chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Burning sensation, Dizziness, Pain in extremity
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 724395), concerns a 48-year-old, adult female patient. On 24-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as unknown, route of administration, anatomical location, batch number and expiry date: not reported). On 27-Oct-2017, 3 days after vaccination, the patient experienced extreme dizziness and pain in the left arm with burning sensation (reported as nerve like burning). At the time of the report, the patient had not recovered from the events. The reporter assessed the case as non-serious. Updated received on 20-Sep-2018: Non-significant case correction (IRD: 26-Aug-2018): The sentence in the narrative was changed from 'burning sensation in the nerve' to 'burning sensation (reported as nerve like burning)'. The case comment was amended accordingly.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Chills, Cough, Myalgia, Pyrexia
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 724399), concerns a 49-year-old, adult female patient. The patient's historical condition included factor II mutation. The patient received influenza vaccine in the past and experienced fever, chills, joint pain, muscle aches, coughing, sneezing and other respiratory issues. The patient was allergic to penicillin, DEMEROL and thiomersal. The concomitant medications included COUMADIN, Simvastatin and Omeprazole. On 17-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 7 plus), route of administration: intramuscular, anatomical location: right arm, batch number: 195241 and expiry date: not reported]. On the same day, after vaccination, the patient experienced fever, chills, joint pain, muscle aches, coughing, sneezing and other respiratory issues. As of 23-Oct-2017, the patient still had the symptoms (not recovered). At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious. This case was linked to the case: 201803584 due to same patient. Update received on 20-Sep-2018: Significant case correction: (26-Aug-2018): The events (sneezing and coughing) were changed from symptoms to diagnosis. The outcome for all the events changed from not recovered to recovered. No changes were done in the narrative and case comment.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Respiratory disorder, Sneezing
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 724399), concerns a 49-year-old, adult female patient. The patient's historical condition included factor II mutation. The patient received influenza vaccine in the past and experienced fever, chills, joint pain, muscle aches, coughing, sneezing and other respiratory issues. The patient was allergic to penicillin, DEMEROL and thiomersal. The concomitant medications included COUMADIN, Simvastatin and Omeprazole. On 17-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 7 plus), route of administration: intramuscular, anatomical location: right arm, batch number: 195241 and expiry date: not reported]. On the same day, after vaccination, the patient experienced fever, chills, joint pain, muscle aches, coughing, sneezing and other respiratory issues. As of 23-Oct-2017, the patient still had the symptoms (not recovered). At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious. This case was linked to the case: 201803584 due to same patient. Update received on 20-Sep-2018: Significant case correction: (26-Aug-2018): The events (sneezing and coughing) were changed from symptoms to diagnosis. The outcome for all the events changed from not recovered to recovered. No changes were done in the narrative and case comment.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Paraesthesia
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 722406), concerning a 34-year-old, adult, female patient. On 24-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as 1, batch number: 195213, route of administration: intramuscular, anatomical location: left arm and expiry date: not reported). On 25-Oct-2017, one day after the vaccination, the patient experienced tingling in the vaccinated arm which was reported after days shot was given. At the time of this report, the outcome of the event is unknown. The reporter assessed the case as non-serious. Update received on 26-Sep-2018: Significant case correction (IRD: 26-Aug-2018): The listedness of the event (paraesthesia) was changed from 'listed' to unlisted' as per the PL Flu Vaccine Cell Subunit NVD. No changed were done in the narrative.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Nasal congestion, Paraesthesia oral, Swollen tongue
