chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Swelling
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 715724), concerns a 41-year-old, adult, female patient. The patient had no current illness. The patient's historical condition and concomitant medications were not reported. 14-Sep-2017 at 09:00 am, the patient was administered with FLUCELVAX QIV (dose: 0.5ml [reported as 1], batch number: 195213, anatomical location: left arm, route of administration: unk, expiry date: not reported). On the same day (14-Sep-2017) at 05:00 pm, after the administration of vaccine, the patient experienced excessive swelling on the left side from face to toes. On an unspecified date, the patient had recovered from the event. The reporter assessed this case as non-serious.
Age: 29.0
Sex: M
Vaccine: FLUC4
Symptoms: Fatigue, Pain in extremity
Clinical narrative: This is spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 715734), concerns a 29-year-old, adult male patient. The patient had no medical history and any current illnesses. On 30-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml [unk as reported], route of administration: unknown, anatomical location: left arm, batch number: 195218). On 31-Aug-2017, 1 day after vaccination, the patient experienced fatigue and pain in extremity. It was reported that, the patient visited physician's office and had an emergency room visit for the events. The patient had recovered from events (fatigue and pain in extremity). The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 715829), concerns a 21-year-old adult female patient. The patient was allergic to amoxicillin and Ceclor. The patient did not have any current illnesses and was not receiving any concomitant medications at the time of vaccination. On 13-Sep-2017, the patient received FLUCELVAX QIV (dose: 0.5 ml (unk as reported), route of administration: intramuscular, anatomical location: right arm, batch number: 195126 and expiry date: not reported). On 15-Sep-2017, 2 days after vaccination, the patient's injection site was red, warm, hard and tender. On the same day, at 3 pm, the injection site induration and erythema measured was found to be 30 mm x 50 mm. The patient took ZYRTEC in the morning, BENADRYL at bedtime, Ibuprofen as needed and applied ice packs several times a day as directed. The patient recovered from all the events (injection site erythema, injection site induration, injection site pain and injection site warmth). The reporter assessed this case as non-serious.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 11-June-2018 by Seqirus from VAERS (VAERS ID: 715850) concerns a 51-year-old, adult, female patient. The patient had no current illness. The patient's historical condition and concomitant medications were not reported. On 20-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml [reported as 1], route of administration: intramuscular, anatomical location: right arm, batch number: 195216, expiry date: not reported. On the same day after the administration of vaccine, the patient experienced hot, red, golf ball size swelling at the injection site. Pain scale was reported as 7. On an unspecified date, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest discomfort, Dizziness, Nausea, Paraesthesia oral, Pruritus
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 715924), concerns a 21-year-old, adult, female patient. The patient's current illness included asthma, chronic sinusitis and nasal congestion (since unspecified dates). The patient reported that there is no other medical history. The patient's concomitant medications included CAMRESE, Montelukast and DYMISTA. On 27-Sep-2017, the patient received FLUCELVAX QIV [dose: 0.5 ml (reported as 1 dose), route of administration: injection (reported as syr), anatomical location: left arm, batch number: 195237 and expiry date: not reported]. On the same day after vaccination, the patient had dizziness, nausea, hives on left arm, that progressed over few hours, tight chest, tingling lips, itching on face, back and stomach. The patient visited emergency department and was treated with BENADRYL and DECADRON. Itching was stopped but reoccurred the next morning. At the time of this report, the patient had recovered from the events (chest discomfort, dizziness, nausea, paraesthesia oral and urticaria) but had not recovered from pruritis. The reporter assessed this case as non-serious.
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 715924), concerns a 21-year-old, adult, female patient. The patient's current illness included asthma, chronic sinusitis and nasal congestion (since unspecified dates). The patient reported that there is no other medical history. The patient's concomitant medications included CAMRESE, Montelukast and DYMISTA. On 27-Sep-2017, the patient received FLUCELVAX QIV [dose: 0.5 ml (reported as 1 dose), route of administration: injection (reported as syr), anatomical location: left arm, batch number: 195237 and expiry date: not reported]. On the same day after vaccination, the patient had dizziness, nausea, hives on left arm, that progressed over few hours, tight chest, tingling lips, itching on face, back and stomach. The patient visited emergency department and was treated with BENADRYL and DECADRON. Itching was stopped but reoccurred the next morning. At the time of this report, the patient had recovered from the events (chest discomfort, dizziness, nausea, paraesthesia oral and urticaria) but had not recovered from pruritis. The reporter assessed this case as non-serious.
