chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Lip swelling
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 712302), concerns a 56-year-old, adult, female patient. The patient medical history and the concomitant medications were not reported. On 08-Sep-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: 195213 and expiry date: not reported). On 09-Sep-2017, after 1 day of vaccination, the patient experienced swelling of lips. The patient went to physician. The lab investigations were not reported. At the time of the report, the outcome of the event (lip swelling) was unknown. The reporter assessed the case as non-serious.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Dry throat, Erythema, Paraesthesia, Throat irritation
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 712606), concerns a 36-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 01-Sep-2017, (in early morning) the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported). On the same day, shortly after vaccination, the patient developed erythema and tingling around her left arm and experienced itchiness and dryness in her throat. On an unspecified date, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site bruising
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 712612), concerns a 58-year-old, adult, female patient. The patient's historical condition, current conditions, allergies and concomitant medications were not reported. On 06-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195210A [reported as 195201A] and expiry date: not reported). On the same day, after vaccination, the patient developed bruising around injection site and below the injection site in her arm. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the case as non-serious. Update 03-Jul-2018: Non-significant case correction performed with IRD 11-Jun-2018: In the event tab, verbatim for injection site bruising was changed from brushing to bruising. In the narrative 'brushing around the injection site' was changed to 'bruising around the injection site' and 'patient ad not yet recovered' was changed to 'patient had not yet recovered'. Case comment updated. Amended narrative accordingly.
Age: 8.0
Sex: M
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Somnolence, Syncope
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 712654), concerns a 08-year-old, child, male patient. The patient's historical conditions, concomitant medications were not reported. The patient had no known current illness and no known allergy (NKA). On 11-Sep-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: 195210A and expiry date: not reported). On the same day, after vaccination, the patient experienced fainting, numbness in hands and he could not keep his eyes open. The patient was made to sit at pharmacy under observation for some time. On the same day (11-Sep-2017), after few minutes, the patient had recovered from the events. The reporter assessed the events as non-serious.
Age: 11.0
Sex: M
Vaccine: FLUC4
Symptoms: Dysstasia, Fall, Vision blurred
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 712655), concerns a 11-year-old, child, male patient. The patient's historical conditions, concomitant medications were not reported. The patient had no known current illness and no known allergy (NKA). On 11-Sep-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: 195210A [reported as 95210A] and expiry date: not reported). On the same day within 5-7 minutes of vaccination, the patient had fallen on the ground but was conscious. The patient complained of blurred vision and could not stand. The patient was made to sit for observation. On the same day (11-Sep-2017), after few minutes, the patient had recovered from the events. The reporter assessed the case non-serious.
Age: 13.0
Sex: M
Vaccine: FLUC4
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Fatigue, Injection site erythema
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 713723), concerns a 13-year-old adolescent male patient. The patient's current conditions included asthma, and allergic to eggs, peanuts and latex. The patient's concomitant medications included ASTHMANEX for asthma. On 10-Sep-2017, the patient received FLUCELVAX QIV [dose: 0.5 ml (reported as unk), route of administration: intramuscular, anatomical location, batch number and expiry date: not reported]. On the same day, after vaccination, the patient experienced injection site redness, soreness, hives and rash. The patient also experienced systemic reactions which included general malaise, fatigue, loss of appetite for 24 hours. It was reported that, the patient had stomach ache, cramps and loose stools. In the hindsight, it was noted that epinephrine should have been administered. The patient did not report any rash or hives until late. At the time of report, the patient recovered from all the events. The reporter assessed this case as non-serious.
