chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema, Febrile convulsion, Immunoglobulin therapy, Indifference, Irritability
Clinical narrative: 9/12/2014: Starting around 9pm, non-stop screaming for over 2 hours. 9/13/2014: Start of stomach aches, leg jerking, very fussy/uncomfortable. Cheeks very red. Irritable, stopped smiling, aloof. 10/8/2014: Visit doctor for stomach aches, continually bringing legs to stomach and slamming down, seemed very uncomfortable. 10/23/2014: First noticed high temp (100.3). Lips appeared very red. Incredibly fussy. 10/25/2014: Hard time breathing, eating, high temp (102). Went to ER. Temp 103.9. Had fever induced seizure. Stopped eating. Body rash began. Cold like symptoms (mild cough, stuffy nose).  10/26/2014: Admitted to hospital. Hard time breathing. Red eyes, cracked and bleeding lips. Very aloof. 10/29/2014: Difficulty breathing, worsening of all symptoms above. Diagnosed as Kawasaki disease. IVIG treatment. 10/31/2014: Hospital discharge. No more fever. 11/3/2014: New rash on arms and legs. Biopsied - rare psoriasi from Kawasaki disease. 11/12/2014: Stridor. Between 11/12/2014 - 12/25/2014: Skin on fingers and toes began peeling, nails pushed out from psoriasis, etc...
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Kawasaki's disease, Lip haemorrhage, Nail disorder, Nasal congestion, Nasopharyngitis
Clinical narrative: 9/12/2014: Starting around 9pm, non-stop screaming for over 2 hours. 9/13/2014: Start of stomach aches, leg jerking, very fussy/uncomfortable. Cheeks very red. Irritable, stopped smiling, aloof. 10/8/2014: Visit doctor for stomach aches, continually bringing legs to stomach and slamming down, seemed very uncomfortable. 10/23/2014: First noticed high temp (100.3). Lips appeared very red. Incredibly fussy. 10/25/2014: Hard time breathing, eating, high temp (102). Went to ER. Temp 103.9. Had fever induced seizure. Stopped eating. Body rash began. Cold like symptoms (mild cough, stuffy nose).  10/26/2014: Admitted to hospital. Hard time breathing. Red eyes, cracked and bleeding lips. Very aloof. 10/29/2014: Difficulty breathing, worsening of all symptoms above. Diagnosed as Kawasaki disease. IVIG treatment. 10/31/2014: Hospital discharge. No more fever. 11/3/2014: New rash on arms and legs. Biopsied - rare psoriasi from Kawasaki disease. 11/12/2014: Stridor. Between 11/12/2014 - 12/25/2014: Skin on fingers and toes began peeling, nails pushed out from psoriasis, etc...
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Ocular hyperaemia, Psoriasis, Pyrexia, Rash, Rash generalised
Clinical narrative: 9/12/2014: Starting around 9pm, non-stop screaming for over 2 hours. 9/13/2014: Start of stomach aches, leg jerking, very fussy/uncomfortable. Cheeks very red. Irritable, stopped smiling, aloof. 10/8/2014: Visit doctor for stomach aches, continually bringing legs to stomach and slamming down, seemed very uncomfortable. 10/23/2014: First noticed high temp (100.3). Lips appeared very red. Incredibly fussy. 10/25/2014: Hard time breathing, eating, high temp (102). Went to ER. Temp 103.9. Had fever induced seizure. Stopped eating. Body rash began. Cold like symptoms (mild cough, stuffy nose).  10/26/2014: Admitted to hospital. Hard time breathing. Red eyes, cracked and bleeding lips. Very aloof. 10/29/2014: Difficulty breathing, worsening of all symptoms above. Diagnosed as Kawasaki disease. IVIG treatment. 10/31/2014: Hospital discharge. No more fever. 11/3/2014: New rash on arms and legs. Biopsied - rare psoriasi from Kawasaki disease. 11/12/2014: Stridor. Between 11/12/2014 - 12/25/2014: Skin on fingers and toes began peeling, nails pushed out from psoriasis, etc...
