chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. In 2012, patients were vaccinated with a dose of RECOMBIVAX HB (dose, route and lot number not reported) that was improperly stored. Nurse reported that RECOMBIVAX HB was exposed to temperature as low as -1C for several occasions from January of 2012 to July of 2012. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. No treatment information was reported. At the time of report, patient's outcomes were unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to unspecified number of patients of unknown age and gender. In 2012, patients were vaccinated with a dose of VAQTA (dose, route and lot number not reported) that was improperly stored. Nurse reported that VAQTA was exposed to temperature as low as - 1C for several occasions from January of 2012 to July of 2012. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. No treatment information was reported. At the time of report, patient's outcomes were unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 1.49
Sex: M
Vaccine: HEPA
Symptoms: Needle issue, No adverse event, Syringe issue
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a 17 months old patient who on 25-JUL-2012, was vaccinated with a dose of VAQTA (route and lot number not reported). The licensed practical nurse reported that she was administering VAQTA and the vaccine leaked out between the needle and the syringe when she was administering the product. The nurse clarified that this was not the prefilled syringe, the dose came from a single dose vial. No adverse symptoms were reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 years old female patient with hypercholesterolemia and diabetes and no drug reactions/allergies. The patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (Lot# not reported) subcutaneously into right deltoid on 09-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that at the same date (09-AUG-2012) the patient received ZOSTAVAX, the patient developed soreness and redness at the injection site. The pharmacist reported that the patient presented to the pharmacy yesterday, 12-AUG-2012, to inquire about the injection site reaction, and the pharmacist reported that the injection site was "swollen to the size of a baseball", red, and warm to the touch. The pharmacist also stated that there did not seem to be a rash, but she did say that the red and swollen area looked "rough". The pharmacist did not know if the patient had reported this adverse experience to her prescribing physician. No treatment was given. At the time of reporting, the patient was not recovered. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender who on an unknown date was vaccinated with a dose of (Merck) VARIVAX (dose, route and lot number not reported) that was expired. The vaccine expired on 20-JUL-2011. The patient was not experiencing any known symptoms. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Doctor of osteopathy refers to a patient of unknown age who on an unknown date was vaccinated a dose of VARIVAX (Merck) (dose, route and lot # not reported) instead of ZOSTAVAX. No adverse effect was reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Electroencephalogram normal, Grand mal convulsion, Nuclear magnetic resonance imaging normal
Clinical narrative: Grand Mal seizure.  She has one at the same time every month.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood test, Computerised tomogram, Electroencephalogram, Febrile convulsion, Pyrexia
Clinical narrative: July 31, 2012: Seizures caused by fever, admitted into hospital due to seizures being back-to-back. The hospital had to administer seizure medicine b/c the seizures would not stop on their own.  Hospital ran several teat to make sure it wasnt something additional.  Aug. 27, 2012: red bumps all over back and legs
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Rash erythematous, Urine analysis, X-ray
Clinical narrative: July 31, 2012: Seizures caused by fever, admitted into hospital due to seizures being back-to-back. The hospital had to administer seizure medicine b/c the seizures would not stop on their own.  Hospital ran several teat to make sure it wasnt something additional.  Aug. 27, 2012: red bumps all over back and legs
Age: 74.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: Continuing fever rising to 101.3.
Age: 47.0
Sex: F
Vaccine: FLUX, HEP, HEPA, PPV, TYP
Symptoms: Aphagia, Arthralgia, Asthenia, Body temperature increased, Dizziness
Clinical narrative: All over and joint aches, weakness, nausea, dizzy, sweating, temperature of 101 after Tylenol, unable to eat and redness and heat in a 2 inch raised stripe around my arm. Had the shot not oral where some of these are listed. Felt like/ wanted to die took Tylenol every 3 hours and forced fluids.
Age: 47.0
Sex: F
Vaccine: FLUX, HEP, HEPA, PPV, TYP
Symptoms: Erythema, Feeling abnormal, Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: All over and joint aches, weakness, nausea, dizzy, sweating, temperature of 101 after Tylenol, unable to eat and redness and heat in a 2 inch raised stripe around my arm. Had the shot not oral where some of these are listed. Felt like/ wanted to die took Tylenol every 3 hours and forced fluids.
Age: 47.0
Sex: F
Vaccine: FLUX, HEP, HEPA, PPV, TYP
Symptoms: Pain, Skin warm
Clinical narrative: All over and joint aches, weakness, nausea, dizzy, sweating, temperature of 101 after Tylenol, unable to eat and redness and heat in a 2 inch raised stripe around my arm. Had the shot not oral where some of these are listed. Felt like/ wanted to die took Tylenol every 3 hours and forced fluids.