Age: 13.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site rash, Injection site urticaria, Malaise, Muscle spasms
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 713723), concerns a 13-year-old adolescent male patient. The patient's current conditions included asthma, and allergic to eggs, peanuts and latex. The patient's concomitant medications included ASTHMANEX for asthma. On 10-Sep-2017, the patient received FLUCELVAX QIV [dose: 0.5 ml (reported as unk), route of administration: intramuscular, anatomical location, batch number and expiry date: not reported]. On the same day, after vaccination, the patient experienced injection site redness, soreness, hives and rash. The patient also experienced systemic reactions which included general malaise, fatigue, loss of appetite for 24 hours. It was reported that, the patient had stomach ache, cramps and loose stools. In the hindsight, it was noted that epinephrine should have been administered. The patient did not report any rash or hives until late. At the time of report, the patient recovered from all the events. The reporter assessed this case as non-serious.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Lip swelling, Pruritus, Swelling face, Urticaria
Clinical narrative: This spontaneous case, initially received from regulatory authority (VAERS ID: 713903) (reported to RA by other health professional) on 05-Dec-2017, concerning a 29-year-old, adult, female patient. The patient's underwent a shoulder surgery and the patient was allergic to Sulfa drugs. The patient's concomitant medication included PERCOCET and Clonazepam for PRN status post shoulder surgery (as reported). On 18-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195221 and expiry date: not reported). On 20-Sep-2017, after 3 days of vaccination, the patient had a lot of itching and presented with scalp itching from one-day, same day morning she woke up with hives, all over her body. She felt swollen, behind her ears and more slightly her lips and face. It was reported that she didn't have symptoms like fever, abdominal pain, difficulty breathing or SOB, nausea and vomiting (N/V as reported). No lab test was done. The patient was advised to go to ER or urgent care immediately. At the time of this report, the outcome of the events was not reported. The reporter assessed the case as non-serious.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Back pain, Hypoaesthesia, Joint range of motion decreased, Musculoskeletal pain, Paraesthesia
Clinical narrative: This spontaneous case, was initially received from other health professional via health authority (VAERS ID: 715720) on 05-Dec-2017, concerning a 29-year-old adult female patient. The patient medical history and concomitant medications were not reported. On 18-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195231, route of administration: intramuscular, anatomical location: left arm). It was reported that, vaccine was given in bursa not in deltoid muscle (too high on the upper arm). On the same day, after the vaccination, the patient had shoulder pain and inability to adduct or abduct that shoulder. The patient was unable to sleep on her left side and back without significant pain. The patient also had tingling and numbness in left arm, which radiated to left hand. It was reported that, all the events were ongoing for 2 weeks. The patient went to the physician office visit. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the case as non-serious and considered the causality as related to the suspect vaccine.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Product administered at inappropriate site, Sleep disorder
Clinical narrative: This spontaneous case, was initially received from other health professional via health authority (VAERS ID: 715720) on 05-Dec-2017, concerning a 29-year-old adult female patient. The patient medical history and concomitant medications were not reported. On 18-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195231, route of administration: intramuscular, anatomical location: left arm). It was reported that, vaccine was given in bursa not in deltoid muscle (too high on the upper arm). On the same day, after the vaccination, the patient had shoulder pain and inability to adduct or abduct that shoulder. The patient was unable to sleep on her left side and back without significant pain. The patient also had tingling and numbness in left arm, which radiated to left hand. It was reported that, all the events were ongoing for 2 weeks. The patient went to the physician office visit. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the case as non-serious and considered the causality as related to the suspect vaccine.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Altered state of consciousness, Asthenia, Back pain, Blood pressure decreased, Body temperature increased
