chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: HEPA, IPV, MMR
Symptoms: Abdominal X-ray, Arthralgia, Blood test, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: On August 25th, patient began to have pain and weakness in his left arm. I gave him some Motrin but later on that same evening he could not walk to the bathroom without help. The next day, Aug. 26th, he was able to walk on his own until about 4pm and then had the paralysis again. Each day he would be able to walk for the first part of the day but by around 2pm he would be too weak and we would have to carry him. He complained of should pain, ankle pain, knee pain, elbow pain, etc. The pain and weakness would move around from one joint to the other and from one side to the other. We saw Dr. on 8/28/08 and had an x-ray of his ankle done. Results were unremarkable. On 8/30/08 we took him to Urgent Care and additional x-rays were done. Once again, unremarkable. On 9/1/08, we took him to Dr. who diagnosed him with a virus that attacks his joints. He said it would go away within two weeks and it did. He slowly regained his strength and was back to mostly normal activity by 9/3/08. I now suspect Guillain Barre Syndrome brought on by the vaccinations.
Age: 5.0
Sex: M
Vaccine: HEPA, IPV, MMR
Symptoms: Muscular weakness, Musculoskeletal pain, Pain in extremity, Viral infection, X-ray normal
Clinical narrative: On August 25th, patient began to have pain and weakness in his left arm. I gave him some Motrin but later on that same evening he could not walk to the bathroom without help. The next day, Aug. 26th, he was able to walk on his own until about 4pm and then had the paralysis again. Each day he would be able to walk for the first part of the day but by around 2pm he would be too weak and we would have to carry him. He complained of should pain, ankle pain, knee pain, elbow pain, etc. The pain and weakness would move around from one joint to the other and from one side to the other. We saw Dr. on 8/28/08 and had an x-ray of his ankle done. Results were unremarkable. On 8/30/08 we took him to Urgent Care and additional x-rays were done. Once again, unremarkable. On 9/1/08, we took him to Dr. who diagnosed him with a virus that attacks his joints. He said it would go away within two weeks and it did. He slowly regained his strength and was back to mostly normal activity by 9/3/08. I now suspect Guillain Barre Syndrome brought on by the vaccinations.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Abasia, Decreased appetite, Headache, Injected limb mobility decreased, Injection site pain
Clinical narrative: Headache, poor appetite, severe leg pain. My son could not walk on it for 2 days. On the leg shot was administered, patient would not bend his knee and would keep it straight.
Age: 38.0
Sex: M
Vaccine: TD
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: fever, body ache, headache, chills, tired
Age: 0.5
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: Very High Fever of 102.6 and difficulty breathing. Fever will not go down even after administing Infant Tylenol. Ended up In Emergency room. Went down with Ibuprofen to 100.8 but came back next morning at 102.4 and stayed between 100.8 to 102.6 all day on 07/03/2011.
Age: 1.01
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting and diarrhea
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Nodule, Pain, Swelling
Clinical narrative: My arm is all red and puffy, and has a big knot in the middle of it. My arm hurts when I try to move it.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Back pain, Chest pain, Electrocardiogram ST segment elevation, General symptom, Laboratory test normal
Clinical narrative: maculo-papular rash, sudden onset of chest pain, substernal, radiating to back, pain lasted approx 3hrs relieved with Toradol dose in ED, sx's improved w/leaning forward
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Pericardial rub, Rash maculo-papular, Troponin
Clinical narrative: maculo-papular rash, sudden onset of chest pain, substernal, radiating to back, pain lasted approx 3hrs relieved with Toradol dose in ED, sx's improved w/leaning forward
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Back pain, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Blood magnesium normal, Blood phosphorus normal
Clinical narrative: maculo-papular rash, sudden onset of chest pain, substernal, radiating to back, pain lasted approx 3hrs relieved with Toradol dose in ED, sx's improved w/leaning forward
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: C-reactive protein increased, Chest discomfort, Chest pain, Dyspnoea, Echocardiogram abnormal
Clinical narrative: maculo-papular rash, sudden onset of chest pain, substernal, radiating to back, pain lasted approx 3hrs relieved with Toradol dose in ED, sx's improved w/leaning forward
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Ejection fraction normal, Electrocardiogram ST segment elevation, Extrasystoles, Full blood count normal, General symptom
Clinical narrative: maculo-papular rash, sudden onset of chest pain, substernal, radiating to back, pain lasted approx 3hrs relieved with Toradol dose in ED, sx's improved w/leaning forward
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Headache, Liver function test normal, Metabolic function test normal, Middle insomnia, Mitral valve incompetence
Clinical narrative: maculo-papular rash, sudden onset of chest pain, substernal, radiating to back, pain lasted approx 3hrs relieved with Toradol dose in ED, sx's improved w/leaning forward
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Palpitations, Pericarditis, Pleural effusion, Rash, Rash erythematous
Clinical narrative: maculo-papular rash, sudden onset of chest pain, substernal, radiating to back, pain lasted approx 3hrs relieved with Toradol dose in ED, sx's improved w/leaning forward
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Rash maculo-papular, Rash pruritic, Red blood cell sedimentation rate normal, Sleep disorder, Tricuspid valve incompetence
Clinical narrative: maculo-papular rash, sudden onset of chest pain, substernal, radiating to back, pain lasted approx 3hrs relieved with Toradol dose in ED, sx's improved w/leaning forward
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Troponin normal
Clinical narrative: maculo-papular rash, sudden onset of chest pain, substernal, radiating to back, pain lasted approx 3hrs relieved with Toradol dose in ED, sx's improved w/leaning forward
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: 1 1/2 inch wheal on (R) thigh.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Headache, Injection site reaction, Myalgia, Rash erythematous
Clinical narrative: Red rash (2"RD) 2" from vaccine site; some discomfort -> lunch (#5). Soreness muscular at site at triceps (#3); Thurs (6/23): Head pain (#3); stom. disc & triceps soreness (#3); Fri (6/24) Headache (#0); stom. disc (#3); soreness (#2); (6/25) Head pain (#2), stom. disc & soreness (#3) rash still there (#2) - All symptoms gone (6/29 = 9 days) except rash/redness (95% gone) (7/5) rash 96% gone!
