chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain, Product administered at inappropriate site
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 67 years old female patient who experienced bit red at the injection site and pain, FLUZONE HD intramuscular rather than subcutaneously and FLUZONE HIGH-DOSE was administered close to the elbow rather than in the deltoid, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 16-Oct-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ030AA via subcutaneous route. On an unknown date, patient developed a non-serious bit red at the injection site and pain following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was also a case of actual medication error due to Inappropriate route of vaccination and vaccine administered at inappropriate site. (Other relevant tests included no lab test.) Final diagnosis was FLUZONE HIGH-DOSE was administered close to the elbow rather than in the deltoid, FLUZONE HD intramuscular rather than subcutaneously and bit red at the injection site. It was not reported if the patient received a corrective treatment. The patient outcome was reported as Unknown for bit red at the injection site and pain. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU4, MENB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 20 years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UI997AA, expiration date: 30-JUN-2019, site of administration: right deltoid and route was not reported) on 07-Sep-2018 and FLUZONE (Batch number: UJ009AB, expiration date: 30-JUN-2019, site of administration: left deltoid and route was not reported) on 17-Oct-2018. Concomitant medications included TRUMENBA. The patient's medical history were not reported. It was an actual medication error due to extra dose administered (20 year old male received FLUZONE QUADRIVALENT on 07-Sep-2018 and 17-Oct-2018/No AE). No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 8.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an eight years old male patient and reported that Flublok was inadvertently given to an 8 years old patient, while he received vaccineFLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. No other vaccines given at the time. On 20-Oct-2018, the patient received a dose of 0.5 ml suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QFAA1820 and expiry date: 30-Jun-2019) via intramuscular route in the right deltoid. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid serious case received from a pharmacist. This case involves a male patient (age was not reported) who was administered with an expired dose of FLUZONE HIGH DOSE (lot number and expiry date not reported) on 20-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is an actual medication error case due to expired vaccine used. It was reported that male patient was administered with an expired dose of vaccine on 20-Oct-2018. It was not reported that the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four years old male patient who received 0.5 ml FLUBLOK QIV lot QFAA1816, expiry date: 30-Jun-2019 via intramuscular route in the left arm. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to Inappropriate age at vaccine administration. It was reported that administered FLUBLOK to a four-year-old patient. No reaction reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 0.17
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from non-healthcare professional. This case involves a two-months old patient who was vaccinated with a dose of PENTACEL (batch number: C5447AA, expiration date: 18-Oct-2019, dose and route of administration was not reported) in left thigh on an unspecified date. The patient's medical history was not reported. Concomitant medications included PREVNAR and ROTAVIRUS VACCINE. It was an actual medication error due to inappropriate reconstitution technique as the patient received PENTACEL component DTaP-IPV without the Hib component. No known reported symptoms. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 2 months old patient who received vaccine PENTACEL. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect PENTACEL lot number, expiry date not reported via unknown route in unknown administration site. It was an actual medication error due to inappropriate reconstitution technique. It was reported that staff accidentally gave the diluent from PENTACEL directly to the patient without mixing it with the lyophilized Hib component. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a health professional (epidemiologist). This case involves 12 adult patients (unknown gender) who received vaccine FLUZONE after there were two temperature excursions. The patient's past medical history and concomitant medications were not provided. It was a case of actual medication error due to incorrect product storage error. It was reported that on first occasion, vaccines were left out for 2 hours at 71 degrees and 4 hours at 71 degrees on second occasion. Vaccines were stored at temperature outside the recommended range (2 degree to 8 degree C; 35 degree to 46 degree F). It was unknown if any patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves four patients (age and gender was not reported) who were vaccinated with a dose of FLUZONE QUADRIVALENT (lot number and expiry date was not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was not reported