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 724423), concerns a 63-year-old, adult, female patient. The patient's historical condition included urticaria. The patient's current conditions included, asthma and hypothyroidism (reported as medical history) and severe allergies to casein, corn starch, lactose, soy, gluten and tomatoes. The patient had no current illnesses. The patient's medications at the time of vaccination included, Doxepin, PULMICORT and TIROSINT for unknown indications. On 11-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195217, expiry date: not reported]. On the same day within 1 hour after vaccination, the patient experienced tingling and swelling of tongue which lasted for about 8 hours. On the same night, the patient took BENADRYL at a dose of 25 mg at bedtime. On 12-Oct-2017 (next day as reported), the patient developed nasal congestion that lasted for 15 days. The events were reported by the patient to healthcare provider on 27-Oct-2017. The patient did not undergo any laboratory investigations. It was reported that the patient made an office visit. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious. Update received on 27-Sep-2018: Significant case correction (IRD: 26-Aug-2018): The onset date of the event nasal congestion was changed from '28-Oct-2017' to '12-OCT-2017'. The determined causality of the event (nasal congestion) was changed from 'not related' to 'related'. The narrative and case comment amended accordingly.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Bladder discomfort, Cardiac discomfort, Chills, Fatigue, Heart rate increased
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 724519), concerns a 62-year-old, adult, female patient. The patient's current conditions included hypertension and hepatitis C (reported as historical condition). The patient did not have any allergies. The concomitant medications included vitamin D, losartan, ARMOUR THYROID, and TYLENOL for unknown indications. On 17-Oct-2017 at 08:00 am the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left arm, dose: 0.5 ml (frequency reported as 1), batch number: 195241 and expiry date not reported]. On the same day, after vaccination, approximately at 09:15 am the patient's heart started racing to 140s (unit unspecified) which lasted about an hour. Approximately at 10:15 am heart rate came back down to around 100-110 unit unspecified) and started palpitating which lasted about 3 hours till 1 pm. The patient felt like her heart was a bowl of jelly, it felt like it was jiggling. Through those 3 hours, patient felt chilled, shaky and tired. The patient's bottom lip felt tingly and slightly swollen. The patient felt slightly wheezy but not enough to use an inhaler. Patient had no difficulty in breathing or swallowing. Also, from 11 am to 12:30 pm the patient's bladder filled to the point of being uncomfortable and she urinated a very marked amount 3 times. The patient stated that it was marked quantity for her as she did not urinate that often and had not drunk any more fluids than ordinary. The patient thought, she should have gone to the emergency department (ED) after searching on internet about the events. On 18-Oct-2017, the site was very sore, red, warm and started itching. On 19-Oct-2017 the site was still sore, pink, warm and itching intensely, also patient was coughing up green gunk (patient had no cough or production prior to the vaccine). On 20-Oct-2017 there was a little discomfort at the site but still itching (less intensely), patient did not experience coughing or production anymore. On 21-Oct-2017, the patient had a little discomfort at the site with slight itching. On 22-Oct-2017 all symptoms had gone (recovered). The reporter assessed the case as non-serious. Update received on 29-Sep-2018: Significant case correction (IRD: 26-Aug-2018): The event 'heart rate increased' was deleted from events tab. No changes were made in the narrative.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 724519), concerns a 62-year-old, adult, female patient. The patient's current conditions included hypertension and hepatitis C (reported as historical condition). The patient did not have any allergies. The concomitant medications included vitamin D, losartan, ARMOUR THYROID, and TYLENOL for unknown indications. On 17-Oct-2017 at 08:00 am the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left arm, dose: 0.5 ml (frequency reported as 1), batch number: 195241 and expiry date not reported]. On the same day, after vaccination, approximately at 09:15 am the patient's heart started racing to 140s (unit unspecified) which lasted about an hour. Approximately at 10:15 am heart rate came back down to around 100-110 unit unspecified) and started palpitating which lasted about 3 hours till 1 pm. The patient felt like her heart was a bowl of jelly, it felt like it was jiggling. Through those 3 hours, patient felt chilled, shaky and tired. The patient's bottom lip felt tingly and slightly swollen. The patient felt slightly wheezy but not enough to use an inhaler. Patient had no difficulty in breathing or swallowing. Also, from 11 am to 12:30 pm the patient's bladder filled to the point of being uncomfortable and she urinated a very marked amount 3 times. The patient stated that it was marked quantity for her as she did not urinate that often and had not drunk any more fluids than ordinary. The patient thought, she should have gone to the emergency department (ED) after searching on internet about the events. On 18-Oct-2017, the site was very sore, red, warm and started itching. On 19-Oct-2017 the site was still sore, pink, warm and itching intensely, also patient was coughing up green gunk (patient had no cough or production prior to the vaccine). On 20-Oct-2017 there was a little discomfort at the site but still itching (less intensely), patient did not experience coughing or production anymore. On 21-Oct-2017, the patient had a little discomfort at the site with slight itching. On 22-Oct-2017 all symptoms had gone (recovered). The reporter assessed the case as non-serious. Update received on 29-Sep-2018: Significant case correction (IRD: 26-Aug-2018): The event 'heart rate increased' was deleted from events tab. No changes were made in the narrative.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Lip swelling, Nervousness, Palpitations, Paraesthesia oral, Productive cough
