chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Malaise, Pyrexia, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: On 5/27, I began to break out in red raised bumps on my legs and feet. On 5/28, I felt really lousy. I had a fever of almost 102. The fever lasted one day. I had more of these lesions appear on my hands, legs, arms. I currently have them in various stages (new to drying up) on my feet, legs, torso, hands, arms, neck, face, ears, and scalp...probably about 40 or so total, bilaterally. They are really itchy. I have seen and have had chicken pox before. This is what they look like to me. I contacted my doctor by email. He didn't think they would be related to the vaccine, but I thought I should report it in case this has happened to anyone else.
Age: 61.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Rash vesicular
Clinical narrative: On 5/27, I began to break out in red raised bumps on my legs and feet. On 5/28, I felt really lousy. I had a fever of almost 102. The fever lasted one day. I had more of these lesions appear on my hands, legs, arms. I currently have them in various stages (new to drying up) on my feet, legs, torso, hands, arms, neck, face, ears, and scalp...probably about 40 or so total, bilaterally. They are really itchy. I have seen and have had chicken pox before. This is what they look like to me. I contacted my doctor by email. He didn't think they would be related to the vaccine, but I thought I should report it in case this has happened to anyone else.
Age: 61.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Feeling abnormal, Malaise, Pyrexia, Rash generalised, Rash pruritic
Clinical narrative: On 5/27, I began to break out in red raised bumps on my legs and feet. On 5/28, I felt really lousy. I had a fever of almost 102. The fever lasted one day. I had more of these lesions appear on my hands, legs, arms. I currently have them in various stages (new to drying up) on my feet, legs, torso, hands, arms, neck, face, ears, and scalp...probably about 40 or so total, bilaterally. They are really itchy. I have seen and have had chicken pox before. This is what they look like to me. I contacted my doctor by email. He didn't think they would be related to the vaccine, but I thought I should report it in case this has happened to anyone else.
Age: 61.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Scab, Varicella
Clinical narrative: On 5/27, I began to break out in red raised bumps on my legs and feet. On 5/28, I felt really lousy. I had a fever of almost 102. The fever lasted one day. I had more of these lesions appear on my hands, legs, arms. I currently have them in various stages (new to drying up) on my feet, legs, torso, hands, arms, neck, face, ears, and scalp...probably about 40 or so total, bilaterally. They are really itchy. I have seen and have had chicken pox before. This is what they look like to me. I contacted my doctor by email. He didn't think they would be related to the vaccine, but I thought I should report it in case this has happened to anyone else.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Injection-site reaction. Red rash.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Diarrhoea, Glossodynia, Hyperhidrosis, Rash generalised
Clinical narrative: Sweating, itchy/burning rash over entire body, stinging tongue, diarrhea. Acute onset, better with Benadryl.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash pruritic
Clinical narrative: Sweating, itchy/burning rash over entire body, stinging tongue, diarrhea. Acute onset, better with Benadryl.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site swollen as big as tangerine fruit. Red itchy, headache for two days. Very discomfort from pain.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Injection site swollen as big as tangerine fruit. Red itchy, headache for two days. Very discomfort from pain.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Very soon after administration patient experienced itching around injection site and a sensation down arm and into fingers. I observed at pharmacy and patient went home. Patient took BENADRYL at home. Next day injection site was warm, swollen, red itchy, and hard. Large red circle around injection site.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Sensory disturbance
Clinical narrative: Very soon after administration patient experienced itching around injection site and a sensation down arm and into fingers. I observed at pharmacy and patient went home. Patient took BENADRYL at home. Next day injection site was warm, swollen, red itchy, and hard. Large red circle around injection site.
