chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site nerve damage, Injection site pain, X-ray
Clinical narrative: This is a spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 721827), concerns a 63-year-old, adult, female patient. The patient had no historical conditions. The patient had been allergic to tetracycline and clindamycin. The patient had no current illness. The patient's concomitant medications included FOSAMAX and Multiple vitamins. On 01-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: injection (reported as SYR), anatomical location: right arm, batch number and expiry date: not reported). On 03-Oct-2017, after 3 days of vaccination, the patient was not able to move her arm. She had constant feeling of stabbed pain in anterior deltoid (reported as stabbed by a knife in anterior deltoid). After 3 weeks of onset, the patient was till not able to move her arm, so she went to the orthopaedic visit. The orthopaedician confirmed that, her nerve was hit when the injection was given and stated it would take 8-10 weeks for her nerve to regenerate. 3 X-rays were done (results not reported). At the time of this report, the patient had not yet recovered from the events. The reporter assessed the case as non-serious.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Headache, Induration, Nausea, Oropharyngeal pain
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 21-FEB-2018 by Seqirus from VAERS (VAERS ID: 721838), concerns a 66-year-old, adult, female patient. The patient's historical vaccine included: PCV 13 administered on 12-Oct-2015 with no adverse effects. The patient's current condition included hypothyroidism. The patient's concomitant medications included levothyroxine. On 17-Oct-2017, the patient was administered with AFLURIA (QIV) (dose:0.5ml, route of administration, anatomical location, batch number and expiry date: not reported) and PNEUMOVAX (dose, route of administration, anatomical location, manufacturer, trade, batch number and expiry date: not reported. The patient reported that, she had received incorrect influenza shot type. On the same day, approximately 6 hrs after 2 vaccinations, the patient had pain and soreness in left arm. On the following day (18-Oct-2017), the patient's arm became bright red spread from shoulder to elbow, it raised became hard and hot with red edges. On an unspecified date, the patient had experienced headache, mild nausea and throat discomfort (described as like congestion/cold). The symptoms were persisted for 4 days. It was reported that, the patient's arm became normal after 5 days. The reporter considered this case as non-serious.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm, Wrong drug administered
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 21-FEB-2018 by Seqirus from VAERS (VAERS ID: 721838), concerns a 66-year-old, adult, female patient. The patient's historical vaccine included: PCV 13 administered on 12-Oct-2015 with no adverse effects. The patient's current condition included hypothyroidism. The patient's concomitant medications included levothyroxine. On 17-Oct-2017, the patient was administered with AFLURIA (QIV) (dose:0.5ml, route of administration, anatomical location, batch number and expiry date: not reported) and PNEUMOVAX (dose, route of administration, anatomical location, manufacturer, trade, batch number and expiry date: not reported. The patient reported that, she had received incorrect influenza shot type. On the same day, approximately 6 hrs after 2 vaccinations, the patient had pain and soreness in left arm. On the following day (18-Oct-2017), the patient's arm became bright red spread from shoulder to elbow, it raised became hard and hot with red edges. On an unspecified date, the patient had experienced headache, mild nausea and throat discomfort (described as like congestion/cold). The symptoms were persisted for 4 days. It was reported that, the patient's arm became normal after 5 days. The reporter considered this case as non-serious.
Sex: M
Vaccine: FLU4
Symptoms: Chills, Headache, Hot flush, Hyperhidrosis, Migraine
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 721930), concerns a 32-year-old, adult male patient. The patient's current condition included: allergic to sulfa medications. The patient's concomitant medications included Multi-vitamins, fish oil, vitamin D, Green tea extract and whey protein. On 18-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration: injection, anatomical location: left arm, batch number: XF32808 and expiry date: not reported). On the same day, after vaccination at 15:30 hrs, the patient had a headache and received TYLENOL. At 17:00 hrs, the patient experienced strong migraine and took rest in migraine state. The patient also had a fever, felt nauseous with some hot flashes with sweating (twice) and shivering. On 20-Oct-2017, the patient stated that, he hurts when he sneezes. On 21-Oct-2017 to 22-Oct-2017, the patient stated that, during physical motion, his head hurts and felt nauseous. On 23-Oct-2017, at 05:30 hrs, the patient woke up with small migraine. The patient stated that he received the migraine over the counter medicine. It was reported that, during physical activities he was still being nauseous, his neck felt tense. The outcome of the events was unknown. The reporter assessed the case as non-serious.