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Urticaria papular
Clinical narrative: Papular urticaria - face, abdomen, arms.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: (L) upper arm 50mm x 40mm light pink color & induration. (+) tender (+) itching.
Age: 40.0
Sex: M
Vaccine: TD
Symptoms: Cold sweat, Dizziness
Clinical narrative: Per patient, he felt dizzy outside of waiting area while making appointment for I 693. He said that he had not slept or eaten prior to coming for his vaccinations. Patient felt clammy to touch. He was aao x 3 and with family. He was assisted to a wheelchair and brought to an exam room and was seen by the clinic Nurse Practitioner. Patient denies any medical history during this time of visit. Patient was offered Ensure to drink and allowed to rest until recovered. He was instructed to go to ER or urgent care when symptoms persist. Vital signs stable. BP 120/79 and HR 80. Patient verbalized understanding of instructions.
Age: 18.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: VIIth nerve paralysis
Clinical narrative: Bells Palsy
Age: 1.38
Sex: F
Vaccine: DTAP, IPV, MMR, PNC13
Symptoms: Blister, Rash
Clinical narrative: Large circular rashes on both arms, mirrored kidney shaped rashes on bilateral sides of abdomen, blisters back of R hand- no fever or change of demeanor
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Lymphadenopathy, Pyrexia
Clinical narrative: 10 days after vaccine developed fever 0f 101-102. Swollen glands at neck - achey joints.
Age: 57.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Chills, Pyrexia
Clinical narrative: Fever (101-102), chills, arthralgias
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pruritus, Local reaction, Vaccination complication, Vaccination site swelling
Clinical narrative: The pt reports that he received AVA#3 IM (left arm) on 3/17/10. He was in his normal state of good health at that time. On 3/18/10 the pt noted a 2cm area of redness and swelling around the vaccination site. It was also "itchy". He denied generalized rash, pruritus, SOB, difficulty swallowing, diarrhea, or abd pain. The next day the pt states that the red, swollen area had increased to about 4-5cm and that the itching at the site was worse. He was treated with MOTRIN and BENADRYL with 60% improvement on 3/21/10 and resolution of all sx on 3/22/10. On 9/29/10 the pt received AVA#4 IM (right arm) in the am. Later that evening the pt noted about 2cm of redness and swelling at the injection site again with "itchiness" at that area only. He had no other sx. On 9/30/10 he noted about 4-5cm of redness and swelling and increased itchiness. He reported to medical on 10/1/10. At that time he states that the swelling and redness extended down to his elbow and that it was "very itchy". He was treated with ATARAX and MOTRIN with marked improvement (75%) on 10/3/10 and resolution by 10/4/10. A review of the note 10/2/10: "exam shows local reaction to anthrax vaccination. Advised against anthrax immunization in the future.
Age: 11.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Injection site pain, Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Has taken Flu vax in the past with no problems. Pain at injection site has never gone away, 2-3 months later pain began to radiate to ankles, hands. Sometimes because of pain, it is hard to sleep at night and make movements. Has been at doctor and specialist and both agreed that there might have been some nerve damage. Last saw primary care doctor 1-2 weeks ago who recommended oxycode for pain.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Miller Fisher syndrome
Clinical narrative: Miller Fisher variant Guillain-Barre Syndrome.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray abnormal, Laboratory test abnormal, Pneumonia, Vaccination complication
Clinical narrative: Reaction to vaccine. Ended up in hospital with pneumonia. Hospitalization lasted 5 days.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Culture negative, Emotional distress, Enema administration, Haematochezia
Clinical narrative: 1 day after vaccinations, pt. developed fever to 38.4 degrees C, incapability and passed large amount of fecal after her meal. Barium enema performed, (-) for intussusception; septic work up performed with all cultures being negative.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Laboratory test normal, Pyrexia
Clinical narrative: 1 day after vaccinations, pt. developed fever to 38.4 degrees C, incapability and passed large amount of fecal after her meal. Barium enema performed, (-) for intussusception; septic work up performed with all cultures being negative.
