chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Balance disorder, Disorientation, Hallucination, visual, Vertigo
Clinical narrative: Case number PHHYY2015US154408 is an initial spontaneous report received from a consumer via Vaccine Adverse Events Reporting System (VAERS reference number: 597475) on 24 NOV 2015. This report refers to a 66 year old female patient. Her medical history included Bell's palsy. Her current conditions included allergy to antibiotics, COX-2 inhibitors and citrus. Her concomitant medications were prednisone 4 mg daily and Tylenol arthritis once daily. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 24 SEP 2015. On 26 SEP 2015, the patient experienced vertigo, disorientation and lack of balance. She had no rash, fever or nausea. She reported that a lighted clock face moved up and down in the dark when she was still. The events outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 2.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Scratch, Vaccination site swelling
Clinical narrative: Case number PHHY2015US154534, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 597844) website on 24 Nov 2015. This report refers to a 02 years old male patient. Medical history included reactive airway (not formally considered asthma). Concurrent conditions included allergy to Augmentin and cold. Concomitant medication was not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer unknown and batch number: not reported) intramuscularly in right arm on 28 Sep 2015. On 29 Sep 2015, the patient experienced swelling and redness around the site of the vaccine measured as 2 inches by 2.5 inches, scratch marks and radiating heat form site of vaccination. The patient was taken to an emergency room. The outcome of the events was reported as unknown. Events were reported as non-serious. The causality of the events was not reported.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Musculoskeletal stiffness, Pain in extremity, Vaccination error
Clinical narrative: Case number PHHY2015US154564, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 5978555) website on 24 Nov 2015. This report refers to a 55 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 06 Oct 2014. On 06 Oct 2014, the patient immediately experienced pain and stiffness in upper arm, residual soreness in upper arm and vaccine was administered improperly. The patient also reported that he could barely use upper arm for many months. The patient was taken to the emergency room. The outcome of the events was reported as unknown. The seriousness of the events was reported as non serious by the health authority. The causality of the events was not reported.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site joint movement impairment, Injection site pain, Poor quality sleep
Clinical narrative: Case number PHHY2015US155235, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 598098) website on 24 Nov 2015. This report refers to a 57-year-old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the right arm on 30 Sep 2015. On the same day after vaccination, the patient experienced severe pain in the right shoulder (same side as injection) with certain movements. The patient had a limited mobility of right shoulder without inducing extreme pain and any minimal movement woke up the patient while sleeping. Outcome of the events was reported as unknown. Events were reported as non serious and causality was not reported.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Burning sensation, Mobility decreased, Musculoskeletal pain, Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHHY2015US155333, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 598098) website on 24 Nov 2015. This report refers to a female patient of an unknown age. Past medical history and concomitant medications were not reported. Current condition included multiple unspecified allergies to unspecified pain medications. Concomitant medications included analgesics (manufacturer unknown) and TYLENOL. The patient took TYLENOL thirty minutes before the vaccination. The patient vaccination history included administration of pneumococcal vaccine (manufacturer not reported). The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in arm and PNEUMOVAX 23 (batch number: not reported) intramuscularly in the arm both administered at 12.00 on 28 Sep 2015. On the same day 6 hours after vaccination, the patient experienced swelling and burning of her fingers and her shoulder started hurting. She took another TYLENOL, but it did not work. On the same day after vaccination at 8 o clock, 8 hours after vaccination, the patient was not able to move her arm. She tried using a cold pack on her arm, which helped, but her hand was still swollen. In the night of 28 Sep 2015, she did not sleep well, and could not move in bed. She also used alternating cold water bottles and hot, but only slept for 2 hours. On 29 Sep 2015 at 14:00, 26 hours post vaccination, she could lift her arm, but it was still sore, but was getting better. The patient did not seek medical attention because her arm seemed to be getting better. No lab diagnostics studies were performed. The patient reported that inability to move her arm lasted for 24 hours (resolved on approximately 29 Sep 2015 at 20:00). Outcome of the event injected limb mobility decreased was reported as complete recovery and outcome of other events were reported as condition improving. Events were reported as non serious and causality was not reported. No further information was expected no contact details were provided and reporter did not wish contact the physician.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Poor quality sleep, Sensory loss
Clinical narrative: Case number PHHY2015US155333, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 598098) website on 24 Nov 2015. This report refers to a female patient of an unknown age. Past medical history and concomitant medications were not reported. Current condition included multiple unspecified allergies to unspecified pain medications. Concomitant medications included analgesics (manufacturer unknown) and TYLENOL. The patient took TYLENOL thirty minutes before the vaccination. The patient vaccination history included administration of pneumococcal vaccine (manufacturer not reported). The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in arm and PNEUMOVAX 23 (batch number: not reported) intramuscularly in the arm both administered at 12.00 on 28 Sep 2015. On the same day 6 hours after vaccination, the patient experienced swelling and burning of her fingers and her shoulder started hurting. She took another TYLENOL, but it did not work. On the same day after vaccination at 8 o clock, 8 hours after vaccination, the patient was not able to move her arm. She tried using a cold pack on her arm, which helped, but her hand was still swollen. In the night of 28 Sep 2015, she did not sleep well, and could not move in bed. She also used alternating cold water bottles and hot, but only slept for 2 hours. On 29 Sep 2015 at 14:00, 26 hours post vaccination, she could lift her arm, but it was still sore, but was getting better. The patient did not seek medical attention because her arm seemed to be getting better. No lab diagnostics studies were performed. The patient reported that inability to move her arm lasted for 24 hours (resolved on approximately 29 Sep 2015 at 20:00). Outcome of the event injected limb mobility decreased was reported as complete recovery and outcome of other events were reported as condition improving. Events were reported as non serious and causality was not reported. No further information was expected no contact details were provided and reporter did not wish contact the physician.
