chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling abnormal, Hypertension
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 729126), concerning a 66-year-old, elderly female patient. The patient's medical history and concomitant medications were not reported. On 02-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195242, expiry date: not reported). On 03-Nov-2017, after 1 day of vaccination, the patient experienced controlled hypertension for a long time. Later, she had high blood pressure which was out of control for 2 weeks. It was reported that, the patient visited physician's office as she felt horrible (feeling abnormal). The patient had recovered from the events (hypertension and feeling abnormal). The reporter assessed the events as non-serious.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Joint range of motion decreased, Joint range of motion measurement, Loss of personal independence in daily activities, Pain
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 14-Mar-2018, by Seqirus from VAERS (VAERS ID: 729142), concerns a 48-year-old female patient. The patient's medical history was not reported. However, the patient's concomitant medication included estradiol, alprazolam or trazodone, calcium, vitamin D3, vitamin E, fish oil, GARLIQUE, zinc, magnesium taurate, melatonin, ginkgo biloba, Probiotic, MOVE FREE ultra, inner defense essential oil supplement. On 04-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195240A). On an unspecified date, 2-3 days after vaccination, the patient thought that, she had a shoulder injury somehow, but had not fallen or strained it. Ground Zero of the pain was observed right where the shot was given but didn't put it together at first and went to chiropractor with no relief. Certain motions caused extreme pain and range of mobility was limited. The patient faced difficulty to put on or take of shirts, shampoo or dry hair etc. It did not get better but worsened to tingling in arm and hand/fingers. The patient consulted her family doctor on 30-Nov-2017 and range of motion was tested. The patient was diagnosed for reaction to flu shot and prescribed with Methylprednisolone 4mg DSPK, Gabapentin 300 mg and physical therapy. At the time of this report, the patient had not yet recovered from the events. The reporter assessed this case as non-serious.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Paraesthesia, Vaccination complication
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 14-Mar-2018, by Seqirus from VAERS (VAERS ID: 729142), concerns a 48-year-old female patient. The patient's medical history was not reported. However, the patient's concomitant medication included estradiol, alprazolam or trazodone, calcium, vitamin D3, vitamin E, fish oil, GARLIQUE, zinc, magnesium taurate, melatonin, ginkgo biloba, Probiotic, MOVE FREE ultra, inner defense essential oil supplement. On 04-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195240A). On an unspecified date, 2-3 days after vaccination, the patient thought that, she had a shoulder injury somehow, but had not fallen or strained it. Ground Zero of the pain was observed right where the shot was given but didn't put it together at first and went to chiropractor with no relief. Certain motions caused extreme pain and range of mobility was limited. The patient faced difficulty to put on or take of shirts, shampoo or dry hair etc. It did not get better but worsened to tingling in arm and hand/fingers. The patient consulted her family doctor on 30-Nov-2017 and range of motion was tested. The patient was diagnosed for reaction to flu shot and prescribed with Methylprednisolone 4mg DSPK, Gabapentin 300 mg and physical therapy. At the time of this report, the patient had not yet recovered from the events. The reporter assessed this case as non-serious.
