chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster disseminated, Pruritus, Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist on 21-NOV-2014 refers to a 61 year old male patient with hypercholesterolemia and hypertension. Patient had no known allergies. On 14-NOV-2014 the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX vial 19400 PFU (lot # K009770, expiration date: 09-OCT-2015), subcutaneous in the left upper arm. The primary reporter was requesting a lot check for the lot of ZOSTAVAX that the following patient received. Concomitant therapies included hydrochlorothiazide, PROZAC, LIPITOR and losartan potassium (Manufacturer unknown). The reporter stated that the patient developed "disseminated zoster", almost immediately after receiving ZOSTAVAX. The event onset date was also reported as 15-NOV-2014. She reported that the day after the patient received ZOSTAVAX (15-NOV-2014), the patient started itching, and then he developed varicella-like lesions on his body. The reporter stated that the patient was a physician, so she believed that his opinion was credible. The patient consulted physician for seeking medical attention. There was no lab diagnostics studies performed. The reporter stated that the patient did consult his healthcare provider, and a nurse practitioner in his physician's practice, prescribed VALTREX for him. The patient filled the prescription for VALTREX on 21-NOV-2014 (also reported as today) and he had started taking VALTREX. For an answer to the questions about significant disability, the pharmacist stated, she hadn't been seeing his patients because of this rash, so she might consider this adverse event significant disability since he couldn't work right now. The outcome of disseminated zoster was reported as recovering/resolving. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Chronic inflammatory demyelinating polyradiculoneuropathy, Computerised tomogram, Guillain-Barre syndrome, Neuropathy peripheral
Clinical narrative: After Flu vaccination, severe peripheral neuropathy developed within two days, requiring patient to be hospitalized for pain control, life monitoring, symptoms continue to progress, suspected CIDP or Guillain-Barre syndrome acquired.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Urine analysis
Clinical narrative: After Flu vaccination, severe peripheral neuropathy developed within two days, requiring patient to be hospitalized for pain control, life monitoring, symptoms continue to progress, suspected CIDP or Guillain-Barre syndrome acquired.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Asthma, Condition aggravated, Erythema, Local swelling
Clinical narrative: Vomiting, joint pain, swelling and redness in arm, asthma attack.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vomiting
Clinical narrative: Vomiting, joint pain, swelling and redness in arm, asthma attack.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and erythema at injection, spreading from shoulder to elbow.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Eyelid function disorder, Eyelid ptosis, Ocular hyperaemia, VIIth nerve paralysis
Clinical narrative: Received immunization 11/19/14 am. Developed left red eye and strange taste in mouth 112/20/14 am. Noted decreased blinking and also drooping of left eye eve 11/20/14; mouth droop on (L) side 11/21/14 eve. Diagnosed with Bell's Palsy on 11/22/14.
Age: 17.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Blood creatinine, Blood electrolytes, Blood glucose, Blood urea, Chest pain
Clinical narrative: Running track, sprints developed right sided chest pain, dizziness, near syncope with tunnel vision, then shaking of hands and feet on 11/11/14.
Age: 17.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Dizziness, Electrocardiogram normal, Full blood count normal, Presyncope, Tremor
Clinical narrative: Running track, sprints developed right sided chest pain, dizziness, near syncope with tunnel vision, then shaking of hands and feet on 11/11/14.
Age: 17.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Tunnel vision
Clinical narrative: Running track, sprints developed right sided chest pain, dizziness, near syncope with tunnel vision, then shaking of hands and feet on 11/11/14.
Age: 0.57
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, RV5
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: An hour after vaccines, pt started vomiting up to 12 x. Taken to ER. Put on IV antibiotics. Stayed in hospital for 1 day. Put on antibiotics due to high WBC #s.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown demographics. No current condition was reported. No historical medication was reported. On an unknown date unspecified number of patients were vaccinated with improperly stored ROTATEQ (dose, strength and route was unknown). No adverse effects were reported. No concomitant medication was reported. The outcome of improperly stored ROTATEQ administered to unspecified number of patients was unknown. No PQC was involved. This is one of the several reports related via same reporter. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Erythema, Skin warm, Swelling
Clinical narrative: x 2 days, red, swollem hot to touch and pain in the arm pit. On-call nurse evaluated and instructed her to seek appt w/PCM.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Erythema, Skin warm, Swelling
Clinical narrative: x2 days-red, swollen, hot to touch and pain in the armpit. On-call nurse evaluated and instructed her to seel appt w/PCM.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Borrelia test, Laboratory test, Muscle spasms, Muscle twitching
Clinical narrative: Patient received Flu vaccine IM on 27 October 2014. Patient reports two days later started having pain in left thigh. Pain progressed to twitching and spasms whole walking/standing, but relieved when sitting/squatting) also left lower back pain. Patient seen by Orthopedist   3MRI's with no problems found. Pain meds and steroids were delivered IM with no pain relief in first 4 days.  Patient reports started on muscle relaxer, received relief with reduction in muscle twitching. Patient  started to have some tingling in left foot and now some twitching in  right leg as well as left arm. Patient saw a neurologist November 7th. Patient seen by a neurologist who diagnosed her with radiculoneuritis secondary to flu vaccine.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Neuritis, Nuclear magnetic resonance imaging, Pain in extremity, Paraesthesia, X-ray
Clinical narrative: Patient received Flu vaccine IM on 27 October 2014. Patient reports two days later started having pain in left thigh. Pain progressed to twitching and spasms whole walking/standing, but relieved when sitting/squatting) also left lower back pain. Patient seen by Orthopedist   3MRI's with no problems found. Pain meds and steroids were delivered IM with no pain relief in first 4 days.  Patient reports started on muscle relaxer, received relief with reduction in muscle twitching. Patient  started to have some tingling in left foot and now some twitching in  right leg as well as left arm. Patient saw a neurologist November 7th. Patient seen by a neurologist who diagnosed her with radiculoneuritis secondary to flu vaccine.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Right arm swelled as big as a baseball per patient, red and hot to touch.
