chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Injection site swelling, Pain, White blood cell count increased
Clinical narrative: Patient complains of tender, swelling, and erythema at pneumococcal injection site.  Cold pack was applied.  3 hours later site is painful, with redness and swelling of 7 cm.  Patient also has temperature of 99.5, chilling, and aching.  Diphenhydramine is administered.  One hour later, temperature if 100.5, physician examines & notes swelling of vaccination area, and orders cephalexin, acetaminophen, diphenhydramine, and ice.  The following day, the site appearance is stable & patient is dismissed on cephalexin.  Patient presents to our ED on 3/3/13 with worsening symptoms & is admitted with left leg cellulitis & is treated with IV vancomycin x 2 days combined with clindamycin IV x 4 days followed with po clindamycin to continue 7 more days at dismissal.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Joint swelling
Clinical narrative: Red, swollen left shoulder.
Age: 29.0
Sex: M
Vaccine: DTAP
Symptoms: Eye swelling, Teething
Clinical narrative: Right eye swollen, pain on top right side of teeth, similar symptoms to a sinus infection.  Went to facility, saw medic, took Benadryl and Tylenol with no relief.  Symptoms resolved 1 week later.
Age: 31.0
Sex: M
Vaccine: DTAP
Symptoms: Facial pain, Gingival pain, Injection site pain, Myalgia, Toothache
Clinical narrative: Radiating pain from injection site (L Shoulder), to L cheek, jaw muscles sore and neck muscles sore.  Pain spread to gums and teeth on L side from 1 hr post injection to 18 hours post injection.
Age: 24.0
Sex: F
Vaccine: DTAP
Symptoms: Chills, Fatigue, Injection site bruising, Injection site erythema, Injection site infection
Clinical narrative: After receiving a tetanus vaccination on my mid-upper left arm, I had redness, swelling, and bruising around a large part of my arm for 7 days, and was told by a different doctor that it was infected at the injection site. I had a low grade fever (100.2) for 4 days after vaccination was given, along with body aches, chills, and tiredness.
Age: 24.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: After receiving a tetanus vaccination on my mid-upper left arm, I had redness, swelling, and bruising around a large part of my arm for 7 days, and was told by a different doctor that it was infected at the injection site. I had a low grade fever (100.2) for 4 days after vaccination was given, along with body aches, chills, and tiredness.
Age: 9.0
Sex: F
Vaccine: HEP, HPV4, IPV, MMR, VARCEL
Symptoms: Drooling, Muscle twitching, Somnolence, Urinary incontinence
Clinical narrative: Began with verbal sounds, slight twitching of all extremities, drooling. Lasted 1-2 minutes. Pt. lost control of bladder. Pt. than feel into a deep sleep for 3-4 minutes, afterward awoke, and seemed alert and responsive, with no obvious lasting effects.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site irritation, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Raised, hard, hot area near injection about 1.5 inches. Arm irritated in the area of injection. Raised area hot, painful and slightly itchy. On evening of 3/30/13 migraine headache. On 3/31 runny nose and still painful irritated arm. On 4/1 the raised area is slightly reduced, now rash appears as a double rash.  Outer rash is about 6 inches in diameter. Inner area about 2 inches.  Still irritated on 4/1 and swollen.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Migraine, Rash, Rhinorrhoea
Clinical narrative: Raised, hard, hot area near injection about 1.5 inches. Arm irritated in the area of injection. Raised area hot, painful and slightly itchy. On evening of 3/30/13 migraine headache. On 3/31 runny nose and still painful irritated arm. On 4/1 the raised area is slightly reduced, now rash appears as a double rash.  Outer rash is about 6 inches in diameter. Inner area about 2 inches.  Still irritated on 4/1 and swollen.
Age: 1.02
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: VARICELLA VACCINE WAS GIVEN IN L THIGH SHOWED A 5CM X 2.5 CM OVAL RED AREA, SLIGHTLY RAISED AREA THAT IS NOT HOT TO TOUCH, IT IS NOT FLUCTUANT. IT APPEARS TO BE SLIGHTLY UNCOMFORTABLE TO HIM WHEN AREA IS TOUCHED.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypersensitivity, Local swelling, Rash
Clinical narrative: LOCALIZED RASH AND SWELLING.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Lip pain, Mouth ulceration, Upper respiratory tract infection
Clinical narrative: Her lip started hurting in the evening after receiving the vaccine. The next morning, she had cold sores in her mouth. She went to her physician today & he told her he thought it was from a URI & took several biopsies. He gave her a medication for the sores.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Computerised tomogram, Cough, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: My arm was very sore. I could not lift my arm without intense pain. Saturday, I had a low grade fever. Intensity of pain in my arm was severe. Sunday, I started wheezing, coughing, and developed a rash. I took Benadryl and Aleve. Monday, rash had doubled in size, still coughing, wheezing.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Rash, Wheezing
Clinical narrative: My arm was very sore. I could not lift my arm without intense pain. Saturday, I had a low grade fever. Intensity of pain in my arm was severe. Sunday, I started wheezing, coughing, and developed a rash. I took Benadryl and Aleve. Monday, rash had doubled in size, still coughing, wheezing.