Age: 1.27
Sex: F
Vaccine: FLUX
Symptoms: Lethargy, Pyrexia
Clinical narrative: EXTREMELY HIGH FEVER. HIGHEST WAS 104.8. VERY LETHARGIC.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Drooling, Headache, Muscular weakness, Pain in extremity
Clinical narrative: Muscle pain left arm and left side Dizziness Generalized muscle weakness Excessive salivation/drooling Moderate continuous throbbing headache Frequent dark odorus urination Symptoms gradually cleared over 72 hours
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Salivary hypersecretion, Urine odour abnormal
Clinical narrative: Muscle pain left arm and left side Dizziness Generalized muscle weakness Excessive salivation/drooling Moderate continuous throbbing headache Frequent dark odorus urination Symptoms gradually cleared over 72 hours
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood immunoglobulin G increased, Blood immunoglobulin M decreased, Pruritus, Urticaria, Varicella virus test positive
Clinical narrative: Patient called on 8/21/12 c/o hives and itching s/p VARIVAX on 8/14/12. Seen in office on 8/22/12 for evaluation. Seen by PA for evaluation. Labs ordered.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Rash
Clinical narrative: Patient developed a large (approximately 5" diameter) rash, and severe flu-like symptoms - she said could barely get out of bed the next day.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Pruritus, Rash, Swelling face
Clinical narrative: Patient reported swelling of lips & face. Itching and rash on skin.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Presyncope
Clinical narrative: Dizziness, near-syncope episode, normal vital signs. No further complications.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling
Clinical narrative: Patient got a flu shot on 8/31/12 and called on 9/1/12 saying she had a red raised area, that was also a little swollen.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a child. The patient was vaccinated with a dose of MMR II (lot# not reported) and expired sterile diluent (lot# G001274, exp May 2012) on approximately 15-AUG-2012 ("within the past week"). No adverse effects were reported. The reporter stated that the MMR II lot was not expired, just the sterile diluent. It was unknown if the patient sought medical attention. Additional information is not expected.
Age: 30.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 30 years old female patient with high blood pressure and aspirin allergies. The patient was vaccinated with PNEUMOVAX23 (vaccination site unknown) (Lot# was reported as H009826) on 09-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 09-AUG-2012 within a couple hours the patient experienced swelling, heat and redness at the injection site. The next day on 10-AUG-2012 the reaction spread around her arm. At the time of reporting, on 13-AUG-2012 the area now felt bruised. The patient had sought medical attention via consulting physician. The patient was treated with ibuprofen, BENADRYL and ice. The outcome was reported as recovering/resolving at the time of reporting. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Contusion, Erythema, Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 30 years old female patient with high blood pressure and aspirin allergies. The patient was vaccinated with PNEUMOVAX23 (vaccination site unknown) (Lot# was reported as H009826) on 09-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 09-AUG-2012 within a couple hours the patient experienced swelling, heat and redness at the injection site. The next day on 10-AUG-2012 the reaction spread around her arm. At the time of reporting, on 13-AUG-2012 the area now felt bruised. The patient had sought medical attention via consulting physician. The patient was treated with ibuprofen, BENADRYL and ice. The outcome was reported as recovering/resolving at the time of reporting. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site warmth, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 30 years old female patient with high blood pressure and aspirin allergies. The patient was vaccinated with PNEUMOVAX23 (vaccination site unknown) (Lot# was reported as H009826) on 09-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 09-AUG-2012 within a couple hours the patient experienced swelling, heat and redness at the injection site. The next day on 10-AUG-2012 the reaction spread around her arm. At the time of reporting, on 13-AUG-2012 the area now felt bruised. The patient had sought medical attention via consulting physician. The patient was treated with ibuprofen, BENADRYL and ice. The outcome was reported as recovering/resolving at the time of reporting. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain, Insomnia, Maternal exposure during pregnancy
Clinical narrative: Extreme pain in arm where shot was administered. Could not sleep because of pain.
Age: 30.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Abdominal distension, Abdominal pain lower, Erythema, Gait disturbance, Oedema peripheral
Clinical narrative: Severe swelling, pain and erythema of leg from knee to lower abdomen. Difficutly with ambulation due to pain.
Age: 30.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Pain in extremity
Clinical narrative: Severe swelling, pain and erythema of leg from knee to lower abdomen. Difficutly with ambulation due to pain.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram, Dysarthria, Full blood count, Neurological examination, VIIth nerve paralysis
Clinical narrative: Bell's Palsy -  Blurred vision, slurred speech, drooping side of face.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Bell's Palsy -  Blurred vision, slurred speech, drooping side of face.