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 724519), concerns a 62-year-old, adult, female patient. The patient's current conditions included hypertension and hepatitis C (reported as historical condition). The patient did not have any allergies. The concomitant medications included vitamin D, losartan, ARMOUR THYROID, and TYLENOL for unknown indications. On 17-Oct-2017 at 08:00 am the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left arm, dose: 0.5 ml (frequency reported as 1), batch number: 195241 and expiry date not reported]. On the same day, after vaccination, approximately at 09:15 am the patient's heart started racing to 140s (unit unspecified) which lasted about an hour. Approximately at 10:15 am heart rate came back down to around 100-110 unit unspecified) and started palpitating which lasted about 3 hours till 1 pm. The patient felt like her heart was a bowl of jelly, it felt like it was jiggling. Through those 3 hours, patient felt chilled, shaky and tired. The patient's bottom lip felt tingly and slightly swollen. The patient felt slightly wheezy but not enough to use an inhaler. Patient had no difficulty in breathing or swallowing. Also, from 11 am to 12:30 pm the patient's bladder filled to the point of being uncomfortable and she urinated a very marked amount 3 times. The patient stated that it was marked quantity for her as she did not urinate that often and had not drunk any more fluids than ordinary. The patient thought, she should have gone to the emergency department (ED) after searching on internet about the events. On 18-Oct-2017, the site was very sore, red, warm and started itching. On 19-Oct-2017 the site was still sore, pink, warm and itching intensely, also patient was coughing up green gunk (patient had no cough or production prior to the vaccine). On 20-Oct-2017 there was a little discomfort at the site but still itching (less intensely), patient did not experience coughing or production anymore. On 21-Oct-2017, the patient had a little discomfort at the site with slight itching. On 22-Oct-2017 all symptoms had gone (recovered). The reporter assessed the case as non-serious. Update received on 29-Sep-2018: Significant case correction (IRD: 26-Aug-2018): The event 'heart rate increased' was deleted from events tab. No changes were made in the narrative.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Urine output increased, Wheezing
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 724519), concerns a 62-year-old, adult, female patient. The patient's current conditions included hypertension and hepatitis C (reported as historical condition). The patient did not have any allergies. The concomitant medications included vitamin D, losartan, ARMOUR THYROID, and TYLENOL for unknown indications. On 17-Oct-2017 at 08:00 am the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left arm, dose: 0.5 ml (frequency reported as 1), batch number: 195241 and expiry date not reported]. On the same day, after vaccination, approximately at 09:15 am the patient's heart started racing to 140s (unit unspecified) which lasted about an hour. Approximately at 10:15 am heart rate came back down to around 100-110 unit unspecified) and started palpitating which lasted about 3 hours till 1 pm. The patient felt like her heart was a bowl of jelly, it felt like it was jiggling. Through those 3 hours, patient felt chilled, shaky and tired. The patient's bottom lip felt tingly and slightly swollen. The patient felt slightly wheezy but not enough to use an inhaler. Patient had no difficulty in breathing or swallowing. Also, from 11 am to 12:30 pm the patient's bladder filled to the point of being uncomfortable and she urinated a very marked amount 3 times. The patient stated that it was marked quantity for her as she did not urinate that often and had not drunk any more fluids than ordinary. The patient thought, she should have gone to the emergency department (ED) after searching on internet about the events. On 18-Oct-2017, the site was very sore, red, warm and started itching. On 19-Oct-2017 the site was still sore, pink, warm and itching intensely, also patient was coughing up green gunk (patient had no cough or production prior to the vaccine). On 20-Oct-2017 there was a little discomfort at the site but still itching (less intensely), patient did not experience coughing or production anymore. On 21-Oct-2017, the patient had a little discomfort at the site with slight itching. On 22-Oct-2017 all symptoms had gone (recovered). The reporter assessed the case as non-serious. Update received on 29-Sep-2018: Significant case correction (IRD: 26-Aug-2018): The event 'heart rate increased' was deleted from events tab. No changes were made in the narrative.