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Screaming, Skin exfoliation, Stridor
Clinical narrative: 9/12/2014: Starting around 9pm, non-stop screaming for over 2 hours. 9/13/2014: Start of stomach aches, leg jerking, very fussy/uncomfortable. Cheeks very red. Irritable, stopped smiling, aloof. 10/8/2014: Visit doctor for stomach aches, continually bringing legs to stomach and slamming down, seemed very uncomfortable. 10/23/2014: First noticed high temp (100.3). Lips appeared very red. Incredibly fussy. 10/25/2014: Hard time breathing, eating, high temp (102). Went to ER. Temp 103.9. Had fever induced seizure. Stopped eating. Body rash began. Cold like symptoms (mild cough, stuffy nose).  10/26/2014: Admitted to hospital. Hard time breathing. Red eyes, cracked and bleeding lips. Very aloof. 10/29/2014: Difficulty breathing, worsening of all symptoms above. Diagnosed as Kawasaki disease. IVIG treatment. 10/31/2014: Hospital discharge. No more fever. 11/3/2014: New rash on arms and legs. Biopsied - rare psoriasi from Kawasaki disease. 11/12/2014: Stridor. Between 11/12/2014 - 12/25/2014: Skin on fingers and toes began peeling, nails pushed out from psoriasis, etc...
Age: 20.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Wrong drug administered
Clinical narrative: Incorrect immunization given. Patient was given anthrax, instead of Typhoid.
Age: 77.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Joint range of motion decreased, Myalgia, Vaccination complication
Clinical narrative: Muscular pain, decreased ROM on lower extremities.
Age: 0.75
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Nuclear magnetic resonance imaging normal, Partial seizures, Seizure
Clinical narrative: Child had a seizure.ng seizures for the entire month of November he was diagnosed with focal epilepsy.  Child had a normal MRI and CAT scan and does not show any developmental problems.  Epilepsy occurred after flu vaccination.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Erythema, Injected limb mobility decreased, Injection site joint pain
Clinical narrative: This is a spontaneous report from a contactable nurse. A 75-year-old female patient received PREVNAR 13 (lot number J20348, expiry date 31May2016, NDC: 0005-1971-02) on 26Mar2015, intramuscular, in left deltoid, at 0.5 ml single. No other vaccines were given that day or within four weeks prior. Medical history included ongoing osteoporosis diagnosed sometime before 2013, ongoing hyperlipidemia diagnosed sometime before 2013 and allergies to sulfa. Concomitant medications included lovastatin tablets for cholesterol at 20 mg, 1x/day nightly and oral colestipol for cholesterol at 5 g, 2x/day. On 26Mar2015 the patient experienced migratory polyarthritis. Patient did not go to the Emergency room, but did call the doctor and was treated with medications including ibuprofen. On unknown date she experienced joint swelling/accompanied by swelling and redness, fever, chills, her arm was very sore at the injection site. On an unspecified date in Mar2015 she could barely move. The events were described as follows. The event migratory polyarthritis started off with intermittent migratory joint pain that began in the left shoulder two hours after receiving the vaccination. It was migratory to the right shoulder within 24 hours. The initial site (left shoulder) resolved with migration to the other (right) shoulder, then involved the left hand. The right shoulder resolved and then it went to the right hand. It has gone to the right foot and ankle. All joints accompanied by swelling and redness during the time of involvement. For the first seven days of the involvement she also had fever and chills, but no other symptoms. The patient called back on 30Mar2015 and talked about the injection site, that her arm was very sore all the way up to the shoulder and she could barely move. She was treated with BENADRYL and ibuprofen with little improvement of the pain. She was started on a MEDROL dose pack on 06Apr2015. The patient was going to perform the following investigations: uric acid, rheumatoid factor, sedimentation rate, and ANA panel comprehensive, but they still needed to be collected. The patient was not recovered from migratory polyarthritis. She recovered from fever and chills on unknown date. She was recovering from vaccination site pain. Outcomes of the other reported events were unknown at time of report. According to the reporter there was a reasonable possibility that migratory polyarthritis was related to PREVNAR 13.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Joint swelling, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable nurse. A 75-year-old female patient received PREVNAR 13 (lot number J20348, expiry date 31May2016, NDC: 0005-1971-02) on 26Mar2015, intramuscular, in left deltoid, at 0.5 ml single. No other vaccines were given that day or within four weeks prior. Medical history included ongoing osteoporosis diagnosed sometime before 2013, ongoing hyperlipidemia diagnosed sometime before 2013 and allergies to sulfa. Concomitant medications included lovastatin tablets for cholesterol at 20 mg, 1x/day nightly and oral colestipol for cholesterol at 5 g, 2x/day. On 26Mar2015 the patient experienced migratory polyarthritis. Patient did not go to the Emergency room, but did call the doctor and was treated with medications including ibuprofen. On unknown date she experienced joint swelling/accompanied by swelling and redness, fever, chills, her arm was very sore at the injection site. On an unspecified date in Mar2015 she could barely move. The events were described as follows. The event migratory polyarthritis started off with intermittent migratory joint pain that began in the left shoulder two hours after receiving the vaccination. It was migratory to the right shoulder within 24 hours. The initial site (left shoulder) resolved with migration to the other (right) shoulder, then involved the left hand. The right shoulder resolved and then it went to the right hand. It