chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Blood test abnormal, Drug administered to patient of inappropriate age, Ear pain, Eating disorder
Clinical narrative: See letter & 3 exhibits here to attached. Enclosed please find a completed vaccines adverse event report, and attached "Exhibit A", "Exhibit B" and Exhibit C". This report and attachments describes the adverse medical problems that I have experienced as a result of a TDAP vaccine shot, which I received on August 10, 2010. I was an active person, who walked, outdoors, at least 5 days a week and was employed, for 26 years, as a paralegal. I retired, from that position, on August 1, 2010. My husband and I were anticipating a trip to celebrate my retirement. Regretfully, our trip did not occur, because of the severe medical problems, I experienced after administration of the TDAP shot. During my routine semi-annual office examination, on August 5th, a physician said that I needed a Tetanus booster shot. She said that her office was expecting a supply of the TDAP vaccine, which included Tetanus vaccine, and that I should call, and schedule an appointment for that shot. Following her directions, I called the following week, and received the TDAP vaccine on August 10, 2010. Several days after that shot, I began to feel ill. Thus I began a series of appointments with the Dr. and her nurse practitioner. At each visit, my symptoms increased. I experienced general lethargy, sore throat, ear pain, severe joint pain, swelling in hands and feet, low grade fever, lost weight, and difficulty in sleeping, walking, and eating. Each day was a nightmare. Various medications were prescribed, but nothing helped. During the September 13th appointment, Dr. contacted another doctor, of an arthritis clinic and made an appointment for me to see Dr. on September 15, 2010. Dr. ordered multiple blood tests and x-rays, and concluded that I have Sero-Negative Inflammatory Arthritis. When questioned, Dr. mentioned that vaccines, as well as other factors, could be a possible cause of my condition. Since my initial office visit, on September 15th, I have had regular visits with Dr., and it appears that I will need long standing treatment, for this illness. When consulting the Center for Disease Control & Prevention's web site, I discovered that in Section C-H, it stated that the TDAP vaccine is not licensed for use in adults aged 65 years. Please advise me regarding the safety of the specific vaccine I received. This could be helpful in determining what course of treatment, if any, could be undertaken, to help resolve my medical situation. Also asvise me if the administration, of TDAP vaccine, has produced a medical condition, such as I have experienced, or if it could otherwise adversely affect the health of other persons, including those 65 years or older.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Gait disturbance, Insomnia, Lethargy, Malaise, Oedema peripheral
Clinical narrative: See letter & 3 exhibits here to attached. Enclosed please find a completed vaccines adverse event report, and attached "Exhibit A", "Exhibit B" and Exhibit C". This report and attachments describes the adverse medical problems that I have experienced as a result of a TDAP vaccine shot, which I received on August 10, 2010. I was an active person, who walked, outdoors, at least 5 days a week and was employed, for 26 years, as a paralegal. I retired, from that position, on August 1, 2010. My husband and I were anticipating a trip to celebrate my retirement. Regretfully, our trip did not occur, because of the severe medical problems, I experienced after administration of the TDAP shot. During my routine semi-annual office examination, on August 5th, a physician said that I needed a Tetanus booster shot. She said that her office was expecting a supply of the TDAP vaccine, which included Tetanus vaccine, and that I should call, and schedule an appointment for that shot. Following her directions, I called the following week, and received the TDAP vaccine on August 10, 2010. Several days after that shot, I began to feel ill. Thus I began a series of appointments with the Dr. and her nurse practitioner. At each visit, my symptoms increased. I experienced general lethargy, sore throat, ear pain, severe joint pain, swelling in hands and feet, low grade fever, lost weight, and difficulty in sleeping, walking, and eating. Each day was a nightmare. Various medications were prescribed, but nothing helped. During the September 13th appointment, Dr. contacted another doctor, of an arthritis clinic and made an appointment for me to see Dr. on September 15, 2010. Dr. ordered multiple blood tests and x-rays, and concluded that I have Sero-Negative Inflammatory Arthritis. When questioned, Dr. mentioned that vaccines, as well as other factors, could be a possible cause of my condition. Since my initial office visit, on September 15th, I have had regular visits with Dr., and it appears that I will need long standing treatment, for this illness. When consulting the Center for Disease Control & Prevention's web site, I discovered that in Section C-H, it stated that the TDAP vaccine is not licensed for use in adults aged 65 years. Please advise me regarding the safety of the specific vaccine I received. This could be helpful in determining what course of treatment, if any, could be undertaken, to help resolve my medical situation. Also asvise me if the administration, of TDAP vaccine, has produced a medical condition, such as I have experienced, or if it could otherwise adversely affect the health of other persons, including those 65 years or older.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Oropharyngeal pain, Pyrexia, Seronegative arthritis, Weight decreased, X-ray abnormal