Sex: M
Vaccine: FLU4
Symptoms: Muscle tightness, Nausea, Pain
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 721930), concerns a 32-year-old, adult male patient. The patient's current condition included: allergic to sulfa medications. The patient's concomitant medications included Multi-vitamins, fish oil, vitamin D, Green tea extract and whey protein. On 18-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration: injection, anatomical location: left arm, batch number: XF32808 and expiry date: not reported). On the same day, after vaccination at 15:30 hrs, the patient had a headache and received TYLENOL. At 17:00 hrs, the patient experienced strong migraine and took rest in migraine state. The patient also had a fever, felt nauseous with some hot flashes with sweating (twice) and shivering. On 20-Oct-2017, the patient stated that, he hurts when he sneezes. On 21-Oct-2017 to 22-Oct-2017, the patient stated that, during physical motion, his head hurts and felt nauseous. On 23-Oct-2017, at 05:30 hrs, the patient woke up with small migraine. The patient stated that he received the migraine over the counter medicine. It was reported that, during physical activities he was still being nauseous, his neck felt tense. The outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Dizziness
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 721949), concerns a 25-year-old, adult, female patient. The patient's historical conditions included IBS (irritable bowel syndrome), anemia and suspected Raynaud's disease (unspecified dates). The patient's current conditions included abscess on jawline from bacterial infection and received penicillin for 07 days which ended on 15-Oct-2017. The patient had been allergic to eggs, tree nuts and sesame seed. The patient's concomitant medications included mushroom extract from medicinal mushrooms such as Reishi, Chaga, and Cordyceps for an unknown indication. The patient did not receive any other herbal remedies, supplements, or medications. On 19-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF33308 and expiry date: not reported). On 20-Oct-2017, after 1 day of vaccination, the patient had high-grade fever for more than 7 hours, chills, extreme nausea, migraine, severe low back pain, joint aches, muscle weakness, dizziness, headache and weakness. It was reported that, patient's current events were moderate in nature (from 10/10 to 6/10 on the pain scale). At the time of this report, the patient had not yet recovered from the events back pain, weakness, nausea, chills, migraine, joint aches, muscle weakness and dizziness. The patient was recovering from the event fever. The reporter assessed the events as non-serious. Non-significant case correction received with IRD 21-Feb-2018: Spelling mistake in narrative was corrected and case comment was amended.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Migraine, Muscular weakness, Nausea, Pyrexia
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 721949), concerns a 25-year-old, adult, female patient. The patient's historical conditions included IBS (irritable bowel syndrome), anemia and suspected Raynaud's disease (unspecified dates). The patient's current conditions included abscess on jawline from bacterial infection and received penicillin for 07 days which ended on 15-Oct-2017. The patient had been allergic to eggs, tree nuts and sesame seed. The patient's concomitant medications included mushroom extract from medicinal mushrooms such as Reishi, Chaga, and Cordyceps for an unknown indication. The patient did not receive any other herbal remedies, supplements, or medications. On 19-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF33308 and expiry date: not reported). On 20-Oct-2017, after 1 day of vaccination, the patient had high-grade fever for more than 7 hours, chills, extreme nausea, migraine, severe low back pain, joint aches, muscle weakness, dizziness, headache and weakness. It was reported that, patient's current events were moderate in nature (from 10/10 to 6/10 on the pain scale). At the time of this report, the patient had not yet recovered from the events back pain, weakness, nausea, chills, migraine, joint aches, muscle weakness and dizziness. The patient was recovering from the event fever. The reporter assessed the events as non-serious. Non-significant case correction received with IRD 21-Feb-2018: Spelling mistake in narrative was corrected and case comment was amended.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Headache, Myalgia, Nausea, Palpitations
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 722001), concerning a 63-year-old, adult male patient. The patient's historical condition included, glaucoma. It was reported that, the patient did not have any previous symptoms in the previous 20 years of flu shots. Concomitant medication included, LUMIGAN eye drops. On 20-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (reported as 1 dose), route of administration: intramuscular, anatomical location: left arm, batch number: reported as 333320317, expiry date: not reported). On the same day, after vaccination, the patient had nausea, muscle aches, headache, chills with uncontrollable shaking and rapid pounding heartbeat for 12 hours. Later, he had headache and muscle ache for another 24 hours. The patient had recovered from all the events. The reporter assessed this case as non-serious.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 722001), concerning a 63-year-old, adult male patient. The patient's historical condition included, glaucoma. It was reported that, the patient did not have any previous symptoms in the previous 20 years of flu shots. Concomitant medication included, LUMIGAN eye drops. On 20-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (reported as 1 dose), route of administration: intramuscular, anatomical location: left arm, batch number: reported as 333320317, expiry date: not reported). On the same day, after vaccination, the patient had nausea, muscle aches, headache, chills with uncontrollable shaking and rapid pounding heartbeat for 12 hours. Later, he had headache and muscle ache for another 24 hours. The patient had recovered from all the events. The reporter assessed this case as non-serious.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Back pain, Blood pressure measurement, Chest pain, Dizziness