Age: 20.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient complained of body aches & concentrated pain at left leg injection site @ 2:22am.  Patient spiked fever of 102.7 with erythema and swelling of left thigh @ 12:45 am.  Diphenhydramine was administered 2/16/13.  Patient was stable for dismissal that day with instructions to return to our ED if leg symptoms worsen.  She presented to our ED later that day & was admitted to our hospital with diagnosis of left leg cellulitis secondary to pneumococcal vaccine.  She was treated with 1 dose of cefazolin in ED, followed with clindamycin IV on the general floor.  She was dismissed 2/17/13 with instructions & prescription for oral clindamycin x 6 days.
Age: 20.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Patient complained of body aches & concentrated pain at left leg injection site @ 2:22am.  Patient spiked fever of 102.7 with erythema and swelling of left thigh @ 12:45 am.  Diphenhydramine was administered 2/16/13.  Patient was stable for dismissal that day with instructions to return to our ED if leg symptoms worsen.  She presented to our ED later that day & was admitted to our hospital with diagnosis of left leg cellulitis secondary to pneumococcal vaccine.  She was treated with 1 dose of cefazolin in ED, followed with clindamycin IV on the general floor.  She was dismissed 2/17/13 with instructions & prescription for oral clindamycin x 6 days.
Age: 0.06
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying
Clinical narrative: 3 WEEK OLD FEMALE GIVEN PEDIARIX, HIB, PREVNAR AND ROTATEQ. MOM WENT TO ER 5 HOURS LATER BECAUSE PATIENT WAS CRYING. GIVEN ANALGESIC FOR PAIN AND DISCHARGED HOME FROM ER.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: High fever (103.1) and rash on back.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cyst, Injection site erythema, Injection site infection, Injection site pruritus, Nausea
Clinical narrative: Patient reported itching at injection site and feeling a little nauseated. Patient felt fine after 10-15 minutes. The next day patient went to ER, and redness around injection site had grown to a few inches. Patient was given prednisone and antibiotics. According to patient, ER told her it felt like a cyst and gave antibiotics if infection.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Fatigue, Nausea, Nervousness
Clinical narrative: Quick onset vertigo, then dizziness, felt faint, became shaky, then very weak, felt nauseous, very tired.  Called doctor at 10:40, he advised to take Claritin/loratadine, which I did right away. Within two hours, felt fine except a little tired.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Quick onset vertigo, then dizziness, felt faint, became shaky, then very weak, felt nauseous, very tired.  Called doctor at 10:40, he advised to take Claritin/loratadine, which I did right away. Within two hours, felt fine except a little tired.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Injection site pain, Pain, Pain in extremity, Ultrasound scan
Clinical narrative: SORE, BURNING SENSATION AT INJECTION SITE. RADIATING DOWN THE RT. ARM TO MY HAND. WORSENED AND SPREAD TO DEEPER DELTOID AREA, WORSENING PAIN WHEN OUTSTRETCHING ARM. SEVERE BRING PAIN WITH MOTION OF RT. ARM. CONSULTED ORTHOPEDIC DR - NEGATIVE X-RAY. 5 MONTHS THERAPY AT CHIROPRACTOR - U/S WITH STIM, EXERCISES, HEAT. LITTLE IMPROVEMENT TO DATE.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: X-ray limb normal
Clinical narrative: SORE, BURNING SENSATION AT INJECTION SITE. RADIATING DOWN THE RT. ARM TO MY HAND. WORSENED AND SPREAD TO DEEPER DELTOID AREA, WORSENING PAIN WHEN OUTSTRETCHING ARM. SEVERE BRING PAIN WITH MOTION OF RT. ARM. CONSULTED ORTHOPEDIC DR - NEGATIVE X-RAY. 5 MONTHS THERAPY AT CHIROPRACTOR - U/S WITH STIM, EXERCISES, HEAT. LITTLE IMPROVEMENT TO DATE.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Nuclear magnetic resonance imaging brain, Partial seizures, Pyrexia, Upper respiratory tract infection
Clinical narrative: Fever and focal seizure < 24 hour after Imm's given. Had mild URI sx.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Pt developed 2 episodes of cold sores after being vaccinated. No history of cold sores prior to vaccines.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Diarrhoea
Clinical narrative: Diarrhea for 2 weeks after receiving the ROTATEQ vaccine.
Age: 1.76
Sex: F
Vaccine: HEPA, HIBV, MMRV, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None - temp 99.0.