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Itching with hives and rash on hands and chest. Saw Dr. 06/27/2011. Was given a steroid shot and some cream. Still has some rash.
Age: 23.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Chills, Dizziness, Hyperventilation, Nausea, Vomiting
Clinical narrative: Vaccines given at approximately noon.  After lunch, reaction started with nausea, chills, light-headed, vomited x1, hyperventilating.  Seen in EC and treated with IV fluids and Benadryl 50 mg IV.  Discharged at 1730.
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Abdominal pain upper, Diarrhoea, Eye swelling, Lip swelling, Pruritus generalised
Clinical narrative: stomache, and diarrhea, severe swelling of lips and eyes severe itching hives all over body
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: stomache, and diarrhea, severe swelling of lips and eyes severe itching hives all over body
Age: 4.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, PNC13, VARCEL
Symptoms: Gait disturbance, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PATIENT HAD BIG RED ROUND MARK ON HER LEFT THIGH, WAS A BIT SWOLLEN AND SHE WAS HAVING TROUBLE WALKING BECAUSE IT WAS PAINFUL. TREATMENT WAS MOTRIN AND HEAT PATCH.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Diarrhoea, Headache, Injection site pain
Clinical narrative: sharp pain between shoulder blades lasting 1-2 hrs (ibuprofen), sharp pain centered entire left arm and shoulder region 1-2 hrs (extra strength Tylenol), pain then continued from left shoulder region up into neck region causing headache 1-2 hrs (ibuprofen/Tylenol), stomach pain/discomfort, diarrhea, cramping
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: sharp pain between shoulder blades lasting 1-2 hrs (ibuprofen), sharp pain centered entire left arm and shoulder region 1-2 hrs (extra strength Tylenol), pain then continued from left shoulder region up into neck region causing headache 1-2 hrs (ibuprofen/Tylenol), stomach pain/discomfort, diarrhea, cramping
Age: 1.91
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Accidental exposure, Injection site rash, Rash
Clinical narrative: Symptoms  included clustered pimply white bumps around the injection area (both upper legs), and spread to both arms and then lower back legs. HepA was injected by the nurse "accidentally" without parental consent/signature even though parent specifically stated that she would like to opt out from the HepA and just have her daughter get the 3 required vaccines (MMR, Chickenpox, and pneumococcal).
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Asthenia, Dizziness, Headache, Nausea
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 16 year old female patient with asthma, allergic rhinitis, no drug reactions or allergies and a history of uterine bleeding, who on 21-JUN-2011 was vaccinated with the first dose of GARDASIL intramuscularly (Lot number 1017Z). No other vaccines were administered concomitantly. Concomitant therapy included FLONASE, ADVAIR and albuterol (manufacturer unknown). The licensed visiting nurse reported that on 21-JUN-2011, later that day the patient developed headache, dizziness, nausea, vomiting, weakness for two days and sleepiness. On 24-JUN-2011 the patient was seen by a physician at a health center and he recommended that the patient received no more GARDASIL vaccinations. No lab diagnostics studies were performed. TYLENOL was given as a treatment for the experience. At the time of the report, the patient had fully recovered (date not provided). Headache, dizziness, nausea, vomiting, weakness for two days and sleepiness were considered to be temporarily disabling by the licensed practical nurse since the patient missed days of school. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Somnolence, Vomiting
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 16 year old female patient with asthma, allergic rhinitis, no drug reactions or allergies and a history of uterine bleeding, who on 21-JUN-2011 was vaccinated with the first dose of GARDASIL intramuscularly (Lot number 1017Z). No other vaccines were administered concomitantly. Concomitant therapy included FLONASE, ADVAIR and albuterol (manufacturer unknown). The licensed visiting nurse reported that on 21-JUN-2011, later that day the patient developed headache, dizziness, nausea, vomiting, weakness for two days and sleepiness. On 24-JUN-2011 the patient was seen by a physician at a health center and he recommended that the patient received no more GARDASIL vaccinations. No lab diagnostics studies were performed. TYLENOL was given as a treatment for the experience. At the time of the report, the patient had fully recovered (date not provided). Headache, dizziness, nausea, vomiting, weakness for two days and sleepiness were considered to be temporarily disabling by the licensed practical nurse since the patient missed days of school. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Vaccination site oedema, Vaccination site warmth
Clinical narrative: Vaccine placed 6-28-11. 6-29-11 noted redness, edema and warmth on (L) arm at vaccine site.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Joint stiffness, Myalgia
Clinical narrative: Joint pain & muscle aches & joint stiffness.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Abdominal pain upper, Dysphagia, Throat tightness
Clinical narrative: Developed stomach pain felt throat closing, difficulty swallowing few minutes.
