chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: FLUC4
Symptoms: Product administered at inappropriate site
Clinical narrative: This spontaneous case, reported by other health care professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (ID: 730883), concerns a 68-year-old elderly female patient. The patient's current conditions included allergy to Sulfamethoxazole, trimethoprim, clindamycin, morphine and FLAGYL. The patient's concomitant medications were not reported. It was unknown, whether the patient had received concomitant medications or not. On 22-Nov-2017, the patient received FLUCELVAX QIV (dose: 0.5 ml (dose: 1 as reported), route of administration: intramuscular, anatomical location: left arm, batch number: 195211 and expiry date: not reported). On the same day about 6 PM in the evening, the patient felt slight pain and stiffness in the arm especially when lifting the arm vertically above her head. It was reported that the positive of the bandage that covered the puncture site was noticeably high on the left appendage, nearly at the site where the deltoid muscle connects to the clavicle. Hence the patient suspected that the vaccine might had missed the deltoid and deposited in the sub deltoid bursa. As of 15-Dec-2017, the patient was still experiencing tenderness and soreness at the site and lifting of the arm vertically was still impaired. There was no redness or swelling or discoloration at the site or at time of injection or afterwards. The patient was not physically impaired by the soreness when the arm was lifted or moved at that time but still she had discomfort upon movement. The patient thought that healing was ongoing and good prognosis for full recovery. No laboratory tests were performed or requested for the patient. The outcome of the events, injected limb mobility decreased, injection site pain was recovering, and pain was not recovered. The reporter assessed this case as non-serious.
Age: 24.0
Sex: M
Vaccine: FLUC4
Symptoms: Diarrhoea, Dizziness, Feeling abnormal, Nausea, Thirst
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: 730940), concerns a 24-year-old, adult, male patient. The patient's historical conditions included sickness, dizziness, nausea, excessive thirst, diarrhea and lethargy to unspecified vaccination. The patient had no known drug allergies. The patient had been sensitive to fatty foods (since an unspecified date) and no relevant concomitant medications were taken at the time of vaccination. The patient was healthy and normal prior to vaccination. On 02-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195247 and expiry date: not reported). On the same day, after the vaccination, at evening, the patient experienced dizziness, nausea, excessive thirst, diarrhoea and felt abnormal (reported as felt horrible). It was reported that, all the symptoms persisted for 4 days and did not received any medical treatment. The patient felt lethargic throughout the week. On an unspecified date in Dec-2017, the patient had recovered from the events. The reporter assessed the events as non-serious. Significant case correction received with IRD 14-Mar-2018: Listedness of the event diarrhoea was corrected from unlisted to listed in Agency. No changes were made in narrative.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Injection site pain, Injection site reaction, Nasopharyngitis, Skin warm
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: 730946), concerns a 45-year-old adult female patient. The patient's historical drug included Flu shot, and experienced injection site reaction. The patient was allergic to latex, metals and certain food items. On 13-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195247, expiry date: not reported). On 14-Dec-2017, the patient had a reaction to flu shot in the right upper arm where the flu shot was given. The patient showed signs of redness, tender to palpation as well as warm to touch. The patient also experienced cold like symptoms and muscle aches (reported as intense) in the area where flu shot was given. The patient recovered from the events. The reporter assessed this case as non-serious.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Tenderness
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: 730946), concerns a 45-year-old adult female patient. The patient's historical drug included Flu shot, and experienced injection site reaction. The patient was allergic to latex, metals and certain food items. On 13-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195247, expiry date: not reported). On 14-Dec-2017, the patient had a reaction to flu shot in the right upper arm where the flu shot was given. The patient showed signs of redness, tender to palpation as well as warm to touch. The patient also experienced cold like symptoms and muscle aches (reported as intense) in the area where flu shot was given. The patient recovered from the events. The reporter assessed this case as non-serious.
Age: 33.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Limb injury, Mobility decreased, Product administered at inappropriate site
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 731085), concerns a 33-year-old, adult, male patient. The patient had no medical history, current illness and allergy. The patient did not receive any concomitant medication. On 15-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: arm, batch number: 195234 and expiry date: not reported). It was reported that, vaccine was given in deltoid area which was too high in shoulder area. On the same day, after the vaccination, the patient complained of injection site pain, limb injury and limited limb mobility. The patient had a scheduled appointment with his PCP (primary care physician) as pain and mobility issues had worsened. At the time of this report, confirm diagnosis had not been made and PCP appointment was pending. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the events as non-serious and considered the causality of the events as related to the suspect vaccine.