Age: 29.0
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 29-year-old patient. On 14-APR-2013 the patient was vaccinated with a dose of (merck) PROQUAD (lot#, expiration date and route not reported). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. On 24-MAY-2013 the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot # 1108AA, expiration date 18-MAY-2013 and route not reported). No adverse effect reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site reaction, Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 57-year-old female patient. Current conditions included high cholesterol, allergic to cephalosporin, migraines and allergic to penicillin. The patient's medical history included head injury without seizures. On 22-MAY-2013 the patient was vaccinated with dose 1, ZOSTAVAX (lot # J000853, expiration date 23-APR-2014) (reported as 23-APR-2013) subcutaneously in the right deltoid. Concomitant medications included phenobarbital, COMBIPATCH, pravastatin and IMITREX. On 23-MAY-2013, the patient experienced a welt around the injection site which does not itch but it "hurts" and rash around the injection site. There was no relevant lab data. As of 25-MAY-2013, it was unknown if she would continue to receive ZOSTAVAX or if she experienced a welt. The outcome of the events were unknown. Causality was not reported. This is one of the two reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # J000853 and expiration date 23-APR-2013) injected into her left deltoid. Her relevant medical history, concomitant medications and past drug history were unknown. On 22-MAY-201e the patient experienced rash around the injection site which "hurts like a bee sting". There was no relevant lab data. The outcome of hurts like a bee sting and rash around the injection site was unknown. As of 25-MAY-2013, it was unknown if she would continue to receive ZOSTAVAX or if she experienced a rash. This is second of the two reports received from the same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Atrial fibrillation, Headache, Mass, Pallor, Wheezing
Clinical narrative: Massive Afib reaction which has put me into Afib almost everyday since 5/3/13..that is a month. Put on blood thinners and was necessary to have a TEE and Cardio version.  Local reaction hard lump 4" long that started on 5/1/13.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Atrial fibrillation, Blood test, Cardioversion, Echocardiogram normal, Induration
Clinical narrative: Massive Afib reaction which has put me into Afib almost everyday since 5/3/13..that is a month. Put on blood thinners and was necessary to have a TEE and Cardio version.  Local reaction hard lump 4" long that started on 5/1/13.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Local reaction, Mass
Clinical narrative: Massive Afib reaction which has put me into Afib almost everyday since 5/3/13..that is a month. Put on blood thinners and was necessary to have a TEE and Cardio version.  Local reaction hard lump 4" long that started on 5/1/13.
Age: 0.85
Sex: M
Vaccine: PNC13
Symptoms: Abdominal pain upper, Abnormal behaviour, Crying, Decreased appetite, Depressed mood
Clinical narrative: Patient had on-going fever for +72 hours, diarrhea all that time as well.  Patient then developed severe stomach cramps and appeared extremely nauseous.  He also exhibited fretful sleeping, was lethargic, had sore injection leg and declined using leg for about two days.  He cried often, was irritable often, required loading much more frequently than usual.  He had a poor appetite and decline favorite foods.  He was ill, unhappy and nearly a wholly different baby.
Age: 0.85
Sex: M
Vaccine: PNC13
Symptoms: Diarrhoea, Injection site pain, Irritability, Lethargy, Malaise
Clinical narrative: Patient had on-going fever for +72 hours, diarrhea all that time as well.  Patient then developed severe stomach cramps and appeared extremely nauseous.  He also exhibited fretful sleeping, was lethargic, had sore injection leg and declined using leg for about two days.  He cried often, was irritable often, required loading much more frequently than usual.  He had a poor appetite and decline favorite foods.  He was ill, unhappy and nearly a wholly different baby.
Age: 0.85
Sex: M
Vaccine: PNC13
Symptoms: Nausea, Pyrexia, Sleep disorder
Clinical narrative: Patient had on-going fever for +72 hours, diarrhea all that time as well.  Patient then developed severe stomach cramps and appeared extremely nauseous.  He also exhibited fretful sleeping, was lethargic, had sore injection leg and declined using leg for about two days.  He cried often, was irritable often, required loading much more frequently than usual.  He had a poor appetite and decline favorite foods.  He was ill, unhappy and nearly a wholly different baby.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Laboratory test abnormal, Speech disorder developmental
Clinical narrative: Mom believes patient regressed in speech after MMR given.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Very strong waves of spasm- like pain from shoulder down to elbow and sometimes fingers that lasted to about 6 am the following morning.  Also could not move left arm without very strong pain in shoulder and arm.
Age: 33.0
Sex: F
Vaccine: PNC
Symptoms: Increased upper airway secretion, Injection site pain, Limb discomfort, Productive cough
Clinical narrative: Coughing with production of solid green phlegm from lungs. Coughing began Friday, increasing over past few days. Moderate pain from injection site persists. Unable to raise arm without significant discomfort.
Age: 10.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis.
Age: 10.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Anaphylactic reaction, Dyspnoea, Malaise, Pallor, Skin discolouration
Clinical narrative: Anaphylaxis.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Pain
Clinical narrative: Patient report bilateral aching that has been since his last anthrax shot, which has progressively gotten worse.
Age: 0.35
Sex: M
Vaccine: DTAPH, IPV, PPV, RVX
Symptoms: Rash erythematous
Clinical narrative: Developed small red bumps on thighs shortly after vaccine administration. Has developed more bumps each day since recieving vaccines. Bumps cover entire thigh area. As of 06/02/2013 the rash is still present.