Clinical narrative: See letter & 3 exhibits here to attached. Enclosed please find a completed vaccines adverse event report, and attached "Exhibit A", "Exhibit B" and Exhibit C". This report and attachments describes the adverse medical problems that I have experienced as a result of a TDAP vaccine shot, which I received on August 10, 2010. I was an active person, who walked, outdoors, at least 5 days a week and was employed, for 26 years, as a paralegal. I retired, from that position, on August 1, 2010. My husband and I were anticipating a trip to celebrate my retirement. Regretfully, our trip did not occur, because of the severe medical problems, I experienced after administration of the TDAP shot. During my routine semi-annual office examination, on August 5th, a physician said that I needed a Tetanus booster shot. She said that her office was expecting a supply of the TDAP vaccine, which included Tetanus vaccine, and that I should call, and schedule an appointment for that shot. Following her directions, I called the following week, and received the TDAP vaccine on August 10, 2010. Several days after that shot, I began to feel ill. Thus I began a series of appointments with the Dr. and her nurse practitioner. At each visit, my symptoms increased. I experienced general lethargy, sore throat, ear pain, severe joint pain, swelling in hands and feet, low grade fever, lost weight, and difficulty in sleeping, walking, and eating. Each day was a nightmare. Various medications were prescribed, but nothing helped. During the September 13th appointment, Dr. contacted another doctor, of an arthritis clinic and made an appointment for me to see Dr. on September 15, 2010. Dr. ordered multiple blood tests and x-rays, and concluded that I have Sero-Negative Inflammatory Arthritis. When questioned, Dr. mentioned that vaccines, as well as other factors, could be a possible cause of my condition. Since my initial office visit, on September 15th, I have had regular visits with Dr., and it appears that I will need long standing treatment, for this illness. When consulting the Center for Disease Control & Prevention's web site, I discovered that in Section C-H, it stated that the TDAP vaccine is not licensed for use in adults aged 65 years. Please advise me regarding the safety of the specific vaccine I received. This could be helpful in determining what course of treatment, if any, could be undertaken, to help resolve my medical situation. Also asvise me if the administration, of TDAP vaccine, has produced a medical condition, such as I have experienced, or if it could otherwise adversely affect the health of other persons, including those 65 years or older.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Corrective lens user, Vision blurred
Clinical narrative: After my daughter received the three shots of GARDASIL vaccine she was left with permanent blurred vision. Before the shot she had just passed an athletic physical with 20/15 vision. After the shots she kept complaining of blurred vision. I called her doctor and the nurse called me back and the only response I received from her was that blurred vision was not a side effect of the vaccine. Now my daughter has to wear contacts and glasses.
Age: 1.2
Sex: F
Vaccine: PNC
Symptoms: Convulsion, Cough, Decreased appetite, Dysphonia, Irritability
Clinical narrative: Adverse reaction to PREVNAR vaccine high fever seizures hoarseness cough drowsiness irritable loss of appetite.
Age: 1.2
Sex: F
Vaccine: PNC
Symptoms: Pyrexia, Somnolence
Clinical narrative: Adverse reaction to PREVNAR vaccine high fever seizures hoarseness cough drowsiness irritable loss of appetite.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Rash macular
Clinical narrative: 15 min after flu vaccine administered - pt returned to office w/2 red blotches on cheeks. BENADRYL 5 ml given.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Death
Clinical narrative: Pt. came into clinic for annual flu shot. Was non-ill appearing. Wife received same flu shot at the same time with no adverse rxn. Pt. then went home and later passed away in house (residence).
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Flushing, Nausea, Vomiting
Clinical narrative: Symptoms: Symptoms: 1. Dizziness, 2. Nausea Vomiting, 3. Flushing Suspect Drug # 1 Dosing: Flu vaccine yearly.
Sex: F
Vaccine: TD, TTOX
Symptoms: Headache, Incorrect dose administered, Injection site pain, Nausea
Clinical narrative: Sore arm where both were given. Got a little nauseated & headache. Two tetanus incorrectly given same day Td & tetanus toxoid.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: Flu vac given 10/6/10 (L) deltoid by LPN pt back to clinic 10/25/10 with c/o pain in shoulder (L) 11/12/10 pain cont & seen number of times / MRI on 12/10/10.
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Head injury, Laceration, Loss of consciousness, Syncope
Clinical narrative: Student had TDAP vaccine was instructed to wait 10-15 minutes and sit on a chair. Stud. was standing fainted about 5 min. after the taking the shot. Hit his head on a metal part of a trash can, sustained approx 1 inch cut on his forehead. Student was out for a few seconds and was asking what happened when he gained consciousness. Ice applied to forehead. BP- 100/80, at 2:15p, 2:25p - BP normal, PR - 88, oriented to time, place and person. Student said he didn't eat lunch because he did not like the food for lunch in the school cafeteria. Orange and crackers given. Sch. nurse called mother and told her what happened, student awake and alert. Instructed mother to come pick student up and have him checked by a doctor. Emphasized the importance of being checked by the doctor today 3:00p mother here to pick student up. Student awake, alert and oriented. Vital signs stable. Reminded mother to take patient to the doctor to be checked.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Urticarial rash 24 hrs post vaccines. No meds. No new exposures. Breastfed. Rash resolved spontaneously.