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 722125), concerns a 37-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 18-Oct-2017 at 11:35, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (1 as reported), route of administration: intramuscular, anatomical location: right arm, batch number: 00844611A and expiry date: not reported). On the same day, 5 minutes after vaccination, the patient reported nausea and dizziness. Later, progressed to chest pain and back pain which were tearful. The lead provider observed that, the patient was in general distress and red rash was raised. The patient received Epinephrine 0.5 mg from the emergency services (911), reported the patient blood pressure as 116/80 (units not reported) and continued to monitor the patient. It was reported that, breathing was still labored. After administration of treatment drug, the patient still felt anxious, but in reduced state of stress and rash had spreaded over upper body and arms. Later, the patient transferred to the hospital. At the time of the report, the outcome of the events (feeling anxious, chest pain, dizziness, emotional distress, rash erythematous, stress, tearfulness, back pain and nausea) was unknown. The reporter assessed the case as non-serious. Non-significant case correction received 21-Feb-2018: The narrative statement was corrected.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Emotional distress, Nausea, Rash, Rash erythematous
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 722125), concerns a 37-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 18-Oct-2017 at 11:35, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (1 as reported), route of administration: intramuscular, anatomical location: right arm, batch number: 00844611A and expiry date: not reported). On the same day, 5 minutes after vaccination, the patient reported nausea and dizziness. Later, progressed to chest pain and back pain which were tearful. The lead provider observed that, the patient was in general distress and red rash was raised. The patient received Epinephrine 0.5 mg from the emergency services (911), reported the patient blood pressure as 116/80 (units not reported) and continued to monitor the patient. It was reported that, breathing was still labored. After administration of treatment drug, the patient still felt anxious, but in reduced state of stress and rash had spreaded over upper body and arms. Later, the patient transferred to the hospital. At the time of the report, the outcome of the events (feeling anxious, chest pain, dizziness, emotional distress, rash erythematous, stress, tearfulness, back pain and nausea) was unknown. The reporter assessed the case as non-serious. Non-significant case correction received 21-Feb-2018: The narrative statement was corrected.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Stress, Tearfulness
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 722125), concerns a 37-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 18-Oct-2017 at 11:35, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (1 as reported), route of administration: intramuscular, anatomical location: right arm, batch number: 00844611A and expiry date: not reported). On the same day, 5 minutes after vaccination, the patient reported nausea and dizziness. Later, progressed to chest pain and back pain which were tearful. The lead provider observed that, the patient was in general distress and red rash was raised. The patient received Epinephrine 0.5 mg from the emergency services (911), reported the patient blood pressure as 116/80 (units not reported) and continued to monitor the patient. It was reported that, breathing was still labored. After administration of treatment drug, the patient still felt anxious, but in reduced state of stress and rash had spreaded over upper body and arms. Later, the patient transferred to the hospital. At the time of the report, the outcome of the events (feeling anxious, chest pain, dizziness, emotional distress, rash erythematous, stress, tearfulness, back pain and nausea) was unknown. The reporter assessed the case as non-serious. Non-significant case correction received 21-Feb-2018: The narrative statement was corrected.
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: This serious spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 722146), concerns a 40-year-old adult female patient. On 23-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration: intramuscular, anatomical location: right arm, batch number: XF30607, expiry date: not reported). On the same day, after 30 minutes of vaccination, the patient experienced hives at the injection site and on wrist. The outcome of the event was unknown. The reporter assessed this case as non-serious.