Age: 69.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Erythema, Oedema, Vaccination complication
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 715947), concerns a 69-year-old, elderly female patient. The patient's current conditions included, dyslipidemia, depression, hypothyroidism, hypertension. The patient had seasonal allergies and allergy to codeine. The concomitant medications included, atorvastatin, meloxicam, lisinopril, bupropion, amlodipine, ZYRTEC, SYNTHROID, PROZAC. On 24-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (1 dose), route of administration: intramuscular, anatomical location: left arm, batch number: 195124, expiry date: not reported). On the same day, the patient was also administered with PNEUMOVAX (dose: 1 dose, route of administration: intramuscular, anatomical location: left arm, batch number: M012127, expiry date: not reported). On 25-Sep-2017, the next day of vaccination, the patient experienced erythematous/edematous reaction reported as vaccination complication. The patient consulted a physician and denied decreased use of arm. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious. Update on 03-Jul-2018: Non-significant case correction was received with IRD 11-Jun-2018: The sentence (However, PNEUMOVAX is the co-suspect in this case which was administered on the same day) was added in the case comment.
Age: 60.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema, Pruritus
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: 716581), concerns a 60-year-old, adult, male patient. The patient's historical conditions included chronic obstructive sleep apnea and allergic reaction to dogs. The patient's current conditions included high blood pressure (reported as medical history) and seasonal allergic rhinitis. The patient's concomitant medications included HYZAAR, TOPROL XL, potassium chloride, LIPTIOR, Co Q10, Omega-6, aspirin and Multivitamin. On 05-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195212, expiry date: not reported). On the same day, after vaccination, the patient experienced intense itching and redness near the injection site. The patient was given BENADRYL (50 mg) and ice pack was applied to the affected area. It was reported that, the events lasted for 2 hours. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: This is a spontaneous case, initially received from FDA (VAERS ID: 719511) (reported to HA by other health professional on 26-Jan-2018, concerns a 47-year-old, adult, female patient. The patient had no medical history, allergies and current illness. The patient did not received any concomitant medications. On an unspecified date, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, batch number: 195239, anatomical location and expiry date: not reported). On the day of vaccination, the patient had hives and after 5 days of vaccination, the patient had hives all over her body. The patient was treated with BENADRYL and prednisone, which did not subside the event. At the time of this report, the outcome of the event was not reported. The reporter assessed the event as non-serious and considered the causality of the event as related to the suspect vaccine.
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Mobility decreased, 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: 720428), concerns a 58-year-old, adult male patient. The patient had no historical condition, allergies and current illness. The patient did not receive any concomitant medications. On 04-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: 195233, expiry date: not reported]. On the same day, after vaccination, the patient experienced muscle soreness and could not lift his arm. The events were reported 12 days after the vaccination. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious. Update 29-Aug-2018: Significant case correction was performed with IRD 16-Aug-2018: The event 'myalgia' was mapped as symptom for the event 'vaccination site movement impairment'. No changes were done in the narrative and case comment.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Burning sensation, Impaired work ability, Injection site pain, Insomnia, Loss of personal independence in daily activities
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: 722725), concerns a 50-year-old, adult, female patient. The patient had no relevant medical history and drug reactions or allergies. On 28-Sep-2017, the patient was administered FLUCELVAX (QIVc) (dose: 0.5 ml, frequency, route of administration, anatomical location, batch number, expiry date: not reported). Within 10 minutes after vaccination, the patient reported a burning sensation from point of shot to entire wrist. Then shortly thereafter the patient's arm started to hurt very badly. By the time the patient left the store, it was painful for her to even lift bags. It was reported that the pain continued to get worse each day and was difficult to even sleep because the arm was so sore. The patient also had limited mobility with the arm. There were certain tasks that she could not do because she could not move her arm properly. It had affected her work because she could not lift. Her arm would seem good for a time and then out of nowhere the pain returned and it was impossible to do simple things like open a jar, put sheets on the bed or take clothes out of the washer. The patient had been extremely affected in her day to day life, especially because that was my prominent arm. The patient had pain (still after 4 weeks later), not as bad as the first few weeks but still she had problems. On an unspecified date, the patient visited the office. On 19-Oct-2017, the patient underwent ultrasound of arm, which revealed no excess fluid in the arm. 