has gone to the right foot and ankle. All joints accompanied by swelling and redness during the time of involvement. For the first seven days of the involvement she also had fever and chills, but no other symptoms. The patient called back on 30Mar2015 and talked about the injection site, that her arm was very sore all the way up to the shoulder and she could barely move. She was treated with BENADRYL and ibuprofen with little improvement of the pain. She was started on a MEDROL dose pack on 06Apr2015. The patient was going to perform the following investigations: uric acid, rheumatoid factor, sedimentation rate, and ANA panel comprehensive, but they still needed to be collected. The patient was not recovered from migratory polyarthritis. She recovered from fever and chills on unknown date. She was recovering from vaccination site pain. Outcomes of the other reported events were unknown at time of report. According to the reporter there was a reasonable possibility that migratory polyarthritis was related to PREVNAR 13.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Polyarthritis, Pyrexia, Swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. A 75-year-old female patient received PREVNAR 13 (lot number J20348, expiry date 31May2016, NDC: 0005-1971-02) on 26Mar2015, intramuscular, in left deltoid, at 0.5 ml single. No other vaccines were given that day or within four weeks prior. Medical history included ongoing osteoporosis diagnosed sometime before 2013, ongoing hyperlipidemia diagnosed sometime before 2013 and allergies to sulfa. Concomitant medications included lovastatin tablets for cholesterol at 20 mg, 1x/day nightly and oral colestipol for cholesterol at 5 g, 2x/day. On 26Mar2015 the patient experienced migratory polyarthritis. Patient did not go to the Emergency room, but did call the doctor and was treated with medications including ibuprofen. On unknown date she experienced joint swelling/accompanied by swelling and redness, fever, chills, her arm was very sore at the injection site. On an unspecified date in Mar2015 she could barely move. The events were described as follows. The event migratory polyarthritis started off with intermittent migratory joint pain that began in the left shoulder two hours after receiving the vaccination. It was migratory to the right shoulder within 24 hours. The initial site (left shoulder) resolved with migration to the other (right) shoulder, then involved the left hand. The right shoulder resolved and then it went to the right hand. It has gone to the right foot and ankle. All joints accompanied by swelling and redness during the time of involvement. For the first seven days of the involvement she also had fever and chills, but no other symptoms. The patient called back on 30Mar2015 and talked about the injection site, that her arm was very sore all the way up to the shoulder and she could barely move. She was treated with BENADRYL and ibuprofen with little improvement of the pain. She was started on a MEDROL dose pack on 06Apr2015. The patient was going to perform the following investigations: uric acid, rheumatoid factor, sedimentation rate, and ANA panel comprehensive, but they still needed to be collected. The patient was not recovered from migratory polyarthritis. She recovered from fever and chills on unknown date. She was recovering from vaccination site pain. Outcomes of the other reported events were unknown at time of report. According to the reporter there was a reasonable possibility that migratory polyarthritis was related to PREVNAR 13.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Insomnia, Pain, Pain in extremity
Clinical narrative: After left arm was down for a period, not easily able to pull up without hurting.  Achy feeling up to shoulder and down pass elbow. Trouble sleeping at night if arm is left in permanent position.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Epicondylitis, Insomnia, Pain, Pain in extremity
Clinical narrative: After left arm was down for a period, not easily able to pull up without hurting.  Achy feeling up to shoulder and down pass elbow. Trouble sleeping at night if arm is left in permanent position.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Exposure during pregnancy, Pregnancy test positive, Uterine dilation and curettage
Clinical narrative: This spontaneous retrospective pregnancy report as received from a nurse practitioner refers to an approximately 16 year old female patient. No medical history and current conditions were reported. On 03-FEB-2015 patient was given an unspecified pregnancy test which came back negative. On 03-FEB-2015 (reported as on the same visit) the patient was vaccinated with first dose of GARDASIL (lot # J012212, expiry: 18-FEB-2016) (dosing regimen and frequency unknown). It was also reported the product was confirmed as GARDASIL and not GARDASIL 9. No concomitant medications were reported. On 25-FEB-2015, the patient came back to office due to lack of menstrual period and suspicion of pregnancy and the patient underwent another unspecified pregnancy test which came back positive. The nurse reported that at that time it had been 6 weeks since the patient's last menstrual period. The patient became pregnant with Last Menstrual Period of 14-JAN-2015 and Estimated Date of Delivery of 21-OCT-2015. The date of conception was 28-JAN-2015. Nurse practitioner reported that the patient was then seen at an unspecified medical center on 01-APR-2015 due to miscarriage, where an outpatient Uterine dilation and curettage was performed. It was reported that the patient sought medical attention. The action taken with the therapy with GARDASIL was unknown. The outcome of the events was unknown. The reporter causality was not provided. No product quality complaint was involved. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Pain
Clinical narrative: Vaccine administered into bursa. Pt has had recurring pain and received a cortisone injection. Pain resolved, but in pain again now. Hurts to lift arm.