Age: 27.0
Sex: M
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Disorientation, Fatigue, Pyrexia
Clinical narrative: fever, disorientation, fatigue for 3 days stayed home from work for 1 week recovered and returned to work
Age: 1.06
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Blister, Blood test normal, Culture
Clinical narrative: Seen on 5/6 for 1 yr WCC, got varicella, MMR, Hep A shots.  Started last night with fever and extreme fussiness.  Then Mom saw a few red bumps on her legs.  This morning the rash had spread to involve both her legs, is blistering, and there are a few blisters next to her mouth.  She continues to be very fussy. Ate breakfast okay this morning.  Only other exposure Mom can think of was that she was in the gym nursery over the weekend.
Age: 1.06
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Full blood count normal, Irritability, Pyrexia, Rash erythematous, Urine analysis normal
Clinical narrative: Seen on 5/6 for 1 yr WCC, got varicella, MMR, Hep A shots.  Started last night with fever and extreme fussiness.  Then Mom saw a few red bumps on her legs.  This morning the rash had spread to involve both her legs, is blistering, and there are a few blisters next to her mouth.  She continues to be very fussy. Ate breakfast okay this morning.  Only other exposure Mom can think of was that she was in the gym nursery over the weekend.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Antinuclear antibody, Antiphospholipid syndrome, Autoimmune disorder, Fatigue, Malaise
Clinical narrative: Cold/Sinus issues.  Severe migraines.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Migraine, Nasopharyngitis, Rheumatoid arthritis, Sinus disorder, Systemic lupus erythematosus
Clinical narrative: Cold/Sinus issues.  Severe migraines.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Temporomandibular joint syndrome
Clinical narrative: Cold/Sinus issues.  Severe migraines.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Antiphospholipid syndrome, Fatigue, Headache, Laboratory test, Malaise
Clinical narrative: Cold/Sinus issues.  Severe migraines.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Multi-organ disorder, Rheumatoid arthritis, Systemic lupus erythematosus, Temporomandibular joint syndrome
Clinical narrative: Cold/Sinus issues.  Severe migraines.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Back pain, Headache, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Feverish, involuntary shaking, pain in legs, arms, and back. Severe headache followed, lasting about eight hours.
Age: 1.02
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Fever 104.3 F for about 50 hours, followed by all-over rash
Age: 32.0
Sex: F
Vaccine: TD
Symptoms: Cough, Injection site erythema, Injection site pruritus, Injection site rash, Pyrexia
Clinical narrative: Coughing, low grade fever 99.0, red itchy rash at injection site (Benadryl).
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Developed swelling at site on right deltoid, redness, hard, very tender to touch. Swelling contiune to get worse and went to the ER on 07/04/2011. ER MD I & D'd site and packed. Was placed on oral antibotics of Doxycycline Hyclate 100mg twice daily for 10 days & Bactrim DS twice daily for 10 cays and pain medication of hydrocodone 5mg every 4-6 hours prn pain.
Age: 1.19
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site nodule, Mucous stools
Clinical narrative: Development of a tender nodule at site of administration.  Nodule became pea sized and persisted for 3-4 weeks.  Patient's stools became "mucousy".
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Feeling abnormal, Pyrexia, Urticaria, Vomiting
Clinical narrative: Had hard vomiting for 6 hours, hives on chest and up neck, fever of 99, was "out of it" for 24 hours--was feeling better by the 30th.
Age: 1.23
Sex: F
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Erythema multiforme
Clinical narrative: Erythema Multiforme, no fever
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Edema and erythema to right deltoid approx 1cm x 1cm. Instructed to apply ice, Benadryl and Tylenol prn for signs/symptoms.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: VIIth nerve paralysis
Clinical narrative: Patient developed Bells Palsy (R) side about 21 day after the vaccination with HPV.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Herpes zoster, Rash, Skin burning sensation
Clinical narrative: Warm feeling and rash on the left side and left upper leg and around waist. Pt stated that rash burn.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: Pt broke out in rash/hives that lasted 5 days. Pt took BENADRYL. Unrelieved by CLARITIN.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site swelling, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: Had tingling, itchy patches - no rash, all over body lasted 3 days. Now arthralgia - feet, wrists, hands and back where back surgery was performed 15 years ago. Aching muscle in arm. Still having arthralgia inj site still puffy aching muscle in arm.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: Had tingling, itchy patches - no rash, all over body lasted 3 days. Now arthralgia - feet, wrists, hands and back where back surgery was performed 15 years ago. Aching muscle in arm. Still having arthralgia inj site still puffy aching muscle in arm.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Local swelling
Clinical narrative: Localized swelling, redness, inflammation (L) upper arm.
