chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. No medical history was reported. On 13-JUN-2013, the patient was vaccinated with an expired dose of GARDASIL (lot # 668670/0476AA, expiry: 03-JUN-2013) 0.5 ml, intramuscularly. No concomitant medications were reported. No adverse effect reported. This is one of 2 reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15 year old male patient. It was reported that patient received his first dose of GARDASIL (injection, strength, lot#, dose/frequency, route and duration were unspecified) on 10-JUN-2013 and just received a second dose of GARDASIL (injection, strength, lot#, dose/frequency, route and duration were unspecified) today, on 18-JUN-2013. No adverse effect reported. The outcome was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure before pregnancy, Pregnancy test
Clinical narrative: This spontaneous pregnancy report was received from a medical assistant refers to a approximately 19 year old female patient with no drug allergies/reactions. The patient's medical history included hypoglycemia, anemia, ovarian cysts and kidney cysts. The medical assistant reported that after the patient completed the three dose series of GARDASIL (lot# H021346, expiry: 01-OCT-2015)0.5 ml, intramuscularly and became pregnant. The reporter stated the patient received her first dose on an unknown date in November 2012, the second dose one month after (December 2012), and the third dose five months after the second dose (approximately on May 2013). No concomitant medications were reported. The LMP and EDD was not known. The pregnancy outcome was outcome pending. Patient had an unspecified pregnancy test: result not reported. Patient sought medical attention(office visit). Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Urticaria
Clinical narrative: This spontaneous report as received from a 22 year old female Medical Assistant refers to herself with no pertinent medical history. The patient reported that when she took LORTAB (UCB, Inc) and metaxalone (manufacturer unspecified) she got hives. On 30-APR-2013 the patient was vaccinated IM in the right deltoid with the third dose of GARDASIL (dosage and lot # not reported). Concomitant therapies included metformin, amitriptyline hydrochloride, EFFEXOR, SEROQUEL and LOESTRIN. On 30-APR-2013, she had pain at the injection site. The pain started soon after the injection was administered and had been persistent ever since. There was no treatment given for the event. There were no lab diagnostics studies performed. The patient sought medical attention via seeing her unspecified primary care provider. The outcome of pain at the injection site was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 17-JUN-2013 the patient was vaccinated with an expired dose of M-M-R II (lot # 0515AA expiry date 08-APR-2013; strength, dose, route and site unspecified). No adverse effect was reported. The outcome of the event was unknown. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a 72-year-old female patient with no pertinent medical history and no drug reactions or allergies. On 18-JUN-2013 the patient was vaccinated with 0.5 milliliter (ml) (also reported as standard dose) PNEUMOVAX23 (lot # H017759 and expiration date 04-JUL-2014) intramuscularly. Concomitant therapies included ALTACE, calcium, LIPITOR and vitamins (reported as multivitamins). She was reporting that a patient developed redness, swelling and pain at the injection site after receiving a dose of PNEUMOVAX23. The patient was diagnosed with cellulitis. Treatment was rendered for the event. Patient was prescribed with BACTRIM, cold compress and antihistamines. No laboratory diagnostic studies were performed. Patient did not recover from the event. The patient sought medical attention for the events by visiting the doctor. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV2
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. No medical history was reported. on 13-JUN-2013, the patient was vaccinated with an expired dose of GARDASIL (lot # 668670/0476AA, expiry: 03-JUN-2013) 0.5 ml, intramuscularly. No concomitant medications were reported. No adverse effect reported. This is one of 2 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age. On an unknown date (reported as a over year ago), the patient was vaccinated with first dose of GARDASIL (lot number, expiry date and route was not reported). On 19-JUN-2013, the patient was in the office to receive the second dose of GARDASIL (lot number, expiry date and route was not reported). Concomitant medications were not reported. No adverse effects reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Addison's disease, Arthralgia, Asthenia, Bacteraemia, Biopsy lymph gland