Age: 83.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Joint swelling, Skin warm
Clinical narrative: Left arm swelling from top of arm to elbow with redness, warm to touch.
Age: 1.22
Sex: F
Vaccine: FLU4
Symptoms: Face oedema, Rash
Clinical narrative: Developed rash on leg, then edema to face and lips. Received 10 mg Benadryl by mouth.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abnormal behaviour, Hypersomnia, Screaming, Staring, Unresponsive to stimuli
Clinical narrative: Baby screamed with a very high pitched sound. After she calmed down (about 15 minutes after receiving the vaccine) she was acting like she was completely disconnected from the world. She had a blank look on ther eyes and did not follow objects or recognized my voice. She did not eat and she slept all day and all night.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal discomfort, Fatigue, Injection site reaction
Clinical narrative: C/o upset stomach, fatigue and red arm at site of injection.  Wife is a doctor and talked to on-call provider at her place of employment, rx for abx given.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Joint range of motion decreased, Muscular weakness
Clinical narrative: Constant pain in left shoulder joint, limited range of arm movement, limited amount of ability to lift weight.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Diarrhoea, Headache, Pain
Clinical narrative: Diarrhea (11/21: 2:25 am, 5:00 am; 11/23: 7 am; 9 am) Mild fever 100 degrees F, aches, chills, headache (11/21 11am - 6pm) cough (11/19-ongoing).
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Diarrhea (11/21: 2:25 am, 5:00 am; 11/23: 7 am; 9 am) Mild fever 100 degrees F, aches, chills, headache (11/21 11am - 6pm) cough (11/19-ongoing).
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On unspecified dates, since 23-OCT-2014, the patients were vaccinated with ROTATEQ (dose number, route, lot # and expiration date were not provided). In 2014, doses of ROTATEQ that were exposed to a supported temperature excursion (0.2 C for 55 hours) had been administered to unspecified patients on unspecified date, since 23-OCT-2014. No adverse effects had been observed or reported. It was unknown if the patients sought medical attention. At the time of the report, the patients status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Joint range of motion decreased
Clinical narrative: Raised reddened area at injection site limiting range of motion.
Age: 55.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Pyrexia, Systemic inflammatory response syndrome, Tachycardia
Clinical narrative: Swelling and pain at injection site then developing tachycardia and fever leading to diagnosis of SIRS.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure immeasurable, Depressed level of consciousness, Dizziness, Hypotension, Shock
Clinical narrative: I felt like I was going to pass out faint my blood pressure was really low. My vision was tunnel like with no peripheral vision. My friends who are nurses could not get a reading for 15 minutes. I felt like I was in shock.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Tunnel vision
Clinical narrative: I felt like I was going to pass out faint my blood pressure was really low. My vision was tunnel like with no peripheral vision. My friends who are nurses could not get a reading for 15 minutes. I felt like I was in shock.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Biopsy colon abnormal, Clostridium test, Diarrhoea, Endoscopy
Clinical narrative: Chronic, severe diarrhea which lasted 2 weeks+.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Confusional state, Contusion, Headache, Hypoaesthesia
Clinical narrative: Continued bruising and swelling. Joint stiffness, muscle pain, numbness, headache confusion. Increased tremors throughout body. All symptoms continue to worsen and am unable to work due to the pain, numbness, mental fog and limb weakness and control.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Joint stiffness, Muscular weakness, Myalgia, Swelling, Tremor
Clinical narrative: Continued bruising and swelling. Joint stiffness, muscle pain, numbness, headache confusion. Increased tremors throughout body. All symptoms continue to worsen and am unable to work due to the pain, numbness, mental fog and limb weakness and control.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Injection site pain, Mobility decreased, Musculoskeletal pain
Clinical narrative: During routine flu immunization, felt a sharp pain at the injection site and a sensation as if something was being forced into my arm. Subsequently and to this day, I've had pain in my shoulder and difficulty moving/lifting my arm.  Pain level and difficulty moving was highest upon waking in the morning. I had difficulty dressing/undressing and performing other daily tasks. Pain level/difficulty moving showed no improvement until about 20 November, when it began to improve but still has not cleared up completely. There was no redness, swelling, or lumps at the site. In my lifetime (I am 48), I have never experienced pain or other complications from an immunization that persisted more than two days.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Blood pressure increased, Computerised tomogram head, Disorientation, Dizziness, Electrocardiogram