Age: 2.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia, Urticaria
Clinical narrative: Case number PHHY2015US155402, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 598282) on 24 Nov 2015. This report refers to a 02 years old male patient. Past medical history and concomitant medications were not reported. Current conditions included milk allergy, egg allergy and wheat allergy. The patient vaccinated with a seasonal influenza vaccine (manufacturer unknown, batch number and expiry date: not reported) in the left leg on 30 Sep 2015. On 01 Oct 2015, hives broke out over entire face of the patient and experienced fever. The patient was treated with TYLENOL. Outcome of the event pyrexia was reported as condition improving and outcome of the broke out in hives over entire face was not reported. Events were reported as non serious and causality was not reported.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Disorientation, Flushing, Headache, Malaise, Pyrexia
Clinical narrative: Case number PHHY2015US154921, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 598369) website on 24 Nov 2015. This report refers to a 49-year-old male patient. The patient had no medical history and current illness. Concomitant medication included simvastatin. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into the left arm on 30 Sep 2015. On the same day after vaccination the patient experienced severe headache, malaise, flushing. low grade fever and disorientation. The patient slept for 10.5 hours in the night. The patient felt relatively normal on the next day. Final outcome of the events was recovered. Events were reported as non-serious and causality of the events was not reported.
Age: 78.0
Sex: M
Vaccine: FLUX
Symptoms: Migraine
Clinical narrative: Case number PHHY2015US154456, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 598392) website on 24 NOV 2015. This report refers to a 78 year old male patient. Medical history and concomitant medication were not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 08 SEP 2015. On the same day, after vaccination, the patient developed migraine headaches. Outcome of the events was unknown. Events were reported as non-serious. Causality was not reported.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Contusion, Mobility decreased, Musculoskeletal pain, Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHHY2015US154605, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 598406) website on 24 NOV 2015. This report refers to a 41-year-old female patient. Historical conditions included slight asthma. Current conditions included penicillin allergy and minocin, Zithromax, sulfa. Concomitant medical included: Singulair, oral contraceptive (manufacturer unknown), cetirizine (manufacturer unknown), Multi vitamin, levothyroxine (manufacturer unknown). The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 20 OCT 2014. The same day after vaccination the patient experienced terrible arm pain/bruising the first couple of days, could not lift arm past chest, could not lift any weighted objects took ibuprofen for pain gained back mobility in arm, and swelling/bruising which was decreased after about 3 days over the course of the past year. The patient shoulder pain flares up frequently (daily/every other day) and it was seemed to be getting worse over the time. Pain (sharp/throbbing) was present event with little activity. The patient visited to emergency room. The patient was lying in the bed, sitting at desk/computer and applying pressure on the injection site yields a bruising pain as well and frequently taking ibuprofen (manufacturer unknown) and Aleve for pain, as well as applying menthol creams/sticks. Outcome of the event swelling/bruising as condition improving and for rest of the events were condition unchanged. Seriousness of events were reported as non-serious and causality was not reported.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Weight bearing difficulty
Clinical narrative: Case number PHHY2015US154605, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 598406) website on 24 NOV 2015. This report refers to a 41-year-old female patient. Historical conditions included slight asthma. Current conditions included penicillin allergy and minocin, Zithromax, sulfa. Concomitant medical included: Singulair, oral contraceptive (manufacturer unknown), cetirizine (manufacturer unknown), Multi vitamin, levothyroxine (manufacturer unknown). The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 20 OCT 2014. The same day after vaccination the patient experienced terrible arm pain/bruising the first couple of days, could not lift arm past chest, could not lift any weighted objects took ibuprofen for pain gained back mobility in arm, and swelling/bruising which was decreased after about 3 days over the course of the past year. The patient shoulder pain flares up frequently (daily/every other day) and it was seemed to be getting worse over the time. Pain (sharp/throbbing) was present event with little activity. The patient visited to emergency room. The patient was lying in the bed, sitting at desk/computer and applying pressure on the injection site yields a bruising pain as well and frequently taking ibuprofen (manufacturer unknown) and Aleve for pain, as well as applying menthol creams/sticks. Outcome of the event swelling/bruising as condition improving and for rest of the events were condition unchanged. Seriousness of events were reported as non-serious and causality was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Decreased appetite, Pain, Pyrexia, Somnolence
