chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injection site pustule
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: 725951), concerns a 73-year-old, elderly female patient. The patient's historical condition included diabetes. The patient's current condition, allergies and medications at the time of vaccination were unknown. On 09-Oct-2017, the patient was administered suspect vaccine FLUCELVAX QIVc [dose: 0.5 ml (frequency: unknown), route of administration: intramuscular, anatomical location: right arm, batch number: 195126, expiry date: not reported] and non-company suspect vaccine PNEUMOVAX [route of administration: intramuscular, anatomical location: left arm, batch number: N022303, dose: not reported (frequency: reported as n/a, not available), expiry date: not reported]. On an unspecified date in Oct-2017, the patient developed pustules on her left arm where the co-suspect vaccine PNEUMOVAX was administered, which was reported to the pharmacy by the patient's doctor of medicine (MD). The patient's lab data was unknown. It was reported that the patient visited office. At the time of this report, the outcome of the event was unknown. The reporter assessed this case as non-serious.
Age: 56.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, 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: 725960), concerning a 56-year-old, adult, female patient. The patient's historical condition included: hypertension. The patient had no allergies. On 06-Nov-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, anatomical location: right arm, route of administration: unknown, batch number and expiry date: not reported) and co-suspect ZOSTAVAX (frequency reported as 1, batch number: M041087, route of administration: subcutaneous, anatomical location: left arm and dose, expiry date: not reported). On the next day, after vaccination, the patient developed 3-inch diameter circle around the injection site on her left arm. The area was red, hot to the touch, and slightly swollen. The patient was not bothered by it and there was not much pain. The aforementioned information was reported by the patient on 09-Nov-2017. The patient was advised to take BENADRYL to see if it would reduce the reaction and was told that the pharmacist would follow up with the patient on Saturday 11-Nov-2017. The patient was informed to seek medical help if the reaction gets worsened. At the time of the report, the outcome of the events was unknown. The reported assessed the case as non-serious.
Age: 38.0
Sex: M
Vaccine: FLUC4
Symptoms: Grip strength decreased, Hypoaesthesia, Injected limb mobility decreased, Pain in extremity
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: 725962), concerns a 38-year-old, adult male patient. On 16-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: 195214 and expiry date: not reported). On 17-Oct-2017, one day after vaccination, the patient experienced numbness and pain in the arm, for the duration of 4 weeks. The patient did not have full mobility or grip in his left arm/hand. On an unspecified date, the patient made an office visit. It was reported that, the patient would follow-up with a doctor for further review. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity, Product administered at inappropriate site
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: 726083), concerns a 35-year-old, adult female patient. 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: 195233, and expiry date: not reported). The patient reported that, the intern gave her the vaccine higher than previous vaccines. On 10-Nov-2017, 4 days after vaccination, the patient experienced pain in her arm. The patient was waiting to see if it resolved on its own in a few days or else she might seek medical treatment. At the time of this report, the patient was still experiencing pain in her arm (not recovered). The reporter assessed the case as non-serious. Update received on 27-Sep-2018: Non-significant case correction (IRD 26-Aug-2018): The verbiage 'considered as drug administered at inappropriate site' was added in the case comment.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pain, Pain in extremity, Peripheral 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: 726253), concerns a 46-year-old, adult female patient. The patient had no allergies. On 29-Oct-2017, the patient received FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported. On the same day (29-Oct-2017), after vaccination, the patient experienced swelling, redness, soreness and sharp pain in arm. The patient was prescribed with prednisone and TYLENOL. It was reported that, the patient visited office. At the time of report, the outcome of the events (swelling, redness, soreness and sharp pain in arm) were unknown. The reporter assessed the case as non-serious.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood pressure increased, Condition aggravated