Age: 61.0
Sex: F
Vaccine: TYP, YF
Symptoms: Anti-cyclic citrullinated peptide antibody positive, Arthralgia, Joint swelling, Palindromic rheumatism, Tenderness
Clinical narrative: Pain, swelling, tenderness R wrist developed over a 3-4 hour period, worsened for 8 hours. Was seen by orthopedics, x-rayed and seen by rheumatologist. Treated with steroids. Improved over 24-48 hours with no residue at that time. Since then almost monthly episodes involving wrists, hips and shoulders. Initiation of methotrexate 2 months ago without recurrence: palindromic rheumatism...
Age: 42.0
Sex: F
Vaccine: MEN, PPV
Symptoms: Chills, Hyperhidrosis, Pain, Pyrexia, Wheezing
Clinical narrative: Wheezing in evening, relieved with inhaler, chills and fever onset app. 11 PM, continued through Sunday with low fever, body aches, sweats and chills.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Headache, Neck pain, Pyrexia
Clinical narrative: Severe headache, fever over 101, back and neck pain. It is now 06/02/2013 and I am still experiencing headache, fever, neck and back pain. Living on rotating Tylenol and Ibuprofen.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Fever of 103.8, 3 days after vaccine.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Abnormal behaviour, Poor sucking reflex, Pyrexia
Clinical narrative: We are unsure if this is a cause/effect relationship, but we saw a drastic behavioral change in our 1-year old after vaccination.  The day following his MMR & chickenpox vaccination he would no longer suck on a bottle or a cup.  It seemed like he lost the sucking reflex.  He would chew on a nipple or a cup nozzle, but would not actually suck.  After a couple days we brought him to see a doctor.  The doctor thought he simply was ready to switch from the bottle to a cup, being bored with a bottle.  However, even with using a cup he would not suck.  After about a week of continuing to use cups alone, he starting sucking again on them. He also had a fever following the vaccination.  He seemed to recover from that fairly quickly.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Malaise, Nausea, Pallor
Clinical narrative: Driving home from appt, daughter said she didn't feel well, was cold & felt like throwing up.  I looked at her & she was completely white.  Brought her back to clinic & they said she stressed herself out.  But looking back now I think it was definitely more than that.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via sales representative refers to a 21 year old female patient. On an unknown date the patient was vaccinated with the first GARDASIL (Lot # not reported) (dose, route not reported). No other co suspects were reported. No concomitant therapy was reported. On an unknown date the patient was vaccinated with the first dose of GARDASIL and subsequently fainted and maybe had some seizure activity. The outcome of the patient maybe had some seizure activity and was administered her first dose of GARDASIL and subsequently fainted was unknown. The relation between the events and therapy with GARDASIL was unknown. Upon internal review the patient maybe had some seizure activity was considerd to be other important medical event. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Pt experienced warmth at injection site, redness, and knot. Subsided after 5-7 days with continued improvement - no physician appt required.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Left arm - very large red area, swollen and itchy covering a large part of upper arm and an even redder area in the middle of this area. Started the day after vaccine and still worsening 3 days after.
Age: 0.7
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 35 week old female patient. The pharmacist reported that the patient received her first dose of RECOMBIVAX HB (lot# was not reported, 0.5ml, intramuscular) on 11-MAY-2013 and her second dose of RECOMBIVAX HB (lot# was not reported, 0.5ml, intra-muscular) on 28-MAY-2013. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4, MMR, PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of male and female patients between 0 and 19 years of age. The reporter reported the patients were administered GARDASIL (lot# was not reported) and PNEUMOVAX23 (lot# was not reported) exposed to 31F for a cumulative total of 15 days from 01-APR-2013 to 23-MAY-2013. Other suspect therapies included M-M-R II (lot# was not reported). No adverse events reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a clinical medical assistant to a patient of unknown age and gender. On 30-APR-2013, the patient was vaccinated with ZOSTAVAX 0.65 ml, intramuscular in deltoid (lot number and exportation date were not reported). No information was reported on medical history, drug reaction allergies or concomitant medications. No adverse reaction. The patient sought medical attention in office. Follow up information was received from the medical assistant concerning the male patient. It was reported that vaccine was given intramuscularly (IM) instead of subcutaneously (SQ). There was no adverse event. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Human chorionic gonadotropin positive, Live birth, Maternal exposure before pregnancy
Clinical narrative: Information has been received from a physician, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 21 year old female with no medical history and no drug allergies who on 18-AUG-2011 was vaccinated with VARIVAX (Merck), 0.5 ml (lot # and expired date not reported). There was no concomitant medication. Shortly after receipt of the vaccine, the patient became pregnancy. Her LMP was 02-SEP-2011. Estimated date of delivery was 08-JUN-2012. The patient sought unspecified medical attention. Follow up information was received from a healthcare worker. It was reported that the patient delivered a healthy baby on 24-MAY-2012. More information regarding the baby and the information regarding the delivery was unknown. Additional information is not expected.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 78 year old female patient who was allergic to naproxen 250 mg tablet. On 24-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot # J000436, expiry date 10-APR-2014) (strength, dose, frequency, route and site unspecified). Concomitant medication was unspecified. Patient's pertinent medical history included "lots of medications". On 24-MAY-2013, the patient after receiving the ZOSTAVAX, developed a raised red inflamed area at the injection site. The patient also stated that she developed soreness of her arm. The patient went to the pharmacy for medical attention, and she was informed by pharmacy to use a hydrocortisone cream and to take an unspecified pain reliever for treatment. No laboratory diagnostics studies were performed. The outcome of the events was reported as recovering/resolving. Additional information is not expected.
