chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Pain in extremity, Peripheral 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: 720331), concerns a 60-year-old, adult male patient. On 11-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: 195238, expiry date: not reported) and non-company suspect product PNEUMOVAX (dose: frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: N013541, expiry date: not reported). On the same day, after vaccination, the patient experienced very swollen and sore arm. On an unspecified date, the patient had made a physician office visit. At the time of report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Dermatitis, Erythema, Inflammation, Pruritus, 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: 720341), concerns a 59-year-old, adult, female patient. On an unspecified date in 2016, the patient received FLUBLOK for unknown indication and developed a rash which was not severe. The patient was allergic to antibiotics and latex. The patient's concomitant medication included ZOCOR. On 27-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: 195226 and expiry date: not reported]. On 07-Oct-2017, 10 days after vaccination, the patient developed severe rash on the left arm and left leg. The patient also experienced red and itchy skin with slight inflammation. 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: Erythema, rash and pruritus were mapped as symptoms of dermatitis.
Age: 68.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Peripheral swelling, Skin warm
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: 720344), concerning a 68-year-old, elderly, female patient. The patient's concurrent condition included diabetes (reported as medical history). And the patient was allergic to penicillin and morphine (since an unspecified date). The patient had no current illness at the time of vaccination. The patient's concomitant medications included metformin, simvastatin, hydrocodone APAP and phentermine. On 05-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195238 and expiry date: not reported) and non-company suspect product PNEUMOVAX (route of administration: intramuscular, anatomical location: left arm, batch number: N013521, dose and expiry date: not reported). On the same day (05-Oct-2017), about 3 hours after the vaccination, the patient's arm became hot and was swollen from elbow to shoulder. The patient applied ice and was treated with oral antihistamines. It was reported that the swelling lasted for the next day but was improving in the morning. On 06-Oct-2017 (second day as reported), the patient's arm became normal. At the time of the report, the patient had recovered from the events. The reporter assessed the case as non-serious. Update received on 29-Aug-2018: Significant case correction was performed with IRD 16-Aug-2018: The phrase "causality of the events' has been changed to 'causality of the events: skin warm and peripheral swelling' in the case comment. Upon internal review it was realized that, listedness was wrong for the event peripheral swelling. Hence, the listedness of the event peripheral swelling was changed from unlisted to listed.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Malaise, Neck 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: 720347), concerns a 50-year-old, adult female patient. The patient's medical history included high blood pressure. The patient had no current condition. The patient was allergic to quinones. 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: 195224 and expiry date: not reported). On 13-Oct-2017, one day after vaccination, the patient experienced soreness in arm, neck pain, fever [it was confirmed that the patient had no fever, upon consulting doctor (MD)] and was sick. On 15-Oct-2017, the patient went to the pharmacy to pick up some antiviral to treat the unspecified cause that was found during the walk-in. 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: M
Vaccine: FLUC4
Symptoms: Injection site bruising, Injection site discolouration, Swelling, Tenderness, Vaccination 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: 720352), concerns a 56-year-old, adult male patient. On 01-Aug-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml [frequency: 1], route of administration: intramuscular, anatomical location: left arm, batch number: 195214, expiry date: not reported). On the same day (01-Aug-2017) after vaccination, the patient developed swelling and tenderness. By 02-Aug-2017 (reported as, the day after the vaccination), the vaccinated site became extremely swollen and tender to touch which persisted for over a week. The swelling began to resolve by the second day and it seemed to have recovered by the end of the week. However, it was still reported to be a little sore. On an unspecified date in Aug-2017, about 3 weeks after vaccination, the patient developed bruising (which did not hurt unless poked) in the area that was dark purple, yellow, and greenish in colour and it seemed to have spread over the entire deltoid area where the vaccine was administered. 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: M
Vaccine: FLUC4
Symptoms: Vaccination 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: 720352), concerns a 56-year-old, adult male patient. On 01-Aug-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml [frequency: 1], route of administration: intramuscular, anatomical location: left arm, batch number: 195214, expiry date: not reported). On the same day (01-Aug-2017) after vaccination, the patient developed swelling and tenderness. By 02-Aug-2017 (reported as, the day after the vaccination), the vaccinated site became extremely swollen and tender to touch which persisted for over a week. The swelling began to resolve by the second day and it seemed to have recovered by the end of the week. However, it was still reported to be a little sore. On an unspecified date in Aug-2017, about 3 weeks after vaccination, the patient developed bruising (which did not hurt unless poked) in the area that was dark purple, yellow, and greenish in colour and it seemed to have spread over the entire deltoid area where the vaccine was administered. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, 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: 720426), concerns a 59-year-old, adult female patient.  The patient had no current illness. The patient was allergic to beta-dime (as reported). 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: 195218 and expiry date: not reported]. On 13-Oct-2017, 1 day after vaccination, the patient experienced injection site red, hard and warm to touch. The patient was treated with warm compresses, ice packs and BENADRYL. The patient also developed injection site itching (reported as which might occur). It was reported that, the patient had a visual examination. 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: Significant case correction was performed 16-Aug-2018: The current condition beta-dime allergy was deleted from the patient tab and mentioned in the narrative.
