chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Skull X-ray
Clinical narrative: Start with cough, 11/07/2014 went to emergency facility, diagnose bronchitis gave me Prednsone, Claritin and albuterol. Cough continue after treatment went to a generalist diagnosed sinusitis. Give me some nasal decongestant, antibiotics, send to take a head xray an refer me to a OTORHINOLARYNGO SPECIALIST HE CHECK ME gave me Alegra and Singulair. Feel a little better but the cough still prevailed until today 12/04/2014.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Arm was numb and very painful to touch I can sleep without taking Motrin every 6 hours.
Age: 0.17
Sex: M
Vaccine: DPP
Symptoms: CSF lymphocyte count abnormal, CSF neutrophil count increased, Lymphocyte percentage, Monocyte count increased, Neutrophil count increased
Clinical narrative: Sudden onset high fever (102.6) at home.  Responded with Tylenol. Lab values showed CSF and WBC changes.
Age: 0.17
Sex: M
Vaccine: DPP
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Sudden onset high fever (102.6) at home.  Responded with Tylenol. Lab values showed CSF and WBC changes.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Hyperaesthesia, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: The pneumococcal polysaccharide vaccine (23) was administered on 12/01/2014.  By that afternoon I was experiencing itching, redness, swelling and quite a bit of pain in my left arm above my elbow near the injection site. Later in the evening of 12/01/2014 by arm was very painful, still red with a rash and more swelling. On Tuesday, 12/01/2014 I started to swell on the lower left arm at and below the elbow. The itching sensation was gone but I still had the rash.  There was quite a bit of swelling below the elbow as well as pain.  The pain in my arm above the elbow had lessened quite a bit. By Tuesday evening, the swelling above the elbow had lessened as well but I continued to have swelling and pain at and below the elbow.  The rash was covering a greater distance  around the injection site and below.  My temperature was normal throughout the entire time of the adverse reaction.  I called facility and talked with the doctor on call.  He suggested taking Benadryl. I took the first dose of Benadryl on Tuesday around 10:00 p.m.   By Wednesday morning, the swelling and pain in my upper arm had lessened even more.  The rash continued as did the pain in my lower arm.   I took the Benadryl all day on Wednesday.   By Wednesday early evening, the pain in my entire arm had lessened quite a bit.  The rash was almost gone and the swelling around my elbow had decreased a little.  This morning (Thursday) my arm is still a little sensitive when touched but the rash is gone and the swelling is has reduced so that my upper arm looks like it is almost back to normal.  The swelling on my lower arm has decreased dramatically but is still a little swollen.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: The pneumococcal polysaccharide vaccine (23) was administered on 12/01/2014.  By that afternoon I was experiencing itching, redness, swelling and quite a bit of pain in my left arm above my elbow near the injection site. Later in the evening of 12/01/2014 by arm was very painful, still red with a rash and more swelling. On Tuesday, 12/01/2014 I started to swell on the lower left arm at and below the elbow. The itching sensation was gone but I still had the rash.  There was quite a bit of swelling below the elbow as well as pain.  The pain in my arm above the elbow had lessened quite a bit. By Tuesday evening, the swelling above the elbow had lessened as well but I continued to have swelling and pain at and below the elbow.  The rash was covering a greater distance  around the injection site and below.  My temperature was normal throughout the entire time of the adverse reaction.  I called facility and talked with the doctor on call.  He suggested taking Benadryl. I took the first dose of Benadryl on Tuesday around 10:00 p.m.   By Wednesday morning, the swelling and pain in my upper arm had lessened even more.  The rash continued as did the pain in my lower arm.   I took the Benadryl all day on Wednesday.   By Wednesday early evening, the pain in my entire arm had lessened quite a bit.  The rash was almost gone and the swelling around my elbow had decreased a little.  This morning (Thursday) my arm is still a little sensitive when touched but the rash is gone and the swelling is has reduced so that my upper arm looks like it is almost back to normal.  The swelling on my lower arm has decreased dramatically but is still a little swollen.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Myalgia
Clinical narrative: Diffuse myalgia and chills for 3 days, all subsided as soon as she took a Benadryl on day 3.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Mobility decreased, Pain, Sleep disorder
Clinical narrative: Sore arm at site of injection (as expected) however, soreness worsened over following days now 2.5 weeks later unable to sleep on that side; lift arm above head w/o pain, lift w/o pain, or maintain range of motion. Aching pain is constant. Seeking follow-up.
