chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Erythema, Pain, Skin warm
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: 726223), concerns a 57-year-old, adult female patient. The patient's historical conditions were unknown. The patient did not have any current conditions. The patient had no known allergies. It was unknown if the patient received any concomitant medications. On 01-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: 195238 and expiry date: not reported). On the same day, the patient also received co-suspect vaccine PNEUMOVAX (frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: N019348, dose and expiry date: not reported). As suspect and co-suspect vaccines were administered in the same arm, it was considered as drug administration error. On the same day (01-Nov-2017), within 6 hours of vaccination, the patient experienced soreness, redness and skin was hot to touch. On an unspecified date, the patient made an office visit and consulted the doctor. The patient's doctor neither thought that it was an infection nor any tissue damage but thought it was just some kind of reaction. It was reported that, the doctor started antibiotics (unspecified) for the patient. The patient did not undergo any laboratory investigations. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 64.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Headache, Injection site erythema, Injection site reaction, Injection site swelling, Musculoskeletal discomfort
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: 726341), concerns a 64-year-old, adult, male patient. The patient's current condition included myasthenia gravis (reported as medical history). The concomitant medication included Mycophenolate for an unknown indication. On 06-Nov-2017, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left arm, dose: 0.5 ml, frequency reported as 1, batch number: 195242 and expiry date: not reported]. The patient was also administered non-company suspect vaccine PNEUMOVAX [route of administration: intramuscular, anatomical location: left arm, frequency reported as 1, batch number: N014188, dose and expiry date: not reported]. As both the suspect and co-suspect vaccines were administered in the same arm. On the same day after vaccination, the patient woke up at night 11 PM with soreness, fever, stiffness in left arm/shoulder and leg. The patient said that, the left arm felt almost paralyzed. The site of injection was red and swollen. The patient also complained of severe headache and neck ache. As of 09-Nov-2017 (after 3 days), the patient's condition was getting better. At the time of this report, the patient was recovering from all the events. The reporter assessed the case as non-serious.
Age: 64.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Musculoskeletal stiffness, 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: 726341), concerns a 64-year-old, adult, male patient. The patient's current condition included myasthenia gravis (reported as medical history). The concomitant medication included Mycophenolate for an unknown indication. On 06-Nov-2017, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left arm, dose: 0.5 ml, frequency reported as 1, batch number: 195242 and expiry date: not reported]. The patient was also administered non-company suspect vaccine PNEUMOVAX [route of administration: intramuscular, anatomical location: left arm, frequency reported as 1, batch number: N014188, dose and expiry date: not reported]. As both the suspect and co-suspect vaccines were administered in the same arm. On the same day after vaccination, the patient woke up at night 11 PM with soreness, fever, stiffness in left arm/shoulder and leg. The patient said that, the left arm felt almost paralyzed. The site of injection was red and swollen. The patient also complained of severe headache and neck ache. As of 09-Nov-2017 (after 3 days), the patient's condition was getting better. At the time of this report, the patient was recovering from all the events. The reporter assessed the case as non-serious.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Limb injury, Product administered at inappropriate site
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: 726577), concerns a 61-year-old, adult male patient. On 16-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, batch number: 195228, anatomical location: unknown, expiry date: not reported]. It was reported that, the vaccine was administered too high which resulted in shoulder injury. At the time of this report, the outcome of the event shoulder injury was not reported. The reporter assessed the case as non-serious. Update received on 20-Sep-2018: Significant case correction received with IRD: 26-Aug-2018: The company causality for the event shoulder injury was changed from not related to related. Case comment was modified.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Chapped lips, Lip blister, Lip erythema, Lip pain, Lip 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: 726916), concerns a 41-year-old, adult female patient. On 13-Sep-2017, the patient had in unspecified surgery and experienced some reactions to items such as the bandage which caused redness. The patient had no known allergies to medications or food but had site-specific reactions such as redness to adhesive, after being on skin for a while. The patient's concomitant medications included TYLENOL (taken approximately 2 hours prior to vaccine) and ADVIL allergy (on 10-Nov-2017 at approximately 6 am), 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: 195244, and expiry date: not reported). On the same day (10-Nov-2017), about 2 hours after vaccination, the patient experienced tingling, burning sensation and chapping of lips, which worsened throughout the night: On 11-Nov-2017 (the next day), the patient experienced swelling, redness, blisters and chapped around the lips. The patient also complained pain around the lips. The patient was treated with BENADRYL and DECADRON. On 14-Nov-2017, the patient's symptoms were completely cleared (recovered). It was reported that the patient denied any use of new products or medications. The reporter assessed the case as non-serious. Update received on 11-Oct-2018: Non-significant case correction (IRD: 26-Aug-2018): ADVIL allergy was added as concomitant medication in the product tab. The narrative was amended accordingly.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Oral discomfort, Paraesthesia oral