Clinical narrative: NAUSEA; DIZZINESS; SEVERE LEFT ARM PAIN; EXTREME WEAKNESS OF LEFT ARM - UNABLE TO LIFT ARM (HAD TO USE RIGHT ARM TO LIFT LEFT ARM); DISORIENTATION AND STAGGERING; URGENCY TO URINATE; IRREGULAR HEART BEAT & INCREASED BLOOD PRESSURE, PER EMS; TRANSPORTED TO HOSPITAL ER; RECEIVED IV FLUIDS & TORADOL DURING ER VISIT; SYMPTOMS SUBSIDED DURING ER STAY; DISCHARGED TO HOME FROM ER A FEW HOURS LATER; WEAKNESS AND PAIN IN LEFT ARM GRADUALLY DECREASED OVER NEXT FEW DAYS.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Gait disturbance, Heart rate irregular, Injected limb mobility decreased, Laboratory test, Micturition urgency
Clinical narrative: NAUSEA; DIZZINESS; SEVERE LEFT ARM PAIN; EXTREME WEAKNESS OF LEFT ARM - UNABLE TO LIFT ARM (HAD TO USE RIGHT ARM TO LIFT LEFT ARM); DISORIENTATION AND STAGGERING; URGENCY TO URINATE; IRREGULAR HEART BEAT & INCREASED BLOOD PRESSURE, PER EMS; TRANSPORTED TO HOSPITAL ER; RECEIVED IV FLUIDS & TORADOL DURING ER VISIT; SYMPTOMS SUBSIDED DURING ER STAY; DISCHARGED TO HOME FROM ER A FEW HOURS LATER; WEAKNESS AND PAIN IN LEFT ARM GRADUALLY DECREASED OVER NEXT FEW DAYS.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Muscular weakness, Nausea, Pain in extremity
Clinical narrative: NAUSEA; DIZZINESS; SEVERE LEFT ARM PAIN; EXTREME WEAKNESS OF LEFT ARM - UNABLE TO LIFT ARM (HAD TO USE RIGHT ARM TO LIFT LEFT ARM); DISORIENTATION AND STAGGERING; URGENCY TO URINATE; IRREGULAR HEART BEAT & INCREASED BLOOD PRESSURE, PER EMS; TRANSPORTED TO HOSPITAL ER; RECEIVED IV FLUIDS & TORADOL DURING ER VISIT; SYMPTOMS SUBSIDED DURING ER STAY; DISCHARGED TO HOME FROM ER A FEW HOURS LATER; WEAKNESS AND PAIN IN LEFT ARM GRADUALLY DECREASED OVER NEXT FEW DAYS.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Limb discomfort, Pain in extremity
Clinical narrative: Patient reported "1st day after getting Tdap my arm was sore but ok. Second day it was horrible. Arm felt heavy like it is made out of metal and concrete all the way down including my fingers. Can't lift it. Hand and lower arm better now. No swelling but tender at the site. No fever.
Age: 0.18
Sex: F
Vaccine: DTAP, HIBV, RV5
Symptoms: Abdominal mass, Chest X-ray normal, Enema administration, Hypophagia, Ileocolectomy
Clinical narrative: Well appearing at time of appointment with ongoing stridor assoc with laryngomalacia (CXR obtained with normal cardiopulm finding). 3 days later lethargic with decreased PO intake. Seen in ED with RLQ mass and intussusception on U/S. Failed enema, failed Lap reduction, open surgery with ileocolectomy with re-anastomosis.
Age: 0.18
Sex: F
Vaccine: DTAP, HIBV, RV5
Symptoms: Intestinal anastomosis, Intussusception, Lethargy, Ultrasound abdomen abnormal, Viral infection
Clinical narrative: Well appearing at time of appointment with ongoing stridor assoc with laryngomalacia (CXR obtained with normal cardiopulm finding). 3 days later lethargic with decreased PO intake. Seen in ED with RLQ mass and intussusception on U/S. Failed enema, failed Lap reduction, open surgery with ileocolectomy with re-anastomosis.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: The patient stated that she has experienced pain and decreased mobility in the shoulder of the arm in which she received shot. She states she has had to attend physical therapy.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Pt. received flu shot (AFLURIA, lot # T59607) on 11-12-14 in the late morning and later that evening, broke out in hives over lower body. Denies any new meds. foods, etc. to ER -> rec'd BENADRYL IM, then po rx. Hives subsided.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever 100.4F. Hives. Started 30-60 min after administration of vaccine.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: (L) deltoid area swelling, warmth, redness and itching about 1 hr after vaccination with flu. Pr. took BENADRYL and itchiness decreased. Call to pt next day-symptoms improving.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Pruritus generalised
Clinical narrative: Patient received vaccine (FLUVIRIN) 11/8/14. Reported rash below injection site and itching all over" on 11/9/14.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Swelling face
Clinical narrative: Significant facial swelling less than 24 hours after vaccine given. Tx with epinephrine 1:1000/ml 0/4 ml. Prednisone 30 mg po and ZYRTEC 10mg po. Transferred to ER.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Infection, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Two days after vaccine pt noticed redness and swelling around injection site. The sit was warm to touch as well went to physician on 11/17 and was prescribed BACTRIM DS for an infection. After 2 days of BACTRIM, pt was doing better and injection site was clearing up.