Age: 53.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Activities of daily living impaired, Asthenia, Dyspnoea, Injection site erythema, Injection site pain
Clinical narrative: Visited Doctor on April 7, 2011 for routine discussion on cholesterol and discuss what vaccinations I should have. I was administered two vaccinations around 5:00 pm, one in each arm: T-DAP and PNEUMO. The PNEUMO would be my 2nd pneumonia vaccination. First one would have been over 10 years ago. I had a tetanus shot by a public offering in 2009. I asked doctor if it was OK to take both at same time and he said yes. I developed symptoms of difficulty breathing, awful pain in arm where pneumonia vaccination was given and arm turned red with rash and ballooned twice the size of the arm in the next 5 hours. Couldn't get rest and by morning all symptoms worsened. Pain was so intense you could not touch the arm. Arm continued to swell up 6 inches in length on all sides of vaccination. I was very weak with no energy. In fact I had to take off work on April 8 as was too sick and weak. This continued all weekend into the next week and eventually had to take off work 4-13 all days. The physician's assistant said it might be from an infected needle which is why she wanted me to go on anti-biotics. I feel the medicine in the vaccination was BAD and or contained a substance that was toxic, spoiled or caused allergic reaction in me that could have killed me if my breathing would have continued to get worse. I live in a rural area so it is not easy to get to the emergency room as it is 40 minutes away. I live alone so I could not drive myself there so just tried to stay calm and take medicines that were prescribed.
Age: 53.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site rash, Injection site swelling, Insomnia, Malaise, Restlessness
Clinical narrative: Visited Doctor on April 7, 2011 for routine discussion on cholesterol and discuss what vaccinations I should have. I was administered two vaccinations around 5:00 pm, one in each arm: T-DAP and PNEUMO. The PNEUMO would be my 2nd pneumonia vaccination. First one would have been over 10 years ago. I had a tetanus shot by a public offering in 2009. I asked doctor if it was OK to take both at same time and he said yes. I developed symptoms of difficulty breathing, awful pain in arm where pneumonia vaccination was given and arm turned red with rash and ballooned twice the size of the arm in the next 5 hours. Couldn't get rest and by morning all symptoms worsened. Pain was so intense you could not touch the arm. Arm continued to swell up 6 inches in length on all sides of vaccination. I was very weak with no energy. In fact I had to take off work on April 8 as was too sick and weak. This continued all weekend into the next week and eventually had to take off work 4-13 all days. The physician's assistant said it might be from an infected needle which is why she wanted me to go on anti-biotics. I feel the medicine in the vaccination was BAD and or contained a substance that was toxic, spoiled or caused allergic reaction in me that could have killed me if my breathing would have continued to get worse. I live in a rural area so it is not easy to get to the emergency room as it is 40 minutes away. I live alone so I could not drive myself there so just tried to stay calm and take medicines that were prescribed.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Eating disorder, Enema administration, Haematochezia, Intussusception, Lethargy
Clinical narrative: Initial report received on 22 June 2011 from another manufacturer (Reference number WAES 1106USA01587), who had received the original report from a registered nurse. The following is verbatim from the report. "Information has been received from a nurse concerning a 9 week old female with no known drug allergies and no pertinent medical history who on 01-JUN-2011 was vaccinated with the first dose of ROTATEQ (lot # 668964/1200Z) orally. There was no concomitant medication. The patient experienced intussusception following administration of her first dose of ROTATEQ on 08-JUN-2011 (also reported as 2 weeks after vaccination). She was eating poorly, had blood in her stool, and became lethargic. Patient sought medical attention by office visit. Patient was changed to ALIMENTUM formula for possible mild allergy. on 08-JUN-2011 she was diagnosed with intussusception and hospitalized. Ultrasounds of abdomen and contrast enema were performed, although, results were not provided. Intussusception was treated with surgery. She recovered and was discharged on 10-JUN-2011. Follow-up information has been received from the registered nurse who reported that the patient with no medical history other than a possible milk protein allergy was also given other vaccines on 01-JUN-2011 including DAPTACEL, ACTHIB, IPOL and PREVNAR 13. Onset of symptoms was on 08-JUN-2011, there was no vomiting mentioned in phone call from mother to office. The patient was not seen in the office; the patient's mother was instructed to take baby to the hospital, where the patient was admitted. The baby did not require surgery. Air contrast enema was performed on 09-JUN-2011 as treatment. There were no predisposing factors. The patient's gestational age at birth was 39 weeks and weight at birth was 8# 3 oz. The nurse reported that the adverse event was not disabling or life threatening. No further information is available. Patient was hospitalized." Documents held by sender: None.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Surgery, Ultrasound abdomen