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Pain, Pain in extremity
Clinical narrative: Right arm and side sore.
Age: 8.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal discomfort, Injection site reaction, Musculoskeletal stiffness, Pain in extremity, Pyrexia
Clinical narrative: Woke up with an upset stomach and low grade fever. By 9:00 am while at school fever spiked to 100 degrees. Also, complained about pain in her leg (feels like she has a knot there, even there isn't one that can be seen or felt by hand).   Both her and sister complained about muscle stiffness at injection site.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Bone pain, Injection site pain, Musculoskeletal disorder, Musculoskeletal pain
Clinical narrative: Pain at site of injection, but also could feel pain in my humerus.  The soreness eventually went away, but I continue to have stabbing pain in my shoulder with any movement overhead.  It is painful to take my shirt off, get things out of cabinets.  If I attempt to throw a ball with my son, my arm is so sore that I can barely use it for the rest of the day and into the next.  I have tried applying heat to the site, but this only seems to make it worse.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Pain at site of injection, but also could feel pain in my humerus.  The soreness eventually went away, but I continue to have stabbing pain in my shoulder with any movement overhead.  It is painful to take my shirt off, get things out of cabinets.  If I attempt to throw a ball with my son, my arm is so sore that I can barely use it for the rest of the day and into the next.  I have tried applying heat to the site, but this only seems to make it worse.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Tremor
Clinical narrative: This case was reported by a physician and described the occurrence of tremors in a 55-year-old female patient who received FLUARIX QUADRIVALENT (batch number GA22N, expiry date 30th June 2015). Previously administered products included influenza vaccine. Concurrent medical conditions included raised liver function tests, infectious mononucleosis and cytomegalovirus infection. On 17th October 2014 14:37, the patient received FLUARIX QUADRIVALENT. On 17th October 2014, 2 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced tremors (serious criteria disability). On an unknown date, the outcome of the tremors was recovering/resolving. The reporter considered the tremors to be possibly related to FLUARIX QUADRIVALENT. Additional information: The subject didn't experience any events following previous vaccinations. Within 2 hours of vaccination, the patient experienced extreme tremors. She has therefore been out of work for 1 month. The patient consulted a neurologist and the reporting physician. At the time of reporting, the concurrent medical conditions were resolved and the liver function test was normal.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site injury, Injection site pain
Clinical narrative: Extreme left shoulder pain and loss of all movement of left arm.  I think the pharmacy person put the shot too high up on my shoulder and now I have to go to physical therapy and miss work due to this SIRVA as diagnosed by my doctor.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Shot site became hard and swollen, was red and warm to the touch and was itchy.
Age: 65.0
Sex: F
Vaccine: MMR
Symptoms: Antiphospholipid antibodies negative, Arthralgia, Borrelia test negative, Gait disturbance, Hypokinesia
Clinical narrative: Painful swollen right large toe joint, then moved to ankles, knees, wrists and hands. Moving from one joint to another occurred over 7-10 days.   Continue with hand pain at time of this report (which is 12/4/14).  The pain was disruptive of walking, bending knees and using hands.
Age: 65.0
Sex: F
Vaccine: MMR
Symptoms: Joint swelling, Rheumatoid factor negative
Clinical narrative: Painful swollen right large toe joint, then moved to ankles, knees, wrists and hands. Moving from one joint to another occurred over 7-10 days.   Continue with hand pain at time of this report (which is 12/4/14).  The pain was disruptive of walking, bending knees and using hands.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Migraine
Clinical narrative: My daughter has excrutiating migraines and headaches daily. Lasting as long as 9 consecutive days with no sign of pressure release.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Inflammation, Insomnia, Pain in extremity
Clinical narrative: Patient called the evening of 12/3/14 and stated that she had an adverse reaction to the flu vaccine. She stated that her arm had been painful since the vaccine was administered making it difficult to sleep, wash her hair, and dress herself. She stated that she contacted her PCP who gave her some medication to reduce inflammation. She still has not had relief and stated she was going to have xray/CT/MRI later this week. We advised her that we would report the incident to the CDC and encouraged her to continue to follow up with her PCP and keep us informed of her condition.