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: 726916), concerns a 41-year-old, adult female patient. On 13-Sep-2017, the patient had in unspecified surgery and experienced some reactions to items such as the bandage which caused redness. The patient had no known allergies to medications or food but had site-specific reactions such as redness to adhesive, after being on skin for a while. The patient's concomitant medications included TYLENOL (taken approximately 2 hours prior to vaccine) and ADVIL allergy (on 10-Nov-2017 at approximately 6 am), 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: 195244, and expiry date: not reported). On the same day (10-Nov-2017), about 2 hours after vaccination, the patient experienced tingling, burning sensation and chapping of lips, which worsened throughout the night: On 11-Nov-2017 (the next day), the patient experienced swelling, redness, blisters and chapped around the lips. The patient also complained pain around the lips. The patient was treated with BENADRYL and DECADRON. On 14-Nov-2017, the patient's symptoms were completely cleared (recovered). It was reported that the patient denied any use of new products or medications. The reporter assessed the case as non-serious. Update received on 11-Oct-2018: Non-significant case correction (IRD: 26-Aug-2018): ADVIL allergy was added as concomitant medication in the product tab. The narrative was amended accordingly.
Age: 41.0
Sex: F
Vaccine: FLUC4, FLUX
Symptoms: Back pain, Injection site 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: 727032), concerns a 41-year-old, adult female patient. The patient did not have any historical conditions. The patient's vaccination history included flu shots and experienced awful pain in her left upper back shoulder area (in 2015 and in 2016). The patient's current conditions included, Penicillin (PCN) allergy. The patient had no current illnesses. The patient was not taking any medications at the time of vaccination. On 04-Oct-2017, the patient was administered suspect vaccine FLUCELVAX QIVc [dose: 0.5 ml (frequency: unknown), route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported]. On 06-Oct-2017, 2 days after vaccination, the patient developed pain at the injection site, left shoulder pain and pain in upper left back area. It was reported that the patient still experienced the pain and soreness. The patient was prescribed with unspecified anti-inflammatory medication that did not help much. The patient stated that she had not thought about the adverse reaction (awful pain in the left upper back shoulder area) that she had previously experienced with flu vaccinations. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 41.0
Sex: F
Vaccine: FLUC4, FLUX
Symptoms: Back pain, Musculoskeletal 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: 727032), concerns a 41-year-old, adult female patient. The patient did not have any historical conditions. The patient's vaccination history included flu shots and experienced awful pain in her left upper back shoulder area (in 2015 and in 2016). The patient's current conditions included, Penicillin (PCN) allergy. The patient had no current illnesses. The patient was not taking any medications at the time of vaccination. On 04-Oct-2017, the patient was administered suspect vaccine FLUCELVAX QIVc [dose: 0.5 ml (frequency: unknown), route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported]. On 06-Oct-2017, 2 days after vaccination, the patient developed pain at the injection site, left shoulder pain and pain in upper left back area. It was reported that the patient still experienced the pain and soreness. The patient was prescribed with unspecified anti-inflammatory medication that did not help much. The patient stated that she had not thought about the adverse reaction (awful pain in the left upper back shoulder area) that she had previously experienced with flu vaccinations. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 65.0
Sex: F
Vaccine: FLUC4
Symptoms: Cough, Feeling cold, Impaired work ability, Lethargy, Oropharyngeal pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 727061), concerns a 65-year-old, elderly female patient. The patient had no historical condition, current condition and allergies. The concomitant medications included levothyroxine, metoprolol and paroxetine for unknown indications. On 01-Sep-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as unknown, route of administration: intramuscular, anatomical location: arm, batch number and expiry date: not reported). On 02-Sep-2017, next day of vaccination, the patient experienced chills, fever, ache all over, sore throat, cough and was lethargic. The patient still had severe cough at the time of this report. The patient missed her work. The patient was taking unspecified antibiotics and aspirin. The symptoms subsided 4 days later (recovered) but she was still sick (not recovered). The reporter assessed the case as non-serious.