Age: 15.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Hypersensitivity, Peripheral swelling, Skin warm, Throat tightness
Clinical narrative: This spontaneous case, reported by other non healthcare professional (mother) to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 720477), concerns a 15-year-old, adolescent, female patient. The patient did not have any current illnesses or history/allergies. The patient was not taking any medications at the time of vaccination. On 13-Oct-2017 (reported to as 'Friday') at approximately 1:45 p.m., 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 the same day (13-Oct-2017), after administration of vaccine (reported as 'just before 2 pm'), the patient developed hives all over her left arm with, the left arm and left leg both having become red and hot to the touch, and the arm was swollen as well. When it was reported to the school staff that the patient experienced throat tightness, she was administered an EPIPEN before the emergency medical services (EMS) was called immediately thereafter. With the permission patient's mother (reporter), the school nurse gave the patient BENADRYL with a dose of 25 mg. As the paramedics advised to either take the patient to a hospital or to a doctor, she was taken directly from school to her pediatrician. Since the patient's paediatrician was concerned that the allergic reaction could resume when the EPIPEN wore off, she was directed to a hospital. The patient's paediatrician consulted another paediatrician and also an allergies who thought it was the preservative in the flu shot that the patient had most likely reacted to, and all three doctors advised them to stay in the office until they closed, so that the patient's condition while the EPIPEN wore off could be monitored by a physician. The patient was advised to continue with BENADRYL and was also prescribed Prednisone for three days, along with additional EPIPENS in case the reaction would resume. The paediatrician informed the patient's mother that the patient could never be administered a flu shot again. The patient did not undergo any laboratory investigations. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 15.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: This spontaneous case, reported by other non healthcare professional (mother) to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 720477), concerns a 15-year-old, adolescent, female patient. The patient did not have any current illnesses or history/allergies. The patient was not taking any medications at the time of vaccination. On 13-Oct-2017 (reported to as 'Friday') at approximately 1:45 p.m., 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 the same day (13-Oct-2017), after administration of vaccine (reported as 'just before 2 pm'), the patient developed hives all over her left arm with, the left arm and left leg both having become red and hot to the touch, and the arm was swollen as well. When it was reported to the school staff that the patient experienced throat tightness, she was administered an EPIPEN before the emergency medical services (EMS) was called immediately thereafter. With the permission patient's mother (reporter), the school nurse gave the patient BENADRYL with a dose of 25 mg. As the paramedics advised to either take the patient to a hospital or to a doctor, she was taken directly from school to her pediatrician. Since the patient's paediatrician was concerned that the allergic reaction could resume when the EPIPEN wore off, she was directed to a hospital. The patient's paediatrician consulted another paediatrician and also an allergies who thought it was the preservative in the flu shot that the patient had most likely reacted to, and all three doctors advised them to stay in the office until they closed, so that the patient's condition while the EPIPEN wore off could be monitored by a physician. The patient was advised to continue with BENADRYL and was also prescribed Prednisone for three days, along with additional EPIPENS in case the reaction would resume. The paediatrician informed the patient's mother that the patient could never be administered a flu shot again. The patient did not undergo any laboratory investigations. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Back pain, Dizziness, Dysstasia, Flushing
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: 720664), concerns a 49-year-old, adult female patient. The patient had no historical conditions and current illness. On 14-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, batch number: 195228 (reported as 1955228), anatomical location: unknown and expiry date: not reported]. On the same day, immediately after vaccination, the patient experienced symptoms, which included shooting pain across the middle of back, lower back spasms, feeling of fainting, flushing head, back spasms, difficulty in standing and weakness. At the time of this report, the patient had recovered from the event. The reporter assessed the case as non-serious. Update 29-Aug-2018: Significant case correction was performed with IRD 16-Aug-2018: All events (shooting pain across the middle of back, lower back spasms, feeling of fainting, flushing head, back spasms, difficulty in standing and weakness) were captured as symptoms of diagnosis immediate post-injection reaction in event tab. The narrative and case comment were corrected accordingly.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Muscle spasms