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 716092), concerns a 56-year-old adult female patient. The patient's current illness included seasonal allergies, hypothyroid, elevated cholesterol and penicillin allergy. The patient's concomitant medication included estradiol, levothyroxine, NEXIUM, atorvastatin, MV, calcium and HCTZ (Hydrochlorothiazide). On 02-Oct-2017 at 14:00, the patient  received FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195229 and expiry date: not reported]. On the same day, at 18:00 left office.The patient was feeling very weak and lightheaded. The patient also had neck hurt and back hurt. By 18:30 pm, 4 hrs 30 min after vaccine administration, the patient had very lightheaded and felt like she would pass out. The patient's blood pressure was found to be 88/54 and heart rate was 110. By 19:00, the patient developed hard chills and by 200:00 the temperature raised to 102.7. The patient took TYLENOL and got hydrated. By midnight, the temperature was reduce to 99.5 and everything was normal in the morning. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Dizziness, Neck pain
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 716092), concerns a 56-year-old adult female patient. The patient's current illness included seasonal allergies, hypothyroid, elevated cholesterol and penicillin allergy. The patient's concomitant medication included estradiol, levothyroxine, NEXIUM, atorvastatin, MV, calcium and HCTZ (Hydrochlorothiazide). On 02-Oct-2017 at 14:00, the patient  received FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195229 and expiry date: not reported]. On the same day, at 18:00 left office.The patient was feeling very weak and lightheaded. The patient also had neck hurt and back hurt. By 18:30 pm, 4 hrs 30 min after vaccine administration, the patient had very lightheaded and felt like she would pass out. The patient's blood pressure was found to be 88/54 and heart rate was 110. By 19:00, the patient developed hard chills and by 200:00 the temperature raised to 102.7. The patient took TYLENOL and got hydrated. By midnight, the temperature was reduce to 99.5 and everything was normal in the morning. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 13.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 716266), concerns a 13-year-old, adolescent male patient. The patient's relevant medical history, current conditions, allergies and concomitant medications were unknown. On 26-Sep-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency: unknown, route of administration: injection (reported as SYR), anatomical location: left arm, batch number: 195225A and expiry date: not reported). On 28-Sep-2017, 2 days after vaccination, the patient experienced redness, soreness, warmth and swelling at the injection site. The patient's relevant lab data was unknown. It was reported that, the patient visited office. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: This is a non-serious spontaneous case, initially received on 05-Dec-2017, from health authority (VAERS ID: 716346) via other health professional, concerning a 47-year-old, adult, female patient. The patient's current conditions included fibromyalgia and SI (sacroiliac) joint dysfunction. The patient's concomitant medications included: Trazodone, ADVIL and Meloxicam for unknown indication. On 19-Sep-2017, the patient was administered with FLUCELVAX QIV (route of administration: injection (SYR as reported), batch number: 195218, dose, anatomical location, expiry date: not reported), as the vaccine was administered inappropriately (as reported: vaccine being placed too high on arm, which hit her deltoid tendon). On 26-Sep-2017, after 8 days of vaccination, the patient was not able to move her arm as she had lot of pain. On 02-Oct-2017, the patient visited physician's office due to pain in her shoulder as she was unable to move her arm. At the time of this report, the patient had not yet recovered from the events. Significant case correction received with the IRD 05-Dec-2017: The onset date of the event "drug administered at inappropriate site" was changed from 26-Sep-2017 to 19-Sep-2017. The outcome of the event 'drug administered at inappropriate site' was changed from not recovered to unknown. The narrative was amended accordingly.
