chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Kawasaki's disease
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (Agency# 714549). This spontaneous report as received from a regulatory authority refers to a 16-year old male patient. The patient had no concurrent conditions. The patient's medical history included Type 1 diabetes. The patient's medical history and concomitant medications were not reported. On 14-SEP-2017, the patient was vaccinated with GARDASIL 9 and influenza vaccine intramuscularly (Lot#, dose and expiry date were unknown) for prophylaxis. Other suspect therapy included FLUARIX QUADRIVALENT (strength, dose, lot # and expiry date were not reported) via intramuscular route for prophylaxis. On 21-SEP-2017, the patient experienced kawasaki's disease. On an unknown date, the patient was hospitalized due to Kawasaki's disease. The outcome of kawasaki's disease was unknown. Causality for the event was not reported. Follow up information was received from a health care professional via FDA on 05-NOV-2018. This case referred to a 16-year old male patient. The facility details where the vaccines were administered was updated. Follow up has been received on 18-JAN-2019. It has been determined that case # US-009507513-1811USA004008 is a duplicate of case # US-009507513-1712USA013027. Therefore, case # US-009507513-1811USA004008 is being deleted from our files and the cases are consolidated into case # US-009507513-1712USA013027.
Age: 44.0
Sex: M
Vaccine: FLUC4, HEP
Symptoms: Rash generalised
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: 715083), concerns a 44-year-old, adult, male patient. The patient's relevant medical history, allergies and concomitant medications were not reported. On 25-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (reported as, unknown), route of administration, anatomical location, batch number, expiry date: not reported). On 26-Aug-2017, the next day of vaccination, the patient experienced rashes all over the body. The patient took BENADRYL, but event was not resolved. Then, the patient took MEDROL dose pack. Rash improved a bit, but again worsened. At the time of this report, the patient had not recovered from the event. The reporter assessed this case as non-serious.
Age: 69.0
Sex: M
Vaccine: FLUC4
Symptoms: Urticaria
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: 715316), concerns a 69-year-old, elderly, male patient.  The patient's medical history and the concomitant medications were not reported. On 26-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: 195224 and expiry date: not reported. On 28-Sep-2017, after 2 days of vaccination, the patient experienced raised hives from waist to the down. Lab investigations were not reported. At the time of the report, the outcome of the event (hives) was unknown. The reporter assessed the case as non-serious.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Dyspnoea, Dysstasia, Flushing, Immediate post-injection reaction
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: 715417), concerns a 36-year-old, adult female patient. The patient was allergic to green peas and morphine. The concomitant medications included, B12 injections, ENSKYCE birth control pills. The patient neither had any chronic illness nor took any other vaccines. On 29-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (1 dose), route of administration: intramuscular, anatomical location: right arm, batch number: 195226, expiry date: not reported). On the same day after vaccination (within 1 to 2 minutes), the patient experienced flushing, nausea, dizziness, shortness of breath and difficulty in standing or sitting up. These reactions were considered as immediate post-injection reaction. The patient was treated with ZOFRAN 4 mg SL and BENADRYL 25 mg. EPIPEN was not used even though, the drug was available and the EMTs (emergency medical technicians) were alerted. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Nausea, Posture abnormal
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: 715417), concerns a 36-year-old, adult female patient. The patient was allergic to green peas and morphine. The concomitant medications included, B12 injections, ENSKYCE birth control pills. The patient neither had any chronic illness nor took any other vaccines. On 29-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (1 dose), route of administration: intramuscular, anatomical location: right arm, batch number: 195226, expiry date: not reported). On the same day after vaccination (within 1 to 2 minutes), the patient experienced flushing, nausea, dizziness, shortness of breath and difficulty in standing or sitting up. These reactions were considered as immediate post-injection reaction. The patient was treated with ZOFRAN 4 mg SL and BENADRYL 25 mg. EPIPEN was not used even though, the drug was available and the EMTs (emergency medical technicians) were alerted. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Disorientation, Hypoaesthesia, Pain, Palpitations, Paraesthesia