Clinical narrative: Symptoms = Serum sickness. Addison's disease, bacteremia, sepsis, pneumonia in both lungs, swollen lymph nodes in chest, neck, underarms, daily chills & fever, rash all over, intense itching, nausea, dizziness, extreme weakness, hunger, swollen hands and feet, extreme joint pain in hands, feet, and knees, thrush, diarrhea. The last 2 weeks he would not eat (no appetite) and his mouth was very painful. There were times when he couldn't think clearly. Most symptoms appeared soon after the vaccine and got worse with time. For the last week, he was too weak to stand for more than a few minutes. Treatment: Steroid shots, prednisone daily, BENADRYL, CLARITIN, anti-itch pills and cream, intravenous antibiotics (VANCOMYCIN, ROCEPHIN, ZITHROMAX, GENTAMYCIN), ZOSYN, ZANTAC, ZOFRAN, oxygen after 5-16-13, breathing treatments, COMBIVENT, SYMBICORT, MAGIC MOUTHWASH. My husband was in the ER 4 times, had 10 doctor visits, and was admitted to the hospital 3 times: 5-10-13 to 5-16-13; 5-21-13 to 5-31-13; 5-31-13 was taken by ambulance to hospital. He was discharged 6-4-13 and he died the next day. On 6-5-13, Dr at hospital inserted a breathing tube and a central line. My husband was to be flown to another hospital when he went into cardiac arrest on the plane and did not survive. Please tell me what happened. On February 8 before he got this vaccine, he was healthy and strong. I hope you will contact me.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Candidiasis, Cardiac arrest, Chills, Cognitive disorder, Death
Clinical narrative: Symptoms = Serum sickness. Addison's disease, bacteremia, sepsis, pneumonia in both lungs, swollen lymph nodes in chest, neck, underarms, daily chills & fever, rash all over, intense itching, nausea, dizziness, extreme weakness, hunger, swollen hands and feet, extreme joint pain in hands, feet, and knees, thrush, diarrhea. The last 2 weeks he would not eat (no appetite) and his mouth was very painful. There were times when he couldn't think clearly. Most symptoms appeared soon after the vaccine and got worse with time. For the last week, he was too weak to stand for more than a few minutes. Treatment: Steroid shots, prednisone daily, BENADRYL, CLARITIN, anti-itch pills and cream, intravenous antibiotics (VANCOMYCIN, ROCEPHIN, ZITHROMAX, GENTAMYCIN), ZOSYN, ZANTAC, ZOFRAN, oxygen after 5-16-13, breathing treatments, COMBIVENT, SYMBICORT, MAGIC MOUTHWASH. My husband was in the ER 4 times, had 10 doctor visits, and was admitted to the hospital 3 times: 5-10-13 to 5-16-13; 5-21-13 to 5-31-13; 5-31-13 was taken by ambulance to hospital. He was discharged 6-4-13 and he died the next day. On 6-5-13, Dr at hospital inserted a breathing tube and a central line. My husband was to be flown to another hospital when he went into cardiac arrest on the plane and did not survive. Please tell me what happened. On February 8 before he got this vaccine, he was healthy and strong. I hope you will contact me.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Diarrhoea, Differential white blood cell count, Dizziness, Dysstasia
Clinical narrative: Symptoms = Serum sickness. Addison's disease, bacteremia, sepsis, pneumonia in both lungs, swollen lymph nodes in chest, neck, underarms, daily chills & fever, rash all over, intense itching, nausea, dizziness, extreme weakness, hunger, swollen hands and feet, extreme joint pain in hands, feet, and knees, thrush, diarrhea. The last 2 weeks he would not eat (no appetite) and his mouth was very painful. There were times when he couldn't think clearly. Most symptoms appeared soon after the vaccine and got worse with time. For the last week, he was too weak to stand for more than a few minutes. Treatment: Steroid shots, prednisone daily, BENADRYL, CLARITIN, anti-itch pills and cream, intravenous antibiotics (VANCOMYCIN, ROCEPHIN, ZITHROMAX, GENTAMYCIN), ZOSYN, ZANTAC, ZOFRAN, oxygen after 5-16-13, breathing treatments, COMBIVENT, SYMBICORT, MAGIC MOUTHWASH. My husband was in the ER 4 times, had 10 doctor visits, and was admitted to the hospital 3 times: 5-10-13 to 5-16-13; 5-21-13 to 5-31-13; 5-31-13 was taken by ambulance to hospital. He was discharged 6-4-13 and he died the next day. On 6-5-13, Dr at hospital inserted a breathing tube and a central line. My husband was to be flown to another hospital when he went into cardiac arrest on the plane and did not survive. Please tell me what happened. On February 8 before he got this vaccine, he was healthy and strong. I hope you will contact me.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Full blood count, Hunger, Lymphadenopathy, Metabolic function test, Nausea