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Fatigue, Headache, Laboratory test normal, Neck pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 716366), concerns a 10-year-old, female child patient. On 02-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195214 and expiry date: not reported). On an unspecified date in Oct-2017, 48 hours after vaccination, the patient experienced neck pain, fatigue and headache. The patient had made a physician office visit. On an unspecified date, the examination for meningitis performed and the result was found to be negative. The patient received the treatment with MOTRIN, ice massage therapy, massage of neck, push fluids. The patient took rest and her symptoms were monitored. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Joint dislocation
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 716381), concerns a 50-year-old, adult, female patient. The patient had no historical conditions, current illnesses and was not taking any concomitant medications. On 13-Sep-2017, the patient was administered FLUCELVAX QIV [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195210A and expiry date: not reported]. On 16-Sep-2017, 3 days after vaccination, the patient's left arm deltoid became sore which got worsen through the weekend and beginning of next week. The patient also experienced warmth and redness in the left upper extremity and in the left shoulder. On an unspecified date in Sep-2017, it was reported that the patient felt shoulder dislocation. On an unspecified date, the patient had an emergency room and office visit. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Fatigue, Nausea, Pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 716417), concerns a 62-year-old, adult, female patient. The patient's current condition included hypertension (reported as medical history) for which the patient was taking unspecified blood pressure medication since an unspecified date. The patient had no allergies. On 03-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as 1, route of administration: injection (reported as SYR), anatomical location: left arm, batch number: 195223 and expiry date: not reported). On the same day, at 06:00 pm after vaccination, the patient experienced body aches, chills, nausea and fatigue. The symptoms lasted for approximately 5 hours (recovered). The reporter assessed the case as non-serious.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Anxiety, Blood glucose normal, Blood potassium increased, Dizziness, Erythema
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 716506), concerning a 43-year-old, adult, female patient. The patient's historical conditions included: dizziness and a feeling of light headedness, and the patient reported that her doctor (reported as MD) was working on her possible immune issues. The patient's historical drugs included: Morphine, codeine and IVP dye for unknown indications. The patient stated that, she did not experience any reaction to the flu shot in the past. The patient's concurrent condition included: palpitation (reported as medical history), anaemia, electrolyte imbalance and pre-diabetes. The patient's concomitant medications included: atenolol for an unknown indication. On 04-Oct-2017, the patient was administered FLUCELVAX (QIVc) (dose: 0.5 ml [frequency reported as 1], batch number: 195128, route of administration: intramuscular, anatomical location: left arm and expiry date: not reported). On the same day, about an hour after the vaccination, the patient felt unwell and complained of dizziness and faint feeling. The patient had left arm pain originating at the injection site and both arms were urticaric with a pruritus developing on chest. On the same day, the patient reported pain in arm and redness. The patient was alert, oriented and somewhat anxious. The patient's lips were pink and did not present the signs of respiratory distress. On an unspecified date, the patient's vital signs were found to be normal and had a body temperature 97.4, heart rate 60, respiratory rate 16, blood pressure 100/60 (units were not reported). Since the patient was pre-diabetic, ACCUCHECK was performed and was found to be 94 (unit was not reported). After about 20 minutes of rest and assurance she stated that she was feeling better. The arm redness was clearing up. The patient said that she would call her family doctor once she gets back to her office, and she was at the point, thinking of driving home to rest. On an unspecified date, the patient was treated with ibuprofen 200 mg per oral for the arm pain. The patient reported that in the last month (Sep-2017), the patient's potassium level (K as reported) was elevated and became anaemic but was unable to say the actual haematocrit levels (HCT). At the time of the report, the patient had recovered from the events. The reporter assessed the case as non-serious. Update received on 27-Sep-2018: Significant case correction (IRD: 16-Aug-2018): The onset of the events (pain in arm and erythema) was changed from 'Oct-2017' to '04-Oct-2017'. The month (Sep) was added in the onset date for the event (blood potassium increased). The haematocrit description and the sentence 'patient did not experience any reaction to flu shot in the past' was added in the narrative. The narrative and case comment amended accordingly.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Malaise, Pain in extremity, Pruritus, Urticaria