Age: 39.0
Sex: M
Vaccine: FLUC4
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: This spontaneous case, reported by other health care professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 729163), concerns a 39-year-old, adult, male patient. The patient had no relevant medical history and no relevant concomitant medications were taken at the time of vaccination. On 01-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195224 and expiry date: not reported). On the same day (01-Nov-2017) after vaccination, the patient developed muscle soreness which he thought as normal. The patient described that the soreness was resolved but replaced with stabbing pain which occurred when he moved his arm. The patient stated that pain was intermittent. The patient had recovered from the event muscle soreness and not yet recovered from other events (pain and pain in arm). The reporter considered the case as non-serious
Sex: F
Vaccine: FLUC4, PPV, TDAP
Symptoms: Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 729165), concerns a 53-year-old, adult female patient. The patient's medical history included asthma. The patient had no allergies, lab data or current illness. On 01-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (reported as 1), route of administration, anatomical location: right arm, batch number: 195224, expiry date: not reported), PNEUMOVAX (1 dose, dose, route of administration: intramuscular, anatomical location: right arm, batch number: N024384, expiry date: not reported) and BOOSTRIX (dose: 1 dose, route of administration: intramuscular, anatomical location: left arm, batch number TF422 (as reported), expiry date: not reported). On 02-Dec-2017, the patient experienced pain in all body and arms, headache and minor fever. The patient took 2 TYLENOL. On 03-Dec-2017, the patient felt better and pharmacist provided counselling for the patient. On an unspecified date, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Pyrexia
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 729659), concerning a 25-year-old, adult female patient. The patient's historical condition included: attention deficit disorder (ADD). The patient was allergic to antibiotics (Amoxicillin/Cefdinir/Erythromycin/Penicillins). Concomitant medication included: CONCERTA. On 27-Oct-2017, the patient had runny nose during injection. On 13-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195240, expiry date: not reported. The patient stated that, she did not get hurt or abnormal pain at the time of vaccination. On 30-Nov-2017, after 17 days of vaccination, the patient had erythema and edema to right deltoid around injection site. The patient noted to have each day mild itching increasing daily around injection site and mild fever. The patient visited physician's office where she was advised to apply warm compresses to the area and start BENADRYL for itching. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 15.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Contusion, Discomfort, Haemorrhage, Pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 14-May-2018 by Seqirus from VAERS (VAERS ID: 729669), concerns a 15-year-old female patient. The patient's medical history was not reported. The patient's concomitant medications included AUGMENTIN, YASMIN, BENZACLIN for an unknown indication. On 04-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml (1 as reported), route of administration: intramuscular, anatomical location: right arm, batch number: 195233). On the same day, after vaccination the patient had bleeding and then a bruise which was dark brown in colour and the size of a 50-cent piece on the arm. It was reported that, the patient had slight pain, weakness and discomfort. The outcome of all the events were not recovered. The reporter assessed the case as non-serious.
Age: 47.0
Sex: M
Vaccine: FLUC4
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 729689), concerns a 47-year-old, adult male patient. The patient's current conditions included hypertension and hyperlipidaemia. The patient's concomitant medications included simvastatin and lisinopril for unknown indications. The patient had no known drug allergies an illness at the time of vaccination. On 01-Dec-2017, around 14:00 hrs, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195246, expiry date: not reported). On the same day evening, the patient developed pain in the arm/shoulder. On Saturday evening, the pain became noticeable. The patient had no redness or swelling at the site, shoulder or armpit region. The patient reported achiness and stiffness in the shoulder. He was able to raise his arm above the head, but experienced limited range of motion with certain movements. The patient denied fever, chills and ill feeling. The patient did not want to seek medical attention, but was provided with list of occupational health clinics for follow up. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 64.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Arthralgia, Inflammation, Pain in extremity
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 729697), concerning a 64-year-old, adult female patient. It was reported that the patient had no relevant medical history, no current illness, no allergies. However, it was also reported that the patient's concomitant medications included Amlodipine for an unknown indication. On 02-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (reported as 1 dose), route of administration: intramuscular, anatomical location: left arm, batch number: 195238, expiry date: not reported). On the same day, the patient also received non-company suspect drug ZOSTAVAX (1 dose, route of administration: subcutaneous, anatomical location: left arm, batch number: N025566, expiry date: not reported). On 06-Nov-2017, after 4-5 days of immunization, the patient's both wrists and fingers started aching with night inflammation. She felt it may get better. On 05-Dec-2017, she visited physician. Upon consulting the physician's office, it was informed that the physician could not rule out immunization as cause of her symptoms but may not be related since both of her hands or wrists were in pain. The patient was taking 2 Ibuprofen (dose: 200 mg, 3-4 times daily for her pain. Inflammation worsened during night and subsided in the morning. The patient planned for an X-ray of her hands in the future. At the time of this report, the patient had not yet recovered from the events (ache wrists, pain of extremities and inflammation). The reporter assessed the case as non-serious.
