chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Dermatitis allergic, Injection site pruritus, Rash, Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash over right arm at site of vaccine and itching and swelling.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Immunisation reaction, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 55 year old female patient. There was no pertinent medical history. The patient's medical history included rash after use of an unspecified strength of AVELOX tablets. On 26-NOV-2013, the patient was vaccinated with ZOSTAVAX lot # H021712 expiry date 06-MAR-2014 (dose and route not reported). There was no concomitant medication. On 28-NOV-2013, the patient experienced an injection site reaction. The site was red, hot, painful and spread down to the patients elbow. Patient visited the physician's office and began treatment with amoxicillin due to "cellulitis versus immunization reaction". No lab diagnostics performed. There was no rash to obtain samples from. The outcome of the events was reported as not recovered. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 55 year old female patient. There was no pertinent medical history. The patient's medical history included rash after use of an unspecified strength of AVELOX tablets. On 26-NOV-2013, the patient was vaccinated with ZOSTAVAX lot # H021712 expiry date 06-MAR-2014 (dose and route not reported). There was no concomitant medication. On 28-NOV-2013, the patient experienced an injection site reaction. The site was red, hot, painful and spread down to the patients elbow. Patient visited the physician's office and began treatment with amoxicillin due to "cellulitis versus immunization reaction". No lab diagnostics performed. There was no rash to obtain samples from. The outcome of the events was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. On 14-JUN-2013 the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular. No concomitant medications were reported. on 15-AUG-2013 the patient was vaccinated with GARDASIL dose 2 and 3 weeks early on 21-NOV-2013 the patient was vaccinated with GARDASIL dose 3. No adverse effect was reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Antibody test, Inappropriate schedule of drug administration, Measles antibody, Mumps antibody test negative, Rubella antibody test
Clinical narrative: This spontaneous report as received from a physician refers to an 18 year old female patient. On 24-AUG-1998 the patient was vaccinated with the first dose of MMR II (lot number, dose, route not reported). Concomitantly on 24-AUG-1998 the patient was vaccinated with the fourth dose of DTP/Hib. On 14-MAR-2000 the patient was vaccinated with the second dose of MMR II (lot number, dose, route not reported). The patient's prior vaccination history included three doses of poliovirus vaccine (unspecified) (first dose on 27-FEB-1995, second dose on 27-APR-1995 and third dose  on 24-AUG-1996) and three doses of DTP/Hib (first dose on 27-FEB-1995, second dose on 27-APR-1995, third dose on 24-JUL-1995). The patient was vaccinated with the fifth dose of DTP/Hib on approximately 1999, when she was 5 year old. It was reported that the patient underwent antibody tests (non fasting). The specimen was collected on 21-AUG-2013 at 09:16 (date of report: 22-AUG-2013). The mumps virus antibody (IgG) test was negative and showed 0.6 AI LO which indicated that the patient was non-immune. Other tests performed from the same sample were: rubeola/measles (IgG) 4.9 AI (immune); varicella zos.. (IgG) 3.1 AI (immune); Rubella, IgG 94.2 IU/mL (immune). The outcome of Mumps virus antibody test negative was not reported. It was stated that nothing would be done unless the patient wants another MMR vaccine for school. This is one of several reports received from the same source (linked MARRS#s: 1309USA012393, 1310USA006775, 1310USA006778).  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 17 year old female patient. There was no pertinent medical history and no drug reactions or allergies. On 02-OCT-2013, the patient was vaccinated with GARDASIL lot # J003727 expiry date 07-NOV-2015, first dose, (dose and route not reported) to prevent human papillomavirus (HPV). Concomitant therapies included ethinyl estradiol, SPRINTEC. On 02-OCT-2013, 6 hrs after onset of  therapy, the patient experienced dizziness and shortness of breath. The patient did not report these symptoms to anyone prior to her appointment in the office on 03-DEC-2013 when she came in to receive her second dose of GARDASIL. No treatment given for the events. No lab diagnostics performed. The outcome of shortness of breath and dizziness was reported as recovered on 02-OCT-2013. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a Registered nurse, refers to an approximately 14 year old, female patient. On 05-SEP-2013, the patient was vaccinated with the first dose of GARDASIL, 0.5 ml, (lot J002641, expiration date 17-MAY-2013), intramuscular. Co-suspect therapies were not reported. Concomitant therapies included BOOSTRIX and multivitamins (unspecified). On 05-SEP-2013, registered nurse reported that the patient developed hives after receiving the first dose of GARDASIL. The reporter stated that the hives were all over the body, even between her hair lines. Patient saw a nurse practitioner for the event. On 07-SEP-2013, two days after vaccination, the patient recovered from the event. At the time of the report, the causality for the event was unknown. Additional information has been requested.