Age: 19.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Urticaria
Clinical narrative: Hives on legs and back. Given PO steroids and BENADRYL. Seen in ER on 11/11/14.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Chest pain, Chills, Pyrexia, Tremor
Clinical narrative: Case number PHEH2014US022974 is an initial spontaneous report received from a physician on 14 Nov 2014. This report refers to an 18 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with an intramuscular dose of MENVEO (batch number: not reported) on 12 Nov 2014. About 8 hours later on the same date, he experienced fever, rigors, shakiness and chest pain. The events outcome was reported as condition unchanged. The seriousness was not reported, but the event chest pain was upgraded as medically significant based on the information available on the source documents. The causality of the events was not reported.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site pruritus, Injection site swelling, Local swelling, Skin warm
Clinical narrative: ITCHING/SWELLING AT SITE OF INJECTION AND ABOUT 2 INCHES LOWER ON MY ARM 2 1 1/2 DIA RED WELTS.  AREA WARM & SWOLLEN.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: ITCHING/SWELLING AT SITE OF INJECTION AND ABOUT 2 INCHES LOWER ON MY ARM 2 1 1/2 DIA RED WELTS.  AREA WARM & SWOLLEN.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Dyskinesia, Fall, Head injury, Headache, Hypersensitivity
Clinical narrative: Pt was seen out of the provider's peripheral vision to start falling to the floor (vaccine was given while seated about 5 minutes previously). Pt was then seen on floor with seizure-like movements of head and upper limbs for 5-10 seconds. It is possible the patient struck his head when falling against fire extinguisher on the wall or the wall itself. Pt regained consciousness with no memory of event. Felt ill. Given 50mg Benadryl PO in case of allergic rxn. Had headache immediately after fall and felt nauseated but no vomiting. Vital signs were within normal limits following incident. Rescue was called and transported pt to hospital ER.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Malaise, Nausea, Seizure like phenomena
Clinical narrative: Pt was seen out of the provider's peripheral vision to start falling to the floor (vaccine was given while seated about 5 minutes previously). Pt was then seen on floor with seizure-like movements of head and upper limbs for 5-10 seconds. It is possible the patient struck his head when falling against fire extinguisher on the wall or the wall itself. Pt regained consciousness with no memory of event. Felt ill. Given 50mg Benadryl PO in case of allergic rxn. Had headache immediately after fall and felt nauseated but no vomiting. Vital signs were within normal limits following incident. Rescue was called and transported pt to hospital ER.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site vesicles, Injection site warmth
Clinical narrative: Around 9:00 p.m. that evening started out with small rash.  By 11/25/2014 9:00 a.m. went to pharmacy to speak to pharmacist because rash spread from injection point to armpit and down to elbow.  By then blisters appeared and rash area was hot and burning.  Hurt to have any clothing over rash area.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Paraesthesia
Clinical narrative: Patient described her symptoms via a phone call received 11/26/2014 as the following: She had developed a large red sore (approximately 3 inch diameter) where the injection had been given. She described that her entire arm hurt once the sore had developed. Additionally that her whole hand would give a tingling sensation occasionally with the pain. The patient stated that the pain developed immediately after receiving the immunization, and the large sore and tingling was noticed within approximately 2 hours after the immunization.
Age: 11.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Body temperature increased, Nausea, Retching, Slow response to stimuli, Staring
Clinical narrative: Came to Mom felt sick to stomach had dry hives, then began shaking all over, blank stare, slow to respond to Mother, all occurred in 15 minutes, temp went from 99-103 during that 15 minutes. Mother took child to doctor 11/26/2014 and he said it was a vaccine reaction.
Age: 11.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Tremor, Vaccination complication, Vaccine positive rechallenge
Clinical narrative: Came to Mom felt sick to stomach had dry hives, then began shaking all over, blank stare, slow to respond to Mother, all occurred in 15 minutes, temp went from 99-103 during that 15 minutes. Mother took child to doctor 11/26/2014 and he said it was a vaccine reaction.
Age: 1.23
Sex: M
Vaccine: MENHIB, VARCEL
Symptoms: Diet refusal, Petit mal epilepsy, Pyrexia, Rash, Screaming
Clinical narrative: Started with 9 hours of straight screaming, fever of 104, rash, refusal to eat for 3 days (survived on breast milk) then 3 days later had "absence seizure.)
Age: 1.51
Sex: F
Vaccine: HEPA
Symptoms: Erythema multiforme, Injection site discolouration, Injection site dryness, Injection site erythema, Injection site reaction
Clinical narrative: Received DTaP on 10/28/2014. 1 week later developed an urticarial rash with an elliptical erythema at site of DTaP and dryness surrounded by urticaria on leg. Between 11/13 and 11/28/2014 injection site no longer looked dry and the rash became less raised but continued to spread symmetrically to other leg, onto abdomen and onto arms. Consistent with an erythema multiforme rash but clearly has ablanching erythematous discoloration at the injection site. Mildy itchy if doesn't have pants on. No other symptoms. Otherwise acting fine.