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: 715704), concerns a 35-year-old, adult female patient. The patient's historical conditions included polycystic ovary (PCO) and historical procedure included surgery for endometriosis (on an unspecified date in May-2017). The patient never a reaction to flu shot in the past. The patient was allergic to pollen and codeine. The concomitant medications included LOESTRIN, PROZAC, CLARITIN and Probiotics. On 28-Sep-2017, around 03:00 pm, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195212 and expiry date: not reported). On the same day, after vaccination, around 9:00 pm the patient experienced heart racing, tingling and numbness in the entire left side of the body. The patient also developed extreme soreness and she was very disoriented. The patient had no fever, nausea or vomiting and was able to sleep off as her husband kept an eye on her. No lab tests were done. By 09:00 am that morning (on an unspecified date) the patient felt fine and had no side effects at all. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Rash generalised
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: 715738), concerns a 24-year-old, adult female patient. The patient had no known historical conditions or allergies (NKA). The patient's current condition included contact dermatitis (since an unspecified date). The patient's concomitant medications included prednisone and desonide. On 26-Sep-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: arm, batch number: 195210A and expiry date: not reported). On 27-Sep-2017 (reported as Wednesday), 01 day after vaccination, the patient felt itchy, which continued for the next day (reported as Thursday). On 29-Sep-2017 (reported as Friday), 03 days after vaccination, the patient developed a full body rash. On an unspecified date, the patient went to the clinic and was prescribed with Hydroxyzine 50 mg and MEDROL Dosepak. The patient's lab data was unknown. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Joint range of motion decreased, Limb discomfort, Musculoskeletal pain, Product administered at inappropriate site
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: 715801), concerns a 32-year-old, adult female patient. The patient's historical drug included Z-PAK and MEDROL (reported as on 22-Aug-2017). The patient had no current illnesses and allergies. The patient did not receive any concomitant medications. On 17-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: 195214, expiry date: not reported), and the injection seemed higher than the normal. On the same day (17-Sep-2017) after vaccination, the patient experienced heaviness and pain in shoulder area. In addition, the limited range of motion and pain in shoulder increased over the last 2 weeks. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site swelling
Clinical narrative: This is spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 715886), concerns a 61-year-old, elderly female patient. The patient's had no current conditions and concomitant medications were not reported. On 25-Sep-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5ml [4 as reported], route of administration: subcutaneous, anatomical location: left arm, batch number: 195215). On the same day, after vaccination, the patient experienced swelling from elbow to shoulder at the injection site. The patient had recovered from event (injection site swelling). The case was assessed as non-serious.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Vaccination site 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: 715980), concerns a 57-year-old, adult female patient. The patient's historical conditions included, gastroesophageal reflux disease (GERD) and dyslipidaemia. The patient's current conditions included, arthritis and penicillin allergy. The patient denied any current illnesses. However, the patient's medication at the time of vaccination included, Glucosamine chondroitin for an unknown indication. On 29-Sep-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency: 1, route of administration: intramuscular location: left arm, batch number: 195128, expiry date: not reported). On 01-Oct-2017, 2 days after vaccination, the patient developed erythema of area 4 cm x 5 cm, in her left deltoid, at the vaccination site. The erythematous area was non-indurated and non-tender to palpation. It was reported that the patient made an physician office visit. At the time of this report, the patient had recovered from the event. The reporter assessed this case as non-serious.
Age: 8.0
Sex: M
Vaccine: FLUC4
Symptoms: 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: 716265), concerns an 8-year-old, male child patient. The patient's historical condition, allergies, current illness and concomitant medications were unknown. On 26-Sep-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: 195225A, expiry date: not reported). On 28-Sep-2017, 2 days after vaccination, the patient developed redness from his shoulder to elbow. On the same day, the patient had made a physician office visit and was seen by a physician. The patient's lab data was unknown. At the time of this report, the outcome of the event was unknown. The reporter assessed this case as non-serious.