Age: 1.27
Sex: F
Vaccine: HIBV
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Fever began that night.  Fever lasted until approximately 11 a.m. on 12/14/2013.  A visible rash appeared on baby's face that evening and spread to the rest of her body.
Age: 15.0
Sex: M
Vaccine: DT
Symptoms: Skin fissures
Clinical narrative: Parent's Hands Rhagades
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Muscle swelling, Myalgia
Clinical narrative: Severe swelling and pain in muscles in the area of the injection.  Lasted for more than three days.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Inject site reaction on left arm triceps region. Red and warm to touch. Measured 2 in wide by 4 in. long. Instructed patient to take 50mg Benadryl and to follow up with physician on next day to determine if any additional action will be necessary.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia
Clinical narrative: Left hand pinky and half of right finger tingling.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Decreased appetite, Dyspnoea, Fatigue, Full blood count, Headache
Clinical narrative: Difficulty breathing, fever, muscle aches, headache, swelling of injection lower arm and hand, high blood pressure, loss of appetite, weight loss, fatigue.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Hypertension, Injection site swelling, Laboratory test, Local swelling, Myalgia
Clinical narrative: Difficulty breathing, fever, muscle aches, headache, swelling of injection lower arm and hand, high blood pressure, loss of appetite, weight loss, fatigue.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Vitamin B12, Weight decreased
Clinical narrative: Difficulty breathing, fever, muscle aches, headache, swelling of injection lower arm and hand, high blood pressure, loss of appetite, weight loss, fatigue.
Age: 9.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Arthralgia, Eye swelling, Laboratory test, Lip swelling, Migraine
Clinical narrative: High fever 105.8, all over joint pain, hives, swelling of eyes and lips, migraine headahe, muscle stiffness (cramping). Treatment Motrin, Tylenol, Benadryl, Prednisone.
Age: 9.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Muscle spasms, Musculoskeletal stiffness, Pyrexia, Urticaria
Clinical narrative: High fever 105.8, all over joint pain, hives, swelling of eyes and lips, migraine headahe, muscle stiffness (cramping). Treatment Motrin, Tylenol, Benadryl, Prednisone.
Age: 9.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Arthralgia, Headache, Influenza virus test negative, Local reaction, Local swelling
Clinical narrative: High fever 105.8, all over joint pain, hives, swelling of eyes and lips, migraine headahe, muscle stiffness (cramping). Treatment Motrin, Tylenol, Benadryl, Prednisone.
Age: 9.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Neck pain, Pyrexia
Clinical narrative: High fever 105.8, all over joint pain, hives, swelling of eyes and lips, migraine headahe, muscle stiffness (cramping). Treatment Motrin, Tylenol, Benadryl, Prednisone.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling, Malaise, Pain, Rash papular, Swelling face
Clinical narrative: Approx. 9 AM, notice slightly raised rash on legs, applied hydrocortisone cream.  Approx. 10 AM noticed swelling of lips and along jaw line, went to pharmacy, told to take Benadryl.  Felt achy and "blah" for rest of day and next 2 days. Rash and face kept at bay only if I kept taking Benadryl and applying cream.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Axillary pain, Mobility decreased, Muscular weakness, Musculoskeletal pain
Clinical narrative: Armpit pain, pain in back at shoulder blade, pain down arm, unable to make a fist, pain at elbow.  Unable to use my arm and hand effectively due to pain and lack of being able to control muscles in hand.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Armpit pain, pain in back at shoulder blade, pain down arm, unable to make a fist, pain at elbow.  Unable to use my arm and hand effectively due to pain and lack of being able to control muscles in hand.
Age: 8.0
Sex: F
Vaccine: FLUX
Symptoms: Cardiac murmur, Dyspnoea, Flushing, Laboratory test, Musculoskeletal stiffness
Clinical narrative: Complained of difficulty breathing at school. Taken to school clinic; nurses noted she was wheezing and flush. Paramedics arrived and her oxygen levels stabilized, however as she attempted to walk discovered her legs were painful and stiff below the knees.  She became unable to bear weight on legs, and paramedics took her to the hospital.  By that evening, following many horrifying hours of uncertainty, she regained function of her legs.