Age: 33.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Blood glucose increased, Fatigue, IIIrd nerve paralysis, Vision blurred
Clinical narrative: Within first few hrs after Hep B and VARIVAX was given started to have blurry vision. After vaccinations 2/20/13 had mild blurrienss, but attributed it to "tiredness". In Feb blurriness resolved in 2-3 weeks. After most recent immunizations symptoms worsened until she went to see eye doctor 3/26/13. Was told by eye doctor she was having "ocular paralysis" from Hep B vaccine. On 3/27/13 says blurriness is resolving.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Patient was diagnosed with chickenpox.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: Patient called pharmacy to say he woke up day after administration on 3/31/13 with a itchy rash at siteof injection. He called pharmacy on 4/1/13, said it was less itchy today but wanted to report it.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperhidrosis, Nausea, Paraesthesia oral, Throat tightness
Clinical narrative: Mom reports patient felt like throat was closing up, lip was tingling, felt nauseous, broke out in a sweat. Felt better an hour later after a dose of BENADRYL.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Vaccines were given, patient went to waiting room and within a few minutes he came back with hives on face & trunk. Hives pruritic. Moderate hives. 9ml BENADRYL given by mouth.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Rash
Clinical narrative: This spontaneous report was received from a more than 80 year old female consumer (reporting on herself), with allergy to penicillin and to sulfa, who had shingles when she was 8. On 15-MAR-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiration date not reported) (dose, frequency not reported, route unspecified, injection in the arm). No concomitant medications were reported. On 16-MAR-2013, the patient experienced her hands had broken out in a rash in between her fingers, on the back of her hand by the wrist, down to the tip of her thumb and her hands were swollen. The patient did not sought medical attention and no treatment was given. Laboratory diagnostic studies were not performed. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Sex: M
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: This spontaneous report was received from a physician refers to a male patient of unknown age who on an unknown date, was scheduled to receive a dose of GARDASIL (dose and route not reported). It was reported that the patient received a blood draw during his office visit and at some point during the visit the patient fainted and suffered a seizure. It was unspecified if the patient had actually received GARDASIL. At the time of the report, the patient's outcome was unknown. The relatedness for fainted and seizure and GARDASIL was unknown. Upon internal review seizure was considered to be medically significant. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody abnormal, Viral titre decreased
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On an unknown date, more than 20 years ago, an employee received a RECOMBIVAX HB series (also reported as the name and manufacturer of the hepatitis B vaccine were unknown) (lot number and expiration date were not reported) (dose, frequency and route not reported). No other co suspect or concomitant medications were reported. It was reported that right now the employee had low hepatitis b titers. The outcome of low hepatitis b titers was reported as not recovered. This case is related to MARRS cases 1303USA011314, 1303USA014013. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On an unknown date, more than 20 years ago, an employee received a of RECOMBIVAX HB series (also reported as the name and manufacturer of the hepatitis B vaccine were unknown) (lot number and expiration date were not reported) (dose, frequency and route not reported). No other co suspect or concomitant medications were reported. It was reported that right now the employee had low hepatitis b titers. The outcome of low hepatitis b titers was reported as not recovered. This case is related to MARRS cases 1303USA011314, 1303USA014014. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Healthcare worker refers to a 19 year old male patient. The Healthcare worker reported that on 25-JAN-2013 the patient received his first dose of GARDASIL injection (lot # H012670, expiration date 21-MAR-2015), 0.5 ml, intramuscular (anatomical location unspecified). The patient received the second dose of GARDASIL on 25-FEB-2013 and his third on 25-MAR-2013. No adverse effects reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. It was reported that on 15-MAR-2013, last Friday, the patient was vaccinated with a dose of ZOSTAVAX (lot number and route not reported). No other co suspect or concomitant medications were reported. The pharmacist reported that the patient developed an injection site reaction following vaccination with ZOSTAVAX (no rash). The pharmacist reported that the injection site reaction was described as a red area (the total red area was 4 to 5 inches in diameter at the injection site, with a darker oval of red at the center that was about 2 inches in diameter), swollen, warm and painful to the touch area at the injection site of the ZOSTAVAX vaccination, without rash or itching. As of 18-MAR-2013, the patient's condition was progressing. This case is linked to the case # 1303USA010770. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a female patient of unknown age. On 25-MAR-2013 the patient was vaccinated with GARDASIL (lot # and expiration date unspecified) injection 120 DF, (dose, route and anatomical location unspecified). The Registered Nurse reported that on 25-MAR-2013, the patient experienced pain and burning at the injection site where GARDASIL was administered. At the time of the report the outcome of pain and burning at the injection site where GARDASIL was administered, was unknown. Additional information is not expected.