Age: 40.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Crying, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: This is spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID:724612), concerns a 40-year-old, adult male patient. The patient's concomitant medications included tramadol, tizanidine, testosterone, pseudoephedrine for an unknown indication. On 30-Oct-2017, the patient received the suspect vaccine FLUCELVAX QIVc (dose: 0.5ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195228 and expiry were not reported). On the same day, the patient also received non-company suspect PNEUMOVAX (dose: unknown, route of administration: intramuscular, anatomical location: left arm, batch number: N022303 as reported and expiry were reported). It was reported that, approximately 12 hours after receiving the non-company suspect PNEUMOVAX, the patient returned to the pharmacy and complained of severe pain woke him up crying in the middle of night. No redness or visible evidence at the injection site was noted, but muscle was warm and swollen. The patient winced in pain to move his shirt sleeve up. The patient wanted to consult a doctor to have it evaluated. On an unspecified date, the patient had an emergency room visit and physician's office visit. It was stated that, he believed an injury in his rotator cuff. At the time of this report, the outcome of the events (crying, injection site reaction, injection swelling, injection site warmth, middle insomnia and pain) was unknown. The reporter assessed the case as non-serious. Update received on 29-Sep-2018: Significant case correction (IRD: 26-Aug-2018): The as determined causality for the events-injection site swelling, injection site warmth and injection site reaction was changed from related to unassessable. The case comment was amended accordingly.
Age: 40.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Pain, Rotator cuff syndrome, Sleep disorder
Clinical narrative: This is spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID:724612), concerns a 40-year-old, adult male patient. The patient's concomitant medications included tramadol, tizanidine, testosterone, pseudoephedrine for an unknown indication. On 30-Oct-2017, the patient received the suspect vaccine FLUCELVAX QIVc (dose: 0.5ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195228 and expiry were not reported). On the same day, the patient also received non-company suspect PNEUMOVAX (dose: unknown, route of administration: intramuscular, anatomical location: left arm, batch number: N022303 as reported and expiry were reported). It was reported that, approximately 12 hours after receiving the non-company suspect PNEUMOVAX, the patient returned to the pharmacy and complained of severe pain woke him up crying in the middle of night. No redness or visible evidence at the injection site was noted, but muscle was warm and swollen. The patient winced in pain to move his shirt sleeve up. The patient wanted to consult a doctor to have it evaluated. On an unspecified date, the patient had an emergency room visit and physician's office visit. It was stated that, he believed an injury in his rotator cuff. At the time of this report, the outcome of the events (crying, injection site reaction, injection swelling, injection site warmth, middle insomnia and pain) was unknown. The reporter assessed the case as non-serious. Update received on 29-Sep-2018: Significant case correction (IRD: 26-Aug-2018): The as determined causality for the events-injection site swelling, injection site warmth and injection site reaction was changed from related to unassessable. The case comment was amended accordingly.