Age: 8.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Weight bearing difficulty, Wheezing
Clinical narrative: Complained of difficulty breathing at school. Taken to school clinic; nurses noted she was wheezing and flush. Paramedics arrived and her oxygen levels stabilized, however as she attempted to walk discovered her legs were painful and stiff below the knees.  She became unable to bear weight on legs, and paramedics took her to the hospital.  By that evening, following many horrifying hours of uncertainty, she regained function of her legs.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient reported feeling numb and pain on left arm -> shoulder blade. Sx happened when patient walk out of the store but the shot was administered in right arm. Pt said no swelling, redness or rash at injection site. Reported this SE a month later after received the shot on 12/12/13.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Injection site reaction: "soreness, feels hot" (2 days after immunization given).
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia
Clinical narrative: Patient reported nerve pain throughout arm vaccine was administered shortly after administration last more severely for a couple weeks. Pain has subsided, but not completely.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Cough, Dyspnoea, Gait disturbance, Injection site pain
Clinical narrative: This consumer report (initial receipt 27-Nov-2013) concerns a 54 year old female patient. Concomitant medications included a low dose estrogen. On the 14-Nov-2013, the patient received AFLURIA injection (batch number 08549211A) 0.5 mL in the left deltoid. On an unspecified date, right after receiving the injection, the patient developed some soreness at the injection site. Then two hours later, the patient experienced severe stomach pains. The patient stated that she could barely walk and was bowling over. Thirty minutes later, the patient started wheezing, having breathing problems and coughing problems. The patient was taken to the emergency room where she was treated with albuterol and BENADRYL injection. She stated that having these medications she felt really shaky but could breathe again. The patient continued to use her albuterol. Outcome was reported as recovering.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Nervousness, Wheezing
Clinical narrative: This consumer report (initial receipt 27-Nov-2013) concerns a 54 year old female patient. Concomitant medications included a low dose estrogen. On the 14-Nov-2013, the patient received AFLURIA injection (batch number 08549211A) 0.5 mL in the left deltoid. On an unspecified date, right after receiving the injection, the patient developed some soreness at the injection site. Then two hours later, the patient experienced severe stomach pains. The patient stated that she could barely walk and was bowling over. Thirty minutes later, the patient started wheezing, having breathing problems and coughing problems. The patient was taken to the emergency room where she was treated with albuterol and BENADRYL injection. She stated that having these medications she felt really shaky but could breathe again. The patient continued to use her albuterol. Outcome was reported as recovering.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age (gender unspecified). On an unknown date the patient was vaccinated with ZOSTAVAX. Dose and route were unspecified. Pharmacist mentioned that the patient received ZOSTAVAX and then got shingles. The outcome of shingles was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 19-OCT-2013 the patient was vaccinated with M-M-R II (dosing details not reported). On 29-NOV-2013, the second dose of M-M-R II was administered 43 days after onset of first dose. The patient experienced no adverse effect. No product quality complaint involved. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Rash
Clinical narrative: This spontaneous report as received from a physician via a representative refers to a 60 years of age or above male patient at the time of event. Approximately 2 years ago, approximately in December 2011 the patient was vaccinated with ZOSTAVAX (lot# and expiration date unknown), dose reported as single standard injection, subcutaneous for prevention of shingles. The patient had received KENALOG (manufactured/dose unspecified) 2 months prior to the ZOSTAVAX vaccine, approximately in October 2011. The patient developed a non-painful rash immediately after vaccination with ZOSTAVAX that occurred on one side of the patient's back, approximately in December 2011. The patient visited doctor's office at time of event. No treatment was given for the event. The patient was recovered on its own (date unspecified). Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Cellulitis, Dyspnoea, Erythema, Injection site rash, Nausea
Clinical narrative: Case number PHHY2013US097367, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 494640) website on 05 Sep 2013 and follow up information was received from Quality Assurance (QA ref: 251036) department on 03 Dec 2013. This report refers to a 26-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: A12115, Expiry date: Aug 2014), intramuscularly in the right arm on 11 Jun 2013. On the same day, she stated that, she noticed a rash around the site and she ignored it. On 13 Jun 2013, she experienced extreme pain, edema and erythema. She took ibuprofen and she did not have the relief. On 14 Jun 2013, she returned to clinic for care. She experienced nausea, vomiting and shortness of breath. She was diagnosed with cellulitis. She was treated with BACTRIM DS for 10 days. The outcome of the events was reported as completely recovered as of 19 Jun 2013. The seriousness and causality of the events was not reported. Based on the batch review performed, it was concluded that the concerned MENVEO batch was manufactured in accordance with approved internal procedures and was in compliance with the cGMP requirements. Follow up information received from QA department on 03 Dec 2013: Batch review report was updated.