Age: 18.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant youth inadvertently give FLUMIST.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Erythema, edema at site of injection measuring 20 x 12 cm.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Redness/swelling.
Sex: F
Vaccine: PNC13
Symptoms: Cerebrovascular accident, Immediate post-injection reaction, Local swelling, Paralysis
Clinical narrative: This is a spontaneous report from a contactable Medical Assistant (who called on behalf of a physician) through a Pfizer Sales Representative. A female patient of unspecified age received PREVNAR 13 at single dose, on unknown date. Medical history and concomitant medications were not provided. On an unspecified date the patient experienced paralysis of hands, stroke and severe swelling in both arms. The patient went to emergency room because of the swelling (she went to ER twice because of it). The reporter did not know how recent was the stroke. At time of the report the swelling got progressed. The Medical Assistant believed that the events were due to the vaccine as the situation developed immediately after giving the shot and the patient had to go to the emergency room twice. Events final outcome at time of report was unknown.
Age: 50.0
Sex: M
Vaccine: PNC13
Symptoms: Blister, Contusion, Eye operation, Local swelling, Loss of consciousness
Clinical narrative: This is a spontaneous report from a non clinical study program. A 51-year-old male patient received a shot of PREVNAR 13, on last week of Mar2014 at single dose. The patient mentioned that doctor gave PREVNAR 13 to him because he was HIV positive (since 17 years). The patient was very healthy before vaccination. On an unknown date in 2014 he had a very bad reaction, he had bruises and blister on his eyelid, rash and blister all over his body, severe swelling in his feet, fever, he blacked out a few times and he had surgery on his eyes. The doctor said that it was the result of PREVNAR 13. Patient also had darkening of his toenails and it was reported that "it looked like he had full blown AIDS". He has not undergone any blood test recently. The outcome of the events was unknown.
Age: 50.0
Sex: M
Vaccine: PNC13
Symptoms: Nail discolouration, Pyrexia, Rash generalised, Vaccination complication
Clinical narrative: This is a spontaneous report from a non clinical study program. A 51-year-old male patient received a shot of PREVNAR 13, on last week of Mar2014 at single dose. The patient mentioned that doctor gave PREVNAR 13 to him because he was HIV positive (since 17 years). The patient was very healthy before vaccination. On an unknown date in 2014 he had a very bad reaction, he had bruises and blister on his eyelid, rash and blister all over his body, severe swelling in his feet, fever, he blacked out a few times and he had surgery on his eyes. The doctor said that it was the result of PREVNAR 13. Patient also had darkening of his toenails and it was reported that "it looked like he had full blown AIDS". He has not undergone any blood test recently. The outcome of the events was unknown.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the nurse practitioner refers to a patient of unknown demographics. on 21-NOV-2014 the patient was vaccinated with ROTATEQ (Dose, route not reported) for an unknown indication. On 21-NOV-2014, the patient received improperly stored ROTATEQ. The reporter stated that the dose which patient received was not the patient's first dose. Nurse did not provide the data when the patient first received ROTATEQ. No adverse symptoms reported. The temperature excursion for ROTATEQ was found to be supported with in-house stability data. No product quality complaint was involved. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site urticaria, Vaccination site pain, Vaccination site warmth
Clinical narrative: Patient received pneumonia vaccine and right arm, red, warm to touch, pain, and large welp in vaccine site.
Age: 37.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Pain, red, and warm to touch in left arm.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Pain
Clinical narrative: I continue to have moderate to severe pain in my arm where I received the INFs (influenza split virus) shot.  It is painful to raise my arm.
Age: 64.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Asthenia, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Soreness in left arm, unable to lift or carry weight, pain at night, unable to lift arm straight up or bend it backwards, loss of strength and flexibility, hurts when running (back and forth motion).  Have treated with aspirin, heat and rest.
Age: 14.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: Mild nausea, medium stomach pain. No treatment.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Fever of 103.0, large area of redness at injection site on left arm Fever resolved by 12/04/2014, redness remains at injection site on left arm.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an healthcare worker refers to unspecified patients of unknown ages. Since an unknown date in July 2014, the patients were vaccinated with improperly stored ROTATEQ (lot#, strength, dosage, frequency and route unknown). No adverse effects were reported on the reporting time. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Rash with redness and swelling at site of injection.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood test, Chest X-ray, Electrocardiogram, Guillain-Barre syndrome
Clinical narrative: I contracted Guillain Barre Syndrome.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood test, Chest X-ray, Electrocardiogram, Guillain-Barre syndrome
Clinical narrative: Contracted Guillain Barre Syndrome.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Left arm pain w/ some swelling, pruritis and redness.