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Allergy test, Pain in extremity, Pyrexia, Swelling, Vaccination complication
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 724639), concerning a 58-year-old, adult, male patient. The patient's historical condition included: vertigo. The patient had no known allergies. The patient had no current illness at the time of the vaccination. Concomitant medications included: fluticasone, lisinopril/HCTZ, paroxetine, phentermine, vitamin B12, CENTRUM SILVER daily vitamin for unknown indications. On 25-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml [frequency reported as 1], batch number: 195250, route of administration: intramuscular, anatomical location: right arm and expiry date: not reported). On the next day, after the vaccination, the patient experienced very bad reaction to the flu injection, developed swelling to double the size, severe pain in arm and fever. On an unspecified date, the patient made an office visit and emergency visit. The patient was treated with unspecified steroids and antibiotics for 7 days. On 02-Nov-2017, the patient had undergone serum allergy test but the results were not reported. At the time of the report, the patient had recovered from the events. The reported assessed the case as non-serious.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Dyspnoea, Pharyngeal paraesthesia
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 724668), concerning a 62-year-old, adult, female patient. The patient's historical condition included: short-term memory loss. The patient had allergies to neomycin, gentamicin , erythromycin, iodine/iodides, sulfa drugs and others. On 02-Nov-2017, the patient was administered FLUCELVAX (QIVc) [dose: 0.5 ml (frequency reported as 1), batch number: 195233, route of administration: intramuscular, anatomical location: right arm and expiry date: not reported). On the same day after the vaccination, the patient developed tingling throat and weight when breathing and was worried that it might be a start of anaphylactic reactions. Since the patient had many allergies, she was concerned that this was another reaction. The patient took diphenhydramine (25 mg) immediately on the reporter's recommendation, but the reporter didn't want to use EPIPEN and was waiting to see if the reaction materialized. Hence the emergency services were called, who took her blood pressure and calmed the patient down. After 15-20  minutes of joking around, it was concluded that this was not an anaphylactic reaction. The patient refused the transport to the emergency department and thus left with her husband, both walking, talking, and laughing. Later, on phone follow up, at 2 hours and 6 hours the patient was fine and was back to normal. At the time of the report, the patient had recovered from the events. The reported assessed the case as non-serious. Update received on 27-Sep-2018: Significant case correction (IRD 26-Aug-2018): The listedness of the event pharyngeal paraesthesia was corrected from listed to unlisted in Agency.
Age: 39.0
Sex: M
Vaccine: FLUC4
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 724729), concerns a 39-year-old, adult male patient. The patient had received Tdap vaccine in 2012 at his age of 34 and had experienced a large indurated area on his left arm with left arm pain which had recovered. The patient did not have any current conditions. The patient was allergic to pollen and animal dander. Concomitant medications included levothyroxine and clomiphene citrate, for unknown indications. On 11-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical site: left arm, batch number: 195220 and expiry date: not reported). On 13-Oct-2017, 2 days after vaccination, the patient developed a raised, red and itchy rash under his left armpit which progressed to right armpit, around beltline and into bilateral groin areas. The patient used over the counter hydrocortisone cream. The rash which was noted under left armpit was pink 1 inch in length and 1/4 inches in width with no drainage. The patient also experienced a small patch of rash in groin area but declined the assessment of that rash. The patient had not consulted a physician and did not undergo any laboratory investigations. On an unspecified date in 2017, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Nodule, Skin warm, Swelling
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 724750), concerns a 58-year-old adult, female patient. The patient's historical condition included heart disease [unspecified]. The patient had no current illness and no allergies. On 01-Nov-2017, the patient received 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 the following day of vaccination, the patient developed a knot that was warm to the touch, red and swollen. The patient was counselled to use cold compress, as anti-inflammatory was not be administered. At the time of report, the outcome of the events (knot, warm to the touch, red and swollen) was unknown. The reporter assessed the case as non-serious.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site discolouration, Injection site swelling
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 725239), concerns a 57-year-old, adult female patient. The patient's concomitant medication included lansoprazole. On 24-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical site: left arm, batch number: 195224 (reported as 135224) and expiry date: not reported]. On the same day, after vaccination, the patient developed a ball-shaped swelling and black-blue color of skin at the injection site. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 725246), concerns a 28-year-old, adult female patient. The patient has no known allergies (reported as NKA). The patient's concomitant medications included citalopram and diclofenac for unknown indications. On 05-Nov-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical site: left arm, batch number: 195228 and expiry date: not reported). On the same day, after vaccination, the patient developed lard raised swelling with redness at injection site. On 06-Nov-2017, the patient developed bruising on the outer edge of the injection site. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 40.0
Sex: M
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 725260), concerns a 40-year-old, adult male patient. The patient had no relevant medical history, current conditions and allergies. The patient did not receive any concomitant medications. On 08-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, frequency reported as unknown, route of administration: intramuscular, anatomical site: left arm, batch number and expiry date: not reported]. On the same day, after vaccination, the patient experienced pain which progressively worsened over time with range of motion to extreme pain. On an unspecified date, the patient made an office visit. The patient did not undergo any laboratory investigations. At the time of this report, the patient had not recovered from the event. The reporter assessed the case as non-serious. Update received on 26-SEP-2018: Non-significant case correction (IRD: 26-AUG-2018): The sentence in the narrative was changed from "the patient experienced extreme pain which progressively worsened over time from normal range of motion" to "the patient experienced pain which progressively worsened over time with range of motion to extreme pain" and the sentence in the case comment was changed from "patient experienced extreme pain, on the same day after vaccination with the suspect vaccine FLUCELVAX QIVc" to "patient experienced pain, on the same day after vaccination with the suspect vaccine FLUCELVAX QIVc".