Sex: M
Vaccine: HEP, HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. The patient had completed both VAQTA, (dose, lot # and route not reported) and RECOMBIVAX HB (dose, lot # and route not reported) series on an unspecified date. On 08-APR-2015, the patient was inadvertently vaccinated with an extra dose of both VAQTA, (dose, lot#, expiration date, route and injection site were not reported) and RECOMBIVAX HB, (dose, lot#, expiration date, route and injection site were not reported). This is one of several reports received from the same reporter. No adverse effects were reported. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Abdominal pain upper, Bedridden, Fatigue, Pain, Pyrexia
Clinical narrative: Information has been received from a father referring to his 14 year old son. The patient had no pertinent medical history and no drug reactions/allergies. On 17-APR-2015 the patient was vaccinated with dose 1 of GARDASIL (lot#, route and dose unknown). There was no concomitant medication. On 19-APR-2015 the patient experienced stomach aches, fever, being tired, unspecified aches, and being bed ridden after received GARDASIL. The reporter could not confirm whether the vaccines was GARDASIL or GARDASIL 9. There was no treatment and no lab given to the event. The therapy was reported as continued and patient did not seek medical attention. The outcome of the events was reported as not recovered/not resolved. No PQC involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever. Muscle aches.
Age: 42.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Received flu vaccine (R) deltoid and since has had acute (R) arm and (R) shoulder pain.
Age: 42.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Received flu vaccine (R) deltoid and since has had acute (R) arm and (R) shoulder pain.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Dyskinesia, Electroencephalogram normal
Clinical narrative: Pt began with right shoulder shrugging and has continued. Seen at ER 4/17/2015. Episodes are currently 1-2 times per hour, was >40 times per day. No episodes known during sleep. Seen by Neurologist, EEG done and within normal limits.
Age: 0.34
Sex: M
Vaccine: HIBV, IPV, PNC13, RV5, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Inflammation, Pain
Clinical narrative: Inflammation, redness, pain.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site reaction, Varicella post vaccine
Clinical narrative: 10-15 varicella lesions on arms, legs, trunk.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: Diarrhoea, Intussusception, Nuclear magnetic resonance imaging, Surgery, Vomiting
Clinical narrative: This spontaneous report as received from a consumer refers to a 5 month old male reporter's grandson. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-APR-2015, the patient was vaccinated with a dose of ROTATEQ (oral, dose, frequency, lot # and expiration date unspecified by the reporter). On 19-APR-2015, the patient developed a diarrhea and vomiting and was hospitalized. On the same day, the patient also received a surgery (reported as "open surgery") for life-threatening intussusception. The patient had not been discharged at the time of this report. The patient was treated with TYLENOL. Lab diagnostics studies included nuclear magnetic resonance imaging (MRI) and an x-ray on an unknown date. Results not provided. The patient sought medical attention and the event intussusception required intervention to prevent serious criteria (medically significant). The outcome of the adverse events was reported as recovering. The relatedness between the adverse events and the vaccination with ROTATEQ was not reported. Additional information has been requested.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: X-ray
Clinical narrative: This spontaneous report as received from a consumer refers to a 5 month old male reporter's grandson. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-APR-2015, the patient was vaccinated with a dose of ROTATEQ (oral, dose, frequency, lot # and expiration date unspecified by the reporter). On 19-APR-2015, the patient developed a diarrhea and vomiting and was hospitalized. On the same day, the patient also received a surgery (reported as "open surgery") for life-threatening intussusception. The patient had not been discharged at the time of this report. The patient was treated with TYLENOL. Lab diagnostics studies included nuclear magnetic resonance imaging (MRI) and an x-ray on an unknown date. Results not provided. The patient sought medical attention and the event intussusception required intervention to prevent serious criteria (medically significant). The outcome of the adverse events was reported as recovering. The relatedness between the adverse events and the vaccination with ROTATEQ was not reported. Additional information has been requested.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: Intussusception, Malaise, Surgery
Clinical narrative: This spontaneous report as received from a consumer refers to a 5 month old male reporter's grandson. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-APR-2015, the patient was vaccinated with a dose of ROTATEQ (oral, dose, frequency, lot # and expiration date unspecified by the reporter). On 19-APR-2015, the patient developed a diarrhea and vomiting and was hospitalized. On the same day, the patient also received a surgery (reported as "open surgery") for life-threatening intussusception. The patient had not been discharged at the time of this report. The patient was treated with TYLENOL. Lab diagnostics studies included nuclear magnetic resonance imaging (MRI) and an x-ray on an unknown date. Results not provided. The patient sought medical attention and the event intussusception required intervention to prevent serious criteria (medically significant). The outcome of the adverse events was reported as recovering. The relatedness between the adverse events and the vaccination with ROTATEQ was not reported. Additional information has been requested.