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: Non-significant case correction (IRD 16-Aug-2018): The verbiage of the narrative was updated from 'the patient had ultrasound of arm which showed no any fluid excess in the arm' to 'the patient underwent ultrasound of arm, which revealed no excess fluid in the arm'. The verbiage of the case comment was updated from 'The causality of the events was considered as related due to plausible temporal relationship between the events burning sensation and pain in arm and for the other events due to consequences of the event pain in arm' to 'The causality of the events was considered as related for all the events except insomnia due to plausible temporal relationship between the events and vaccination'. The narrative was amended accordingly.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Pain in extremity, Ultrasound scan normal
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: 722725), concerns a 50-year-old, adult, female patient. The patient had no relevant medical history and drug reactions or allergies. On 28-Sep-2017, the patient was administered FLUCELVAX (QIVc) (dose: 0.5 ml, frequency, route of administration, anatomical location, batch number, expiry date: not reported). Within 10 minutes after vaccination, the patient reported a burning sensation from point of shot to entire wrist. Then shortly thereafter the patient's arm started to hurt very badly. By the time the patient left the store, it was painful for her to even lift bags. It was reported that the pain continued to get worse each day and was difficult to even sleep because the arm was so sore. The patient also had limited mobility with the arm. There were certain tasks that she could not do because she could not move her arm properly. It had affected her work because she could not lift. Her arm would seem good for a time and then out of nowhere the pain returned and it was impossible to do simple things like open a jar, put sheets on the bed or take clothes out of the washer. The patient had been extremely affected in her day to day life, especially because that was my prominent arm. The patient had pain (still after 4 weeks later), not as bad as the first few weeks but still she had problems. On an unspecified date, the patient visited the office. On 19-Oct-2017, the patient underwent ultrasound of arm, which revealed no excess fluid in the arm. 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: Non-significant case correction (IRD 16-Aug-2018): The verbiage of the narrative was updated from 'the patient had ultrasound of arm which showed no any fluid excess in the arm' to 'the patient underwent ultrasound of arm, which revealed no excess fluid in the arm'. The verbiage of the case comment was updated from 'The causality of the events was considered as related due to plausible temporal relationship between the events burning sensation and pain in arm and for the other events due to consequences of the event pain in arm' to 'The causality of the events was considered as related for all the events except insomnia due to plausible temporal relationship between the events and vaccination'. The narrative was amended accordingly.
Age: 24.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Dysphagia, Pruritus, Rash, Throat tightness
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: 722737), concerns a 24-year-old, adult male patient. The patient had no historical conditions and current conditions. The patient was allergic to penicillin. The patient had no concomitant conditions. On 25-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195240A and expiry date: not reported]. On the same day (25-Oct-2017), after vaccination, the patient experienced dizziness, itching, tightness of throat, swallowing difficulty and rash on left arm and chest, which were reported an hour after the vaccination. On the same day, at 09:59 AM, the patient went emergency room (ER) and treated promethazine (25 mg, intramuscularly) and triamcinolone acetonide (40 mg, intramuscularly). Later, the conditions were improved and was then discharged. No lab investigations were done. 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.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Musculoskeletal 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: 722771), concerns a 57-year-old, adult, female patient. The patient's historical conditions, current illness, allergies and concomitant medications were not reported. On 03-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: 195211 and expiry date: not reported]. On 05-Oct-2017, 2 days after vaccination, the patient developed shoulder pain. On 24-Oct-2017, it was firstly reported to the pharmacy and the patient was recommended to consult with her primary care physician (PCP). No lab tests were done. 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 was performed with IRD 16-Aug-2018: The sentence was changed from 'the patient recommended' to 'the patient was recommended' in the narrative. The case comment was corrected.