Age: 63.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Blood pressure decreased, Emotional distress, Hypotension, Syncope, Unresponsive to stimuli
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 722238), concerning a 63-year-old, adult female patient. The patient had no known drug allergies. Current condition included: COPD (chronic obstructive pulmonary disease) since an unspecified date. Concomitant medications included: Lisinopril, Multivitamin, Aspirin, Alendronate sodium, Vitamin D, Albuterol sulfate, ANORO ELLIPTA, ARNUITY ELLIPTA, VENTOLIN HFA for unknown indications. On 23-Oct-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported). On the same day, the patient also received non-company suspect drug PREVNAR 13 (dose: 1 (as reported), route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported). On 23-Oct-2017, after administration of vaccine, the patient experienced vasovagal syncope. She was breathing but was not responsive. Later, she became aware of her surroundings and stated that she doesn't handle injections well as she passes out. She became very upset. Hence, ambulance was called due to her low BP (blood pressure). The patient was taken to emergency room by physician. However, she was coherent upon arrival. At the time of this report, the patient had recovered from all the events. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Mass, Skin warm, Swelling
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 722463), concerns a 61-year-old, adult, female patient. The patient's current condition included asthma, high blood pressure (from an unspecified date). The concomitant medications included Lisinopril, Levothyroxine, Omeperazole and ADVAIR for an unknown indication (on an unspecified date). On 24-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF30506 and expiry date: not reported). On the same day, after few hours of injection, the patient noticed lump and swelling. On 25-Oct-2017, the lump became to baseball size and had redness and warm. At the time of the report, the outcome of the events (mass, swelling, skin warm and redness) were not reported. The reporter assessed the events as non-serious.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Fatigue, Headache, Malaise
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 722532), concerns a 33-year-old, adult, female patient. The patient's historical condition included anxiety, insomnia, depression (on an unspecified date) and hives (from 09-Oct-2017 to 11-Oct-2017). The current condition included allergy to dill (from 09-Oct-2017 which is ongoing). The concomitant medications included B complex, Vitamin D, Bupropion and N-acetyl cysteine for an unknown indication (on an unspecified date). On 17-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (1 as reported), route of administration: intramuscular, anatomical location: right arm, batch number: XF33408 and expiry date: not reported). On the same day, after 2 hours of vaccination, the patient experienced headache and after 12 hours, the patient experienced diarrhoea, malaise, fatigue. At the time of the report, the patient had recovered from the events (diarrhoea, malaise, fatigue and headache). The reporter assessed the case as non-serious. Significant case correction received 21-Feb-2018: The onset latency of the events was added in tab and narrative. Narrative was amended accordingly.
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Product administered at inappropriate site
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 722605), concerns a 57-year-old, adult, female patient. On 09-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: injection (reported as SYR), anatomical location: left arm, batch number 00644623A and expiry date: not reported). On the same day (09-Oct-2017) while administration of vaccine, the nurse injected high in the deltoid, which possibly irritated the joint. The patient had left shoulder pain for 2 weeks. It was reported that, the patient also had pain with ROM (range of motion). The patient went to the physician office visit for the events. On 23-Oct-2017, the patient's physician examination was done for which result was not reported. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the events as non-serious.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 722657), concerns a 39-year-old, adult female patient. The patient's current condition included allergy to penicillin (PCN) and concomitant medications included: multivitamin, vitamin D, calcium, ibuprofen all for an unknown indications. On 09-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm (high in deltoid), batch number: 00644623A (as reported (06644623A), expiry date: not reported). On the same day, the patient had pain in arm and shoulder. The patient also had pain with the use of the arm. The outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: This is spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 722661), concerns a 30-year-old, adult female patient. The patient had no current conditions and no known drug allergy (NKDA as reported). The patient was on birth control medication (as reported). It was reported that, the patient had a physical examination done on an unspecified date. On 06-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml (1 as reported), batch number: 00644623A, anatomical location: left arm, route of administration: intramuscular). It was reported that, the patient was given vaccination high in the deltoid, resulted pain in shoulder with use for 2 weeks. The outcome of the event (musculoskeletal pain) was unknown. The reporter assessed the case as non-serious.