Clinical narrative: Case number PHHY2015US154289, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 598411) website on 24 Nov 2015. This report refers to a 53-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with a seasonal Influenza vaccine (manufacturer and batch number: not reported) in right arm intramuscularly on 16 Sep 2015. On the same day after 4 hours of vaccination the patient experienced all over body ached, fever, loss of appetite, wanted to just sleep. The patient did not receive any treatment. The patient went home for work and did not work the next day and only 1/2 day after that. The outcome of the events were complete recovery and seriousness and causality was not reported. Following an internal review for the data received on 24 Nov 2015, significant case correction was performed: Changed coding for the events. All over body ached to 'General body pain' and wanted to just sleep coded to excessive daytime sleepiness and deleted event activities of daily living impaired.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Blood test, Cardiac stress test, Chest pain, Congestive cardiomyopathy
Clinical narrative: Shortness of breath, lethargy, chest pains, aches in joints, diarrhea (chronic) currently being treated for cardiomyopathy with spironolactone, metoprolol, furosemide.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Dyspnoea, Echocardiogram, Electrocardiogram, Lethargy
Clinical narrative: Shortness of breath, lethargy, chest pains, aches in joints, diarrhea (chronic) currently being treated for cardiomyopathy with spironolactone, metoprolol, furosemide.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Pulmonary function test
Clinical narrative: Shortness of breath, lethargy, chest pains, aches in joints, diarrhea (chronic) currently being treated for cardiomyopathy with spironolactone, metoprolol, furosemide.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 21-SEP-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Claimant alledges after receiving a flu shot, she has had pain in her arm that has not subsided. The customer is reporting an injury to her left upper arm.
Age: 80.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injury, Pain in extremity
Clinical narrative: Claimant alledges after receiving a flu shot, she has had pain in her arm that has not subsided. The customer is reporting an injury to her left upper arm.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysphagia, Dyspnoea, Enlarged uvula, Headache, Malaise
Clinical narrative: Headache, sore arm, Swollen throat while laying down only.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain, Neck pain, Pharyngeal erythema, Pharyngeal oedema, Rhinorrhoea
Clinical narrative: Headache, sore arm, Swollen throat while laying down only.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Upper respiratory tract congestion
Clinical narrative: Headache, sore arm, Swollen throat while laying down only.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Headache, Pain in extremity, Pharyngeal oedema
Clinical narrative: Headache, sore arm, Swollen throat while laying down only.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Feeling abnormal, Pyrexia, Skin warm, Syncope
Clinical narrative: My daughter woke up and said she did not feel good. Her forehead was hot. We took her temperature and she had a fever. While leaving the bathroom, she fainted. She had a fever and stayed home the next day.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Hyperventilation
Clinical narrative: Began to hyperventilate.
Age: 15.0
Sex: F
Vaccine: HPVX
Symptoms: Abdominal pain upper, Electroencephalogram abnormal, Loss of consciousness, Muscle twitching, Seizure
Clinical narrative: Within 5 minutes of receiving her 2nd round of Gardasil, my daughter passed out on the exam table. Since that time she has been having periodic fainting spells, including but not limited to severe stomach pains. Her recent spells have developed muscle twitches in her arms. And we took her to the emergency room. Now going to doctors looking for answers. An ultrasound showed nothing in the abdomen but the EEG is showing signs of seizures.  My daughter was the picture of health before receiving this vaccine and her doctor is convinced it is not from the HPV vaccine.  I am convinced it is. I'm praying I have not caused my daughter to be sterile! Please let me know if any remedies have yet been found!
Age: 15.0
Sex: F
Vaccine: HPVX
Symptoms: Syncope, Ultrasound abdomen normal
Clinical narrative: Within 5 minutes of receiving her 2nd round of Gardasil, my daughter passed out on the exam table. Since that time she has been having periodic fainting spells, including but not limited to severe stomach pains. Her recent spells have developed muscle twitches in her arms. And we took her to the emergency room. Now going to doctors looking for answers. An ultrasound showed nothing in the abdomen but the EEG is showing signs of seizures.  My daughter was the picture of health before receiving this vaccine and her doctor is convinced it is not from the HPV vaccine.  I am convinced it is. I'm praying I have not caused my daughter to be sterile! Please let me know if any remedies have yet been found!
