chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: FLUC4
Symptoms: Laboratory test, Pallor, Seizure like phenomena, Yawning
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 733527), concerns a 11-year-old, female child. The patient had no known allergies, medical history, concomitant medication, current illness or lab data. On 10-Jan-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location; left arm, batch number: 195241, expiry date: not reported). On 10-Jan-2018 (on the same day), shortly after vaccination, the patient showed symptoms of seizure-like-activity and was helped to lay down on the floor by mother. Within a few seconds, the patient woke up and was able to tell her name, date of birth. Within a few minutes, patient was seated in a chair for observation. She was pale and yawning. The patient could talk and took sips of water. Approximately at 05:15 pm, the blood pressure was found to be 97/67 with pulse 77 (units and normal range was not provided). Approximately at 05:30 pm, the patient was able to stand and walk. About 07:30 pm, the patient's mother was contacted and the patient was taken to the local emergency room as pallor and yawning continued. Unspecified lab tests were performed. On 11-Jan-2018, at 01:45 pm, the patient contacted the primary care physician and reported the incident to the employee in office. As per the employee, the patient was fine (reported as okay). At the time of this report, the patient had recovered from the events.
Sex: F
Vaccine: FLUC4
Symptoms: Electrocardiogram normal, Fall, Head injury, Loss of consciousness, Syncope
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 733535), concerning a 10-year-old, female child. The patient's historical condition included: atopic dermatitis. Current condition included: allergic rhinitis. It was reported that, the patient had no known food, drug, latex or venom allergy. Concomitant medication included: ketoconazole for an unknown indication. On 29-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (reported as 7+), route of administration: intramuscular, anatomical location: left arm, batch number: 195249, expiry date: not reported). It was reported that, the patient received vaccine in a seated position. Upon standing, one minute later she experienced a syncopal episode followed by brief generalized tonic-clonic activity. Total duration of loss of consciousness (LOC) was less than one minute. No loss of bowel/bladder control or postictal state was noted. She had head injury as she fell off. Hence, she was evaluated in the emergency room (ER) where electrocardiogram (ECG) was unremarkable (normal) and later she was released home. The patient had recovered from all the events (generalized tonic-clonic seizure, head injury, fall, loss of consciousness and syncope). The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: Tonic clonic movements
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 733535), concerning a 10-year-old, female child. The patient's historical condition included: atopic dermatitis. Current condition included: allergic rhinitis. It was reported that, the patient had no known food, drug, latex or venom allergy. Concomitant medication included: ketoconazole for an unknown indication. On 29-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (reported as 7+), route of administration: intramuscular, anatomical location: left arm, batch number: 195249, expiry date: not reported). It was reported that, the patient received vaccine in a seated position. Upon standing, one minute later she experienced a syncopal episode followed by brief generalized tonic-clonic activity. Total duration of loss of consciousness (LOC) was less than one minute. No loss of bowel/bladder control or postictal state was noted. She had head injury as she fell off. Hence, she was evaluated in the emergency room (ER) where electrocardiogram (ECG) was unremarkable (normal) and later she was released home. The patient had recovered from all the events (generalized tonic-clonic seizure, head injury, fall, loss of consciousness and syncope). The reporter assessed the events as non-serious.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Discomfort, Pain, Pain in extremity
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 733672), concerns a 37-year-old adult female patient. On 04-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195231, expiry date: not reported). On the same day after vaccination, the patient had pain. It was reported that, the patient had normal discomfort on the day of vaccination, but the pain in arm radiated down her left arm and heat made it worse. No palliative care was taken. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Cough, Disease prodromal stage, Groin pain, Neurological symptom
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 733750), concerning a 49-year-old, adult, female patient. The historical condition included prodromal symptom such as anaphylactic reaction to RITUXAN and Gentamicin which was deep painful right groin pain. The patient was vaccinated with Hepatitis B and was found to be allergic. Current conditions included: lupus, Ehlers-Danlos syndrome, Hashimoto's thyroiditis. The patient was allergic to Gluten, thiomersal, LEVAQUIN, Gentamicin, Dapsone, RITUXAN, Clomethiazole and sulfas. Concomitant medications included: Prednisone, SYNTHROID, CYTOMEL and PROZAC for an unknown indication. On 16-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (reported as 1 dose), route of administration: intramuscular, anatomical location: left arm, batch number: 195239, expiry date: not reported). Within an hour of getting the vaccine, the patient experienced prodromal symptom which was deep painful right groin pain. In addition, she had chronic cough since the vaccination and neurological sensation on the skin and on her face as well. It was reported that, the patient made physician's office visit for the events. No lab test was done. At the time of this report, the patient had not yet recovered from all the events. The reporter assessed the case as non-serious. Significant case correction received on 14-Mar-2018: In the event tab, event coding for nervous system disorder was changed from neurological impairment to nervous system disorder NOS. Upon internal review, it was realized that the event onset date was incorrectly captured. Hence, the event onset date was corrected from 16-Oct-2017 to 16-Nov-2017 for all the events. In narrative, IRD was changed from 14-Feb-2018 to 14-Mar-2018 and the word 'historical condition' was added.
