, following her vaccination, the patient experienced slight tingling in her tongue and hot feeling in her arm region. Thereafter the patient further complained of being lightheaded, dizzy and flushed. The patient felt that her heart raced and her whole body was hot (though she did not have any fever). Subsequently, after 45 minutes, the patient's arm became red and was swollen which prompted her to go to urgent care where she was administered BENADRYL and was under observation. Eventually, the patient got better, went home and fell asleep. Over the weekend, the patient described that her skin was itchy which had abated to some extent, but she still had some itchiness which was more than normal. On an unknown date, the patient visited office. At the time of this report, the outcome of the events had recovered. The reporter assessed this case as non-serious.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Paraesthesia oral, Peripheral swelling, Pruritus
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 718211), concerns a 27-year-old, adult, female patient. The patient's concomitant medication included LEXAPRO. The patient had drug allergy with LEVAQUIN. On 06-Oct-2017, the patient was administered FLUCELVAX (QIVc) [dose: 0.5 ml (frequency reported as unknown), route of administration: intramuscular, anatomical location: right arm, batch number: 195220, expiry date: not reported]. On the same day, following her vaccination, the patient experienced slight tingling in her tongue and hot feeling in her arm region. Thereafter the patient further complained of being lightheaded, dizzy and flushed. The patient felt that her heart raced and her whole body was hot (though she did not have any fever). Subsequently, after 45 minutes, the patient's arm became red and was swollen which prompted her to go to urgent care where she was administered BENADRYL and was under observation. Eventually, the patient got better, went home and fell asleep. Over the weekend, the patient described that her skin was itchy which had abated to some extent, but she still had some itchiness which was more than normal. On an unknown date, the patient visited office. At the time of this report, the outcome of the events had recovered. The reporter assessed this case as non-serious.
Age: 72.0
Sex: M
Vaccine: FLUC4
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 718234), concerns a 72-year-old, adult male patient. On 06-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml [frequency: 1], route of administration: intramuscular, anatomical location: left arm, batch number: 195234, expiry date: not reported). On 07-Oct-2017, 1 day after vaccination, the patient developed swelling below the elbow on the vaccinated arm and, the arm was warm to touch. There was no reaction at the injection site. The patient was referred to his doctor. It was reported that the patient visited office. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: This spontaneous case, reported by other non-healthcare professional (consumer) to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 718248), concerns a 53-year-old, adult, female patient. The patient's historical condition included osteoarthritis in hips. The patient had no allergies and current illnesses. The patient's concomitant medications included iron and B12 supplements. On 19-Sep-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: injection (reported as SYR), anatomical location: left arm, batch number: 195218 and expiry date not reported]. On the same day, after vaccination, patient experienced severe pain in her left arm at the site of the injection since 3 weeks. It was limiting patient's range of motion and she could not do some normal daily activities without severe pain like taking off a shirt. The patient had made a physician office visit. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Blood test, Dysstasia, Electrocardiogram, Fatigue
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 718263), concerns a 57-year-old, adult, female patient. The patient had no relevant medical history and drug reactions or allergies. The patient's concomitant medication included: DIOVAN HCT, lansoprazole, estradiol, ZETIA, LIPITOR, FINACEA CREAM, escitalopram; CQ10, milk thistle, women's silver vitamin, omega 3 fish oil. On 01-Oct-2017, the patient was administered FLUCELVAX (QIVc) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: Right Arm, batch number: 195124, frequency, expiry date: not reported). On 05-Oct-2017, 4 days after vaccination, the patient experienced severe fatigue, weakness, numbness, could barely stand or walk and had to hold on to something (gait disturbance). The patient presented to ER 3 hours after the onset of symptoms. EKG (electrocardiography) and bloodwork were performed, and the patient was monitored for symptoms after administration of fluids. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Gait disturbance, Hypoaesthesia