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Cold sweat, Dizziness, Peripheral coldness
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: 722865), concerns a 21-year-old, adult female patient. The patient had no medical history and did not receive any concomitant medications. On 25-Oct-2017, the patient received the suspect vaccine FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: 195233, expiry date: not reported). On the same day, shortly after vaccination, the patient felt light headed, clammy. The patient did not say anything until 10-15 minutes after shot. The patient was made to take rest for a while. The patient looked well while leaving but had little cold in hands and feet. Overall the patient was ok. At the time of report, the patient had recovered from the events (hands and feet felt a little cold, clammy and light headed). The reporter assessed the case as non-serious. Update on 29-Aug-2018: Non-significant case correction was performed with IRD 16-Aug-2018: Case comment was amended.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
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: 722900), concerns a 61-year-old, female patient. The patient's current condition included high blood pressure [reported as HBP (as history)]. The patient had no known drug allergy. The patient's concomitant medications included CRESTOR, PROTONIX, metoprolol, CELEBREX, COMBIVENT, CYMBALTA, VALTREX and potassium for an unknown indication. On 17-Oct-2017, the patient received the suspect vaccine FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: 195212, expiry date: not reported). On 18-Oct-2017, one day after vaccination, the patient experienced soreness in arm. The patient was advised that, soreness in arm was normal after vaccination and told to call back if it still hurt, however the patient did not contact. The patient was told to take MORTIN to relieve soreness. At the time of report, the patient had recovered from the event. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: Injection site reaction, Pain in extremity, Rash pruritic
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: 722965), concerns a 57-year-old, adult female patient. The patient's current condition included arthritis and was allergic to kiwi and cranberry fruits. Concomitant medications included amlodipine and meloxicam for unknown indications. On 02-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195216 and expiry date: not reported). On 10-Oct-2017, 8 days after vaccination, the patient experienced itchy-rash, pain in arm and injection site reaction. It was reported that, the patient had no induration at needle-stick site. The patient did not undergo any lab investigations. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Cough, Influenza like illness, Oral mucosal eruption, Pain
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: 724788), concerning a 63-year-old, adult, female patient. On an unspecified date, at an age of 52 years, the patient administered seasonal influenza vaccine fro unknown indication and experienced migraine. The patient had seasonal allergy, allergies to cats, dogs, pork and watermelon (on an unspecified date). The patient's concomitant medications included amlodipine and hydrochlorothiazide (HCTZ) for unknown indications. On 24-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: 195241 and expiry date: not reported]. On 31-Oct-2017, 7 days after vaccination, the patient developed flu like symptoms which included chills, body ache, runny nose, cough and perioral rash. At the time of the report, the outcome of the events was unknown. The reporter assessed the case as non-serious. This case was linked to 201803643 (same patient).
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Rhinorrhoea
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: 724788), concerning a 63-year-old, adult, female patient. On an unspecified date, at an age of 52 years, the patient administered seasonal influenza vaccine fro unknown indication and experienced migraine. The patient had seasonal allergy, allergies to cats, dogs, pork and watermelon (on an unspecified date). The patient's concomitant medications included amlodipine and hydrochlorothiazide (HCTZ) for unknown indications. On 24-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: 195241 and expiry date: not reported]. On 31-Oct-2017, 7 days after vaccination, the patient developed flu like symptoms which included chills, body ache, runny nose, cough and perioral rash. At the time of the report, the outcome of the events was unknown. The reporter assessed the case as non-serious. This case was linked to 201803643 (same patient).
Age: 57.0
Sex: F
Vaccine: FLUC4, PPV, TDAP
Symptoms: Arthralgia, Back pain, Headache, Injected limb mobility decreased, Injection site reaction
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: 724797), concerns a 57-year-old, adult, female patient. The patient's medical history included possible lupus, Hashimoto's thyroiditis. The patient had a non-specified auto immune disease (reported while speaking about reaction of vaccine on 03-Nov-2017). On 24-Oct-2017, the patient was administered FLUCELVAX (QIVc) [dose: 0.5 ml (frequency reported as 1), batch number: 195224, route of administration: intramuscular, anatomical location: left arm, expiry date: not reported]. The patient was also administered non-company suspect vaccines PNEUMOVAX dose (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: N004564, expiry date: not reported] and BOOSTRIX [route of administration: intramuscular, anatomical location: right arm, batch number: G95PP, dose, expiry date: not reported]. Both the vaccines (FLUCELVAX QIVc and PNEUMOVAX) were given in the same arm (left arm). On 26-Oct-2017, 2 days after the vaccination, the patient experienced extreme arm soreness and inability to move left arm. The patient also had fever, sore back, sore knees, headache and splotches on upper left arm. On an unknown date, 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 verbatim of the event rash macular was updated to splotches on upper left arm/macular rash. The overall case outcome was changed from 'recovered/resolved' to 'unknown'. No changes were done in the narrative.