Age: 74.0
Sex: F
Vaccine: FLUC4
Symptoms: Muscle spasms, Nausea
Clinical narrative: This spontaneous case, reported by other Health Professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 733799), concerns a 74-year-old elderly female patient. The patient's historical condition included thyroid disorder (unspecified date). The patient had been allergic to egg. On 12-Jan-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5ml (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195241 and expiry date: not reported). On 13-Jan-2018, after 1 day of vaccination, the patient experienced intense leg cramping and nausea. It was reported that, the patient had the symptoms when she consumed the eggs. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious. Significant care correction received with IRD 14-Mar-2018: The as determined causality of the events (Cramps leg and Nausea) was corrected from not related to related.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous case, reported by Other Health Professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 733815), concerns a 55-year-old female patient. The patient's current condition included macrolide antibiotics allergy. The patient's concomitant medications methocarbamol, etodolac, gabapentin, alprazolam, amitriptyline, oxycodone. On 11-Jan-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5ml (1 as reported), route of administration: intramuscular, anatomical location: left arm, batch number: 195126). On 12-Jan-2018, a day after vaccination, the patient had redness at injection site and warm painful sensations. It was reported that, the skin surrounding the injection site felt swollen and hard to the touch. The patient did not self-treat the symptoms. The symptoms were persistent until the day of report (as reported). The outcome of the events was not reported (reported as unknown). The reporter assessed the case as non-serious.
Age: 18.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Cough, Dysphonia, Eye pain, Influenza
Clinical narrative: This spontaneous case, reported by other non-healthcare professional (consumer) to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 734147), concerns an 18-year-old, adult, female patient. The patient had no historical condition and current illness. The patient had been allergic to blackberries. The patient did not receive any concomitant medications. On 14-Jan-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: injection (reported as SYR), anatomical location: right arm, batch number and expiry date: not reported]. It was reported that, the patient had no symptoms prior to flu shot. On the same day, within 4 hours of vaccination, the patient developed a fever of 100.5. The patient took ADVIL at bedtime and felt better by 15-Jan-2018 (reported as Monday morning). However later that day, the fever returned and in the next few days, the patient developed fever, chills, body aches, cough, eye soreness, hoarseness, body itching and sore throat. On 17-Jan-2018, 03 days after vaccination, the patient went to the clinic and was diagnosed with the flu. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 18.0
Sex: F
Vaccine: FLUC4
Symptoms: Oropharyngeal pain, Pain, Pruritus, Pyrexia
Clinical narrative: This spontaneous case, reported by other non-healthcare professional (consumer) to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 734147), concerns an 18-year-old, adult, female patient. The patient had no historical condition and current illness. The patient had been allergic to blackberries. The patient did not receive any concomitant medications. On 14-Jan-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: injection (reported as SYR), anatomical location: right arm, batch number and expiry date: not reported]. It was reported that, the patient had no symptoms prior to flu shot. On the same day, within 4 hours of vaccination, the patient developed a fever of 100.5. The patient took ADVIL at bedtime and felt better by 15-Jan-2018 (reported as Monday morning). However later that day, the fever returned and in the next few days, the patient developed fever, chills, body aches, cough, eye soreness, hoarseness, body itching and sore throat. On 17-Jan-2018, 03 days after vaccination, the patient went to the clinic and was diagnosed with the flu. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 50.0
Sex: M
Vaccine: FLUC4
Symptoms: Syncope
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 734405), concerns a 50-year-old, adult, male patient. The patient's current condition included hypertension and hyperlipidaemia (reported as medical history). The patient had no allergies. The concomitant medications included lisinopril, aspirin and simvastatin for unknown indications. On 17-Jan-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195246, expiry date: not reported]. On the same day, few minutes after vaccination, the patient fainted, and emergency services were called. The patient mentioned his tendency to faint with "Shots" to the pharmacist. Emergency services arrived within 15 minutes and patient was alert enough to converse with an emergency personnel. The same day (17-Jan-2018), the patient had recovered from the event. The reporter assessed this case as non-serious.