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 718263), concerns a 57-year-old, adult, female patient. The patient had no relevant medical history and drug reactions or allergies. The patient's concomitant medication included: DIOVAN HCT, lansoprazole, estradiol, ZETIA, LIPITOR, FINACEA CREAM, escitalopram; CQ10, milk thistle, women's silver vitamin, omega 3 fish oil. On 01-Oct-2017, the patient was administered FLUCELVAX (QIVc) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: Right Arm, batch number: 195124, frequency, expiry date: not reported). On 05-Oct-2017, 4 days after vaccination, the patient experienced severe fatigue, weakness, numbness, could barely stand or walk and had to hold on to something (gait disturbance). The patient presented to ER 3 hours after the onset of symptoms. EKG (electrocardiography) and bloodwork were performed, and the patient was monitored for symptoms after administration of fluids. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 62.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Asthenia, Chills, Erythema, Injection site erythema, Peripheral swelling
Clinical narrative: This spontaneous case, reported by health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 718272), concerns a 62-year-old, adult female patient. The patient's historical condition included asthma. The patient's concomitant medications, current conditions and allergies were not reported. On 23-Sep-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm (upper deltoid), batch number: 195223 and expiry date: not reported] and PNEUMOVAX [dose, frequency reported as 1, route of administration: intramuscular, anatomical location: left arm (lower portion of the deltoid), batch number: N011867 and expiry date: not reported). On 24-Sep-2017, 1 day after vaccination, the patient's arm was swollen like a balloon. The patient experienced chills and felt generalised weakness for next few days. The patient did not report the symptoms until 28-Sep-2018. Five days later, when the patient reported to the pharmacy about the events, her arm was still a little red but not swollen. It was reported that, the central part of the redness looked like the reaction that might be due to PNEUMOVAX which was administered at the lower portion of the deltoid. At the time of this report, the patient had recovered from the events swollen arm, chills and generalised weakness and had not recovered from redness and injection site redness. The reporter assessed this case as non-serious. Update received on 29-Sep-2018: Significant case correction (16-Aug-2018): As determined causality of the event injection site redness was corrected from unassessable to related. The case comment was amended accordingly.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Cough, Dysphonia, Fatigue, Headache, Myalgia
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 718276), concerns a 61-year-old, adult female patient. The patient's current illness included secondary Sjogren's syndrome, type 2 diabetes [reported as medical history] and systemic lupus. The patient was allergic to shellfish. The patient's concomitant medications included Metformin, NORCO and PLAQUENIL. On 09-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: injection (reported as SYR), anatomical location: left arm, batch number and expiry date: not reported]. On the same day, after vaccination, the patient experienced extreme fatigue and fever of 102, muscle aches, headache, hoarseness and cough. On an unspecified date, the patient had made a physician office visit. At the time of this report, the outcome of the events was not reported. The reporter assessed the case as non-serious. Update 29-Aug-2018: Non-significant case correction performed with IRD 16-Aug-2018: in the narrative, a part of the sentence in the event description that was stated as "the patient was extreme fatigue" was modified as "the patient experienced extreme fatigue".
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Pyrexia
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 718276), concerns a 61-year-old, adult female patient. The patient's current illness included secondary Sjogren's syndrome, type 2 diabetes [reported as medical history] and systemic lupus. The patient was allergic to shellfish. The patient's concomitant medications included Metformin, NORCO and PLAQUENIL. On 09-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: injection (reported as SYR), anatomical location: left arm, batch number and expiry date: not reported]. On the same day, after vaccination, the patient experienced extreme fatigue and fever of 102, muscle aches, headache, hoarseness and cough. On an unspecified date, the patient had made a physician office visit. At the time of this report, the outcome of the events was not reported. The reporter assessed the case as non-serious. Update 29-Aug-2018: Non-significant case correction performed with IRD 16-Aug-2018: in the narrative, a part of the sentence in the event description that was stated as "the patient was extreme fatigue" was modified as "the patient experienced extreme fatigue".
Age: 71.0
Sex: M
Vaccine: FLUC4
Symptoms: Influenza
Clinical narrative: This spontaneous case, reported by other non-healthcare professional (consumer) to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 719441), concerns a 71-year-old, elderly, male patient. The patient had no relevant history, allergies and current illness. The patient did not receive any concomitant medications. On 08-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency: 1, route of administration: intramuscular, anatomical location: left arm, batch number: 195218 and expiry date: not reported). On 09-Oct-2017, 10 hours after vaccination, the patient developed full blown influenza. It was reported that, the patient had a physician office visit. No lab investigations were performed. At the time of this report, the outcome of the event was unknown. The reporter assessed the case as non-serious.
