chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: Fever of 102.5, body aches, stomach ache, headache, lips hurting, joints hurting, shaking in the evening. Fever through the night until 4am 11/22/2014 when Tylenol given, then tiredness.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient reports that her whole arm hurts. She tried ice. Benadryl helped her sleep but didn't improve the arm pain. As of 11/20/2014, the pain still exists.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Injection site rash, Pain in extremity
Clinical narrative: Patient complains of a rash at the injection site, arm pain, and radiating elbow/elbow joint pain.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Fatigue, Headache, Inflammation, Lymphadenopathy
Clinical narrative: Began with headache and sore sinus, increase fatique, night sweats followed with exhaustion on Sunday, sick from work on Monday, Tuesday lymph nodes in neck swollen and I went to urgent care center,  tested for mono, streph which was negative, sent for CBC to rule out lymphoma because my neck lymph nodes were so swollen, exhaustion continued,  Thursday sudden flashes in eye and blurred vision.  Went to see ophthalmologist that afternoon at 3 pm. Sick from work on Friday,  I feel I was very healthy befor receiving the flu shot and after receiving it, I has such a inflammatory response to it  I have been sick since.  I still have vision problems and exhaustion  I have voiced issues with taking the flu shot to my manager and occupational health in past.  It is mandatory at my job or else we have to wear a mask for flu season.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Mononucleosis heterophile test negative, Night sweats, Photopsia, Sinus headache
Clinical narrative: Began with headache and sore sinus, increase fatique, night sweats followed with exhaustion on Sunday, sick from work on Monday, Tuesday lymph nodes in neck swollen and I went to urgent care center,  tested for mono, streph which was negative, sent for CBC to rule out lymphoma because my neck lymph nodes were so swollen, exhaustion continued,  Thursday sudden flashes in eye and blurred vision.  Went to see ophthalmologist that afternoon at 3 pm. Sick from work on Friday,  I feel I was very healthy befor receiving the flu shot and after receiving it, I has such a inflammatory response to it  I have been sick since.  I still have vision problems and exhaustion  I have voiced issues with taking the flu shot to my manager and occupational health in past.  It is mandatory at my job or else we have to wear a mask for flu season.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Streptococcus test negative, Vision blurred
Clinical narrative: Began with headache and sore sinus, increase fatique, night sweats followed with exhaustion on Sunday, sick from work on Monday, Tuesday lymph nodes in neck swollen and I went to urgent care center,  tested for mono, streph which was negative, sent for CBC to rule out lymphoma because my neck lymph nodes were so swollen, exhaustion continued,  Thursday sudden flashes in eye and blurred vision.  Went to see ophthalmologist that afternoon at 3 pm. Sick from work on Friday,  I feel I was very healthy befor receiving the flu shot and after receiving it, I has such a inflammatory response to it  I have been sick since.  I still have vision problems and exhaustion  I have voiced issues with taking the flu shot to my manager and occupational health in past.  It is mandatory at my job or else we have to wear a mask for flu season.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Diarrhoea, Dizziness, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat, felt like passing out, aching joints, high fever (4 PM), vomiting (2:45 PM), diarrhea (next morning).
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Sore throat, felt like passing out, aching joints, high fever (4 PM), vomiting (2:45 PM), diarrhea (next morning).
Age: 64.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Injection site nodule, Injection site swelling
Clinical narrative: Swelling at injection site. Feels like a node per patient and after examination.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Injection site erythema, Nausea, Pain
Clinical narrative: Redness at site injection, severe pain, persistent headache and nausea.
Age: 61.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Injected limb mobility decreased, Vaccination site pain
Clinical narrative: Very sore left arm where vaccine given and as time went on, inability to use arm.
Age: 61.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Injected limb mobility decreased, Injection site inflammation, Injection site pain, Tendonitis
Clinical narrative: Very sore left arm where vaccine given and as time went on, inability to use arm.
Age: 1.52
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Diarrhoea, Irritability, Pyrexia, Rash
Clinical narrative: Frequent diarrhea for 4 days; emesis twice; fever up to 103.5 for four days; crankiness with poor appetite; rash on leg and cheeks.
Age: 1.52
Sex: M
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Frequent diarrhea for 4 days; emesis twice; fever up to 103.5 for four days; crankiness with poor appetite; rash on leg and cheeks.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Headache, Musculoskeletal pain, Neck pain, Palpitations
Clinical narrative: Aching in shoulder, all around neck and into upper back.  Almost fainted, so laid in the floor.  Heart was racing.  Horrible headache.  Weak and laid in floor for 30 minutes b/c couldn't get up.  Event lasted about an hour.