Age: 15.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of consciousness, Visual impairment
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 734643), concerns a 15-year-old, female adolescent patient. The patient had no historical condition and current illness. On 19-Jan-2018, the patient received FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), batch number: 195239, anatomical location: left arm, route of administration: unknown and expiry date: not reported). On the same day, after vaccination, the patient got up from a sitting position to leave and experienced vision darkness. Eventually, the patient passed out, approximately 5 minutes after receiving the flu shot. The patient was placed on the floor and after that, she was awake and alert. The patient's mother was contacted 3 days later, and it was reported that, the patient was fine. The same day (19-Jan-2018), the patient had recovered from the event. The reporter assessed the case as non-serious.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Syncope
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 734659), concerns a 29-year-old, adult female patient. The patient received an unspecified vaccine for immunization and felt dizzy in past. On 23-Jan-2018, the patient received FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195243 and expiry date: not reported). On the same day, after vaccination, the patient fainted. Eventually, the patient felt better and was advised to take ADVIL with meal. The patient took ADVIL. The patient was recovered completely after 20 minutes of monitoring by the pharmacist. It was reported that, the patient refused to call ambulance. The reporter assessed the case as non-serious.
Age: 13.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of consciousness, Seizure, Syncope
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 735287), concerns a 13-year-old, adolescent, female patient. The patient received Human papillomavirus (HPV) vaccine, two years prior to the suspect vaccination and experienced unspecified adverse reactions (reported as similar reactions as occurred after receiving suspect vaccine). The patient had no relevant medical history, allergies, current illness and concomitant medications. On 25-Jan-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), batch number: 195233, route of administration: intramuscular, anatomical location: right arm and expiry date: not reported]. On the same day after the vaccination, the patient's mother returned stating that her daughter should sit down as she felt that the patient was going to pass out. The patient fainted after being seated. As the patient lost consciousness, emergency services were called. It was reported that the patient had seized for a moment. The patient completely regained the consciousness before the call to emergency call service ended. At 05:48 pm, the vitals were taken (before the arrival of paramedics) which showed blood pressure as 85/46 and heart rate as 66 (units not specified). The patient was taken to the ambulance for observation after the arrival of paramedics. It was reported that the ultimate outcome was unknown and the patient's family was not reachable. At the time of the report, the patient had recovered from the event (syncope). The reporter assessed the case as non-serious.
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Fall, Head injury, Loss of consciousness
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 735768), concerns a 10-year-old, female child patient. On 30-Jan-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: injection (reported as SYR), anatomical site: right arm, batch number: 195220 and expiry date: not reported]. On the same day, after vaccination, the patient passed out. Eventually, the patient fell and hit her head on a padded chair. There was no evident injury noted as it was hit on the padded chair. It was reported that, the patient did not experience any symptoms other than dizziness after falling down. The patient was alert immediately afterward (recovered). The reporter assessed this case as non-serious.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Cough, Influenza, Influenza virus test positive, Product quality issue
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 735824), concerns a 59-year-old, adult, female patient. The patient did not have any medical history and current illness. The patient's concomitant medication included CORGARD. On 25-Sep-2017, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: unknown, dose: 0.5 ml, batch number and expiry date: not reported]. On 10-Dec-2017, seventy-six days after vaccination, the patient became severely ill with fever greater than 102 degrees, had severe cough, and chills for 5 days. The patient had contracted influenza virus (explicitly coded as vaccination failure). The patient underwent rapid swab test and it was confirmed that the patient had influenza. The reporter stated that the vaccine was ineffective. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding QAIR number was 1033286. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious. Non-significant follow up received on 18-Sep-2018. Added QA reference number (1033286) in additional information.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Pyrexia, Vaccination failure
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 735824), concerns a 59-year-old, adult, female patient. The patient did not have any medical history and current illness. The patient's concomitant medication included CORGARD. On 25-Sep-2017, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: unknown, dose: 0.5 ml, batch number and expiry date: not reported]. On 10-Dec-2017, seventy-six days after vaccination, the patient became severely ill with fever greater than 102 degrees, had severe cough, and chills for 5 days. The patient had contracted influenza virus (explicitly coded as vaccination failure). The patient underwent rapid swab test and it was confirmed that the patient had influenza. The reporter stated that the vaccine was ineffective. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding QAIR number was 1033286. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious. Non-significant follow up received on 18-Sep-2018. Added QA reference number (1033286) in additional information.