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: 726263), concerns a 57-year-old, adult female patient. The patient's current condition (reported as medical history) included high blood pressure which was controlled by medication. 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: right arm, batch number: 195240A and expiry date: not reported). On 07-Nov-2017, one day after vaccination, the patient had a spike in blood pressure which was not controlled by medication. And lasted several hours (reported as 12 plus). On an unspecified date, the patient made an office visit. On an unspecified date in Nov-2017, the patient had recovered from the events. The reporter assessed the case non-serious. Update received on 29-Sep-2018: Non-significant case correction (IRD: 26-Aug-2018): The verbiage in the narrative was updated from "The patient's medical history included' to 'The patient's current condition (reported as medical history) included'. The narrative was amended accordingly. The verbiage 'female patient with current condition of hypertension' was updated in the case comment.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Lymphadenopathy, Musculoskeletal stiffness, Myalgia, Ocular discomfort
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: 726271), concerns a 36-year-old, adult, female patient. The patient's medical history included high fevers after influenza vaccine with loss of consciousness. The patient had a drug allergy with Penicillin and Vancomycin. No current illness was reported for the patient. On 09-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: 195229, expiry date: not reported]. On the same day after vaccination, the patient experienced headache, severely swollen lymph nodes, muscle pain, stiff neck and pressure in eyes. The outcome of the events was unknown. The reporter assessed this case as non-serious. This case is linked to case number 201803563 due to same reporter.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Musculoskeletal pain, 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: 726293), concerning a 26-year-old, adult, female patient. The patient had no allergies. On 03-Oct-2017, the patient was administered FLUCELVAX (QIVc) (dose: 0.5 ml [frequency reported as 1], batch number: 195238, route of administration: intramuscular, anatomical location: left arm and expiry date: not reported). On 05-Oct-2017, 2 days after the vaccination (reported as few days after vaccination), the patient developed pain. The patient also experienced pain especially in the shoulder. On an unspecified date, the patient made an office visit. At the time of the report, the outcome of the event pain had not recovered and for the event shoulder pain it was unknown. The reporter assessed the case as non-serious.
Age: 44.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site urticaria, 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: 726558), concerns a 44-year-old, adult male patient. The patient's historical condition included Raynaud's disease and soreness in arm. The patient had no current condition and no allergies. The concomitant medication included Cetirizine as over the counter (OTC) allergy medication. On 10-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: 195232 and expiry date: not reported). On 11-Nov-2017, one day after vaccination, the patient developed red hives on his left upper arm and more soreness in arm (than the past). Hence, the patient was treated with BENADRYL on 13-Nov-2017. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 54.0
Sex: M
Vaccine: FLUC4
Symptoms: Burning sensation, Erythema, Pain, 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: 726574), concerning a 54-year-old, adult, male patient. On 24-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, batch number: 195225A, route of administration: intramuscular, anatomical location: unknown and expiry date: not reported). On the next day, after the vaccination, the patient developed rash with redness on the face and swollen bumps across the glabella and right eyebrow. The swollen bumps were quite itchy and facial skin redness had a burning and stinging sensation. On 26-Oct-2017, the patient woke up noticing that the red macular rash had spread to arms and torso. At the time of the report, the outcome of the events was not reported. The reported assessed the case as non-serious.
Age: 54.0
Sex: M
Vaccine: FLUC4
Symptoms: Rash pruritic
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: 726574), concerning a 54-year-old, adult, male patient. On 24-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, batch number: 195225A, route of administration: intramuscular, anatomical location: unknown and expiry date: not reported). On the next day, after the vaccination, the patient developed rash with redness on the face and swollen bumps across the glabella and right eyebrow. The swollen bumps were quite itchy and facial skin redness had a burning and stinging sensation. On 26-Oct-2017, the patient woke up noticing that the red macular rash had spread to arms and torso. At the time of the report, the outcome of the events was not reported. The reported assessed the case as non-serious.