Age: 35.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site swelling
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: 716823), concerns a 35-year-old, adult, male patient. On 27-Sep-2017, the patient was administered FLUCELVAX QIVC [dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, batch number: 195124 (reported as 196124), anatomical location: left arm and expiry date: not reported]. On 28-Sep-2017, 1 day after vaccination, the patient developed soreness and swelling around injection site. The patient was recommended to use cold compress and take BENADRYL as directed. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious. Update on 29-Aug-2018: Non-significant case correction was performed with IRD 16-Aug-2018: Case comment was amended.
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache
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: 718002), concerning a 22-year-old, adult, female patient. The patient's historical condition included Meniere's disease. It was reported that the patient had no history of severe headaches. The patient was allergic to penicillin. The patient's concomitant medication included SPRINTEC. On 05-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: 195222 and expiry date: not reported]. On the same day, after vaccination, the patient experienced severe headache in the right side of posterior side of head, and felt it was moving to other areas. The patient had no vision loss, vertigo and nausea. On an unspecified date, the patient made an office visit. At the time of the report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 64.0
Sex: M
Vaccine: FLUC4
Symptoms: Pruritus, Rash generalised, 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: 718170), concerns a 64-year-old, adult male patient. The patient did not have any medical history, allergies, current illness, and concomitant medications. On 04-Oct-2017, the patient was administered FLUCELVAX QIVc [route of administration: not reported, dose: 0.5 ml, batch number: 195218, anatomical location and expiry date: not reported]. On 05-Oct-2017 (reported as within 24 hours), after the vaccination, the patient experienced generalized rash and hives with no respiratory complications. The patient had a scheduled dermatology appointment and they were to call in a cortisone cream but did not. On an unspecified date in Oct-2017 (reported as today), the patient visited to the clinic with intense itching. The patient declined the biopsy which was advised by the dermatologist. The reporter informed that, the patient was kept on prednisone at the dose of 60 mg for 4 days and an unspecified anti-itching medication. At the time of this report, the outcome of the events was not resolved. The reporter assessed the case as non-serious. Update 29-Aug-2018: Significant case correction was performed with IRD 16-Aug-2018: The onset date of event pruritus was changed from 05-Oct-2017 to Oct-2017. The case comment was corrected.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Myalgia
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: 718198), concerns a 59-year-old, adult female patient. The patient's medical history, current illness, allergies and concomitant medications were unknown. On 20-Sep-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: injection (reported as SYR), anatomical location: left arm, batch number: 195225A, and expiry date: not reported). On the same day (20-Sep-2017), after vaccination, the patient experienced muscle aches, soreness and tenderness at the injection site. As of 09-Oct-2017, the patient had not visited the physician. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 65.0
Sex: M
Vaccine: FLUC4
Symptoms: Myalgia
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: 718204), concerns a 65-year-old, elderly, male patient. The patient's medical history, current illness, allergies and concomitant medications were unknown. On 20-Sep-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: injection (reported as SYR), anatomical location: left arm, batch number: 195225A and expiry date: not reported]. On the same day, after vaccination, patient had soreness and tenderness in the muscles. It was reported that as of 10-Oct-2017, the patient had not went to the doctor. At the time of this report, the patient had not recovered from the event. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUX, FLUC4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This non-serious spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 719522), concerns an adult female patient of unspecified age. On an unspecified date in 2016, the patient was administered influenza vaccine (dose, anatomical location, batch number, route of administration, expiry date, trade name, manufacturer: not reported). On an unspecified date in 2016, after vaccination, the patient developed redness and swelling at injection site. At the time of this report, the outcome of the events was not reported. This case was cross linked to case 201803418 due to same patient.
Sex: F
Vaccine: FLUX, FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: This non-serious spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 719522), concerns an adult female patient of unspecified age. On an unspecified date in 2016, the patient was administered influenza vaccine (dose, anatomical location, batch number, route of administration, expiry date, trade name, manufacturer: not reported). On an unspecified date in 2016, after vaccination, the patient developed redness and swelling at injection site. At the time of this report, the outcome of the events was not reported. This case was cross linked to case 201803418 due to same patient.