Age: 66.0
Sex: F
Vaccine: FLUC4
Symptoms: Gingival pain, Immediate post-injection reaction, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 719443), concerns a 66-year-old, elderly female patient. The patient's historical condition and current illness were unknown. The patient was allergic to crab and sulfonamide drugs (since an unspecified date). The patient's concomitant medications were unknown. On 01-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195242 and expiry date: not reported). On the same day, immediately after vaccination, the patient experienced pain, numbness and tingling at the injection site which moved up to her shoulder. Over the following 72 hours, the patient complained of pain at the injection site, numbness in shoulder and oral pain in the gums on the left side of her body. It was reported that the patient had not followed up for medical attention as of 10-Oct-2017. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 10.0
Sex: M
Vaccine: FLUC4
Symptoms: Abdominal pain upper, Erythema of eyelid, Pallor, Pruritus, Rash erythematous
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 719454), concerns a 10-year-old, male child patient. The patient's historical condition included upper respiratory infection (URI) when he was young. The patient's current condition included seasonal allergies. The patient's concomitant medication included FLINTSTONES vitamins. On 10-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number; 195224, expiry date: not reported). On the same day, within 10-15 minutes of vaccination, the patient complained of stomach ache. After the patient reached home, he appeared a little pale and about 30 minutes after vaccination, the patient itched himself and developed rash of small red bumps on upper body and redness around the eyes. The patient's mother called up the pharmacy at about 04:45 PM who prescribed BENADRYL and was advised to call the physician. The doctor confirmed the treatment plan and cautioned to check for the signs of difficulty in breathing. At about 05:45 PM, the patient's parent was called, and they confirmed that there was no worsening of symptoms, but rash had moved down to his lower extremities. It was reported that, there were no signs of breathing problem and confirmed to continue with BENADRYL for 1-2 days. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious.
Age: 20.0
Sex: F
Vaccine: FLUX, FLUC4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 719522), concerns a 20-year-old, adult female patient. On an unspecified date in 2016, the patient was administered influenza vaccine for an unknown indication and developed redness and swelling at injection site. The patient's historical condition included lupus. The patient's current illness included rheumatoid arthritis (reported as medical history). The patient had no known drug allergies. The patient's concomitant medications included ENBREL, methotrexate, and tramadol. On 05-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195242 and expiry date: not reported]. On 07-Oct-2017, 2 days after vaccination the patient developed redness, itching, pain and tenderness at the vaccination area. The area was non-fluctuant and became erythematous with a wheal of 3 x 2 centimeters (cm), warm, minimum tenderness to palpation, rash, and a lesion noted on the left side. It was reported that the patient made an office visit. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious. Update on 29-Aug-2018: Significant case correction was performed 16-Aug-2018: The listedness for the event erythema changed from unlisted to listed in Agency and for the event injection site wheal changed from unlisted to listed in both Agency and Agency. The short form of centimeters had been changed from '(CM)' to 'cm' in the narrative.
Age: 20.0
Sex: F
Vaccine: FLUX, FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 719522), concerns a 20-year-old, adult female patient. On an unspecified date in 2016, the patient was administered influenza vaccine for an unknown indication and developed redness and swelling at injection site. The patient's historical condition included lupus. The patient's current illness included rheumatoid arthritis (reported as medical history). The patient had no known drug allergies. The patient's concomitant medications included ENBREL, methotrexate, and tramadol. On 05-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195242 and expiry date: not reported]. On 07-Oct-2017, 2 days after vaccination the patient developed redness, itching, pain and tenderness at the vaccination area. The area was non-fluctuant and became erythematous with a wheal of 3 x 2 centimeters (cm), warm, minimum tenderness to palpation, rash, and a lesion noted on the left side. It was reported that the patient made an office visit. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious. Update on 29-Aug-2018: Significant case correction was performed 16-Aug-2018: The listedness for the event erythema changed from unlisted to listed in Agency and for the event injection site wheal changed from unlisted to listed in both Agency and Agency. The short form of centimeters had been changed from '(CM)' to 'cm' in the narrative.
Age: 20.0
Sex: F
Vaccine: FLUX, FLUC4
Symptoms: Rash, Skin lesion, Vaccination site pain
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 719522), concerns a 20-year-old, adult female patient. On an unspecified date in 2016, the patient was administered influenza vaccine for an unknown indication and developed redness and swelling at injection site. The patient's historical condition included lupus. The patient's current illness included rheumatoid arthritis (reported as medical history). The patient had no known drug allergies. The patient's concomitant medications included ENBREL, methotrexate, and tramadol. On 05-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195242 and expiry date: not reported]. On 07-Oct-2017, 2 days after vaccination the patient developed redness, itching, pain and tenderness at the vaccination area. The area was non-fluctuant and became erythematous with a wheal of 3 x 2 centimeters (cm), warm, minimum tenderness to palpation, rash, and a lesion noted on the left side. It was reported that the patient made an office visit. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious. Update on 29-Aug-2018: Significant case correction was performed 16-Aug-2018: The listedness for the event erythema changed from unlisted to listed in Agency and for the event injection site wheal changed from unlisted to listed in both Agency and Agency. The short form of centimeters had been changed from '(CM)' to 'cm' in the narrative.