Age: 55.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Amyotrophic lateral sclerosis, Dysarthria, Fall, Fatigue, Gait disturbance
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of ALS in a 55-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 11 October 2012 the subject received a dose of FLUARIX (.5 cc, unknown route, left deltoid). At an unknown duration of time after vaccination with FLUARIX, described as "symptoms started after vaccination", the subject experienced fatigue and weakness. Within months of vaccination with FLUARIX, the subject experienced ALS. The nurse reported that "symptoms continue to get worse and his prognosis is poor." The healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the events were worse.
Age: 55.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Irritable bowel syndrome, Laboratory test, Lumbar puncture, Muscle twitching, Muscular weakness
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of ALS in a 55-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 11 October 2012 the subject received a dose of FLUARIX (.5 cc, unknown route, left deltoid). At an unknown duration of time after vaccination with FLUARIX, described as "symptoms started after vaccination", the subject experienced fatigue and weakness. Within months of vaccination with FLUARIX, the subject experienced ALS. The nurse reported that "symptoms continue to get worse and his prognosis is poor." The healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the events were worse.
Age: 55.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging, Speech disorder
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of ALS in a 55-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 11 October 2012 the subject received a dose of FLUARIX (.5 cc, unknown route, left deltoid). At an unknown duration of time after vaccination with FLUARIX, described as "symptoms started after vaccination", the subject experienced fatigue and weakness. Within months of vaccination with FLUARIX, the subject experienced ALS. The nurse reported that "symptoms continue to get worse and his prognosis is poor." The healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the events were worse.
Age: 55.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Amyotrophic lateral sclerosis, Asthenia, Fatigue
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of ALS in a 55-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 11 October 2012 the subject received a dose of FLUARIX (.5 cc, unknown route, left deltoid). At an unknown duration of time after vaccination with FLUARIX, described as "symptoms started after vaccination", the subject experienced fatigue and weakness. Within months of vaccination with FLUARIX, the subject experienced ALS. The nurse reported that "symptoms continue to get worse and his prognosis is poor." The healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the events were worse.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old male patient with no pertinent medical history or drug reactions/allergies. On 26-MAy-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # H022152, expired date 18-MAR-2014) subcutaneously. Concomitant therapies included omeprazole (manufacturer unknown), lisinopril (manufacturer unknown), potassium (unspecified), metformin, CARDURA and chlorthalidone. On 29-MAY-2013, the patient developed blisters with full of clear fluid at the injection site, the injection site had a scab and was also red and irritated about the size of silver dollar coin. The patient saw the pharmacist for medical attention. No treatment was given for the adverse events. No lab diagnostics studies was performed. At the time of the report, the patient had not recovered from the events. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site scab, Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old male patient with no pertinent medical history or drug reactions/allergies. On 26-MAy-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # H022152, expired date 18-MAR-2014) subcutaneously. Concomitant therapies included omeprazole (manufacturer unknown), lisinopril (manufacturer unknown), potassium (unspecified), metformin, CARDURA and chlorthalidone. On 29-MAY-2013, the patient developed blisters with full of clear fluid at the injection site, the injection site had a scab and was also red and irritated about the size of silver dollar coin. The patient saw the pharmacist for medical attention. No treatment was given for the adverse events. No lab diagnostics studies was performed. At the time of the report, the patient had not recovered from the events. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Broke out with rash over back and stomach. Itchy and seems to be spreading. Not going to be seen by administering DR until around 6/10/2013.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Rash pruritic, Scab, Scar