Clinical narrative: Initial report received on 22 June 2011 from another manufacturer (Reference number WAES 1106USA01587), who had received the original report from a registered nurse. The following is verbatim from the report. "Information has been received from a nurse concerning a 9 week old female with no known drug allergies and no pertinent medical history who on 01-JUN-2011 was vaccinated with the first dose of ROTATEQ (lot # 668964/1200Z) orally. There was no concomitant medication. The patient experienced intussusception following administration of her first dose of ROTATEQ on 08-JUN-2011 (also reported as 2 weeks after vaccination). She was eating poorly, had blood in her stool, and became lethargic. Patient sought medical attention by office visit. Patient was changed to ALIMENTUM formula for possible mild allergy. on 08-JUN-2011 she was diagnosed with intussusception and hospitalized. Ultrasounds of abdomen and contrast enema were performed, although, results were not provided. Intussusception was treated with surgery. She recovered and was discharged on 10-JUN-2011. Follow-up information has been received from the registered nurse who reported that the patient with no medical history other than a possible milk protein allergy was also given other vaccines on 01-JUN-2011 including DAPTACEL, ACTHIB, IPOL and PREVNAR 13. Onset of symptoms was on 08-JUN-2011, there was no vomiting mentioned in phone call from mother to office. The patient was not seen in the office; the patient's mother was instructed to take baby to the hospital, where the patient was admitted. The baby did not require surgery. Air contrast enema was performed on 09-JUN-2011 as treatment. There were no predisposing factors. The patient's gestational age at birth was 39 weeks and weight at birth was 8# 3 oz. The nurse reported that the adverse event was not disabling or life threatening. No further information is available. Patient was hospitalized." Documents held by sender: None.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Feeding disorder of infancy or early childhood, Haematochezia, Intussusception, Somnolence
Clinical narrative: Initial report received on 22 June 2011 from another manufacturer (Reference number WAES 1106USA01587), who had received the original report from a registered nurse. The following is verbatim from the report. "Information has been received from a nurse concerning a 9 week old female with no known drug allergies and no pertinent medical history who on 01-JUN-2011 was vaccinated with the first dose of ROTATEQ (lot # 668964/1200Z) orally. There was no concomitant medication. The patient experienced intussusception following administration of her first dose of ROTATEQ on 08-JUN-2011 (also reported as 2 weeks after vaccination). She was eating poorly, had blood in her stool, and became lethargic. Patient sought medical attention by office visit. Patient was changed to ALIMENTUM formula for possible mild allergy. on 08-JUN-2011 she was diagnosed with intussusception and hospitalized. Ultrasounds of abdomen and contrast enema were performed, although, results were not provided. Intussusception was treated with surgery. She recovered and was discharged on 10-JUN-2011. Follow-up information has been received from the registered nurse who reported that the patient with no medical history other than a possible milk protein allergy was also given other vaccines on 01-JUN-2011 including DAPTACEL, ACTHIB, IPOL and PREVNAR 13. Onset of symptoms was on 08-JUN-2011, there was no vomiting mentioned in phone call from mother to office. The patient was not seen in the office; the patient's mother was instructed to take baby to the hospital, where the patient was admitted. The baby did not require surgery. Air contrast enema was performed on 09-JUN-2011 as treatment. There were no predisposing factors. The patient's gestational age at birth was 39 weeks and weight at birth was 8# 3 oz. The nurse reported that the adverse event was not disabling or life threatening. No further information is available. Patient was hospitalized." Documents held by sender: None.
Age: 61.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Abscess, Erythema, Injection site reaction, Local reaction, Necrosis
Clinical narrative: This case was reported by a physician via an office manager and described the occurrence of abscess formation in a 61-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included hypercholesterolemia, hypertension and neck pain. Concurrent vaccination included PNEUMOVAX (Merck) given on 09 June 2011. Concurrent medications included BENICAR, LIPITOR, Ibuprofen, ESTRACE and PROVERA. On 09 June 2011 at 10:30 the subject received 1st dose of BOOSTRIX at 0.5 ml in the left arm. On 16 June 2011, 7 days after vaccination with BOOSTRIX, the subject experienced an injection site reaction which was described as developing an abscess 3cm by 6cm at the injection site. The abscess was aspirated and 3 cc's of pus was extracted. The site also became necrotic. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting the events of injection site reaction and abscess formation were unresolved. The physician considered the events of injection site reaction and abscess formation to be probably related to vaccination with BOOSTRIX. Outcome and attribution of injection site necrosis was not reported.
Age: 61.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Skin lesion
Clinical narrative: This case was reported by a physician via an office manager and described the occurrence of abscess formation in a 61-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included hypercholesterolemia, hypertension and neck pain. Concurrent vaccination included PNEUMOVAX (Merck) given on 09 June 2011. Concurrent medications included BENICAR, LIPITOR, Ibuprofen, ESTRACE and PROVERA. On 09 June 2011 at 10:30 the subject received 1st dose of BOOSTRIX at 0.5 ml in the left arm. On 16 June 2011, 7 days after vaccination with BOOSTRIX, the subject experienced an injection site reaction which was described as developing an abscess 3cm by 6cm at the injection site. The abscess was aspirated and 3 cc's of pus was extracted. The site also became necrotic. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting the events of injection site reaction and abscess formation were unresolved. The physician considered the events of injection site reaction and abscess formation to be probably related to vaccination with BOOSTRIX. Outcome and attribution of injection site necrosis was not reported.