Age: 4.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Injection site induration, Injection site warmth
Clinical narrative: 3 x 3" indurated area on anterior (R) thigh, warm to touch, non tender, no drainage.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness & itching at site of injection.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Epistaxis
Clinical narrative: Pt received GARDASIL #1 on 3/1/11. On 3/2/11 awoke with nosebleed in am, felt "dizzy" for about 5 hours. Resolved. Felt fine on 3/3/11.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: (L) upper arm, edematous, hot to touch and erythematous. IZ given at 10 am - swelling started 5 pm on same day=3/2/11 size 10cm x 9cm.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Pt experience diarrhea vomiting and fever of 101 degrees after receiving 2 mo shots.
Age: 9.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Syncope
Clinical narrative: Patient fainted after vaccination was given, possible syncope.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Feeding disorder of infancy or early childhood, Hypothermia, Intensive care, Laboratory test normal
Clinical narrative: Hypothermia, poor feedings - admitted to NICU
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: 10 cm x 10 cm red, warm, swollen,  & rash area around injection site (L) arm.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Asthenia, Dizziness, Pyrexia, Vomiting
Clinical narrative: Fever, dizziness, vomiting, weakness.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Condition aggravated, Cough, Ear infection, Urticaria
Clinical narrative: Hive like rash 15 min after vaccines, also cough became worse. HR 103 O2 - 96% gave BENADRYL 12pm. At 12:05 still with same symptoms, gave EPIPEN Jr. at 12:40 pm HR 85 O2 - 98% rash cleared and cough became only occasionally, pt was resting comfortably. Doctor examined after also. Pt does have an ear infection.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Ultrasound scan
Clinical narrative: 3/1/11 Positive pregnancy test in office sono in office confirmed pregnancy. EDC - 10/25/11 6 weeks LMP - 1/17/11 pregnancy precautions were advised.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 24 hrs after vaccinating 3" x 4" red, raised, hot, hard area appeared at KINRIX site. Site was also itchy and patient ran a fever of 100.9 degrees F. Mother gave TYLENOL & administered topical cortisone cream to area. 48 hrs after vaccination site remains  the same. Mother taking child to pediatrician.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: 24 hrs after vaccinating 3" x 4" red, raised, hot, hard area appeared at KINRIX site. Site was also itchy and patient ran a fever of 100.9 degrees F. Mother gave TYLENOL & administered topical cortisone cream to area. 48 hrs after vaccination site remains  the same. Mother taking child to pediatrician.
Age: 28.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: 7/24/10 - vaccinated - 7/26/10 c/o rash pinpoint vesicular rash arms & pruritic BENADRYL.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram, Drug administered at inappropriate site, Injection site haemorrhage, Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: Spoke with patient's son, stated that his mother received flu shot it was too high in arm. That she has had significant, unbearable pain since the shot. Said it was very painful & bled a lot at the time of injection. Has been to PCP and put on pain meds. Had to go to ER because pain was so bad. Had MRI, ultrasound, CT scan & diagnosed with tendonitis. She is going to physical therapy.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Tendonitis, Ultrasound scan
Clinical narrative: Spoke with patient's son, stated that his mother received flu shot it was too high in arm. That she has had significant, unbearable pain since the shot. Said it was very painful & bled a lot at the time of injection. Has been to PCP and put on pain meds. Had to go to ER because pain was so bad. Had MRI, ultrasound, CT scan & diagnosed with tendonitis. She is going to physical therapy.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Dyspnoea, Rash
Clinical narrative: Difficulty swallowing & breathing, rash.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Blood creatine phosphokinase normal, Blood thyroid stimulating hormone normal, Muscular weakness, Paraesthesia, Vaccination complication
Clinical narrative: Tingling, progressive weakness of legs. Seen 11/11/10 by neurologist that felt it was not Guillain Barre, but a strange reaction to flu vaccine. Resolved on own.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy
Clinical narrative: PT STATED THAT LYMPH NODES LEFT AXILLA WERE SWOLLEN AND WAS NOT SURE IF THAT HAD ANYTHING TO DO WITH THE TDAP.  ON 2/28/11 SHE RETURNED PHONE CALL AND STATED EVERYTHING WAS FINE.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Erythema, Injection site pruritus, Mass, Nausea, Oedema peripheral
Clinical narrative: Back of right arm became red and swollen. Went from a lump size of a small plum to a size of an orange. Skin was red and warm to the touch. Seen by school nurse-ice applied, administered Tylenol, and applied Caladryl Anti-Itch Cream beacause she c/o of itching at the injection site. Patient also complained of nausea for 24 hours. No fever.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash erythematous
Clinical narrative: Rash on the back, that slowly (over 2 days) got more red, and spread further down the back and onto the stomach.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Nausea, Paraesthesia, Rash, Rash macular
Clinical narrative: Nausea 1/15 and 1/16, developed blotchy rash on back and abdomen, numbness/tingling in left arm. Patient awoke vomiting on 17th.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Nausea 1/15 and 1/16, developed blotchy rash on back and abdomen, numbness/tingling in left arm. Patient awoke vomiting on 17th.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Blister, Rash maculo-papular
Clinical narrative: Macularpapular rash on bilateral hands and feet with some clear filled vesicles.  Rash can be found on both palmar/plantar surfaces as well as volar surfaces.  Patient responded to oral diphenhydramine 25mg PO q6h.  Pt was also given prednisone 40mg PO for 5 days.