Sex: F
Vaccine: FLUX, FLUC4
Symptoms: Rash, Skin lesion, Vaccination site pain
Clinical narrative: This non-serious spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 719522), concerns an adult female patient of unspecified age. On an unspecified date in 2016, the patient was administered influenza vaccine (dose, anatomical location, batch number, route of administration, expiry date, trade name, manufacturer: not reported). On an unspecified date in 2016, after vaccination, the patient developed redness and swelling at injection site. At the time of this report, the outcome of the events was not reported. This case was cross linked to case 201803418 due to same patient.
Age: 18.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
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: 719652), concerns an 18-year-old, adult female patient. The patient has no historical condition, current illness, allergies and concomitant medications. On 09-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195213A and expiry date: not reported]. On 10-Oct-2017, 1 day after vaccination, the patient's right deltoid area became red, swollen slightly and hard at the injection site. It was reported that the patient went to emergency room and prescribed with prednisone, BENADRYL for five days and was asked to return if the events worsen. At the time of this report, the outcome of the events was not recovered. The reporter assessed the events as non-serious.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash
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: 719720), concerns a 40-year-old, adult female patient. The patient was allergic to iodine. The patient did not receive any concomitant medications. On 01-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: 195214 and expiry date: not reported). On 29-Sep-2017, 28 days after vaccination, the patient experienced systemic rash on her stomach and arms. On an unspecified date, the patient made an emergency room visit. It was reported that, the patient's husband was a registered pharmacist (RPH) who reported the aforementioned information to VAERS. On an unspecified date, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 6.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
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: 719777), concerns a 06-year-old, female child patient. The patient's historical condition included asthma (as toddler) and had no other issues during last 4 years. The patient had no current illness and no known drug allergy. The patient did not receive any concomitant medication. On 10-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, anatomical location: right leg, batch number and expiry date: not reported). On 11-Oct-2017, 1 day after vaccination, the patient developed large local reaction (measured 9 cm wide and 8.5 cm long, circular area) with redness, slight swelling, bruising and warmth at the injection site (slightly above center of circle). There was no decrease in function of the affected limb, no breathing issues and no anaphylaxis or other symptoms. On an unknown date, the patient visited office. The patient's symptoms started to resolve 48 hrs after injection. At the time of this report, the patient was recovering from the events. The reporter assessed the case as non-serious. Update on 29-AUG-2018: Significant case correction was performed with IRD 16-AUG-2018. All the events were mapped as the symptoms of the event local reaction. Update received on 26-Sep-2018: Non-significant case correction (IRD: 16-Aug-2018): The onset latency was corrected from 'same day after vaccination' to '1 day after vaccination' in narrative and case comment.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injection site pruritus
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: 720277), concerns a 27-year-old, adult female patient. The patient's concomitant medications included Amphetamine salts, Levothyroxine and Tri-Estarylla for unknown indications. On 06-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: arm, batch number and expiry date: not reported). On the same day, immediately after vaccination, the patient began to be very itchy at the administration site and itchiness continued for at least a week. At the time of this report, the patient had not recovered from the event. The reporter assessed the case as non-serious.
Age: 51.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injection site erythema
Clinical narrative: This is spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 720353), concerns a 51-year-old, adult female patient. The patient had no medical history, current illness and allergies. The patient's concomitant medications were unknown. On 05-Oct-2017, the patient administered FLUCELVAX QIVc [dose: 0.5ml (frequency reported 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195233 and expiry date: not reported) and administered non-company suspect product ZOSTAVAX [dose: (frequency reported 1), route of administration: subcutaneous, anatomical location: right arm, batch number: N020852 and expiry date: not reported]. On 08-Oct-2017, 2 days after vaccination, the patient developed a red area around the injection site (without a rash). The patient was told to mark the area and apply ice on it. On 15-Oct-2017, it was reported that the red area was spread larger beyond the marked area with a 4 1/2 inch long and 2 1/2 inch wide. The patient was advised to apply ice again and to be in contact with a doctor. No lab investigations were done. At the time of this report, the patient had not recovered from the event. The reporter assessed the case as non-serious. Update on 29-AUG-2018: Significant case correction was performed 16-AUG-2018. The determined causality of the event was changed from related to unassessable and case comment was amended accordingly.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Pain, Pain in extremity
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: 720430), concerns a 53-year-old, adult, female patient. The patient's current condition included blood pressure and was taking medications for the blood pressure. On 12-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 the same day, after vaccination, it was reported that the patient had no issues in the morning but developed the pain in left arm started at around 05:00 PM. The patient was unable to have a full range of motion without pain. The patient had a warm compress at last night and the pain was appeared to be improved since last night. At the time of this report, the outcome of the events (pain and pain extremity) was recovering and the event (mobility decreased) was not reported. The reporter assessed this case as non-serious.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Rash
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: 720433), concerns a 63-year-old, adult female patient. The patient was allergic to latex and VALIUM. On 09-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: 195225A, expiry date: not reported). On the same day (09-Oct-2017) after vaccination, the patient noticed bumps, itching started on left arm, left upper chest and face. Hence, the patient decided to visit emergency room. At the time of this report, the outcome of the events was not reported. The reporter assessed the events as non-serious. Update on 29-Aug-2018: Non-significant case correction was performed with IRD 16-Aug-2018: Case comment was amended.