Age: 26.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Oedema, Pain, Vomiting
Clinical narrative: Case number PHHY2013US097367, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 494640) website on 05 Sep 2013 and follow up information was received from Quality Assurance (QA ref: 251036) department on 03 Dec 2013. This report refers to a 26-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: A12115, Expiry date: Aug 2014), intramuscularly in the right arm on 11 Jun 2013. On the same day, she stated that, she noticed a rash around the site and she ignored it. On 13 Jun 2013, she experienced extreme pain, edema and erythema. She took ibuprofen and she did not have the relief. On 14 Jun 2013, she returned to clinic for care. She experienced nausea, vomiting and shortness of breath. She was diagnosed with cellulitis. She was treated with BACTRIM DS for 10 days. The outcome of the events was reported as completely recovered as of 19 Jun 2013. The seriousness and causality of the events was not reported. Based on the batch review performed, it was concluded that the concerned MENVEO batch was manufactured in accordance with approved internal procedures and was in compliance with the cGMP requirements. Follow up information received from QA department on 03 Dec 2013: Batch review report was updated.
Age: 71.0
Sex: F
Vaccine: PPV, PNC10
Symptoms: Erythema, Injection site pain, Joint swelling, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 71 year old female patient. On 02-SEP-2013, the patient was vaccinated with PNEUMOVAX 23 (batch # H016283 and lot # 0601AE) dose 1, intramuscularly in the left arm deltoid. Concomitant therapies included omeprazole (manufacturer unknown), amitriptyline hydrochloride (manufacturer unknown) and lisinopril (manufacturer unknown). On 03-SEP-2013, the patient's arm was visibly red and slightly swollen around the elbow. Patient stated that her entire arm from shoulders to fingers was very painful but it was better two days later. Patient purchased ibuprofen and BENADRYL later. One week later, patient said she felt fine. On 09-SEP-2013, the patient recovered from the events. Causality assessment was not provided. This is 1 of the 2 reports linked to the MARRS # 1310USA007704 (same reporter link). It was also reported that the administering pharmacist contacted the other 7 patients who had also been vaccinated from this lot # and expiration date and no other reactions were reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV, PNC10
Symptoms: Erythema, Joint swelling, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 71 year old female patient. On 02-SEP-2013, the patient was vaccinated with PNEUMOVAX 23 (batch # H016283 and lot # 0601AE) dose 1, intramuscularly in the left arm deltoid. Concomitant therapies included omeprazole (manufacturer unknown), amitriptyline hydrochloride (manufacturer unknown) and lisinopril (manufacturer unknown). On 03-SEP-2013, the patient's arm was visibly red and slightly swollen around the elbow. Patient stated that her entire arm from shoulders to fingers was very painful but it was better two days later. Patient purchased ibuprofen and BENADRYL later. One week later, patient said she felt fine. On 09-SEP-2013, the patient recovered from the events. Causality assessment was not provided. This is 1 of the 2 reports linked to the MARRS # 1310USA007704 (same reporter link). It was also reported that the administering pharmacist contacted the other 7 patients who had also been vaccinated from this lot # and expiration date and no other reactions were reported. Additional information has been requested.
Sex: U
Vaccine: DTAPIPV, FLU3, HIBV, PNC13, RV5, UNK
Symptoms: Wrong drug administered
Clinical narrative: None stated.
Sex: U
Vaccine: DTAPIPV, FLU3, HIBV, PNC13, RV5, UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 19.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Altered state of consciousness, Bacterial test negative, CSF white blood cell count positive, Drug screen, Encephalitis
Clinical narrative: I am looking and pouring through many cases of deaths with the flu shot.  They all parallel what I went through when I had Reyes Syndrome.  I am more than 99% positive patient had it.  You at the CDC and FDA must look into it.  You are the ones with the labs and lab equipment.  I am certain that if the first doctor who saw patient after he had the flu shot was aware of the stages of Reyes, he could have ordered some simple tests and caught it in stage one.  I have been through so much in my life attributed to surviving Reyes and have personally spoken to his mother.  It freaks me out that not one doctor even checked for it.  Inject a lab animal with the flu shot then give him aspirin or any drug like Tylenol etc. that has been tied with Reyes Syndrome and then educate doctors.  My whole family has had the flu shot and agree fully to getting it in the future.  Just please have someone in your labs look into this.  You have all the info on how many deaths have been attributed to the flu shot.  He could have been admitted in the first stage not when he slipped into a coma.  Please go to your labs and get to work on this.  Prove me wrong or right.  I hate Reyes Syndrome as I survived.