Sex: U
Vaccine: HPV4, PPV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age. It was reported that GARDASIL (lot number not provided) and PNEUMOVAX 23 (lot number not provided) might have been administered after experiencing 3 exposures to 29.5F for a cumulative total time of 62 hours.  Number of patients unspecified. It was unspecified if the patients had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody abnormal, Viral titre decreased
Clinical narrative: this spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. on an unknown date, more than 20 years ago, an employee received a RECOMBIVAX HB series (manufacturer of the hepatitis B vaccine were unknown) (lot number and expiration date were not reported) (dose, frequency and route not reported). No other co suspect or concomitant medications were reported. It was reported that right now the employee had low hepatitis b titers. The outcome of low hepatitis b titers was reported as not recovered. This case is related with MARRS cases 1303USA014013 and 1303USA014014. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blindness, Ophthalmological examination abnormal, Visual impairment
Clinical narrative: Severe headaches, dizziness, fatigue, sudden vision loss and sensitivity to light.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Corrective lens user, Headache, Vision blurred, Visual acuity reduced
Clinical narrative: Severe headaches, dizziness, fatigue, sudden vision loss and sensitivity to light.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dizziness, Fatigue, Headache, Photophobia, Sudden visual loss
Clinical narrative: Severe headaches, dizziness, fatigue, sudden vision loss and sensitivity to light.
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP, HEPA, TDAP
Symptoms: Abdominal pain upper, Headache, Hypoaesthesia, Immediate post-injection reaction, Injection site pain
Clinical narrative: With in 1 hour of vaccine arm pain and heaviness; with in 24 hours severe headache onset...returned to MD office for "sinus infection" diagnosis...1 course of antibiotics did not resolve head pain...return to MD for second type of antibiotic; pain did not resolve. Trip to ER at the end of August for migraine IV cocktail, eventually 10 of 10 pain reduced to 3/10 pain and D/C to home, but headache recurred, return to hospital for 2 additional ER and hospital admits. Patient currently on Amitriptyline and Topamax for functional control of pain but no resolution and pain level frequently increases with no effective remedy.
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP, HEPA, TDAP
Symptoms: Irritable bowel syndrome, Migraine, Nuclear magnetic resonance imaging normal, Pain
Clinical narrative: With in 1 hour of vaccine arm pain and heaviness; with in 24 hours severe headache onset...returned to MD office for "sinus infection" diagnosis...1 course of antibiotics did not resolve head pain...return to MD for second type of antibiotic; pain did not resolve. Trip to ER at the end of August for migraine IV cocktail, eventually 10 of 10 pain reduced to 3/10 pain and D/C to home, but headache recurred, return to hospital for 2 additional ER and hospital admits. Patient currently on Amitriptyline and Topamax for functional control of pain but no resolution and pain level frequently increases with no effective remedy.
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP, HEPA, TDAP
Symptoms: Headache, Laboratory test, Nuclear magnetic resonance imaging normal, Pain in extremity, Sensation of heaviness
Clinical narrative: With in 1 hour of vaccine arm pain and heaviness; with in 24 hours severe headache onset...returned to MD office for "sinus infection" diagnosis...1 course of antibiotics did not resolve head pain...return to MD for second type of antibiotic; pain did not resolve. Trip to ER at the end of August for migraine IV cocktail, eventually 10 of 10 pain reduced to 3/10 pain and D/C to home, but headache recurred, return to hospital for 2 additional ER and hospital admits. Patient currently on Amitriptyline and Topamax for functional control of pain but no resolution and pain level frequently increases with no effective remedy.
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP, HEPA, TDAP
Symptoms: Sinusitis
Clinical narrative: With in 1 hour of vaccine arm pain and heaviness; with in 24 hours severe headache onset...returned to MD office for "sinus infection" diagnosis...1 course of antibiotics did not resolve head pain...return to MD for second type of antibiotic; pain did not resolve. Trip to ER at the end of August for migraine IV cocktail, eventually 10 of 10 pain reduced to 3/10 pain and D/C to home, but headache recurred, return to hospital for 2 additional ER and hospital admits. Patient currently on Amitriptyline and Topamax for functional control of pain but no resolution and pain level frequently increases with no effective remedy.
Age: 11.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Cyanosis, Dizziness, Dyspnoea, Erythema, Fall
Clinical narrative: Student felt faint, skin pale, diaphoretic within an hour of receiving vaccine.  First aid administered by school nurse. Stabilized. Rested in health office.
Age: 11.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Heart rate increased, Lip swelling, Nausea, Pallor
Clinical narrative: Student felt faint, skin pale, diaphoretic within an hour of receiving vaccine.  First aid administered by school nurse. Stabilized. Rested in health office.
Age: 11.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Student felt faint, skin pale, diaphoretic within an hour of receiving vaccine.  First aid administered by school nurse. Stabilized. Rested in health office.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Rash, Scab
Clinical narrative: He has more than 20 raised bumps that are crusting over. They erupted over the course of about 4 days.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Rash papular
Clinical narrative: He has more than 20 raised bumps that are crusting over. They erupted over the course of about 4 days.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Has developed a rash with about 23 bumps. New ones are developing every day. The night of onset he also had fever and vomiting.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Rash papular
Clinical narrative: Has developed a rash with about 23 bumps. New ones are developing every day. The night of onset he also had fever and vomiting.