Age: 73.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: This is a spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 729756), concerns a 73-year-old, elderly, female patient. The patient's historical condition included arthritis (unspecified date). The patient had no current illness. The patient was allergic to statins. The patients' concomitant medications included Levothyroxine, MOBIC, Sertraline, OTEZLA, gabapentin, AMBIEN and PROLIA for an unknown indication. On 05-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported). On 06-Dec-2017, after 1 day of vaccination, the patient experienced swelling and redness at injection site. The patient also had arm pain down to her hand and she went the physician office. No lab investigation was performed. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the events as non-serious. Non-significant case correction received with IRD on 14-Mar-2018: The grammatical errors were corrected in narrative.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Hyperhidrosis, Pruritus, Urticaria
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 729839), concerns a 34-year-old, adult female patient. The patient's historical conditions included, neuropathy, abdominal pain, epilepsy, ulcerative colitis, nausea, acid reflux, mood disorder, chronic migraine and allergy to vancomycin, REMICADE, STADOL, AZACTAM, Chlorhexidine Gluconate, Tape, INVANZ. The concomitant medications included ZUBSLOV, Tizanidine, LYRICA. On 03-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195238, expiry date: not reported). On the same day, within 30 minutes of vaccination, the patient developed dizziness, sweating, itching from hives. The patient was taken to the emergency room and stayed overnight. The patient was treated with epinephrine and ZOFRAN. 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
Symptoms: Contusion
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 14-March-2018 by Seqirus from VAERS (VAERS ID: 729848), concerning a 61-year-old, adult female patient. The patient's historical condition included: cancer. The patient had no known allergies. The patient had no current condition and it was unknown if she administered with any concomitant medication. On 30-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195233, expiry date: not reported). On 07-Dec-2017, after 7 days of vaccination (explicitly reported as about 5 days), the patient experienced a big bruise in the arm. Information regarding lab data was not reported. The outcome of the event was unknown. The reporter assessed the case as non-serious.
Age: 55.0
Sex: M
Vaccine: FLUC4
Symptoms: Back pain
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 729915), concerns a 55-year-old, adult, male patient. The patient's historical condition included dyslipidemia and chronic pain (unspecified date). The patient's current conditions included HBP (high blood pressure, since an unspecified date). The patient's allergies and concomitant medications were not reported. On 18-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195233 and expiry date: not reported). On 20-Nov-2017, after 2 days of vaccination, the patient had sharp pain on left lower back, which moved to right lower back. It was reported, the patient never experienced same pain in past. The patient stated that, pain progressively got better, but still bothered him. The patient was recommended to follow up with PCP (primary care physician). The reporter assessed the events as non-serious.
Age: 66.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Injection site erythema, Insomnia, Malaise, Nausea, Vaccination site induration
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 729985), concerns a 66-year-old, elderly male patient. The patient's current condition included allergy to tetanus due to horse serum. On 05-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: injection (reported as syr), anatomical location: right arm, batch number, expiry date: not reported) and PNEUMOVAX (route of administration: injection (reported as syr), anatomical location: right arm, dose, batch number, expiry date: not reported). On the same day, after vaccination, the patient developed redness, induration, and pain in the upper arm at the site of vaccination. The patient also had malaise, nausea and difficulty in sleeping after vaccination. The patient visited physician for the event. After 2 days, gastrointestinal (GI) symptoms had resolved. The patient had persistent redness and soreness and induration of the upper arm (not recovered). The outcome of the events (difficulty in sleeping and malaise) was not reported. The reporter assessed the case as non-serious.