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Arm started hurting and I could not raise it. It kept hurting for days. My arm has continued to hurt and I have trouble raising it.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Feeling abnormal, Influenza
Clinical narrative: Based upon the follow-up information received on 27-Jan-2016, influenza vaccine was added as a company suspect drug. Initial information regarding this clinically sponsored solicited case was received on 13-Jan-2016 from the patient via the Patient Support Program. This case concerns an approximately 64 year old adult male patient who had mild flu symptoms few days after and was feeling tired and felt funny, unspecified time after receiving Praluent and influenza vaccine. No past drugs or concurrent conditions were reported. On 30-Dec-2015, the patient commenced therapy with subcutaneous alirocumab injection at the dose of 75 mg every other week (lot/batch number and expiry date unspecified) for Hyperlipidemia, unspecified delivered via alirocumab prefilled pen. On an unknown date, the patient started treatment with influenza vaccine (dose, form, route, frequency, lot/batch number and expiry date: unknown). On an unknown date, the patient reported having mild flu symptoms that started a few days after last injection. An unspecified time later, since an unknown date, the patient has been feeling tired lately. Reportedly, today was the first day he was starting to feel a little bit better. He has had sinus trouble for over 20 years and it was not unusual for him to have flu symptoms. Upon follow-up it was reported the patient felt funny after the 1st injection. He did develop flu-like symptoms. Symptoms were not severe. Patient not sure if it was the alirocumab or the flu shot that he received 2 weeks before. No information on any corrective treatment received was provided, and alirocumab was continued as planned. At time of reporting, the outcome of was unknown for feeling abnormal and recovering for other events. Reporter causality: Unknown for alirocumab and not reported for influenza vaccine. Company causality: Not associated for alirocumab and associated for influenza vaccine. Additional information was received on 27-Jan-2016 from the patient via patient support program: Influenza vaccine was added as a company suspect drug, new event of feeling abnormal was added and narrative was amended.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Infection, Injection site erythema, Injection site pain, Mass
Clinical narrative: Initial unsolicited report received from a non- healthcare professional on 27 January 2016. This case involves a 64-year-old female patient who was vaccinated with a first dose of ADACEL (batch number: U5263AA, expiry date: 21 January 2016, dose and route of administration was not reported) in the left deltoid on 22 January 2016. Illness at time of vaccination was None and Pre-existing physician diagnosed allergies, birth defects, medical conditions concomitant medications includes arthritis, hypertension and had no known allergies. On 23 January 2016, one day following the vaccination the patient had pain and redness at the injection site. Patient came into the office to be evaluated on 27 January 2016 and was diagnosed with an infection and a lump, which was red and hot. Patient required doctor visit. Lab data was reported none. Corrective treatment was reported unknown. The outcome of the event was not recovered. List of documents held by sender: none/yes.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: Initial unsolicited report received from a non- healthcare professional on 27 January 2016. This case involves a 64-year-old female patient who was vaccinated with a first dose of ADACEL (batch number: U5263AA, expiry date: 21 January 2016, dose and route of administration was not reported) in the left deltoid on 22 January 2016. Illness at time of vaccination was None and Pre-existing physician diagnosed allergies, birth defects, medical conditions concomitant medications includes arthritis, hypertension and had no known allergies. On 23 January 2016, one day following the vaccination the patient had pain and redness at the injection site. Patient came into the office to be evaluated on 27 January 2016 and was diagnosed with an infection and a lump, which was red and hot. Patient required doctor visit. Lab data was reported none. Corrective treatment was reported unknown. The outcome of the event was not recovered. List of documents held by sender: none/yes.
Age: 63.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity
Clinical narrative: Very sore left arm...always get flu shot, never had reaction like this!