whether the patient experienced any adverse events following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid serious case received from a consumer (told by nurse). This case involves an 83-years old female patient who experienced numbness up one leg to her calve and Guillain Barre Syndrome, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date (about two weeks prior), the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site. On an unspecified date, the patient developed a serious Guillain Barre Syndrome and a numbness up one leg to her calve one-week following the administration of INFLUENZA VACCINE. It was reported that after injection of about 2 weeks prior and after 1 week started having numbness up one leg to her calve and possible GBS (Guillain Barre Syndrome). (Other relevant tests included no lab data). Final diagnosis was Guillain Barre Syndrome. It was not reported if the patient received a corrective treatment. The patient outcome was reported as Unknown for numbness up one leg to her calve and Guillain Barre Syndrome. List of documents held by sender: none. Sender's Comments: This case involves an 83-years old patient who presented with possible Guillain Barre Syndrome with numbness up one leg to her calve post vaccination with FLUZONE HIGH DOSE. Time to onset is unknown. Guillain-Barré Syndrome is a expected following FLUZONE HIGH DOSE vaccination. However, further information including patient's medical history, medical condition at the time of vaccination, clinical description of GBS, lab investigation reports result would be relevant for accurate assessment. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 2 weeks old patient for whom FLUZONE QUAD pediatric prefilled syringe was given to a child less than 6 months old was reported, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On an unknown date, the patient received a 0.25 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via intramuscular route in the thigh nos. Reporter reported that she did not order this vaccine to be given but it was administered by nurse. No side effects noticed yet. This case is actual medication error case due to inappropriate age at vaccine administration. Final diagnosis was FLUZONE QUAD pediatric prefilled syringe was given to a child less than 6 months old. Outcome of the event was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 73.0
Sex: F
Vaccine: FLUR4
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 73 years old female patient who received two doses of 0.5 mL of vaccine FLUBLOK QIV lot QFAA1810, expiry date: 30-06-19 via intramuscular route in the left deltoid on 01-Oct-2018 and 22-Oct-2018 respectively. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to Extra dose administered. It was reported that inadvertently gave a second dose of FLUBLOK QUADRIVALENT to the same patient. First dose was administered on 01-Oct-2018 and the second dose was administered on 22-Oct-2018. It was a case of actual medication error due to Extra dose administered. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: M
Vaccine: TDAP
Symptoms: Parosmia
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown age male patient who experienced phantosmia, while he received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date roughly in 2010, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number not reported) via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious phantosmia (parosmia) 2 weeks following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Final diagnosis was phantosmia. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not recovered/Not resolved on an unknown date for phantosmia. It was reported that the event persists periodically today but not as intense. List of documents held by sender: none.
Sex: M
Vaccine: FLUR4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves male patient of an unknown age who experienced tingling in the left arm and numbness in the left arm, while he received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in the left deltoid (dose and expiry date not reported). On an unknown date, patient developed a non-serious tingling in the left arm and numbness in the left arm lasted a short while following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. Other relevant tests included no lab data. Final diagnosis was numbness in the left arm and tingling in the left arm. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. List of documents held by sender- none.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Soreness at injection site, big time fatigue, headache, shivering. I was fine by the evening of 10/3/18.
Age: 57.0
Sex: F
Vaccine: FLUC4, FLUR4
Symptoms: Bacterial test negative, Guillain-Barre syndrome, Neurological examination abnormal, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: GUILLAIN BARRE SYNDROME.
Age: 57.0
Sex: F
Vaccine: FLUC4, FLUR4
Symptoms: Viral test negative
Clinical narrative: GUILLAIN BARRE SYNDROME.
Age: 57.0
Sex: F
Vaccine: FLUC4, FLUR4
Symptoms: Endotracheal intubation, Gait inability, Guillain-Barre syndrome, Intensive care, Medical device implantation
Clinical narrative: GUILLAIN BARRE SYNDROME.
Age: 57.0
Sex: F
Vaccine: FLUC4, FLUR4
Symptoms: Motor dysfunction, Muscular weakness, Paralysis, Respiratory failure, Tracheostomy
Clinical narrative: GUILLAIN BARRE SYNDROME.