Age: 10.0
Sex: M
Vaccine: FLUC4
Symptoms: Blood glucose normal, Ear congestion, Fall, Loss of consciousness
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 736453), concerns a 10-year-old, male child patient. On 27-Jan-2018, the patient was administered FLUCELVAX QIVc (0.5 ml, frequency: unknown, anatomical location: left arm, batch number: 195239, route of administration: unknown and expiry date: not reported). On the same day, after vaccination, the patient passed out, while on the way out. The patient did not hit his head or hurt himself in the fall. The patient said that his ear felt full right before fainting. Fire department came and checked the patient's pulse, oxygen saturation (O2 sat) and blood sugar and the result of which were normal. The reporter checked the patient on Sunday and his mother said that he was ok. The outcome of the events was recovered. The reporter assessed the case as non-serious.
Age: 12.0
Sex: M
Vaccine: FLUC4
Symptoms: Loss of consciousness, Malaise
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 736617), concerns a 12-year-old, adolescent, male patient. The patient's father reported that the patient had passed out after vaccination previously and experienced malaise. The patient's current illness included GI issue and the physician confirmed that the patient could be administered the shot. The patient was tensed prior to vaccination. On 07-Feb-2018, the patient was administered FLUCELVAX (QIVc) [dose: 0.5 ml (frequency reported as unknown), route of administration: intramuscular, anatomical location: right arm, batch number: 196498, expiry date: not reported]. On the same day, after vaccination the pharmacist noticed that the patient had passed out during shot administration. The patient was not feeling well, and the pharmacist had asked the patient to remain seated. The patient passed out again and came back. The patient was given food and drink and was seated for 15 minutes. Eventually, the patient felt fine and left the pharmacy unassisted with father. The outcome of the events had recovered. The reporter assessed this case as non-serious. Update received on 09-Oct-2018: Significant case correction (IRD: 25-Sep-2018): Malaise was added as a reaction to vaccination in medical history. The term 'syncopal episodes' was replaced by 'passed out'. In case comment, the word 'assesses' was changed to 'assessed'.
Age: 24.0
Sex: M
Vaccine: FLUC4
Symptoms: Fall, Loss of consciousness
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 736880), concerns a 24-year-old, adult male patient. The patient had possible reaction to antibiotic in past but could not remember the name [might be SUPRAX]. The patient's mother reported that he passed out in past and that was not the first time he had. The patient was not taking any medications at the time of vaccination. The patient did not have any current illnesses. On 08-Feb-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 196498 and expiry date: not reported). On the same day after vaccination, the patient passed out, falling to the floor while ringing the customer out at the register. The patient did not hit his head and was conscious and breathing. After confirming that the patient was not having any difficulty breathing, the reported called 911. The paramedics arrived and checked the patient's blood pressure and pulse which were normal. The patient felt fine after approximately 10 minutes and refused to go to the hospital in the ambulance. The outcome of the events was recovered. The reporter assessed the case as non-serious.
Age: 14.0
Sex: F
Vaccine: FLUC4
Symptoms: Syncope
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 736935), concerns a 14-year-old, female adolescent patient. The patient had no historical condition, current illness and allergies. The patient did not receive any concomitant medications. On 09-Feb-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 196498 and expiry date: not reported]. On the same day, 15 minutes after vaccination, the patient fainted. No lab investigations were performed. At the time of this report, the patient had recovered from the event. The reporter assessed the case as non-serious.