Age: 57.0
Sex: F
Vaccine: FLUC4, PPV, TDAP
Symptoms: Pain in extremity, Pyrexia, Rash macular
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: 724797), concerns a 57-year-old, adult, female patient. The patient's medical history included possible lupus, Hashimoto's thyroiditis. The patient had a non-specified auto immune disease (reported while speaking about reaction of vaccine on 03-Nov-2017). On 24-Oct-2017, the patient was administered FLUCELVAX (QIVc) [dose: 0.5 ml (frequency reported as 1), batch number: 195224, route of administration: intramuscular, anatomical location: left arm, expiry date: not reported]. The patient was also administered non-company suspect vaccines PNEUMOVAX dose (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: N004564, expiry date: not reported] and BOOSTRIX [route of administration: intramuscular, anatomical location: right arm, batch number: G95PP, dose, expiry date: not reported]. Both the vaccines (FLUCELVAX QIVc and PNEUMOVAX) were given in the same arm (left arm). On 26-Oct-2017, 2 days after the vaccination, the patient experienced extreme arm soreness and inability to move left arm. The patient also had fever, sore back, sore knees, headache and splotches on upper left arm. On an unknown date, 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 verbatim of the event rash macular was updated to splotches on upper left arm/macular rash. The overall case outcome was changed from 'recovered/resolved' to 'unknown'. No changes were done in the narrative.
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Eye swelling, Ocular hyperaemia
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: 724853), concerns a 09-year-old, female child patient. The patient neither had any medical history nor current illness. The patient did not receive any concomitant medications. On 26-Oct-2017, the patient received FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: 195235, expiry date: not reported). On the same day, about 15-20 minutes later, the child developed eye swelling and redness in the left eye. The child had no itching, shortness of breath and rash. It was reported that, the eye did completely shut due to swelling. The child was given BENADRYL orally by school nurse and monitored for approximately 20 minutes. No further reaction or increased swelling were noted. Until the presence of mother, a teacher at school was able to keep close eye on the child. The patient had recovered from the events (eye swelling and redness in the left eye). The reporter assessed the case as non-serious. Update received on 29-Sep-2018: Non-significant case correction (IRD: 26-Aug-2018): The verbiage in the narrative was updated from 'It was reported that, the eye did not swell, but completely shut' to 'It was reported that, the eye did completely shut due to swelling'. The narrative was amended accordingly.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling abnormal, Injection site pain, Insomnia, Musculoskeletal pain
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: 724881), concerns a 41-year-old, adult female patient. The patient had no historical conditions and current illnesses. The patient was allergic to penicillin. The patient's medication at the time of vaccination included MIRENA and STRATTERA for unknown indications. On 07-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]. During vaccination (reported as, initially) the patient felt like the needle hit a nerve and had a nerve-like sensation down in her finger. On 07-Oct-2017, the patient developed pain in the shoulder. The patient visited her physician and was prescribed hydrocodone to help her sleep at night and was planning on getting a hydrocortisone injection in her shoulder for the pain. 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 correct (IRD: 26-Aug-2018): The onset date of the event (shoulder pain) was changed from unspecified date in 'Oct-2017' to '07-Oct-2017' in the event tab. The narrative and case comment amended accordingly.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Muscle tightness
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: 724943), concerns a 54-year-old, adult female patient. On 02-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration, anatomical location, batch number and expiry date: not reported). On the same day, after vaccination, the patient experienced a pinch and tight muscle in upper left arm. The tightness had not gone away for a month. On an unspecified date, the patient made a physician office visit. At the time of this report, the outcome of the event was unknown. The reporter assessed the case as non-serious.