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 716506), concerning a 43-year-old, adult, female patient. The patient's historical conditions included: dizziness and a feeling of light headedness, and the patient reported that her doctor (reported as MD) was working on her possible immune issues. The patient's historical drugs included: Morphine, codeine and IVP dye for unknown indications. The patient stated that, she did not experience any reaction to the flu shot in the past. The patient's concurrent condition included: palpitation (reported as medical history), anaemia, electrolyte imbalance and pre-diabetes. The patient's concomitant medications included: atenolol for an unknown indication. On 04-Oct-2017, the patient was administered FLUCELVAX (QIVc) (dose: 0.5 ml [frequency reported as 1], batch number: 195128, route of administration: intramuscular, anatomical location: left arm and expiry date: not reported). On the same day, about an hour after the vaccination, the patient felt unwell and complained of dizziness and faint feeling. The patient had left arm pain originating at the injection site and both arms were urticaric with a pruritus developing on chest. On the same day, the patient reported pain in arm and redness. The patient was alert, oriented and somewhat anxious. The patient's lips were pink and did not present the signs of respiratory distress. On an unspecified date, the patient's vital signs were found to be normal and had a body temperature 97.4, heart rate 60, respiratory rate 16, blood pressure 100/60 (units were not reported). Since the patient was pre-diabetic, ACCUCHECK was performed and was found to be 94 (unit was not reported). After about 20 minutes of rest and assurance she stated that she was feeling better. The arm redness was clearing up. The patient said that she would call her family doctor once she gets back to her office, and she was at the point, thinking of driving home to rest. On an unspecified date, the patient was treated with ibuprofen 200 mg per oral for the arm pain. The patient reported that in the last month (Sep-2017), the patient's potassium level (K as reported) was elevated and became anaemic but was unable to say the actual haematocrit levels (HCT). At the time of the report, the patient had recovered from the events. The reporter assessed the case as non-serious. Update received on 27-Sep-2018: Significant case correction (IRD: 16-Aug-2018): The onset of the events (pain in arm and erythema) was changed from 'Oct-2017' to '04-Oct-2017'. The month (Sep) was added in the onset date for the event (blood potassium increased). The haematocrit description and the sentence 'patient did not experience any reaction to flu shot in the past' was added in the narrative. The narrative and case comment amended accordingly.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Hypoaesthesia, Paraesthesia oral, Tongue disorder
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 716565), concerns a 50-year-old, adult female patient. The patient did not have any relevant medical history, current illness, drug allergies or allergy to food or other products. The patient's concomitant medications included ZYRTEC, aspirin and ESTRACE. On 04-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, anatomical location: right arm, batch number: 195128 and expiry date: not reported). On the same day (04-Oct-2017), after vaccination, the patient complained of tongue thickening and tingling sensation. The medical director, via telephone, advised the patient to take BENADRYL. The patient was given 25 mg of BENADRYL (liquid) at 3:01 pm and 3:05 pm and was observed for 1 hour for the oxygen, pulse rate and breathing. At 4 pm, the patient felt better. It was reported that, the patient denied shortness of breath (SOB). The patient was also advised to call 911 and contact her primary care physician (PCP) if symptoms returned. On 05-Oct-2017, the patient stated that, she woke up with headache that morning, still had tingling in the corner of her mouth and little numbness at her fingertips. The patient also stated that, she had contacted her primary care physician who advised her not to get flu vaccine anymore and start taking ALLEGRA and stop taking ZYRTEC. The patient did not have any relevant lab data. The patient was recovering from the events tongue thickening and tingling sensation. The patient had not recovered from the event tingling mouth and numbness in fingers. The outcome of the event headache was not reported. The reporter assessed the case as non-serious. Update received on 26-Sep-2018: Significant case correction (16-Aug-2018): The outcome of the event headache was changed from recovered to not reported, numbness in fingers (hypoaesthesia) from recovered to not recovered and tingling sensation (paresthesia) from not recovered to recovering. The treatment given was captured as "yes" to all events except headache. The narrative was amended accordingly.