Age: 60.0
Sex: M
Vaccine: FLUX, FLU4
Symptoms: Pain, Pain in extremity, X-ray
Clinical narrative: This RN received phone call from spouse of individual who received a flu vaccine at their place of employment on 9-27-2018. Spouse reports husband received flu vaccine and almost immediately had issues with pain and has continued to progress. Reports left arm is unusable without unbearable pain. Reports went to Walk-In Clinic on 10-24-2018 as "could not stand the pain anymore." Reports XRay completed and informed to follow-up with Primary Care Physician. Has appointment on November 8, 2018, Physician.
Age: 60.0
Sex: M
Vaccine: FLUX, FLU4
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: This RN received phone call from spouse of individual who received a flu vaccine at their place of employment on 9-27-2018. Spouse reports husband received flu vaccine and almost immediately had issues with pain and has continued to progress. Reports left arm is unusable without unbearable pain. Reports went to Walk-In Clinic on 10-24-2018 as "could not stand the pain anymore." Reports XRay completed and informed to follow-up with Primary Care Physician. Has appointment on November 8, 2018, Physician.
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Condition aggravated, Seizure
Clinical narrative: Today (10/26/2018) child had 7 minute seizure. Mother states worse she has ever had. Vaccine she had was riv4?
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Large swelling, redness, hot to touch and painful.
Age: 14.0
Sex: F
Vaccine: FLUR3
Symptoms: Fatigue, Headache, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative
Clinical narrative: Awoke early in the morning (Oct. 23) after receiving vaccine at 5am with headache, sore throat, fatigue and body aches at 12:30pm had fever of 102.7 which responded to tylenol. Later in evening fever was 101.8 at 9pm and again responded well to tylenol. Symptoms persisted into the next day (Oct. 24th) until about 1pm. Had low grade fever 99.4 in the morning. Symptoms had significantly decreased by 2pm.
Age: 14.0
Sex: F
Vaccine: FLUR3
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Streptococcus test negative
Clinical narrative: Awoke early in the morning (Oct. 23) after receiving vaccine at 5am with headache, sore throat, fatigue and body aches at 12:30pm had fever of 102.7 which responded to tylenol. Later in evening fever was 101.8 at 9pm and again responded well to tylenol. Symptoms persisted into the next day (Oct. 24th) until about 1pm. Had low grade fever 99.4 in the morning. Symptoms had significantly decreased by 2pm.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves Adult female patient of unknown age who experienced redness at injection site, heat at injection site, swelling and slight rash, while she received vaccine FLUZONE QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ034AB via unknown route. On an unknown date, the patient developed a non-serious redness at injection site following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious heat at injection site following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious swelling following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious slight rash following the administration of INFLUENZA QUADRIVAL A-B VACCINE. (Other relevant tests included No lab data.) Final diagnosis was slight rash, swelling, and heat at injection site and redness at injection site. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for swelling, as Unknown for redness at injection site, as Unknown for slight rash and as Unknown for heat at injection site. List of documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache
Clinical narrative: Headache and fatigue.
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: WAS GIVEN DTAP INSTEAD OF TDAP.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Malaise, Migraine
Clinical narrative: Migraine headache and malaise that started about 4 hours after the injection and has continued into today (10/26/18). I am pregnant.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site inflammation, Injection site pain
Clinical narrative: Pain to left arm, shoulder, reduced range of motion, inflammation.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Fall, Tremor
Clinical narrative: Patient came to office with parent for second GARDASIL and flu vaccine. Reviewed allergies, no previous reactions to vaccines. GARDASIL administered in left deltoid. Flu vaccine administered in right deltoid. Patient stated she felt okay. Patient stood up, then fell to the ground. Unclear if patient hit head. Patient's body shook for 2 seconds. Patient opened eyes. RN called for assistance. Dr. and nursing staff came to room. Blood pressure 104/60, heart rate 81. Dr. stayed in room for 15 minutes to monitor patient. Patient drank 20 oz water, states she feels okay. Denies pain or light headedness. Patient stood and walked without difficulty. Per Dr., okay for patient to leave office. Advised parent to call office with any questions, concerns, or if any new symptoms arise. Patient left office in stable condition with mother.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Feeling abnormal, Headache, Insomnia
Clinical narrative: 130ish heart rate all night long, shivers, maybe a fever (didn't get up to take it but felt like I had a high fever), headache that wouldn't go away, body/muscle aches, a little raw throat, about 6 inches of hot redness around area. I felt better around 3:00 p.m. I had to call in sick since didn't sleep most of night and still felt terrible at 6 a.m.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pyrexia, Skin warm, Throat irritation
Clinical narrative: 130ish heart rate all night long, shivers, maybe a fever (didn't get up to take it but felt like I had a high fever), headache that wouldn't go away, body/muscle aches, a little raw throat, about 6 inches of hot redness around area. I felt better around 3:00 p.m. I had to call in sick since didn't sleep most of night and still felt terrible at 6 a.m.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Pruritus, Urticaria
Clinical narrative: Tingling, itching and hives all over hands only. Started evening after receiving vaccine and has not gone away since (dose on 10/11, todays date 10/26).