Clinical narrative: Broke out with rash over back and stomach. Itchy and seems to be spreading. Not going to be seen by administering DR until around 6/10/2013.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Gastrointestinal disorder, Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to an 81 year old male patient. No information regarding the patient's medical history was provided. On 04-APR-2013 the patient was vaccinated with ZOSTAVAX, subcutaneously. Dose was not provided. Batch/Lot no. was not provided. No concomitant medication was reported. 2 to 3 days after vaccination the patient was presented with a bad case of shingles, reported as the worst shingles the doctor had ever seen. On an unknown date the patient was hospitalized due to paralysis of his gastrointestinal (GI) tract. The patient received treatment (unspecified). The reporter considered these events to be events of significant disability or incapacity. It was reported that the patient recovered (date unknown) or was recovering from the events. No causality assessment was provided. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Deafness neurosensory, Immunodeficiency, Renal transplant, Transplant
Clinical narrative: This spontaneous report as received from a pharmacy student with a doctor of pharmacy degree refers to a 66 year old female patient. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose, route and lot # unknown) at 61 years of age. On an unknown date, the patient had a kidney transplant, became immunocompromised and needed a cochlear transplant following vaccination with PNEUMOVAX23. No treatment was given. The patient contacted pharmacy to seek medical attention. The healthcare student had no other information on the patient's kidney transplant and becoming immunocompromised following vaccination with PNEUMOVAX. The healthcare student reported that the patient was scheduled to have a cochlear transplant, but had no other information about the cochlear transplant. The outcome of the events was unknown. Upon internal review, kidney transplant was considered to be medical significant. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Feeling hot, Throat tightness, Tongue disorder
Clinical narrative: Feeling hot around ears, tongue heavy with tightness back of throat, lightheadedness. Tx: In ER, received SOLUMEDROL and PEPCID.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness and induration surrounding injection site.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: 5-9-13 came to office with 102.7 fever since Tuesday (1 week after vaccines).
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Erythema, Induration, Pain, Pruritus, Skin warm
Clinical narrative: Swelling, redness, itchy, warm to touch, hard to touch. Painful when touched.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Swelling
Clinical narrative: Swelling, redness, itchy, warm to touch, hard to touch. Painful when touched.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, MMR, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient was given an MMR vaccine at 2 months of age.  Patient is fine at this point.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Erythema, Fatigue, Feeling abnormal, Headache
Clinical narrative: Pain in vaccinated arm; raised red welts running across arm and toward armpit; headache, woozy feeling and tiredness; feeling of fever, but no fever.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Pain in vaccinated arm; raised red welts running across arm and toward armpit; headache, woozy feeling and tiredness; feeling of fever, but no fever.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Immediately after HPV injection given pt passed out.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Pruritus, Skin swelling
Clinical narrative: Severe groin pruritus and swelling of the foreskin.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain
Clinical narrative: Shoulder pain from shot but lasted about 10 months per patient before resolved.  Just notified of reaction during routine visit today.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Asthma, Cerebral infarction, Combined immunodeficiency, Cytogenetic analysis abnormal, Dermatitis atopic
Clinical narrative: This spontaneous report was received from a physician concerning an approximately 3 year old male patient. At the time of this report patient was 6 years old. The patient had a normal vaccination history. On an unknown date, when the patient was 12 months old (approximately on an unknown date in 2008), the patient was vaccinated with the first dose of VARIVAX (Merck) (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. The child had no adverse reactions immediately postvaccination after VARIVAX (Merck) or other childhood vaccines. On an unknown date, beginning at age 3, the patient began to experience recurrent skin infections, including herpes simplex at age 3 (unknown date in 2010), another herpes simplex infection at age 4 (unknown date in 2011), and herpes zoster at age 5 (unknown date in 2012). These were each confirmed via diagnostic testing. The child was treated each time with unspecified antiviral therapy and recovered from each episode. In addition to those 3 skin episodes, he also developed atopic dermatitis, eczema, asthma, eosinophilia, pneumonia and pneumatocele on an unknown date. The patient subsequently had an immunological workup and was found to have a rare disorder called DOCK8 immunodeficiency syndrome which was confirmed via genetic testing (date of diagnosis was unknown). It was reported that DOCKS disorder results in severe immunodeficiency. In addition to severe eczema, staphylococcal skin abscesses and pneumonia, patients with this syndrome may also develop cutaneous viral infections with human papilloma virus (HPV), molluscum contagiosum, herpes simplex virus (HSV), and varicella zoster virus (VZV). He indicated that most children