Sex: F
Vaccine: HPVX
Symptoms: Acne, Adverse event, Alopecia, Contusion, Death
Clinical narrative: This spontaneous report has been received was received via social media from a mother's patient and refers to a female patient of unknown age. The patient's concurrent conditions, concomitant therapies, pertinent medical history and drug reactions or allergies were not provided. On an unspecified date, the patient was vaccinated with an unidentified Merck hpv vaccine administered (name and lot number not provided) GARDASIL (strength, dose, frequency, route of administration and batch/lot# were nor provided) / GARDASIL 9 for prophylaxis. On an unspecified date, the patient experienced an adverse event and was hospitalized. It was also reported that, the patient experienced sepsis and meningitis on an unknown date. The patient experienced body ache, leg ached, arm did not stop bleeding, puffy face, breaking out with acne, lethargic, exhausted, fever with 104 (no units provided), hemoglobin: 4 (units not provided), sore throat and lymph nodes, bruising and petechiae in her legs which corresponded to the symptoms of leukaemia. The mother reported that the a nurse in the country of incidence gave HPV vaccine to her daughter who then got a cancer and died, on an unknown date. The cause of the death was not provided. It was unknown if an autopsy was performed. The outcome of cancer (neoplasm malignant), leukemia, meningitis, sepsis, hair loss and the adverse event was not provided.  The causal relationship between the events and the GARDASIL/GARDASIL9 was not provided. Upon internal review, the events of neoplasm malignant, sepsis, meningitis and leukaemia were considered to be medically significant.; Reported Cause(s) of Death: unknown cause of death.
Sex: F
Vaccine: HPVX
Symptoms: Fatigue, Haemoglobin decreased, Haemorrhage, Lethargy, Leukaemia
Clinical narrative: This spontaneous report has been received was received via social media from a mother's patient and refers to a female patient of unknown age. The patient's concurrent conditions, concomitant therapies, pertinent medical history and drug reactions or allergies were not provided. On an unspecified date, the patient was vaccinated with an unidentified Merck hpv vaccine administered (name and lot number not provided) GARDASIL (strength, dose, frequency, route of administration and batch/lot# were nor provided) / GARDASIL 9 for prophylaxis. On an unspecified date, the patient experienced an adverse event and was hospitalized. It was also reported that, the patient experienced sepsis and meningitis on an unknown date. The patient experienced body ache, leg ached, arm did not stop bleeding, puffy face, breaking out with acne, lethargic, exhausted, fever with 104 (no units provided), hemoglobin: 4 (units not provided), sore throat and lymph nodes, bruising and petechiae in her legs which corresponded to the symptoms of leukaemia. The mother reported that the a nurse in the country of incidence gave HPV vaccine to her daughter who then got a cancer and died, on an unknown date. The cause of the death was not provided. It was unknown if an autopsy was performed. The outcome of cancer (neoplasm malignant), leukemia, meningitis, sepsis, hair loss and the adverse event was not provided.  The causal relationship between the events and the GARDASIL/GARDASIL9 was not provided. Upon internal review, the events of neoplasm malignant, sepsis, meningitis and leukaemia were considered to be medically significant.; Reported Cause(s) of Death: unknown cause of death.
Sex: F
Vaccine: HPVX
Symptoms: Lymph node pain, Meningitis, Neoplasm malignant, Oropharyngeal pain, Pain
Clinical narrative: This spontaneous report has been received was received via social media from a mother's patient and refers to a female patient of unknown age. The patient's concurrent conditions, concomitant therapies, pertinent medical history and drug reactions or allergies were not provided. On an unspecified date, the patient was vaccinated with an unidentified Merck hpv vaccine administered (name and lot number not provided) GARDASIL (strength, dose, frequency, route of administration and batch/lot# were nor provided) / GARDASIL 9 for prophylaxis. On an unspecified date, the patient experienced an adverse event and was hospitalized. It was also reported that, the patient experienced sepsis and meningitis on an unknown date. The patient experienced body ache, leg ached, arm did not stop bleeding, puffy face, breaking out with acne, lethargic, exhausted, fever with 104 (no units provided), hemoglobin: 4 (units not provided), sore throat and lymph nodes, bruising and petechiae in her legs which corresponded to the symptoms of leukaemia. The mother reported that the a nurse in the country of incidence gave HPV vaccine to her daughter who then got a cancer and died, on an unknown date. The cause of the death was not provided. It was unknown if an autopsy was performed. The outcome of cancer (neoplasm malignant), leukemia, meningitis, sepsis, hair loss and the adverse event was not provided.  The causal relationship between the events and the GARDASIL/GARDASIL9 was not provided. Upon internal review, the events of neoplasm malignant, sepsis, meningitis and leukaemia were considered to be medically significant.; Reported Cause(s) of Death: unknown cause of death.