Age: 65.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, Pyrexia
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 727061), concerns a 65-year-old, elderly female patient. The patient had no historical condition, current condition and allergies. The concomitant medications included levothyroxine, metoprolol and paroxetine for unknown indications. On 01-Sep-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as unknown, route of administration: intramuscular, anatomical location: arm, batch number and expiry date: not reported). On 02-Sep-2017, next day of vaccination, the patient experienced chills, fever, ache all over, sore throat, cough and was lethargic. The patient still had severe cough at the time of this report. The patient missed her work. The patient was taking unspecified antibiotics and aspirin. The symptoms subsided 4 days later (recovered) but she was still sick (not recovered). The reporter assessed the case as non-serious.
Age: 2.0
Sex: F
Vaccine: FLUC4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
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: 727088), concerns a 02-year-old, female child patient. The patient had no known drug allergy (NKDA). The patient did not received any concomitant medications. On 09-Oct-2017, the patient (under age of 4 years) was administered FLUCELVAX QIVc (dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left leg, batch number: 195236 and expiry date: not reported) (explicitly coded as inappropriate age at vaccine administration) rather than the appropriate dose of FLUZONE 0.25 ml (reported as wrong drug administered). The reporter assessed the case as non-serious.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Oedema peripheral
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: 727199), concerns a 58-year-old, adult, female patient. On an unspecified date, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as 1, anatomical location: arm, batch number: 195240, route of administration: unknown, and expiry date not reported). On an unspecified date, 12 hours later after vaccination, the patient's armpit was swollen. It was reported that, no treatment was taken by the patient. At the time of this report, the outcome of the event was unknown. The reporter assessed the case as non-serious.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site hypoaesthesia, Injection site pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 728026), concerns a 25-year-old, adult female patient. The patient had no medical history and current illnesses. The patient did not received any concomitant medications. On 15-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as unknown, route of administration: intramuscular, anatomical location: left arm, batch number: 195228 and expiry date: not reported). On 16-Oct-2017, one day after vaccination (reported as beginning of next day), the patient's arm near injection site became very sore with little numbness. The pain and lack of motion did not get better. On 25-Oct-2017, the patient saw the doctor and was put on an 8 days course of oral prednisone. The patient felt better, but the pain came back after the steroid course was done. 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: Significant case correction (IRD: 26-Aug-2018): The event 'pain' was deleted from the event tab. The case comment was changed from 'A 25-year-old, female patient developed soreness and numbness near injection site and lack of motion of the injected arm, one day after the administration of FLUCELVAX QIVc' to 'A 25-year-old, female patient developed soreness and numbness near injection site, one day after the administration of suspect vaccine FLUCELVAX QIVc and injected limb mobility decreased on an unspecified date in Oct-2017, after administration of suspect vaccine FLUCELVAX QIVc'.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash, Rash erythematous, Rash pruritic
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: 729133), concerns a 63-year-old, adult female patient. The patient had a history of red and itchy rash (strong in nature) due pneumococcal vaccine. On 28-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195233, expiry date: not reported). On 30-Nov-2017, after 2 days of vaccination, the patient developed a non-bumpy extremely red, itchy rash from the neck down to groin. The patient had visited physician for consultation. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 18.0
Sex: F
Vaccine: FLUC4
Symptoms: Allergy test, Urticaria
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: 729139), concerning an 18-year-old, adult female patient. The patient's medical history and concomitant medications were not reported. On 15-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195228, expiry date: not reported). On 16-Nov-2017, after 1 day of vaccination, the patient developed hives. Hence, she visited physician's office and underwent laboratory test. She was relieved after taking BENADRYL. At the time of this report, the outcome of the event was not reported. The reporter assessed the events as non-serious.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Myalgia, 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: 729173), concerns a 34-year-old adult female patient. The patient's historical condition included Celiac disease. The patient's concomitant medications included Vitamins for an unknown indication. On 01-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration, anatomical location, batch number, expiry date: not reported). On 03-Dec-2017, 2 days after vaccination, the patient experienced pain from the shoulder to the fingertips, joint and muscle pain. At the time of this report, the outcome of the events was not recovered. The reporter assessed this case as non-serious.