Age: 85.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site swelling, Pain
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially received on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 719687), concerns an 85-year-old, elderly male patient. On 14-Sep-2017, the patient was vaccinated FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195215, expiry date not reported]. On 15-Sep-2017, 1 day after vaccination, the patient experienced pain and swelling at the injection site. On 11-Oct-2017, the patient complained of pain. On an unspecified date, the patient visited his doctor, who was given a cream (name not disclosed) for application at the site. It was reported that, the patient's injection site was still swollen. At the time of this report, the patient had not recovered from the events. The reporter assessed the events as non-serious. Update received on 20-Sep-2018: Significant case correction (IRD: 16-Aug-2018): The event (injection site pain) was deleted. The narrative and case comment were corrected.
Age: 16.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 719694), concerns a 16-year-old, female adolescent patient. The patient had no medical history and current illness. The patient had no known allergies (NKA) and no known concomitant medications. On 11-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195224 and expiry date: not reported]. On the same day, after vaccination, the patient sat down on the bench outside the pharmacy and waited for her mother and sister to receive the vaccine. Within 1-2 minutes of vaccination, the patient passed out. After less than 10 seconds, the patient woke up, laid on the bench for 2-3 minutes and sat up without any other complications. It was reported that, the patient offered water and support, but her mother was there with the patient to support. The patient took rest while her mother and sister received their flu shots. The patient sat for another 5 minutes. Then, the patient stood up and walked by her own without any assistance. The same day (11-Oct-2017), the patient had recovered from the event. The reporter assessed the case as non-serious.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site rash, Pain in extremity
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 719799), concerns a 32-year-old, adult female patient. On 18-Sep-2017, the patient was administered FLUCELVAX QIVc (dose: 05. ml [frequency reported a 1], batch number: 195216, route of administration and anatomical location: unknown, expiry date: not reported). On 19-Sep-2017, 1 day after vaccination, the patient developed rash around injection site and pain in arm from shoulder to hand. The patient received ibuprofen and felt better. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 8.0
Sex: M
Vaccine: FLUC4
Symptoms: Blood pressure decreased, Head injury, Syncope
Clinical narrative: This is spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 719900), concerns a 08-year-old, male child. The patient had no medical history and current illness. On 09-Oct-2017, the patient received the suspect vaccine FLUCELVAX QIVc (dose: 0.5 ml, frequency: unknown, route of administration: intramuscular, anatomical location: unknown, batch number: 195230). On the same day, 5-7 minutes after vaccination, the patient fainted and hit his head. Paramedics were called and they stated everything was fine (reported as ok). The patient was waiting for a follow-up with MD [Doctor of Medicine]. The patient was made to lay down to check the blood pressure [BP] and was found to be decreased. The MD stated that the decreased BP was due to flu shot. At the time of this report, the patient had recovered from all the events (fainted, hit head and BP decreased). The reporter assessed the case as non-serious.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest discomfort, Feeling abnormal, Nausea, Paraesthesia oral, Tongue disorder
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 719962), concerns a 52-year-old, adult, female patient. The patient had been allergic to eggs, shellfish, pineapple, lisinopril, neomycin and SEPTRA. The patient's concomitant medication included Metoprolol and SYNTHROID for unknown indications. On 01-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: right arm, batch number: 195238, expiry date: not reported]. On the same day, 20 minutes after vaccination, the patient complained of blurred vision, abnormal feeling (reported as 'not feeling right'), nausea, chest tightness, tingling of lips and thick tongue. Eventually, the patient was transferred to emergency department, where she received oxygen, unspecified aerosol and medications for the symptoms. On an unspecified date in Oct-2017, the patient had recovered from the events. The reporter assessed this case as non-serious. Update received on 20-Sep-2018: Significant case correction (IRD: 16-Aug-2018): The stop date for all the events was changed from '01-Oct-2017' to 'Oct-2017'. The case comment was corrected.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Vision blurred