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Body temperature increased, Fatigue, Myalgia, Swelling
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 725275), concerns a 52-year-old, adult female patient. The patient had no historical condition, current conditions and allergies. On 14-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: injection (reported as SYR), anatomical site: left arm, batch number: 195230 and expiry date: not reported]. On the same day, after vaccination, the patient experienced increased body temperature and fatigue, joint pain, muscle pain and swelling for 24 hours. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 64.0
Sex: M
Vaccine: FLUC4, PPV, VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 725348), concerning a 64-year-old, adult, male patient. The patient's concomitant medication included blood thinners. On 28-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: 195235 and expiry date: not reported] and non-company suspect products PNEUMOVAX [dose: frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: N019983 and expiry date: not reported] and ZOSTAVAX [dose: frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: N024561 and expiry date: not reported]. On 31-Oct-2017, 3 days after vaccination, the patient developed redness, swelling and lot of pain. On an unspecified date, the patient made a physician office visit. At the time of the report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Confusional state, Hypoaesthesia
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 725352) concerning a 34-year-old, adult female patient. The patient's current condition included bipolar disorder (reported as medical history) and the patient was hospitalized for bipolar psychosis (on an unspecified date). The patient was allergic to latex, TRIMOX and WELLBUTRIN SR (since unspecified dates). The patient's concomitant medications included LAMICTAL, DEPO PROVERA, trazodone, CYMBALTA, olanzapine and spironolactone. On 23-Aug-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: 195216 (915216 as reported) and expiry date: not reported]. On 05-Sep-2017, 13 days after vaccination, the patient developed numbness on the left side and confusion. On an unspecified date, the patient made an emergency room and 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: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Dizziness, Hypoaesthesia, Muscular weakness, Myalgia
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 725357), concerning a 31-year-old, adult, female patient. The patient had no historical condition, current illness, allergies and concomitant medications. On 10-Oct-2017 (Tuesday as reported) around 04:30 PM, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency: 1 as reported), route of administration: intramuscular, anatomical location: left arm, batch number: 195211 and expiry date: not reported]. On the same day, 30 minutes after vaccination, the patient's left arm became numb and weak with pain. On 11-Oct-2017 (Wednesday), the patient had muscle aches and chills without fever. On 12-Oct-2017 (Thursday), the patient felt little more weakness in left arm. On 13-Oct-2017 (Friday), the patient felt more dizziness. On an unspecified date, the patient had an emergency room and office visit. At the time of the report, the outcome of the events was not reported. The reporter assessed the case as non-serious. Update received on 20-Sep-2018: Significant case correction: (IRD: 26-Aug-2018): The event (condition aggravated) was added. The case comment was amended accordingly. No changes were done in the narrative. Update received on 29-Sep-2018: Non-significant case correction (IRD: 26-Aug-2018): The phrase 'painful L arm' was changed to 'painful left arm' in the case comment. The spelling of the word aggravated was changed from 'aggrevated' to 'aggravated' in case comment. No changes were made in the narrative.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 725357), concerning a 31-year-old, adult, female patient. The patient had no historical condition, current illness, allergies and concomitant medications. On 10-Oct-2017 (Tuesday as reported) around 04:30 PM, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency: 1 as reported), route of administration: intramuscular, anatomical location: left arm, batch number: 195211 and expiry date: not reported]. On the same day, 30 minutes after vaccination, the patient's left arm became numb and weak with pain. On 11-Oct-2017 (Wednesday), the patient had muscle aches and chills without fever. On 12-Oct-2017 (Thursday), the patient felt little more weakness in left arm. On 13-Oct-2017 (Friday), the patient felt more dizziness. On an unspecified date, the patient had an emergency room and office visit. At the time of the report, the outcome of the events was not reported. The reporter assessed the case as non-serious. Update received on 20-Sep-2018: Significant case correction: (IRD: 26-Aug-2018): The event (condition aggravated) was added. The case comment was amended accordingly. No changes were done in the narrative. Update received on 29-Sep-2018: Non-significant case correction (IRD: 26-Aug-2018): The phrase 'painful L arm' was changed to 'painful left arm' in the case comment. The spelling of the word aggravated was changed from 'aggrevated' to 'aggravated' in case comment. No changes were made in the narrative.