Age: 73.0
Sex: M
Vaccine: FLUC4, PNC13
Symptoms: Injection site hypoaesthesia, Injection site pain, Injection site pruritus, Injection site swelling, Swelling face
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: 731088), concerns a 73-year-old, elderly male patient. On 08-Dec-2017, the patient was administered with FLUCELVAX QIV (batch number: 195241, dose, route of administration, anatomical location, expiry date: unknown) and PREVNAR 13 (batch number: 589081 (as reported), dose, route of administration, anatomical location, expiry date: unknown). On the same day, after vaccination, the patient reported that, the area was swollen, sore, itching and numb. The patient also had facial swelling. The outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 731095), concerns a 61-year-old adult female patient. The patient's medical history was not reported. On 08-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (N/A as reported), route of administration: intramuscular, anatomical location: left arm, batch number: 195215). On 18-Dec-2017, the patient cannot lift her hand and it was sore. The outcome of the event was not reported. The reporter assessed the case as non-serious.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 731111), concerns a 48-year-old, adult, female patient. The patient's current conditions included chronic knee pain, sleep apnea, menopause, lumbar disc degeneration. The patient was allergic to sulfa and SEPTRA. The patient's concomitant medications included Valacyclovir, eszopiclone, Probiotic nos, Gabapentin, Naproxen, MVI, BENADRYL, calcium, GILDESS FE, FLEXERIL, ASA for an unknown indication. On 12-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195232 and expiry date: not reported). On the same day (12-Oct-2017), the patient experienced redness, skin rash, itching and hives. It was reported that, the patient made a visit to physician's office for the events. The patient had recovered from all the events. The reporter considered this case as non-serious.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood pressure increased, Heart rate increased, Swollen tongue
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: 731266), concerns a 51-year-old, adult, female patient. It was reported that, the patient was allergic to latex, sulfa and possibly egg (from an unspecified date). On 19-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (1 as reported), route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported). On the same day, after vaccination, the patient experienced increased heart rate and blood pressure. It was reported that, the patient's tongue was swollen and the patient received epinephrine (on an unspecified date). The patient went to emergency department and received further treatment. At the time of the report, the patient had recovered from the events (swelling of tongue, increased blood pressure and heart rate increased). The reporter assessed the case as non-serious.
Age: 51.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
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: 731282), concerns a 51-year-old adult female patient. The patient's current condition included pre-diabetes since an unspecified date. The patient had no known allergies. The concomitant medications included lisinopril, Metformin, potassium, Multivitamins for an unknown indication. On 19-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195234, expiry date: not reported). On the same day, the patient was also administered with ZOSTAVAX (route of administration: subcutaneous, anatomical location: right arm, batch number and expiry date: not reported). On 20-Dec-2017, 1 day after vaccination, the patient experienced swelling, redness and warmth where injection was administered. It was reported that, swollen area was hard under the skin and was getting bigger throughout the day. Patient denies of itching or shortness of breath. The outcome of the events was not recovered. The reporter assessed this case as non-serious.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Pain, Tenderness
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: 731449), concerns a 41-year-old adult female patient. The patient's concomitant medications included fluoxetine, Multivitamin and SYNTHROID for an unknown indication. On 19-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195230, expiry date: not reported). On 01-Dec-2017, 12 days after vaccination, the patient experienced pain at the injection site. It was reported that, pain was dull, achy, but not sharp in nature. The patient had neither recovered completely from pain nor the pain was worsening. On 21-Dec-2017, patient's condition had improved but still she experienced minimal tenderness or pain. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 11.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Loss of consciousness