Age: 32.0
Sex: F
Vaccine: RAB
Symptoms: Dyspnoea, Erythema, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: REDNESS, SWELLING, SEVERE ITCHING OF LEFT SHOULDER-JAW AND HAIR LINE, SHORTNESS OF BREATH. SUNDAY 2 08:30PM RASH ON NECK AND CHEST.
Age: 32.0
Sex: F
Vaccine: RAB
Symptoms: Local swelling, Pruritus, Rash
Clinical narrative: REDNESS, SWELLING, SEVERE ITCHING OF LEFT SHOULDER-JAW AND HAIR LINE, SHORTNESS OF BREATH. SUNDAY 2 08:30PM RASH ON NECK AND CHEST.
Sex: U
Vaccine: PPV
Symptoms: Influenza like illness
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a patient of unknown gender and age. Medical history was not provided. On an unknown date the patient was vaccinated with PNEUMOVAX23 (indication not provided). Concomitant medication was not provided. On an unknown date, 2 weeks after onset of therapy the patient developed flu-like symptoms. The outcome of flu-like symptoms was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a Nurse Practitioner via the Company Representative refers to a 17 year old patient. On 12-MAR-2013 "6 days ago", the patient was vaccinated with the second dose of GARDASIL (lot# not reported). The Nurse Practitioner stated that approximately on 18-MAR-2013, 6 days after vaccination, a patient had shooting arm pain and loss of range of motion. The patient's arm did not hurt if it was not moving but it hurt when the arm was raised to side or above her head. The N.P. recommended her to take 800 mg of ibuprofen. The patient had experienced "shooting pain" from upper arm down to knuckles since receiving a dose of GARDASIL on 12-MAR-2013. The patient got pain when the arm was raised. The N.P. did not see any visual reactions on the injection site. The patient sought unspecified medical attention. At the time of reporting, the patient was not recovered. The relatedness for the events was unknown for GARDASIL. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist from a pharmacist refers to a 65 year old female patient. On 05-JUN-2012 the patient was vaccinated with ZOSTAVAX 0.5 ml once (route and lot # were unknown). Concomitant therapies included MICARDIS and PREMARIN. On 06-JUN-2012, the patient reported a sore arm and swollen glands. The outcome of patient reported events was reported as recovered/resolved within 5 days (before 10-JUN-2012). The reporter considered events was related to ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On an unknown date a patient received her second dose of GARDASIL 0.5 mL IM, 9 months after she received her first dose of GARDASIL. No adverse effect reported. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Erythema, Induration, Oedema peripheral
Clinical narrative: This spontaneous report as received from a other health professional refers to a male child between 4-6 years of age with no reported medical history. On an unknown date, during the 12-15 month well check up visit, the patient was vaccinated with his first dose of M-M-R II (date, dose, and route and lot number unknown). On an unknown date the patient was vaccinated with his standard second dose of M-M-R II (date, dose and lot number unknown). No other suspect therapies were reported. Concomitant therapies included varicella virus vaccine live (manufacturer unspecified), DTAP and poliovirus vaccine inactivated (manufacturer unspecified). On 19-MAR-2013, reported as last week, the patient developed a hard, red, swollen leg in which the swelling was fairly severe after receiving MMRII vaccine. No treatment information was reported. The outcome of hard, red, swollen leg is unknown. The reporters relatedness of hard, red, swollen leg to M-M-R II is unknown. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a mother's consumer refers to a 1 year old female patient. On 20-MAR-2013, the patient was vaccinated with VARIVAX (Merck) (manufacturer unknown) in the thigh as routine vaccination (lot number, dose not provided). On the same day, the patient received PROQUAD (Merck) (manufacturer unknown) (lot number, dose not reported) in thigh as routine vaccination. At that time, patient not showed any physical or emotional adverse reactions. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Maternal exposure before pregnancy, Trichomoniasis, Ultrasound abdomen
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician for GARDASIL a pregnancy registry product, concerning an 22 year old female patient with none pertinent medical history and none drug reactions/allergies. In September 2012 (exact date unspecified) the patient was vaccinated with the first dose of GARDASIL (lot number not provided) injection. The patient become pregnant with LMP of 31-DEC-2012 (currently 13 weeks pregna) and EDD of 07-OCT-2013. The pregnancy outcome was outcome pending. The lab diagnostics studies was performed: Ultrasound (mid February) and Blood test for pregnancy (date unspecified). In mid February 2013 (exact date unspecified) the patient experienced vaginal trichomonas infection. The patient contacted physician. The vaginal Trichomonas infection was treated with vaginal Metronidazole cream. The physician did not know if the vaginal Trichomonas infection had resolved at the time of the call. In March 2013 (exact date unspecified) the patient was vaccinated with the second dose of GARDASIL (lot number not provided) injection. The patient received the second dose of GARDASIL while pregnant. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. Approximately on an unknown date in 2007 (reported as 6 years ago), the patient who was vaccinated with first dose of GARDASIL (Lot number, expiry date, route and dose were not reported) was in the office inquiring about the second dose. The patient was not experiencing any known symptoms. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On unknown dates the patient was vaccinated with three doses of GARDASIL (lot# not reported), 0.5 ml, intramuscularly, with a one month interval between each dose. No adverse effect reported. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old patient with medical history of hypertension and chickenpox. On 09-MAR-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose not reported) (lot # H013017, exp. date 09-OCT-2013) subcutaneous in the left arm. The patient's concomitant medication and past drug history was unknown. In March 2013 the patient developed redness, swelling the "size of a golfball" in the left armpit and slightly into this chest area. His relevant laboratory data was unknown. At of 13-MAR-2013 it was unknown if the patient would continue therapy with ZOSTAVAX. The patient continued to experience swelling under his arm, however it has improved. Outcome for redness was unknown. Relationship between redness, swelling the "size of a golfball" in his left armpit and slightly into his chest area and therapy with ZOSTAVAX was unknown. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse regarding herself: a 65 year old female patient. Medical history was not reported. On 07-DEC-2012 the patient was vaccinated with PNEUMOVAX 23 lot # H013581, intramuscular (indication not reported). Concomitant therapies included METOPROLOL. On 14-DEC-2012 (discrepancy: reported as 14-DEC-2013), 8 days after onset of therapy the patient experienced flu like symptoms including fever, chills, body aches and headaches, and an upper respiratory infection. The outcome of flu like symptoms (including fever, chills, body aches, headaches) and upper respiratory infection was reported as recovered after about one week. No further information was provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Upper respiratory tract infection
Clinical narrative: This spontaneous report as received from a registered nurse regarding herself: a 65 year old female patient. Medical history was not reported. On 07-DEC-2012 the patient was vaccinated with PNEUMOVAX 23 lot # H013581, intramuscular (indication not reported). Concomitant therapies included METOPROLOL. On 14-DEC-2012 (discrepancy: reported as 14-DEC-2013), 8 days after onset of therapy the patient experienced flu like symptoms including fever, chills, body aches and headaches, and an upper respiratory infection. The outcome of flu like symptoms (including fever, chills, body aches, headaches) and upper respiratory infection was reported as recovered after about one week. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner refers to a adult patient of unknown age and gender. No medical history was reported. On an unknown date in October 2012, patient received their first dose of RECOMBIVAX HB (lot#, expiry not reported), 0.5 ml, intramuscularly. On 29-MAR-2013, the patient was vaccinated later with dose 2 of RECOMBIVAX HB (lot#, expiry not reported), 0.5 ml, intramuscularly. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Neck mass, Ultrasound scan
Clinical narrative: This spontaneous report was received from a father refers to his 16 year old son (who is also the patient). The patient had no pertinent medical history or drug reactions or allergies. On 21-MAR-2013, the patient was vaccinated with a dose of GARDASIL, (lot number, expiry date and route was not reported). On 25-MAR-2013, the patient had lump/mass on the right side of his neck. There was no pain associated with the lump. On 27-MAR-2013, ultrasound was conducted and results were awaited. The outcome of lump/mass on the right side of his neck was reported as not recovered. The patient sought medical attention. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 67 year old male patient. The patient has vancomycin allergy. On 14-MAR-2013, the patient was vaccinated with a dose of 0.5 ml PNEUMOVAX23 (lot number H010515, expiry date was not reported, route was intramuscular). Concomitant therapies include doxazosin, fenofibrate, glucosamine, metformin, ZESTORETIC, NEXIUM, warfarin and cholestyramine. On 14-MAR-2013, the patient developed swollen arm from his left shoulder to his wrist after receiving a dose of PNEUMOVAX23. The patient did not have any laboratory tests performed. As a treatment the patient was given steroid and ROCEPHIN injection. The outcome of the event was reported as recovered on 16-MAR-2013. The patient sought medical attention (patient went to a urgent care). Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Vaccination site induration
Clinical narrative: 4 inch x 4 inch area of induration surrounding vaccine site present 1 week after administration. No s/s infection, will monitor.