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: 720664), concerns a 49-year-old, adult female patient. The patient had no historical conditions and current illness. On 14-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, batch number: 195228 (reported as 1955228), anatomical location: unknown and expiry date: not reported]. On the same day, immediately after vaccination, the patient experienced symptoms, which included shooting pain across the middle of back, lower back spasms, feeling of fainting, flushing head, back spasms, difficulty in standing and weakness. At the time of this report, the patient had recovered from the event. The reporter assessed the case as non-serious. Update 29-Aug-2018: Significant case correction was performed with IRD 16-Aug-2018: All events (shooting pain across the middle of back, lower back spasms, feeling of fainting, flushing head, back spasms, difficulty in standing and weakness) were captured as symptoms of diagnosis immediate post-injection reaction in event tab. The narrative and case comment were corrected accordingly.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site haemorrhage, Injection site urticaria, 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: 720815), concerns a 50-year-old, adult female patient. The patient's historical condition, current condition and allergies were not reported. The patient did not receive any concomitant medication. 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: 195233 and expiry date: not reported]. On the same day immediately after vaccination, the patient developed instant welt and redness at the injection site, tingling in her left hand and her left hand was noticeably colder to the touch than her right hand. The patient's injection site bled significantly. It was reported that while administration of the vaccine, the vein at the site of administration came to the surface when the needle was retracted. The patient was held for observation for 15 minutes and no other symptoms appeared. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious. Update received on 27-Sep-2018: Significant case correction (16-Aug-2018): All the symptoms were mapped to immediate post-injection reaction and the event (injection site reaction) was also mapped as a symptom to immediate post-injection reaction. The case comment amended accordingly.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Peripheral coldness
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: 720815), concerns a 50-year-old, adult female patient. The patient's historical condition, current condition and allergies were not reported. The patient did not receive any concomitant medication. 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: 195233 and expiry date: not reported]. On the same day immediately after vaccination, the patient developed instant welt and redness at the injection site, tingling in her left hand and her left hand was noticeably colder to the touch than her right hand. The patient's injection site bled significantly. It was reported that while administration of the vaccine, the vein at the site of administration came to the surface when the needle was retracted. The patient was held for observation for 15 minutes and no other symptoms appeared. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious. Update received on 27-Sep-2018: Significant case correction (16-Aug-2018): All the symptoms were mapped to immediate post-injection reaction and the event (injection site reaction) was also mapped as a symptom to immediate post-injection reaction. The case comment amended accordingly.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypertension, Palpitations
Clinical narrative: This is spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 720834), concerns a 37-year-old, adult, female patient. The patient's concomitant medication included CENTRUM for an unknown indication. On 15-Oct-2017, the patient received the suspect vaccine FLUCELVAX QIVc (dose: 0.5 ml, route of administration: injection [SYR as reported], anatomical location: left arm, lot number: NDC 704610201 (as reported)). The reported batch number (NDC 704610201), did not match Seqirus batch numbers, however, because the reporter named product 'FLUCELVAX QIVc' as the suspect vaccine, this report had been conservatively entered as a Seqirus case. On the same day, 3 hours after vaccination, the patient experienced palpitations and high blood pressure. The patient visited the physician's office. The patient's blood pressure 147/93 (units and normal range not reported) and pulse rate was 123 (units and normal range not reported). The reporter stated that, the events were continued for 48 hrs and still continued. At the time of report, the patient had not yet recovered from the events. The reporter assessed the case as non-serious. Update 29-Aug-2018: Significant case correction was performed with IRD 16-Aug-2018: The event palpitation was added as a separate event.