with this immunodeficiency do not live past the age of 10 years old. On an unknown date, the physician consulted the patient due to his having neurologic symptoms and being hospitalized (date unspecified). The patient was subsequently diagnosed with VZV vasculopathy. His cerebrospinal fluid (CSF) contained a high level of VZV antibodies. Polymerase chain reaction (PCR) analysis of the CSF revealed it was positive for Oka vaccine strain VZV. The child did not have any skin lesion. A magnetic resonance imaging (MRI) of the brain revealed multiple cerebral infarctions and large cerebral arteries. The patient was treated with unspecified antiviral therapy, and within 1 week, he was completely better. He had no neurologic sequelae and a repeat brain MRI was significantly improved. The patient discharged from the hospital (date unspecified). At the time of reporting, he continued to be very well and fully recovered. The relatedness for the events was unknown for VARIVAX (Merck). Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Dilatation atrial, Eczema, Eosinophilia, Herpes simplex, Herpes zoster
Clinical narrative: This spontaneous report was received from a physician concerning an approximately 3 year old male patient. At the time of this report patient was 6 years old. The patient had a normal vaccination history. On an unknown date, when the patient was 12 months old (approximately on an unknown date in 2008), the patient was vaccinated with the first dose of VARIVAX (Merck) (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. The child had no adverse reactions immediately postvaccination after VARIVAX (Merck) or other childhood vaccines. On an unknown date, beginning at age 3, the patient began to experience recurrent skin infections, including herpes simplex at age 3 (unknown date in 2010), another herpes simplex infection at age 4 (unknown date in 2011), and herpes zoster at age 5 (unknown date in 2012). These were each confirmed via diagnostic testing. The child was treated each time with unspecified antiviral therapy and recovered from each episode. In addition to those 3 skin episodes, he also developed atopic dermatitis, eczema, asthma, eosinophilia, pneumonia and pneumatocele on an unknown date. The patient subsequently had an immunological workup and was found to have a rare disorder called DOCK8 immunodeficiency syndrome which was confirmed via genetic testing (date of diagnosis was unknown). It was reported that DOCKS disorder results in severe immunodeficiency. In addition to severe eczema, staphylococcal skin abscesses and pneumonia, patients with this syndrome may also develop cutaneous viral infections with human papilloma virus (HPV), molluscum contagiosum, herpes simplex virus (HSV), and varicella zoster virus (VZV). He indicated that most children with this immunodeficiency do not live past the age of 10 years old. On an unknown date, the physician consulted the patient due to his having neurologic symptoms and being hospitalized (date unspecified). The patient was subsequently diagnosed with VZV vasculopathy. His cerebrospinal fluid (CSF) contained a high level of VZV antibodies. Polymerase chain reaction (PCR) analysis of the CSF revealed it was positive for Oka vaccine strain VZV. The child did not have any skin lesion. A magnetic resonance imaging (MRI) of the brain revealed multiple cerebral infarctions and large cerebral arteries. The patient was treated with unspecified antiviral therapy, and within 1 week, he was completely better. He had no neurologic sequelae and a repeat brain MRI was significantly improved. The patient discharged from the hospital (date unspecified). At the time of reporting, he continued to be very well and fully recovered. The relatedness for the events was unknown for VARIVAX (Merck). Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Neurological symptom, Nuclear magnetic resonance imaging brain abnormal, Pneumonia, Polymerase chain reaction, Pulmonary pneumatocele
Clinical narrative: This spontaneous report was received from a physician concerning an approximately 3 year old male patient. At the time of this report patient was 6 years old. The patient had a normal vaccination history. On an unknown date, when the patient was 12 months old (approximately on an unknown date in 2008), the patient was vaccinated with the first dose of VARIVAX (Merck) (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. The child had no adverse reactions immediately postvaccination after VARIVAX (Merck) or other childhood vaccines. On an unknown date, beginning at age 3, the patient began to experience recurrent skin infections, including herpes simplex at age 3 (unknown date in 2010), another herpes simplex infection at age 4 (unknown date in 2011), and herpes zoster at age 5 (unknown date in 2012). These were each confirmed via diagnostic testing. The child was treated each time with unspecified antiviral therapy and recovered from each episode. In addition to those 3 skin episodes, he also developed atopic dermatitis, eczema, asthma, eosinophilia, pneumonia and pneumatocele on an unknown date. The patient subsequently had an immunological workup and was found to have a rare disorder called DOCK8 immunodeficiency syndrome which was confirmed via genetic testing (date of diagnosis was unknown). It was reported that DOCKS disorder results in severe immunodeficiency. In addition to severe