Age: 55.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Erythema, Tenderness, Tendonitis
Clinical narrative: Pt came in with R arm tenderness, redness away from site of injection.  Pain extends to wrist (pt described like tendonitis) and stated some neck tenderness.  Area of injection was R deltoid- area of injection not inflamed or any raised area.  Referred pt to follow up with physician and take ibuprofen for swelling, if fever, for pain.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Lethargy, Pyrexia, Respiratory tract congestion
Clinical narrative: Constant high fever and mild congestion and occasional lethargy.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Diagnostic procedure, Dizziness, Facial paresis, Guillain-Barre syndrome
Clinical narrative: Initial sensory problems in upper extremities and head/face, progressed to weakness and fasciculations, and ultimately involved lower extremities as well as tinnitus and frequent dizziness.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Laboratory test, Muscle contractions involuntary, Muscular weakness, Nerve conduction studies abnormal, Sensory disturbance
Clinical narrative: Initial sensory problems in upper extremities and head/face, progressed to weakness and fasciculations, and ultimately involved lower extremities as well as tinnitus and frequent dizziness.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Tinnitus
Clinical narrative: Initial sensory problems in upper extremities and head/face, progressed to weakness and fasciculations, and ultimately involved lower extremities as well as tinnitus and frequent dizziness.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Swelling at injection site, became red, hard and very hot to the touch.  Fever and chills.  Spot started out the size of fifty cent piece and grew to cover upper arm growing more and more painful  Returned to dr on 11/21/2014 he prescribed antibiotics. Cephalexin 500mg 2 tabs 2x daily.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Swelling at injection site, became red, hard and very hot to the touch.  Fever and chills.  Spot started out the size of fifty cent piece and grew to cover upper arm growing more and more painful  Returned to dr on 11/21/2014 he prescribed antibiotics. Cephalexin 500mg 2 tabs 2x daily.
Age: 43.0
Sex: M
Vaccine: FLUX
Symptoms: Chest discomfort, Cough
Clinical narrative: Cough, tightness in chest.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal disorder
Clinical narrative: Patient came into the pharmacy today 11/21/14, and talked to tech and pharmacist claiming that she could not use her left arm. She now had to seek physical therapy for it. She stated that I injected her FLUZONE HD in her upper back. This is not true. I administered 2 shots 10/10/14 around 7 pm. One was her and one to her husband. She states I injected her husband in the left arm and for some reason I injected her in her back. She never reported any redness at the site of injection. This is the 1st time I heard from her. Given her husband and her left the store they are not okay. I had to chase them down to give them.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Confusional state, Dizziness, Hyperhidrosis, Loss of consciousness
Clinical narrative: Felt dizzy weak passed out. Feel mentally confused and have been breaking out in hives ever since vaccination. Extreme sweating since vaccination.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Felt dizzy weak passed out. Feel mentally confused and have been breaking out in hives ever since vaccination. Extreme sweating since vaccination.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: Redness all over lower face and neck and chest 4 hours after injection. At time of injection, swelling after shot. Patient feels fine other than dermatologic reaction. She sent picture to dermatologist-saw nothing to worry. Patient recovered next day.
Age: 53.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Induration, Local swelling
Clinical narrative: Swelling of the arm, hard as a brick. No SOB, no rash.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Local injection site reaction - redness, swelling, discomfort. Treated with cool compress and BENADRYL.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Injection site erythema, Injection site pruritus, Injection site swelling, Skin exfoliation
Clinical narrative: Pt developed itching on left thigh at injection site on 11/19/14 pt had onset of redness and swelling of left thigh with localized blisters and sloughed skin. Prescribed KEFLEX x 7 days for possible infection and BENADRYL PRN for itching.
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional (nurse) refers to an unspecified number of patients of unknown demographics. Patient's pertinent medical history and drug allergies were not reported. On an unknown date all patients were switched to PEDVAXHIB in 4-dose series (dose, frequency, route of administration, lot # and expiry date not reported) rather than 3-dose series as recommended. No concomitant medications were reported. On an unknown date, patients were switched to PEDVAXHIB from ACTHIB which was given in a 4-dose series. No adverse effects were reported. Outcome of the events were not reported. No product quality complaint was reported. Causality was reported as not related to PEDVAXHIB. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MNQ, TD
Symptoms: Back pain
Clinical narrative: Sudden onset of lower back pain right lower lumbar area - had to go to local ER due to pain.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Exposure during pregnancy, Guillain-Barre syndrome, Hypoaesthesia, Neonatal disorder
Clinical narrative: Progressively worsening numbness, tinglin, and weakness, eventually diagnosed with Guillain-Barre syndrome when she was 31 weeks pregnant. She has had a prolonged and ongoing hospitalization/inpatient rehab admission with multiple admissions and readmissions. She delivered her child but the baby also prolonged required hospitalization.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: Progressively worsening numbness, tinglin, and weakness, eventually diagnosed with Guillain-Barre syndrome when she was 31 weeks pregnant. She has had a prolonged and ongoing hospitalization/inpatient rehab admission with multiple admissions and readmissions. She delivered her child but the baby also prolonged required hospitalization.