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Herpes zoster, Injection site pain, Mammogram, Pain
Clinical narrative: Employee received flu vaccination on 9/12/18. That night the pain at the injection site woke her up out of sleep and she had to take over the counter medication for relief (Motrin). Employee continued to have pain at injection site and the next day developed a red rash along arm, down left breast and chest, and across shoulder. Employee then began to have shooting sharp pain down shoulder and into left breast. Employee went to see her doctor who ordered imaging. About 2 weeks after vaccine employee developed blisters where red rash was that were very painful. Clothing against the rash exacerbated the pain. Employee talked to her doctor through online portal and based on her description the doctor said it sounded like shingles and offered medication to employee. Employee declined as she was already towards the end of the shingles course.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Ultrasound breast
Clinical narrative: Employee received flu vaccination on 9/12/18. That night the pain at the injection site woke her up out of sleep and she had to take over the counter medication for relief (Motrin). Employee continued to have pain at injection site and the next day developed a red rash along arm, down left breast and chest, and across shoulder. Employee then began to have shooting sharp pain down shoulder and into left breast. Employee went to see her doctor who ordered imaging. About 2 weeks after vaccine employee developed blisters where red rash was that were very painful. Clothing against the rash exacerbated the pain. Employee talked to her doctor through online portal and based on her description the doctor said it sounded like shingles and offered medication to employee. Employee declined as she was already towards the end of the shingles course.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pruritus, Swelling
Clinical narrative: Flu like symptoms, localized swelling and itching.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Within minutes after injection of Flu vaccine patient started having itching and redness to site with hives further down her left arm. Patient was given epinephrine 0.3 mg/0.3 ml IM and itching was relieved within 20 minutes and redness was stopped.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Joint range of motion decreased, Rotator cuff syndrome, X-ray limb abnormal
Clinical narrative: Uncommon pain and swelling at injection site several hours after injection. Pain and swelling remain plus diminished range of motion of left arm and left shoulder from time period of injection to current date. Diagnosed with shoulder impingement syndrome due to vaccine. Type of treatment includes large doses of NSAID and physical therapy for 6 weeks.
Age: 33.0
Sex: M
Vaccine: SMALL
Symptoms: Cardiac discomfort, Chills, Hyperhidrosis, Lung disorder, Pain
Clinical narrative: Lungs were burning and heart felt weird when I got home from work. I had a fever, sweating, body aches and chills later that day and also while sleeping that night. A few days later I broke out with a red rash in my armpits.
Age: 33.0
Sex: M
Vaccine: SMALL
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Lungs were burning and heart felt weird when I got home from work. I had a fever, sweating, body aches and chills later that day and also while sleeping that night. A few days later I broke out with a red rash in my armpits.
Age: 64.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Asthenia, Decreased appetite, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Within 12 hour's after the vaccine I awoke with pain redness in the left deltoid around 4:30am.  The area was hot, painful about a "quarter" size. I had nausea, fever 100.5, malaise, body weakness, exhaustion, thoughts were cloudy. The initial 24 hour period post vaccine was extremely bad. I did not have an appetite for one week. The rash progressed on a daily basis which I documented by photos.