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Feeling hot, Flushing, Pruritus generalised, 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: 720842), concerning a 32-year-old, adult, female patient. The patient's historical conditions included: asthma, intro-lobar pulmonary sequestration, endometriosis, chronic pancreatitis, seizure, sleeping disorder, migraines, osteoporosis, throat swelling, itching and vitamin B12 deficiency. The patient had experienced erythema, hot feeling, flushing, generalised pruritus, rash and warm skin from prior vaccination with flu shot in 2016. The patient's historical drugs included: LEVAQUIN and REGLAN which caused rash, PYRIDIUM which caused diarrhoea, morphine which caused anger/rage and hallucinations. The patient's concurrent conditions included: type 2 diabetes, depression and anxiety (reported as medical history), and pain, upper respiratory tract infection, hormone therapy (since an unspecified date in the month of September) and acid reflux. The patient had strawberry allergy causing rash, grape allergy and environmental allergy. The concomitant medications included: CYMBALTA for depression, anxiety and pain management; Fluoxetine HCL for anxiety and hormones; NEXIUM for acid reflux; Metformin HCL for type 2 diabetes; SINGULAIR and CLARITIN for unknown indications. On 03-Oct-2017, the patient was administered FLUCELVAX (QIVc) (dose: 0.5 ml [frequency reported as 1], batch number: 195213, route of administration: intramuscular, anatomical location: left arm and expiry date: not reported). On the same day, about 15 to 20 min after vaccination, the patient felt warm, hot inside and flush to the face. It was itchy on her face and all over her body on the inside and outside. The patient's face was red and appeared to have a rash. On an unspecified date, the patient received 25 mg pill of BENADRYL dye-free liquid gels, which helped mostly. On the next day (04-Oct-2017) at morning, when the patient woke up, she still felt itchy all over the body which slowly went away with time, and there were no more adverse reactions. The patient had not taken any more medications beside her daily scheduled ones which included SINGULAIR and CLARITIN. At the time of the report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Skin warm
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: 720842), concerning a 32-year-old, adult, female patient. The patient's historical conditions included: asthma, intro-lobar pulmonary sequestration, endometriosis, chronic pancreatitis, seizure, sleeping disorder, migraines, osteoporosis, throat swelling, itching and vitamin B12 deficiency. The patient had experienced erythema, hot feeling, flushing, generalised pruritus, rash and warm skin from prior vaccination with flu shot in 2016. The patient's historical drugs included: LEVAQUIN and REGLAN which caused rash, PYRIDIUM which caused diarrhoea, morphine which caused anger/rage and hallucinations. The patient's concurrent conditions included: type 2 diabetes, depression and anxiety (reported as medical history), and pain, upper respiratory tract infection, hormone therapy (since an unspecified date in the month of September) and acid reflux. The patient had strawberry allergy causing rash, grape allergy and environmental allergy. The concomitant medications included: CYMBALTA for depression, anxiety and pain management; Fluoxetine HCL for anxiety and hormones; NEXIUM for acid reflux; Metformin HCL for type 2 diabetes; SINGULAIR and CLARITIN for unknown indications. On 03-Oct-2017, the patient was administered FLUCELVAX (QIVc) (dose: 0.5 ml [frequency reported as 1], batch number: 195213, route of administration: intramuscular, anatomical location: left arm and expiry date: not reported). On the same day, about 15 to 20 min after vaccination, the patient felt warm, hot inside and flush to the face. It was itchy on her face and all over her body on the inside and outside. The patient's face was red and appeared to have a rash. On an unspecified date, the patient received 25 mg pill of BENADRYL dye-free liquid gels, which helped mostly. On the next day (04-Oct-2017) at morning, when the patient woke up, she still felt itchy all over the body which slowly went away with time, and there were no more adverse reactions. The patient had not taken any more medications beside her daily scheduled ones which included SINGULAIR and CLARITIN. At the time of the report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Paraesthesia oral, Pruritus generalised, 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: 720898), concerns a 61-year-old, adult, female patient. The patient's historical condition was unknown (reported as unsure). The patient's current illness was unknown. The patient had multiple allergies (unspecified). The patient's concomitant medication was reported as nothing new. On 05-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, batch number: 195226A, anatomical location and expiry date: not reported]. On the same day (05-Oct-2017), after vaccination, the patient experienced slight rash, tingling of lips, itching and redness all over the body. The patient had no laboratory investigations. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 7.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema, Pain, Swelling, 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: 720911), concerns a 7-year-old, male child patient. The patient's historical conditions, current illness, allergies and concomitant were unknown. On 17-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: 195236, expiry date: not reported]. On the same day, after vaccination, the patient experienced pain, swelling, redness and vomiting. The patient's lab data was unknown. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious.