Age: 52.0
Sex: M
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Lymphadenopathy
Clinical narrative: Crazy swelling in glands under arm painful difficulty in lifting up left arm that received flu shot.
Age: 26.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Guillain-Barre syndrome, Paraesthesia
Clinical narrative: Pins and needles in hands and feet.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Periarthritis
Clinical narrative: Extreme shoulder pain, frozen shoulder, ongoing pain and limited range of motion after two weeks.
Age: 28.0
Sex: F
Vaccine: DTAP
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Pain in arm and shoulder lasting from date of vaccination to present; diminished range of motion in shoulder; throbbing pain throughout the day. 3+ weeks and counting. Unable to use arm without pain.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Joint range of motion decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging, Periarthritis
Clinical narrative: Extreme soreness at injection site. Pain progressed to include shoulder and decreased range of motion. On 11/21/2014, ~4 weeks after vaccine, treatment sought. Physician diagnosed frozen shoulder & referred me to a shoulder surgeon to evaluate need for MRI and/or physical therapy. There is no history of shoulder problems prior to vaccine.
Age: 10.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Very sore at the shot site, swelling of the shoulder where shot was given.  Fever of 102.3. Headache. He was taken to ER to be checked out.  He was given Ibuprofen and Benadryl and an Ice pack.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: I experience shooting pain in my upper left arm and shoulder especially at night when I'm sleeping. This went on for about 10 days it is slowly getting better but I still experience pain when raising my left arm and doing any weights that focus on my shoulder or tricep.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Nasopharyngitis, Rhinorrhoea, Sneezing
Clinical narrative: Cold symptoms, runny nose, sneezing, malaise.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Renal pain
Clinical narrative: Extreme lower back/kidney pain.  Worsened over the next couple of days.  Then started to get better. Still have slight pain on 11/23/2014.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Hives on face, antihistamine and prednisone dose pack. (continue to take antihistamine as symptoms remain although not as severe.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling abnormal, Injected limb mobility decreased, Injection site pain, Injection site warmth, Insomnia
Clinical narrative: Shortly after the injection the site became very hot and sore. My arm swelled to twice its size. The pain was so horrible I could not lift my arm. I had to hold it down with my forearm folded along my waste. A large patch of bright red welted rash appeared. I could not sleep for two nights. I couldn't move the rest of Saturday, all of Sunday, and most of Monday. Benadryl and Tylenol were of no help. I went to work on Monday and told my boss I was ill and may have to leave. The symptoms lingered until Wednesday. I will never get a pneumonia shot ever again. This was an excruciating experience. I felt the flu shot in my left arm was also agitated by this event. I did not feel good at all.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Malaise, Mobility decreased, Rash erythematous, Urticaria
Clinical narrative: Shortly after the injection the site became very hot and sore. My arm swelled to twice its size. The pain was so horrible I could not lift my arm. I had to hold it down with my forearm folded along my waste. A large patch of bright red welted rash appeared. I could not sleep for two nights. I couldn't move the rest of Saturday, all of Sunday, and most of Monday. Benadryl and Tylenol were of no help. I went to work on Monday and told my boss I was ill and may have to leave. The symptoms lingered until Wednesday. I will never get a pneumonia shot ever again. This was an excruciating experience. I felt the flu shot in my left arm was also agitated by this event. I did not feel good at all.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Induration, erythema (in a circular pattern around injection site), pain: all at injection site.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Bacterial test, Blood count, Blood test, Injection site pain, White blood cell count
Clinical narrative: Left arm began to get sore, where injection was given, pain increased as time went on, noticed pain around 9 P.M.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: X-ray
Clinical narrative: Left arm began to get sore, where injection was given, pain increased as time went on, noticed pain around 9 P.M.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Electrocardiogram ambulatory, Emotional distress, White blood cell count increased
Clinical narrative: Extreme, severe, acute chest pain.  It started suddenly and I was in such distress that my husband had to rush me to the ER.  Then I was transported to Hospital to the PCU.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Arthralgia, Discomfort, Joint range of motion decreased, Nuclear magnetic resonance imaging