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: 731583), concerns a 11-year-old, child, female patient. The patient's medical history, allergy and concomitant medications were not reported. It was reported that, the patient thought she had "psyched herself out" before the vaccination. On 21-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (1 as reported), route of administration: intramuscular, anatomical location: right arm, batch number: 195243 and expiry date: not reported). On the same day, after the vaccination, the patient felt lightheaded for few seconds and then passed out on standing. The patient's mother catch and lowered her to the floor. The patient woke up after few seconds and pharmacy staff offered her water and candy. The same day (21-Dec-2017), the patient recovered from the event. The reporter assessed the event as non-serious. Non-significant case correction received with IRD on 14-Mar-2018: The grammatical errors were corrected in narrative.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 731613), concerns a 59-year-old, adult female patient. The patient's medical history, concomitant medication and current illness was unknown. The patient had allergy to DEMEROL and had no lab data. It was reported that, the patient had no adverse reaction flu shot in the past. On 22-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location: right arm, batch number: 195233, expiry date: not reported). On the same day, within 10 minutes of vaccination the patient felt dizziness (described as dizziness was coming in waves). The patient was given water to drink and about 45 minutes later, the patient went home. The outcome of the event was unknown. The reporter assessed the case as non-serious.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Bursitis, Pain, Tendonitis
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 731642), concerns a 39-year-old, adult, female patient. The patient had no historical condition, allergies and current illness. The patient did not receive any concomitant medications. On 15-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: 195225A and expiry date: not reported). On an unspecified date in 2017, (after few days of vaccination), the patient experienced persistent pain. Two weeks after vaccine administration, the patient had a doctor visit. On 22-Dec-2017, after 2 months 8 days of vaccination, the doctor stated that, it was the form of tendinitis or bursitis. It was reported that, the patient still had pain (reported as hurting) after 6 weeks of the onset of event and her full mobility had back after 9 weeks of the onset of the events. On an unspecified date, the patient had recovered from the events. The reporter assessed the events as non-serious. Non-significant case correction received with the IRD 14-Mar-2018: The onset latency (2 months 8 days) of the events bursitis and tendinitis was added in narrative.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Rash macular
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: 731724), concerning a 27-year-old, adult female patient. It was reported that, the patient had previous allergic reactions to anesthesia. The patient's current conditions included: anxiety and multiple allergies (unspecified). On 01-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195245, expiry date: not reported). On the same day after vaccination, the patient developed red and blotchy skin. So, she visited emergency room for treatment. However, it was unknown if she received any treatment. The patient had recovered from the event rash macular. The reporter assessed this case as non-serious.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Computerised tomogram abnormal, Computerised tomogram spine, Dizziness, Fatigue, Headache
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: 731725), concerning a 39-year-old, adult female patient. The patient had no historical condition, current condition, allergies and no concomitant medications were administered. On 16-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195245, expiry date: not reported). On the same day, around 5:00 hrs, he patient felt weakness in both lower legs. Hence, she visited emergency room (ER). By the time she also felt tingling in her arms, legs and hands. Subsequently, the patient underwent computed tomography (CT) scan of the lumbar spine and found spinal stenosis in her back. She continues to feel fatigue and lightheadedness with a headache on and off. The reporter felt that, there was a chance that the events could be due to flu vaccine. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious. Significant case correction received with IRD 14-Mar-2018: The events weakness in both lower legs, tingling in her arms, legs and hands, fatigue, lightheadedness and headache were mapped as symptoms of spinal stenosis. No changes were made in the narrative.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Lumbar spinal stenosis, Muscular weakness, Paraesthesia
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: 731725), concerning a 39-year-old, adult female patient. The patient had no historical condition, current condition, allergies and no concomitant medications were administered. On 16-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195245, expiry date: not reported). On the same day, around 5:00 hrs, he patient felt weakness in both lower legs. Hence, she visited emergency room (ER). By the time she also felt tingling in her arms, legs and hands. Subsequently, the patient underwent computed tomography (CT) scan of the lumbar spine and found spinal stenosis in her back. She continues to feel fatigue and lightheadedness with a headache on and off. The reporter felt that, there was a chance that the events could be due to flu vaccine. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious. Significant case correction received with IRD 14-Mar-2018: The events weakness in both lower legs, tingling in her arms, legs and hands, fatigue, lightheadedness and headache were mapped as symptoms of spinal stenosis. No changes were made in the narrative.