Age: 19.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Full blood count, Lumbar puncture, Malaise, Meningitis, Pyrexia
Clinical narrative: I am looking and pouring through many cases of deaths with the flu shot.  They all parallel what I went through when I had Reyes Syndrome.  I am more than 99% positive patient had it.  You at the CDC and FDA must look into it.  You are the ones with the labs and lab equipment.  I am certain that if the first doctor who saw patient after he had the flu shot was aware of the stages of Reyes, he could have ordered some simple tests and caught it in stage one.  I have been through so much in my life attributed to surviving Reyes and have personally spoken to his mother.  It freaks me out that not one doctor even checked for it.  Inject a lab animal with the flu shot then give him aspirin or any drug like Tylenol etc. that has been tied with Reyes Syndrome and then educate doctors.  My whole family has had the flu shot and agree fully to getting it in the future.  Just please have someone in your labs look into this.  You have all the info on how many deaths have been attributed to the flu shot.  He could have been admitted in the first stage not when he slipped into a coma.  Please go to your labs and get to work on this.  Prove me wrong or right.  I hate Reyes Syndrome as I survived.
Age: 19.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Urine analysis, White blood cell count normal
Clinical narrative: I am looking and pouring through many cases of deaths with the flu shot.  They all parallel what I went through when I had Reyes Syndrome.  I am more than 99% positive patient had it.  You at the CDC and FDA must look into it.  You are the ones with the labs and lab equipment.  I am certain that if the first doctor who saw patient after he had the flu shot was aware of the stages of Reyes, he could have ordered some simple tests and caught it in stage one.  I have been through so much in my life attributed to surviving Reyes and have personally spoken to his mother.  It freaks me out that not one doctor even checked for it.  Inject a lab animal with the flu shot then give him aspirin or any drug like Tylenol etc. that has been tied with Reyes Syndrome and then educate doctors.  My whole family has had the flu shot and agree fully to getting it in the future.  Just please have someone in your labs look into this.  You have all the info on how many deaths have been attributed to the flu shot.  He could have been admitted in the first stage not when he slipped into a coma.  Please go to your labs and get to work on this.  Prove me wrong or right.  I hate Reyes Syndrome as I survived.
Age: 19.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Death
Clinical narrative: I am looking and pouring through many cases of deaths with the flu shot.  They all parallel what I went through when I had Reyes Syndrome.  I am more than 99% positive patient had it.  You at the CDC and FDA must look into it.  You are the ones with the labs and lab equipment.  I am certain that if the first doctor who saw patient after he had the flu shot was aware of the stages of Reyes, he could have ordered some simple tests and caught it in stage one.  I have been through so much in my life attributed to surviving Reyes and have personally spoken to his mother.  It freaks me out that not one doctor even checked for it.  Inject a lab animal with the flu shot then give him aspirin or any drug like Tylenol etc. that has been tied with Reyes Syndrome and then educate doctors.  My whole family has had the flu shot and agree fully to getting it in the future.  Just please have someone in your labs look into this.  You have all the info on how many deaths have been attributed to the flu shot.  He could have been admitted in the first stage not when he slipped into a coma.  Please go to your labs and get to work on this.  Prove me wrong or right.  I hate Reyes Syndrome as I survived.
Age: 19.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Coma, Death, Laboratory test, Reye's syndrome
Clinical narrative: I am looking and pouring through many cases of deaths with the flu shot.  They all parallel what I went through when I had Reyes Syndrome.  I am more than 99% positive patient had it.  You at the CDC and FDA must look into it.  You are the ones with the labs and lab equipment.  I am certain that if the first doctor who saw patient after he had the flu shot was aware of the stages of Reyes, he could have ordered some simple tests and caught it in stage one.  I have been through so much in my life attributed to surviving Reyes and have personally spoken to his mother.  It freaks me out that not one doctor even checked for it.  Inject a lab animal with the flu shot then give him aspirin or any drug like Tylenol etc. that has been tied with Reyes Syndrome and then educate doctors.  My whole family has had the flu shot and agree fully to getting it in the future.  Just please have someone in your labs look into this.  You have all the info on how many deaths have been attributed to the flu shot.  He could have been admitted in the first stage not when he slipped into a coma.  Please go to your labs and get to work on this.  Prove me wrong or right.  I hate Reyes Syndrome as I survived.
Age: 9.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Arthralgia, Eye swelling, Laboratory test, Lip swelling, Migraine
Clinical narrative: Pneumococcal Polyvalent 23 vaccine caused large local reaction and fever 104-105. Right arm swollen. At peak of symptoms he reported some joint pain, headache, fever and slight neck pain. Given BENADRYL, MOTRIN and TYLENOL.