Sex: F
Vaccine: HPVX
Symptoms: Pain in extremity, Petechiae, Pyrexia, Sepsis, Swelling face
Clinical narrative: This spontaneous report has been received was received via social media from a mother's patient and refers to a female patient of unknown age. The patient's concurrent conditions, concomitant therapies, pertinent medical history and drug reactions or allergies were not provided. On an unspecified date, the patient was vaccinated with an unidentified Merck hpv vaccine administered (name and lot number not provided) GARDASIL (strength, dose, frequency, route of administration and batch/lot# were nor provided) / GARDASIL 9 for prophylaxis. On an unspecified date, the patient experienced an adverse event and was hospitalized. It was also reported that, the patient experienced sepsis and meningitis on an unknown date. The patient experienced body ache, leg ached, arm did not stop bleeding, puffy face, breaking out with acne, lethargic, exhausted, fever with 104 (no units provided), hemoglobin: 4 (units not provided), sore throat and lymph nodes, bruising and petechiae in her legs which corresponded to the symptoms of leukaemia. The mother reported that the a nurse in the country of incidence gave HPV vaccine to her daughter who then got a cancer and died, on an unknown date. The cause of the death was not provided. It was unknown if an autopsy was performed. The outcome of cancer (neoplasm malignant), leukemia, meningitis, sepsis, hair loss and the adverse event was not provided.  The causal relationship between the events and the GARDASIL/GARDASIL9 was not provided. Upon internal review, the events of neoplasm malignant, sepsis, meningitis and leukaemia were considered to be medically significant.; Reported Cause(s) of Death: unknown cause of death.
Age: 25.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Allergy test, Cough, Lower respiratory tract congestion, Pain, Pulmonary function test
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 02-Aug-2018 by Seqirus from VAERS (VAERS ID: 744961), concerning a 25-year-old, adult, female patient. On unspecified dates in 2009, 2010, 2011, 2013 and 2014, the patient administered the influenza vaccine and 2 weeks after vaccination developed reproducible likely non-immunoglobulin E [IgE] mediated reactions with same severity which included fever with a temperature 101-104, body aches, upper and lower respiratory tract congestion, and cough which persisted for several weeks. The patient's current conditions included allergic rhinitis (reported as medical history) and patient was allergic to sulfa drugs (since an unspecified date). On 01-Sep-2015, the patient was administered influenza vaccine (dose: unknown, route of administration, anatomical site, trade name, manufacturer, batch number and expiry date: not reported). On an unspecified date in Sep-2015, 2 weeks after vaccination [as reported], the patient experienced fever with a temperature 101-104, body aches, upper and lower respiratory tract congestion, and cough which persisted for several weeks. The patient had made an emergency room and physician office visit. On an unspecified date in 2015, the patient underwent pulmonary evaluation for reaction and was sent for allergy evaluation to identify the potential etiology (findings not reported). It was reported that, the patient did not decline yearly vaccinations as she worked as a registered nurse in a hospital. At the time of the report, the patient had recovered from the events. The reporter assessed the case as non-serious and the causality of the events as related to the suspect vaccine.
Age: 25.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pyrexia, Upper respiratory tract congestion
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 02-Aug-2018 by Seqirus from VAERS (VAERS ID: 744961), concerning a 25-year-old, adult, female patient. On unspecified dates in 2009, 2010, 2011, 2013 and 2014, the patient administered the influenza vaccine and 2 weeks after vaccination developed reproducible likely non-immunoglobulin E [IgE] mediated reactions with same severity which included fever with a temperature 101-104, body aches, upper and lower respiratory tract congestion, and cough which persisted for several weeks. The patient's current conditions included allergic rhinitis (reported as medical history) and patient was allergic to sulfa drugs (since an unspecified date). On 01-Sep-2015, the patient was administered influenza vaccine (dose: unknown, route of administration, anatomical site, trade name, manufacturer, batch number and expiry date: not reported). On an unspecified date in Sep-2015, 2 weeks after vaccination [as reported], the patient experienced fever with a temperature 101-104, body aches, upper and lower respiratory tract congestion, and cough which persisted for several weeks. The patient had made an emergency room and physician office visit. On an unspecified date in 2015, the patient underwent pulmonary evaluation for reaction and was sent for allergy evaluation to identify the potential etiology (findings not reported). It was reported that, the patient did not decline yearly vaccinations as she worked as a registered nurse in a hospital. At the time of the report, the patient had recovered from the events. The reporter assessed the case as non-serious and the causality of the events as related to the suspect vaccine.