Age: 66.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 729985), concerns a 66-year-old, elderly male patient. The patient's current condition included allergy to tetanus due to horse serum. On 05-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: injection (reported as syr), anatomical location: right arm, batch number, expiry date: not reported) and PNEUMOVAX (route of administration: injection (reported as syr), anatomical location: right arm, dose, batch number, expiry date: not reported). On the same day, after vaccination, the patient developed redness, induration, and pain in the upper arm at the site of vaccination. The patient also had malaise, nausea and difficulty in sleeping after vaccination. The patient visited physician for the event. After 2 days, gastrointestinal (GI) symptoms had resolved. The patient had persistent redness and soreness and induration of the upper arm (not recovered). The outcome of the events (difficulty in sleeping and malaise) was not reported. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: Bursitis, Immediate post-injection reaction, Injected limb mobility decreased, Muscular weakness, Nuclear magnetic resonance imaging abnormal
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 729987), concerns a 29-year-old, adult female patient. The patient had no relevant medical history and was not taking any concomitant medications at the time of vaccination. On 19-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195210A and expiry date: not reported). On the same day (19-Sep-2017) immediately after vaccination, the patient experienced pain on left arm with decreased range of motion and had weakness. The patient received over the counter (OTC) non-steroidal anti-inflammatory drugs (NSAIDs) and ice packs and did stretching. It was reported that, the symptoms lasted for about 6-8 weeks, it gradually improved on own. On an unspecified date, after 2 months of vaccination, the patient had magnetic resonance imaging (MRI), which showed mild sub acromial-subdeltoid bursitis. At the time of the report, the outcome of the events had recovered. The reporter considered the case as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 729987), concerns a 29-year-old, adult female patient. The patient had no relevant medical history and was not taking any concomitant medications at the time of vaccination. On 19-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195210A and expiry date: not reported). On the same day (19-Sep-2017) immediately after vaccination, the patient experienced pain on left arm with decreased range of motion and had weakness. The patient received over the counter (OTC) non-steroidal anti-inflammatory drugs (NSAIDs) and ice packs and did stretching. It was reported that, the symptoms lasted for about 6-8 weeks, it gradually improved on own. On an unspecified date, after 2 months of vaccination, the patient had magnetic resonance imaging (MRI), which showed mild sub acromial-subdeltoid bursitis. At the time of the report, the outcome of the events had recovered. The reporter considered the case as non-serious.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Deafness, Dizziness, Lip discolouration, Pallor, Peripheral swelling
Clinical narrative: This spontaneous case, reported by Other Health Professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 729992), concerns a 40-year-old adult female patient. The patient had no allergic history. On 08-dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml (1 as reported), route of administration: intramuscular, anatomical location: right arm, batch number: 195246). On the same day, after vaccination, the patient had swelling in the arm, hearing loss, pale skin, light headed and discoloration of lips. The patient was given with EPIPEN and BENADRYL, while paramedics were called (as reported). The outcome of all the events was recovered. The reporter assessed the case as non-serious. Non-significant case correction received with IRD 14-Mar-2018: The treatment medications were removed from the case comment.
Age: 16.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Nausea
Clinical narrative: This is a spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 730029), concerns a 16-year-old, adolescent female patient. The patient's historical condition, current illness and concomitant medications were not reported. The patient had been allergic to tree nut, peanuts and shellfish. On 10-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195244 and expiry date: not reported). On the same day, after 05 minutes of vaccination, the patient experienced light headache and her vital signs (blood pressure, pulse and temperature) were found to be normal. The patient was advised to have some water and sit for 20 minutes. It was reported that, patient felt better, but still had a little nausea. The same day (10-Dec-2017), the patient recovered from the event headache and not recovered from the event nausea. The reporter assessed the events as non-serious.