Age: 5.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Local reaction, Pain, Pyrexia
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: 720954), concerns a 05-year-old female child patient. The patient's historical condition, current illness, allergies and concomitant medications were reported as unknown. On 17-Oct-2017, the patient received FLUCELVAX QIVc [dose: 0.5 ml, route of administration: injection (reported as SYR), anatomical location: left arm, batch number: 195236, expiry date: not reported]. On the same after vaccination, the patient developed local redness, low grade fever, aches and pains. The patient's lab data was unknown. At the time of this report, the patient had not recovered from the events (erythema, pain and pyrexia). The reporter assessed this case as non-serious.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood glucose normal, Blood test normal, Computerised tomogram normal, Dizziness, Malaise
Clinical narrative: This spontaneous case, reported by health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 721003), concerns a 59-year-old, adult female patient. The patient was allergic to penicillin. The patient did not have any history. The concomitant medications included LOVAZA, Multivitamin, Vitamin B, Vitamin D and Turmeric. On 17-Oct-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: 195239 and expiry date: not reported). On the same day (17-Oct-2017), 6 hours after vaccination, the patient had a quick onset of extreme dizziness and general malaise which lasted approximately 6 hours. The patient was taken to emergency room by ambulance and the emergency medical technician (EMT) staff monitored her. The patient was given small dose of VALIUM and anti-dizziness drug in the emergency room (ER). The patient rested through night and next day. It was reported that after 22 hours, the symptoms had much relieved but not completely. On an unspecified date in Oct-2017, computerised tomogram (CAT) scan, nuclear magnetic resonance imaging (MRI), blood work and urine analysis were performed, and the reports were normal for all. Blood sugar and blood pressure were monitored and found to be normal and healthy. At the time of this report, the patient was recovering from the events. The reporter assessed the case as non-serious.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Nuclear magnetic resonance imaging normal, Urine analysis normal
Clinical narrative: This spontaneous case, reported by health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 721003), concerns a 59-year-old, adult female patient. The patient was allergic to penicillin. The patient did not have any history. The concomitant medications included LOVAZA, Multivitamin, Vitamin B, Vitamin D and Turmeric. On 17-Oct-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: 195239 and expiry date: not reported). On the same day (17-Oct-2017), 6 hours after vaccination, the patient had a quick onset of extreme dizziness and general malaise which lasted approximately 6 hours. The patient was taken to emergency room by ambulance and the emergency medical technician (EMT) staff monitored her. The patient was given small dose of VALIUM and anti-dizziness drug in the emergency room (ER). The patient rested through night and next day. It was reported that after 22 hours, the symptoms had much relieved but not completely. On an unspecified date in Oct-2017, computerised tomogram (CAT) scan, nuclear magnetic resonance imaging (MRI), blood work and urine analysis were performed, and the reports were normal for all. Blood sugar and blood pressure were monitored and found to be normal and healthy. At the time of this report, the patient was recovering from the events. The reporter assessed the case as non-serious.