Age: 0.37
Sex: M
Vaccine: DPP
Symptoms: Erythema multiforme, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Rash started in baby's belly bottom after few hours started spreading thru his whole body- we have taken to the Doctor early next day and he advised that it was a viral and we just had to wait, same day his both legs and arms were swelling at the point that they turned PURPLE. Fever was not higher than 101.6 (rectal), baby was taken to the doctor again and advised that what the baby had was called ERYTHEMA MULTIFORME but that he could NOT say if it was due to the vaccines or not, I have requested a test to see what had affected him but I was told that no test is available for this.
Age: 1.22
Sex: F
Vaccine: DTAP, HIBV, PPV
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dysphagia, Facial paresis, Guillain-Barre syndrome, Paraesthesia
Clinical narrative: Weakness, tingle in legs and arms, difficult swallowing, facial weakness.
Sex: F
Vaccine: RV5
Symptoms: Accidental exposure to product, Diarrhoea, Exposure via direct contact, Eye infection, Nausea
Clinical narrative: This spontaneous report as received from a field representative which reported that the nurse who is the patient in this case reported to the representative, that on an unspecified date while administering ROTATEQ (route and indication were not provided) part of the dose went into her eye because the infant patient she was administering to spit it back out. Since then the nurse has developed an eye infection, diarrhoea and nausea. The representative also reported "since the infant patient spit the ROTATEQ out the infant did not receive a full dose, no adverse effect were reported. No relevant medical history were reported. Concomitant medications were not reported. All adverse events refers only to the nurse. The outcome of part of the dose went into my eye, nausea, diarrhea and eye infection was reported as not recovered/not resolved. Action taken with the therapy drug were not reported. No further information was provided.
Age: 21.0
Sex: M
Vaccine: FLUN4
Symptoms: Asthenia, Chills, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: Stated he felt nausea, tiredness, general weakness, headache, loose stools at time of onset. To treat he took OTC ibuprofen. Symptoms reduced in severity over the next three days, and remained the same for about one week. On the 28th symptoms worsened and now include loss of appetite, chills, and more pronounced weakness. Stated he has not made an appointment with a health care provider yet. Also has had several brief encounters with people exhibiting mild sickness due to employment in a customer service job.
Age: 21.0
Sex: M
Vaccine: FLUN4
Symptoms: Headache, Nausea
Clinical narrative: Stated he felt nausea, tiredness, general weakness, headache, loose stools at time of onset. To treat he took OTC ibuprofen. Symptoms reduced in severity over the next three days, and remained the same for about one week. On the 28th symptoms worsened and now include loss of appetite, chills, and more pronounced weakness. Stated he has not made an appointment with a health care provider yet. Also has had several brief encounters with people exhibiting mild sickness due to employment in a customer service job.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Burning sensation, Chills, Dizziness, Hyperhidrosis
Clinical narrative: Severe aches, weakness, faintness, vomiting, loss of bladder control, burning feet, sweating, shivering.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Urinary incontinence, Vomiting
Clinical narrative: Severe aches, weakness, faintness, vomiting, loss of bladder control, burning feet, sweating, shivering.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: I noticed that my face had a rash and I started to feel I was breaking out in hives on my body because I began to itch. I called the advice nurse around October 7, 2014 to explain my symptoms and she suggested hydrocortisone cream and benadryl to no avail.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fall, Vision blurred
Clinical narrative: About 2-3 minutes post administration, patient felt dizzy and fell face down. She complained of dizziness and blurry vision. 911 responded.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pain, swelling, redness and heat, cool compresses ordered, Ibuprofen, may take Benadryl, cannot r/o cellulitis.  Antibiotic given but instructed to hold if better.
Age: 33.0
Sex: F
Vaccine: TYP
Symptoms: Nervous system disorder
Clinical narrative: This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labelling documents. This spontaneous report was received from a consumer and concerns a 33 year old female: Local case ID 95-011. The subject's height, weight and medical history were not reported. The subject received typhoid vaccine oral ty21a (capsule, hard, oral) on an unspecified date as prophylactic vaccination. Concomitant medications were not reported. On 01-AUG-1993, the subject developed a neurological disorder. Action taken with typhoid vaccine oral ty21a was unknown. The subject had not recovered from neurological disorder, at the time of the report. This report was serious (medically significant).