Age: 0.37
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Local reaction, Vaccination site reaction
Clinical narrative: Pt came back crying. Provider look at where. Vaccine were given. Local reaction on left leg where vaccine given. Give TYLENOL in office has at tomorrow.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Atrial fibrillation, Catheterisation cardiac normal, Chest pain, Electrocardiogram normal, Muscular weakness
Clinical narrative: Arm weakness leg weakness chest pain walk only by use of walker-began 6-8 hrs. after shot. Went to hospital with heart attack (A Fib). Spent 5 days in the hospital.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Myocardial infarction, Nuclear magnetic resonance imaging normal, Walking aid user, X-ray normal
Clinical narrative: Arm weakness leg weakness chest pain walk only by use of walker-began 6-8 hrs. after shot. Went to hospital with heart attack (A Fib). Spent 5 days in the hospital.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 4-18-15 pt called pharmacy stating she had redness and swelling at injection site that had been getting bigger since receiving shot on 4-13-15. Rph told pt to stop by a clinic, MD or rph to show someone that would advise her or to take BENADRYL, ibuprofen, use ice until seen. 4-19-15 pt went to hospital emergency room and got BACTRIM DS and KEFLEX.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Rash, Rash pruritic
Clinical narrative: C/O "50 cent piece" size, raised, itchy rash just above belt line on his abdomen-started on Sun. 4/19/15. Also c/o backache at same time, but was doing manual labor over the weekend also. I referred him to his doctor for eval.
Age: 11.0
Sex: F
Vaccine: HEP, HEPA, MNQ, TDAP
Symptoms: Amnesia, Computerised tomogram head normal, Face injury, Fall, Head injury
Clinical narrative: Pt apparently fell off exam table after vaccines given, and hit face/head. No loss of consciousness. Pt observed 20 min, discharged home. Went to ER that night for memory loss, CT negative. Exam normal.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Breath holding, Crying
Clinical narrative: Episode of crying for 30-40 min, hard to console, almost breath holding.
Age: 1.02
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Exposure to communicable disease, Varicella post vaccine
Clinical narrative: Had VARIVAX #1 on 8/16/12. Went to another country and exposed to chicken pox by family member there. (2 wks ago). Came in to office on 4/17/15 with 14 pox.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Injection site bruising, Injection site mass, Local swelling
Clinical narrative: Pt received MMR booster 4/17/15, pt returned to office today 4/21/15 for Tdap vaccine. She mentions that her right arm where MMR booster was injected has "a lump and feels bruised". Area on back of right arm shows 2cm raised area, surrounded by 5cm redness.
Age: 1.68
Sex: F
Vaccine: DTAP, MMR
Symptoms: Rash
Clinical narrative: Rash shotty posterior cervical nodes bilaterally.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong technique in drug usage process
Clinical narrative: Pt was given diluent only: the vaccine was not added to the syringe. Then patient was given the vaccine correctly after the error was discovered.
Age: 46.0
Sex: M
Vaccine: FLUN4
Symptoms: Arthralgia, Asthenia, Malaise, Sinus congestion, Sinus headache
Clinical narrative: Received Flu vax nasal beginning of October. Have had severe sinusitis ever since. Had subsequent sinus infection - 2 courses of Abx. As of today Dec 10 2014, I am still dealing with sinus pain, congestion. Also have had weakness, joint pain and malaise the entire time.