Clinical narrative: Symptoms = Serum sickness. Addison's disease, bacteremia, sepsis, pneumonia in both lungs, swollen lymph nodes in chest, neck, underarms, daily chills & fever, rash all over, intense itching, nausea, dizziness, extreme weakness, hunger, swollen hands and feet, extreme joint pain in hands, feet, and knees, thrush, diarrhea. The last 2 weeks he would not eat (no appetite) and his mouth was very painful. There were times when he couldn't think clearly. Most symptoms appeared soon after the vaccine and got worse with time. For the last week, he was too weak to stand for more than a few minutes. Treatment: Steroid shots, prednisone daily, BENADRYL, CLARITIN, anti-itch pills and cream, intravenous antibiotics (VANCOMYCIN, ROCEPHIN, ZITHROMAX, GENTAMYCIN), ZOSYN, ZANTAC, ZOFRAN, oxygen after 5-16-13, breathing treatments, COMBIVENT, SYMBICORT, MAGIC MOUTHWASH. My husband was in the ER 4 times, had 10 doctor visits, and was admitted to the hospital 3 times: 5-10-13 to 5-16-13; 5-21-13 to 5-31-13; 5-31-13 was taken by ambulance to hospital. He was discharged 6-4-13 and he died the next day. On 6-5-13, Dr at hospital inserted a breathing tube and a central line. My husband was to be flown to another hospital when he went into cardiac arrest on the plane and did not survive. Please tell me what happened. On February 8 before he got this vaccine, he was healthy and strong. I hope you will contact me.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Oedema peripheral, Oral pain, Pneumonia, Pruritus, Pyrexia
Clinical narrative: Symptoms = Serum sickness. Addison's disease, bacteremia, sepsis, pneumonia in both lungs, swollen lymph nodes in chest, neck, underarms, daily chills & fever, rash all over, intense itching, nausea, dizziness, extreme weakness, hunger, swollen hands and feet, extreme joint pain in hands, feet, and knees, thrush, diarrhea. The last 2 weeks he would not eat (no appetite) and his mouth was very painful. There were times when he couldn't think clearly. Most symptoms appeared soon after the vaccine and got worse with time. For the last week, he was too weak to stand for more than a few minutes. Treatment: Steroid shots, prednisone daily, BENADRYL, CLARITIN, anti-itch pills and cream, intravenous antibiotics (VANCOMYCIN, ROCEPHIN, ZITHROMAX, GENTAMYCIN), ZOSYN, ZANTAC, ZOFRAN, oxygen after 5-16-13, breathing treatments, COMBIVENT, SYMBICORT, MAGIC MOUTHWASH. My husband was in the ER 4 times, had 10 doctor visits, and was admitted to the hospital 3 times: 5-10-13 to 5-16-13; 5-21-13 to 5-31-13; 5-31-13 was taken by ambulance to hospital. He was discharged 6-4-13 and he died the next day. On 6-5-13, Dr at hospital inserted a breathing tube and a central line. My husband was to be flown to another hospital when he went into cardiac arrest on the plane and did not survive. Please tell me what happened. On February 8 before he got this vaccine, he was healthy and strong. I hope you will contact me.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised, Red blood cell sedimentation rate, Sepsis, Serum sickness, Urine analysis
Clinical narrative: Symptoms = Serum sickness. Addison's disease, bacteremia, sepsis, pneumonia in both lungs, swollen lymph nodes in chest, neck, underarms, daily chills & fever, rash all over, intense itching, nausea, dizziness, extreme weakness, hunger, swollen hands and feet, extreme joint pain in hands, feet, and knees, thrush, diarrhea. The last 2 weeks he would not eat (no appetite) and his mouth was very painful. There were times when he couldn't think clearly. Most symptoms appeared soon after the vaccine and got worse with time. For the last week, he was too weak to stand for more than a few minutes. Treatment: Steroid shots, prednisone daily, BENADRYL, CLARITIN, anti-itch pills and cream, intravenous antibiotics (VANCOMYCIN, ROCEPHIN, ZITHROMAX, GENTAMYCIN), ZOSYN, ZANTAC, ZOFRAN, oxygen after 5-16-13, breathing treatments, COMBIVENT, SYMBICORT, MAGIC MOUTHWASH. My husband was in the ER 4 times, had 10 doctor visits, and was admitted to the hospital 3 times: 5-10-13 to 5-16-13; 5-21-13 to 5-31-13; 5-31-13 was taken by ambulance to hospital. He was discharged 6-4-13 and he died the next day. On 6-5-13, Dr at hospital inserted a breathing tube and a central line. My husband was to be flown to another hospital when he went into cardiac arrest on the plane and did not survive. Please tell me what happened. On February 8 before he got this vaccine, he was healthy and strong. I hope you will contact me.
Age: 1.29
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Death, Resuscitation, Sepsis
Clinical narrative: This medically confirmed spontaneous report (initial receipt 18-Jun-2013) concerns a female patient approximately 2 years old. Some time in January or February of 2013, the patient developed sepsis and subsequently passed away. The patient had received a flu shot (influenza vaccine, batch and manufacturer unspecified) prior to developing sepsis. The patient had been hospitalised (hospital information and duration unspecified) and CPR (cardiopulmonary resuscitation) had been conducted. The event outcome was fatal. Reporter's comments: The reporter considered events serious due to hospitalisation, intervention to prevent serious criteria (CPR conducted), life threatening events (patient passed away) and death.