Age: 55.0
Sex: F
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: 720434), concerns a 55-year-old, adult female patient. On 06-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 the same day, after vaccination, the patient experienced pain at injection site and limited range of motion in that arm. On an unspecified date, the patient made a physician office visit. At the time of this report, the outcome of the events was not reported. The reporter assessed the case as non-serious.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Joint range of motion decreased, Pain in extremity, Paraesthesia
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: 723926), concerns a 26-year-old, adult female patient. On 06-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 the same day (06-Oct-2017), after vaccination, the patient experienced immediate pain in vaccinated arm with numbness and tingling to same hand and fingers. The patient developed extreme limitation with range of motion. On an unspecified date, the patient made an office visit. At the time of this report, the outcome of the events was not reported. The reporter assessed the case as non-serious.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Diarrhoea, Headache, Pain, Pyrexia, Vomiting
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: 720521), concerns a 49-year-old, adult female patient. On 05-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195241, expiry date: not reported). Within 24 hours of vaccination, the patient developed body aches, headache, vomiting, diarrhea and low-grade fever which lasted for two days (recovered). The reporter assessed the case as non-serious.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Dreamy state, Dysphagia, Lethargy, Pharyngeal oedema
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: 720567), concerns a 58-year-old, adult female patient. The patient's current condition included anxiety (reported as medical history). The patient had no current illness and the patient was allergic to egg. The concomitant medications included alendronate, buspirone, diazepam and doxepin. On 12-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: 195242 and expiry date: not reported]. On 13-Oct-2017, 1 day after vaccination, the patient felt like in a dream state and dizziness. It was reported that the patient felt that she was dreaming in the midnight that her throat was swollen but that her husband informed her that she was actually awake. The patient was unable to get off her couch for 3 days. The patient also felt very dizzy and unable to swallow. No lab investigations were done. On an unspecified date, the patient had recovered from the events. The reporter assessed the case as non-serious. Update 29-Aug-2018: Non-significant case correction performed 16-Aug-2018: A part of the case comment was modified from "experienced swollen throat, lethargy, unable to swallow and dreamy state" to "experienced swollen throat in a dreamy state, lethargy, and inability to swallow".