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: Grip strength decreased, Injection site pain, 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: 721045), concerns a 23-year-old, adult female patient. The patient's historical condition included fibromyalgia. The patient was allergic to the adhesive band aids. The patient's concomitant medication was unknown. On 15-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency: unknown, route of administration: intramuscular, anatomical location: left arm, batch number; 195224 and expiry date: not reported). On the same day, after vaccination, the patient experienced tingling in hand, difficulty in holding object and soreness at the injection site. It was reported that, the patient visited office. 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: 52.0
Sex: M
Vaccine: FLUC4
Symptoms: Cyanosis, Hypotension, Tremor, Vision blurred
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: 721063), concerns a 52-year-old, adult, male patient. On an unspecified date (5 years ago as reported), the patient at age of 47 years, received seasonal influenza vaccine and developed severe headache and pneumonia. The patient had no current illness. On 13-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), anatomical location: right arm, batch number: 195212, route of administration: unknown and expiry date: not reported]. On the same day (13-Oct-2017), 30 minutes after vaccination, the patient became hypotensive with systolic blood pressure (B/P) 80 and also experienced cyanosis of lips, uncontrollable shaking and blurred vision. The patient had recovered from the events in about 1 hour. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious. This case was linked to 201803286 due to same patient.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity, Sleep disorder
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: 721109), concerns a 44-year-old, adult female patient. The patient's historical condition included psoriatic arthritis. The patient was allergic to sulfa, Morphine, DEMEROL and STADOL. The patient's concomitant medication included HCTZ. On 26-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, expiry date: not reported). On the same day, after vaccination, the patient experienced pain down her arm and 1 day after vaccination, the patient experienced shoulder stiffness and pain due to which patient wakes up at night. The patient did not undergo any laboratory investigations. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 77.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Pain in extremity, Pain in jaw
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: 721119), concerning a 77-year-old, elderly, female patient. The patient had no historical conditions and current illnesses at the time of vaccination. On 05-Oct-2017, the patient was administered FLUCELVAX (QIV) (dose: 0.5 ml (frequency reported as 2), batch number: 195239, route of administration: intramsucular, anatomical location: unknown and expiry date: not reported). On the next day (06-Oct-2017), the patient when awoke with experiencing entire jaw pain/ache when pressure was applied for 1 day. The patient had a dull pain that extended from site of administration to wrist, while laying on left side for 2 weeks, only when pressure was applied. At the time of the report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Insomnia, Pain in extremity
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: 721121), concerns a 62-year-old, adult, female patient. The patient did not have any medical history and current illnesses. Patient did not take any medications at the time of vaccination. On 05-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, anatomical location: left arm, batch number: 195210A, route of administration: unknown and expiry date: not reported]. On the same day, after vaccination, at night, the patient's left arm was very painful, was unable to move her arm and could not sleep due to pain. On 06-Oct-2017, next morning, the patient experienced red round swelling and bump at injection site. No lab investigations were performed. At the time of this report, the patient had recovered 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. The 'as determined causality' of the event insomnia was changed from related to not related in the event assessment tab. The case comment was amended accordingly.
Age: 20.0
Sex: F
Vaccine: FLUC4, HEP, MMR, VARCEL
Symptoms: Injection site erythema, 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: 721139), concerns a 20-year-old, adult female patient. The patient had no historical conditions. The patient's current conditions included mushroom allergy and seasonal allergy. On 06-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 6), route of administration: intramuscular, anatomical location: right arm, batch number: 195228, expiry date: not reported] and non-company suspect vaccines ENGERIX B (dose: frequency reported as 1, route of administration: intramuscular, anatomical location: right arm, batch number: KL3D4, expiry date: not reported), MMR II (dose: frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: N013866, expiry date: not reported) and VARIVAX (dose: frequency reported as 1, route of administration: subcutaneous, anatomical location: left arm, batch number: N017699, expiry date: not reported). Both the vaccines (FLUCELVAX QIVc and ENGERIX B) was given in the same arm (right). On 07-Oct-2017, 1 day after vaccination, the patient developed erythema and pruritus at injection site. The patient had made a physician office visit. The patient did not undergo any laboratory investigations. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious. Update 29-Aug-2018: Non-significant case correction was performed with IRD 16-Aug-2018: The case comment was modified, and no changes were done in the narrative.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Myalgia, Pain in extremity, Paraesthesia, Tenderness