Age: 59.0
Sex: M
Vaccine: FLUC4
Symptoms: Headache, Musculoskeletal stiffness, Neck pain
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: 726811), concerning a 59-year-old, adult, male patient. The patient's current condition included thyroid disorder (since an unspecified date) (reported as medical history). The patient had no current illness and allergies. The patient's concomitant medications included vitamin D3 and thyroid medications. On 07-Nov-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 10-Nov-2017, 3 days after vaccination, the patient experienced a stiff and painful neck in the evenings. The patient experienced a very mild headache. It was reported that the symptoms resolved for the rest of the day and then re-occurred in the evening. The pain and stiffness were not unbearable. The patient has not visited any doctor and has not taken any medications for the symptoms. No lab investigations were done. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Paraesthesia, Splint application
Clinical narrative: This is a spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 726845), concerns a 42-year-old, adult female patient. The patient's historical conditions included fatty liver, mitral regurgitation, degenerative disc disease [DDD]. The patient did not have any current illness. On 19-Oct-2017, the patient received FLUCELVAX QIVc (dose: 0.5 ml, frequency: unknown, route of administration: intramuscular, anatomical location: right arm, batch number: 195245, expiry date: not reported). On the same day, 20 minutes after vaccination, the patient experienced numbness and tingling in the right lateral aspect of the palm and wrist which progressed to pain within 24 hours. On an unspecified date, the patient had an emergency room visit and physician office visit. It was reported that, the MD [physician's] note was attached (unspecified). At the time of report, the patient was wearing splint in the right hand/wrist. The patient had not yet recovered from the events. The reporter assessed the case as non-serious.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, 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: 726935), concerning a 41-year-old, adult, female patient. The patient did not have any allergies. On 12-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: 195230 and expiry date: not reported]. On 13-Nov-2017, one day after vaccination, the patient experienced severe itching and swelling and ended up going to the emergency room (ER). At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 61.0
Sex: F
Vaccine: FLUC4, PPV, VARZOS
Symptoms: Injection site erythema, Injection site rash, Product administration error
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: 726983), concerns a 61-year-old, adult female patient. The patient's historical conditions included hyperlipidaemia and muscle cramps. The patient's current conditions included hypertension and diabetes (reported as medical history). The patient's medications at the time of vaccination included Lisinopril, Naproxen, Levothyroxine and Pioglitazone for unknown indications. On 01-Nov-2017, the patient was administered suspect vaccine FLUCELVAX QIVc [dose: 0.5 ml (frequency: 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195242, expiry date: not reported] and non-company suspect vaccines, PNEUMOVAX [frequency: 1, route of administration: intramuscular, anatomical location: right arm, batch number: N019348, dose, expiry date: not reported] and ZOSTAVAX (frequency: 1, route of administration: subcutaneous, anatomical location: left arm, batch number: N022035, dose, expiry date: not reported). As both the vaccines (FLUCELVAX QIVc and ZOSTAVAX) was administered in the same arm, it was considered as drug administration error. On 04-Nov-2017, 3 days after vaccination, the patient developed a large rash and redness in the left arm at the injection site. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious.
Age: 55.0
Sex: M
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Limb discomfort, 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: 727397), concerns a 55-year-old, adult male patient. The patient had no historical conditions and current condition. The patient had no known drug allergies. On 27-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, frequency: unknown, route of administration: intramuscular, anatomical location: left arm, batch number: 195234, expiry date: not reported]. On the same day (27-Oct-2017) after the vaccination, the patient experienced tingling, discomfort and numbness down his left arm. Most of the numbness was located on the end of the thumb of the left hand. It was reported that, the symptoms did not improve or worsen in the past 3 weeks. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 5.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
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: 727404), concerns a 05-year-old, male child patient. The patient's historical conditions were unknown. The patient did not have any current conditions and allergies. The patient did not received any concomitant medications. On 16-Nov-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: 195233 and expiry date: not reported). On 18-Nov-2017, 2 days after vaccination, the patient experienced redness around the injection site. The injection site was warm and slightly raised (swelling). On an unspecified date, the patient made an office visit and was seen by the doctor who prescribed cephalexin. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 27.0