Age: 26.0
Sex: M
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 716587), concerns a 26-year-old, adult, male patient. The patient had no historical conditions (no medical problems as reported), current illness, and no known drug allergies. The patient was not taking any concomitant medications. On 03-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195213A and expiry date: not reported). On the same day (03-Oct-2017), after vaccination, the patient observed for 15 minutes for any adverse reactions. After 2 and half hour, the patient called the office and reported that at approximately an hour after vaccination, the patient developed severe left shoulder pain and difficulty in moving his arm. It was reported that it was a rare and potential reaction from the vaccine which was listed in VIS form. The patient recommended to apply an ice pack to the area and take ibuprofen for the discomfort. A follow-up phone call was attempted on the next day and no return call was received. No lab investigations were done. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Fatigue, Feeling hot, Palpitations, Somnolence
Clinical narrative: This spontaneous case, reported by other non-health professional (consumer) to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 716822), concerns a 59-year-old adult female patient. The patient had no historical condition and current illness. The patient had sulfamethoxazole allergy, seasonal allergy to grass, tree pollens and patient was allergic to dust, mold, cat, dog, raw apples, nectarines, Bing cherries and plums. The patient's concomitant medications included extra strength hair, skin and nails vitamins. On 05-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: injection (reported as SYR), anatomical location: left arm, batch number and expiry date: not reported]. On the same day, about 15 minutes after vaccination, the patient experienced heart racing and light-headedness, followed by warm rush through his body which felt like a dye was injected for a medical test. Heart racing lasted for about 10 minutes and light-headedness lasted for about an hour. As the patient was very tired in the evening, he slept 3 hours earlier than normal. On an unspecified date, the patient had made a physician office visit. Lab investigations were not performed. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site paraesthesia, Paraesthesia
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 716867), concerning a 23-year-old, adult, female patient. The patient's historical conditions included diabetes and hypothyroidism (on an unspecified date). The patient had no current illness and allergies. The patient did not receive any concomitant medications. On 17-Aug-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195213 and expiry date: not reported). On 03-Oct-2017, 47 days after vaccination, the patient experienced numbness and tingling in the right arm. Upon awakening, the numbness and tingling occurred throughout the entire right arm and then it only occurred in the upper right arm, sporadically throughout the day. It was reported that the patient had no numbness and tingling in the lower arm throughout the day. The patient was recommended to consult a doctor if the symptoms did not improve. No lab investigations were done. At the time of the report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Pain, Pyrexia
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 716873), concerns a 29-year-old, adult female patient. The patient was allergic to LEVAQUIN and sulfa drugs. On 29-Sep-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: arm, batch number: 195214 and expiry date: not reported]. On 01-Oct-2017, 2 days after vaccination, the patient experienced joint pain, fever and body aches. On an unspecified date, the patient made an emergency room visit. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 42.0
Sex: F
Vaccine: FLUC4, PPV, TDAP
Symptoms: Injection site erythema, Injection site warmth, Pyrexia, Vaccination site swelling
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 717909), concerns a 42-year-old, adult, female patient. The patient's historical condition included multiple sclerosis. The patient was allergic to unspecified NSAIDs. The patient's current illness and concomitant medications were unknown. On 04-Oct-2017, the patient was administered FLUCELVAX (QIVc) [dose: 0.5 ml, batch number: 195128, route of administration: intramuscular, anatomical location: right arm, expiry date: not reported]. The patient was also administered non-company suspect vaccine PNEUMOVAX [dose, route of administration: intramuscular, anatomical location: right arm, batch number: N000463, expiry date: not reported]. Both the vaccines (FLUCELVAX QIVc and PNEUMOVAX) were given in the same arm (right arm). The other non-company suspect vaccine administered was BOOSTRIX [route of administration: intramuscular, anatomical location: left arm, batch number: G9329, dose, expiry date: not reported]. On 05-Oct-2017, 1 day after vaccination, the patient complained that her right arm was red and swollen near flu and pneumonia vaccination site which was warm to touch in a ring about 4 inches in diameter. The patient also reported fever. On 07-Oct-2017 (Saturday), the patient