Age: 64.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Injection site warmth, Malaise, Nausea, Pyrexia, Rash
Clinical narrative: Within 12 hour's after the vaccine I awoke with pain redness in the left deltoid around 4:30am.  The area was hot, painful about a "quarter" size. I had nausea, fever 100.5, malaise, body weakness, exhaustion, thoughts were cloudy. The initial 24 hour period post vaccine was extremely bad. I did not have an appetite for one week. The rash progressed on a daily basis which I documented by photos.
Age: 64.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Thinking abnormal
Clinical narrative: Within 12 hour's after the vaccine I awoke with pain redness in the left deltoid around 4:30am.  The area was hot, painful about a "quarter" size. I had nausea, fever 100.5, malaise, body weakness, exhaustion, thoughts were cloudy. The initial 24 hour period post vaccine was extremely bad. I did not have an appetite for one week. The rash progressed on a daily basis which I documented by photos.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site pain, Pruritus, Skin warm, Swelling
Clinical narrative: Redness, swelling, hot, tender at site, itching.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Feeling cold, Gingival bleeding, Gingival swelling, Hot flush, Swelling face
Clinical narrative: After the vaccination (that same day), one particular tooth started hurting like it was going to fall out, but it was not loose. The next morning, I noticed (and a deacon at church noticed) the entire right side of my face was swollen. My gums were swollen, and they were bleeding--this continued until the swelling went down. The swelling lasted for approximately 2 weeks. I was also getting hot and cold flashes throughout the day and night during this time, waking up in the morning so cold. In addition, my hands were shaking/trembling--this was noted by others. They still shake/tremble as of this report date (10/26/2018). The facial swelling has not gone down, but one area is still tender.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Toothache, Tremor
Clinical narrative: After the vaccination (that same day), one particular tooth started hurting like it was going to fall out, but it was not loose. The next morning, I noticed (and a deacon at church noticed) the entire right side of my face was swollen. My gums were swollen, and they were bleeding--this continued until the swelling went down. The swelling lasted for approximately 2 weeks. I was also getting hot and cold flashes throughout the day and night during this time, waking up in the morning so cold. In addition, my hands were shaking/trembling--this was noted by others. They still shake/tremble as of this report date (10/26/2018). The facial swelling has not gone down, but one area is still tender.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Fatigue, Lip blister, Skin discolouration
Clinical narrative: I received the vaccine on 10/16/18. I felt a little bit weak and tired for 4 - 6 days after receiving the vaccine. On Friday, October 19th, I woke up with a small blister to the left of my upper lip. I applied warm compresses with apple side vinegar for the next three days. Blister cleared out nicely. Then on Monday, October 22nd, I woke up with an orange dot, half the size of a dime in the palm of my left hand. I took a picture of this to share with my doctor but it cleared up in two days. I am not sure if this is as a result of the flu shot, but these events did surface after taking the flu shot so I did not have anything else to attribute them to. It is not my place to report of others, but I know of at least two other persons who received vaccines on the same day and are now walking around with lip blisters. Thought I should give my feedback.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Pyrexia, Vomiting
Clinical narrative: Pt. states sudden chills, fever, headache and vomited once starting approx. 5 hours after getting the shot on 10/25. Called 10/26 to report. Pt states she is still have issues but not bound to the bed.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Swelling
Clinical narrative: Patient presented to pharmacy with swelling in left arm from shoulder to elbow. She also stated that the swelling was over to her collarbone. The area was warm to the touch and red.
Age: 12.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Injection site pain, Mobility decreased, Pain, Pallor
Clinical narrative: This is for the MMR. She almost immediately started to feel tired and drained. There was a significant amount of soreness not just in the shot area but about the entire body. She ran a fever for 2 days and could not move hardly for 3 or 4 days. Her coloring is just now starting to come back after more than a week and a half. She complained the entire time of being so tired and was not in a good place. Till this day the injection spot is still sore.