Clinical narrative: I felt nothing at the time of injection, but I thought the position of the vaccine was strange (too superior and posterior to be in the belly of my deltoid).  When my arm started to ache a few hours later, it was not the same kind of discomfort I've experienced with the last 20+ seasonal flu vaccines I've received. Instead of getting better, within a few days, I had severe pain in my shoulder joint and profound loss of range of motion, particularly forward elevation and adduction/external rotation. By 10/28, taking 600 mg ibuprofen multiple times/day and in the worst pain of my life (including appendicitis and C-section).  I progressed to 800 mg dosage before beginning acupuncture treatments on 11/8.  With acupuncture, I am recovering my motion enough to put on my own bra and drive and perform daily activities and I am managing my pain, but I still am uncomfortable and unable to do many of the things I could (such as lifting my toddler over my head) prior to the vaccination.  I experienced no injury or other events that lead me to believe that this could be related to something other than the flu vaccination.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: I felt nothing at the time of injection, but I thought the position of the vaccine was strange (too superior and posterior to be in the belly of my deltoid).  When my arm started to ache a few hours later, it was not the same kind of discomfort I've experienced with the last 20+ seasonal flu vaccines I've received. Instead of getting better, within a few days, I had severe pain in my shoulder joint and profound loss of range of motion, particularly forward elevation and adduction/external rotation. By 10/28, taking 600 mg ibuprofen multiple times/day and in the worst pain of my life (including appendicitis and C-section).  I progressed to 800 mg dosage before beginning acupuncture treatments on 11/8.  With acupuncture, I am recovering my motion enough to put on my own bra and drive and perform daily activities and I am managing my pain, but I still am uncomfortable and unable to do many of the things I could (such as lifting my toddler over my head) prior to the vaccination.  I experienced no injury or other events that lead me to believe that this could be related to something other than the flu vaccination.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Balance disorder, Disorientation, Dizziness, Heart rate increased
Clinical narrative: Intense dizziness and loss of balance (an disorientation) and a fast heartbeat, on rising. Stayed in bed and rested for three more hours.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Accidental exposure to product
Clinical narrative: None, patient was given a influenza vaccination by accident.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Concussion, Convulsion, Depression, Head injury
Clinical narrative: Panic Attacks, Tachycardia. Syncope, Head Injuries, Concussions. Seizures. Convulsions. POTS (Postural Orthostatic Tachycardia Syndrome). Depression. Anxiety. Neurological Problems. Tremors.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Neurological symptom, Panic attack, Postural orthostatic tachycardia syndrome, Syncope, Tachycardia
Clinical narrative: Panic Attacks, Tachycardia. Syncope, Head Injuries, Concussions. Seizures. Convulsions. POTS (Postural Orthostatic Tachycardia Syndrome). Depression. Anxiety. Neurological Problems. Tremors.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor
Clinical narrative: Panic Attacks, Tachycardia. Syncope, Head Injuries, Concussions. Seizures. Convulsions. POTS (Postural Orthostatic Tachycardia Syndrome). Depression. Anxiety. Neurological Problems. Tremors.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site rash, Neck pain
Clinical narrative: Patient developed a headache with neck pain. Patient also experienced a rash at the injection site.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Nerve injury, Neuralgia
Clinical narrative: Guest described feeling pain at the injection site that did not improve after several days. She visited her physician, who informed her that he thought the needle had hit a nerve in her arm and that was what was causing her pain. She was prescribed something for nerve pain (she did not tell me the name of the drug) that had somewhat improved her symptoms.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: CLIENT IS COMPLAINING OF MUCH PAIN RADIATING FROM THE INJECTION SITE. IT IS PERSISTING EVEN AFTER USE OF IBUPROFEN.
Age: 0.33
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Crying, Decreased appetite, Insomnia, Irritability
Clinical narrative: Increased irritability, decreased sleep, decreased appetite, significantly increased crying.
Age: 25.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema, Pain, Pyrexia
Clinical narrative: Pain, edema, fever.
Sex: F
Vaccine: HEP
Symptoms: Agitation, Apparent life threatening event, Cyanosis, Electrocardiogram normal, Electroencephalogram normal
Clinical narrative: Two events 8/26 daughter agitated fed then 90 mins later child found not breathing, pale, blue lips.  Picked up baby started rousing, then baby looked seizure-like. Eyes fixed upward, stiff back, limp limbs child was breathing when ambulance came and vitals all normal but child was extremely lethargic not responsive to environment.  Two weeks later it happened again only no blue lips as we were able to respond and call 911 faster.
Sex: F
Vaccine: HEP
Symptoms: Gaze palsy, Hypotonia, Lethargy, Musculoskeletal stiffness, Nuclear magnetic resonance imaging normal
Clinical narrative: Two events 8/26 daughter agitated fed then 90 mins later child found not breathing, pale, blue lips.  Picked up baby started rousing, then baby looked seizure-like. Eyes fixed upward, stiff back, limp limbs child was breathing when ambulance came and vitals all normal but child was extremely lethargic not responsive to environment.  Two weeks later it happened again only no blue lips as we were able to respond and call 911 faster.