presented to pharmacy with events. The patient was then sent to urgent care across the road. It was unsure if it was infection or an allergy, so prednisone and clindamycin was prescribed. The outcome of the events was not reported. The reporter assessed this case as non-serious. Update received on 26-Sep-2018: Non-significant case correction (IRD: 16-Aug-2018): The verbiage in the narrative was modified from "On 05-Oct-2017, 1 day after vaccination, the patient developed red and swollen arm which was warm to touch in a ring about 4 inches in diameter on the right arm where flu and pneumonia vaccine was administered" to "On 05-Oct-2017, 1 day after vaccination, the patient complained that her right arm was red and swollen near flu and pneumonia vaccination site which was warm to touch in a ring about 4 inches in diameter". The verbiage in the case comment was updated from "experienced the right arm redness, swelling, warmth and fever, 1 day after vaccination" to "experienced fever, injection site erythema, vaccination site swelling and warmth, 1 day after vaccination". Narrative and case comment were amended accordingly.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 718009), concerns a 30-year-old, adult, female patient. The patient had no known allergies. On 07-Oct-2017, the patient was administered FLUCELVAX (QIVc) [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195224, expiry date: not reported]. On the same day, during administration of the vaccine, the patient fainted and had regained consciousness quickly. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 60.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Headache, Malaise, Pain in extremity, Rash, Urticaria
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 07-Oct by Seqirus from VAERS (VAERS ID: 718023), concerns a 60-year-old, adult, female patient. The patient's historical drugs included Prednisone, Metronidazole, Leflunomide, PLAQUENIL, Gabapentin, DILAUDID, LYRICA and Oxycodone. The patient's current conditions included gastroesophageal reflux disease (GERD), psoriasis, rheumatoid arthritis, hypertension and hyperlipidemia (all of which were reported as medical history). The patient's concomitant medications included Lisinopril/HCTZ, Potassium, Naproxen, Pantoprazole, Methotrexate, Folic acid, Atorvastatin, NORCO, Vitamin D, Lysine and Salmon oil for unknown indications. On 03-Oct-2017, the patient was administered suspect vaccine FLUCELVAX QIVc [anatomical location: right arm, dose: 0.5 ml, batch number: 195210A, route of administration: intramuscular and expiry date: not reported] and non-company suspect vaccine PNEUMOVAX [route of administration: intramuscular, anatomical location: left arm, batch number: N020501, dose and expiry date: not reported]. On the same day, after vaccination, the patient developed soreness in arm. On 04-Oct-2017 (reported as Wednesday), the patient developed headache and malaise. On 06-Oct-2017 (reported as Friday morning), the patient developed rash and welt on her left arm which was 3 inches long and 2 inches wide. It was reported that the patient's headache and malaise had improved but that the rash was still present. Patient reported that she had full movement. At the time of this report, the patient had not recovered from the events, sore arm, rash and welt. However, the patient was recovering from the events, malaise and headache. The reporter assessed the case as non-serious Update 29-Aug-2018: Significant case correction was performed with IRD 16-Aug-2018: The event onset date for pain in extremity was changed from 04-Oct-2017 to 03-Oct-2017 and for rash onset date was changed from 03-Oct-2017 to 06-Oct-2017. The as determined causality of rash was changed from related to not related and of pain in arm was changed from related to unassessable. The case comment was modified to reflect the updated information. The narrative was amended accordingly.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Myalgia, Rash vesicular
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 718029), concerns a 55-year-old, adult, female patient. The patient had no current illness and was allergic to aspirin (since an unspecified date). On 28-Sep-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: right arm, batch number: 195212 and expiry date: not reported]. On 30-Sep-2017, 2 days after vaccination, the patient experienced severe muscle aches or pains and blister like rash on 5 different areas of the body. The patient was treated with BENADRYL. It was reported that, the patient would consult the physician (MD as reported), if the symptoms did not subside in a couple of days (reported as dates). At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious. Update 29-Aug-2018: Significant case correction was performed 16-Aug-2018: The determined causality of the event (blistery rash) was changed from 'related' to 'not related' and the case comment was amended accordingly.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood pressure increased, Burning sensation, Formication, Heart rate increased, Muscle spasms