Age: 1.51
Sex: F
Vaccine: HEPA
Symptoms: Pallor, Pruritus, Rash, Urticaria
Clinical narrative: Received DTaP on 10/28/2014. 1 week later developed an urticarial rash with an elliptical erythema at site of DTaP and dryness surrounded by urticaria on leg. Between 11/13 and 11/28/2014 injection site no longer looked dry and the rash became less raised but continued to spread symmetrically to other leg, onto abdomen and onto arms. Consistent with an erythema multiforme rash but clearly has ablanching erythematous discoloration at the injection site. Mildy itchy if doesn't have pants on. No other symptoms. Otherwise acting fine.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Bacterial infection, Erythema, Injection site erythema, Injection site induration
Clinical narrative: I received the vaccination from a pharmacist and she used a sterile needed and also used gloves and sterilized the area with alcohol. My symptoms are; Red, Swollen, hot, burning, hard lump under the skin and painful area at injection site and the whole top of the arm. Symptoms continued for days and days and got progressively worse. Pain and redness spreading from the injection site to the whole top of arm and under arm pit. I couldn't take the pain anymore so I went to see a doctor. The doctor informed me that the injection site was infected with a bacterial infection. I was prescribed antibiotic today 11/26/2014 as of today it has still not cleared up. I still have a painful, swollen arm.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: I received the vaccination from a pharmacist and she used a sterile needed and also used gloves and sterilized the area with alcohol. My symptoms are; Red, Swollen, hot, burning, hard lump under the skin and painful area at injection site and the whole top of the arm. Symptoms continued for days and days and got progressively worse. Pain and redness spreading from the injection site to the whole top of arm and under arm pit. I couldn't take the pain anymore so I went to see a doctor. The doctor informed me that the injection site was infected with a bacterial infection. I was prescribed antibiotic today 11/26/2014 as of today it has still not cleared up. I still have a painful, swollen arm.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Wrong drug administered
Clinical narrative: Intended to give child Kinrix but administered Pediarix instead, by mistake.
Age: 4.0
Sex: M
Vaccine: DTPIPV, FLUX, MMR, VARCEL
Symptoms: Computerised tomogram, Convulsion, Electroencephalogram, Mobility decreased
Clinical narrative: Multiple seizures. Unable to move for up to 6 hours during first ER visit has been on Keppra the last 2 years to keep seizures at bay.
Age: 76.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Lip swelling, Paraesthesia oral, Pruritus generalised, Testicular swelling, Throat irritation
Clinical narrative: Client awoke to find lips swollen, itchy throat tingling mouth, testicles swelled, generalized hives and itching. Went to physician received treatment to stop adverse effects of swelling, itching. Felt normal two days after receiving medical treatment.
Age: 76.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Urticaria
Clinical narrative: Client awoke to find lips swollen, itchy throat tingling mouth, testicles swelled, generalized hives and itching. Went to physician received treatment to stop adverse effects of swelling, itching. Felt normal two days after receiving medical treatment.
Age: 1.36
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Pt developed a significant chicken pox rash.  As of 11/26/2014 pt has not recovered from that rash.  He was examined in our office and mother asked that we report this reaction because of the severity of the rash.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient developed redness and itching at the injection site which had spread down to her elbow by 11/25/2014.  Patient was encouraged to take Zyrtec for the redness and itching and to followup with her doctor if the problem spreads further.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling, redness, warmth, area of firm lump, pain, itching continued to increase over four days despite elevation of arm, Benadryl and application of ice.  Seen by physician on 4th day, who prescribed Keflex 500mg four times daily.  Day 6, lump remains though smaller, warmth and erythema remains.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Upper extremity mass
Clinical narrative: Swelling, redness, warmth, area of firm lump, pain, itching continued to increase over four days despite elevation of arm, Benadryl and application of ice.  Seen by physician on 4th day, who prescribed Keflex 500mg four times daily.  Day 6, lump remains though smaller, warmth and erythema remains.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Erythema
Clinical narrative: Started getting a significantly redder complex. It only got worse.
Sex: F
Vaccine: FLUX
Symptoms: Cellulitis
Clinical narrative: Case number PHEH2014US023099, is an initial spontaneous report received from a consumer on 22 Sep 2014. This report refers to a female patient of unknown age. Her historical condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with an influenza vaccine (manufacturer and batch number: not reported) via intramuscular route. On an unknown date after vaccination, she developed cellulitis. Final outcome was complete recovery. Seriousness was not reported. However, seriousness assessment of cellulitis was internally upgraded based on the NVS-IME list. Causality was not reported.