Age: 9.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Muscle spasms, Musculoskeletal stiffness, Pyrexia, Urticaria
Clinical narrative: Pneumococcal Polyvalent 23 vaccine caused large local reaction and fever 104-105. Right arm swollen. At peak of symptoms he reported some joint pain, headache, fever and slight neck pain. Given BENADRYL, MOTRIN and TYLENOL.
Age: 9.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Arthralgia, Headache, Influenza virus test negative, Local reaction, Local swelling
Clinical narrative: Pneumococcal Polyvalent 23 vaccine caused large local reaction and fever 104-105. Right arm swollen. At peak of symptoms he reported some joint pain, headache, fever and slight neck pain. Given BENADRYL, MOTRIN and TYLENOL.
Age: 9.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Neck pain, Pyrexia
Clinical narrative: Pneumococcal Polyvalent 23 vaccine caused large local reaction and fever 104-105. Right arm swollen. At peak of symptoms he reported some joint pain, headache, fever and slight neck pain. Given BENADRYL, MOTRIN and TYLENOL.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy test, Chills, Delusion, Pyrexia, Urticaria
Clinical narrative: Hives covering most of body, accompanied by fever, chills, delusion.
Age: 0.45
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Fatigue, Rash
Clinical narrative: Facial Rash, Fatigue.
Sex: M
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Headache, Migraine
Clinical narrative: This spontaneous report as received from nurse practitioner (as informed by the mother of an unspecified patient) refers to a male patient of unknown age. No medical history was reported. On an unknown date, the patient was vaccinated with a second dose of GARDASIL (lot#, route of administration, dosage were not reported). No concomitant medication was reported. On an unknown date, the patient experienced a severe headache, a migraine after receiving the second dose of GARDASIL. The patient sought medical attention. The patient was seen in the emergency room. The headache lasted for one week and the patient was unable to attend school. It was also reported by the physician that the headache was severe. On an unspecified date, headache was resolved and the outcome of migraine was unknown. The event severe headache was considered serious as it had caused disability (patient was unable to attend school). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Cerebrovascular accident
Clinical narrative: This spontaneous report as received from nurse practitioner refers to a patient of unknown age who is one of her daughter's friends. On an unknown date, the patient was vaccinated with GARDASIL (strength, dose, frequency and route unknown). On an unknown date, the patient had stroke (medically significant) after vaccination with GARDASIL. The outcome of stroke was unknown. Upon internal review stroke was considered as medically significant event. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a practice manager refers to a patient of unknown age. On 15-FEB-2013 the patient was vaccinated with the first dose of PNEUMOVAX23 (lot#, expiration date, dose, route and indication not reported) and on 15-APR-2013, the patient was vaccinated with the second dose of PNEUMOVAX23 (lot#, expiration date, dose, route and indication not reported). No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a unknown number of patients of unknown age and gender. On an unknown date in 2013 the patients were vaccinated with GARDASIL. It was reported that unknown number of patients might have received improperly stored GARDASIL doses exposed to 31F from 15-OCT-2013 to 10-DEC-2013. No adverse effect reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient with DEMEROL allergy. On 19-NOV-2013 the patient was vaccinated with ZOSTAVAX (lot # J011212, expiration date 29-AUG-2014), 0.65 ml, subcutaneous in the left arm. The patient developed a rash on her left arm, at the injection site after receiving ZOSTAVAX on an unknown date in 2013. The patient came back in to the pharmacy on an unknown date to seek medical attention. No lab diagnostics studies were performed. The patient was using hydrocortisone (manufacturer unknown) cream on the rash. The patient was recovering from the event at the time of reporting. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a child of unknown gender. On 10-DEC-2013 the patient was vaccinated with PROQUAD (Merck), 0.5 ml, subcutaneous and VARIVAX (Merck) of unknown dose via unknown route. Lot and expiry date were not reported for either products. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 27-NOV-2013 the patient was vaccinated with GARDASIL (lot # was reported as 0840AA, Exp 14-OCT-2013), 0.5 ml, intramuscular that expired on 14-OCT-2013. No adverse effects were reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. On an unknown date, the patient (reported as patient's sister) was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported). No concomitant medications were reported. The patient developed polymyalgia after ZOSTAVAX administration on an unknown date. The patient sought medical attention (details unspecified). No product quality issue was involved. The outcome of polymyalgia was unknown. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant (who was also the practice supervisor) refers to a patient of unknown age and unknown gender. On 03-DEC-2013 the patient was supposed to receive PROQUAD (Merck) but a nurse administered MMR II, intramuscularly (dose, LOT # unknown) instead. No symptoms reported. Additional information has been requested.