Age: 36.0
Sex: M
Vaccine: ANTH, FLUC4
Symptoms: Erythema, Pruritus, Urticaria
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: 724995), concerning a 36-year-old, adult, male patient. The patient's current condition included common cold and no fevers. The patient was allergic to amoxicillin and kiwi. His concomitant medication included BENADRYL (25 mg liquid x 1 given at 1950). On 04-Nov-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml [frequency reported as 7+), route of administration: intramuscular, anatomical location: left arm, batch number: 195248 and expiry date: not reported) and non-company vaccine BIOTHRAX (dose: frequency reported as 7+, batch number: FAV510A, route of administration: intramuscular, anatomical location: right arm and expiry date: not reported). On the same day around noon, after vaccination, the patient developed itching in left armpit then bilaterally. Later in the evening, once the clothing was removed, the patient noticed redness. At 18:00 hours, the patient developed hives across his chest, nipple line up to the clavicle, down the trunk circumferentially and passed groin to bilateral lower extremity (BLE) anterior to shins and bilateral arms to the wrists. It was reported that, the patient had no hives on buttocks, posterior lower extremity (LE), feet or hands or neck or face. No lab investigations were performed. At the time of the report, the patient had not recovered from the events. The reported assessed the case as non-serious. Update received on 28-Sep-2018: Non-significant case correction (IRD: 26-Aug-2018) - The chronology in para-2 was corrected in the narrative, added the description of BENADRYL in narrative and amended accordingly.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Headache, Nausea, Photophobia, Pregnancy test urine negative
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 724996), concerns a 36-year-old, adult female patient. The patient had no medical history. The patient did not received any concomitant medications. On 04-Nov-2017, the patient received the suspect vaccine FLUCELVAX QIVc (dose: 0.5ml frequency: 1 batch number: 195249, route of administration: intramuscular, anatomical location: left arm, expiry date: not reported). On the same day (04-Nov-2017), after vaccination, over a 2-hour period, the patient experienced headache in the left portion of head which began to increase in pain. It was reported that, the pain had spread from left temple to right temple and then the pressure reported that, headaches, nausea and dizziness led to vomiting few times over a 30-minutes period. On an unspecified date, the patient was taken to the emergency department. The patient was treated with ZOFRAN for nausea, an hour later the patient was able to take MOTRIN. It was stated that, the patient's blood pressure and temperature were normal as the nurse did not reveal any abnormalities in the readings. However, the patient's urine sample showed pregnancy negative. At the time of this report, the patient had recovered from all the events (headaches, head discomfort, dizziness, nausea, vomiting, sensitivity to light). The reporter assessed the case as non-serious.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Vomiting
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 724996), concerns a 36-year-old, adult female patient. The patient had no medical history. The patient did not received any concomitant medications. On 04-Nov-2017, the patient received the suspect vaccine FLUCELVAX QIVc (dose: 0.5ml frequency: 1 batch number: 195249, route of administration: intramuscular, anatomical location: left arm, expiry date: not reported). On the same day (04-Nov-2017), after vaccination, over a 2-hour period, the patient experienced headache in the left portion of head which began to increase in pain. It was reported that, the pain had spread from left temple to right temple and then the pressure reported that, headaches, nausea and dizziness led to vomiting few times over a 30-minutes period. On an unspecified date, the patient was taken to the emergency department. The patient was treated with ZOFRAN for nausea, an hour later the patient was able to take MOTRIN. It was stated that, the patient's blood pressure and temperature were normal as the nurse did not reveal any abnormalities in the readings. However, the patient's urine sample showed pregnancy negative. At the time of this report, the patient had recovered from all the events (headaches, head discomfort, dizziness, nausea, vomiting, sensitivity to light). The reporter assessed the case as non-serious.
Age: 64.0
Sex: M
Vaccine: FLUC4
Symptoms: Vaccination complication
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: 725102), concerns a 64-year-old, adult male patient. The patient had no historical condition. The patient was allergic to non-steroidal anti-inflammatory drug (NSAID). The patient did not receive any concomitant medication. On 24-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported and unknown, route of administration: intramuscular, anatomical location: left arm, batch number: 195225A, and expiry date: not reported). On the same day, after vaccination, the patient developed reaction to the vaccine. On 27-Oct-2017, at afternoon, the doctor called the pharmacy and reported the aforementioned information. The reporter was not sure about the lab tests done. At the time of this report, the patient had not recovered from the event. The reporter assessed the case as non-serious and assessed the causality as related (reaction to the vaccine).