Age: 28.0
Sex: M
Vaccine: FLUC4
Symptoms: Cough, Formication, Hyperhidrosis, Injection site discolouration, Pain
Clinical narrative: This spontaneous case, reported by Other health professional to VAERS and initially retrieved o n14-Mar-2018 by Seqirus from VAERS (VAERS ID: 729352), concerns a 28-year-old adult male patient. The patient's medical history and concomitant medications were not reported. On 16-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml (unk as reported), batch number: 195242, route of administration: intramuscular, anatomical location: right arm). On the same day, 20 minutes after vaccination, the patient sweated. Reported, the patient had a sensation of something traveling across his back from right to left once while driving home. Subsequently, on the next day he developed body aches, wheezing, cough, half dollar size spot at injection site which had dark and light patches (injection site discolouration). The outcome of all the events was unknown. The reporter assessed the case as non-serious. Non-significant case correction received with IRD 14-Mar-2018: Case comment was corrected.
Age: 28.0
Sex: M
Vaccine: FLUC4
Symptoms: Wheezing
Clinical narrative: This spontaneous case, reported by Other health professional to VAERS and initially retrieved o n14-Mar-2018 by Seqirus from VAERS (VAERS ID: 729352), concerns a 28-year-old adult male patient. The patient's medical history and concomitant medications were not reported. On 16-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml (unk as reported), batch number: 195242, route of administration: intramuscular, anatomical location: right arm). On the same day, 20 minutes after vaccination, the patient sweated. Reported, the patient had a sensation of something traveling across his back from right to left once while driving home. Subsequently, on the next day he developed body aches, wheezing, cough, half dollar size spot at injection site which had dark and light patches (injection site discolouration). The outcome of all the events was unknown. The reporter assessed the case as non-serious. Non-significant case correction received with IRD 14-Mar-2018: Case comment was corrected.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities
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: 729402), concerning a 46-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 VIIBRYD for an unknown indication. On 17-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: 195233, expiry date: not reported). On 18-Nov-2017, after 1 day of vaccination, the patient developed pain on her left shoulder (injected arm) which made her hard to lift the shoulder. When she pressed the affected area, she could feel the pain. Activity like changing clothes was a hard task for her because of shoulder pain. Hence, she took OTC (over the counter) Ibuprofen but it didn't help her much. At the time of this report, the patient had not yet recovered from the events (injected limb mobility decreased, injection site pain and activities of daily living impaired). The reporter assessed the events as non-serious.
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Burning sensation, Feeling hot
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: 729596), concerns a 58-year-old adult male patient. The patient's historical condition gout and GERD (Gastroesophageal reflux disease). The patient's current condition included high blood pressure and high cholesterol. It was reported that, the patient had no allergies (none as reported). The patient's concomitant medications included Lisinopril, Allopurinol, NEXIUM, ZOCOR, Aspirin. On 05-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml (1 as reported), route of administration: intramuscular, anatomical location: left arm, batch number: 195232). On the same day, after vaccination, the patient had burning arm, warm sensation all over the body and sat down (as reported). The patient was taken to the emergency department. It was reported that, the patient was under observation and released later. The outcome of all the events was recovered. The reporter assessed the case as non-serious.
Age: 57.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain
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: 729662), concerning a 57-year-old, adult male patient. The patient's historical condition and concomitant medication were unknown. The patient had no current illness. On 30-Oct-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: 195234, expiry date: not reported). On 30-Nov-2017, after 31 days of vaccination, the patient had pain around upper left shoulder and thought, it might be from flu shot. It was reported that, the patient made physician's office visit. However, no lab data was performed. The patient had not yet recovered from the even injection site pain. The reporter assessed the events as non-serious.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
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: 729777), concerning a 30-year-old, adult female patient. It was reported that, the patient never had urticaria to an influenza vaccine before. The patient had no medical history and no known allergies. Concomitant medication included: Sertraline. 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: 195246, expiry date: not reported). On 06-Dec-2017, after 1 day of vaccination, the patient woke up with hives covering her entire torso, buttock and legs. By mid-morning, the symptoms started to decrease and by afternoon the hives were resolved. It was reported that, no lab data was performed. The reporter assessed the case as non-serious.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash, Rash pruritic, Urticaria