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Insomnia, Musculoskeletal pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 725454), concerns a 53-year-old, adult female patient. The patient had no historical condition and current illness. The patient was allergic to sulpha drugs. The patient did not receive any concomitant medications. On 14-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical site: left arm, batch number: 195212 and expiry date: not reported]. On 16-Oct-2017, 2 days after vaccination, the patient experienced shoulder pain and was unable to sleep on that shoulder. On an unspecified date, the patient made a physician office visit. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the case as non-serious.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 725459), concerns a 51-year-old, adult female patient. The patient's historical conditions included diabetes and asthma. The patient's current conditions were unknown. The patient had no known allergies. The patient's concomitant medications were unknown. On 29-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195244 and expiry date: not reported]. On the same day, after vaccination, the patient experienced pain, inflammation and redness at the injection site. The patient had soreness when she lifted her arm. The patient made an physician office visit given prednisone and non-steroidal anti-inflammatory drug (NSAID) by the primary care physician (PCP). At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious. Update received on 20-Sep-2018: Non-significant case correction (IRD: 26-Aug-2018): The treatment drug (prednisone) was added in product tab. The treatment received in the event tab was changed from 'unk' to 'yes' for all the events.
Age: 13.0
Sex: F
Vaccine: FLUC4
Symptoms: Balance disorder, Chest discomfort, Disorientation, Feeling hot, Hyperhidrosis
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 725465), concerns a 13-year-old, adolescent female patient. The patient had no allergies. On 07-Nov-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: 195240 and expiry date: not reported). On the same day, not more than 5 minutes after vaccination, the patient felt a little disoriented and started to lose her balance. The patient's chest felt weird and she had trouble hearing. The patient's grandmother said that, the patient felt very hot and was sweating. About 20 minutes later, the patient started to feel better but said she couldn't remember what her grandmother was saying to her. On the same day, the patient had recovered from the events. The reporter assessed the case as non-serious. Update received on 11-Oct-2018: Non-significant case correction (IRD: 26-Aug-2018): The verbiage in the case comment was corrected from 'felt little disoriented, started to lose her balance, her chest felt weird, had trouble hearing, felt very hot, started to sweat (onset latency: within 5 minutes) and about 20 minutes later, she could not remember what her grandmother was saying before' to 'experienced disorientation, loss of balance, chest discomfort, sweating, feeling hot and trouble hearing and memory impairment, within 5 minutes'.
Age: 13.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoacusis, Memory impairment
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 725465), concerns a 13-year-old, adolescent female patient. The patient had no allergies. On 07-Nov-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: 195240 and expiry date: not reported). On the same day, not more than 5 minutes after vaccination, the patient felt a little disoriented and started to lose her balance. The patient's chest felt weird and she had trouble hearing. The patient's grandmother said that, the patient felt very hot and was sweating. About 20 minutes later, the patient started to feel better but said she couldn't remember what her grandmother was saying to her. On the same day, the patient had recovered from the events. The reporter assessed the case as non-serious. Update received on 11-Oct-2018: Non-significant case correction (IRD: 26-Aug-2018): The verbiage in the case comment was corrected from 'felt little disoriented, started to lose her balance, her chest felt weird, had trouble hearing, felt very hot, started to sweat (onset latency: within 5 minutes) and about 20 minutes later, she could not remember what her grandmother was saying before' to 'experienced disorientation, loss of balance, chest discomfort, sweating, feeling hot and trouble hearing and memory impairment, within 5 minutes'.