Sex: M
Vaccine: FLUC4
Symptoms: Fall, Head injury, Hyperhidrosis, Hyporesponsive to stimuli, Incoherent
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: 727436), concerns a 27-year-old, adult male patient. The patient was allergic to CECLOR drug and LEVAQUIN antibiotic. The patient's concomitant medications included citalopram, meloxicam and fluticasone nasal spray [2 sprays each nostril every day (QD)], all for unknown indications. On 19-Nov-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, batch number: 195216, anatomical location and expiry date: not reported). On the same day, 2 to 3 minutes after vaccination, the patient felt real shakiness (nervousness) and then fell on the floor. A shopper reported that, the patient hit his head on the floor during the fall. The patient neither appeared to lose consciousness nor to be familiar with surroundings but experienced sweating and appeared incoherent. As the patient became more responsive, approximately after 5 minutes, he sat on a chair at the spot and was given ice to apply on his head. The patient appeared to be alert in about 15 to 20 minutes and left the spot. The patient stated that the injection did not hurt did not feel different at the time of injection. The patient also stated that he got shots for his back weekly and had no problems. On the same date, the patient had recovered from the events (sweating, appeared incoherent, abnormal feeling and fall). On an unspecified date, the patient had also recovered from the event head injury. The reporter assessed the events as non-serious. Update received on 27-Sep-2018: Non-significant case correction (IRD: 26-Aug-2018): In the case comment, the sentence was corrected from 'the company assessed the causality of the events feeling' to 'the company assessed the causality of the events nervousness'. Update received on 11-Oct-2018: Non-significant case correction (IRD: 26-Aug-2018): The term 'shaky feelings' was changed to 'nervousness' in the case comment.
Age: 27.0
Sex: M
Vaccine: FLUC4
Symptoms: Nervousness, Tremor
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: 727436), concerns a 27-year-old, adult male patient. The patient was allergic to CECLOR drug and LEVAQUIN antibiotic. The patient's concomitant medications included citalopram, meloxicam and fluticasone nasal spray [2 sprays each nostril every day (QD)], all for unknown indications. On 19-Nov-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, batch number: 195216, anatomical location and expiry date: not reported). On the same day, 2 to 3 minutes after vaccination, the patient felt real shakiness (nervousness) and then fell on the floor. A shopper reported that, the patient hit his head on the floor during the fall. The patient neither appeared to lose consciousness nor to be familiar with surroundings but experienced sweating and appeared incoherent. As the patient became more responsive, approximately after 5 minutes, he sat on a chair at the spot and was given ice to apply on his head. The patient appeared to be alert in about 15 to 20 minutes and left the spot. The patient stated that the injection did not hurt did not feel different at the time of injection. The patient also stated that he got shots for his back weekly and had no problems. On the same date, the patient had recovered from the events (sweating, appeared incoherent, abnormal feeling and fall). On an unspecified date, the patient had also recovered from the event head injury. The reporter assessed the events as non-serious. Update received on 27-Sep-2018: Non-significant case correction (IRD: 26-Aug-2018): In the case comment, the sentence was corrected from 'the company assessed the causality of the events feeling' to 'the company assessed the causality of the events nervousness'. Update received on 11-Oct-2018: Non-significant case correction (IRD: 26-Aug-2018): The term 'shaky feelings' was changed to 'nervousness' in the case comment.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: 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: 727443), concerns a 64-year-old, adult female patient. The patient had no allergies. The patient stated that, she was not sick at the time of vaccination. On 27-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical site: left arm, batch number: 195224 and expiry date: not reported). On an unspecified date in Oct-2017, after vaccination, the patient stated that, her arm had been sore for 3 weeks following the vaccination. The aforementioned information was reported by the patient to the corporate headquarters on 19-Nov-2017. On an unspecified date, the patient made an office visit. It was reported that, the pharmacy supervisor would follow up with her. The patient was recommended to see her family physician to evaluate the pain.  At the time of this report, the outcome of the event was unknown. The reporter assessed the case as non-serious.