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: 721398), concerning a 59-year-old, adult, female patient. The patient had no allergies and current illnesses at the time of vaccination. The patients current condition included: hypothyroidism (reported as medical history). The concomitant medication included: SYNTHROID. On 03-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, batch number: 195222, route of administration: intramuscular, anatomical location: left arm and expiry date: not reported]. It was reported that, the patient had no pain with injection. On an unknown date in Oct-2017, in next couple of days the patient experienced tenderness (reported as expected) but no swelling. The patient was unable to lift arm above shoulder and described the pain as similar to sore muscle (but not a nerve pain), 3 to 4 days after the vaccination. The patient also experienced tingling-like sensation. On 17-Oct-2017, the patient visited the pharmacy seeking OTC (over the counter) treatment for sore arm. The patient took ADVIL occasionally and warm compression therapy. No lab investigations were performed. On 18-Oct-2017, during a follow up call, the patient reported that her arm was feeling better. At the time of the report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Cough, Erythema, Nausea, Skin warm, 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: 721450), concerns an 81-year-old, elderly female patient. On 17-Oct-2017, the patient was administered suspect vaccine FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as unknown, route of administration: intramuscular, anatomical location: left arm, batch number: 195220 and expiry date: not reported). On the same day, the patient was administered non-company suspect PNEUMOVAX (frequency reported as unknown, route of administration: intramuscular, anatomical location: left arm, batch number: N022303 and expiry date: not reported). It was reported that, both the vaccines were administered in the same arm. On 18-Oct-2017, one day after vaccination, the patient experienced redness, hot to touch, swelling, nausea and cough. It was reported that, the patient visited office. At the time of this report, the outcome of the events were not reported. The reporter assessed the case as non-serious.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Fall, Loss of consciousness, Syncope
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: 721640), concerns a 38-year-old, adult, female patient. The patient's history, allergies and current illnesses were not reported. Patient did not take any medications at the time of vaccination. On 13-Oct-2017, around 7 PM, the patient went to take her annual flu shot. The reporter had gone over her vaccine consent and administration record form and had asked her if she had any issues with vaccines in the past. The patient stated she was scared of needles. The reporter noticed she had her other arm clenched indicating this as well, so reporter had her 9 year old daughter try to distract her as well. The patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left arm, dose: 0.5 ml (frequency reported as 1), batch number: 195224 and expiry date not reported]. On the same after administering the vaccine, the patient responded that it was quick and she didn't even feel it. Shortly after vaccination, the patient started feeling dizzy so the reporter told her to sit down. The reporter asked patient if she wanted water and she said yes. So the reporter grabbed a cup for her and checked up on her once again. Patient said she was going to sit for a little longer. In the meantime, reporter went to verify a few more prescriptions and walked over one more time. After heading back to the Registered Pharmacist (RPh) station to verify more prescriptions, at this point the reporter heard a sound and the patient had then fainted. Another patient was a first responder, the reporter ran over to check her pulse and noted that patient was still unconscious at the time. Nurse practitioner within the store came over to assist. Patient woke up from the fall soon after (approximately 2 min). Patient was alert and orient and her daughter was a little frazzled and scared. 911 was called, they showed up after 5 min to evaluate the patient after the fall. Patient did not undergo any laboratory tests. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 70.0
Sex: F
Vaccine: FLUC4, PNC13
Symptoms: Extra dose administered, No adverse event
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: 721644), concerns a 70-year-old, elderly female patient. 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: 195238 and expiry date: not reported] and non-company suspect vaccine PREVNAR 13 [dose: (frequency reported as 1), route of administration: intramuscular, anatomical location: right arm, batch number: R28321 and expiry date: not reported). On 13-Oct-2018, the patient received a duplicate shot (explicitly coded as extra dose administered). It was reported that the nurse had confirmed that the patient received a flu shot and pneumonia shot, prior to the administration. The patient did not experience any adverse reaction. The reporter assessed the case as non-serious. The reporter assessed the case as non-serious. Update on 29-AUG-2018: Non-significant case correction was performed with IRD 16-AUG-2018. The co-suspect was removed in the case comment and modified.
Age: 29.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
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: 721663), concerns a 29-year-old, adult male patient. On 18-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: 195211, expiry date: not reported]. On the same day, 5 hours after vaccination, the patient developed a large red lump on his left shoulder which was warm to touch, 48 hours later, the patient still had lump on his arm which was warm as well. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Fatigue, 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: 721709), concerns a 35-year-old, adult female patient. The patient was allergic to egg. On 20-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195231, expiry date and frequency were not reported). On the same day 30 min after vaccination, the patient experienced a really bad headache and fatigue. Later, the patient was taken into a treatment room and had her vital signs monitored without any need of additional services. At the time of this report, the outcome of the events was not reported. The reporter assessed the events as non-serious. Update 29-Aug-2018: Significant case correction was performed 16-Aug-2018: The listedness for event 'Documented allergy to administered drug' was changed from listed to unlisted.