Age: 12.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: This is for the MMR. She almost immediately started to feel tired and drained. There was a significant amount of soreness not just in the shot area but about the entire body. She ran a fever for 2 days and could not move hardly for 3 or 4 days. Her coloring is just now starting to come back after more than a week and a half. She complained the entire time of being so tired and was not in a good place. Till this day the injection spot is still sore.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Apnoea, Blood glucose decreased, Death, Hypotonia, Resuscitation
Clinical narrative: Patient found in bed, limp and apneic, at 4 AM and rushed to hospital emergency room where efforts to revive were unsuccessful.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Rash, Skin warm, Tenderness
Clinical narrative: Only had this vaccine as a second dose. Previous vaccine was at the same time as a DTP (different arms). First vaccine woke up the next morning with a low grade fever and rash. After 2-3 days rash spread to about 5 inches across and very painful to touch and hot. Second dose had a small rash and low grade fever the next morning as well. After less than 48 hours the rash is about 6 inches long and 3 inches wide. Very tender, painful and hot.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Discomfort, Fatigue, Headache, Injection site pain
Clinical narrative: I was exhausted all day after having the injection with a stomach ache. When I went to bed around midnight, my entire body was sore. I could not get comfortable. Everything ached. The injection site is sore and swollen. My stomach ache was worse, with some nausea. This morning I have the same symptoms and a bad headache. I am very tired, achy and sore (neck, arms, back legs...seems like everywhere).
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Nausea, Neck pain, Pain, Pain in extremity
Clinical narrative: I was exhausted all day after having the injection with a stomach ache. When I went to bed around midnight, my entire body was sore. I could not get comfortable. Everything ached. The injection site is sore and swollen. My stomach ache was worse, with some nausea. This morning I have the same symptoms and a bad headache. I am very tired, achy and sore (neck, arms, back legs...seems like everywhere).
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient's arm is red, sore, puffy, warm to the touch and extremely painful.  Symptoms presented within 24 hours and has gotten worse over the past 2 days.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Migraine, Pain, Pyrexia, Swelling
Clinical narrative: Migraine, severe chills to the point of body tremors, 102 fever, major body aches, swelling of my neck.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Migraine, severe chills to the point of body tremors, 102 fever, major body aches, swelling of my neck.
Age: 39.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Pt received pneumonia and influenza vaccines from PCP's office on 10/24/18 in the same arm (left). She presented to Urgent Care on 10/26/18 with left arm redness, swelling, and increased tenderness. No signs for cellulitis but pt was given topical triamcinolone 01% cream for topical relief, advised ice/heat as needed and given a prescription for BACTRIM DS BID x7 days to begin if symptoms worsen over the next 24-48 hours.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Local reaction
Clinical narrative: Pt had a local reaction to the injection site of a 50 cent piece size redness and warmth. The nurse at the facility of where she received the injection during an on-site clinic event states it is not a reaction that the patient needs to be seen for. She states she had marked the parameters and will watch it through the day. I spoke with our Standing Order physician: and she states this reaction can happen occasionally and just to keep an eye on it.
Age: 27.0
Sex: F
Vaccine: FLUR4
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: A couple hours after injection, about 3 inches below injection site became swollen and a red patch formed in a circular shape. The swelling progressed and size increased over the next couple of days until it resolved 3 and a half days later. Arm was also hard to lift and painful.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Hypotonia, Pain in extremity, Peripheral swelling
Clinical narrative: 6 hrs after injection arm pain 10/10, arm went limp, associated swelling next day pain reduced to 2/10.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Crying, Feeling hot, Somnolence, Tremor, Unresponsive to stimuli
Clinical narrative: Started feeling warm at 8:00pm (3 hours after vaccination), TYLENOL 5ml was given at 8:10pm. Shortly after, was in mom's arms, looking at her, when his arms and legs began to shake. Family called 911. Estimated episode lasted between 5 and 10 minutes. Squad arrived 4 minutes after call and patient was no longer seizing. Family reports patient was unresponsive immediately after shaking stopped, then began crying, and has been sleepy since. Arrived at Hospital ED at 8:31pm. Ibuprofen 148mg was given at 9:27pm, and patient was discharged at 10:48pm.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Erythema, Hypertension, Rash
Clinical narrative: Systemic Reaction to FLUARIX. Rash, redness, minor difficulty breathing, increase b/p. Treated with epi, benadryl, solumedrol, iv fluids. Monitored for 2 hours. Patient stabilized.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pain, redness, warmth at injection site.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash, hives, itching to chest, neck, scalp, ears.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Pyrexia
Clinical narrative: This occurred with first dose on 5/30/2018 as well. About 5 hours after injection, a severe headache started. About 12 hours post injection, severe diarrhea with fever and chills. All symptoms resolved within 36 hours with just residual fatigue. Neither doctor or pharmacy was notified as symptoms were listed as possible side effects and fully resolved. (Still better than getting shingles.)