Age: 1.1
Sex: M
Vaccine: MMR
Symptoms: Aspiration bone marrow abnormal, Body temperature increased, Coombs indirect test positive, Fall, Feeling abnormal
Clinical narrative: This literature marketed report as received from the authors in a literature article refers to a 13 month old male patient. The patient's current conditions or medical history were not reported. On an unknown date, the patient was vaccinated with a dose of MMR vaccine (manufacturer unknown) (dose, route, lot number and expiration date not reported). On an unspecified date, the patient presented to the emergency department due to two episodes of blood vomitus. Two days prior he had fallen from a height off two stairs and sustained a rapidly enlarging hematoma on his forehead. A hematoma to the lip was noted on the day of presentation. 10 days prior to presentation he was vaccinated with MMR vaccine, (manufacturer unknown). There was no reported history of fever, recent upper respiratory illness or other illness. Physical examination in the ED demonstrated a fussy but alert child, HR 145, RR 36, T 100.2F, with a five centimeter hematoma on the forehead, hemorrhagic lesion on the upper lip, gingival bleeding and multiple petechiae on the upper and lower extremities. The rest of the physical examination was unremarkable. Laboratory investigation was significant for platelet count of 5K/uL, Hgb 8.4 g/dL and Hct of 24.7% on CBC. Indirect Coombs test and Stool Guaiac were positive. In PICU his hemoglobin further dropped to 4.0 g/dL, requiring transfusion. Bone marrow aspiration revealed absence of lymphoblasts with increased megakaryocytes and red blood cell precursors. He was treated with IVIG 1g/kg/day for 2 days and Methylprednisolone 4mg/kg/day for 4 days then continued on PO prednisone 2mg/kg/day to be continued for one week. CBC on the seventh day of admission showed platelets of 311 K/uL, and increase of hemoglobin hematocrit to 9.4 g/dL and 28%. ITP after MMR vaccine, (manufacturer unknown) typically occurs within 6 weeks of vaccination. Mild bruising and petechiae are common. Hospitalization is rarely required. Transfusion is required in 1 of 1.8 million vaccines. Platelet counts are typically >20,000 K/uL, higher than non-vaccine associated ITP. This is the first report of thrombocytopenia resulting in severe hemorrhagic complications in an immunocompetent recipient of the MMR vaccine (manufacturer unknown). Outcome of thrombocytopenia was unknown at the time of the report. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: MMR
Symptoms: Full blood count abnormal, Gingival bleeding, Haematemesis, Haematocrit decreased, Haematoma
Clinical narrative: This literature marketed report as received from the authors in a literature article refers to a 13 month old male patient. The patient's current conditions or medical history were not reported. On an unknown date, the patient was vaccinated with a dose of MMR vaccine (manufacturer unknown) (dose, route, lot number and expiration date not reported). On an unspecified date, the patient presented to the emergency department due to two episodes of blood vomitus. Two days prior he had fallen from a height off two stairs and sustained a rapidly enlarging hematoma on his forehead. A hematoma to the lip was noted on the day of presentation. 10 days prior to presentation he was vaccinated with MMR vaccine, (manufacturer unknown). There was no reported history of fever, recent upper respiratory illness or other illness. Physical examination in the ED demonstrated a fussy but alert child, HR 145, RR 36, T 100.2F, with a five centimeter hematoma on the forehead, hemorrhagic lesion on the upper lip, gingival bleeding and multiple petechiae on the upper and lower extremities. The rest of the physical examination was unremarkable. Laboratory investigation was significant for platelet count of 5K/uL, Hgb 8.4 g/dL and Hct of 24.7% on CBC. Indirect Coombs test and Stool Guaiac were positive. In PICU his hemoglobin further dropped to 4.0 g/dL, requiring transfusion. Bone marrow aspiration revealed absence of lymphoblasts with increased megakaryocytes and red blood cell precursors. He was treated with IVIG 1g/kg/day for 2 days and Methylprednisolone 4mg/kg/day for 4 days then continued on PO prednisone 2mg/kg/day to be continued for one week. CBC on the seventh day of admission showed platelets of 311 K/uL, and increase of hemoglobin hematocrit to 9.4 g/dL and 28%. ITP after MMR vaccine, (manufacturer unknown) typically occurs within 6 weeks of vaccination. Mild bruising and petechiae are common. Hospitalization is rarely required. Transfusion is required in 1 of 1.8 million vaccines. Platelet counts are typically >20,000 K/uL, higher than non-vaccine associated ITP. This is the first report of thrombocytopenia resulting in severe hemorrhagic complications in an immunocompetent recipient of the MMR vaccine (manufacturer unknown). Outcome of thrombocytopenia was unknown at the time of the report. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: MMR
Symptoms: Haemoglobin decreased, Haemorrhagic disorder, Immunoglobulin therapy, Intensive care, Irritability
Clinical narrative: This literature marketed report as received from the authors in a literature article refers to a 13 month old male patient. The patient's current conditions or medical history were not reported. On an unknown date, the patient was vaccinated with a dose of MMR vaccine (manufacturer unknown) (dose, route, lot number and expiration date not reported). On an unspecified date, the patient presented to the emergency department due to two episodes of blood vomitus. Two days prior he had fallen from a height off two stairs and sustained a rapidly enlarging hematoma on his forehead. A hematoma to the lip was noted on the day of presentation. 10 days prior to presentation he was vaccinated with MMR vaccine, (manufacturer unknown). There was no reported history of fever, recent upper respiratory illness or other illness. Physical examination in the ED demonstrated a fussy but alert child, HR 145, RR 36, T 100.2F, with a five centimeter hematoma on the forehead, hemorrhagic lesion on the upper lip, gingival bleeding and multiple petechiae on the upper and lower extremities. The rest of the physical examination was unremarkable. Laboratory investigation was significant for platelet count of 5K/uL, Hgb 8.4 g/dL and Hct of 24.7% on CBC. Indirect Coombs test and Stool Guaiac were positive. In PICU his hemoglobin further dropped to 4.0 g/dL, requiring transfusion. Bone marrow aspiration revealed absence of lymphoblasts with increased megakaryocytes and red blood cell precursors. He was treated with IVIG 1g/kg/day for 2 days and Methylprednisolone 4mg/kg/day for 4 days then continued on PO prednisone 2mg/kg/day to be continued for one week. CBC on the seventh day of admission showed platelets of 311 K/uL, and increase of hemoglobin hematocrit to 9.4 g/dL and 28%. ITP after MMR vaccine, (manufacturer unknown) typically occurs within 6 weeks of vaccination. Mild bruising and petechiae are common. Hospitalization is rarely required. Transfusion is required in 1 of 1.8 million vaccines. Platelet counts are typically >20,000 K/uL, higher than non-vaccine associated ITP. This is the first report of thrombocytopenia resulting in severe hemorrhagic complications in an immunocompetent recipient of the MMR vaccine (manufacturer unknown). Outcome of thrombocytopenia was unknown at the time of the report. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: MMR