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a consumer (mother of patient) refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL in the arm. Other suspect therapies included AFLURIA. Dose, lot and expiry date were unknown. The vaccines were administered on same day in the same arm and the patient had developed swelling at injection site on that day. The outcome of swelling at injection site is unknown. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from the patient's mother refers to a 1 year old patient of unknown gender. The patient was vaccinated with VARIVAX (Merck) injection (dose, route, lot # and expiration date unknown) and PROQUAD (Merck) (dose, route, lot # and expiration date unknown) on the same day 05-DEC-2013. No adverse effect was reported. No adverse event (AE) or product quality complaint (PQC) was involved. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Insomnia
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 70 year old female patient. Pertinent Medical history and drug reactions/Allergies were none. On 09-DEC-2013 the patient was vaccinated with first dose of PNEUMOVAX23 lot # J004332; expiry: 26-AUG-2013, dose: 0.5 ml (millilitres), intramuscular. Concomitant therapies included lisinopril (manufacturer unknown). On 09-DEC-2013, the patient experienced the arm in which PNEUMOVAX was injected was really sore and she woke up and was unable to go back to sleep. It was reported that the patient when she went to bed on the evening of 09-DEC-2013 the arm in which PNEUMOVAX was injected was really sore, and at 3:00 am on 09-DEC-2013 her arm was in so much pain that she woke up and was unable to go back to sleep. The pharmacist recommended that the patient use a hot pack or a cold pack on the affected arm and use TYLENOL (manufacturer unknown) or ibuprofen (manufacturer unknown). The patient sought medical attention and called the pharmacist. The outcome of the events was reported as not resolved. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 70 year old female patient. Pertinent Medical history and drug reactions/Allergies were none. On 09-DEC-2013 the patient was vaccinated with first dose of PNEUMOVAX23 lot # J004332; expiry: 26-AUG-2013, dose: 0.5 ml (millilitres), intramuscular. Concomitant therapies included lisinopril (manufacturer unknown). On 09-DEC-2013, the patient experienced the arm in which PNEUMOVAX was injected was really sore and she woke up and was unable to go back to sleep. It was reported that the patient when she went to bed on the evening of 09-DEC-2013 the arm in which PNEUMOVAX was injected was really sore, and at 3:00 am on 09-DEC-2013 her arm was in so much pain that she woke up and was unable to go back to sleep. The pharmacist recommended that the patient use a hot pack or a cold pack on the affected arm and use TYLENOL (manufacturer unknown) or ibuprofen (manufacturer unknown). The patient sought medical attention and called the pharmacist. The outcome of the events was reported as not resolved. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Varicella
Clinical narrative: This spontaneous report as received from a healthcare worker, who is also the office manager, refers to a female patient of unknown age who was allergic to codeine, DEMEROL and penicillin (reactions unspecified). There was no pertinent medical history. On 10-JUN-2013 the patient was vaccinated with ZOSTAVAX lot # J001008 and expiry date 24-APR-2015, via subcutaneous route for vaccination. Dose was unknown. Concomitant therapies included ATIVAN and DEXEDRINE. Sometime after vaccination, on an unknown date in 2013, the patient developed one painful varicella lesion on the right upper side of her buttocks. The office manager reported that the lesion resolved on an unspecified date. Packet was offered but healthcare professional (HCP) was adamant about not receiving because the lesion has resolved. Packet was not faxed. The outcome of one painful, varicella lesion on the right upper side of her buttocks was reported as resolved. Treatment given and lab diagnostic studies performed were none. Medical attention was not sought. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, Pregnancy test urine positive, Vaginal haemorrhage
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N.) for a GARDASIL, a Pregnancy Registry product, concerning a 22 year old pregnant female patient with asthma, amenorrhoea and hyperlipidemia and none drug allergies who on 23-SEP-2011, and 29-NOV-2011, was vaccinated with a first dose of GARDASIL (route, expiration date and Lot # unspecified) and the second dose of GARDASIL, 0.5 ml, intramuscular (Lot # 668985/0690AA) (expiration date 30-JUL-2013). Concomitant therapy included prenatal vitamins (unspecified), gemfibrozil 600mg, montelukast sodium and ADVAIR. It was also reported expiration date that the nurse was not sure if the patient was still taking these medications or if they were discontinued when the patient discovered that she was pregnant. Subsequently, in approximately October 2011 the patient became pregnant (an urine pregnancy test, hcg beta quantitative). On an unspecified date, the patient experienced some spotting. No treatments was given for the events. The patient had sought medical attention during second prenatal office