Age: 25.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Cough, Lower respiratory tract congestion, Pain, Pyrexia, Upper respiratory tract congestion
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 02-Aug-2018 by Seqirus from VAERS (VAERS ID: 744961), concerning a 25-year-old, adult, female patient. On unspecified dates in 2009, 2010, 2011, 2013 and 2014, the patient administered the influenza vaccine and 2 weeks after vaccination developed reproducible likely non-immunoglobulin E [IgE] mediated reactions with same severity which included fever with a temperature 101-104, body aches, upper and lower respiratory tract congestion, and cough which persisted for several weeks. The patient's current conditions included allergic rhinitis (reported as medical history) and patient was allergic to sulfa drugs (since an unspecified date). On 01-Sep-2015, the patient was administered influenza vaccine (dose: unknown, route of administration, anatomical site, trade name, manufacturer, batch number and expiry date: not reported). On an unspecified date in Sep-2015, 2 weeks after vaccination [as reported], the patient experienced fever with a temperature 101-104, body aches, upper and lower respiratory tract congestion, and cough which persisted for several weeks. The patient had made an emergency room and physician office visit. On an unspecified date in 2015, the patient underwent pulmonary evaluation for reaction and was sent for allergy evaluation to identify the potential etiology (findings not reported). It was reported that, the patient did not decline yearly vaccinations as she worked as a registered nurse in a hospital. At the time of the report, the patient had recovered from the events. The reporter assessed the case as non-serious and the causality of the events as related to the suspect vaccine.
Age: 44.0
Sex: M
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: This spontaneous case, reported by other healthcare professionals to VAERS and initially retrieved on 25-Sep-2018 from VAERS (VAERS ID: 747564), concerns a 44-year-old, adult, male patient. The patient had no historical condition and current condition. The patient did not receive any concomitant medications. On 12-Feb-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: injection (SYR as reported), anatomical location: left arm, batch number: 196498 and expiry date: not reported]. On 14-Feb-2018, two days after vaccination, the patient developed serious hives all over his body. The patient took unspecified allergy medicine, which resulted in temporary relief, but continuously in 12 hours the patient experienced hives again. The patient had made a physician office visit. At the time of this report, the patient had not recovered from the event. The reporter assessed the case as non-serious.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Antinuclear antibody, Bartonella test, Blood creatine phosphokinase, C-reactive protein
Clinical narrative: 2 Days after receiving the vaccine I had a knot in my muscle that developed into a pimple like pustule. On Wednesday the 17th I was then seen by primary care for lymph node swelling under my left armpit. I was then in the ER Nov 2nd and Nov 6th for chest and abdominal pain. Upon CAT scan I was diagnosed with pericarditis with pericardial effusion, and acute diverticulitis.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Computerised tomogram abnormal, Diverticulitis, Ehrlichia test, Fibrin D dimer
Clinical narrative: 2 Days after receiving the vaccine I had a knot in my muscle that developed into a pimple like pustule. On Wednesday the 17th I was then seen by primary care for lymph node swelling under my left armpit. I was then in the ER Nov 2nd and Nov 6th for chest and abdominal pain. Upon CAT scan I was diagnosed with pericarditis with pericardial effusion, and acute diverticulitis.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Full blood count, Lymphadenopathy, Metabolic function test, Nodule, Parasite blood test
Clinical narrative: 2 Days after receiving the vaccine I had a knot in my muscle that developed into a pimple like pustule. On Wednesday the 17th I was then seen by primary care for lymph node swelling under my left armpit. I was then in the ER Nov 2nd and Nov 6th for chest and abdominal pain. Upon CAT scan I was diagnosed with pericarditis with pericardial effusion, and acute diverticulitis.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Pericardial effusion, Pericarditis, Rash pustular, Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: 2 Days after receiving the vaccine I had a knot in my muscle that developed into a pimple like pustule. On Wednesday the 17th I was then seen by primary care for lymph node swelling under my left armpit. I was then in the ER Nov 2nd and Nov 6th for chest and abdominal pain. Upon CAT scan I was diagnosed with pericarditis with pericardial effusion, and acute diverticulitis.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Troponin
Clinical narrative: 2 Days after receiving the vaccine I had a knot in my muscle that developed into a pimple like pustule. On Wednesday the 17th I was then seen by primary care for lymph node swelling under my left armpit. I was then in the ER Nov 2nd and Nov 6th for chest and abdominal pain. Upon CAT scan I was diagnosed with pericarditis with pericardial effusion, and acute diverticulitis.