Sex: U
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 730170), concerning a patient of unspecified age and gender. The patient's medical history and concomitant medication was not reported. The patient had no current illness. On an unspecified date, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195213, expiry date: not reported). On an unspecified date, after vaccination, the patient had severe pain and limited mobility in right arm. Few months later, the patient's condition was improving. However, the patient still had limited mobility. At the time of this report, the patient was still recovering from the event painful R (right) arm and had not recovered from the event mobility decreased. The reporter assessed this case as non-serious.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 730218), concerns a 33-year-old, adult, female patient. The patient's current condition included anxiety (on an unspecified date). The patient had no allergies and no other current illnesses. The concomitant medications included citalopram, Prenatal vitamins and calcium/fiber supplements all for an unknown indication. On 21-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195233 and expiry date: not reported). On an unspecified date, approximately 1 week after vaccination, the patient experienced soreness in left arm which was increasing, along with decreased range of motion in same arm. At the time of report, the patient had no recovered from events (injected limb mobility decreased and pain in extremity). The reporter assessed the case as non-serious.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Cough, Crying, Dysphonia, Dyspnoea, Erythema
Clinical narrative: This spontaneous case, reported by non-health care professional (other) to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 730223), concerns a 56-year-old, adult, female patient. The patient's current conditions included chronic obstructive pulmonary disease (COPD), emphysema and sensitivity to morphine (since unspecified dates). The concomitant medications included Albuterol, SYMBICORT and INCRUSE (on an unspecified date). On 01-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (1 as reported), route of administration: injection (reported as SYR), anatomical location: left arm, batch number and expiry date: not reported) for COPD and Emphysema. On the same day, after vaccination, the patient's arm became red, swollen and painful. By the third day of vaccination, the patient experienced shortness of breath. Within a week of vaccination, the patient experienced tachycardia, hoarseness, coughing and wheezing. These events continued for 2 months. The patient was treated for these symptoms, like a flare up of COPD due to the flu shot but was not resolved. Later, the patient went to hospital (2 times) and was on antibiotics, prednisone, breathing treatments. It was also reported that, on an unspecified date, blood tests for heart enzyme (myocardial necrosis marker), nuclear magnetic resonance imaging (MRI) contrast, X-ray and scan with contrast was performed, results showed as  normal, but the patient felt mess and cried a lot. The patient was unable to do simple tasks and felt very hard. At the time of this report, the patient had not recovered from the events (shortness of breath, coughing, hoarseness, redness, painful arm, swollen arm, tachycardia, wheezing, loss of personal independence in daily activities and crying). The reporter assessed the causality of the events, shortness of breath, cough, wheezing as related to the flu vaccine. The reporter assessed this case as non-serious. Significant case correction received 14-Mar-2018: The reporter causality of the events coughing, wheezing, shortness of breath was changed from not reported to related. Narrative was amended. Update on 27-Jun-2018: Non-significant case correction was performed 14-Mar-2018: The sentence 'the patient arm became red, swollen and painful' was corrected to 'the patient's arm became red, swollen and painful' in the narrative.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling abnormal, Loss of personal independence in daily activities, Myocardial necrosis marker normal, Nuclear magnetic resonance imaging normal, Pain in extremity
Clinical narrative: This spontaneous case, reported by non-health care professional (other) to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 730223), concerns a 56-year-old, adult, female patient. The patient's current conditions included chronic obstructive pulmonary disease (COPD), emphysema and sensitivity to morphine (since unspecified dates). The concomitant medications included Albuterol, SYMBICORT and INCRUSE (on an unspecified date). On 01-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (1 as reported), route of administration: injection (reported as SYR), anatomical location: left arm, batch number and expiry date: not reported) for COPD and Emphysema. On the same day, after vaccination, the patient's arm became red, swollen and painful. By the third day of vaccination, the patient experienced shortness of breath. Within a week of vaccination, the patient experienced tachycardia, hoarseness, coughing and wheezing. These events