Age: 76.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Malaise, Muscular weakness, Nasopharyngitis, Weight decreased
Clinical narrative: Started out as cold like symptoms, but continued to get worse. Lost 30-35 lbs over 2 weeks. Has extreme muscle weakness. Was admitted to hospital, where he was diagnosed with Guillain-Barre syndrome. Was in the hospital for 2 weeks. Still has significant muscle weakness and is currently seeing therapy and specialists. Still trying to get answers. Started getting sick before Thanksgiving and was admitted to the hospital X-mas day.
Age: 25.0
Sex: M
Vaccine: FLUN3, HEPAB, JEV
Symptoms: Expired drug administered
Clinical narrative: Patient received expired FLUMIST.
Age: 24.0
Sex: M
Vaccine: YF
Symptoms: Expired drug administered
Clinical narrative: Patient received an expired vaccine.
Age: 22.0
Sex: F
Vaccine: YF
Symptoms: Expired drug administered
Clinical narrative: Patient received an expired vaccine.
Age: 20.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: Patient received expired FLUMIST vaccine.
Age: 22.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: Patient received expired FLUMIST.
Age: 33.0
Sex: F
Vaccine: FLUN3, HEP, TDAP
Symptoms: Expired drug administered
Clinical narrative: Patient received expired FLUMIST.
Age: 26.0
Sex: M
Vaccine: FLUN3, TYP, YF
Symptoms: Expired drug administered
Clinical narrative: Patient received expired FLUMIST.
Age: 29.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: Patient was given expired FLUMIST.
Age: 26.0
Sex: M
Vaccine: FLUN3, YF
Symptoms: Expired drug administered
Clinical narrative: Patient received expired FLUMIST.
Age: 26.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: Patient received expired FLUMIST.
Age: 26.0
Sex: M
Vaccine: FLUN3, TDAP, TYP
Symptoms: Expired drug administered
Clinical narrative: Patient received expired FLUMIST.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: C-reactive protein increased, Chest X-ray abnormal, Cough, Febrile convulsion, Full blood count abnormal
Clinical narrative: Patient received MMR, Varicella, Hepatitis A and PREVNAR 13 on 29 November 2010 around noon at the Immunizations Department. On 30 November 2010, patient had runny nose, cough, and a fever of 102.5 F. Parents took child to Emergency Department. Patient had 103 F fever when he had a febrile seizure in the ER per parent around 8:20pm. Child was treated in ER and released home with recommendations to use TYLENOL and MOTRIN for fever management. On 1 December 2010, patient followed up with Dr at the Clinic. Patient was evaluated, parents counseled on dehydration and fever management, and provided with TYLENOL and MOTRIN. On 2 December 2010, parents took child to Emergency Department because child appeared ill and continued with fevers. In the ED the child had a fever of 102.9 F, had 6 breathing treatments without improvement, had + RSV lab work and pneumonia on the right lower lobe. Patient was admitted, treated for 4 days, and discharged on 6 December 2010 with Albuterol and Amoxicillin. Patient to follow-up with Clinic on the 8th and 15th December 2010 for pneumonia and RSV.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Lobar pneumonia, Metabolic function test abnormal, Pyrexia, Respiratory syncytial virus infection, Respiratory syncytial virus test positive
Clinical narrative: Patient received MMR, Varicella, Hepatitis A and PREVNAR 13 on 29 November 2010 around noon at the Immunizations Department. On 30 November 2010, patient had runny nose, cough, and a fever of 102.5 F. Parents took child to Emergency Department. Patient had 103 F fever when he had a febrile seizure in the ER per parent around 8:20pm. Child was treated in ER and released home with recommendations to use TYLENOL and MOTRIN for fever management. On 1 December 2010, patient followed up with Dr at the Clinic. Patient was evaluated, parents counseled on dehydration and fever management, and provided with TYLENOL and MOTRIN. On 2 December 2010, parents took child to Emergency Department because child appeared ill and continued with fevers. In the ED the child had a fever of 102.9 F, had 6 breathing treatments without improvement, had + RSV lab work and pneumonia on the right lower lobe. Patient was admitted, treated for 4 days, and discharged on 6 December 2010 with Albuterol and Amoxicillin. Patient to follow-up with Clinic on the 8th and 15th December 2010 for pneumonia and RSV.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rhinorrhoea
Clinical narrative: Patient received MMR, Varicella, Hepatitis A and PREVNAR 13 on 29 November 2010 around noon at the Immunizations Department. On 30 November 2010, patient had runny nose, cough, and a fever of 102.5 F. Parents took child to Emergency Department. Patient had 103 F fever when he had a febrile seizure in the ER per parent around 8:20pm. Child was treated in ER and released home with recommendations to use TYLENOL and MOTRIN for fever management. On 1 December 2010, patient followed up with Dr at the Clinic. Patient was evaluated, parents counseled on dehydration and fever management, and provided with TYLENOL and MOTRIN. On 2 December 2010, parents took child to Emergency Department because child appeared ill and continued with fevers. In the ED the child had a fever of 102.9 F, had 6 breathing treatments without improvement, had + RSV lab work and pneumonia on the right lower lobe. Patient was admitted, treated for 4 days, and discharged on 6 December 2010 with Albuterol and Amoxicillin. Patient to follow-up with Clinic on the 8th and 15th December 2010 for pneumonia and RSV.