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2017 by Seqirus from VAERS (VAERS ID: 718033), concerns a 31-year-old, adult, female patient. On an unspecified date, the patient administered TDAP vaccine (reported as TSaP) and developed severe swelling, increased heart rate and blood pressure. The patient's historical condition included osteoarthritis. The patient was allergic to penicillin, erythromycin, LEVAQUIN and azithromycin. The concomitant medications included CYRED for birth control. On 24-Sep-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195222 and expiry date: not reported). On the same day, 30 minutes post vaccination, the patient's arm was warm to touch and felt like a bad sunburn, which moved to the neck and down rest of the arm after 6 hours. The patient experienced ant crawling sensation over her arm and within 24 hours had the same feeling in other arm and neck. The patient was severely nauseous and experienced muscle spasm, high fever (101 degrees), weakness and burning sensation in the vaccinated arm. The patient's blood oxygen was 92 percent, blood pressure (BP) was 142/91 (increased in blood pressure) and heart rate was found to be 137 (units and normal values not reported). At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious. Update received on 29-Sep-2018: Significant case correction (IRD: 16-Aug-2018): The BP 142/91, blood oxygen 92 percent and heart rate 137 were coded as events. The narrative and case comment were corrected accordingly.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Muscular weakness, Nausea, Oxygen saturation decreased, Pain of skin, Pyrexia
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2017 by Seqirus from VAERS (VAERS ID: 718033), concerns a 31-year-old, adult, female patient. On an unspecified date, the patient administered TDAP vaccine (reported as TSaP) and developed severe swelling, increased heart rate and blood pressure. The patient's historical condition included osteoarthritis. The patient was allergic to penicillin, erythromycin, LEVAQUIN and azithromycin. The concomitant medications included CYRED for birth control. On 24-Sep-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195222 and expiry date: not reported). On the same day, 30 minutes post vaccination, the patient's arm was warm to touch and felt like a bad sunburn, which moved to the neck and down rest of the arm after 6 hours. The patient experienced ant crawling sensation over her arm and within 24 hours had the same feeling in other arm and neck. The patient was severely nauseous and experienced muscle spasm, high fever (101 degrees), weakness and burning sensation in the vaccinated arm. The patient's blood oxygen was 92 percent, blood pressure (BP) was 142/91 (increased in blood pressure) and heart rate was found to be 137 (units and normal values not reported). At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious. Update received on 29-Sep-2018: Significant case correction (IRD: 16-Aug-2018): The BP 142/91, blood oxygen 92 percent and heart rate 137 were coded as events. The narrative and case comment were corrected accordingly.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Skin warm
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2017 by Seqirus from VAERS (VAERS ID: 718033), concerns a 31-year-old, adult, female patient. On an unspecified date, the patient administered TDAP vaccine (reported as TSaP) and developed severe swelling, increased heart rate and blood pressure. The patient's historical condition included osteoarthritis. The patient was allergic to penicillin, erythromycin, LEVAQUIN and azithromycin. The concomitant medications included CYRED for birth control. On 24-Sep-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195222 and expiry date: not reported). On the same day, 30 minutes post vaccination, the patient's arm was warm to touch and felt like a bad sunburn, which moved to the neck and down rest of the arm after 6 hours. The patient experienced ant crawling sensation over her arm and within 24 hours had the same feeling in other arm and neck. The patient was severely nauseous and experienced muscle spasm, high fever (101 degrees), weakness and burning sensation in the vaccinated arm. The patient's blood oxygen was 92 percent, blood pressure (BP) was 142/91 (increased in blood pressure) and heart rate was found to be 137 (units and normal values not reported). At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious. Update received on 29-Sep-2018: Significant case correction (IRD: 16-Aug-2018): The BP 142/91, blood oxygen 92 percent and heart rate 137 were coded as events. The narrative and case comment were corrected accordingly.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 718090), concerns a 25-year-old, adult, female patient. On 04-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: injection (reported as SYR), batch number: 195212, anatomical location: left arm and expiry date: not reported]. On the same day, immediately after vaccination, the patient developed numbness in the left arm. The patient had made an office visit. At the time of this report, the outcome of the event was unknown. The reporter assessed the case as non-serious. Update on 29-Aug-2018: Significant case correction was performed with IRD 16-Aug-2018. The event numbness of upper arm was mapped as a symptom of the event immediate post-injection reaction. Case comment was amended accordingly.