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Injection site was LEFT arm.  Unable to lift LEFT arm for 24 hours then 24 hours PAIN and SORE.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Malaise
Clinical narrative: Patient reported pain to left shoulder at site of injection and generalized malaise.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Lymphadenopathy, Pain
Clinical narrative: Pain, local swelling, swollen supraclavicular and axillary nodes.
Age: 33.0
Sex: F
Vaccine: TYP
Symptoms: Amyotrophic lateral sclerosis, Asthenia, Muscle atrophy, Muscle twitching
Clinical narrative: This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labelling documents. This spontaneous report was received from a consumer or other non health professional and concerns a 33 year old female; local ID: 0134. The subject's weight and medical history were unknown. The subject received typhoid vaccine oral ty21a (heat, Phenol inactivated) (capsule, hard) on an unspecified date in AUG-1993. Concomitant medications were not reported. On an unknown date in SEP-1993, the subject developed a twitching syndrome in the upper right and left extremeties with weakness and muscle atrophy. The subject was later diagnosed with a motor neuron disease described as 'of ALS nature'. Action taken with TYPHOID VACCINE ORAL TY21A was unknown. At the time of this report, the subject had not recovered from the event. This report was serious (medically significant).
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Eye pruritus, Throat tightness
Clinical narrative: Patient reports that his throat feels like it is closing and his eyes are itchy.  The reaction is similar to a reaction he had when he ate shrimp, which he is allergic to. This started roughly 3 hours after his vaccine was given.  Patient was instructed to seek immediate medical attention, either at the ER or a clinic.  If this was not available to him, then we instructed him to go to a pharmacy to purchase Benadryl and take 25mg immediately.
Age: 28.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced significant pain and swelling to injection sites in left deltoid. Presented to PCM with redness, heat and induration of 150 x 130 mm in left deltoid approximately 24 hours after immunizations were administered. States he also ran a "low grade" fever on the night the vaccines were administered, 12/02/2014. Also complains of nasal congestion and body aches.
Age: 28.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Nasal congestion, Pain, Pyrexia
Clinical narrative: Patient experienced significant pain and swelling to injection sites in left deltoid. Presented to PCM with redness, heat and induration of 150 x 130 mm in left deltoid approximately 24 hours after immunizations were administered. States he also ran a "low grade" fever on the night the vaccines were administered, 12/02/2014. Also complains of nasal congestion and body aches.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Hypokinesia, Joint swelling, Pain, Pyrexia
Clinical narrative: Patient received the quad vaccine in the afternoon. Within a couple of hours, her chronic pain level had increased from a 6 (on 1-10 scale) to a 9.5. She ran a slight fever (99.5 to 101 F) for about one week. The increase in pain significantly restricted her movements. Both of her wrists and left knee were swollen at the joint for 2 days. We followed up at our clinic one week later (next Wednesday) and, on the advice of the physician assistant we saw, the emergency room on the same day. At the emergency room she received a 60 mg shot of toradol which did nothing to alleviate her pain, along with some advice that her pain wasn't real. Today, 12/04/2014 is one month later and patient is still at a 9 to 9.5 for pain level. She is becoming permanently disabled by the continued increase of her chronic pain.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Dizziness, Dysstasia, Musculoskeletal stiffness, Vomiting
Clinical narrative: Patient felt dizzy on Tuesday afternoon and started throwing up, felt like head was on fire (but no fever), head locked in place. Was on bathroom floor throwing up and could not get up, had to call 911 to get her to the ER. Continued being dizzy and throwing and was given meds in ER. She threw up again and was given IV anti-enemtics. Blood work showed increase in white blood cell and was admitted in the hospital for 2 days.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: White blood cell count increased
Clinical narrative: Patient felt dizzy on Tuesday afternoon and started throwing up, felt like head was on fire (but no fever), head locked in place. Was on bathroom floor throwing up and could not get up, had to call 911 to get her to the ER. Continued being dizzy and throwing and was given meds in ER. She threw up again and was given IV anti-enemtics. Blood work showed increase in white blood cell and was admitted in the hospital for 2 days.