Symptoms: Lip haematoma, Megakaryocytes increased, Occult blood positive, Petechiae, Platelet count decreased
Clinical narrative: This literature marketed report as received from the authors in a literature article refers to a 13 month old male patient. The patient's current conditions or medical history were not reported. On an unknown date, the patient was vaccinated with a dose of MMR vaccine (manufacturer unknown) (dose, route, lot number and expiration date not reported). On an unspecified date, the patient presented to the emergency department due to two episodes of blood vomitus. Two days prior he had fallen from a height off two stairs and sustained a rapidly enlarging hematoma on his forehead. A hematoma to the lip was noted on the day of presentation. 10 days prior to presentation he was vaccinated with MMR vaccine, (manufacturer unknown). There was no reported history of fever, recent upper respiratory illness or other illness. Physical examination in the ED demonstrated a fussy but alert child, HR 145, RR 36, T 100.2F, with a five centimeter hematoma on the forehead, hemorrhagic lesion on the upper lip, gingival bleeding and multiple petechiae on the upper and lower extremities. The rest of the physical examination was unremarkable. Laboratory investigation was significant for platelet count of 5K/uL, Hgb 8.4 g/dL and Hct of 24.7% on CBC. Indirect Coombs test and Stool Guaiac were positive. In PICU his hemoglobin further dropped to 4.0 g/dL, requiring transfusion. Bone marrow aspiration revealed absence of lymphoblasts with increased megakaryocytes and red blood cell precursors. He was treated with IVIG 1g/kg/day for 2 days and Methylprednisolone 4mg/kg/day for 4 days then continued on PO prednisone 2mg/kg/day to be continued for one week. CBC on the seventh day of admission showed platelets of 311 K/uL, and increase of hemoglobin hematocrit to 9.4 g/dL and 28%. ITP after MMR vaccine, (manufacturer unknown) typically occurs within 6 weeks of vaccination. Mild bruising and petechiae are common. Hospitalization is rarely required. Transfusion is required in 1 of 1.8 million vaccines. Platelet counts are typically >20,000 K/uL, higher than non-vaccine associated ITP. This is the first report of thrombocytopenia resulting in severe hemorrhagic complications in an immunocompetent recipient of the MMR vaccine (manufacturer unknown). Outcome of thrombocytopenia was unknown at the time of the report. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: MMR
Symptoms: Thrombocytopenia, Transfusion
Clinical narrative: This literature marketed report as received from the authors in a literature article refers to a 13 month old male patient. The patient's current conditions or medical history were not reported. On an unknown date, the patient was vaccinated with a dose of MMR vaccine (manufacturer unknown) (dose, route, lot number and expiration date not reported). On an unspecified date, the patient presented to the emergency department due to two episodes of blood vomitus. Two days prior he had fallen from a height off two stairs and sustained a rapidly enlarging hematoma on his forehead. A hematoma to the lip was noted on the day of presentation. 10 days prior to presentation he was vaccinated with MMR vaccine, (manufacturer unknown). There was no reported history of fever, recent upper respiratory illness or other illness. Physical examination in the ED demonstrated a fussy but alert child, HR 145, RR 36, T 100.2F, with a five centimeter hematoma on the forehead, hemorrhagic lesion on the upper lip, gingival bleeding and multiple petechiae on the upper and lower extremities. The rest of the physical examination was unremarkable. Laboratory investigation was significant for platelet count of 5K/uL, Hgb 8.4 g/dL and Hct of 24.7% on CBC. Indirect Coombs test and Stool Guaiac were positive. In PICU his hemoglobin further dropped to 4.0 g/dL, requiring transfusion. Bone marrow aspiration revealed absence of lymphoblasts with increased megakaryocytes and red blood cell precursors. He was treated with IVIG 1g/kg/day for 2 days and Methylprednisolone 4mg/kg/day for 4 days then continued on PO prednisone 2mg/kg/day to be continued for one week. CBC on the seventh day of admission showed platelets of 311 K/uL, and increase of hemoglobin hematocrit to 9.4 g/dL and 28%. ITP after MMR vaccine, (manufacturer unknown) typically occurs within 6 weeks of vaccination. Mild bruising and petechiae are common. Hospitalization is rarely required. Transfusion is required in 1 of 1.8 million vaccines. Platelet counts are typically >20,000 K/uL, higher than non-vaccine associated ITP. This is the first report of thrombocytopenia resulting in severe hemorrhagic complications in an immunocompetent recipient of the MMR vaccine (manufacturer unknown). Outcome of thrombocytopenia was unknown at the time of the report. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Headache, Influenza like illness, Injection site swelling, Respiratory tract congestion
Clinical narrative: (R) arm swollen from deltoid to elbow for few days. Also felt flu-like symptoms lower back pain, headache, respiratory congestion.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Chills, Erythema, Injected limb mobility decreased, Local swelling
Clinical narrative: Patient notes got influenza and pneumonia vaccine on 11/20/14, both in left arm. 6-8 hours after began with severe fevers, chills, and shaking. Notes (L) arm became very red, swollen, severely painful, could not move, was vomiting. Given cephalexin for cellulitis.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Pyrexia, Tremor, Vomiting
Clinical narrative: Patient notes got influenza and pneumonia vaccine on 11/20/14, both in left arm. 6-8 hours after began with severe fevers, chills, and shaking. Notes (L) arm became very red, swollen, severely painful, could not move, was vomiting. Given cephalexin for cellulitis.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Local swelling
Clinical narrative: 11/19/14 patient's arm swelled the night of injection. 11/20/14 went to urgent care and diagnosed w/ cellulitis received antibiotics. 11/21/14 no improvement went to hospital for IV antibiotics.