Sex: F
Vaccine: HEP
Symptoms: Pallor, Respiratory arrest, Seizure like phenomena, Sleep study normal, Unresponsive to stimuli
Clinical narrative: Two events 8/26 daughter agitated fed then 90 mins later child found not breathing, pale, blue lips.  Picked up baby started rousing, then baby looked seizure-like. Eyes fixed upward, stiff back, limp limbs child was breathing when ambulance came and vitals all normal but child was extremely lethargic not responsive to environment.  Two weeks later it happened again only no blue lips as we were able to respond and call 911 faster.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Eye swelling, Paralysis, Sensation of heaviness
Clinical narrative: PARALYZING. EYES SWOLLEN. HANDS JOINTS ACHE.  LEGS FEEL LIKE CONCRETE.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia, Swelling face
Clinical narrative: Face felt tingly and a bit numb, puffy, but it wasn't visually puffy.
Age: 0.51
Sex: F
Vaccine: 6VAX-F, FLUX, IPV, PPV, RVX
Symptoms: Cough, Crying, Diarrhoea, Diet refusal, Dysphonia
Clinical narrative: She became very irritable at 11:00 am on 11/21/14 just before vomiting.  She started a fever of 100.7.  She remained irritable all day, would barely eat, or sleep except for a couple hours after receiving Ibuprofen.  That night she was up crying all night, but seemed out of it at the same time, had 5 episodes of diarrhea, was congested and hoarse, and even after Ibuprofen would whimper like in pain and couldn't sleep.  Her fever broke around 11:00am on 11/23 (today). She remains very irritable, unable to sleep, hoarse/coughing/congested, doesn't want to eat much and seems to be in pain.  She is normally a very happy baby and barely gets fussy.
Age: 0.51
Sex: F
Vaccine: 6VAX-F, FLUX, IPV, PPV, RVX
Symptoms: Hypophagia, Insomnia, Irritability, Moaning, Pain
Clinical narrative: She became very irritable at 11:00 am on 11/21/14 just before vomiting.  She started a fever of 100.7.  She remained irritable all day, would barely eat, or sleep except for a couple hours after receiving Ibuprofen.  That night she was up crying all night, but seemed out of it at the same time, had 5 episodes of diarrhea, was congested and hoarse, and even after Ibuprofen would whimper like in pain and couldn't sleep.  Her fever broke around 11:00am on 11/23 (today). She remains very irritable, unable to sleep, hoarse/coughing/congested, doesn't want to eat much and seems to be in pain.  She is normally a very happy baby and barely gets fussy.
Age: 0.51
Sex: F
Vaccine: 6VAX-F, FLUX, IPV, PPV, RVX
Symptoms: Pyrexia, Respiratory tract congestion, Vomiting
Clinical narrative: She became very irritable at 11:00 am on 11/21/14 just before vomiting.  She started a fever of 100.7.  She remained irritable all day, would barely eat, or sleep except for a couple hours after receiving Ibuprofen.  That night she was up crying all night, but seemed out of it at the same time, had 5 episodes of diarrhea, was congested and hoarse, and even after Ibuprofen would whimper like in pain and couldn't sleep.  Her fever broke around 11:00am on 11/23 (today). She remains very irritable, unable to sleep, hoarse/coughing/congested, doesn't want to eat much and seems to be in pain.  She is normally a very happy baby and barely gets fussy.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Tendon injury
Clinical narrative: Patient received vaccine on 10/28/14, called 2 wks later complaining of arm pain. Told to call MD about complaint. Pt called 11/22/14 saying MD says a tendon may have been "hit" during vaccination.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Joint injury, Periarthritis
Clinical narrative: SIRVA. Adhesive capsulitis. Doctors visits. Physical therapy.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Diarrhoea, Ear pain, Influenza like illness, Oropharyngeal pain, Vomiting
Clinical narrative: Pt described getting stomach flu-like symptoms the next day - vomiting and diarrhea - and that since then she has had an earache and sore throat.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Headache, Hyperhidrosis, Insomnia, Nausea
Clinical narrative: Upon arriving home: Restlessness, hot/cold sweats, headache, insomnia, nausea.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Restlessness
Clinical narrative: Upon arriving home: Restlessness, hot/cold sweats, headache, insomnia, nausea.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: After administration pt's left arm was sore. The next morning the pt could not fully extend left arm. It's 2 mos later pt cannot fully extend arm.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Laryngoscopy, Speech disorder, Vocal cord paralysis
Clinical narrative: Patient stated that she became hoarse and could barely talk. Dr confirmed she had left vocal chord paralysis.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse assistant refers to an unspecified number of patients of unknown age. The unspecified patients medical history was not provided. Since on an unknown date in August 2014, the unspecified patients were vaccinated with improperly stored GARDASIL (dose, frequency and lot # were not reported). No adverse effects were reported. No product quality complaint (PQC) was reported for GARDASIL. This case is linked to case # 1411USA010152 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to an unspecified number of patients of unknown demographics. Patient's pertinent medical history and drug allergies were not reported. On an unknown date, an unspecified number of patients received improperly stored PEDVAXHIB, intramuscular (dose, frequency, route of administration, lot # and expiry date not reported). No symptoms were reported. Outcome of the event was not reported. No product quality complaint (PQC) was reported. Causality was reported as not related to PEDVAXHIB. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refer to patient of unknown age and gender. On an unknown date the patient was vaccinated with M-M-R II, lot # K000737, expiration date:16-JAN-2016 (strength, dosage, frequency and route unknown) which was temperature excursion. The patient was vaccinated at private doctor's clinic/hospital with public funds. The manufacturer was contacted. Vaccine was stable and no adverse event was observed or reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient in her 80's. The patient's drug allergies and pertinent medical history was unspecified. Approximately in November 2014 (reported as about a week ago) the patient was vaccinated with ZOSTAVAX (route, frequency and lot # were not reported). Concomitant medications were unspecified. Approximately in November 2014 (reported as about a week ago) the patient experienced vomiting a few hours after receiving ZOSTAVAX. The outcome of vomiting was unknown. The causality of vomiting was not reported. No product quality complaint was reported for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unknown number of patients with unknown age and gender. On unknown dates the patients were vaccinated with M-M-R II, lot # J016235, expiration date: 19-DEC-2015 (strength, dosage, frequency and route unknown). There was temperature excursion during vaccine storage. The patient was vaccinated at private doctor's clinic/hospital with public funds. The manufacturer was contacted. Vaccine was stable and no adverse event was observed or reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. On 11-NOV-2014, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency was unknown), inadvertently administered in the left dorsal gluteal muscle as an intramuscular injection. No adverse events was reported. No product quality complaint (PQC) involved. The outcome of the event was unknown. No further information provided. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Pain, Rash, Swelling
Clinical narrative: PNEUMOVAX 23 administered on 11/20/14 - pt reports swelling and pain on 11/21/14 - says pain and soreness along with stiffness into shoulder - has rash on 11/22/14. ER visit. MD prescribes prednisone/ULTRAM/CLEOCIN.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Blood test, Chills, Malaise, Pyrexia
Clinical narrative: Achy joints, fever over 101 degrees, sick feeling, chills, went to ER and they gave fluids and antibiotics. The next day he was starting to feel better.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling, Skin warm
Clinical narrative: Redness at injection site. Redness and swelling going down arm just past the elbow. Hot and tender to the touch. Went to hospital and started taking BENADRYL.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Redness at injection site. Redness and swelling going down arm just past the elbow. Hot and tender to the touch. Went to hospital and started taking BENADRYL.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (certificated medical assistant) refers to a patient of unknown age. On 10-NOV-2014 the patient was vaccinated with an expired dose of ZOSTAVAX lot # J000433, expired date: 10-APR-2014) 0.65 ml subcutaneously. There was no adverse experience. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse assistant refers to a unspecified number of patients of unknown age. The unspecified patients medical history was not provided. Once on an unknown date in August 2014, the unspecified patients were vaccinated with improperly stored PEDVAXHIB (dose, frequency and lot # were not reported0. No adverse effects were reported. No product quality complaint (PQC) was reported for PEDVAXHIB. This case is linked to 1411USA004945 (same reporter link). Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a certified nurse practitioner (C.N.P.) refers to an adult female patient. It was reported that on an unknown date the patient who was to have received ZOSTAVAX and instead a medical assistant gave her VARIVAX (Merck) (dose, route and lot# not reported). Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician refers to a female patient of unknown age. On 22-FEB-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot#, route, dose not reported). No concomitant medications were reported. On an unknown date, the patient subsequently found out that she was 2 to 4 weeks pregnant. The LMP (last menstrual period) was estimated as an unknown date in 2013 and EDD (expected date of delivery) was not known. The pregnancy outcome was pending. The patient sought medical attention (contacted her physician). This physician was not the reporting physician). Additional information is not expected as without any patient identifying information, the reporter was unable to provide information.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's pertinent medical history was not reported. On 10-NOV-2014 the patient was inadvertently vaccinated with PROQUAD (dose, frequency and lot # were not reported) and VARIVAX (dose, frequency and lot # were not reported) instead of VARIVAX. No adverse effects were reported. No product complaint was reported for PROQUAD and VARIVAX. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse field representative refers to a 61 year old patient. The patient's pertinent medical history and drug allergies were not reported. On 05-NOV-2014 the patient was vaccinated with VARIVAX (Merck) (dose, frequency and lot # were not reported) instead of ZOSTAVAX. No adverse effects were noted. No product complaint was reported for VARIVAX (Merck). Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Painful, swelling, redness to region lasting several days.