Age: 0.39
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rash generalised
Clinical narrative: Had her routine 4 month immz, broke out in rash all over next day, afebrile, normal appetite and activity.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pain in arm, from shoulder to fingertips. I can barely use my arm from the pain.  It has been almost 3 weeks and the pain still has not subsided.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Hypopnoea, Myalgia, Pyrexia, Urticaria
Clinical narrative: LOW GRADE FEVER, HEADACHE, MUSCLE PAIN, SHALLOW BREATHING, HIVES ON NECK AND CHEST.
Age: 1.65
Sex: M
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and red at injection site!
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Hypoaesthesia, Insomnia, Night sweats, Paraesthesia
Clinical narrative: The patient has reported night sweats, difficulty sleeping, and severe fatigue for the past 3 weeks.  Also, the patient reported numbness and tingling in the upper extremities.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives; back, buttocks, arms, shoulders; still there as of 12/04/2014.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Fatigue, Idiopathic thrombocytopenic purpura, Petechiae, Platelet count decreased
Clinical narrative: Petichiae, bruising, fatigue...Idiopathic thrombocytopenic purpura (ITP).
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, and itching at injection site. Patient was observed for 30+ minutes and no systemic reactions noted. Patient was recommended to follow-up for medical evaluation with her PCP.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Lethargy, Rash, Skin test positive, Tachycardia
Clinical narrative: Tachycardia for about 3 minutes; shivers and general lethargy for the following day; rash onset 4 days thereafter, lasting for almost 4 weeks.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: The patient came in today on05 December 2014 with the large rash to upper left ams. Patient reports he has scratched at the upper left arm site a couple of times.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness, Rash
Clinical narrative: RASH ON NECK FLU LIKE SYMPTOM.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: On 11/26/14 patient still complains of sore and stiff arm where she can barely move her arm to lift.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Chills, Headache, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Redness of the eyes, sore throat, chills, vomiting. Later on after the chills subsided the fever set in and achy joints and severe headaches occurred.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Vomiting
Clinical narrative: Redness of the eyes, sore throat, chills, vomiting. Later on after the chills subsided the fever set in and achy joints and severe headaches occurred.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Bursitis, Drug administered at inappropriate site, Immediate post-injection reaction, Inflammation
Clinical narrative: I felt immediate intense pain after my flu shot. I went back to the clinic three times that week to get my arm checked because I knew something was wrong. I could barely move my arm and was in excruciating pain which made normal everyday activities (ex: getting dressed in the morning) a challenge. I was told to take Motrin every 4 hours, which I did. After a week and a half, I filed a worker's compensation claim and was referred to a rehab medicine doctor. The doctor diagnosed me with bursitis as a result of the flu shot being administered too high on my shoulder. She prescribed me Meloxicam to reduce the inflamation. I took Meloxicam for 4 weeks. It has now been 3 months since the flu shot. My range of motion in my arm has improved; however, I still suffer intense pain when I move my arm in certain positions, and I cannot carry heavy items, hold my arms up for more than a few seconds, or exercise. My doctor is in the process of scheduling me an MRI because this has gone on for so long and she believes there may be joint damage. I do not know how long my disability will last or if it will be permanent.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Pain, Pain in extremity, Weight bearing difficulty
Clinical narrative: I felt immediate intense pain after my flu shot. I went back to the clinic three times that week to get my arm checked because I knew something was wrong. I could barely move my arm and was in excruciating pain which made normal everyday activities (ex: getting dressed in the morning) a challenge. I was told to take Motrin every 4 hours, which I did. After a week and a half, I filed a worker's compensation claim and was referred to a rehab medicine doctor. The doctor diagnosed me with bursitis as a result of the flu shot being administered too high on my shoulder. She prescribed me Meloxicam to reduce the inflamation. I took Meloxicam for 4 weeks. It has now been 3 months since the flu shot. My range of motion in my arm has improved; however, I still suffer intense pain when I move my arm in certain positions, and I cannot carry heavy items, hold my arms up for more than a few seconds, or exercise. My doctor is in the process of scheduling me an MRI because this has gone on for so long and she believes there may be joint damage. I do not know how long my disability will last or if it will be permanent.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Urticaria
Clinical narrative: Welts all over body.