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: 729820), concerns a 33-year-old, adult, female patient. The patient's historical condition included audible heart murmur (unspecified date). The patient's current illness, allergy and concomitant medication were not reported. 05-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195125 and expiry date: not reported). On the same day, after the vaccination, in evening, the patient had urticarial rash on forearms and upper chest. On 06-Dec-2017, the patient went to the clinic and reported an itchy rash. The patient received diphenhydramine (25 mg) and hydrocortisone cream (1 percent, topical). It was reported that, patient received another dose of diphenhydramine (25 mg) and continued to use hydrocortisone lotion at home. On an unspecified date in Dec-2017, the patient had improvement in symptoms (unspecified symptoms) although some rash were still present. As of 07-Dec-2017, the patient had not yet recovered from the events. The reporter assessed the events as non-serious.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site rash
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 729878), concerning a 46-year-old, adult female patient. The patient's medical history was unknown and had no known allergy. On 17-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195220, expiry date: not reported). On the same day, after vaccination, the patient develop mild rash at the site of injection. The patient was treated with antihistamines and steroid topical creams. It was reported that, the event rash had not resolved as of 07-Dec-2017. The reporter assessed the case as non-serious.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia
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: 730141), concerns a 59-year-old adult female patient. The patient had no historical and current conditions. 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: 195243, expiry date: not reported). On 14-Nov-2017, the patient had severe joint pain in the arm where flu vaccine was given. It was reported that, pain lasted for several weeks. At the time of this report, the patient had not recovered from the event. The reporter assessed this case as non-serious.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Cold sweat, Injection site pain, Mobility decreased, Musculoskeletal pain, Pain
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: 730185), concerns a 31-year-old, adult, female patient. The patient's current condition included type 1 diabetes (from an unspecified date) and had no allergies. The concomitant medications included HUMALOG, LANTUS and Lisinopril (on an unspecified date). On 09-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (1 as reported), route of administration: injection, anatomical location: left arm, batch number: 195229 and expiry date: not reported). On the same day, afternoon, the patient experienced cold sweat, pain at injection site and barely able to lift her arm for four days, by the end of the week, the patient felt her shoulder was frozen. it was reported that, the pain radiated from upper deltoid to posterior of shoulder blade which was throbbing at rest and sharp and stabbing by movement. The shoulder also locked and popped while attempt to raise, unable to lift 5 lb weight. The symptoms were improved with warm weather and worsened again with cold weather and reported jabbing pain. The patient also treated with ADVIL 800 mg bid an tid for 2 weeks (as reported) (on an unspecified date) and Naproxen 500 mg oral bid for 6 days, (on an unspecified date). The patient was recommended to consult orthopaedician for further evaluation. On 04-Dec-2017, follow-up was done and reported that ortho symptoms were improved with Naproxen and still felt discomfort on occasions. At the time of the report, the outcome of the events (cold sweat and discomfort) were unknown and recovering from the events (joint crepitation, frozen shoulder, weight bearing difficulty, shoulder blade pain, throbbing pain, pain in arm and mobility decreased). The reporter assessed the case as non-serious. Non-significant case correction received 14-Mar-2018: Case comment was corrected (onset latency was added). Non-significant case correction received 14-Mar-2018: Case comment was corrected (sentence reformation).
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Periarthritis
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: 730185), concerns a 31-year-old, adult, female patient. The patient's current condition included type 1 diabetes (from an unspecified date) and had no allergies. The concomitant medications included HUMALOG, LANTUS and Lisinopril (on an unspecified date). On 09-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (1 as reported), route of administration: injection, anatomical location: left arm, batch number: 195229 and expiry date: not reported). On the same day, afternoon, the patient experienced cold sweat, pain at injection site and barely able to lift her arm for four days, by the end of the week, the patient felt her shoulder was frozen. it was reported that, the pain radiated from upper deltoid to posterior of shoulder blade which was throbbing at rest and sharp and stabbing by movement. The shoulder also locked and popped while attempt to raise, unable to lift 5 lb weight. The symptoms were improved with warm weather and worsened again with cold weather and reported jabbing pain. The patient also treated with ADVIL 800 mg bid an tid for 2 weeks (as reported) (on an unspecified date) and Naproxen 500 mg oral bid for 6 days, (on an unspecified date). The patient was recommended to consult orthopaedician for further evaluation. On 04-Dec-2017, follow-up was done and reported that ortho symptoms were improved with Naproxen and still felt discomfort on occasions. At the time of the report, the outcome of the events (cold sweat and discomfort) were unknown and recovering from the events (joint crepitation, frozen shoulder, weight bearing difficulty, shoulder blade pain, throbbing pain, pain in arm and mobility decreased). The reporter assessed the case as non-serious. Non-significant case correction received 14-Mar-2018: Case comment was corrected (onset latency was added). Non-significant case correction received 14-Mar-2018: Case comment was corrected (sentence reformation).