Age: 36.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Dyspnoea, Vomiting
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: 731810), concerns a 36-year-old, adult male patient. On 22-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (reported as unknown), route of administration: unknown, anatomical location: unknown, batch number: 195241, expiry date: not reported). On an unspecified date, after vaccination, the patient developed dizziness, vomiting and difficulty in breathing. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from pharmacist on 08-Dec-2017, concerning a 60-year-old, adult female patient. The patient's current conditions included anxiety. The patient's concomitant medications included lorazepam and BUSPAR for an unknown indication. The suspect vaccine FLUCELVAX QIV underwent temperature excursion from 27-40 degrees F. On 08-Dec-2017, the patient was administered with FLUCELVAX QIV which underwent temperature excursion (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195244, expiry date: 30-Jun-2018). It was reported that, no adverse event was occurred after the vaccination. The reporter assessed the events as non-serious. Case correction received with IRD 07-Dec-2017: Updated expiry date of suspect vaccine as 30-Jun-2018 (in the product tab). The narrative was amended accordingly. Non-significant follow up retrieved from VAERS (VAERS ID: 731871) reported to VAERS by pharmacist on 14-Mar-2018: VAERS ID was updated. Amended narrative accordingly.
Age: 52.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Injected limb mobility decreased, Pain, 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: 731891), concerns a 52-year-old adult male patient. The patient's current conditions included hypertension and chronic lower back pain. The patient's concomitant medications included metoprolol succinate, nortriptyline, oxycodone and omeprazole all for an unknown indication. On 26-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195238, expiry date: not reported). On the same day, the patient was also administered with PENUMOVAX (route of administration: intramuscular, anatomical location: right arm, batch number: N025656, dose and expiry date: not reported). On the same day, after the administration of vaccine, the patient experienced severe (reported as excruciating) pain in his right arm and could not move his arm. Upon moving the arm, the patient felt shooting pain. It was reported that, the patient laid on the floor and could not do anything the rest of the day. The patient was treated with oxycodone for pain. The patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 38.0
Sex: M
Vaccine: FLUC4
Symptoms: Ear pain, Headache, Herpes zoster, Musculoskeletal pain, Nodule
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: 731902), concerns a 38-year-old, adult male patient. The patient had no relevant medical history, no allergies and no relevant concomitant medications were taken at the time of vaccination. On 22-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported). On the same day (22-Dec-2017), after 8 hrs of vaccination, the patient felt soreness in shoulders and between the shoulder blades and tingling sensation on right upper chest. After 24 hours of vaccination, the patient developed a painful knot on left latissimus dorsi and tingling sensation spreads to abdomen. After 48 hours of vaccination, the patient developed a pustular rash on upper back and tingling sensation move towards to forearms. After 96 hours of vaccination pustular rash spread to the back, right underarm and right chest. After 130 hours, the patient had dull headache on right side of the head and piercing right ear pain. Occasionally, the patient went to doctor of medicine (MD) and was diagnosed with shingles. At this time of the report, the outcome of the events had not recovered. The reporter considered this case as non-serious. Non-significant case correction received with IRD 14-Mar-2018: Spelling mistake in narrative was corrected.
Age: 38.0
Sex: M
Vaccine: FLUC4
Symptoms: Paraesthesia, Rash pustular
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: 731902), concerns a 38-year-old, adult male patient. The patient had no relevant medical history, no allergies and no relevant concomitant medications were taken at the time of vaccination. On 22-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported). On the same day (22-Dec-2017), after 8 hrs of vaccination, the patient felt soreness in shoulders and between the shoulder blades and tingling sensation on right upper chest. After 24 hours of vaccination, the patient developed a painful knot on left latissimus dorsi and tingling sensation spreads to abdomen. After 48 hours of vaccination, the patient developed a pustular rash on upper back and tingling sensation move towards to forearms. After 96 hours of vaccination pustular rash spread to the back, right underarm and right chest. After 130 hours, the patient had dull headache on right side of the head and piercing right ear pain. Occasionally, the patient went to doctor of medicine (MD) and was diagnosed with shingles. At this time of the report, the outcome of the events had not recovered. The reporter considered this case as non-serious. Non-significant case correction received with IRD 14-Mar-2018: Spelling mistake in narrative was corrected.
Age: 74.0
Sex: M
Vaccine: FLUC4, PNC13
Symptoms: Lip swelling
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 731971), concerns a 74-year-old, elderly male patient. It was reported that, the patient was pre-diabetic and had no lab data. On 14-Dec-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: 195245, expiry date: not reported) and PREVNAR 13 (dose: 1 dose, route of administration: intramuscular, anatomical location: right arm, batch number: S74424, expiry date: not reported). On 15-Dec-2017 morning, after 1 day of vaccination, the patient had swollen upper lip. The patient took ZYRTEC and BENADRYL later that day, on 16-Dec-2017, the patient improved (recovering). The reporter assessed the case as non-serious.