Age: 1.1
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 13 months old patient and unknown gender. On 04-SEP-2014 the patient was vaccinated with a dose of an improperly stored VARIVAX (Merck) (lot J009002, expiration date 19-JUL-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster, Incorrect route of drug administration, Post herpetic neuralgia, Swelling
Clinical narrative: This spontaneous report as received from 43 years old female patient who was a pharmacist on 18-NOV-2014 concerning herself. There were no pertinent medical history and no drug reactions/allergies. On an unknown date of 2006 (also reported as eight years ago) the patient was vaccinated with a dose of ZOSTAVAX, (strength, dose and lot# were unknown) intramuscular. Concomitant therapies included TOPROL XL tablets and LASIX. The patient received the ZOSTAVAX eight years ago via the intramuscular route, instead of subcutaneous, and "shortly after" developed knee pain and swelling. The pharmacist stated in April 2014 she developed a case of shingles on her "front and back"; pharmacist did not specify a specific location just "front and back". The pharmacist stated the knee pain and swelling resolved on an unspecified date as did the rash on her back however, there was a rash was still present around the patient's belly button. The pharmacist also stated she now had postherpetic neuralgia on her back sometimes. The pharmacist saw her unspecified physician "numerous times" regarding the reaction and was prescribed NEURONTIN and Amitriptyline. There was no lab diagnostics studies performed. The outcome of "shingle" and "postherpetic neuralgia" was not recovered. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLUX, VARZOS, FLU4, VARZOS
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: 10/26 Broke out with shingles near injection site on (L) under arm-> shingle down to forearm and 2 on back. 10/27/14-began valacyclovir-discont. 5 days later due to diarrhea. 10/30-3 days fever 101.4.
Age: 59.0
Sex: F
Vaccine: FLUX, VARZOS, FLU4, VARZOS
Symptoms: Diarrhoea, Herpes zoster, Injection site reaction, Pyrexia
Clinical narrative: 10/26 Broke out with shingles near injection site on (L) under arm-> shingle down to forearm and 2 on back. 10/27/14-began valacyclovir-discont. 5 days later due to diarrhea. 10/30-3 days fever 101.4.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RVX, DTAPIPVHIB, PNC13
Symptoms: Respiratory distress
Clinical narrative: Initial case received on 07 November 2014 from a healthcare professional. A 2-month-old male patient had received his first intramuscular dose of PENTACEL (lot number reported "U462AA" (which is invalid), in the left thigh; concomitantly with a dose of PREVNAR 13 (other manufacturer; lot number, route and site of administration not reported) on 04 November 2014. There was no illness reported at the time of vaccination; and no pre-existing allergies, birth defects or medical conditions. On the same day of vaccination, he experienced respiratory distress, decreased breath sounds and was pale for 20 minutes. The patient was taken to the hospital, admitted and was discharged on 05 November 2014. Patient's outcome was reported as unknown.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RVX, DTAPIPVHIB, PNC13
Symptoms: Breath sounds abnormal, Pallor, Respiratory distress
Clinical narrative: Initial case received on 07 November 2014 from a healthcare professional. A 2-month-old male patient had received his first intramuscular dose of PENTACEL (lot number reported "U462AA" (which is invalid), in the left thigh; concomitantly with a dose of PREVNAR 13 (other manufacturer; lot number, route and site of administration not reported) on 04 November 2014. There was no illness reported at the time of vaccination; and no pre-existing allergies, birth defects or medical conditions. On the same day of vaccination, he experienced respiratory distress, decreased breath sounds and was pale for 20 minutes. The patient was taken to the hospital, admitted and was discharged on 05 November 2014. Patient's outcome was reported as unknown.
Age: 14.0
Sex: F
Vaccine: FLUN4, HPV4, FLUN4, HPV4
Symptoms: Chest pain, Computerised tomogram, Dyspnoea, Endoscopy, Oesophageal disorder
Clinical narrative: Woke from nap w/ sudden onset of dysphagia and SOB.  NO cough/URI sx prior.
Age: 14.0
Sex: F
Vaccine: FLUN4, HPV4, FLUN4, HPV4
Symptoms: Oesophageal motility test, Pulmonary function test, X-ray
Clinical narrative: Woke from nap w/ sudden onset of dysphagia and SOB.  NO cough/URI sx prior.
Age: 14.0
Sex: F
Vaccine: FLUN4, HPV4, FLUN4, HPV4
Symptoms: Barium swallow, Chest X-ray normal, Computerised tomogram normal, Dysphagia, Dyspnoea
Clinical narrative: Woke from nap w/ sudden onset of dysphagia and SOB.  NO cough/URI sx prior.