Age: 22.0
Sex: F
Vaccine: HPV2
Symptoms: Lip swelling, Swelling face
Clinical narrative: This spontaneous report was received from a medical assistant concerning an approximately 22 year old female patient with asthma and latex gloves allergy. The medical history of the patient included chickenpox and migraines. On 13-JUN-2013, at 4:00 pm, the patient was vaccinated with dose 1 of GARDASIL (lot number and expiry date reported as H021346 and 01-OCT-2015 respectively), intramuscular. Concomitant therapies included contraceptives (unspecified) and vitamins (unspecified) (reported as multivitamins). On 13-JUN2013, by 08:00 pm, her lips and face were swollen. She took BENADRYL with good results. It was reported that there was no shortness of breath. The patient sought medical attention. The patient presented to the office the next day (on 14-JUN-2013) and she was examined. Her upper lip was still slightly swollen. No lab tests were performed. The patient was recovering from the events. The relatedness for the events was unknown for GARDASIL. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Slight swelling, significant itching, large reddened area around injection site. Resolved after 2 days of BENADRYL.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 25 year old female patient with no pertinent medical history and no drug reactions or allergies. Approximately on an unknown date in 1998 (reported as at the age of 10 years old), the patient was vaccinated with dose 1 (Merck) VARIVAX (lot number, expiry date dose and route unspecified) at a clinic or hospital with funds since her was an employee and it was offered for children. There was no concomitant therapy. On an unknown date, the patient had a titer of not immune. The patient sought an unspecified medical attention. The outcome of titer of not immune was unknown. The relatedness for the event was unknown for (Merck) VARIVAX. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Oedema peripheral
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 41 year old female patient with asthma. On 03-JUN-2013 at 2 pm, the patient was vaccinated with PNEUMOVAX 23 intramuscularly into unspecified arm. Concomitant therapies included fluticasone propionate, ADVAIR, ALBUTEROL, CLARITIN and PRILOSEC. The patient reported that on 03-JUN-2013 at 5 pm to 6 pm, the patient experienced significant pain, redness and itching at the injection site. Her vaccinated arm also swelled significantly from her elbow up to and including shoulder. The patient called the office on 04-JUN-2013 to report this and an unspecified nurse instructed her to use ice packs to reduce the swelling. The patient subsequently visited the nurse practitioner at the office on 05-JUN-2013, where she took measurements of the patient's upper arm to determine the significance of the swelling. The unvaccinated arm measured 28.75 cm in diameter and the vaccinated arm measured 30 cm in diameter. The patient stated that her arm fells better than "yesterday" (04-JUN-2013), but she reported on 05-JUN-2013 that she had a mild headache, both frontal and bi-temporal. The nurse practitioner instructed the patient on 05-JUN-2013 to take BENADRYL for the swelling. The outcome of headache, both frontal and bi-temporal is unknown. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site reaction
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning an approximately 75 year old female patient. On 05-JUN-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date unspecified), subcutaneously in the left arm. No concomitant medications were reported. On 07-JUN-2013, the patient experienced a 2 inch wide circle and rash at the injection site. The patient sought medical attention (contacted pharmacist). She was treated with hydrocortisone (over the counter product). The outcome of the events was reported as not resolved. The relatedness for the events was unknown for ZOSTAVAX. Additional information is not expected.
Age: 1.32
Sex: F
Vaccine: DTAP, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: 11 days post MMR DTaP vaccination fever for 4 d and rash.
Age: 24.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Headache, Neck pain, Pyrexia
Clinical narrative: Low grade fever, erythema - below injection site - (P) headache and achy neck. Good muscle strength and tone. Adv Sx relief - ice - elevate and NSAID.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Lymphadenopathy, Pruritus
Clinical narrative: Redness of injection site, swelling of glands, itchiness.
Sex: U
Vaccine: FLUX
Symptoms: Death
Clinical narrative: This case was reported in a literature article and described the occurrence of unknown cause of death in an adult subject of unspecified gender who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of Influenza vaccine unspecified 2011-2012 season (administration site and route unknown, batch number not provided). At an unspecified time after vaccination with Influenza vaccine unspecified 2011-2012, the subject was hospitalised. The subject died from cause undetermined. It was unknown whether an autopsy was performed. Summary of the literature article: Annual influenza vaccine has been recommended for adults at high risk for influenza complications since 1960; universal vaccination has been recommended since 2010. Two recent reviews both reported that there is little evidence to support vaccine effectiveness against serious influenza complications for adults. Clinical trials have been too small to evaluate influenza complications, and most observational studies have not used laboratory-confirmed influenza as an outcome. The case-positive, control-negative study design is an efficient method to determine vaccine effectiveness that assures appropriate classification of cases and identifies controls with risk factors for both acute respiratory illness and propensity to seek medical care similar to those of influenza-positive patients. During the 2011-2012 influenza season, the authors enrolled hospitalized adults with acute respiratory illness and tested each for influenza using reverse transcription polymerase chain reaction. Influenza vaccination was verified in 35% (6/17) of adults with influenza-associated hospitalizations compared to 64% (97/152) of test-negative controls; adjusted vaccine effectiveness was 71.4% (95% confidence interval, 17.1% - 94.9%). Although the authors enrolled subjects with fairly broad eligibility criteria, discharge diagnoses were not associated with either influenza diagnosis or vaccination status. These data are among the first estimates of vaccine effectiveness for the 2011-2012 influenza season. More important, this study adds to the evidence indicating that inactivated influenza vaccine can prevent more than half of all influenza-associated hospitalizations in older adults. Influenza causes an average of 294 128 hospitalizations annually; most are in adults aged. 50 years. The authors's conclusion stated that given current vaccination rates and a vaccine effectiveness of 60%, more than one-third of these hospitalizations could be prevented by increasing vaccination uptake in this population.