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Headache, Throat tightness
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: 732065), concerns a 10-year-old female child patient. The patient's medical history was not reported. On 12-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (1 as reported), route of administration: intramuscular, anatomical location: left arm, batch number: 195247 and expiry date: not reported). On the same day, after vaccination the patient experienced headache, pressure in throat and dizziness. The outcome of the events was unknown. The reporter assessed the case as non-serious. Non-significant case correction received 14-Mar-2018: The vaccination date was removed from the case comment.
Age: 78.0
Sex: M
Vaccine: FLUC4, PNC13
Symptoms: Dizziness, Syncope
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: 732164), concerns a 78-year-old adult male patient. The patient had no current conditions. The patient was allergic to penicillin and clindamycin. On 29-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195246, expiry date: not reported), on the same day the patient was also administered with PREVNAR 13 (dose: (reported as 1), route of administration: intramuscular, anatomical location: right arm, batch number: S51635, expiry date: not reported). On the same day, after vaccination, the patient felt lightheaded and fainted in the pharmacy. At the time of this report, the outcome of the events was not reported. The reporter assessed this case as non-serious.
Age: 59.0
Sex: M
Vaccine: FLUC4
Symptoms: Tremor
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 732190), concerns a 59-year-old, adult male patient. On 29-Dec-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: 195228, expiry date: not reported). On 30-Dec-2017, the next day of vaccination, the patient had shaking hands. On the same day, at 09:10 hrs, the patient informed the pharmacy about the event and was referred to physician. The patient refused to visit hospital. The outcome of the event was unknown. The reporter assessed the case as non-serious.
Age: 36.0
Sex: M
Vaccine: FLUC4
Symptoms: Crepitations, Injection site 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: 732270), concerns a 36-year-old adult male patient. The patient's current condition included left wrist fracture and was on physiotherapy since an unspecified date. On 26-Oct-2017 (afternoon), the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195215, expiry date: not reported). On the same day, after vaccination, the patient went to clinic due to pain in the upper arm where injection was given. It was reported that patient had sharp pain with range of motion in the deltoid muscle of the left arm, especially with abduction of upper extremity and supination of the forearm/wrist. The patient had good radial/ulnar pulses on left arm and no palpable masses or tenderness of deltoid muscle. Some crepitus palpated with abduction to 90 degrees. It was reported that, patient had been doing band exercises in physiotherapy (PT) with arms flexed at elbow at 90 degrees and extension laterally which may also be causing some inflammation to area. The outcome of the events was not recovered. The reporter assessed this case as non-serious.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Swelling face
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 18-Jun-2018 by Seqirus from VAERS (VAERS ID: 732521), concerns a 57-year-old, adult, male patient. The patient's relevant medical history, current conditions, allergies and concomitant medications were not reported. On 02-Nov-2017, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, manufacturer and trade name: not reported). On 04-Nov-2017, after 2 days of vaccination, the patient developed facial swelling and managed by non-PCP (primary care physician). The patient denied use of any influenza vaccines in future. On an unspecified date, the patient had recovered from the event. The reporter assessed the event as non-serious and considered the causality of the event as related to the suspect vaccine.
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Muscle disorder
Clinical narrative: This is spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 732540), concerns a 58-year-old, adult, male 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 ASA for an unknown indication. On 10-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195219 and expiry date: not reported). On the same day, after the vaccination, the patient experienced extreme left upper arm and bicep pain with limited ROM (range of motion). The pain had increased, and he went to the ART specialist visit, where it was indicated that, patient had adhesion in bicep and deltoid muscle tissues. No lab investigation was done. The reporter assessed the events as non-serious.