Age: 25.0
Sex: F
Vaccine: FLUN3
Symptoms: Palpitations, Pruritus generalised, Tremor
Clinical narrative: Generalized itching, hands shaking and heart racing that began 10 minutes after receiving FLUMIST. Patient seen and given Benadryl 50 mg IM, Prednisone 60mg PO and PEPCID 20mg PO given 60-90 minutes after onset. Patient monitored for 90 minutes and sent home for 24 hours. Instructed to follow-up in 1-2 days.
Age: 32.0
Sex: F
Vaccine: FLUN3
Symptoms: Body temperature increased, Chills, Hot flush, Pruritus, Rash
Clinical narrative: On 16 Sept 2010, patient broke out with a rash on forearms around 11AM. She started having hot flashes, chills. Temperature was 99.1F. Patient noticed bumps on face, neck and arms. By the afternoon, bumps increased and were on chest and legs. Temp retaken 99.9 F. Patient took BENADRYL around 2pm and itchiness subsided. BENADRYL taken again around 1730 and she continued to do so all weekend every 3-4 hours. Resolved 20 Sept 2010.
Age: 1.59
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Urticaria
Clinical narrative: Broke out in hives all over body and ran low grade temp 99 degrees - 100 degrees 24 hours after vaccinations.
Age: 1.76
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (L) leg swollen & red, no tenderness no drainage.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Culture negative, Injection site discharge, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (R) arm injection site swelling, redness, warm to touch, feverish. Continued sx prompted office appt. & antibiotic tx on 2/14/11. Area still draining w/low grade temp. therefore appt on 3/1/11. Area on (R) arm draining. C & S obtained. Culture negative.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Sputum culture
Clinical narrative: (R) arm injection site swelling, redness, warm to touch, feverish. Continued sx prompted office appt. & antibiotic tx on 2/14/11. Area still draining w/low grade temp. therefore appt on 3/1/11. Area on (R) arm draining. C & S obtained. Culture negative.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site pruritus, Malaise
Clinical narrative: About approx 10 mins after vaccination, pt's mom called us over to alert us that her daughter was not feeling well. Pt said the injection site felt itchy & her head really hurt. I had her sit in a private area to take her blood pressure & ask her questions. After another 10 mins, she started feeling better. Also, pt did follow up several hours later. She didn't report any allergy reactions.
Age: 1.51
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Pyrexia, Synovitis
Clinical narrative: Younger sister dx. with strep throat 2/14/11 with 103 fever. Pt. spiked fever 102.5 the afternoon of getting vaccines. She just lied around on mother. Did not walk. Woke up with 99 temp 2/23. Had not walked until mother took to doctors at 4:30pm. Took 3 steps to mother at office. Dr. dx. Transient Synovitis.