Age: 61.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Abscess drainage, Injection site abscess, Injection site necrosis
Clinical narrative: This case was reported by a physician via an office manager and described the occurrence of abscess formation in a 61-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included hypercholesterolemia, hypertension and neck pain. Concurrent vaccination included PNEUMOVAX (Merck) given on 09 June 2011. Concurrent medications included BENICAR, LIPITOR, Ibuprofen, ESTRACE and PROVERA. On 09 June 2011 at 10:30 the subject received 1st dose of BOOSTRIX at 0.5 ml in the left arm. On 16 June 2011, 7 days after vaccination with BOOSTRIX, the subject experienced an injection site reaction which was described as developing an abscess 3cm by 6cm at the injection site. The abscess was aspirated and 3 cc's of pus was extracted. The site also became necrotic. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting the events of injection site reaction and abscess formation were unresolved. The physician considered the events of injection site reaction and abscess formation to be probably related to vaccination with BOOSTRIX. Outcome and attribution of injection site necrosis was not reported.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, MEN, TDAP
Symptoms: Alpha 1 foetoprotein normal, Blood test normal, Caesarean section, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Initial report received on 22 June 2011 and follow-up information received on 29 June 2011 from another manufacturer (Reference number WAES 1102USA00069), who had received the original and follow-up report from a nurse practitioner. The following is verbatim from the report. "Information has been received from a nurse practitioner for the Pregnancy Registry for GARDASIL, concerning a 16 year old female who on 01-SEP-2010 was vaccinated IM with a dose of GARDASIL (lot # 666121/1778Y) before the patient realized she was pregnant. The patient was vaccinated with a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and meningococcal vaccine (unspecified) most likely on the same day before she realized her pregnancy. The pregnancy test was conducted later in the day on 01-SEP-2010. The reporter reported no known adverse effect. The patient's last menstrual period was on 17-JUL-2010. Her estimated delivery date was 23-APR-2011. Ultrasound performed on 16-SEP-2010 and 06-DEC-2010. Obstetric blood works were normal. Follow-up information has been received from the nurse practitioner concerning the 16 year old female with no significant medical history, concurrent medical condition or previous pregnancy who on 01-SEP-2010 was vaccinated with a dose of GARDASIL. The patient became pregnant. The patient's last menstrual period was on 17-JUL-2010. Her estimated delivery date was 23-APR-2011. There was no complication during pregnancy. On 16-SEP-2010 ultrasound was performed to verify dates, which showed intrauterine pregnancy (IUP). On 11-NOV-2010, maternal serum alpha fetoprotein was tested with negative result. On 06-DEC-2010, ultrasound was performed for fetal assessment with normal result. On 18-APR-2011, at 39 gestation week, the patient delivered a normal, healthy female baby weighing 2945 grams (3Kg) via C-section due to failure to progress. The baby's Apgar score were 8/9. Upon internal overview, C-section/failure to progress was determined to be an other important medical event. Follow-up information has been received from the nurse practitioner who reported that the patient received the first dose of GARDASIL on 01-SEP-2010. At the time the patient received GARDASIL vaccination, the patient was six weeks pregnant. At the time of the report, the patient fully recovered from the C-section with no complications. The patient delivered a normal healthy baby. Additional information has been requested." Document held by sender: None.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, MEN, TDAP
Symptoms: Ultrasound antenatal screen normal
Clinical narrative: Initial report received on 22 June 2011 and follow-up information received on 29 June 2011 from another manufacturer (Reference number WAES 1102USA00069), who had received the original and follow-up report from a nurse practitioner. The following is verbatim from the report. "Information has been received from a nurse practitioner for the Pregnancy Registry for GARDASIL, concerning a 16 year old female who on 01-SEP-2010 was vaccinated IM with a dose of GARDASIL (lot # 666121/1778Y) before the patient realized she was pregnant. The patient was vaccinated with a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and meningococcal vaccine (unspecified) most likely on the same day before she realized her pregnancy. The pregnancy test was conducted later in the day on 01-SEP-2010. The reporter reported no known adverse effect. The patient's last menstrual period was on 17-JUL-2010. Her estimated delivery date was 23-APR-2011. Ultrasound performed on 16-SEP-2010 and 06-DEC-2010. Obstetric blood works were normal. Follow-up information has been received from the nurse practitioner concerning the 16 year old female with no significant medical history, concurrent medical condition or previous pregnancy who on 01-SEP-2010 was vaccinated with a dose of GARDASIL. The patient became pregnant. The patient's last menstrual period was on 17-JUL-2010. Her estimated delivery date was 23-APR-2011. There was no complication during pregnancy. On 16-SEP-2010 ultrasound was performed to verify dates, which showed intrauterine pregnancy (IUP). On 11-NOV-2010, maternal serum alpha fetoprotein was tested with negative result. On 06-DEC-2010, ultrasound was performed for fetal assessment with normal result. On 18-APR-2011, at 39 gestation week, the patient delivered a normal, healthy female baby weighing 2945 grams (3Kg) via C-section due to failure to progress. The baby's Apgar score were 8/9. Upon internal overview, C-section/failure to progress was determined to be an other important medical event. Follow-up information has been received from the nurse practitioner who reported that the patient received the first dose of GARDASIL on 01-SEP-2010. At the time the patient received GARDASIL vaccination, the patient was six weeks pregnant. At the time of the report, the patient fully recovered from the C-section with no complications. The patient delivered a normal healthy baby. Additional information has been requested." Document held by sender: None.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, MEN, TDAP