Age: 22.0
Sex: F
Vaccine: FLUC4, TDAP, VARCEL
Symptoms: Dizziness, Fatigue, Injection site rash, Rash papular
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: 7302162), concerns a 22-year-old adult female patient. On 10-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195244, expiry date: not reported). On the same day, the patient was also administered with BOOSTRIX (dose: (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 9XJ5L, expiry date: not reported) and VARIVAX (dose: (reported as 1), route of administration: subcutaneous, anatomical location: left arm, batch number and expiry date: not reported). On 11-Dec-2017, 1 day after vaccination, the patient experienced rash on the back of the left arm. It was reported that, rash was raised and got worsen over the next day. The patient felt fatigue and dizzy (reported as like she may faint). The outcome of the event dizzy reported as recovered and outcome of the events injection site rash and fatigue was unknown. The reporter assessed this case as non-serious.
Age: 27.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Seizure
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: 731435), concerns a 27-year-old, adult, female patient. The patient's historical procedure included tracheostomy (on an unspecified date) and the patient was afebrile. The current conditions included acute pharyngitis, pseudoseizures, mood disorder, anxiety, self-injurious behaviour (on an unspecified date) and suicidal ideation (on 12-Jul-2017). The patient showed high systemic anaphylaxis to shell-fish derived products (from 12-Jul-2017), the patient was anaphylactic to Penicillin G and DEPO-PROVERA (on 06-Jul-2017) and the patient was highly anaphylactic to citrus (finger citron), fish (all fish) (on 12-Jul-2017). The patient's historical drugs included BACTRIM for unknown indication (on 06-Jul-2017), BENADRYL for an unknown indication and experienced rash, itchy and tingling throughout the body (on 06-Jul-2017), the Mushroom extract complex for an unknown indication and experienced rash and hives (on 12-Jul-2017) and prednisone for unknown indication (on an unspecified date). The patient's concomitant medication included Lamotrigine and sertraline HCL for an unknown indication (on an unspecified date). 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: 195250 and expiry date: not reported). On the same day, the patient was administered with non-company suspect product BOOSTRIX (dose, route of administration: intramuscular, anatomical location: left arm, batch number: TB2R2 (as reported) and expiry date: not reported). On the same day, around 04:10 PM or 04:15 PM, 25 minutes after vaccination, the patient developed seizure after receiving Tdap vaccine. First-aid was given by emergency medical services (EMS) and transported to hospital. It was reported that, the no lab tests were done for the patient. At the time of the report, the patient had recovered from the event (seizure). The reporter assessed this case as non-serious. Significant case correction received with IRD on 14-Mar-2018: The start dates for the historical conditions and current conditions were changed from 07-Dec-2017 to 12-Jul-2017 and 07-Jun-2017 to 06-Jul-2017 and the sentence (subject had seizure after receiving Tdap) was corrected. Narrative amended accordingly. Update 10-Jul-2018: Significant case correction was performed with IRD 14-Mar-2018: The company causality for the event seizure was changed from 'unassessable' to 'related'. No changes were done in narrative.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Myalgia
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: 731544), concerns a 27-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 29-Nove-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: injection (SYR as reported), anatomical location: left arm, batch number: 195225A, expiry date: not reported). On the same day (29-Nov-2017) after vaccination, the patient experienced soreness in the muscle. At the time of this report, the outcome of the event was unknown. The reporter assessed this case as non-serious.
Age: 18.0
Sex: F
Vaccine: FLUC4, HEP
Symptoms: Urticaria, Vertigo
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: 731716), concerning an 18-year-old, adult female patient. The patient's historical condition included: Endometriosis. The patient was allergic to codeine. Concomitant medication included: ADIPEX. On 19-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195212, expiry date: not reported). On the same day, the patient was administered with non-company suspect drug ENGERIX-B (route of administration: intramuscular, anatomical location: left arm, batch number: 9X4E7, expiry date: not reported). On the same day, after vaccination, the patient experienced hives and vertigo. The patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 60.0
Sex: F
Vaccine: FLUC4, PPV, VARZOS
Symptoms: Injection site reaction, Urticaria
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: 731752), concerning a 60-year-old, adult female patient. The patient's historical condition: depression and current condition included: hypertension. On 20-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch  number: 195128, expiry date: not reported). On the same day, the patient was administered non-company suspect drug with PNEUMOVAX (route of administration: intramuscular, anatomical location: left leg, batch number: N019838 and expiry date: not reported) and ZOSTAVAX (route of administration: subcutaneous, anatomical location: left arm, batch number N025387 and expiry date: not reported). On 22-Dec-2017, after 2 days of vaccination, the patient had a raised welt at injection site. The patient was recovered from the events welt and injection site reaction. The reporter assessed this case as non-serious.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Musculoskeletal pain
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: 731765), concerns a 30-year-old, adult female patient. The patient had no medical history, no current illness and no allergies. The patient did not receive any concomitant medication. On 01-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration, anatomical location, batch number, expiry date: not reported). On 13-Dec-2017, after 12 days of vaccination, the patient experienced pain down the shoulder. It was reported that, the patient made physician's office visit. At the time of this report, the patient had not yet recovered from the event pain down the shoulder. The reporter assessed the events as non-serious.