Age: 78.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 732602), concerning a 78-year-old, elderly male patient. The patient had no historical condition and no current illness. On 27-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195242, expiry date: not reported). On the same day, after vaccination, the patient had continuous pain in upper arm since administration of vaccine which lasted for over 1-month duration. The patient had not yet recovered from the event pain in upper arm. The reporter assessed the case as non-serious.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site, Tendonitis
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 732689), concerns a 59-year-old, adult, female patient. The patient had no medical history, allergies or current illness. On 11-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (reported as 5), route of administration: injection (reported as syr), anatomical location: left arm, batch number: 195239, expiry date: not reported), extremely high and in the shoulder. The patient felt burning sensation while administration and a sharp pain in the shoulder. After one week, the patient was unable to move the shoulder due to pain and consulted an orthopaedic specialist who diagnosed tendonitis/bursitis. The patient was treated with OTC (over the counter) anti-inflammatory regimen and applied ice. When the treatment did not work even after two weeks, the patient was given steroid injection. The patient reported that, the pain was bad and could hardly lift or move arm due to sharp piercing pain. The physician advised for magnetic resonance imaging (MRI). On an unspecified date, X-ray of left shoulder 2 views was taken AP (anteroposterior) and axillary, which showed GH (as reported). At the time of this report, the patient had not recovered from the events. The patient assessed the case as non-serious. Non-significant case correction received with IRD 14-Mar-2018: Narrative was corrected (on an unspecified date, X-ray of left shoulder 2 views was taken, which showed GH (as reported), AP (anteroposterior) and axillary was changed to 'on an unspecified date, X-ray of left shoulder 2 views was taken AP (anteroposterior) and axillary, which showed GH (as reported)'. Amended narrative accordingly.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: X-ray limb
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 732689), concerns a 59-year-old, adult, female patient. The patient had no medical history, allergies or current illness. On 11-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (reported as 5), route of administration: injection (reported as syr), anatomical location: left arm, batch number: 195239, expiry date: not reported), extremely high and in the shoulder. The patient felt burning sensation while administration and a sharp pain in the shoulder. After one week, the patient was unable to move the shoulder due to pain and consulted an orthopaedic specialist who diagnosed tendonitis/bursitis. The patient was treated with OTC (over the counter) anti-inflammatory regimen and applied ice. When the treatment did not work even after two weeks, the patient was given steroid injection. The patient reported that, the pain was bad and could hardly lift or move arm due to sharp piercing pain. The physician advised for magnetic resonance imaging (MRI). On an unspecified date, X-ray of left shoulder 2 views was taken AP (anteroposterior) and axillary, which showed GH (as reported). At the time of this report, the patient had not recovered from the events. The patient assessed the case as non-serious. Non-significant case correction received with IRD 14-Mar-2018: Narrative was corrected (on an unspecified date, X-ray of left shoulder 2 views was taken, which showed GH (as reported), AP (anteroposterior) and axillary was changed to 'on an unspecified date, X-ray of left shoulder 2 views was taken AP (anteroposterior) and axillary, which showed GH (as reported)'. Amended narrative accordingly.
Age: 54.0
Sex: M
Vaccine: FLUC4
Symptoms: Acupuncture, Injection site pain, Paraesthesia
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 732693), concerns a 54-year-old, adult male patient. The patient's historical procedure included pacemaker insertion (unspecified date). The patient's current condition included diabetes. Patient had no known allergies. The patient's concomitant medications included lisinopril, celecoxib and metformin for an unknown indication. On 10-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195210A and expiry date: not reported). On 24-Sep-2017, approximately 2 weeks of vaccination the patient experienced pain in upper left arm and tingling occasionally. It was reported that, the patient still feels the pain and undergoing acupuncture and 2 physical therapy treatments for 6 weeks. The cardiologist advised the patient, to take pain relievers, exercise the area and to take rest. At the time of this report, the outcome of the events had not recovered. The reporter considered this case as non-serious.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site scab, Pain in extremity
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 732838), concerning a 54-year-old, adult female patient. The patient's medical history, allergies and concomitant medications were not reported. On 02-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid (left arm), batch number: 195248, expiry date: not reported). Around 09-Dec-2017, after 7 days of vaccination, the patient noticed that left arm was sore and became increasingly sore. Around 17-Dec-2017, the patient noticed a break in the skin where the vaccine was given that progressed to become wider, edematous, erythematous with scab formation. The area was raw with zero drainage. She had left (L) shoulder pain since vaccination. The scab resolved within a week. On 29-Dec-2017, the patient made an appointment to physician where the scab was swabbed and 1 gram of ROCEPHIN was given to the patient. On 30-Dec-2017, the patient visited urgent care and was seen by nurse practitioner (NP). The NP believed that the vaccine hit a nerve. Later, on 02-Jan-2018, the patient was seen by orthopaedic who believed that the flu shot was given in the nerve. The physician advised the patient for physical therapy. On 05-Jan-2018, the patient visited for first physical therapy where the physical therapist believed that the median nerve was the affected nerve. Hence, the patient could not reach over head or behind her back. Subsequently, the physical therapist scraped the left deltoid. The patient had recovered from the event scab and not yet recovered from other events (oedema, pain in arm, erythema and injection site pain). The reporter assessed this case as non-serious.