Age: 41.0
Sex: M
Vaccine: FLUC4
Symptoms: Cough, Oropharyngeal pain, Pain, Pyrexia
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: 727722), concerns a 41-year-old, adult male patient. The patient's historical condition included flu-like-symptoms after and unspecified prior vaccination in 2015. The patient had no current conditions or any allergies. The patient's medications at the time of vaccination included Multivitamin and body key protein. On 15-Nov-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency: unknown), route of administration: intramuscular, anatomical location: left arm, batch number: 195221 [reported as 195E21], expiry date: not reported]. On 18-Nov-2017, 3 days after vaccination, the patient experienced body aches, sore throat, fever and cough. The patient took ibuprofen [dose: 800 mg, frequency: three times a day (TID), route of administration: oral] and got better by 21-Nov-2017 (reported as, after 3 days). On an unknown date the patient visited office. The patient did not undergo any laboratory investigations. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 44.0
Sex: M
Vaccine: FLUC4
Symptoms: Dysgeusia, Erythema, Paraesthesia
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: 727990), concerns a 44-year-old, adult male patient. The patient had no historical condition and current condition. The patient had no known allergies. The patient did not receive any concomitant medication. On 21-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: 195216 and expiry date: not reported]. On the same day, 20 minutes after vaccination, the patient noticed a metallic taste and his face turned red. The patient also had a tingling sensation that started on his face and descended his body to his knees, then ascended back to his face. The patient took BENDARYL. At the time of this report, the patient recovered from the events. The reporter assessed the case as non-serious. Update received on 20-Sep-2018: Significant case correction (IRD: 26-Aug-2018): The listedness for the event (paraesthesia) was changed from 'listed' to 'unlisted' in Pl Flu Vaccine Cell Subunit NVD. No changes were done in the narrative.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, 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: 728010), concerning a 51-year-old, adult, female patient. The patient's historical condition included upper respiratory tract infection during the prior month of vaccination (on an unspecified date in Sep-2017 [reported as current illness], but had no symptoms during vaccination. The patient had no allergies and concomitant medication at the time of vaccination. On 23-Oct-2017, the patient was administered FLUCELVAX (QIVc) [dose: 0.5 ml (frequency reported as 1), batch number: 195129, route of administration: intramuscular, anatomical location: left arm and expiry date: not reported]. On the same day, after the vaccination, the patient felt pain at the site of injection and on the shoulder. The patient had difficulty raising hand and trouble dressing herself due to pain. The patient had no rash, itchiness or weakness in the arms, but was painful. The patient had been referred to Orthopaedic for further evaluation as the patient was not willing to come to the clinic for evaluation. On an unspecified date, the patient had makd a physician office visit. No lab investigations were done. At the time of the report, the patient had not recovered from the events. The reporter assessed this case as non-serious. Update received on 27-Sep-2018: Significant case correction (IRD: 26-Aug-2018): The as determined causality for the events, mobility decreased and loss of personal independence in daily activities was changed from not related to related in event assessment tab. The case comment was amended accordingly.
Age: 58.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Chills, Cough, Fatigue, Lethargy, Pyrexia
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: 728421), concerning a 58-year-old, adult, male patient. The patients historical condition included diabetes (date unspecified). The patient's concomitant medications included valsartan, guanfacine and clonazepam. On 18-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: 195239 and expiry date: not reported] and non-company suspect product PNEUMOVAX (dose: (frequency reported as 1), route of administration: intramuscular, anatomical location: right arm, batch number: N022650 and expiry date: not reported]. On the same day (18-Nov-2017), after vaccination, when the patient was walking home, he felt tired. Since the vaccination, the patient was lethargic, coughing, had fever and chills. It was reported that the patient would go to the doctor that day. On an unspecified date, the patient made an emergency room (ER) visit. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious. Update received on 19-Sep-2018: Non-significant case correction: (26-Aug-2018): The sentence in the narrative was changed from 'Since the vaccination, the patient has experienced lethargy, cough, fever, and chills' to 'Since the vaccination, the patient was lethargic, coughing, had fever and chills'. Update received on 11-Oct-2018: Non-significant case correction (26-AUG-2018) - The HLT for the event- Lethargy was changed to 'asthenic conditions' and SOC was changed to 'general disorders and administration site conditions'.