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Anxiety, Dyskinesia, Muscle twitching, Pyrexia
Clinical narrative: Around 8pm on date of administration, patient complained of low grade fever and general anxiety accompanied by uncontrolled movement/nervous twitching of one leg. Patient took alprazolam and BENADRYL which seemed to decrease anxiety symptoms.
Age: 54.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Joint swelling, Pain in extremity
Clinical narrative: Pain (Rt) knee and swollen. Both hands and wrists painful. Started 6/14/13. Symptoms improving.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 24 year old patient. It was reported that the patient gets hives when she takes azithromycin (manufacturer unspecified). No pertinent medical history was reported. On 10-JUN-2013 the patient was vaccinated with the first dose of GARDASIL (0.5 ml once, lot # H020002 expiration date 08-AUG-2013), intramuscular for physician recommended. There was no concomitant medication reported. Nurse reported that after the patient received GARDASIL she loss consciousness and was assisted to the floor. Nurse stated that shortly after, when the patient regained consciousness, her blood pressure and pulse were stable and unspecified physician gave her fluids. The patient was called by the nurse next day, 11-JUN-2013, to check on her status. The nurse stated the patient was fine. Present status reported as recovered. There were no laboratories performed. Upon internal review loss of consciousness was considered medical significant. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Red, painful, itchy spot approx. 4 inches in diameter - presented 4 days after administration.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Lacrimation increased, Pruritus, Rash, Throat irritation
Clinical narrative: Patient complains of itchy rash, itchy throat, watery eyes.
Age: 15.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, DTP, MEN
Symptoms: Syncope
Clinical narrative: Syncope x 2.
Age: 15.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, DTP, MEN
Symptoms: Convulsion, Syncope
Clinical narrative: Syncope x 2.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis
Clinical narrative: This spontaneous report as received from a consumer refers to a patient of unknown age who has had joint pain for arthritis. On an unknown date the patient was vaccinated with ZOSTAVAX and the joint pain for arthritis got worst after vaccine was given. Patient outcome was unknown. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning a female patient of unknown age. The patient was in the office on 19-JUN-2013 (also reported as today) to receive her third dose of GARDASIL (lot number and expiry date unspecified), several years after receiving her first and second dose. No concomitant medications were reported. No adverse events were reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Blood glucose, Bradycardia, Electrocardiogram, Hypotension, Syncope
Clinical narrative: Developed syncope within 10 minutes of receiving GARDASIL. Bradycardic and hypotensive.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. No medical history was reported. The patient received dose 1 of GARDASIL (lot #, expiry not reported) on 25-JAN-2013 and dose 2 of GARDASIL (lot #, expiry not reported) on 09-APR-2013. On 12-JUN-2013, the patient was vaccinated with dose 3 of GARDASIL (lot #, expiry not reported). No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Severe local rxn; Swelling; Erythema.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood culture negative, Erythema, Laboratory test normal, Pain, Skin warm
Clinical narrative: Afebrile. Got shingles vaccines on 6/6/13 - (L) arm SQ inject. Sl. redness/soreness which worsened by 6/7/13. Went to MD on 6/8/13 who sent me to ER due to increased erythema/swelling/hot to touch - cellulitis sx. ER visit and given IV ANCEF and labs done. Sent home on KEFLEX 500mg qid x 7 days and f/u MD appt.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Afebrile. Got shingles vaccines on 6/6/13 - (L) arm SQ inject. Sl. redness/soreness which worsened by 6/7/13. Went to MD on 6/8/13 who sent me to ER due to increased erythema/swelling/hot to touch - cellulitis sx. ER visit and given IV ANCEF and labs done. Sent home on KEFLEX 500mg qid x 7 days and f/u MD appt.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Swelling, redness, site was hard with pain hives on stomach and back fine red rash anterior (L) thigh radiates (L) knee.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Swelling, redness, site was hard with pain hives on stomach and back fine red rash anterior (L) thigh radiates (L) knee.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pruritus, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Later in evening 6/18/13 - Red rash increased up (RT) side (thigh), warm to touch, itching at site. Mildly pink erythematous on day ie exam 6/20/13.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Chest pain, Dysphonia, Electrocardiogram normal, Erythema, Full blood count normal
Clinical narrative: Local reaction left upper arm with swelling, redness, induration (approx 10 x 10 cm), pain, sore throat, hoarseness, chest pain.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Induration, Local reaction, Oedema peripheral, Oropharyngeal pain, Pain in extremity
Clinical narrative: Local reaction left upper arm with swelling, redness, induration (approx 10 x 10 cm), pain, sore throat, hoarseness, chest pain.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: (L)O arm - swelling (+), mild itch (+), (-) for pain.