eczema, staphylococcal skin abscesses and pneumonia, patients with this syndrome may also develop cutaneous viral infections with human papilloma virus (HPV), molluscum contagiosum, herpes simplex virus (HSV), and varicella zoster virus (VZV). He indicated that most children with this immunodeficiency do not live past the age of 10 years old. On an unknown date, the physician consulted the patient due to his having neurologic symptoms and being hospitalized (date unspecified). The patient was subsequently diagnosed with VZV vasculopathy. His cerebrospinal fluid (CSF) contained a high level of VZV antibodies. Polymerase chain reaction (PCR) analysis of the CSF revealed it was positive for Oka vaccine strain VZV. The child did not have any skin lesion. A magnetic resonance imaging (MRI) of the brain revealed multiple cerebral infarctions and large cerebral arteries. The patient was treated with unspecified antiviral therapy, and within 1 week, he was completely better. He had no neurologic sequelae and a repeat brain MRI was significantly improved. The patient discharged from the hospital (date unspecified). At the time of reporting, he continued to be very well and fully recovered. The relatedness for the events was unknown for VARIVAX (Merck). Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Simplex virus test positive, Skin infection, Varicella virus test positive, Viral vasculitis
Clinical narrative: This spontaneous report was received from a physician concerning an approximately 3 year old male patient. At the time of this report patient was 6 years old. The patient had a normal vaccination history. On an unknown date, when the patient was 12 months old (approximately on an unknown date in 2008), the patient was vaccinated with the first dose of VARIVAX (Merck) (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. The child had no adverse reactions immediately postvaccination after VARIVAX (Merck) or other childhood vaccines. On an unknown date, beginning at age 3, the patient began to experience recurrent skin infections, including herpes simplex at age 3 (unknown date in 2010), another herpes simplex infection at age 4 (unknown date in 2011), and herpes zoster at age 5 (unknown date in 2012). These were each confirmed via diagnostic testing. The child was treated each time with unspecified antiviral therapy and recovered from each episode. In addition to those 3 skin episodes, he also developed atopic dermatitis, eczema, asthma, eosinophilia, pneumonia and pneumatocele on an unknown date. The patient subsequently had an immunological workup and was found to have a rare disorder called DOCK8 immunodeficiency syndrome which was confirmed via genetic testing (date of diagnosis was unknown). It was reported that DOCKS disorder results in severe immunodeficiency. In addition to severe eczema, staphylococcal skin abscesses and pneumonia, patients with this syndrome may also develop cutaneous viral infections with human papilloma virus (HPV), molluscum contagiosum, herpes simplex virus (HSV), and varicella zoster virus (VZV). He indicated that most children with this immunodeficiency do not live past the age of 10 years old. On an unknown date, the physician consulted the patient due to his having neurologic symptoms and being hospitalized (date unspecified). The patient was subsequently diagnosed with VZV vasculopathy. His cerebrospinal fluid (CSF) contained a high level of VZV antibodies. Polymerase chain reaction (PCR) analysis of the CSF revealed it was positive for Oka vaccine strain VZV. The child did not have any skin lesion. A magnetic resonance imaging (MRI) of the brain revealed multiple cerebral infarctions and large cerebral arteries. The patient was treated with unspecified antiviral therapy, and within 1 week, he was completely better. He had no neurologic sequelae and a repeat brain MRI was significantly improved. The patient discharged from the hospital (date unspecified). At the time of reporting, he continued to be very well and fully recovered. The relatedness for the events was unknown for VARIVAX (Merck). Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Death, Gallbladder disorder, Nausea
Clinical narrative: Information has been received from a Licensed practical nurse, via a company representative, concerning a 15 year old female patient. On 29-MAR-2013, the patient was vaccinated with the first dose of GARDASIL (dose, route and frequency were not reported) (lot # AE0131; Expiration date was not reported). On 13-SEP-2012, the patient received the second dose of GARDASIL (dose, route and frequency were not reported) (lot # AE0131; Expiration date was not reported), and on 29-MAR-2013, the patient received the third dose of GARDASIL (dose, route and frequency were not reported) (lot #: H015555; Expiration date was not reported). It was reported that in April 2013, shortly after receiving the third dose of GARDASIL, the patient experienced significantly abdominal pain and nausea. The patient sought medical attention through doctor's appointment, and it was determined that the patient would need to have her gallbladder removed. It was reported that surgery was planned at an unspecified time. Also it was reported that the patient discontinued GARDASIL therapy on 29-MAR-2013. It was also reported that the events did not cause significant disability or incapacity. In April 2013, the patient died. It was unknown if autopsy was performed. Cause of death was unknown. At the time of the report, the patient's outcome for abdominal pain, gallbladder disorder and nausea was unknown. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Atelectasis, Blood creatinine increased, Chest X-ray abnormal, Dyspnoea, Erythema