continued for 2 months. The patient was treated for these symptoms, like a flare up of COPD due to the flu shot but was not resolved. Later, the patient went to hospital (2 times) and was on antibiotics, prednisone, breathing treatments. It was also reported that, on an unspecified date, blood tests for heart enzyme (myocardial necrosis marker), nuclear magnetic resonance imaging (MRI) contrast, X-ray and scan with contrast was performed, results showed as  normal, but the patient felt mess and cried a lot. The patient was unable to do simple tasks and felt very hard. At the time of this report, the patient had not recovered from the events (shortness of breath, coughing, hoarseness, redness, painful arm, swollen arm, tachycardia, wheezing, loss of personal independence in daily activities and crying). The reporter assessed the causality of the events, shortness of breath, cough, wheezing as related to the flu vaccine. The reporter assessed this case as non-serious. Significant case correction received 14-Mar-2018: The reporter causality of the events coughing, wheezing, shortness of breath was changed from not reported to related. Narrative was amended. Update on 27-Jun-2018: Non-significant case correction was performed 14-Mar-2018: The sentence 'the patient arm became red, swollen and painful' was corrected to 'the patient's arm became red, swollen and painful' in the narrative.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Peripheral swelling, Scan with contrast normal, Tachycardia, Wheezing, X-ray normal
Clinical narrative: This spontaneous case, reported by non-health care professional (other) to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 730223), concerns a 56-year-old, adult, female patient. The patient's current conditions included chronic obstructive pulmonary disease (COPD), emphysema and sensitivity to morphine (since unspecified dates). The concomitant medications included Albuterol, SYMBICORT and INCRUSE (on an unspecified date). On 01-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (1 as reported), route of administration: injection (reported as SYR), anatomical location: left arm, batch number and expiry date: not reported) for COPD and Emphysema. On the same day, after vaccination, the patient's arm became red, swollen and painful. By the third day of vaccination, the patient experienced shortness of breath. Within a week of vaccination, the patient experienced tachycardia, hoarseness, coughing and wheezing. These events continued for 2 months. The patient was treated for these symptoms, like a flare up of COPD due to the flu shot but was not resolved. Later, the patient went to hospital (2 times) and was on antibiotics, prednisone, breathing treatments. It was also reported that, on an unspecified date, blood tests for heart enzyme (myocardial necrosis marker), nuclear magnetic resonance imaging (MRI) contrast, X-ray and scan with contrast was performed, results showed as  normal, but the patient felt mess and cried a lot. The patient was unable to do simple tasks and felt very hard. At the time of this report, the patient had not recovered from the events (shortness of breath, coughing, hoarseness, redness, painful arm, swollen arm, tachycardia, wheezing, loss of personal independence in daily activities and crying). The reporter assessed the causality of the events, shortness of breath, cough, wheezing as related to the flu vaccine. The reporter assessed this case as non-serious. Significant case correction received 14-Mar-2018: The reporter causality of the events coughing, wheezing, shortness of breath was changed from not reported to related. Narrative was amended. Update on 27-Jun-2018: Non-significant case correction was performed 14-Mar-2018: The sentence 'the patient arm became red, swollen and painful' was corrected to 'the patient's arm became red, swollen and painful' in the narrative.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Pain in extremity, Product administered at inappropriate site
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 730263), concerns a 64-year-old adult female patient. The patient's historical condition includes stroke earlier in year and current illness includes hypertension, high cholesterol, depression, nerve pain, sulfa allergy, codeine allergy and penicillin allergy. The patient's concomitant medications include ropinirole, gabapentin, buspirone, hydrocodone/APAP, FLONASE, lisinopril, aspirin, venlafaxine, atorvastatin. On 03-Nov-2017, the patient received FLUCELVAX QIV (dose: 0.5 ml (dose: 1 as reported), route of administration: intramuscular, anatomical location: right arm, batch number: 195215 and expiry date: not reported). It was reported that, the pharmacist administered the vaccine a little high. On 04-Nov-2017, the patient complained that her arm was still very sore and could not lift it. About a month later, patient complained that her arm was still terribly sore. Patient went to emergency and was prescribed with pain medications. The patient had limited mobility in another arm due to stroke. The outcome of the events was not recovered, and the event drug administered at inappropriate site was not reported. The reporter assessed the case as non-serious. Non-significant case correction received with the IRD 14-Mar-2018: The narrative statement was corrected.