Age: 49.0
Sex: F
Vaccine: FLUC4, PPV, TDAP
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This is spontaneous case, reported by Other Health Professional to VAERS and initially retrieved 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 725471), concerns a 49-year-old, adult female patient. On 26-Oct-2017, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left arm, dose: 0.5 ml [frequency 1 as reported], batch number: 195238 and expiry date not reported]. On the same day, the patient also received the non-company suspect PNEUMOVAX [route of administration: intramuscular, anatomical location: left arm, dose: not reported, frequency 1 as reported, batch number: N019348 as reported and expiry date not reported]. The patient also received the non-company suspect BOOSTRIX [route of administration: intramuscular, anatomical location: right arm, dose: not reported, frequency 1 as reported, batch number: 72232 as reported and expiry date not reported]. On the same day, after vaccination, the patient experienced increased pain and swelling of the right arm. On an unspecified date, the patient had a visit to the physician's office. At the time of this report, the outcome of the events (increased pain and swelling of the right arm) was unknown. The reporter assessed the case as non-serious.
Age: 22.0
Sex: M
Vaccine: FLUC4
Symptoms: Pruritus generalised, Rash, Rash macular
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 725492), concerns a 22-year-old,adult, male patient. It was unknown if the patient had any medical history. patient was allergic to cats. Patient did not have any current illnesses. It was unknown if the patient took any medication at the time of vaccination. On 06-Nov-2017, at about 10:24 hours, the patient was administered FLUCELVAX QIVc, route of administration: intramuscular, anatomical location: left arm, dose: 0.5 ml. batch number: 195248 and expiry date not reported]. On the same day, at 10:32 hours, the patient presented with generalized itchiness and macular rash on extremities. The patient was given BENADRYL (50 mg) intramuscularly in right deltoid. The patient's heart rate and respiratory rate were normal and lungs were clear. At 10:45 hours, itchiness started spreading  to face. There was no airway involvement and no improvements in the symptoms. At 10:55 vital signs were normal, lungs were clear, he was alert/oriented. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Capillary nail refill test, Muscle tightness, Pain in extremity
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 725902), concerns a 36-year-old, adult female patient. The patient's medical history included rheumatoid arthritis, current condition included lupus and patient had milk and yogurt sensitivity. The concomitant medications included ZYRTEC, MINASTRIN and RESTORE probiotic for unknown indications. On 08-Nov-2017, the patient was administered FLUCELVAX QIVc, route of administration: intramuscular, anatomical location: right arm, dose: 0.5 ml, batch number: 195128 and expiry date not reported]. On the same day after vaccination, the patient visited the clinic informing that approximately ten minutes after immunization administration, she started feeling a sensation of right arm soreness with muscle tightening and right-hand joints were hurting. The patient informed of no longer having arm soreness with muscle tightening. After two hours, right hand joints were still hurting. Nurse evaluated injection site, compared both arms/hands/finger joints and no swelling were observed. Right hand fingernails showed capillary refill within less than three seconds. Patient had mobility of each right hand joint. The nurse explained to patient of reporting condition and completing a vaccine adverse event reporting system (VAERS) form. The patient was advised to contact or see primary care physician or attend minor or hospital emergency for evaluation. The patient informed of already calling Lupus doctor and leaving a message. It was unknown if the patient underwent any laboratory tests. At the time of this report, the patient had not recovered from the event (right hand joints hurting) and recovered from right arm soreness and muscle tightening. The reporter assessed the case as non-serious. Update received on 27-Sep-2018: Non-significant case correction IRD 26-Aug-2018: The sentence "the patient did not have any current illnesses' was removed from the narrative. The narrative was amended accordingly.