Clinical narrative: 38 y/o M with PMH IDDM, hypertension, asthma, schizophrenia, discharged yesterday from hospital for lactic acidosis, dehydration, fecal retention, was given Pneumonia shot prior to discharge. Went home yesterday, states last evening started experiencing SOB, general body aches and left arm discomfort. States left arm discomfort was severe, is tender to touch with erythema. Given Levaquin 750 mg PO in ER. Noted to have creatinine 1.6, was 1.1 yesterday. CXR shows vascular congestion and small bilateral effusions. Right mid lung subsegmental atelectasis. Last bowel movement yesterday. Currently resting in bed, NAD.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Limb discomfort, Pain, Pleural effusion, Pulmonary vascular disorder, Tenderness
Clinical narrative: 38 y/o M with PMH IDDM, hypertension, asthma, schizophrenia, discharged yesterday from hospital for lactic acidosis, dehydration, fecal retention, was given Pneumonia shot prior to discharge. Went home yesterday, states last evening started experiencing SOB, general body aches and left arm discomfort. States left arm discomfort was severe, is tender to touch with erythema. Given Levaquin 750 mg PO in ER. Noted to have creatinine 1.6, was 1.1 yesterday. CXR shows vascular congestion and small bilateral effusions. Right mid lung subsegmental atelectasis. Last bowel movement yesterday. Currently resting in bed, NAD.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Abscess drainage, Adverse drug reaction, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Per patient she had pain and swelling in the left upper extremity. Patient was informed to apply ice and take Motrin from ER visit on 5/12/13.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Viral infection
Clinical narrative: Per patient she had pain and swelling in the left upper extremity. Patient was informed to apply ice and take Motrin from ER visit on 5/12/13.
Age: 60.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 4 days after vaccination, pt began to have pain at the injection site, left arm.  7 days after the vaccination, pt developed redness, swelling at the injection site with pruritis.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Abasia, Abnormal behaviour, Activities of daily living impaired, Amnesia, Convulsion
Clinical narrative: Vomiting dizzy fainting jerking on right side in pain then she couldn't hardly speak acting crazy at times couldnt walk or feed herself. She got anti-NMDA receptor encephalitis from it and seizures and she Guillain Barre syndrome.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Dizziness, Dyskinesia, Encephalitis autoimmune, Guillain-Barre syndrome, Pain
Clinical narrative: Vomiting dizzy fainting jerking on right side in pain then she couldn't hardly speak acting crazy at times couldnt walk or feed herself. She got anti-NMDA receptor encephalitis from it and seizures and she Guillain Barre syndrome.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Speech disorder, Syncope, Vomiting
Clinical narrative: Vomiting dizzy fainting jerking on right side in pain then she couldn't hardly speak acting crazy at times couldnt walk or feed herself. She got anti-NMDA receptor encephalitis from it and seizures and she Guillain Barre syndrome.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Blood test, Computerised tomogram, Fatigue, Gingival swelling
Clinical narrative: Came down with influenza, after 5 days, never recovered from symptoms, had enlarged lymphnodes, extreme tiredness and painful knots all over body. I have been to oncologist and had CAT scans and blood work, was sent to infectious disease doctor who thinks that all of my side effects stem from flu vaccine that started a severe reaction in my body that has caused inflammation all over.  I still have swollen lymph nodes and sores in my mouth and swollen gums, weight loss, nausea, and abdominal pain.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Influenza, Lymphadenopathy, Nausea, Nodule
Clinical narrative: Came down with influenza, after 5 days, never recovered from symptoms, had enlarged lymphnodes, extreme tiredness and painful knots all over body. I have been to oncologist and had CAT scans and blood work, was sent to infectious disease doctor who thinks that all of my side effects stem from flu vaccine that started a severe reaction in my body that has caused inflammation all over.  I still have swollen lymph nodes and sores in my mouth and swollen gums, weight loss, nausea, and abdominal pain.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Stomatitis, Weight decreased
Clinical narrative: Came down with influenza, after 5 days, never recovered from symptoms, had enlarged lymphnodes, extreme tiredness and painful knots all over body. I have been to oncologist and had CAT scans and blood work, was sent to infectious disease doctor who thinks that all of my side effects stem from flu vaccine that started a severe reaction in my body that has caused inflammation all over.  I still have swollen lymph nodes and sores in my mouth and swollen gums, weight loss, nausea, and abdominal pain.