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal pain, Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 730268), concerning a 59-year-old, adult female patient. The patient's medical history and concomitant medications were not reported. On 02-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195250, expiry date: not reported). On 06-Nov-2017, after 3 days of vaccination, the patient had low grade fever, fatigue, moderate abdominal pain, nausea and headache. In addition, she had joint pain on the entire left side from toes to head and muscle pain which was moderate to severe in intensity. The patient was treated with Tramadol and ketorolac. The other treatments included: rest, increased fluids and warm packs to sore muscles and abdomen. The patient had recovered from all the events (abdominal pain, joint pain, fatigue, headache, myalgia, nausea and pyrexia) in 3 days (reported as gradually improved). The reporter assessed this case as non-serious.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Nausea, Pyrexia
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 730268), concerning a 59-year-old, adult female patient. The patient's medical history and concomitant medications were not reported. On 02-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195250, expiry date: not reported). On 06-Nov-2017, after 3 days of vaccination, the patient had low grade fever, fatigue, moderate abdominal pain, nausea and headache. In addition, she had joint pain on the entire left side from toes to head and muscle pain which was moderate to severe in intensity. The patient was treated with Tramadol and ketorolac. The other treatments included: rest, increased fluids and warm packs to sore muscles and abdomen. The patient had recovered from all the events (abdominal pain, joint pain, fatigue, headache, myalgia, nausea and pyrexia) in 3 days (reported as gradually improved). The reporter assessed this case as non-serious.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Joint range of motion decreased, Loss of personal independence in daily activities, Muscular weakness, Pain
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 730361), concerns a 29-year-old adult female patient. The patient's medical history was not reported. The patient's concomitant medication included norethindrone for an unknown indication. On 25-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml (1 as reported), route of administration: intramuscular and anatomical location: left arm, batch number: not reported). On the same day, after vaccination, the patient had a painful arm and by the end of the day, the patient experienced limited range of motion. It was reported that, 3 months later the patient's injection site was still painful, limited range of motion hard to raise arm above shoulder height, much weaker in arm (especially when raised up) (as reported). It was stated that, it was very hard to take shirts off over her head then, especially if she needed to try to use any strength to pull it off if it's not loose enough and then followed by pain after she finally exerted enough strength to finally get the shirt off (as reported). The patient's arm was painful to lay in bed or change sleep positions if needing to use left arm at all (as reported). At the time of this report, the patient had not yet recovered from the events. The reporter assessed the case as non-serious. Significant case correction received with the IRD 14-Mar-2018: The causality of the events weakness of arms, pain and injection site pain was corrected from unassessable to related.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 730361), concerns a 29-year-old adult female patient. The patient's medical history was not reported. The patient's concomitant medication included norethindrone for an unknown indication. On 25-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml (1 as reported), route of administration: intramuscular and anatomical location: left arm, batch number: not reported). On the same day, after vaccination, the patient had a painful arm and by the end of the day, the patient experienced limited range of motion. It was reported that, 3 months later the patient's injection site was still painful, limited range of motion hard to raise arm above shoulder height, much weaker in arm (especially when raised up) (as reported). It was stated that, it was very hard to take shirts off over her head then, especially if she needed to try to use any strength to pull it off if it's not loose enough and then followed by pain after she finally exerted enough strength to finally get the shirt off (as reported). The patient's arm was painful to lay in bed or change sleep positions if needing to use left arm at all (as reported). At the time of this report, the patient had not yet recovered from the events. The reporter assessed the case as non-serious. Significant case correction received with the IRD 14-Mar-2018: The causality of the events weakness of arms, pain and injection site pain was corrected from unassessable to related.