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 719962), concerns a 52-year-old, adult, female patient. The patient had been allergic to eggs, shellfish, pineapple, lisinopril, neomycin and SEPTRA. The patient's concomitant medication included Metoprolol and SYNTHROID for unknown indications. On 01-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: right arm, batch number: 195238, expiry date: not reported]. On the same day, 20 minutes after vaccination, the patient complained of blurred vision, abnormal feeling (reported as 'not feeling right'), nausea, chest tightness, tingling of lips and thick tongue. Eventually, the patient was transferred to emergency department, where she received oxygen, unspecified aerosol and medications for the symptoms. On an unspecified date in Oct-2017, the patient had recovered from the events. The reporter assessed this case as non-serious. Update received on 20-Sep-2018: Significant case correction (IRD: 16-Aug-2018): The stop date for all the events was changed from '01-Oct-2017' to 'Oct-2017'. The case comment was corrected.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood pressure increased, Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 719980), concerns a 36-year-old, adult female patient. The patient's current condition included asthma (reported as medical history). The patient had been allergic to penicillin, milk, bees and grass. The patient had no previous illness. The patient's concomitant medications included Albuterol HFA. On 10-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195215, expiry date not reported). On the same day, after vaccination, the patient experienced chest pressure, shortness of breath, increase in blood pressure and light-headedness. On an unspecified date, the patient had made a physician visit. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 6.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 720001), concerns a 6-year-old, child, male patient. The patient's medical history, current illness, concomitant medications and allergies were unknown. On 10-Oct-2017, the patient was administered FLUCELVAX (QIVc) [dose: 0.5 ml (frequency reported as unknown), route of administration: injection (reported as 'SYR'), anatomical location: left arm, batch number: 195225A, expiry date: not reported]. On the same day of vaccination, the patient had symptoms of swelling, redness and hot to touch. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious.
Age: 3.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 720019), concerns a 03-year-old, male child. On 11-Oct-2017, the patient (under age of 4 years) was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: right arm, batch number: 195215, expiry date: not reported]. On 12-Oct-2017, 1 day after vaccination, the patient experienced mild erythema and swelling at the site of injection. It was reported that, the patient did not experience fever, chills or any other adverse events. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious. Update received on 29-Aug-2018: Non-significant case correction (IRD 16-Aug-2018): Added age and gender in the case comment. No changes were made in the narrative.
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site irritation
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 720158), concerns a 7-year-old, female child patient. The patient's historical condition and current illness were not reported. The patient had no egg allergies. On 04-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: injection (reported as SYR), anatomical location: right arm, batch number: 195225A and expiry date was not reported]. On the same day, after vaccination, the patient experienced irritation at injection site and went to school nurse for a cold compress. At the time of this report, the patient had recovered from the event. The reporter assessed the case as non-serious. Update 29-Aug-2018: Non-significant case correction was performed 16-Aug-2017: The repeated word 'vaccine' in case comment was removed.
Sex: F
Vaccine: FLUC4
Symptoms: Insomnia, Mobility decreased, Pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 720233), concerns a 59-year-old, adult female patient. On 27-Sep-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: 195213 and expiry date: not reported). On 12-Oct-2017, 15 days after vaccination, the patient experienced pain, could not sleep and move her arm. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 720272), concerns a 36-year-old, adult female patient. The patient had no historical condition and current condition. The patient was allergic to BENADRYL. The patient did not receive any concomitant medication. On 01-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as unknown, route of administration: intramuscular, anatomical location: left arm, batch number: 195222 and expiry date: not reported). On the same day (01-Oct-2017) after vaccination, the patient developed redness, hot and swollen arm. The patient was advised to put a cold compress on it and take ibuprofen if required. The patient was also advised to seek medical help if symptoms of severe allergic reaction appeared. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 80.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity, Rash vesicular
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 720279), concerns an 80-year-old, elderly male patient. The patient's historical condition included myocardial infarction (in 1987) and his current conditions included, diabetes and unspecified heart disease (reported as medical history). The patient had no known allergies. The patient's medications at the time of vaccination included LANTUS, HUMALOG, PRADAXA, ezetimibe, dutasteride, doxazosin, bumetanide, trazodone, ramipril and carvedilol. On 03-Oct-2017, the patient was administered suspect vaccine FLUCELVAX QIVc (dose: 0.5 ml [frequency: unknown], route of administration: intramuscular, anatomical location: right arm, batch number: 195221, expiry date: not reported) and non-company suspect vaccine ZOSTAVAX (route of administration: subcutaneous, anatomical location: left arm, batch number: N022035, dose and expiry date: not reported). On 09-Oct-2017, 6 days after vaccination, the patient experienced severe blistering rash on right upper chest, shoulder, upper back and shoulder blade area. Later, on an unspecified date in Oct-2017 (reported as this week), the rash progressively got worse and the patient developed sharp, shooting, radiating pain down his right arm from the shoulder area. On an unspecified date, the patient presented to the pharmacy with the rash and he was advised to seek medical treatment for the adverse event. It was reported that the appearance of the rash was consistent with shingles rashes observed in the past at the reporter's pharmacy and in the common medical literature. The patient did not undergo any laboratory investigations. It was reported that the patient visited office. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious. Update received on 27-Sep-2018: Significant case correction received 16-Aug-2018: As reported causality was updated from 'related' to 'not reported' for the events blistery rash and rash aggravated. The verbiage in the narrative was updated from 'the patient had no any allergies' to 'patient had no known allergies. The narrative was amended accordingly. Update received on 28-Sep-2018: Non-significant case correction (16-Aug-2018) - The spelling of 'myocardial' was corrected and added 'reported as medical history' after the current conditions in narrative.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Dizziness, Injection site haemorrhage, Injection site swelling
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 720282), concerns a 37-year-old, adult, female patient. On 14-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195230, expiry date; not reported]. On the same day, after administration of vaccine, the patient was bleeding more than usual and had a bump on the injection site. About 5 minutes later, the patient stated that she felt weak and dizzy. Eventually, 911 was called and had her stay sitting down. Emergency medial technician (EMT) measured her vital and it was completely normal (BP 135/85). About 10 minutes later, she felt better and walked out of the store. At the time of this report, the patient was recovering from the events, weakness and dizziness and had recovered from the events, injection site bleeding and swelling. The reporter assessed this case as non-serious. Update 29-Aug-2018: Significant case correction was performed with IRD 16-Aug-2018: The case comment statement was corrected from "within 24 hours" to "on the same day". Upon internal review, it was realized that, listedness was not done for the event (injection site bleeding). Hence, listedness was done for the event (injection site bleeding).
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site macule, Injection site warmth
Clinical narrative: This spontaneous case, reported by health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 720310), concerns a 57-year-old, adult, female patient. The patient had no known drug allergy (NKDA). The patient's concomitant medications included omeprazole, FLONASE, clonazepam, levothyroxine and MIRALAX. On 08-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195222 and expiry date: not reported). On 09-Oct-2017, 1 day after vaccination, the patient developed a golf ball size lump at injection site which was red and hot. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 45.0
Sex: M
Vaccine: FLUC4
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain, Malaise
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 720325), concerns a 45-year-old adult male patient. The patient's current illness included Strep throat before 15 days of vaccination for which treated with penicillin V and potassium. The patient's concomitant medications included amlodipine besylate, losartan potassium. On 13-Oct-2017, the patient received FLUCELVAX QIVc [dose: 0.5 ml (reported as 1 dose), route of administration: injection (reported as SYR), anatomical location: right arm, batch number and expiry date: not reported]. On 14-Oct-2017, the patient developed 3" long 2" wide red mark at the injection site and the area below the red mark was rock hard, which burnt and very sore. The patient also had slight fever, sore throat, headache, felt sick and vomiting. At the time of this report, the patient had not recovered from the events (headache, injection site induration, injection site pain, injection site reaction, malaise, oropharyngeal pain, pyrexia and vomiting). The reporter assessed this case as non-serious.
Age: 45.0
Sex: M
Vaccine: FLUC4
Symptoms: Oropharyngeal pain, Pyrexia, Vomiting
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 720325), concerns a 45-year-old adult male patient. The patient's current illness included Strep throat before 15 days of vaccination for which treated with penicillin V and potassium. The patient's concomitant medications included amlodipine besylate, losartan potassium. On 13-Oct-2017, the patient received FLUCELVAX QIVc [dose: 0.5 ml (reported as 1 dose), route of administration: injection (reported as SYR), anatomical location: right arm, batch number and expiry date: not reported]. On 14-Oct-2017, the patient developed 3" long 2" wide red mark at the injection site and the area below the red mark was rock hard, which burnt and very sore. The patient also had slight fever, sore throat, headache, felt sick and vomiting. At the time of this report, the patient had not recovered from the events (headache, injection site induration, injection site pain, injection site reaction, malaise, oropharyngeal pain, pyrexia and vomiting). The reporter assessed this case as non-serious.