visits. At the time of report patient spotting was resolved. Follow-up information has been received from a Licensed Practical Nurse (L.P.N.) for a GARDASIL, a Pregnancy Registry product, concerning a 22 year old female patient with hyperlipidemia, no illness at the time of vaccination, with a history of irregular menstruation, who on 26-NOV-2011, (previously reported 29-NOV-2011), received the second dose of GARDASIL, 0.5 ml, IM, in the right deltoid region (Lot # 668985/0690AA). It was reported that the patient was still pregnant. Her last menstrual period was on approximately 19-OCT-2011 and her estimated delivery date was 25-JUL-2012 (previously reported as 07-JUL-2012). The reporter stated that on 01-DEC-2011, the patient experienced vaginal spotting. On an unknown date, the patient recovered from vaginal spotting. Follow up information received. The nurse was called who stated that she would look into the information to see if she could find anything and that if she could would call back but have not been heard from her. The case is lost to follow up. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient experienced redness, itchiness and swelling at the injection site. Patient was asked to follow up with physician where she received prednisone 10mg and BENADRYL and asked to place cold compression on injection site.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Dehydration, Dizziness, Hallucination, Hyperglycaemia, Panic attack
Clinical narrative: Received HPV #2 8/31/12 and waited 15 min without side effects. Starting having episodes of panic and screaming within 2d of receiving vaccine. Had hallucinations. Mom called EMS - took to ED and treated for dehydration, hyperglycemia. Continued with hallucinations. Dizzy spells 7 months.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Screaming
Clinical narrative: Received HPV #2 8/31/12 and waited 15 min without side effects. Starting having episodes of panic and screaming within 2d of receiving vaccine. Had hallucinations. Mom called EMS - took to ED and treated for dehydration, hyperglycemia. Continued with hallucinations. Dizzy spells 7 months.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Hypotension, Loss of consciousness
Clinical narrative: Patient was waiting because I told them to wait for any reactions, 5 minutes later he passed out. I gave him EPIPEN 0.3 auto-injector and he awaked, took him to urgent care, called 911. His BP was really low so he was sent to ER.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Administration site pain, Joint range of motion decreased
Clinical narrative: Persistent soreness at administration site with periods of intense pain. Limited range of motion associated with pain of lifting arm past a certain position. Currently being treated by methocarbamol with reported relief.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Burning sensation, Mobility decreased, Pain in extremity
Clinical narrative: At first his arm was " a normal sore" that he would expect from an IM injection. About 1 week after the vaccine he began to feel a burning sensation/weakness/inability to lift his arm above a certain level in his left shoulder. He first went to the Dr on Nov 19. He was given samples of a steroid - a 4 day course. The first 2 days it helped a lot.
Age: 16.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: Information has been received from a consumer, for GARDASIL, a Pregnancy Registry product, concerning her 16 year old daughter with no drug reactions/allergies and no pertinent medical history, who on 10-MAY-2012 was vaccinated with the first dose GARDASIL (dose, route and lot number not reported) and with a dose of an unspecified meningitis vaccine during an annual physical exam. The reporter stated that pregnancy test drawn during that visit returned a positive result for pregnancy on an unspecified date. No adverse effect reported. It has been reported that the patient was 7 weeks pregnant. The patient's last menstrual period was approximately 29-MAR-2012 and estimated delivery date would be on 03-JAN-2013 (day approximated). The patient sought unspecified medical attention. No treatment was given for an AE. At the time of the report the patient's outcome was unknown. Follow-up information has been received from a physician via Pregnancy Questionnaire for GARDASIL, a Pregnancy Registry product, concerning 16 year old female patient, adopted from another country, with history of mood disorder, who on 10-MAY-2012 was vaccinated with the first dose of GARDASIL (dose and route were not reported) (lot number 672653/1860AA). Concomitant medications included: WELLBUTRIN 150mg daily, lithium 300mg twice daily and LO-OVRAL. The physician reported that the patient's current pregnancy was registered to OB/GYN and that estimated conception date and date of last menstrual period were unknown. At the time of the report the patient's outcome was unknown. Follow-up information has been received from a nurse for GARDASIL, a Pregnancy Registry product, concerning 16 year old female patient. The reporting nurse stated that the patient went to OBGYN but the patient was not seen in their office recently and could not find any baby information. The pregnancy outcome was lost to follow up. Additional information is not expected.