Age: 0.17
Sex: M
Vaccine: FLU3, HIBV, PNC13, RV1
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: FLUARIX 35 month and older dose was given instead of PEDIARIX at 2 months of age.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site scab
Clinical narrative: Scab and redness at injection site that opened and reappeared surrounded by redness size of quarter appearing 3 weeks after injection and lasting for 3 weeks. Area still tender.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Hypoaesthesia, Pain
Clinical narrative: Water blister formed 1 1/2 inches from injection site. Soreness, numb. Patient called 11/14/14 to report.
Age: 60.0
Sex: F
Vaccine: FLUC3
Symptoms: Immediate post-injection reaction, Injection site pain, Joint range of motion decreased, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Pain upon administration of vaccine and immediately thereafter, with little or no improvement until present. Severe pain and drastic decrease in range of motion subsequently. Treatment includes: 3 visits to orthopedics surgeon, 2 courses of MEDROL, 1 cortisone shot, MRI, physical therapy, VICODIN, ULTRACET for pain.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: When moves arm in upward motion has pain. Can not pick heavier objects with out experiencing a sharp pain. Hurts when received vaccine then passed two days later pain in arm started.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Hypoaesthesia, Nuclear magnetic resonance imaging spinal normal, Pain
Clinical narrative: Increasing pain, weakness, numbness. Pt felt was related to existing lumbar issue, but continued to worsen so contacted MD. Continued pain medicine and started physical therapy.
Age: 0.62
Sex: F
Vaccine: FLU3
Symptoms: Cyanosis, Dyspnoea, Pallor
Clinical narrative: 10 hrs after FLUZONE booster, pt developed gasping, blue eyelids and pallor. All resolved w/o Rx.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Radiculitis brachial
Clinical narrative: Brachial neuritis currently being treated by her doctor. Event happen approximately 3 weeks after immunization per pt.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: After the patient got home the injection site became red, warm, "swollen", painful (size of the patient's hand). Today she is improved but still slightly swollen, little warm and less painful. TX: ice and TYLENOL.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient developed a rash all over his back. Nurse at his college student health service administered 50mg BENADRYL
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Electrocardiogram, Lip swelling, Loss of consciousness
Clinical narrative: Hx of having passed out for about 1-2 minutes 29 hrs after flu vaccine was given and her lips also swollen at that time.
Sex: M
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Dizziness after flu shot. Pt denied SOB/hard time breathing/chest pain.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Immediate post-injection reaction, Joint range of motion decreased, Pain
Clinical narrative: Soreness immediately after shot was given, increasing over the course of a month, decreased range of motion, weakness. Treatment: cortisone injection on 11/20/14, Dr.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The medical assistant reported the patient was administered a first dose of PNEUMOVAX23 (0.5 ml, intramuscular) on 18-APR-2014, and was inadvertently administered a second dose of PNEUMOVAX23 (0.5 ml, intramuscular) on 02-DEC-2014. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On an unknown date the patient was vaccinated with expired dose of PNEUMOVAX 23 (lot number, dose and route unspecified). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site mass, Injection site pain, Injection site vesicles
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 86 year old male patient. The patient's pertinent medical history and concurrent conditions were not reported. The patient had no known drug reactions and allergies. On 14-NOV-2014, the patient was subcutaneously vaccinated with ZOSTAVAX (lot # K010647, exp. date 30-OCT-2015, dose: 0.65ml, anatomical location was not reported). Concomitant therapies included allopurinol and enalapril maleate (manufacturer unknown). On approximately 22-NOV-2014 (it was reported that the adverse reaction started "3 to 4 days ago") the patient experienced burning at the injection site, redness approximately 2 to 3 inches in radius around the injection site, a blister about the size of a pencil eraser around the site of injection and a lump under the skin at the site of injection. It was also reported, by a pharmacy student that, on an unknown date, approximately in 2014, the patient was officially diagnosed with shingles. The patient did not seek care from his unspecified primary healthcare provider, he reported the events to the pharmacist. No treatment was given for the adverse events, no laboratory tests were performed. The patient did not recover from the adverse events. The relatedness between vaccination with ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: HIBV, PNC13
Symptoms: Crying, Decreased appetite, Injection site erythema, Irritability