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Acne, Injection site 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: 728433), concerns a 28-year-old, adult, female patient. The patient had no current illnesses or history/allergies and she was not taking any medications at the time of vaccination. On 25-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency: unknown), route of administration, anatomical location, batch number and expiry date: not reported]. On 26-Oct-2017, 1 day after vaccination, the patient experienced pimple-like bumps on both sides of the face and chin, and consistent dull pain at the injection site. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Injection site pain, Pain, Pain in extremity
Clinical narrative: This spontaneous case, reported by other non-health professional (consumer) to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 728463), concerns a 55-year-old, adult female patient. The patient's historical condition included visual migraines and current conditions included diabetes mellitus and hypothyroidism (reported as medical history). The patient was allergic to naproxen, PAMELOR, PAXIL and CHANTIX, pudding and perfumes. Concomitant medications included metformin, levothyroxine, liothyronine, verapamil and WELLBUTRIN for unknown indications. On 18-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195128 and expiry date: not reported). On the same day, during the vaccination, the patient noted that, the vaccine burned similarly to antibiotic injection and had a sensation of receiving multiple sites on the upper arm. The patient experienced normal pain in upper arm, but the pain did not subside, rather increased. The patient felt pain down the back of her arm, through her elbow and wrist and down through her left ring finger. The pain was not constant but was present when she tried to reach above her shoulder or behind and to her left as in reaching onto the back seat of a car to pick something up. The pain was consistent when the patient tried to sleep on her left side. The patient stated that, some days were definitely worse than others. On an unspecified date, the patient made a physician office visit and met the provider. The patient reported that, she did not undergo any laboratory investigations yet. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 59.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Herpes zoster, Neck pain, Pain, Rash, Tenderness
Clinical narrative: This spontaneous case, reported by the pharmacist to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 728453), concerns a 59-year-old, adult female patient. The patient's current conditions included blood pressure, abnormal blood sugar, hormone replacement therapy, hypersensitivity and post-traumatic pain (pain from previous injury). The patient's concomitant therapies included alogliptin; XYZAL, hydrochlorothiazide, estradiol, CYMBALTA, ZOCOR, lisinopril, gabapentin, metoprolol tartrate, MOBIC and levocetirizine. The patient was not on any immunosuppressant therapy, had no illness and felt fine. On 02-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as unknown, route of administration, anatomical site, batch number: unknown and expiry date: not reported). On the same day, the patient went to the pharmacy at 4:00 hours and at 4:09 hours, received the first dose of ZOSTAVAX 19400 PFU (dose: 0.65 ml/once, route of administration: subcutaneous, anatomical site: right arm, batch number: N012614 and expiry date: 16-Mar-2018). On 04-Oct-2017, 2 days after vaccination, the patient experienced tenderness, pain, neck pain and rash on her back and flanks. A week later, the patient returned to the pharmacy with a possible rash and redness at the injection site. It was reported that the patient went to the pharmacy a few days after the vaccination and told about the reaction. On an unspecified date, the pharmacist returned her with the medical doctor. On a visual inspection, the patient was diagnosed with shingles. Furthermore, the patient received unspecified treatment to the aforementioned events. Additionally, the reporter did not provide causality assessment between the events and vaccination with ZOSTAVAX. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious. Update received on 28-Sep-2018: Non-significant case correction (26-Aug-2018): The dose for co-suspect vaccine ZOSTAVAX (0.65 ml) was added in the product tab.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, 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: 728567), concerns a 59-year-old, adult female patient. The patient's historical condition included diabetes. The patient's current condition included auto-immune disorder (unspecified). The patient was allergic to LEVAQUIN. The concomitant medications included CRESTOR, Ramipril and SYNTHROID for unknown indications. On 10-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: 195228 and expiry date: not reported). The patient felt that the shot was given more towards the tricep area. On 11-Nov-2017, 24 hours after vaccination, the patient complained of radiating pain from her shoulder to hand. The patient took prednisone which provided her some relief. On 28-Nov-2017, the patient visited the doctor (MD) and was issued a new script to continue the Prednisone. No diagnosis was given by the doctor, but the patient did say that pain could also be related to some type of autoimmune disorder that she has. At the time of this report, the patient had not recovered from the event. The reporter assessed the case as non-serious.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Pain, Radiculopathy
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: 728779), concerns a 60-year-old, adult, female patient. On 07-Oct-2017, the patient was administered FLUCELVAX QIVc (route of administration: intramuscular, anatomical location: right arm, dose: 0.5 ml, batch number: 195224 and expiry date: not reported). On 14-Oct-2017, 7 days after vaccination, the patient experienced pain at the injection site which worsened for days after vaccination. On an unspecified date, the patient consulted an orthopedist, who stated that the pain was due to the irritation of the nerve. At the time of report, the patient was on physical therapy. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious. Update received on 26-Sep-2018: Non-significant case correction (IRD: 26-Aug-2018) - The case comment was changed from 'The patient experienced nerve root irritation and pain worsened, on an unspecified date after vaccination with the suspect vaccine' to 'The patient further experienced worsening of pain and was diagnosed with radiculopathy, on an unspecified date after vaccination with the suspect vaccine'.