Age: 15.0
Sex: F
Vaccine: HPV2
Symptoms: Cold sweat, Condition aggravated, Drug administered at inappropriate site, Pruritus, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hive in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject's medical history included hive. Concurrent medical conditions included skin allergy. Previous and/or concurrent vaccination included GARDASIL (non-gsk); non-GSK manufacturer; unknown; unknown given on an unspecified date. There were no concurrent medications. On 16 February 2011 the subject received 1st dose of CERVARIX (.5 cc, unknown, unknown thigh) and experienced administered at inappropriate site. On 18 February 2011, 2 days after vaccination with CERVARIX, the subject experienced hive, itching. On 23 February 2011, 7 days after vaccination with CERVARIX, the subject experienced fever and cold sweat; the hives and itching fever continued. The 15-year old subject previously received three doses of GARDASIL two to three years ago. The reporter stated "that it was believed that a booster for HPV would be beneficial and given the CERVARIX data, that is the one they used". The subject received CERVARIX on 16 February 2011 and developed hives and itching on 18 February 2011. The subject was treated with antihistamines and cream. The hives and itching were getting better and on 23 February 2011, she developed a "major case of hives, itching, fever and cold sweats". The nurse, who is the mother of the subject, administered CERVARIX in the thigh at home (administered at inappropriate site). The subject has not previously had any reaction to vaccinations. It was noted that the subject "had hives before but nothing like this". The subject also "has a lot of skin allergies but specifics were no known" at the time of the report. The subject's parents reviewed the two products GARDASIL and CERVARIX looking for ingredient differences that may have caused the reaction". The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the hive, itching, fever and cold sweat were improved and "no serious issues reported in a while". The healthcare professional considered the events were possibly related to vaccination with CERVARIX.
Age: 15.0
Sex: F
Vaccine: HPV2
Symptoms: Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hive in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject's medical history included hive. Concurrent medical conditions included skin allergy. Previous and/or concurrent vaccination included GARDASIL (non-gsk); non-GSK manufacturer; unknown; unknown given on an unspecified date. There were no concurrent medications. On 16 February 2011 the subject received 1st dose of CERVARIX (.5 cc, unknown, unknown thigh) and experienced administered at inappropriate site. On 18 February 2011, 2 days after vaccination with CERVARIX, the subject experienced hive, itching. On 23 February 2011, 7 days after vaccination with CERVARIX, the subject experienced fever and cold sweat; the hives and itching fever continued. The 15-year old subject previously received three doses of GARDASIL two to three years ago. The reporter stated "that it was believed that a booster for HPV would be beneficial and given the CERVARIX data, that is the one they used". The subject received CERVARIX on 16 February 2011 and developed hives and itching on 18 February 2011. The subject was treated with antihistamines and cream. The hives and itching were getting better and on 23 February 2011, she developed a "major case of hives, itching, fever and cold sweats". The nurse, who is the mother of the subject, administered CERVARIX in the thigh at home (administered at inappropriate site). The subject has not previously had any reaction to vaccinations. It was noted that the subject "had hives before but nothing like this". The subject also "has a lot of skin allergies but specifics were no known" at the time of the report. The subject's parents reviewed the two products GARDASIL and CERVARIX looking for ingredient differences that may have caused the reaction". The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the hive, itching, fever and cold sweat were improved and "no serious issues reported in a while". The healthcare professional considered the events were possibly related to vaccination with CERVARIX.
Sex: U
Vaccine: HEPA
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer and described the occurrence of unspecified adverse events in a subject of unspecified age and gender who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of HAVRIX (unknown). At an unspecified time after vaccination with HAVRIX, the subject experienced unspecified adverse events. At the time of reporting the outcome of the events was unspecified. It was reported that the caller would only state the patient had numerous effects from taking the vaccine. The patient was told not to have any more shots. She didn't want to provide any more information as she said the patient's neurologist and legal team would be contacting GSK.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Blepharospasm, Body temperature increased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of eye fluttering in a 2-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 16 July 2010 the subject received unspecified dose of HAVRIX (.5 ml, unknown route). On an unspecified date in July 2010, less than one week after vaccination with HAVRIX, the subject experienced eye fluttering and body temperature elevated. Relevant test results included temperature of 103 degrees Fahrenheit on 20 July 2010. At the time of reporting the outcome of the events was unspecified. On 20 July 2010 at 17:00, the subject's mother informed the healthcare professional that the subject had a temperature of 103 degrees F and eye fluttering.
Age: 40.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Dysgeusia, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of metallic taste in mouth in a 40-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline), ENGERIX B and typhoid vaccine (non-gsk). The subject's medical history included Crohn's disease. Concurrent medical conditions included allergy to horses and asthma. Previous and/or concurrent vaccination included TDAP; GlaxoSmithKline; unknown; unknown given on 22 July 2010. Concurrent medications included VENTOLIN and ADVAIR. On 4 May 2010 the subject received 1st dose of HAVRIX (1 ml, unknown route, left arm), and 1st dose of Typhoid vaccine (Non-GSK) (details unknown). On 4 May 2010, less than one day after vaccination with HAVRIX and Typhoid vaccine (Non-GSK), the subject experienced metallic taste in mouth. On 5 May 2010, the subject experienced injection arm pain (left arm) and unable to move arm. On 8 May 2010, the events were resolved. On 22 July 2010 at 11:45 the subject received unspecified dose of ENGERIX B (1 ml, unknown route and site). On 22 July 2010, immediately after vaccination with ENGERIX B, the subject experienced metallic taste in mouth, lasting for about 5 seconds. On 22 July 2010, the event was resolved. The healthcare professional considered the events were probably related to vaccination with HAVRIX, ENGERIX B and Typhoid vaccine (Non-GSK). Follow-up information received from the healthcare professional on 06 August 2010: Typhoid vaccine (0.5 cc) was administered in the left arm on 04 May 2010. The subject experienced injection arm pain on 04 May 2010, the same day after vaccination with HAVRIX and Typhoid vaccine. The subject received 1st dose of ENGERIX B in her left arm and BOOSTRIX (0.5 cc) in her right arm on 22 July 2010. The dose of BOOSTRIX administered on 22 July 2010 was also considered a suspect product for the event of metallic taste in mouth that occurred the same day.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site swelling, Overdose
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swollen leg in a 2-year-old male subject who was vaccinated with HAVRIX adult (GlaxoSmithKline). On 10 August 2010 the subject received a dose of HAVRIX adult (details unknown), and experienced overdose. On either 10 or 11 August 2010, the same day or 1 day after vaccination with HAVRIX adult, the subject experienced swollen leg. At the time of reporting the outcome of the events was unspecified.