Age: 22.0
Sex: F
Vaccine: TYP
Symptoms: Dizziness, Hypoaesthesia, Nausea, Nervousness, Paraesthesia
Clinical narrative: After 1 hr. of taking oral typhoid, felt shaky, arms numb and tingling, dizzy and nauseous.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site vesicles, Vaccination site induration, Vaccination site swelling
Clinical narrative: 8 x 9 cm swelling with induration at vaccine site no drainage. (+) cluster of vesicles in center of site. (R) lateral upper arm.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Developed redness, sl swelling and skin colored rash to (L) deltoid after hepatitis A vaccine administered. Improved with hydrocortisone cream and oral BENADRYL.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: Localized mild erythema and hive-like swelling. No fevers or pain.
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Migraine, Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a female patient of unknown age. No medical history was reported. Approximately on an unknown date in June 2011 (reported as 2 years ago), the patient was vaccinated with dose 1 of GARDASIL (lot #, expiry not reported). No concomitant medications were reported. The patient was resistant to receiving the second dose of GARDASIL because on an unknown date, the patient experienced severe migraine, fainting and weakness after receiving dose 1 of GARDASIL. The outcome of severe migraine, fainting and weakness was unknown. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Progressive pain, itching, swelling and redness at injection site started 1 hour after injection. Worsening despite Benadryl x 24 hours. After 48 hours, started on Medrol Pak.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Febrile convulsion, Tardive dyskinesia
Clinical narrative: Febrile seizure, lip smacking movements for the next 24 hours.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Feeling hot, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: Pain developed in the left deltoid muscle the shot was administered in.  That evening the pain became EXTREME.  It was a constant pain, not a throbbing pain.  It felt like someone hit me in the deltoid with a baseball bat!  Could not lift the left arm at all, not even an inch because it hurt so much!  That evening developed chills that caused shivers and teeth chattering.  Later became too hot.  Could not sleep that night because of the pain.  The next morning the pain had lessened slightly.  Called the VA clinic and was advised to take Tylenol.  Did that.  Two days later the pain was gone.  Note that I have never had a problem after any other previous immunization.  This one caused extreme pain, chills, then a hot flash.  No other symptoms.
Age: 75.0
Sex: M
Vaccine: TD, VARZOS
Symptoms: Antinuclear antibody negative, Asthenia, Bacterial test negative, Blood culture negative, Blood smear test normal
Clinical narrative: Weakness, fever, chills. Skin rash that spread over body with some pustules. Also in pt. mouth.
Age: 75.0
Sex: M
Vaccine: TD, VARZOS
Symptoms: Borrelia test negative, Central venous catheterisation, Chest X-ray, Chills, Culture throat negative
Clinical narrative: Weakness, fever, chills. Skin rash that spread over body with some pustules. Also in pt. mouth.
Age: 75.0
Sex: M
Vaccine: TD, VARZOS
Symptoms: Influenza virus test negative, Oral pustule, Parasitic test, Platelet count normal, Pyrexia
Clinical narrative: Weakness, fever, chills. Skin rash that spread over body with some pustules. Also in pt. mouth.
Age: 75.0
Sex: M
Vaccine: TD, VARZOS
Symptoms: Rash, Rash generalised, Rash pustular, Urine analysis normal, Varicella virus test negative
Clinical narrative: Weakness, fever, chills. Skin rash that spread over body with some pustules. Also in pt. mouth.
Age: 75.0
Sex: M
Vaccine: TD, VARZOS
Symptoms: Viral test negative
Clinical narrative: Weakness, fever, chills. Skin rash that spread over body with some pustules. Also in pt. mouth.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Fatigue, Headache, Muscular weakness, Pain
Clinical narrative: Headache, tiredness, chills, body aches, muscle weakness.
Age: 55.0
Sex: M
Vaccine: PPV, TD
Symptoms: Chills, Feeling hot, Paraesthesia, Sensory disturbance
Clinical narrative: Began with tingling sensation in fingers then arms felt bloated. Later that evening excruciating pain in body insides felt very hot. Got cold chills. 2 days later still having it.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Injection site erythema, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: Swelling/knotting of the thigh muscles at injection site which lasted more than 3 weeks, redness, soreness, uncontrollable crying for more than two hours, lethargy lasting up to 3 days after injections.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site swelling, Lethargy, Muscle tightness
Clinical narrative: Swelling/knotting of the thigh muscles at injection site which lasted more than 3 weeks, redness, soreness, uncontrollable crying for more than two hours, lethargy lasting up to 3 days after injections.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Fatigue, Headache, Mobility decreased, Myalgia
Clinical narrative: Significant arm pain which made it impossible to move arm, diarrhea, head ache, generalized muscle pain, fatigue.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Significant arm pain which made it impossible to move arm, diarrhea, head ache, generalized muscle pain, fatigue.
Age: 1.17
Sex: F
Vaccine: DTAPHEPBIP, MMR
Symptoms: Dermatitis acneiform, Erythema, Vaccination complication
Clinical narrative: Face was very red like a sunburn.  Then pimple like rash appeared on face and extended down entire body. The rash is still present today (6-21-13).  Mother took child to the doctor yesterday and was told it was a reaction to her MMR vaccine and that rash should go away.  Mother was concerned because rash has been present for over a week and does not look any better.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Death, Pulmonary aplasia
Clinical narrative: Unknown-patient died at home on 5/15/13.  Time of death not indicated on death certificate.  Manner of death indicated as natural and pulmonary aplasia listed as cause of death.