Age: 15.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood glucose normal, Blood pressure increased, Blood urine present, Drug screen negative, Fatigue
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: 728809), concerns a 15-year-old, adolescent, female patient. The patient's current condition included attention-deficit/hyperactivity disorder (ADHD) (reported as medical history). The patient did not have any known allergies. The patient's concomitant medication included CONCERTA. On 10-Oct-2017, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left arm, dose: 0.5 ml, batch number: 195239 and expiry date not reported]. On the same day, within 4 hours after vaccination, the patient experienced jitteriness and shaking, also had increased blood pressure and heart rate according to school nurse. The nurse was unable to obtain complete blood pressure reading at the office due to shaking. The systolic pressure was 104 (unit and normal range unspecified) and was unable to hear diastolic. The patient's heart rate was not recorded. The patient was given MOTRIN and BENADRYL in office and in the evening was given a dose of hydroxyzine as treatment. Patient slept most of the afternoon and most of the evening and was tired the next morning (11-Oct-17) but did not have tremors. On an unknown date, the patient visited the office. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious. Update received on 27-Sep-2018: Significant case correction (26-Aug-2018): Event somnolence was removed from the events tab. The case comment was modified accordingly.
Age: 15.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling jittery, Full blood count normal, Heart rate increased, Tremor, Urine analysis normal
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: 728809), concerns a 15-year-old, adolescent, female patient. The patient's current condition included attention-deficit/hyperactivity disorder (ADHD) (reported as medical history). The patient did not have any known allergies. The patient's concomitant medication included CONCERTA. On 10-Oct-2017, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left arm, dose: 0.5 ml, batch number: 195239 and expiry date not reported]. On the same day, within 4 hours after vaccination, the patient experienced jitteriness and shaking, also had increased blood pressure and heart rate according to school nurse. The nurse was unable to obtain complete blood pressure reading at the office due to shaking. The systolic pressure was 104 (unit and normal range unspecified) and was unable to hear diastolic. The patient's heart rate was not recorded. The patient was given MOTRIN and BENADRYL in office and in the evening was given a dose of hydroxyzine as treatment. Patient slept most of the afternoon and most of the evening and was tired the next morning (11-Oct-17) but did not have tremors. On an unknown date, the patient visited the office. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious. Update received on 27-Sep-2018: Significant case correction (26-Aug-2018): Event somnolence was removed from the events tab. The case comment was modified accordingly.