Clinical narrative: Approx 2-3 hours after vaccination mother noticed progressive redness on right leg were two of vaccines were given, no fever, baby became very fussy, crying, and less appetite.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of PROQUAD (Merck) (lot # not reported) that were improperly stored. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a female patient of unknown age. It was reported that the patient was late getting her second dose of GARDASIL (reported as inj, dose, route of administration, lot number, expiration date were not reported). No adverse symptom was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a female patient of unknown age (pharmacist) via company representative refers to herself. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, lot# and route of administration were not provided). On an unknown date the patient experienced severe reaction, a rash, on the same arm the product was injected into. Outcome of the event was reported as recovered on unknown date. Relatedness between event and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from an anonymous consumer. He reported that he experienced a rash on both legs after receiving ZOSTAVAX. No further information was provided as the consumer refused to participate in answering questions. No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. On an unknown date the patient was vaccinated with VARIVAX (Merck) inadvertently instead of a dose of ZOSTAVAX. No adverse effects reported. No product quality complaint was involved. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 24 hours after administered area started to itch. There was a hard red swollen area measuring 1 1/2 by 1/2 ay administration area. it was painful, swollen, hard and red for approx 5 days.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 18NOV2014 via a telephone call from a pharmacist regarding a male patient. The pharmacist reported that on 17NOV2014 the patient received a dose of ZOSTAVAX (0.65ml subcutaneous) that underwent a temperature excursion. No adverse event was reported. No further information was provided. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a medical assistant refers to a currently 11 year old patient of unknown gender. On an unknown date the patient was vaccinated with a dose of (Oka/Merck) VARIVAX dose, route, lot # and expiration date were not provided. On an unknown date the patient experienced an unspecified reaction post receipt of (Oka/Merck) VARIVAX. The outcome of the event was not provided. Relatedness between the event and (Oka/Merck) VARIVAX was not reported. This case is linked to MARRS # 1412USA002017 (same patient link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse on 04-NOV-2014 refers to an unspecified number of patient of unknown age and gender. The nurse reported that since 04-NOV-2014 an unknown doses of (Oka/Merck) VARIVAX (injection, route, strength, dose and lot # not reported), which underwent supported temperature excursions, had been administered. No adverse effects was reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information  has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 52 year old female patient. No medical history or concurrent conditions were reported. On 29-NOV-2014, the patient was vaccinated with ZOSTAVAX vial, 0.65 ml dose, subcutaneous route (SQ) in the right arm, (lot # K003602, Exp. Date: 20-MAR-2015). Diluent with lot # K014246; Exp. Date: 11-JUN-2017 was used to reconstitute the ZOSTAVAX. Co-suspect or concomitant therapies were not provided. On 30-NOV-2014, the patient developed pain, swelling and an itchy red rash on her arm at the injection site after receiving ZOSTAVAX. Patient returned to pharmacy for medical attention. No treatment was given for the event. At the time of the report, the outcome of the events was reported as not recovered/not resolved. The causal relationship between ZOSTAVAX and the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4, MMRV, PPV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional (medical assistant) which refers to an unknown number of patients of unknown ages. On an unknown date the patients were vaccinated with GARDASIL, 1 DF. Other suspect therapies included PNEUMOVAX 23, PROQUAD (Merck) and VARIVAX (Merck). Route and indication were not provided. On an unknown date the patients experienced have been administered GARDASIL, PNEUMOVAX, PROQUAD, and VARIVAX that were improperly stored and no adverse effects. No concomitant medication were provided. The outcome of have been administered GARDASIL, PNEUMOVAX, PROQUAD, and VARIVAX that were improperly stored and no adverse effects is unknown. Action taken with the therapy drugs was not reported. No further information were provided.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients might have received improperly stored PROQUAD (Merck) (dose, route, lot# and expiration date were not reported). No adverse effects were reported. No PQC (product quality complaint) was reproted. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Lt deltoid region red; swollen to the touch. Very warm measured 5 x 6. Pain throughout left arm and shoulder area.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with diabetes. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot number, expiration date were not reported). Concomitant therapies included NORCO and BYDUREON. On an unknown date, the patient experienced "full blown" case of shingles after ZOSTAVAX and postherpetic neuropathic pain. The patient sought medical attention - contacted pharmacist. VALTREX was given for treatment for the events. The outcome of "full blown" case of shingles and postherpetic neuropathic pain was reported as not recovered. Relatedness between the events and vaccination with ZOSTAVAX was not reported. Additional information has been requested.