Age: 8.0
Sex: M
Vaccine: DTAP, HEP, HEPA, VARCEL
Symptoms: Oedema peripheral, Pain, Pain in extremity, Pruritus
Clinical narrative: Swelling, pain, pruritis of right arm.  Pain with movement.
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Blindness, Immediate post-injection reaction, Syncope, Vision blurred, Visual impairment
Clinical narrative: Vaccine administered at approximately 10:45 AM At 10:50 AM patient said her sight was blurry and fading out and eventually said she could not see.  This was within a two minute span.  During that two minute span she began fainting (dropping to the point that she had to be carry walked to lay down)  Dr. listened to her heart, took her pulse and the nurse took her blood pressure.  She was communicating the entire time.  She rested for about 5 to ten minutes before we left the doctor's office.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Increase dizziness after vaccination.
Age: 39.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Burning sensation, Glossodynia, Paraesthesia oral, Rash generalised, Urticaria
Clinical narrative: Pt states covered in rash over trunk, feet, ankle, front & back of leg, apex of hip joint, outer edge gluteal area. No rash on genitals. Burning/tingling on cheeks & tongue. Went to ER. Received injections: epinephrine, prednisone, Benadryl & Prilosec. Advised to follow up with allergist. Per pt. rash cleared up when awakened 6/20/13 a.m. Residual 2-3 small hives/near axilla area bilaterally.
Age: 18.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Gaze palsy, Hyperhidrosis, Loss of consciousness, Pallor, Urinary incontinence
Clinical narrative: Client in to receive vaccine for college. Gardasil/ Varicella given to Right upper extremity. Writer immediately noticed clients eyes waddled to the side as he passed out. Writer shook client to establish consciousness and his eyes immediately opened. Color pale. Supervisor notified at this time. Incontinent bladder episode noted. Code Blue called per intercom system. Skin diaphoretic. O2 per non-rebreather applied. V/S 79/45 52 Sat 100%. Close monitoring per nursing staff. EMS notified @ 11:52 AM. Vitals monitored Q2H until EMS arrived. Per EMS evaluation and patient declined transport to ED for further treatment.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Injection site anaesthesia, Injection site pruritus, Pruritus, Rash
Clinical narrative: Person reports rash to inner thighs with no associated itching. 3 days later individual reports feeling numbness at injection site that travels the length of her left arm to her fingertips with associated itching.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Faint pink rash to inner arms and thighs, itches.
Age: 17.0
Sex: F
Vaccine: YF
Symptoms: Abasia, Acute disseminated encephalomyelitis, Full blood count, Headache, Immunoglobulin therapy
Clinical narrative: Developed fever, inability to walk, vomiting, headache, then ADEM.
Age: 17.0
Sex: F
Vaccine: YF
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging, Pyrexia, Vomiting
Clinical narrative: Developed fever, inability to walk, vomiting, headache, then ADEM.
Age: 1.52
Sex: M
Vaccine: HIBV
Symptoms: Injection site movement impairment
Clinical narrative: Was not able to walk on leg after PCV vaccine.
Age: 4.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Decreased appetite, Headache, Pyrexia
Clinical narrative: Complained of a headache, loss of appetite. Fever of 101 progressed to 102 within an hour.
Age: 0.15
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site rash, Injection site swelling, Rash, Varicella post vaccine
Clinical narrative: Patient woke up with a rash on the spot of the vaccine on her right leg on 06/16. It progressively got worse and raised the next few days until 6/20 she has a few spots on her head, Parent thought they were bug bites until the next afternoon she had broken out everywhere in chicken pox.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral
Clinical narrative: After administration patient noted swelling in lower extremities, which has continued to present.
Age: 31.0
Sex: F
Vaccine: SMALL
Symptoms: Abscess
Clinical narrative: Patient presented to Emergency Room complaints abscess to left shoulder after Smallpox vaccination.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Local reaction
Clinical narrative: Localized reaction, approx. 2 in diameter raised red bump. Treatment: BENADRYL topical cream. Sym decreasing after 24 hr. Still hard lump at injection site. MD's following up.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Loss of consciousness, Rash erythematous
Clinical narrative: Pt passed out about 10-12 min after GARDASIL #1. Also broke out in flat erythematous rash on (L) deltoid and chest, w/c cleared. VS stable. Pt observed x2 hrs due to on and off dizziness and sent home. Call received the day after from grandma (guardian) that she broke her retainer.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site erythema, Injection site rash, Loss of consciousness, Rash erythematous
Clinical narrative: Pt passed out about 10-12 min after GARDASIL #1. Also broke out in flat erythematous rash on (L) deltoid and chest, w/c cleared. VS stable. Pt observed x2 hrs due to on and off dizziness and sent home. Call received the day after from grandma (guardian) that she broke her retainer.