Age: 46.0
Sex: M
Vaccine: FLUN4
Symptoms: Sinusitis
Clinical narrative: Received Flu vax nasal beginning of October. Have had severe sinusitis ever since. Had subsequent sinus infection - 2 courses of Abx. As of today Dec 10 2014, I am still dealing with sinus pain, congestion. Also have had weakness, joint pain and malaise the entire time.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong technique in drug usage process
Clinical narrative: Patient was given only diluent; the vaccine was not added to the syringe.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given only diluent; the vaccine was not added to the syringe.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Headache, Laboratory test normal, Malaise, Muscle spasms
Clinical narrative: At nite very ill, slept 17 hrs. Legs very weak, headaches, spasms, upper back two weeks of this could hardly make meals. I am still not better. I cant event go food shopping or clean house.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Muscular weakness, Somnolence
Clinical narrative: At nite very ill, slept 17 hrs. Legs very weak, headaches, spasms, upper back two weeks of this could hardly make meals. I am still not better. I cant event go food shopping or clean house.
Age: 20.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to an approximately 20 year old female patient with no medical history. The patient's concurrent conditions included allergy to iodine, shellfish and CEFZIL. On 31-MAR-2015, the patient was inadvertently vaccinated with a single dose of GARDASIL, lot # K009482, expiration date 06-MAR-2017, dose 0.5 ml, intramuscular (administration site was not reported) instead of Tdap, while pregnant. Concomitant therapies included iron (unspecified), minerals (unspecified), vitamins (unspecified) and Tdap. No lab diagnostic studies were performed. No adverse events were reported. The patient became pregnant with Last Menstrual Period (LMP) of approximately 16-SEP-2014 and Estimated Delivery Date (EDD) of 23-JUN-2015. The date of LMP was calculated on basis of gestational age on 31-MAR-2015. Initial exposure to GARDASIL was at third trimester (also reported as 28 weeks). The outcome of the event was not reported. The relatedness between the inadvertent vaccination and GARDASIL was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Apgar score low, Foetal exposure during pregnancy, Stillbirth, Umbilical cord around neck
Clinical narrative: This spontaneous report as received from a registered nurse refers to an approximately 20 year old female patient with no medical history. The patient's concurrent conditions included allergy to iodine, shellfish and CEFZIL. On 31-MAR-2015, the patient was inadvertently vaccinated with a single dose of GARDASIL, lot # K009482, expiration date 06-MAR-2017, dose 0.5 ml, intramuscular (administration site was not reported) instead of Tdap, while pregnant. Concomitant therapies included iron (unspecified), minerals (unspecified), vitamins (unspecified) and Tdap. No lab diagnostic studies were performed. No adverse events were reported. The patient became pregnant with Last Menstrual Period (LMP) of approximately 16-SEP-2014 and Estimated Delivery Date (EDD) of 23-JUN-2015. The date of LMP was calculated on basis of gestational age on 31-MAR-2015. Initial exposure to GARDASIL was at third trimester (also reported as 28 weeks). The outcome of the event was not reported. The relatedness between the inadvertent vaccination and GARDASIL was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 17-APR-2015 the patient was inadvertently vaccinated with expired dose of ZOSTAVAX (dose and route of administration were not reported; lot # K003598 with expiration date: 13-MAR-2015). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an unspecified patients of unknown age and gender. There was no medical history, drug reactions/allergies and concomitant medication provided. On an unknown dates, the unspecified patients were vaccinated with an improperly stored doses of RECOMBIVAX HB (dose, route, lot#, therapy type and expiration date were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an unspecified patients of unknown age and gender. There was no medical history, drug reactions/allergies and concomitant medication provided. On an unknown dates, the unspecified patients were vaccinated with an improperly stored doses of ROTATEQ (route oral, dose, lot # and expiration date were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a 13 year old patient of unknown gender. No current or historical conditions were reported. On 21-APR-2015 (reported as "yesterday"), the patient was vaccinated with improperly stored GARDASIL 0.5 ml, intramuscularly (lot # K001631, expiration date 06-NOV-2016) in unspecified site. It was the second dose of the GARDASIL series for the patient. No adverse effects reported. Additional information is not expected since reporter stated she did not want any adverse event follow correspondence.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye irritation
Clinical narrative: This spontaneous report as received from a 63 year old female patient refers to herself. The patient's medical history included shingles (outbreak was near her eyes) in 2009. On 30-JAN-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number were not reported). On 30-JAN-2013, the patient was still experiencing burning in her eyes. No other symptoms were present. The patient sought medical attention via talking to doctor. There was no treatment given for AE. The outcome of burning sensation in eyes was reported as not recovered. Additional information is not expected, because the physician did not wish to be contacted.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Blood test, Fatigue, Injection site erythema