Age: 25.0
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea, Fatigue, Muscular weakness, Nausea
Clinical narrative: Fatigue, muscle weakness, nausea, diarrhea.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood glucose normal, Fall, Feeling hot, Head injury
Clinical narrative: After receiving HPV vaccine she walked towards waiting area, describes as having felt weak and  had syncope episode - falling to floor, hitting head - episode lasted less than one minute. Felt weak and hot afterwards for about 15 min. VS normal; exam  normal. Was observed 50 minutes - with instruction to seek further medical care if developed other signs of ICP or symptoms as listed on VIS. Left facility with no symptoms.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: After receiving HPV vaccine she walked towards waiting area, describes as having felt weak and  had syncope episode - falling to floor, hitting head - episode lasted less than one minute. Felt weak and hot afterwards for about 15 min. VS normal; exam  normal. Was observed 50 minutes - with instruction to seek further medical care if developed other signs of ICP or symptoms as listed on VIS. Left facility with no symptoms.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Herpes zoster
Clinical narrative: This spontaneous report was received from a 71 year old female patient with sulfa drug allergy, congestive heart failure diagnosed after the vaccine that may have also been present and undiagnosed at the time of vaccination and back problems. The patient's medical history included shingles experienced in 1981. On an unknown date in September 2012, the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route not reported) as a form of treatment and to prevent a recurrence of her shingles attacks. Concomitant therapies included medication for unspecified allergy, thyroid tablets, hydrocortisone and tizanidine hydrochloride for back problems. The patient explained that the vaccine seemed to work to alleviate her symptoms for a short period of time, however the relief did not last as long as other unspecified and periodic shots she had for treatment of the condition. On an unknown date, the patient experienced stomach discomfort and headache after having the ZOSTAVAX. No medical attention was sought. No laboratory diagnostics studies were performed. The outcome of stomach discomfort and headache was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. No medical history was reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot#, dose, route not reported). No concomitant medications were reported. On an unknown date, the physician initially left a voice message on the after hours voice mail requesting an AE form be faxed to his office in order to report an unspecified adverse reaction the patient had experienced to ZOSTAVAX. Patient sought medical attention (unknown type). The outcome of unspecified adverse reaction was unknown. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site warmth, Muscle tightness
Clinical narrative: Patient woke up Sunday (3/31/13) injection site (left tricep area) red and warm. Progressively got worse, muscle tightened up made inflammed circle feel tight & hot. Also had joint & muscle pain (hip, knees, ankles, thighs, calves), not as bad Sunday morning, but got progressively worse and peaked later Sunday and stayed that way. Itching on scalp, buttocks, arms (not all at the same time) Headache. Was seen by Dr. on Monday morning 4/1/13. Presented me with 3 prescriptions (Keflex 500mg, Prednisone 20mg, Vicodin 5/500) at 11:58am 4/1/13.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Myositis, Pruritus, Skin warm
Clinical narrative: Patient woke up Sunday (3/31/13) injection site (left tricep area) red and warm. Progressively got worse, muscle tightened up made inflammed circle feel tight & hot. Also had joint & muscle pain (hip, knees, ankles, thighs, calves), not as bad Sunday morning, but got progressively worse and peaked later Sunday and stayed that way. Itching on scalp, buttocks, arms (not all at the same time) Headache. Was seen by Dr. on Monday morning 4/1/13. Presented me with 3 prescriptions (Keflex 500mg, Prednisone 20mg, Vicodin 5/500) at 11:58am 4/1/13.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Nausea, Pyrexia, Tenderness
Clinical narrative: Fever up to 102, headache, chills, nausea, localized tenderness approximately 10 hours after vaccination. Patient took Aleve with out noticeable improvement. Seen by Provider who prescribed Motrin and if not better in 24 hours to be reevaluated.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Headache, Myalgia, Pyrexia, Rash pustular
Clinical narrative: Diffuse pustular rash on trunk, thigh, buttocks, fever, chills, headache, myalgias starting morning of 1 April 2013.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Rash, Rash vesicular
Clinical narrative: Reason for Appointment  1. Rash  History of Present Illness  Patient presents with left breast rash under the breast for 4 days. Patient noticed rash in the back first then under the breast +itching. Of note, patient has been using firming lotion and had been using tanning cream mixed with it. Patient tried ammoniun hydroxide lotion which helped. Patient received Zostavax shot 3 weeks ago.   Examination  Torso left breast vesicular rash and on the left upper back. Assessment  1. Shingles - 053.9 (Primary)  Treatment  1. Shingles   Start Valtrex tablet, 1 g, 1 tab(s), orally, every 12 hours, 7 day(s), 14, Refills 0 Start Zyrtec tablet, 10 mg, 1 tab(s), orally, once a day, 30 days, 30, Refills 0
Age: 63.0
Sex: M
Vaccine: HEPA
Symptoms: Dysphonia, Headache, Oral discomfort, Throat irritation
Clinical narrative: Hoarseness, burning in the mouth and throat and headache.
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Blister, Feeling abnormal, Insomnia, Malaise, Musculoskeletal stiffness
Clinical narrative: Started with general malaise on 3/27.  Then starting feeling worse and reported to aunt on 3/30 complaining of stiff neck, difficulty sleeping, bumps noted on head, jaw pain and blisters and hives in hair.