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Dizziness, Dysphagia, Dyspnoea, Fatigue
Clinical narrative: Light-headed, dizziness, felt faint, tired, hard to breathe and swallow. Took Benadryl right away. Had same reaction with Tdap back in April 2010. Was asked to send blood sample, sent sample, never heard back after blood was mailed.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Adrenalectomy, Allergy test, Blood test, Chest discomfort, Computerised tomogram
Clinical narrative: Nausea dizziness and vomiting took to ER 8/16/16 gave IV fluids sent home. Back to ER 8/17/15 admitted to hospital August 2015 4 days due to continued nausea dizziness and vomiting. Diagnosed with vestibular neuritis.  Put on steroids. Back to ER about 10 days later high blood pressure and high heart rate. Ptosis of eyes, constipation, lost weight diagnosed with myasthenia gravis. Had EMG sbd single fiber EMG that ruled that out. Had muscle weakness, constipation, skin sensitivity that caused 24/7 itching, chest tightness, sleep disturbances, inability to gain weight despite good appetite, tiredness, ptosis. Continued high blood pressure and high heart rate had MRI, CT scans, urine and blood tests, diagnosed with possible pleochromocytoma. Had surgery 1/26/16 and had left adrenal gland removed and pathology report showed adrenal medullary hyperplasia. Resolved the high BP/ high HR taken off those meds but all other symptoms persisted. Went to allergist 2/9/16 for persistent itching because nothing resolved itching and suggested we report this as adverse GARDASIL reaction.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Constipation, Dizziness, Electromyogram normal, Eyelid ptosis, Fatigue
Clinical narrative: Nausea dizziness and vomiting took to ER 8/16/16 gave IV fluids sent home. Back to ER 8/17/15 admitted to hospital August 2015 4 days due to continued nausea dizziness and vomiting. Diagnosed with vestibular neuritis.  Put on steroids. Back to ER about 10 days later high blood pressure and high heart rate. Ptosis of eyes, constipation, lost weight diagnosed with myasthenia gravis. Had EMG sbd single fiber EMG that ruled that out. Had muscle weakness, constipation, skin sensitivity that caused 24/7 itching, chest tightness, sleep disturbances, inability to gain weight despite good appetite, tiredness, ptosis. Continued high blood pressure and high heart rate had MRI, CT scans, urine and blood tests, diagnosed with possible pleochromocytoma. Had surgery 1/26/16 and had left adrenal gland removed and pathology report showed adrenal medullary hyperplasia. Resolved the high BP/ high HR taken off those meds but all other symptoms persisted. Went to allergist 2/9/16 for persistent itching because nothing resolved itching and suggested we report this as adverse GARDASIL reaction.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Heart rate increased, Hyperadrenalism, Hyperaesthesia, Hypertension, Muscular weakness
Clinical narrative: Nausea dizziness and vomiting took to ER 8/16/16 gave IV fluids sent home. Back to ER 8/17/15 admitted to hospital August 2015 4 days due to continued nausea dizziness and vomiting. Diagnosed with vestibular neuritis.  Put on steroids. Back to ER about 10 days later high blood pressure and high heart rate. Ptosis of eyes, constipation, lost weight diagnosed with myasthenia gravis. Had EMG sbd single fiber EMG that ruled that out. Had muscle weakness, constipation, skin sensitivity that caused 24/7 itching, chest tightness, sleep disturbances, inability to gain weight despite good appetite, tiredness, ptosis. Continued high blood pressure and high heart rate had MRI, CT scans, urine and blood tests, diagnosed with possible pleochromocytoma. Had surgery 1/26/16 and had left adrenal gland removed and pathology report showed adrenal medullary hyperplasia. Resolved the high BP/ high HR taken off those meds but all other symptoms persisted. Went to allergist 2/9/16 for persistent itching because nothing resolved itching and suggested we report this as adverse GARDASIL reaction.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Myasthenia gravis, Nausea, Nuclear magnetic resonance imaging, Pruritus, Scan adrenal gland
Clinical narrative: Nausea dizziness and vomiting took to ER 8/16/16 gave IV fluids sent home. Back to ER 8/17/15 admitted to hospital August 2015 4 days due to continued nausea dizziness and vomiting. Diagnosed with vestibular neuritis.  Put on steroids. Back to ER about 10 days later high blood pressure and high heart rate. Ptosis of eyes, constipation, lost weight diagnosed with myasthenia gravis. Had EMG sbd single fiber EMG that ruled that out. Had muscle weakness, constipation, skin sensitivity that caused 24/7 itching, chest tightness, sleep disturbances, inability to gain weight despite good appetite, tiredness, ptosis. Continued high blood pressure and high heart rate had MRI, CT scans, urine and blood tests, diagnosed with possible pleochromocytoma. Had surgery 1/26/16 and had left adrenal gland removed and pathology report showed adrenal medullary hyperplasia. Resolved the high BP/ high HR taken off those meds but all other symptoms persisted. Went to allergist 2/9/16 for persistent itching because nothing resolved itching and suggested we report this as adverse GARDASIL reaction.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Sleep disorder, Urine analysis, Vaccination complication, Vestibular neuronitis, Vomiting