Sex: U
Vaccine: HEPA
Symptoms: Product quality issue, Rash, Urticaria
Clinical narrative: This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of rash in a subject of unspecified age and gender who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of HAVRIX (details unknown). Between 20 minutes and 18 hours after vaccination with HAVRIX, the subject experienced rash and hives. At the time of reporting the outcome of the events was unspecified. This case involves a pharmaceutical product complaint. The healthcare professional reported that there had been 3 incidents of rash and hives following vaccination with HAVRIX within the time frame of 20 minutes to 18 hours following the administration. This is case 1 of 3 (see case IDs A0878505A and A0878506A for the other reports). Follow-up received on 09 September 2010: QA analysis revealed the complaint to be unsubstantiated.
Sex: U
Vaccine: HEPA
Symptoms: Product quality issue, Rash, Urticaria
Clinical narrative: This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of rash in a subject of unspecified age and gender who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of HAVRIX (details unknown). Between 20 minutes and 18 hours after vaccination with HAVRIX, the subject experienced rash and hives. At the time of reporting the outcome of the events was unspecified. This case involves a pharmaceutical product complaint. The healthcare professional reported that there had been 3 incidents of rash and hives following vaccination with HAVRIX within the time frame of 20 minutes to 18 hours following the administration. This is case 2 of 3 (see case IDs A0878214A and A0878506A for the other reports). Follow-up received on 09 September 2010: QA analysis revealed the complaint to be unsubstantiated.
Sex: U
Vaccine: HEPA
Symptoms: Product quality issue, Rash, Urticaria
Clinical narrative: This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of rash in a subject of unspecified age and gender who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of HAVRIX (details unknown). Between 20 minutes and 18 hours after vaccination with HAVRIX, the subject experienced rash and hives. At the time of reporting the outcome of the events was unspecified. This case involves a pharmaceutical product complaint. The healthcare professional reported that there had been 3 incidents of rash and hives following vaccination with HAVRIX within the time frame of 20 minutes to 18 hours following the administration. This is case 3 of 3 (see case IDs A0878214A and A0878505A for the other reports). Follow-up received on 09 September 2010: QA analysis revealed the complaint to be unsubstantiated.
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, No therapeutic response
Clinical narrative: This case was reported by a pharmacist and described the occurrence of not responding to therapy in a male subject of unspecified age who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date the subject received 2nd dose of HAVRIX (unknown). After vaccination with HAVRIX, the subject was non-reactive (did not respond to therapy). No additional details were provided and no adverse events were noted.
Sex: M
Vaccine: HEPA
Symptoms: Nonspecific reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of nonspecific reaction in an adult male subject who was vaccinated with HAVRIX adult (GlaxoSmithKline). On an unspecified date in 2009 the subject received unspecified dose of HAVRIX adult (unknown). In 2009, 2 days after vaccination with HAVRIX adult, the subject experienced nonspecific reaction. The subject had a reaction two days after receiving HAVRIX. The subject consulted a physician who believed the reaction was to "antibiotic in HAVRIX". The reported nurse believed that this occurred sometime last year (2009). At the time of the report no other details were provided. At the time of reporting the outcome of the event was unspecified. The nurse reported additional cases see A0882391A, A0882436A and previously reported A0797402A.
Age: 56.0
Sex: F
Vaccine: HEPA
Symptoms: Dyspnoea, Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of rash in a 56-year-old female subject who was vaccinated with HAVRIX 1440 (GlaxoSmithKline). On 3 March 2010 the subject received 1st dose of HAVRIX 1440 (unknown). On 3 March 2010, less than one day after vaccination with HAVRIX 1440, the subject experienced rash and shortness of breath. The healthcare professional reported that after receiving HAVRIX 1440, the subject developed a rash on her neck and chest. Then the subject experienced shortness of breath which she sought treatment for in the emergency room (ER). The subject was given prednisone and BENADRYL in the ER. No other information was available at the time of the report. At the time of reporting the outcome of the rash and shortness of breath were unspecified. Follow-up received via the nurse on 02 November 2010 indicated that the subject experienced an unspecified reaction in 2008, but the reporter was not a witness to it. Associated medications taken by the patient were not reported. The reporter only started seeing the patient at her office in 2010. No additional details were provided.