Clinical narrative: Information has been received from a 69 year old female patient concerning herself with breast cancer. The patient had a triple bypass heart surgery five years ago in approximately MAR-2010. The patient had no drug reaction/allergies. On 26-FEB-2015 the patient was vaccinated with ZOSTAVAX, subcutaneously in her right arm (dose, frequency and lot# were not reported). Concomitant therapies included metoprolol. On 27-FEB-2015 (reported as 24 hours later), the patient developed redness, swelling and pain at the injection site. Progressively in the next week, in approximately March 2015, the patient developed fatigue, weakness, muscle and joint pain in her extremities, feet, calves and knees, accompanied with "Charley Horse" cramps in her legs. There was no product quality complaint involved. The patient visited office to seek medical attention. ALEVE was given twice daily for the events, but there was no length of time provided. Quarterly routine blood work was performed on unknown date (no result was reported). The outcome of the events was reported as recovering. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Muscle spasms, Myalgia
Clinical narrative: Information has been received from a 69 year old female patient concerning herself with breast cancer. The patient had a triple bypass heart surgery five years ago in approximately MAR-2010. The patient had no drug reaction/allergies. On 26-FEB-2015 the patient was vaccinated with ZOSTAVAX, subcutaneously in her right arm (dose, frequency and lot# were not reported). Concomitant therapies included metoprolol. On 27-FEB-2015 (reported as 24 hours later), the patient developed redness, swelling and pain at the injection site. Progressively in the next week, in approximately March 2015, the patient developed fatigue, weakness, muscle and joint pain in her extremities, feet, calves and knees, accompanied with "Charley Horse" cramps in her legs. There was no product quality complaint involved. The patient visited office to seek medical attention. ALEVE was given twice daily for the events, but there was no length of time provided. Quarterly routine blood work was performed on unknown date (no result was reported). The outcome of the events was reported as recovering. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown demographics. Pertinent medical history and drug allergies were unspecified. On 23-MAR-2015 the patient was administered with 1 dose of improperly stored (Oka/Merck) VARIVAX, .5 ml, subcutaneous. Concomitant medications were not provided. No adverse effects were reported. Reporting health professional considered the adverse event to be related to (Oka/Merck) VARIVAX. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to a patient of unknown age and gender. There were no medical history and concurrent condition reported. On 21-APR-2015 the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # reported as K025759, Expiration Date 08-JUN-2016, dose and route not provided). There was no concomitant medication reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On unknown dates, the patients were administered with doses of improperly stored GARDASIL (dose, strength, route, lot # unspecified). No adverse effects reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an unspecified patients of unknown age and gender. There was no medical history, drug reactions/allergies and concomitant medication provided. On an unknown dates, the unspecified patients were vaccinated with an improperly stored doses of VAQTA (dose, route, lot # and expiration date were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an 8 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-APR-2015, the patient was inadvertently vaccinated with a dose of GARDASIL, intramuscular (dose, injection site, lot number and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. In June 2009, the patient was vaccinated with the first dose of GARDASIL (lot #, dose and route not reported) and in July 2010, the patient received the second dose of GARDASIL (lot #, dose and route not reported). No adverse effects were reported. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. No information about medical history, concurrent conditions was reported for the patient. On an unknown date the patient was vaccinated with ZOSTAVAX (strength unspecified) dose/frequency 1 single shot. No concomitant therapy was reported. The physician stated that after ZOSTAVAX on an unknown date the patient developed shingles. The outcome of shingles is unknown. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a healthcare worker referring to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On unknown dates, the patients were administered with improperly stored doses of stored GARDASIL (dose strength, route, lot# unspecified). No adverse effects reported. This is one of the several reports received from the same source. 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 registered nurse refers to multiple unspecified patients of unknown ages and gender. No information on patients medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (dose, dose number, route of administration, lot# and expiration date were not reported). No information on patients conconcomitant medication was provided. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