Clinical narrative: Nausea dizziness and vomiting took to ER 8/16/16 gave IV fluids sent home. Back to ER 8/17/15 admitted to hospital August 2015 4 days due to continued nausea dizziness and vomiting. Diagnosed with vestibular neuritis.  Put on steroids. Back to ER about 10 days later high blood pressure and high heart rate. Ptosis of eyes, constipation, lost weight diagnosed with myasthenia gravis. Had EMG sbd single fiber EMG that ruled that out. Had muscle weakness, constipation, skin sensitivity that caused 24/7 itching, chest tightness, sleep disturbances, inability to gain weight despite good appetite, tiredness, ptosis. Continued high blood pressure and high heart rate had MRI, CT scans, urine and blood tests, diagnosed with possible pleochromocytoma. Had surgery 1/26/16 and had left adrenal gland removed and pathology report showed adrenal medullary hyperplasia. Resolved the high BP/ high HR taken off those meds but all other symptoms persisted. Went to allergist 2/9/16 for persistent itching because nothing resolved itching and suggested we report this as adverse GARDASIL reaction.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Weight decreased, Weight gain poor
Clinical narrative: Nausea dizziness and vomiting took to ER 8/16/16 gave IV fluids sent home. Back to ER 8/17/15 admitted to hospital August 2015 4 days due to continued nausea dizziness and vomiting. Diagnosed with vestibular neuritis.  Put on steroids. Back to ER about 10 days later high blood pressure and high heart rate. Ptosis of eyes, constipation, lost weight diagnosed with myasthenia gravis. Had EMG sbd single fiber EMG that ruled that out. Had muscle weakness, constipation, skin sensitivity that caused 24/7 itching, chest tightness, sleep disturbances, inability to gain weight despite good appetite, tiredness, ptosis. Continued high blood pressure and high heart rate had MRI, CT scans, urine and blood tests, diagnosed with possible pleochromocytoma. Had surgery 1/26/16 and had left adrenal gland removed and pathology report showed adrenal medullary hyperplasia. Resolved the high BP/ high HR taken off those meds but all other symptoms persisted. Went to allergist 2/9/16 for persistent itching because nothing resolved itching and suggested we report this as adverse GARDASIL reaction.
Age: 76.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: Arm hurt so bad I couldn't move it, called my Doctor he gave me a Cortisone shot. Which helped it but to this day I'm rubbing it, still hurts. Can't sleep with out help.
Age: 76.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Injected limb mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Arm hurt so bad I couldn't move it, called my Doctor he gave me a Cortisone shot. Which helped it but to this day I'm rubbing it, still hurts. Can't sleep with out help.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Headache, Injection site pain, Lethargy, Oropharyngeal pain
Clinical narrative: Severe arm pain where shot was administered, headache, sore throat, lethargy.
Age: 14.0
Sex: F
Vaccine: FLUN4, HPV9
Symptoms: Chest pain, Injection site pain, Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Pain at injection site started around 2/2/16. Stiffness, pain is worse now. Pain going down arm and into shoulder/chest. Unable to lift arm above shoulder.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Abasia, Acute disseminated encephalomyelitis, Asthenia, Dyskinesia, Lumbar puncture
Clinical narrative: 01/12/2016-01/14/2016-FEVER. 01/15/2015-NEUROLOGICAL DEFICIT, INVOLUNTARY MOVEMENTS, WEAKNESS, INABILITY TO WALK.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Nervous system disorder, Nuclear magnetic resonance imaging, Pyrexia, Vaccination complication
Clinical narrative: 01/12/2016-01/14/2016-FEVER. 01/15/2015-NEUROLOGICAL DEFICIT, INVOLUNTARY MOVEMENTS, WEAKNESS, INABILITY TO WALK.
Age: 1.37
Sex: M
Vaccine: DTAP, FLU4
Symptoms: Balance disorder, Fall, Gait disturbance
Clinical narrative: Pt woke up and had difficulty walking due to poor balance. Swaying while standing and seated, falling when he tries to walk.
Age: 66.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Severe arm pain and stiffness.  Arm was hard to lift, however, I could move it well enough to function. Arm can ache at rest and is still very sore to touch.
Age: 66.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain in extremity, Tenderness
Clinical narrative: Severe arm pain and stiffness.  Arm was hard to lift, however, I could move it well enough to function. Arm can ache at rest and is still very sore to touch.