Age: 14.0
Sex: F
Vaccine: FLUN4, HPV4, FLUN4, HPV4
Symptoms: X-ray with contrast upper gastrointestinal tract
Clinical narrative: Woke from nap w/ sudden onset of dysphagia and SOB.  NO cough/URI sx prior.
Age: 61.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Injected limb mobility decreased, Vaccination site pain
Clinical narrative: I had a laceration on my finger which required wound care and, not having had a tetanus booster for more than ten years, was administered a TdaP vaccine. I was never vaccinated for diphtheria or mumps before, even as a child, though I have had tenanus shots (TT) before with zero ill effects. I awoke the next morning with inflammation and severe pain in the upper arm/lower shoulder area of the arm given the shot. After it increased for a week to the point where I could not even use the arm, I called the doctor to ask what to do. He advised me to come in, which I did. He diagnosed me with deltoid tendonitis and wrote me a prescription for physical therapy. He further advised me to continue ice and Motrin, which I am doing. The tendonitis and pain remain and I have only limited use of the arm.
Age: 61.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Injected limb mobility decreased, Injection site inflammation, Injection site pain, Tendonitis
Clinical narrative: I had a laceration on my finger which required wound care and, not having had a tetanus booster for more than ten years, was administered a TdaP vaccine. I was never vaccinated for diphtheria or mumps before, even as a child, though I have had tenanus shots (TT) before with zero ill effects. I awoke the next morning with inflammation and severe pain in the upper arm/lower shoulder area of the arm given the shot. After it increased for a week to the point where I could not even use the arm, I called the doctor to ask what to do. He advised me to come in, which I did. He diagnosed me with deltoid tendonitis and wrote me a prescription for physical therapy. He further advised me to continue ice and Motrin, which I am doing. The tendonitis and pain remain and I have only limited use of the arm.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: PTS MOTHER STATES THAT SHE WAS EXPERINGCING SOME ITCHING AT THE SIGHT ABOUT 45 MIN AFTER THE VACCINE, PT STARTING TO NOTICE SWELLING, REDNESS AND PAIN DOWNHER FROM THE SHOULDER TO THE ELBOW THE NEXT MORNING.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Arthralgia, Back pain, Chest discomfort, Chest pain
Clinical narrative: Pain and Tightness in the chest, Severe pain in hip and back leaving patient unable to walk, Numbness and Tingling in the extremities, dizziness, Bells Palsy, Muscle Pain, debilitating joint pain.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hypoaesthesia, Laboratory test normal, Myalgia, Pain in extremity
Clinical narrative: Pain and Tightness in the chest, Severe pain in hip and back leaving patient unable to walk, Numbness and Tingling in the extremities, dizziness, Bells Palsy, Muscle Pain, debilitating joint pain.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, VIIth nerve paralysis
Clinical narrative: Pain and Tightness in the chest, Severe pain in hip and back leaving patient unable to walk, Numbness and Tingling in the extremities, dizziness, Bells Palsy, Muscle Pain, debilitating joint pain.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain
Clinical narrative: Upper back pain (thoracic) that lasted for 1 1/2 days.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Gallbladder operation, Herpes zoster
Clinical narrative: This spontaneous report as received from a dentist refers to a 68 year old male patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose 0.65ml, lot# and expiration date were unknown) subcutaneous. Concomitant therapy included unspecified blood pressure medications. On an unknown date the patient had gallbladder surgery after receiving ZOSTAVAX. On an unknown date, while the patient was in an unspecified hospital for the gallbladder surgery, the patient developed shingles at an unspecified time after having the surgery. The shingles did not extend the patient's hospital admission and that the patient was prescribed unspecified antiviral medications for treatment while in the hospital. None lab diagnostics studies were performed. The patient had sought for medical attention. The outcome of events was as recovering/resolving. Upon internal review, the event of gallbladder surgery was considered to be medically significant. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Abdominal pain, Full blood count, Henoch-Schonlein purpura, Joint swelling, Metabolic function test normal
Clinical narrative: A physician report concerns an 8 year old male patient. No information was provided regarding relevant history, concurrent diseases and concomitant medications. He received FLUMIST QUADRIVALENT (intranasal) on 06-Oct-2014. The patient initially complained of swollen elbow on 04-Nov-2014, then noted rash on ankles and developed abdominal pain and was diagnosed with Henoch-Schonlein purpura. The patient was treated with naproxen. At the time of reporting, the Henoch-Schonlein purpura (HSP) was ongoing. The reporter assessed the Henoch-Schonlein purpura (HSP) to be serious on the basis of hospitalization.