Age: 37.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Candida test, Culture, Fungal test, Gram stain, Incisional drainage
Clinical narrative: Patient is a 38-year-old female who presents for evaluation of left arm injection site. Patient had injections in right and left proximal upper extremities on 10/3/18. Patient is unsure of which injections were in which arm. Patient states she noticed a reaction on her proximal left upper extremity about 3 weeks following the shot. States she noticed a knot appear on the proximal left upper extremity. Denies any drainage of lesion on the left proximal upper extremity. Patient reports about 4-5 weeks following injection, she noticed a knot appear on her proximal right upper extremity. States that the lesion on her right arm busted several times and drained a thick white pus-like fluid at first, and later drained a clear yellow fluid. Rates pain 1/10. Denies fever, chills, sweats, nausea, vomiting. US 1/24/19, I&D on 1/25/19, Cultures obtained, wet-to-dry dsg BID.
Age: 37.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Mycobacterium test, Nodule, Purulent discharge, Skin lesion
Clinical narrative: Patient is a 38-year-old female who presents for evaluation of left arm injection site. Patient had injections in right and left proximal upper extremities on 10/3/18. Patient is unsure of which injections were in which arm. Patient states she noticed a reaction on her proximal left upper extremity about 3 weeks following the shot. States she noticed a knot appear on the proximal left upper extremity. Denies any drainage of lesion on the left proximal upper extremity. Patient reports about 4-5 weeks following injection, she noticed a knot appear on her proximal right upper extremity. States that the lesion on her right arm busted several times and drained a thick white pus-like fluid at first, and later drained a clear yellow fluid. Rates pain 1/10. Denies fever, chills, sweats, nausea, vomiting. US 1/24/19, I&D on 1/25/19, Cultures obtained, wet-to-dry dsg BID.
Age: 17.0
Sex: F
Vaccine: HPV9, MMR, VARCEL, HPV9, MMR, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This prospective pregnancy report has been received from an office manager referring to a 17 year old female patient who was 22 weeks pregnant. The patient's concomitant medication included prenatal vitamins. No information was provided regarding the patients' medical history, concurrent conditions or drug reactions/allergies. On 07-JAN-2019, the patient was vaccinated with GARDASIL 9 with lot number R016970 and expiration date on 22-MAR-2021, administered for prophylaxis (strength, dose, dose number, route of administration and anatomical injection site were not reported), (M-M-R II with lot number R000551 and expiration date on 08-JAN-2020, administered for prophylaxis (strength, dose, dose number, route of administration and anatomical injection site were not reported) and VARIVAX with lot number R006754 and expiration date on 06-MAR-2020, administered for prophylaxis (strength, dose, dose number, route of administration and anatomical injection site were not reported). No adverse effects reported. The patient sought for medical attention by seeing the physician and did not receive treatment. No laboratories or studies were performed to the patient.
Age: 17.0
Sex: F
Vaccine: HPV9, MMR, VARCEL, HPV9, MMR, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This prospective pregnancy report has been received from an office manager referring to a 17 year old female patient who was 22 weeks pregnant. The patient's concomitant medication included prenatal vitamins. No information was provided regarding the patients' medical history, concurrent conditions or drug reactions/allergies. On 07-JAN-2019, the patient was vaccinated with GARDASIL 9 with lot number R016970 and expiration date on 22-MAR-2021, administered for prophylaxis (strength, dose, dose number, route of administration and anatomical injection site were not reported), (M-M-R II with lot number R000551 and expiration date on 08-JAN-2020, administered for prophylaxis (strength, dose, dose number, route of administration and anatomical injection site were not reported) and VARIVAX with lot number R006754 and expiration date on 06-MAR-2020, administered for prophylaxis (strength, dose, dose number, route of administration and anatomical injection site were not reported). No adverse effects reported. The patient sought for medical attention by seeing the physician and did not receive treatment. No laboratories or studies were performed to the patient.