Sex: U
Vaccine: MMR
Symptoms: Seroconversion test negative, Serology negative, Vaccination failure
Clinical narrative: Information has been received from the authors in a published literature article, title as above, regarding 7 (also reported as 24% of 28 patients) adolescent or young adult parents of unknown age (between 13 to 26 years) and gender with perinatally acquired human immunodeficiency virus (PAH). On an unknown date, the patients were vaccinated with a dose of MMR II (Manufacturer unknown) (Lot number, expiration date, strength, dose and frequency were not provided). Concomitant medication was not reported. On an unknown date, despite appropriate prior vaccination, the patient experienced measles non-immunity which was defined as IgG titers < 120 miU by plaque reduction neutralization (PRN) assay and < 0.70 IU by measles enzyme immunoassay (EIA) (vaccination failure and seroconversion test negative). The outcome of vaccination failure and Seroconversion test negative was unknown at the time of the report. The reporter considered vaccination failure and Seroconversion test negative to be related to MMR II (manufacturer unknown). A copy of the published article is attached as further documentation of the patient's experienced. This is one of several reports from the same source (MARRS# 1601USA010845, 1601USA010937, 1601USA010936). Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Asthenia, Mobility decreased, Pain in extremity, Tenderness
Clinical narrative: Extreme Arm Pain.  Could not lift arm, and was extremely tender and painful to the touch.  Took about six months for the pain and weakness to go away.
Age: 66.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Muscular weakness, Pain in extremity, Tenderness
Clinical narrative: Extreme Arm Pain.  Could not lift arm, and was extremely tender and painful to the touch.  Took about six months for the pain and weakness to go away.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Injection site reaction
Clinical narrative: Pt given 2 shots on 2-8-16, called and then presented to office with rxn on (L) deltoid. PNP notified, pt assessed - determined to be local rxn given BENADRYL in office and told to do cold compresses at home to call if any ?'s or concerns.
Age: 26.0
Sex: M
Vaccine: FLU3, MMR, TDAP, VARCEL
Symptoms: Dizziness, Dry skin, Pallor
Clinical narrative: Received vaccines at 1445. Became dizzy 3pm placed on exam table. Skin dry but pale. Vital signs stable. Layed on table for 15 min up in chair for 10 min. Became dizzy again back to table. Family called. Left with family 420 pm.
Sex: U
Vaccine: FLUX
Symptoms: Apnoea, Loss of consciousness, Respiratory arrest
Clinical narrative: Initial unsolicited report received from other health care professional via other company (Pfizer) on 1 February 2016. Manufacturer number: 2016043485. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of Flu Vaccine (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Medical history included egg allergy. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced loses consciousness and stops breathing. Lab data and corrective treatments were not reported. Outcome of events was not reported. Upon internal review company decided to consider event serious because of important medical events loss of consciousness and stops breathing. List of documents held by sender: none. Sender's Comments: The manufacturer of the INFLUENZA VACCINE involved in this report is not known. Loss of consciousness and apnea following administration of INFLUENZA VACCINE has been reported. This case is not sufficiently documented. More information including patient's medical history, concomitant medications are needed to further assess this case. Based on the information provided; the role of vaccine cannot be assessed.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis, Pain in extremity, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Pt noticed some swelling and pain in left posterior arm that next morning which continued to swell the day after that on 02/07/2016. Pt was seen at little clinic that Monday afternoon for pain and swelling; had heat and tenderness to touch. Pt was diagnosed with cellulitis and placed on amoxicillin and declined further medical treatment after this.
Age: 42.0
Sex: M
Vaccine: HEPAB
Symptoms: Lip swelling, Pruritus
Clinical narrative: On 2/4/16 patient reported after vaccine, his lips swelled and legs itched. This lasted into the next day - this was unreported at the time. Resolved without treatment.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Chest pain, Electrocardiogram, Pericarditis, Red blood cell sedimentation rate, Troponin
Clinical narrative: Severe chest pain, was taken to ER, was diagnosed with Pericarditis.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal distension, Arthralgia, Breast pain, Flatulence, Musculoskeletal chest pain
Clinical narrative: Patient states joint pain, rash with shooting pain on right breast, pain in rib cage on right side, gas and bloating.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Patient states joint pain, rash with shooting pain on right breast, pain in rib cage on right side, gas and bloating.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Acne, Injection site atrophy, Skin lesion
Clinical narrative: Visible depression of skin over injection site of left deltoid measuring approximately 1 in. x 1.5 in. with 2-3 lesions resembling pimples that appeared over time.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Dizziness, Eye pain, Haematocrit increased, Influenza