Age: 42.0
Sex: M
Vaccine: FLUC4
Symptoms: Chills, Fatigue, Headache, 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: 720632), concerns a 42-year-old, adult, male patient. On an unspecified date in 2017 (8 months ago as reported), the patient received Meningitis vaccine and Hepatitis A vaccine and developed chills, fever, fatigue, headaches, aches and pains, 48 hours after vaccination. The patient had no current illness and allergies. The patient's concomitant medications included FLONASE and Multivitamin. On 16-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 4), route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported]. On the same day (16-Oct-2017), few hours after vaccination, the patient developed chills, extreme fever, extreme fatigue, headaches, body aches and pains. The symptoms began within few hours of vaccination and peaked overnight. It was reported that the symptoms were still persisting, but they improved from overnight. The patient had no lab data. At the time of this report, the outcome of the events was recovering. The reporter assessed the case as non-serious.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Erythema, Injection site bruising, Injection site mass, Injection site pain
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: 720646), concerns a 50-year-old, adult female patient. The Patient's historical condition included: ERB's palsy in her left arm and soreness with lump at the injection site. The Patient's concomitant medications included: B12 vitamin, citalopram hydrobromide, zolpidem tartrate, hydrocodone/Paracetamol. On 22-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, expiry date was not reported). On an unknown date in Sep-2017, the patient experienced soreness with lump at injection site in right deltoid over next 2 days. On 11-Oct-2017, the lump at injection site was still present. On 16-Oct-2017, the bruise at injection site was still present. On an unspecified date in 2017, the patient also experienced redness and discomfort in knee joints. It was reported that the patient visited emergency room and office. On 16-Oct-2017, all the events were reported through employee's worker's comp claim for direction to medical. At the time of this report, the outcome of the events was not recovered. The reporter assessed this case as non-serious. Update received on 27-Sep-2018: Non-significant case correction (IRD 16-Aug-2018): The verbiage of the narrative was updated from 'On 11-Oct-2017, the patient's lump was not going away. As of 16-Oct-2017, the patient's bruising which was ongoing' to 'On 11-Oct-2017, the lump at injection site was still present. On 16-Oct-2017, the bruise at injection site was still present'. The narrative was amended accordingly.
Age: 49.0
Sex: M
Vaccine: FLUC4
Symptoms: Oral pruritus, Pruritus, Pruritus generalised, Tongue pruritus
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: 720689), concerns a 49-year-old, adult male patient. The patient's current condition chronic back pain (reported as medical history) and was allergic to penicillin (since an unspecified date). Concomitant medication included ibuprofen (as needed). On 13-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as unknown, route of administration, anatomical location, batch number and expiry date: not reported). On the same day (13-Oct-2017), after vaccination, the patient developed generalised pruritus without a rash, which was more predominant in the perioral area, tongue, palate and on hands. No lab investigations were done. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 62.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injection site erythema, Injection 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: 720751), concerns a 62-year-old, adult female patient. The patient had no allergies. On 07-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195213 and expiry date: not reported) and non-company co-suspect product ZOSTAVAX (route of administration: subcutaneous, anatomical location: right arm, batch number: N021171, dose: unknown and expiry date: not reported). On 08-Oct-2017, 1 day after vaccination, the patient experienced redness and swelling on the right arm, at injection site of ZOSTAVAX. The patient had been icing the injection site and received oral BENADRYL since then. It was reported that, the sign and symptoms had improved tremendously. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Pityriasis rosea, Rash
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: 720759), concerns a 35-year-old, adult female patient. The patient had no historical condition. Current condition was pre-diabetes. The patient had no allergies. The patient did not receive any concomitant medication. On 05-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, anatomical location: left arm, batch number: 195215 (reported as 19215), route of administration and expiry date: not reported). The Seqirus confirmed that, the reported batch number: 19215 was mapped to batch number: 195215. On 07-Oct-2017, 2 days after vaccination, the patient developed rash and pityriasis rosea. On an unspecified date, the patient made an emergency room visit. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the case as non-serious.
Age: 46.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Lymph gland infection, Wrong technique in product usage process
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: 720775), concerns a 46-year-old, adult female patient. The patient's current conditions included asthma, hypothyroidism, post-menopause. The patient was allergic to penicillin and sulfa drugs. On 25-Sep-2017, the patient was administered suspect vaccine FLUCELVAX QIVc [dose: 0.5ml (frequency: unknown), route of administration: intramuscular, anatomical location: left arm, batch number: 195214] and non-company suspect vaccine BOOSTRIX [route of administration: intramuscular, anatomical location: left arm, batch number: 7Y292 (as reported) and dose: unknown]. On 16-Oct-2017, 21 days after vaccination, the patient developed lymph node infection. The patient believed it to be due to the wrong administration technique. The patient was treated with Z-PAK on the same day and believed it to be helping. At the time of report, the patient had recovered from the event, lymph node infection. The reporter assessed the case as non-serious. Update 29-Aug-2018: Significant case correction performed 16-Aug-2018: The company causality for the event lymph node infection was changed from 'related' to 'not related'. No changes were made in the narrative.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash
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: 720968 and 720943), concerns a 46-year-old, adult, female patient. On an unspecified date, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, batch number: 195129, anatomical location: unknown and expiry date: not reported). On 29-Sep-2017, after vaccination, the patient developed rash. At the time of this report, the outcome of the event was not reported. The reporter assessed the case as non-serious.