Age: 65.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injected limb mobility decreased, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Cellulitis, swelling, pain, redness limited use of arm for 3 days at injection site. TX: KEFLEX P.O.
Age: 45.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Erythema, Hypersensitivity, Infection, Mobility decreased
Clinical narrative: Pt developed redness in area, fever, unable to lift arm and joint pain. Patient went to ER 11/15/14 pm and was given antibiotic BACTRIM DS. Advised probably allergic reaction but could be infection.
Age: 45.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: Pt developed redness in area, fever, unable to lift arm and joint pain. Patient went to ER 11/15/14 pm and was given antibiotic BACTRIM DS. Advised probably allergic reaction but could be infection.
Age: 39.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pyrexia, Tenderness
Clinical narrative: Fever, red, swollen, tender arm within 48 hours. Rx KEFLEX -> changed to AUGMENTIN.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administration error, Exposure to contaminated device, No adverse event
Clinical narrative: Patient was injected after needle went into RPh finger first. No adverse events patient requested Hep B shot.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: 2 weeks after shot pt experiencing soreness and some discomfort from shoulder to elbow.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Gave pt. inject. at 2:06 pm. Asked pt. to stay at store for 15 minutes. Patient fainted in store. 911 was called. Pt. woke up right away. EMTs arrived and walked out with patient.
Age: 83.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Back pain, Disturbance in attention, Dysstasia, Erythema
Clinical narrative: This case was reported by a consumer and described the occurrence of left arm was swollen in a 83-year-old male patient who received FLUARIX QUADRIVALENT (batch number 7239G, expiry date June 2015). The patient's past medical history included blood clot in left leg (Patient takes warfarin because of the blood clot in his leg a few years ago). Concurrent medical conditions included no known drug allergy. Concomitant products included amlodipine, lisinopril, lovastatin, Pneumonia vaccine and warfarin. On 6th October 2014 13:00, the patient received FLUARIX QUADRIVALENT. On an unknown date, the dose was an unknown dose. On 7th October 2014, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced left arm was swollen, concentration difficulty, cannot drive, severe drive, severe allergic reaction, back pain, left arm pain, knee and leg pain, redness in arm, and difficultyto stand up. On an unknown date, the outcome of the left arm was swollen, concentration difficulty, cannot drive, severe allergic reaction, back pain, left arm pain, knee and leg pain and difficulty to stand up were not recovered/not resolved and the outcome of the redness in arm was recovering/resolving. It was unknown if the reporter considered the left arm was swollen, concentration difficulty, cannot drive, severe allergic reaction, back pain, left arm pain, knee and leg pain, redness in arm and difficulty to stand up to be related to FLUARIX QUADRIVALENT. Additional information: Patient reports that around 1:00pm Monday, October 6, 2014, he was administered a FLUARIX QUADRIVALENT vaccine and a pneumonia vaccine in his left arm. He reports that he was fine on Monday, but when he woke up on Tuesday October 6, 2014, he had symptoms of arm pain, redness, and swelling. He also had difficulty concentrating, and could not drive or get out of his chair. On Wednesday, October 8, 2014, the patient consulted with his pharmacist who advised if the reaction worsened that he should go to the ER. The patient went to his doctor on Thursday, October 8, 2014, and the doctor told him that he had a severe allergic reaction that was also neurological in nature to the FLUARIX QUADRIVALENT vaccine. The doctor told him that the reaction would not be from the pneumonia vaccine, and the he would not have gotten the reaction had he got the trivalent flu vaccine. The doctor told him that the reaction could persist for up to two weeks, and he told him to report the experience to the manufacturer. The patient has received flu vaccines yearly for the past 20 years, and he has never had symptoms before.