Age: 79.0
Sex: M
Vaccine: FLUC4
Symptoms: Eye pain, Headache, 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: 732923), concerns a 79-year-old elderly male patient. The patient's medical history was not reported. On 12-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml (unk as reported), route of administration: intramuscular, anatomical location: unknown, batch number: 195239). On the same day, after the vaccination, the patient experienced pain at the injection site, which moved into his shoulder and then eye. It was reported that, the patient also complained of mild headaches (as reported). The outcome of all the events was not recovered. The reporter assessed the case as non-serious. Non-significant case correction received with IRD 14-Mar-2018: The narrative statement was corrected.
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Extra dose administered, Rash
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: 732951), concerns a 09-year-old, female child patient. The patient's medical history was not reported, allergies were unknown. The concomitant medications were unknown. On an unspecified date, it was reported that, the patient received influenza vaccine and experienced an adverse reaction. On 05-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: injection, anatomical location: left arm, batch number: 195225A and expiry date: not reported) which was reported as second dose. On the same day, the patient developed spots on hands and feet (which came and went as reported). The patient also experienced soreness in her joints. The outcome of the event (vaccination complication) was not recovered. The reporter assessed the case as non-serious.
Age: 11.0
Sex: M
Vaccine: FLUC4
Symptoms: Induration, Local reaction, Skin warm, Swelling, Tenderness
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 14-May-2018 by Seqirus from VAERS (VAERS ID: 732953), concerns a 11-year-old child male patient. The patient's historical conditions, current conditions and concomitant medications were unknown. On 14-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: injection (reported as SYR), anatomical location: left arm, batch number: 195236, expiry date: not reported). On the same day after vaccination, the patient experienced localized reaction (swelling, hot, hard, tender to touch). At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia oral, Lip swelling, Paraesthesia
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: 732960), concerns a 44-year-old, adult, female patient. The patient's historical condition included asthma (unspecified date). The patient's allergy and current illness were not reported. The patient's concomitant medications included omeprazole, SINGULAIR and XYZAL for an unknown indication. On 01-Nov-2017, the patient was administered FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195239 and expiry date: not reported). On 02-Nov-2017, after 1 day 1 hr 30 minute of vaccination, at 01:30 am, the patient woke up with swollen, numb lips. The patient also experienced tingling in left ring finger and pinkie finger. On an unspecified date, the patient had recovered from the events. The reporter assessed the events as non-serious. Non-significant case correction received with the iRD 14-Mar-2018: The narrative was corrected.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Hyperhidrosis, Hypoacusis, Nausea, Tremor, Vision blurred
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: 733360), concerns a 52-year-old adult female patient. The patient's concomitant medications included propranolol, zolpidem and LOESTRIN FE for an unknown indication. On 10-Jan-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195126, expiry date: not reported). On the same day after vaccination, the patient had temporary hearing impairment, blurred vision, nausea, diaphoresis. It was reported that, the patient started to shake within 30 minutes of immunization. The patient felt better within 2-3 minutes of sitting upright. The symptoms were fully resolved after 10 minutes. No treatment was administered. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 53.0
Sex: M
Vaccine: FLUC4
Symptoms: Lip swelling, Swelling face
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: 733425), concerns a 53-year-old, adult, male patient. The patient's current condition included high blood pressure (since an unspecified date). The patient's allergy and concomitant medication were not reported. On 10-Jan-2018, (at 2:30 pm), the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location: right arm, batch number: 195126 and expiry date: not reported). On 11-Jan-2018, (at 04:30 am), the patient woke up and noticed lips and face swelling after 21 hrs 30 min of vaccination. On the same day, in afternoon, the patient had a physician appointment. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the events as non-serious.