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 722663), concerns a 55-year-old, adult, female patient. The patient had no medical history and no known drug allergy (NKDA). The patient's concomitant medications included ADVIL, ASA and Vitamin D. On 11-Oct-2017, the patient was administered with AFLURIA QUADRIVAENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 00644623A (reported as 006644623A) and expiry date: not reported). On the same day (11-Oct-2017), while administration of vaccine, injection was given high in the deltoid, which resulted in left shoulder and arm pain for 14 days. The patient went to the physician office and her physical examination was done for which result was not reported. At the time of this report, the outcome of the events was not reported. The reporter assessed the events as non-serious.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 722664), concerns a 46-year-old, adult female patient. The patient's current condition included allergy to BACTRIM and concomitant medication ibuprofen. On 06-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 00644623A, expiry date: not reported), at a site high in the deltoid muscle (explicitly considered as drug administered at inappropriate site). On the same day, the also had left arm and shoulder pain with decreased range of motion for 2 weeks. The patient visited the physician for consultation and unspecified physical exams were done. At the time of this report, the outcome of the events (left arm and shoulder pain with decreased range of motion) was unknown. The reporter assessed the case as non-serious.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Peripheral swelling, Skin discolouration, Syringe issue
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 722677), concerns a 59-year-old, adult, female patient. The patient's medical history, current conditions and concomitant medications were unknown. On 12-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF32808 and expiry date: not reported). It was reported that, during the administration of vaccine, the plunger stopped suddenly (abruptly as reported) and complete dose was not administered to the patient. Again, when a plunger was tried to push with a bit of force some amount of vaccine squirted out. On the same day, immediately after vaccination, the patient started to bleed (blood ran down her arm). The patient's arm was swollen, and had discolouration. It was reported that, the patient was administered with the new vaccine. The Quality assurance reference number (QAIR number) was reported as PR491453. The outcome of the events was unknown. The reporter considered this case as non-serious. Non-significant follow up received from Quality Assurance department on 24-Feb-2018: QAIR reference number PR491453 was added. Narrative amended accordingly.
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Injection site erythema, Injection site mass, Loss of consciousness, Pruritus
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 722689), concerning a 27-year-old, adult female patient. The patient's medical history and current illness was not reported. Concomitant medications included: SYNTHROID and PROZAC. On 25-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location, left arm, back number: XF30607, expiry date: not reported). On the same day, after an hour of getting the shot, the patient passed out. The patient had lump and redness around the injection site. The patient visited her physician where she was advised to heat over it. Subsequently, the patient was resolved. However, redness and itching down the arm was continued. In addition, the patient's arm was warm and had burning sensation. The patient had not yet recovered from the events itching and redness. The outcome of other events (burning sensation, passed out and skin warm) was unknown. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 722689), concerning a 27-year-old, adult female patient. The patient's medical history and current illness was not reported. Concomitant medications included: SYNTHROID and PROZAC. On 25-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location, left arm, back number: XF30607, expiry date: not reported). On the same day, after an hour of getting the shot, the patient passed out. The patient had lump and redness around the injection site. The patient visited her physician where she was advised to heat over it. Subsequently, the patient was resolved. However, redness and itching down the arm was continued. In addition, the patient's arm was warm and had burning sensation. The patient had not yet recovered from the events itching and redness. The outcome of other events (burning sensation, passed out and skin warm) was unknown. The reporter assessed this case as non-serious.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose increased, Malaise, Nervousness, Somnolence
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 722801) concerns a 48-year-old, adult, male patient. The patient's current condition included Type 2 diabetes mellitus. The patient had been allergic to aspirin, MOBIC and NSAIDS. The concomitant medications included Bupropion, LANTUS, Lisinopril, PROTONIX and LATUDA. On 18-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: XF33508 and expiry date: not reported). On the same day, after 15 minutes of vaccination, the patient felt shaky, sleepiness and unwell. The patient went to the physician office visit and her non-fasting glucose level was 271 and vital signs included blood pressure was 142/90 mmHg, rate was 90 beats per minute. It was reported that, patient took rest in physician office for 45 minutes. On unspecified date, the patient had recovered from the events. The reporter assessed the events as non-serious.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site