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in jaw, Urticaria
Clinical narrative: Started with general malaise on 3/27.  Then starting feeling worse and reported to aunt on 3/30 complaining of stiff neck, difficulty sleeping, bumps noted on head, jaw pain and blisters and hives in hair.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Injection site anaesthesia, Injection site pain, Injection site reaction, Paraesthesia
Clinical narrative: Pain in muscle area of left arm, bicep area, where I received vaccine. No pain at all at time of shot.  Pain started 3 days later. After a month of receiving flu vaccine, then also tingling and a little numbness like feeling occurs daily and nighly in my left arm - from muscle/bicep area where I received flu shot down through my upper elbow area on down to my wrist area. Pain, tingling, little numbness feeling occurs each day and night.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cognitive disorder, Convulsion, Encephalopathy, Epilepsy
Clinical narrative: Seizures, encephalopathy.  Chronic epilepsy and cognitive dysfunction.
Age: 0.45
Sex: M
Vaccine: RVX
Symptoms: Abdominal pain, Diarrhoea, Full blood count normal, Lethargy, Pallor
Clinical narrative: Projectile vomiting, severe watery diarrhea, very painful abdominal cramps, lethargy, paleness.
Age: 0.45
Sex: M
Vaccine: RVX
Symptoms: Vomiting projectile
Clinical narrative: Projectile vomiting, severe watery diarrhea, very painful abdominal cramps, lethargy, paleness.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Decreased appetite, Musculoskeletal pain, Myalgia
Clinical narrative: Terrific pain in shoulder; muscles throughout body; chills; loss of appeptite.  Pain continues today, April 2nd.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Injection site discomfort, Injection site erythema, Injection site pain
Clinical narrative: Noticed that not only did I had redness, soreness and swelling at the site of the injection, but the redness, itching, discomfort traveled down past my elbow. Due to the Friday being Good Friday, and the clinic was closed, I called the urgent clinic I usually go to and was told I needed to be seeing, was diagnosed with cellulitis. Was prescribed Keflex, 1,000 mg three times a day. Arm is much better now, although continues to itch a bit.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Limb discomfort, Pruritus
Clinical narrative: Noticed that not only did I had redness, soreness and swelling at the site of the injection, but the redness, itching, discomfort traveled down past my elbow. Due to the Friday being Good Friday, and the clinic was closed, I called the urgent clinic I usually go to and was told I needed to be seeing, was diagnosed with cellulitis. Was prescribed Keflex, 1,000 mg three times a day. Arm is much better now, although continues to itch a bit.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy
Clinical narrative: Noticed swollen lymph node to left clavicle area.  Node is swollen, approx 10mm diameter in size and tender to touch.  States also tired after the vaccine.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Welt 6 inches by 3 inches.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy to vaccine, Alopecia, Chest pain, Dyspnoea, Fatigue
Clinical narrative: Chest pains and breathing, on going uncontrollable vomiting, insomnia, migranes, body aches, chronic fatigue, hair loss, hospitalized 86 times over the past 3 years. All tests inconclusive. Disabled in 2010 and currently on disability. Can not name all the hospitals I have been in in the space below. Just as all the Gardasil injured girls I am still being hospitalized today. I now wears a red hospital wrist band that says ALLERGY the allergy is to Gardasil.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Insomnia, Laboratory test, Migraine, Pain, Vomiting
Clinical narrative: Chest pains and breathing, on going uncontrollable vomiting, insomnia, migranes, body aches, chronic fatigue, hair loss, hospitalized 86 times over the past 3 years. All tests inconclusive. Disabled in 2010 and currently on disability. Can not name all the hospitals I have been in in the space below. Just as all the Gardasil injured girls I am still being hospitalized today. I now wears a red hospital wrist band that says ALLERGY the allergy is to Gardasil.
Age: 55.0
Sex: F
Vaccine: HEPAB, TDAP, TYP
Symptoms: Erythema, Pain, Pruritus, Rash
Clinical narrative: Red, raised rash on skin of left underarm. Pt complains of itching. Pt complains of pain. Pt encouraged to see her PCP, apply hydrocortisone cream over the counter, and take Benadryl 25 mg if itching persists.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Abdominal pain upper, Pyrexia
Clinical narrative: MMR and varicella vaccine were administered at 4:45 pm (2 shots) and low grade fever started at 5:30 pm.  Fever escalated to 104.4 by 11:30 pm and mostly resolved within 24 hours.  Child complained of stomach pains but with no other symptoms within 4 hours of vaccine administration.
Age: 11.0
Sex: F
Vaccine: MNQ, VARZOS
Symptoms: Dyskinesia
Clinical narrative: Patient recieved two vaccines (MCV4-IM and VZV-SubQ) within seconds of recieving VZV patient fell in my arms and began to jerk for 5 seconds, came to unaware of what had happen. Vitals: BP: 88/43, P: 73 Reps: 18. Called 911 transported to Hospital with Fathers consent.