Symptoms: Alpha 1 foetoprotein normal, Caesarean section, Drug exposure during pregnancy, Failed trial of labour, Pregnancy test positive
Clinical narrative: Initial report received on 22 June 2011 and follow-up information received on 29 June 2011 from another manufacturer (Reference number WAES 1102USA00069), who had received the original and follow-up report from a nurse practitioner. The following is verbatim from the report. "Information has been received from a nurse practitioner for the Pregnancy Registry for GARDASIL, concerning a 16 year old female who on 01-SEP-2010 was vaccinated IM with a dose of GARDASIL (lot # 666121/1778Y) before the patient realized she was pregnant. The patient was vaccinated with a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and meningococcal vaccine (unspecified) most likely on the same day before she realized her pregnancy. The pregnancy test was conducted later in the day on 01-SEP-2010. The reporter reported no known adverse effect. The patient's last menstrual period was on 17-JUL-2010. Her estimated delivery date was 23-APR-2011. Ultrasound performed on 16-SEP-2010 and 06-DEC-2010. Obstetric blood works were normal. Follow-up information has been received from the nurse practitioner concerning the 16 year old female with no significant medical history, concurrent medical condition or previous pregnancy who on 01-SEP-2010 was vaccinated with a dose of GARDASIL. The patient became pregnant. The patient's last menstrual period was on 17-JUL-2010. Her estimated delivery date was 23-APR-2011. There was no complication during pregnancy. On 16-SEP-2010 ultrasound was performed to verify dates, which showed intrauterine pregnancy (IUP). On 11-NOV-2010, maternal serum alpha fetoprotein was tested with negative result. On 06-DEC-2010, ultrasound was performed for fetal assessment with normal result. On 18-APR-2011, at 39 gestation week, the patient delivered a normal, healthy female baby weighing 2945 grams (3Kg) via C-section due to failure to progress. The baby's Apgar score were 8/9. Upon internal overview, C-section/failure to progress was determined to be an other important medical event. Follow-up information has been received from the nurse practitioner who reported that the patient received the first dose of GARDASIL on 01-SEP-2010. At the time the patient received GARDASIL vaccination, the patient was six weeks pregnant. At the time of the report, the patient fully recovered from the C-section with no complications. The patient delivered a normal healthy baby. Additional information has been requested." Document held by sender: None.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, MEN, TDAP
Symptoms: Ultrasound antenatal screen normal, Ultrasound foetal, Ultrasound scan normal
Clinical narrative: Initial report received on 22 June 2011 and follow-up information received on 29 June 2011 from another manufacturer (Reference number WAES 1102USA00069), who had received the original and follow-up report from a nurse practitioner. The following is verbatim from the report. "Information has been received from a nurse practitioner for the Pregnancy Registry for GARDASIL, concerning a 16 year old female who on 01-SEP-2010 was vaccinated IM with a dose of GARDASIL (lot # 666121/1778Y) before the patient realized she was pregnant. The patient was vaccinated with a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and meningococcal vaccine (unspecified) most likely on the same day before she realized her pregnancy. The pregnancy test was conducted later in the day on 01-SEP-2010. The reporter reported no known adverse effect. The patient's last menstrual period was on 17-JUL-2010. Her estimated delivery date was 23-APR-2011. Ultrasound performed on 16-SEP-2010 and 06-DEC-2010. Obstetric blood works were normal. Follow-up information has been received from the nurse practitioner concerning the 16 year old female with no significant medical history, concurrent medical condition or previous pregnancy who on 01-SEP-2010 was vaccinated with a dose of GARDASIL. The patient became pregnant. The patient's last menstrual period was on 17-JUL-2010. Her estimated delivery date was 23-APR-2011. There was no complication during pregnancy. On 16-SEP-2010 ultrasound was performed to verify dates, which showed intrauterine pregnancy (IUP). On 11-NOV-2010, maternal serum alpha fetoprotein was tested with negative result. On 06-DEC-2010, ultrasound was performed for fetal assessment with normal result. On 18-APR-2011, at 39 gestation week, the patient delivered a normal, healthy female baby weighing 2945 grams (3Kg) via C-section due to failure to progress. The baby's Apgar score were 8/9. Upon internal overview, C-section/failure to progress was determined to be an other important medical event. Follow-up information has been received from the nurse practitioner who reported that the patient received the first dose of GARDASIL on 01-SEP-2010. At the time the patient received GARDASIL vaccination, the patient was six weeks pregnant. At the time of the report, the patient fully recovered from the C-section with no complications. The patient delivered a normal healthy baby. Additional information has been requested." Document held by sender: None.