Age: 14.0
Sex: F
Vaccine: FLUC4, HPV9, PPV
Symptoms: Erythema, Laboratory test normal, Local reaction, Pain in extremity
Clinical narrative: This is a spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 730395), concerns a 14-year-old, adolescent, female patient. The patient's historical vaccine included DTaP vaccine due to which local reaction occurred in childhood. The patient's current conditions included fatigue (reported as resolving) and sinusitis (since an unspecified date). The patient's concomitant medications were not reported. On 07-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195249 and expiry date: not reported), GARDASIL 9 (dose: 1 (as reported), route of administration: intramuscular, anatomical location: left arm, batch number: N012093 and expiry date: not reported) and PNEUMOVAX (PPV 23) (dose: 1 (as reported), route of administration: intramuscular, anatomical location: right arm, batch number: N0205D and expiry date: not reported). On an unspecified date in Dec-2017, after PNEUMOVAX (PPV 23) vaccination, patient had localized reaction with large area erythema and pain in arm. The patient was taken to ER (emergency room) by her mother. On 10-Dec-2017, no infection was found. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the events as non-serious.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Vertigo
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 730538), concerns a 61-year-old, adult male patient. The patient's current condition included hypertension and had no other conditions. The patient's concomitant medication included lisinopril for and unknown indication. On 30-Nov-2017, approximately at 04:45 hrs, the patient was administered with FLUCELVAX QIv (dose: 0.5 ml, route of administration: intramuscular, batch number: 195242, anatomical location, expiry date: not reported). On 01-Dec-2017 (at midnight), the patient woke up with vertigo/dizziness. On 04-Dec-2017, the events were continuing. On an unspecified date, the patient felt better. The patient was instructed to contact physician if dizziness persisted. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Heart rate increased, Pyrexia, Vomiting
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 730569), concerns a 64-year-old, adult, female patient. The patient's historical condition, allergies, current illness and concomitant medications were not reported. On an unspecified date in Nov-2017 (reported as received within previous 3 weeks of getting the influenza vaccine), the patient was administered with Pneumococcal vaccine (dose, route of administration, anatomical location, batch number and expiry date: not reported) and on 30-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration, anatomical location, batch number and expiry date: not reported). On the same day, after administration of influenza vaccine, the patient experienced fever of 103F, vomiting and increased heart rate. On an unspecified date, the patient had recovered from the events. The reporter assessed the events as non-serious.
Age: 50.0
Sex: M
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 730871), concerns a 50-year-old, adult male patient. The patient had no current condition or medical history. On 09-Dec-2017, the patient was FLUCELVAX QIV (dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195250, expiry date: not reported). On 10-Dec-2017, the next day of vaccination, the patient had pain at the site of injection, that led to pins/needles shooting down arm and numbness to thumb/pointer finger. The outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 68.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: This spontaneous case, reported by other health care professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (ID: 730883), concerns a 68-year-old elderly female patient. The patient's current conditions included allergy to Sulfamethoxazole, trimethoprim, clindamycin, morphine and FLAGYL. The patient's concomitant medications were not reported. It was unknown, whether the patient had received concomitant medications or not. On 22-Nov-2017, the patient received FLUCELVAX QIV (dose: 0.5 ml (dose: 1 as reported), route of administration: intramuscular, anatomical location: left arm, batch number: 195211 and expiry date: not reported). On the same day about 6 PM in the evening, the patient felt slight pain and stiffness in the arm especially when lifting the arm vertically above her head. It was reported that the positive of the bandage that covered the puncture site was noticeably high on the left appendage, nearly at the site where the deltoid muscle connects to the clavicle. Hence the patient suspected that the vaccine might had missed the deltoid and deposited in the sub deltoid bursa. As of 15-Dec-2017, the patient was still experiencing tenderness and soreness at the site and lifting of the arm vertically was still impaired. There was no redness or swelling or discoloration at the site or at time of injection or afterwards. The patient was not physically impaired by the soreness when the arm was lifted or moved at that time but still she had discomfort upon movement. The patient thought that healing was ongoing and good prognosis for full recovery. No laboratory tests were performed or requested for the patient. The outcome of the events, injected limb mobility decreased, injection site pain was recovering, and pain was not recovered. The reporter assessed this case as non-serious.