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Discomfort, Injection site pain, Musculoskeletal stiffness
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 731766), concerns a 22-year-old, adult female patient. The patient had no relevant history and current conditions. No information was available regarding the patient's allergies. On 27-Nov-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, batch number: 195233, route of administration, anatomical site and expiry date: not reported]. On the same day  (27-Nov-2017), after vaccination, the patient complained of pain during injection site. Some days later, the patient experienced discomfort and despite taking ALEVE for pain and stiffness, the discomfort persisted. A month and several days later, the patient still felt painful and stiff. The patient felt that the vaccine was administered a little too high in the deltoid. It was reported that the patient would consult her physician about the vaccination and pain and stiffness. On an unspecified date, the patient made an office visit. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Nodule
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: 731776), concerns a 45-year-old adult female patient. On 05-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195222, expiry date: not reported). On the same day of vaccination, the patient experienced pain at the injection site. After 2 months of vaccination, the patient developed a knot. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious. On 10-Apr-2018, version-1 was opened in error.
Age: 74.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This non-serious spontaneous case, reported by other health professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 732560), concerns a 74-year-old elderly female patient. The patient's historical conditions included tremor, GERD (Gastroesophageal reflux disease), historical drug included lisinopril. The patient's current conditions included high blood pressure, high cholesterol and allergies. The patient's concomitant medication included lorazepam, amlodipine, atenolol, omeprazole, duloxetine, atorvastatin. On 02-Jan-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5ml (1 as reported), route of administration: intramuscular, anatomical location: left arm, batch number: 195238) and PNEUMOVAX (dose: 1 as reported, route of administration: intramuscular, anatomical location: right arm, batch number: N025656). On the 03-Jan-2018, 2 days, morning after vaccination, the patient had swelling from right deltoid to right elbow, red and warm to touch. The outcome of the events was not reported.
Age: 75.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Rash, Skin warm
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 732788), concerns a 75-year-old, elderly, female patient. The patient's current conditions included blood pressure (abnormal), gastroesophageal reflux disease (GERD), tetanus and allergic to sulfa and GA (as reported). The patient's concomitant medications included lisinopril hydrochlorothiazide, PROTONIX, KLONOPIN. On 02-Jan-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration, intramuscular, anatomical location: left arm, batch number: 195233 (1995233 as reported) and expiry date: not reported) and PNEUMOVAX (dose: 1 (as reported), route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported). On the same day (02-Jan-2018) after vaccination, the patient developed rash and warm on upper arm. At the time of this report, the outcome of the events was unknown. The reporter considered the case as non-serious.
Age: 7.0
Sex: M
Vaccine: FLUC4
Symptoms: Cold sweat, Electrocardiogram normal, Feeling abnormal, Head injury, Heart rate decreased
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: 732819), concerns a 07-year-old, male child. The patient had no medical history, allergies or current illness. The patient's medications at the time of vaccination were unknown. On 06-Jan-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 196498, expiry date: not reported). On the same day, after 5 minutes of vaccination, the patient lost consciousness (reported as passed out) and hit his head on the privacy screen. The patient was groggy and lost colour on his face. The skin was clammy and pulse was low. The patient had cut above the eye for which pressure and ice was applied. The patient regained colour when his feet were raised and was able to talk. Medical help was sought after contacting 911 and patient's blood pressure, electrocardiogram (EKG), and pulse was checked (all were within normal). Patient felt dizziness when he stood up and informed the EMT (emergency medical technician) that he did not felt abnormal (reported as didn't feel right). The patient visited physician at the urgent care. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.