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 gender. No information about medical history, concurrent conditions was reported. On 14-APR-2015 the patient was vaccinated with expired dose of ZOSTAVAX 19400 Plaque Forming units (PFU), dose 0.65 ml, lot # K003602, expiration date 20-MAR-2015, subcutaneously. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. 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 licensed vocational nurse refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with doses of improperly (Merck) VARIVAX (dose numbers, frequency, route of administration, lot# and expiration date were not reported). No information on patients concomitant medication was provided. No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a male patient of unknown age. On an unknown date the patient was vaccinated with a single shot of ZOSTAVAX (lot# and route were not reported). Approximately in 2014 (reported as 1 year ago) the patient developed a rash up his arm after receiving ZOSTAVAX. The patient did not seek medical attention. The outcome of the event was unknown. The relationship between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On unknown dates, the patients were administered with improperly stored doses of VAQTA (dose, strength, route, lot # unspecified). No adverse effects reported. This is one of the several reports received from the same source. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Pain at injection site which has not resolved since the immunization was administered.  Patient reported pain at office visit today (4/27/15) but did not contact any health care provider regarding the ongoing pain in his deltoid.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Erythema, Hypokinesia, Pain, Skin warm
Clinical narrative: Abrupt onset erythema, swelling, warmth, and local pain severe enough to limit movement and daily activities.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: Abrupt onset erythema, swelling, warmth, and local pain severe enough to limit movement and daily activities.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Scar
Clinical narrative: This spontaneous report as received from a patient of unknown demographics refers to themselves. No concurrent conditions or medical history were provided. On an unknown date (reported as: more than a year ago), the patient was vaccinated with a dose of ZOSTAVAX injection (strength, dose, route of administration, lot# and expiry date unspecified) and patient hoped they would never get shingles. No concomitant medications were reported. On 23-MAR-2015 (reported as: of this year), the patient broke out with, according to the patient, a severe case of the shingles. Although the sores had gone away, the consumer left with scarring and was still suffering with the pain at reporting time. The patient reported the pain was unbelievable. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 1.05
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site induration, Injection site mass, Pruritus, Rash
Clinical narrative: Hard lump on left leg near injection site. Has multiple little bumps. Itches.
Age: 19.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Loss of consciousness
Clinical narrative: About 5-10 minutes after receiving vaccination, patient passed out. He has done this in the past when receiving vaccines or shots.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Arthralgia, Chills, Headache, Hypertension
Clinical narrative: Day 1- Pain at injection site. Day 2- Full body joint pain. Day 3- Chills and joint pain. Day 4- Chills and joint pain. Day 5- High BP and headache. Day 6- High BP, headache, stomach pain. Day 7- Stomach pain, head and body ache.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: Day 1- Pain at injection site. Day 2- Full body joint pain. Day 3- Chills and joint pain. Day 4- Chills and joint pain. Day 5- High BP and headache. Day 6- High BP, headache, stomach pain. Day 7- Stomach pain, head and body ache.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Rash generalised
Clinical narrative: Generalized rash over all over body, started on arm opposite of injection site, then goes to other areas and all of the rashes comes and go.  Also had headache Monday night.
Age: 24.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Grip strength decreased, Headache, Injected limb mobility decreased, Injection site erythema, Injection site haemorrhage
Clinical narrative: Fever, H/A, left arm, shoulder, forearm, and hand pain and swelling .1cm X 1.5 cm erythema to left deltoid, small amount of ecchymosis, decreased ROM ot left arm.  Grip strength decreased to 4/5 in left hand.
Age: 24.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Musculoskeletal pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Fever, H/A, left arm, shoulder, forearm, and hand pain and swelling .1cm X 1.5 cm erythema to left deltoid, small amount of ecchymosis, decreased ROM ot left arm.  Grip strength decreased to 4/5 in left hand.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, swelling and pain for 2 days.  Subsided on it's own.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Bursitis, Myalgia
Clinical narrative: Muscle pain but not unexpected for vaccine.  Developed subdeltoid bursitis.
Age: 1.01
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash erythematous, Rash vesicular, Vaccination complication
Clinical narrative: The patient is an 1 year old female. The patient is a healthy 12mo old female infant who received varicella vaccine in addition to MMR and hep B on 01 APR 2015. The MOP reports she initially had typical fever and then did fine. Ten days after receipt she developed a vesicular exanthem, initially only to her face and then yesterday to her trunk. She has approximately 10 vesicles but hundreds of small red spots to all extremities and trunk. She was seen by Dr. at clinic and dx with vaccine induced varicella. She has no known exposure to an active infection and does not attend daycare and has limited exposure to other groups. Her symptoms have now fully resolved.