Age: 33.0
Sex: M
Vaccine: HEPA
Symptoms: Dysgeusia
Clinical narrative: This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of metallic taste in mouth in a male subject of unspecified age who was vaccinated with HAVRIX (GlaxoSmithKline). On 4 October 2010 the subject received unspecified dose of HAVRIX (details unknown). On 7 October 2010, 3 days after vaccination with HAVRIX, the subject experienced metallic taste in mouth. At the time of reporting the outcome of the event was unspecified. Follow-up received from the healthcare professional on 11 October 2010: The event was improved. On 11 October 2010 the subject reported that the bitter taste in his mouth had almost gone. Follow-up received from the healthcare professional on 27 October 2010: The subject was 33 years old. Concurrent medical conditions included bee sting allergy, occasional alcohol use and marijuana use several times a week. The dose of HAVRIX was possibly the subject's 1st dose. He was seen in September 2008 and stated that he had already had dose 1 of Hepatitis A vaccine, but when seen on 04 October 2010 he stated he had never had dose 1 and that he did not want it in 2008 and had given the reporter wrong information. HAVRIX was administered intramuscularly in the left arm. The bitter taste occurred when the subject was eating and drinking. The event resolved on 15 October 2010. The reporter did not consider the event to be serious. The reporter considered that the event could not be associated with medical history/concurrent illness, lack of efficacy, erroneous administration, suspected transmission of an infectious agent via a medicinal product or any other reason.
Sex: F
Vaccine: HEPA
Symptoms: Feeling hot, Hypoaesthesia, Pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of heat sensation in arm in an adult female subject who was vaccinated with HAVRIX adult (GlaxoSmithKline). On 28 September 2010 at 13:00 the subject received 1st dose of HAVRIX adult (1 ml, unknown route and site). On 9 October 2010, 11 days after vaccination with HAVRIX adult, the subject experienced heat sensation in arm, stinging arm and arm numbness. At the time of reporting the events were improved. The healthcare professional considered the events were possibly related to vaccination with HAVRIX adult. The healthcare professional reported that an adult subject was vaccinated with HAVRIX and reported that her arm felt hot, stinging, and numbness down her arm for 48 hours after the vaccination. The symptoms were improving but not resolved.
Age: 0.75
Sex: M
Vaccine: FLUX, HEPA
Symptoms: Irritability, Wrong drug administered
Clinical narrative: This case was reported by a consumer and described the occurrence of irritability in a 9-month-old male subject who was vaccinated with Hepatitis A vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included ear infection. Previous and/or concurrent vaccination included influenza virus vaccine; unk manufacturer; unknown given on 12 October 2010. Concurrent medications included Amoxicillin. On 12 October 2010 at 12:00 the subject received 1st dose of Hepatitis A vaccine (unknown, right thigh). On 12 October 2010, the subject was administered Hepatitis A vaccine instead of Hepatitis B vaccine and experienced wrong vaccine administered. On 13 October 2010, one day after vaccination with Hepatitis A vaccine, the subject experienced irritability. The reporter, who was the subject's mother, was uncertain of the brand of Hepatitis A that her child received. A healthcare provider was consulted regarding the event. At the time of reporting the outcome of the irritability was unspecified.
Sex: U
Vaccine: HEPA
Symptoms: Injection site pain
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of HAVRIX (details unknown). At an unspecified time after vaccination with HAVRIX, the subject experienced injection site pain. The subject did not require medical attention. The event was resolved 24 hours after the vaccination. The healthcare professional considered the event was possibly related to vaccination with HAVRIX. The reporting healthcare professional stated that her practice had noticed an increased number of cases of pain at injection site with GlaxoSmithKline's vaccine versus the other competitor. She did not have further details regarding number of patients, etc.
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site soreness in a 34-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergic to COMPAZINE and allergy to REGLAN. Previous and/or concurrent vaccination included hepatitis A vaccine inactivated; manufacturer unspecified; unknown; unknown given in November 2009. There were no concurrent medications. On 15 January 2010 the subject received 2nd dose of HAVRIX (1 ml, intramuscular, unknown). On 15 January 2010, less than one day after vaccination with HAVRIX, the subject experienced injection site soreness and inappropriate schedule of vaccine administered. The subject reported that she possibly received hepatitis A vaccine in November 2009. The subject was immunized on 15 January 2010 which was before the label recommended next dose. The subject also experienced soreness at injection site. The subject denied contact for follow-up. At the time of reporting the outcome of the soreness at injection site was unspecified.