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Hyperhidrosis, Loss of consciousness, Pyrexia, Staring
Clinical narrative: She received her flu shot at the workplace clinic with her family. Upon returning to her house with her family, she was staring at the cupboards in their kitchen. Her dad asked her what she was doing and then she passed out. She was laid to the ground by her father. She was sweating and then awoke. She did have a 99.3 fever after this event. They called and talked to, the ARNP at the Clinic about this occurrence. She stated to just watch her. The next day she was back to her self again. She did pass out after her vaccination last year also and a VAERS was submitted for that incident also.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Headache, Injection site pain, Injection site pruritus
Clinical narrative: Extremely bad muscle and joint pains for approximately 16hours. feverish, weak, headache approximately 16 hours in duration. Blotchy type rash with itching developed at injection site and spread below site about an inch or more. This developed or was noted about 14 hours after injection done on the 23rd. Area still sore,silghtly swollen and itchy today 10/26.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Myalgia, Pyrexia, Rash macular
Clinical narrative: Extremely bad muscle and joint pains for approximately 16hours. feverish, weak, headache approximately 16 hours in duration. Blotchy type rash with itching developed at injection site and spread below site about an inch or more. This developed or was noted about 14 hours after injection done on the 23rd. Area still sore,silghtly swollen and itchy today 10/26.
Age: 15.0
Sex: M
Vaccine: FLUC4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Within 30-60 seconds after receiving the vaccine the patient passed out, within seconds regained consciousness, but reported inability to see. 911 was called, EMT did clear him as most likely vasovagal syncope. Contacted mom 10/24/18 and patient is back to normal. No medical attention was received.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Red circle (4-5? In diameter) around injection site, swollen and firm to touch; minor discomfort.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Mobility decreased, Pain, Paraesthesia
Clinical narrative: Day after vaccine was administered to R deltoid, pt developed pain, which was explained was expected. But decided to come when the pain, and the inability to fully move his arm and the tingling that developed to that arm after 7 days post vaccine.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Warm to the touch, a little red and swollen and sore.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Extreme muscle aches, fever symptoms but no fever.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Chills, Dyspnoea, Headache, Influenza virus test negative
Clinical narrative: Around 1400 on 10-23-18 1 day after injection pt presented to clinic with Headache, chills, fever, nausea, photophobia, stiff neck, weakness, and shortness of breath. DECADRON 10mg was given IM. Pt returns to clinic for follow up on 10-26-18 and has sx's have greatly improved.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Mononucleosis heterophile test negative, Musculoskeletal stiffness, Nausea, Photophobia, Pyrexia
Clinical narrative: Around 1400 on 10-23-18 1 day after injection pt presented to clinic with Headache, chills, fever, nausea, photophobia, stiff neck, weakness, and shortness of breath. DECADRON 10mg was given IM. Pt returns to clinic for follow up on 10-26-18 and has sx's have greatly improved.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Streptococcus test negative
Clinical narrative: Around 1400 on 10-23-18 1 day after injection pt presented to clinic with Headache, chills, fever, nausea, photophobia, stiff neck, weakness, and shortness of breath. DECADRON 10mg was given IM. Pt returns to clinic for follow up on 10-26-18 and has sx's have greatly improved.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Night sweats, Pyrexia, Skin warm, Tenderness
Clinical narrative: Patient reports having fever, night sweats and the arm is red, hot and tender.