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Cough, Myalgia, Respiratory tract congestion, Rhinorrhoea
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: 725115), concerns a 57-year-old, adult female patient. The patient's historical vaccine included unspecified flu vaccine for which the patient experienced runny nose, severe chest congestion, nagging persistent cough and a lot of mucous. The patient's historical condition included chronic high cholesterol, specifically low-density lipoproteins [LDL] levels. The patient's allergic condition included hay fever. The patient had no current illness. The patient did not receive any concomitant medications. On 26-Sep-2017, the patient received FLUCELVAX QIVc [dose: 0.5 ml, route of administration, anatomical location, batch number and expiry date: not reported]. On 20-Oct-2017, 24 days after vaccination, the patient experienced runny nose, severe nagging cough, chest congestion and muscle aches. At the time of this report, the patient had not recovered from the events (runny nose, severe nagging cough, chest congestion and muscle aches). This case '201803660' was linked to the other case '201803661' due to the same patient. The reporter assessed the case as non-serious. Update received on 29-Sep-2018: Significant case correct (26-Aug-2018): The symptom 'cough' was made as separate diagnosis. Update received on 15-Oct-2018: Non-significant case correction (26-Aug-2018): The linked case number was corrected from 201803660 to 201803661 in the narrative.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 725148), concerns a 31-year-old, adult female patient. The patient was allergic to benzene and SUDAFED cold drugs. The patient's concomitant medications included Multivitamin, fiber capsules and apple cider vinegar, all for unknown indications. On the same day, within 2 minutes after vaccination, the patient experienced sharp pain that went down the right arm, tremor in the hand, lost feeling in last 2 fingers of hand, sharp constricting pain in her medial and lateral wrist, burning pins and needles from upper arm down to wrist and lost strength in the right hand. On an unspecified date, the patient made an emergency room visit. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Tremor
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 725148), concerns a 31-year-old, adult female patient. The patient was allergic to benzene and SUDAFED cold drugs. The patient's concomitant medications included Multivitamin, fiber capsules and apple cider vinegar, all for unknown indications. On the same day, within 2 minutes after vaccination, the patient experienced sharp pain that went down the right arm, tremor in the hand, lost feeling in last 2 fingers of hand, sharp constricting pain in her medial and lateral wrist, burning pins and needles from upper arm down to wrist and lost strength in the right hand. On an unspecified date, the patient made an emergency room visit. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Urticaria
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: 725201), concerns a 44-year-old, adult, female patient. On 02-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: 195214 and expiry date not reported]. On the same day, 30 minutes after vaccination, the patient developed hives on face, neck, legs and feet. Patient had intense itching on trunk, scalp and arms. The frequency and volume of hives increased throughout the evening to next day. After call to clinic, the patient began 10 mg of ZYRTEC and made an appointment on the same day to see a doctor. The doctor confirmed that it was wheel hives and suggested to continue ZYRTEC, H2 receptor blocker and BENADRYL at night time. The doctor said if hives were still present after two weeks they might begin steroid treatment. It was reported that, the doctor recommended the patient not to take flu shot again. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2017 by Seqirus from VAERS (VAERS ID: 725218), concerns a 34-year-old, adult female patient. The patient did not have any historical and current condition. The patient had no known drug allergies. The patient's concomitant medication included WELLBUTRIN for an unknown indication. On 04-Nov-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: 195248 and expiry date: not reported). On 06-Nov-2017, 2 days after vaccination, the patient developed large redness at the administration site, heat and pain at the injection site. The patient did not undergo any laboratory investigations as of now. At the time of this report, the outcome of the events was not reported. The reporter assessed the case as non-serious.
Age: 18.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Paraesthesia, Throat tightness
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: 725436), concerning a 18-year-old, adult, female patient. The patient had no known allergies. On 06-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: 195241 and expiry date: not reported]. On the same day, after vaccination, the patient developed tingling in face, arms and hands. The patient was given BENADRYL at the student health center. Around 07:00 pm, the patient felt dizzy and her throat was closing up. Hence, the patient went to the Medical center emergency room (ER). At the time of this report, the patient had recovered form the events. The reporter assessed the case as non-serious.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Hyperhidrosis
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: 726211), concerning a 30-year-old, adult, female patient. The patient had no chronic historical condition, no known allergy (NKA) and no prior current illness. On 09-Nov-2017, around 5:00 pm, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), batch number: 195233, route of administration: intramuscular, anatomical location: left arm and expiry date: not reported]. The patient was relaxed and alert while receiving the shot. On the same day, about 15 minutes after vaccination, the patient became very sweaty and felt like fainting, but patient did not faint. The patient's tank top was soaked with sweat. The patient sat down, and the reporter brought her a glass of water and some candy. Later, the patient started feeling better and felt close to normal after about 15 minutes. The patient stayed seated for about an additional 20 minutes. On an unspecified date, the patient had an office visit. At the time of the report, the patient had recovered from the events. The reporter assessed the case as non-serious. Update received on 27-Sep-2018: Non-significant case correction (26-Aug-2018): The sentence 'On an unspecified date, the patient had an office visit' was added in the narrative.