Age: 1.19
Sex: M
Vaccine: HIBV, MMRV, PNC13
Symptoms: Injection site cellulitis, Injection site discolouration, Injection site induration
Clinical narrative: Cellulitis right anterolateral thigh, induration and discolored. Cephalexin 250 mg/5 mL, 6 mL by mouth 2 times daily for 10 days.
Age: 54.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Biopsy skin abnormal, Herpes zoster, Induration
Clinical narrative: February - pt. noticed hardened area. Late April/Early May - pt. had raised area resembling shingles. June - pt. currently undergoing treatment.
Age: 33.0
Sex: F
Vaccine: HEPA
Symptoms: Malaise, Presyncope
Clinical narrative: Patient received injection and within seconds said that she felt unwell. I asked her to stay in pharmacy to monitor her within a few minutes patient said she was feeling worse. I called 911. The medic arrived and monitored her vitals. Medic said no swelling of throat or tongue. Airways were clear. She was given an injection of 25mg diphenhydramine and transported to hospital. Medic thought vasovagal symptoms of psychosomatic reaction to shot.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Laboratory test, Pain, Pyrexia
Clinical narrative: Sore, redness, fever.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Within 24 hrs. noted an enlarged axillary lymph node on the left side, it is tender and has gotten bigger since. No redness, no tenderness at inj. site left deltoid.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient had swelling and itching at injection site approximately 10 min after shot. Applied ice and gave BENADRYL 25mg oral, since no other symptoms of anaphylaxis were present. We monitored patient for 55 minutes, husband took her to Dr to follow up. Called patient 6/25/13 she was fine - still had redness at injection site. No other symptoms.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration
Clinical narrative: Erythema and induration about 3 cm at site of MMRV. Immediate reaction after vaccination, still present 4 days.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt was given a Tdap (ADACEL) at age 10. He will be 11 in 2 mo. Here for 6th grade PE.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis allergic
Clinical narrative: Got an allergic rash on arm and on body - went to Dr. - got prednisone from Dr.
Age: 14.0
Sex: M
Vaccine: HEP, HEPA, HPV4, MNQ
Symptoms: Erythema, Injection site erythema, Injection site swelling, Rash erythematous, Rash macular
Clinical narrative: Swelling to upper arm (L), noticed by patient around 24 hr. To office at 48hr - first time mother has seen. Pt did not know site is red. (L) upper arm with 2 puncture sites of vaccines in deltoid, irregular splotchy, red, firm rash inferior to sites and posteriority with finger of red nearly to elbow. Margins marked KEFLEX only if worse. BENADRYL 50 mg, cool compresses.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Blood glucose normal, Convulsion, Dizziness, Electrocardiogram normal, Nausea
Clinical narrative: Almost immediately after shot, patient got light headed/dizzy. Then started to seize for less than a minute. EMTs called. Took BP 107/85. Patient was then nauseous. EMTs tested blood sugar, HR and BP. Did not have to transport. Will see dr Monday.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Blood glucose normal, Convulsion, Dizziness, Electrocardiogram normal, Immediate post-injection reaction
Clinical narrative: Almost immediately after shot, patient got light headed/dizzy. Then started to seize for less than a minute. EMTs called. Took BP 107/85. Patient was then nauseous. EMTs tested blood sugar, HR and BP. Did not have to transport. Will see dr Monday.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Nausea
Clinical narrative: Almost immediately after shot, patient got light headed/dizzy. Then started to seize for less than a minute. EMTs called. Took BP 107/85. Patient was then nauseous. EMTs tested blood sugar, HR and BP. Did not have to transport. Will see dr Monday.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Redness at sight within the hour. Less than 24 hrs later, swollen thigh, spreading redness. Dx with cellulitis in ER. Treated with oral KEFLEX and BACTRIM. Still with improving but obvious cellulitic sights at 5 days after vaccine in the office.
Sex: U
Vaccine: PPV
Symptoms: Arthralgia, Injection site swelling, Myalgia
Clinical narrative: This spontaneous report as received from a registered nurse regarding an unknown age and gender patient with no pertinent medical history reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot number and expiration date not reported), (0.5 ml, intramuscular, single dose). No other suspect therapies or concomitant medications were reported. On an unknown date the patient experienced arthralgia, myalgia and injection site swelling after she received PNEUMOVAX 23. It was reported that the symptoms "took a week to resolve" and the patient made a full recovery. No treatment information was reported. The reporting nurse did not assess the causality between arthralgia, myalgia and injection site swelling and PNEUMOVAX 23. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 50 year old female patient. On 30-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date was not reported and route was subcutaneous). On 01-MAY-2013, the patient experienced cellulitis after receiving ZOSTAVAX. On 03-MAY-2013, the patient was prescribed BACTRIM as a treatment. The outcome of cellulitis was reported as recovered. The patient sought medical attention. Additional information has been requested.