Age: 40.0
Sex: M
Vaccine: ANTH, FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
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: 728811), concerns a 40-year-old, adult male patient. The patient had no historical condition and had no illness within one month before vaccination. The patient had no known allergies. The patient did not receive any concomitant medication. On 28-Nov-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195248 and expiry date: not reported). The patient was also administered a non-company co-suspect vaccine, BIOTHRAX (frequency reported as 6, route of administration: intramuscular, anatomical location: left arm, batch number: 300021A, dose and expiry date: not reported). On 29-Nov-2017, one day after vaccination the patient developed redness, warmth and slight swelling at the injection site. The patient stated that the pain was worse than normal pain from anthrax vaccine and that prompted him to look at the site. The patient had no noted rash or hives, fever or chills. The patient used a hot compress on the site to reduce swelling and pain which did help. The patient stated the redness had gone away and swelling had gone down since using warm compress on the site. At the time of this report, the patient was recovering from swelling at the injection site and had recovered from redness at injection site. The outcome of the other events was unknown. 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 case comment was corrected from 'one day after the administration of the suspect vaccines (FLUCELVAX QIVc and BIOTHRAX)' to 'one day after the administration of the suspect vaccine, FLUCELVAX (QIVc) and co-suspect, BIOTHRAX (anthrax vaccine)' and 'the causality was assessed as related due to site specific (injection site) occurrence of the events and plausible temporal relationship between the events and the suspect vaccines' to 'the company assessed the causality of the events as related due to site specific (injection site) occurrence of the events and plausible temporal relationship between the events and the suspect vaccine'. No changes were made in narrative.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Anaphylactic reaction, Cough, Flushing, Pruritus, Skin test positive
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 737137), concerns a 62-year-old, adult, female patient. On an unspecified date in 2011, the patient experienced anaphylaxis to flu vaccine. The patient's historical condition included breast cancer-in remission. The patient's current conditions included persistent asthma and allergic rhinitis (reported as medical history). The patient was allergic to mold, dust and animal dander. The patient had seasonal allergies. The patient's concomitant medications included PROVENTIL HFA, COZAAR and DULERA for unknown indications. On 02-Fev-2018, the patient underwent skin testing to FLUCELVAX QIVc [route of administration: other (as reported), anatomical location: left arm, batch number: 195250, dose and expiry date: not reported] as recommended by the Practice Parameters. The patient underwent skin prick test with 1:10 and there was no reaction at 15 minutes. Skin prick test with full strength was performed and no reaction was observed at 15 minutes. Skin prick test (intradermal) with 1:100 dilution was performed, and the patient tested positive (12mm wheal/48mm flare) with associated flushing, pruritus of ears and face, throat clearing, throat irritation and coughing, which were considered as anaphylaxis. Epinephrine and CLARITIN were administered for anaphylaxis. On the same day (02-Feb-2018), the patient had recovered from the event and symptoms. The patient was monitored for 1 hour after and discharged from clinic in good health. This case was cross-linked to case 201804017 (same patient). The reporter assessed the case as non-serious.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Throat irritation
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 737137), concerns a 62-year-old, adult, female patient. On an unspecified date in 2011, the patient experienced anaphylaxis to flu vaccine. The patient's historical condition included breast cancer-in remission. The patient's current conditions included persistent asthma and allergic rhinitis (reported as medical history). The patient was allergic to mold, dust and animal dander. The patient had seasonal allergies. The patient's concomitant medications included PROVENTIL HFA, COZAAR and DULERA for unknown indications. On 02-Fev-2018, the patient underwent skin testing to FLUCELVAX QIVc [route of administration: other (as reported), anatomical location: left arm, batch number: 195250, dose and expiry date: not reported] as recommended by the Practice Parameters. The patient underwent skin prick test with 1:10 and there was no reaction at 15 minutes. Skin prick test with full strength was performed and no reaction was observed at 15 minutes. Skin prick test (intradermal) with 1:100 dilution was performed, and the patient tested positive (12mm wheal/48mm flare) with associated flushing, pruritus of ears and face, throat clearing, throat irritation and coughing, which were considered as anaphylaxis. Epinephrine and CLARITIN were administered for anaphylaxis. On the same day (02-Feb-2018), the patient had recovered from the event and symptoms. The patient was monitored for 1 hour after and discharged from clinic in good health. This case was cross-linked to case 201804017 (same patient). The reporter assessed the case as non-serious.