Clinical narrative: This spontaneous case, reported by other health care professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 722911), concerns a 44-year-old, adult, female patient. The patient had no relevant medical history and no relevant concomitant medications were taken at the time of vaccination. On 09-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose:0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number: 00644623A and expiry date: not reported). It was reported that, the vaccine was administered high on the deltoid region to the patient, which resulted pain in the left shoulder due to which range of motion (ROM) was decreased. The events lasted for 2 weeks.On an unspecified date, the physical examinations were done. At the time of this report, the patient had recovered from all the events. The reporter considered the case as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: This is spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 722969), concerns a 60-year-old female patient. The patient's current condition included hypothyroidism. The patient had no known drug allergy (NKDA). The patient's concomitant medication included XARELTO and thyroid (as reported). On 09-Oct-2017, the patient was administered with (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm (high in the deltoid), batch number: 00644623A). On the same day, within 30 minutes of vaccine administration, the patient experienced pain in left shoulder, pain with raising arm (as reported). The patient lasted 2 weeks. On an unspecified date, physical examination was done, the results were not available. The outcome of the events was unknown. The reporter assessed the case as non-serious. Non-significant case correction received with IRD 21-Feb-2018: Case comment was amended.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 722970), concerns a 49-year-old, adult, female patient. The patient's historical procedure included mitral valve replacement (unspecified date). The patient had no current conditions. The patient had been allergic to Sulpha drugs, LEVAQUIN and oxycodone. The patient's concomitant medications included ASA, FLEXERIL and MOTRIN. On 09-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 00644623A and expiry date: not reported). On the same day, while administration of vaccine, the injection was given high on the left arm (explicitly coded as vaccine administered at inappropriate site). After the vaccination, the patient had pain in left arm. It was reported that, pain was with range of motion (ROM) and patient went to the physician office visit. No lab investigation was done. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the events as non-serious.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Full blood count normal, Injection site pain, Laboratory test normal, Pain, Product administered at inappropriate site
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 722973), concerning a 28-year-old, adult male patient. The patient had no medical history and known drug allergies. Concomitant medication included, MVI (multivitamin). On 06-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (reported as 1 dose), route of administration: intramuscular, anatomical location: left arm, batch number: 00644623A, expiry date: not reported. It was reported that, the vaccine was administered high in the left deltoid (explicitly coded as drug administered at inappropriate site). On 07-Oct-2017, the patient experienced pain which continued in the left shoulder for 2 weeks. In additional, he had pain with ROM. On 19-Oct-2017, the patient had CBC and chemistry profile done which was found to be within the limits. At the time of this report, the outcome of the events was unknown. The reporter assessed the events as non-serious.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Rash, Skin warm
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 723185), concerns a 52-year-old, elderly adult female patient. The patient's current condition included hypertension (since an unspecified date). The patient's concomitant medication included lisinopril. On 01-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose:0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF32508 and expiry date: not reported). On 27-Oct-2017, after 26 days of vaccination, on patient's left arm became reddened, swelled (bumps) and it was warm to touch. No lab tests done for the patient. The patient had physician office visit for the event. The outcome of the events was unknown. The reporter considered this case as non-serious. Significant case correction received with IRD 21-Feb-2018: The causality of the events was changed from not-related to unassessable. Case comment was amended accordingly.
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site warmth, Pain, Pain in extremity
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 723220), concerns a 47-year-old, adult male patient. The patient's current condition included hypertension, high cholesterol and pre-diabetic (since an unspecified date). On 18-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF32508 and expiry date: not reported) and PNEUMOVAX (route of administration: intramuscular, anatomical location: left arm, batch number: N019983, dose, manufacturer, trade, and expiry date: not reported). On 19-Oct-2017, after 1 day of vaccination the patient had soreness in the arm which was painful while lifting the arm. The area where the pneumonia vaccine administered became red (large 2 plus inch) and very warm. It was reported that, the pain continued for 3 days. No lab tests done for the patient. The outcome of the events was recovered. The reporter considered this case as non-serious.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Aggression, Delirium, Nausea, Pyrexia, Vomiting