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
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: 721049), concerns a 28-year-old, adult female patient. The patient had fainted after receiving HPV vaccine of dose: 1 at the age of 21 years in the past. The patient had seasonal allergies and was allergic to sulphonamide antibiotics (reported as sulfa allergy). On 12-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as 5, route of administration: intramuscular, anatomical location: left arm, batch number: 195128 and expiry date: not reported). On the same day (12-Oct-2017), after vaccination, the patient experienced hives on torso, arms and neck. The patient had no relevant lab data. On an unspecified date, the patient had recovered from the event. The reporter assessed the case as non-serious.
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection 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: 721143), concerns a 22-year-old, adult female patient. The patient had no relevant medical history. The patient was allergic to strawberries and pollen. Concomitant medication included birth control (as reported). On 15-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: 195231 and expiry date: not reported). On 16-Oct-2017, one day after vaccination, the patient experienced redness, tenderness and swelling around the injection site. The patient did not receive any treatment medication. It was reported that, the patient visited office. On an unspecified date, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Pain in extremity
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: 721158), concerns a 63-year-old, adult female patient. The patient's historical condition, current condition and concomitant medications were not reported. The patient had no known allergies (NKA). On 17-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: arm, batch number: 195224 and expiry date: not reported). On the same day (17-Oct-2017), after vaccination, the patient experienced pain in hand and wrist. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAES ID: 721177), concerns a 45-year-old, adult, female patient. The patient had no current illness. On 10-Oct-2017, at 11:40 AM, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195230 and expiry date: not reported]. On the same day, one hour after vaccination (at 12:40 PM), the patient started to feel tightness in her throat and difficulty in breathing. The patient had made an emergency room and physician office visit and received respiratory treatments for the events. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema
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: 721232), concerns a 58-year-old, adult male patient. On 16-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 and expiry date: not reported). On 18-Oct-2017, 2 days after vaccination, the patient developed a large reddened area at the site of injection. At the time of this report, the outcome of the event was unknown. The reporter assessed the case as non-serious. Update 29-Aug-2018: Non-significant case correction was performed with IRD 16-Aug-2018: The rationale of causality was changed from "The causality assessed as related due site-specific occurrence of the event (injection site erythema)" to "The company causality has been assessed as related due to plausible temporal relationship between vaccination and reported event" in case comment.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injection site discolouration, Injection site haemorrhage, Injection site reaction, Injection 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: 721298), concerns a 62-year-old, adult female patient. The patient had no relevant medical history and current illness. The patient did not receive any concomitant medications. On 15-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as unknown, anatomical location: left arm, batch number: 195215, route of administration: unknown, expiry date: not reported). It was reported that, during administration of vaccine the needle touched the bone (bone injury). Hence, the needle was slightly pulled back, injection was finished, and needle was finally pulled out. Immediately, the patient experienced bleeding. One cotton ball was placed which stopped the bleeding. Immediate swelling and discoloration were noted which looked like a pool of blood under the skin. At the time of this report, the outcome of the events was not reported. The reporter assessed the case as non-serious.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Skeletal injury
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: 721298), concerns a 62-year-old, adult female patient. The patient had no relevant medical history and current illness. The patient did not receive any concomitant medications. On 15-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as unknown, anatomical location: left arm, batch number: 195215, route of administration: unknown, expiry date: not reported). It was reported that, during administration of vaccine the needle touched the bone (bone injury). Hence, the needle was slightly pulled back, injection was finished, and needle was finally pulled out. Immediately, the patient experienced bleeding. One cotton ball was placed which stopped the bleeding. Immediate swelling and discoloration were noted which looked like a pool of blood under the skin. At the time of this report, the outcome of the events was not reported. The reporter assessed the case as non-serious.