Clinical narrative: Based on additional information received on 28 January 2016, the case became medically confirmed. Initial unsolicited report received from a consumer on 17 November 2015. This case involves a 44-year-old male patient who was vaccinated with a dose of Flu Vaccine (batch number, route, cycle in series and site of administration was not reported) on 13 October 2014. The patient had allergies to sulfa and "some other antibiotics" and codeine also had history of elevated BP (blood pressure), HIV (Human immunodeficiency virus). Concomitant medications were not reported. On 14 October 2014, one day following the vaccination, the patient experienced dizziness and difficulty in focusing eyes and "panic attack" and it was reported that since vaccination had continued to experience dizziness, eye focus difficulty and developed increased joint pain. The patient also experienced mild case of flu" and malaise. The patient required ER (emergency room)/doctor visit. Lab data included elevated white blood cell counts, red blood cell counts and hematocrit. It was reported that the patient saw his own primary care physician (PCP) for treatment. The patient had not recovered from the events. List of documents held by sender: none. Follow-up information received from a consumer on 21 December 2015. On 13 October 2014 at 10.50 hours, the patient received Flu vaccine (batch number: UI186AA, expiration date: 6 June 2015) in right deltoid. On 25 November 2014 the patient complained of tinnitus, eye pain since influenza vaccine but no change in visual activity and on 18 December 2015 the patient reported severe dizziness when he turns his head. It was reported that, the patient complained of tinnitus but acknowledged chronic problem, prior evaluation with audiometry. On an unspecified date onset of event begun after flu shot and symptoms worse when patient was not busy or pre-occupied. Patient was not seen in clinic since 18 December 2014. On an unspecified date, the patient received Fexofenadine as a corrective treatment. Follow up information received form physician on 28 January 2016. No new information was reported.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Panic attack, Red blood cell count increased, Tinnitus, Vision blurred
Clinical narrative: Based on additional information received on 28 January 2016, the case became medically confirmed. Initial unsolicited report received from a consumer on 17 November 2015. This case involves a 44-year-old male patient who was vaccinated with a dose of Flu Vaccine (batch number, route, cycle in series and site of administration was not reported) on 13 October 2014. The patient had allergies to sulfa and "some other antibiotics" and codeine also had history of elevated BP (blood pressure), HIV (Human immunodeficiency virus). Concomitant medications were not reported. On 14 October 2014, one day following the vaccination, the patient experienced dizziness and difficulty in focusing eyes and "panic attack" and it was reported that since vaccination had continued to experience dizziness, eye focus difficulty and developed increased joint pain. The patient also experienced mild case of flu" and malaise. The patient required ER (emergency room)/doctor visit. Lab data included elevated white blood cell counts, red blood cell counts and hematocrit. It was reported that the patient saw his own primary care physician (PCP) for treatment. The patient had not recovered from the events. List of documents held by sender: none. Follow-up information received from a consumer on 21 December 2015. On 13 October 2014 at 10.50 hours, the patient received Flu vaccine (batch number: UI186AA, expiration date: 6 June 2015) in right deltoid. On 25 November 2014 the patient complained of tinnitus, eye pain since influenza vaccine but no change in visual activity and on 18 December 2015 the patient reported severe dizziness when he turns his head. It was reported that, the patient complained of tinnitus but acknowledged chronic problem, prior evaluation with audiometry. On an unspecified date onset of event begun after flu shot and symptoms worse when patient was not busy or pre-occupied. Patient was not seen in clinic since 18 December 2014. On an unspecified date, the patient received Fexofenadine as a corrective treatment. Follow up information received form physician on 28 January 2016. No new information was reported.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: White blood cell count increased
Clinical narrative: Based on additional information received on 28 January 2016, the case became medically confirmed. Initial unsolicited report received from a consumer on 17 November 2015. This case involves a 44-year-old male patient who was vaccinated with a dose of Flu Vaccine (batch number, route, cycle in series and site of administration was not reported) on 13 October 2014. The patient had allergies to sulfa and "some other antibiotics" and codeine also had history of elevated BP (blood pressure), HIV (Human immunodeficiency virus). Concomitant medications were not reported. On 14 October 2014, one day following the vaccination, the patient experienced dizziness and difficulty in focusing eyes and "panic attack" and it was reported that since vaccination had continued to experience dizziness, eye focus difficulty and developed increased joint pain. The patient also experienced mild case of flu" and malaise. The patient required ER (emergency room)/doctor visit. Lab data included elevated white blood cell counts, red blood cell counts and hematocrit. It was reported that the patient saw his own primary care physician (PCP) for treatment. The patient had not recovered from the events. List of documents held by sender: none. Follow-up information received from a consumer on 21 December 2015. On 13 October 2014 at 10.50 hours, the patient received Flu vaccine (batch number: UI186AA, expiration date: 6 June 2015) in right deltoid. On 25 November 2014 the patient complained of tinnitus, eye pain since influenza vaccine but no change in visual activity and on 18 December 2015 the patient reported severe dizziness when he turns his head. It was reported that, the patient complained of tinnitus but acknowledged chronic problem, prior evaluation with audiometry. On an unspecified date onset of event begun after flu shot and symptoms worse when patient was not busy or pre-occupied. Patient was not seen in clinic since 18 December 2014. On an unspecified date, the patient received Fexofenadine as a corrective treatment. Follow up information received form physician on 28 January 2016. No new information was reported.