Clinical narrative: This spontaneous case, reported by other health care professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 723224), concerns a 57-year-old, adult, female patient. The patient's historical drug included CORTROSYN, received on 18-Sep-2017, no reaction reported. The patient's current condition included hypertension, pre-diabetes, Bell's palsy, asthma, sleep apnea, gastrooesophageal reflux disease (GERD), back ache, and allergic to drug ibuprofen. The patient's concomitant medications included Albuterol sulfate, gabapentin, lisinopril, magnesium, Metformin, Montelukast, Multi for her (unspecified), naproxen, omeprazole, Sertraline, VENTOLIN. On 20-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration, intramuscular, anatomical location: left arm, batch number: 00644623A and expiry date: not reported) and PNEUMOVAX (route of administration: intramuscular, anatomical location: right arm, dose, manufacturer, trade, batch number: N010105, expiry date: not reported). On the same day, after vaccination, around 08:00 pm, the patient felt nauseous, vomited and had fever. It was stated that, the patient became delirious and combative. The patient was taken to hospital in emergency department and received TYLENOL (intravenously). The outcome of the events had recovered. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Body temperature increased, Disturbance in attention, Dizziness, Immediate post-injection reaction
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 723231), concerns a 43-year-old, adult, female patient. The patient had no medical history and allergy. The patient did not receive any concomitant medication. On 20-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF34509, expiry date: not reported). On an the same day, after the vaccination, the patient had immediate discomfort in arm and was unable to lift her arm. On an unspecified date in Oct-2017 (reported as after 48 hours of vaccination), the patient became very lightheaded and dizzy. The patient had heart racing, palpitations, nausea, temperature of 99.8-degree F. It was reported that, symptoms were continued for another day. As of 1 week (as reported), the patient was still dizzy and lightheaded with weakness. The patient was not able to mentally focus and had trouble in reading text. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort, Mobility decreased, Nausea, Palpitations, Vision blurred
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 723231), concerns a 43-year-old, adult, female patient. The patient had no medical history and allergy. The patient did not receive any concomitant medication. On 20-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF34509, expiry date: not reported). On an the same day, after the vaccination, the patient had immediate discomfort in arm and was unable to lift her arm. On an unspecified date in Oct-2017 (reported as after 48 hours of vaccination), the patient became very lightheaded and dizzy. The patient had heart racing, palpitations, nausea, temperature of 99.8-degree F. It was reported that, symptoms were continued for another day. As of 1 week (as reported), the patient was still dizzy and lightheaded with weakness. The patient was not able to mentally focus and had trouble in reading text. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the events as non-serious.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: This spontaneous case, reported by non-health care professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 723298), concerns a 26-year-old, adult, male patient. On an unspecified date in 2016, the patient felt tingling for about 24 to 48 hours after flu vaccination. The patient's historical condition included temporomandibular joint dysfunction (on an unspecified date) and seasonal cold (on an unspecified date, around 9/10 - 9/16 as reported). It was reported that, patient had no allergies and no concomitant medications. On 20-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF30707 and expiry date: not reported). On the same day, the patient experienced painful numbness and tingling on the left side of the body (from eye to foot). At the time of this report, the patient had not recovered from the events (tingling, pain and numbness). The reporter assessed this case as non-serious. Significant case correction received 21-Feb-2018: The LLT for the event (numbness on left side of the body [from eye to foot]) was corrected from numbness generalized to numbness.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 723377), concerns a 63-year-old, adult male patient. The patient had no medical history, allergies, current illness and medications at the time of vaccination. On 16-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (reported as not applicable), route of administration: intramuscular, anatomical location: left arm, batch number: XF30306, expiry date: not reported). On the same day, approximately after 6 hours of vaccination, the patient developed mild body aches. About 8 hours after vaccination, the patient had fever up to 101.5 F along with rigors, fatigue and pronounced body aches. Approximately over a period of 10 hours later fever decreased to 100 F then raised to 101 F. The patient took acetaminophen 1000 mg twice a day over next 12 hours. The event fever resolved within 24 hours of vaccination, whereas fatigue and muscle aches lasted approximately 2 days after vaccination. At the time of this report, patient had also recovered from chills and body pain. The reporter assessed the case as non-serious.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 723766), concerns a 39-year-old, adult, female patient. On 24-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: XF34809 and expiry date: not reported). On the same day, after 4-5 hours of vaccination, the patient started to feel dizzy and lightheaded. On an unspecified date in Oct-2017 (reported as Thursday and Friday), her symptoms progressed to fever, nausea and vomiting for 3 times. Fever subsided on Friday night (as reported). It was reported that, the patient vomited for 1 time (on Saturday). The patient would concern her PCP (primary care physician) on 31-Oct-2017 (Thursday). The patient felt better, and no other symptoms were noted. On an unspecified date, the patient had recovered from the events. The reporter assessed the events as non-serious.