Age: 0.56
Sex: F
Vaccine: DTAPHEPBIP, FLUX, PPV, RVX
Symptoms: Cough, Crying, Feeding disorder neonatal, Insomnia, Pyrexia
Clinical narrative: Runny nose, congestion, cough, fever, inconsolable crying, sleepy but unable to sleep, difficulty drinking bottle due to congestion.
Age: 0.56
Sex: F
Vaccine: DTAPHEPBIP, FLUX, PPV, RVX
Symptoms: Respiratory tract congestion, Rhinorrhoea, Somnolence
Clinical narrative: Runny nose, congestion, cough, fever, inconsolable crying, sleepy but unable to sleep, difficulty drinking bottle due to congestion.
Age: 88.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Erythema and swelling over injection site. Erythema, warmth and pain over large area of upper arm especially over bicep.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Chills, Cough, Fatigue, Nausea
Clinical narrative: Chills, excessive fatigue, runny nose, scratchy throat, sore throat (09/02/12), nausea (intermittent), pain in chest when coughing.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Rhinorrhoea, Throat irritation
Clinical narrative: Chills, excessive fatigue, runny nose, scratchy throat, sore throat (09/02/12), nausea (intermittent), pain in chest when coughing.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Infection, Injection site cellulitis
Clinical narrative: Cellulitis around injection site and entire upper arm. Developed late in the day shots were administered. Patient was seen 9/1/12 and prescribed Cephalexin for infection.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Muscular weakness, Neurological examination normal
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown date. On an unknown date, the patient was vaccinated with the third dose of 0.5 ml GARDASIL (lot# unknown)intramuscular. No other co-suspects were reported. No concomitant medications were reported. On an unknown date, about 2 or 3 days later, the patient experienced numbness and weakness on the inside of the arm she got the shot in and outside of the same arm. The patient had sought medical attention via came into office. The nurse practitioner did a neurological exam on the patient and everything seemed fine. The outcome was unknown. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a current 78 years old female patient with high triglycerides and without drug reactions. The patient was vaccinated with ZOSTAVAX (lot number unknown) on 01-MAR-2010. No other co-suspects were reported. Concomitant medications included TRICOR. In the past few days, in approximate August 2012, the patient developed shingles on her torso after vaccination with ZOSTAVAX. She had seen a dermatologist. Antiviral was given as treatment. The outcome was unknown. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 12 months old male patient with a history of gastroesophageal reflux and no drug allergies. The patient was vaccinated SC, with MMR II (lot # was reported as 0398AA), 0.5ml on 27-JUL-2012. Suspect therapy on the same day included VARIVAX (Merck). Concomitant medications on the same day included HAVRIX, PREVNAR. On 28-JUL-2012 the patient developed fever and measles like rash. The patient had visit the office for medical attention. No lab test was done. No treatment was given. The reporter stated that the patient had fever for 3 days and the rash for 5 days. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a newborn patient of unknown age. The patient was vaccinated with the first dose of RECOMBIVAX HB (0.5mcg/0.5ml, Lot # and expire date unspecified) intramuscularly on 07-AUG-2012 and vaccinated with the second dose of RECOMBIVAX HB "9 days after the first dose of RECOMBIVAX HB on 16-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. No treatment information was reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes virus infection
Clinical narrative: This spontaneous report as received from a consumer refers to his wife, a 63 years old female patient. The patient had none pertinent medical history and none drug allergies. The patient was vaccinated with ZOSTAVAX (lot # reported as "H009779", expiration date March 2013) on 12-AUG-2012. Concomitant medications were reported as none. It was reported that a herpes break out developed on patient's arm after she received the ZOSTAVAX on 13-AUG-2012. The patient sought for medical attention via an office visit. And treatment was given by using antibiotics. The outcome was reported as not recovered. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant C.M.A. refers to a patient of unknown age. The patient was vaccinated subcutaneously with a dose of 0.5 ml (M-M-R II) (lot # 667881/0661Z, expiration date 4-MAY-2012) on 14-AUG-2012. It was reported that it was an expired dose of M-M-R II. No adverse effect was reported. Whether the patient sought for medical attention was not reported. The outcome was unknown. Additional information is not expected.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 9 years old patient. The patient was vaccinated with a dose of 0.5ml PNEUMOVAX 23 (lot # 667914/1067Z, expire date 28-FEB-2012) on 10-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 years old female patient with no drug reactions/allergies. The patient was subcutaneously vaccinated at left arm with 0.65 ml ZOSTAVAX (Lot#/Exp:0363AE/16-MAR-2013) on 07-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that the patient experienced swelling and redness on her left arm, at the injection site after receiving ZOSTAVAX. He stated that the area had the appearance of an "insect bite". The patient had sought medical attention via coming back into the pharmacy. No lab diagnostics studies performed and no treatment was given for the AE. The outcome was reported as not recovered/not resolved. Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Genital herpes, Headache, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician refers to a 58 years old female patient with genital herpes, tinea versicolor, depression, hyperthyroidism, dyslipidemia, simvastatin allergy (MARRS # 1208USA011125) and sulfa allergy. Patient had a history of VZV exposure at elementary school. The patient experienced severe generalized vesicular eruption of chickenpox at age of 20 with no pneumonia when in college. The patient was vaccinated with 0.65 ml ZOSTAVAX (lot # 663178/1414X, expiration date 28-APR-2010) Subcutaneously into left arm on 03-AUG-2012). No other co-suspects were reported. Concomitant medications included: fluoxetine, trazodone hydrochloride, levothyroxine sodium and acyclovir. On 04-AUG-2012 the patient experienced chickenpox-like lesions/papular vesicular rash distributed on arms, legs and trunk. Other systemic symptoms included headache and lightheadedness. The patient also developed severe genital herpes 1 day after vaccine administered. As of the time of the report the patient was still developing new lesions. No treatment information was given. Varicella culture was performed (results not available yet). Maximum temperature of the patient was 99.7 Fahrenheit. The outcome of the events was reported as not recovered. The patient had sought medical attention via office visiting. Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Dizziness, Genital herpes, Headache, Rash papular
Clinical narrative: This spontaneous report as received from a physician refers to a 58 years old female patient with genital herpes, tinea versicolor, depression, hyperthyroidism, dyslipidemia, simvastatin allergy (MARRS # 1208USA011125) and sulfa allergy. Patient had a history of VZV exposure at elementary school. The patient experienced severe generalized vesicular eruption of chickenpox at age of 20 with no pneumonia when in college. The patient was vaccinated with 0.65 ml ZOSTAVAX (lot # 663178/1414X, expiration date 28-APR-2010) Subcutaneously into left arm on 03-AUG-2012). No other co-suspects were reported. Concomitant medications included: fluoxetine, trazodone hydrochloride, levothyroxine sodium and acyclovir. On 04-AUG-2012 the patient experienced chickenpox-like lesions/papular vesicular rash distributed on arms, legs and trunk. Other systemic symptoms included headache and lightheadedness. The patient also developed severe genital herpes 1 day after vaccine administered. As of the time of the report the patient was still developing new lesions. No treatment information was given. Varicella culture was performed (results not available yet). Maximum temperature of the patient was 99.7 Fahrenheit. The outcome of the events was reported as not recovered. The patient had sought medical attention via office visiting. Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular, Skin lesion, Varicella virus test
Clinical narrative: This spontaneous report as received from a physician refers to a 58 years old female patient with genital herpes, tinea versicolor, depression, hyperthyroidism, dyslipidemia, simvastatin allergy (MARRS # 1208USA011125) and sulfa allergy. Patient had a history of VZV exposure at elementary school. The patient experienced severe generalized vesicular eruption of chickenpox at age of 20 with no pneumonia when in college. The patient was vaccinated with 0.65 ml ZOSTAVAX (lot # 663178/1414X, expiration date 28-APR-2010) Subcutaneously into left arm on 03-AUG-2012). No other co-suspects were reported. Concomitant medications included: fluoxetine, trazodone hydrochloride, levothyroxine sodium and acyclovir. On 04-AUG-2012 the patient experienced chickenpox-like lesions/papular vesicular rash distributed on arms, legs and trunk. Other systemic symptoms included headache and lightheadedness. The patient also developed severe genital herpes 1 day after vaccine administered. As of the time of the report the patient was still developing new lesions. No treatment information was given. Varicella culture was performed (results not available yet). Maximum temperature of the patient was 99.7 Fahrenheit. The outcome of the events was reported as not recovered. The patient had sought medical attention via office visiting. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain lower, Chills, Headache, Pyrexia
Clinical narrative: Extreme lower abdominal pain, headache fever 100, chills. Duration 48 hours.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Convulsion, Hyperhidrosis, Muscle contracture, Myoclonus, Pyrexia
Clinical narrative: Generalized myoclonus occurred on the following dates: 7/17, 8/29, 9/01, 9/02. On July 17th I was admitted to the ER with a high fever, soaked in sweat. While being attended by a nurse I began to experience violent muscle convulsions throughout my entire body. The attending physician administered Lorazepam via IV which stopped the convulsions. I followed up with my primary care physician who didn't recommend any additional treatment. The same symptoms reoccurred on 8/20, 9/01, and 9/02. My physician has been on vacation and I have been unable to contact her for the past week during which time I have had 3 episodes of violent convulsions.
Age: 29.0
Sex: F
Vaccine: MMRV
Symptoms: Blood test, Lymphadenopathy, Malaise, Pharyngeal lesion, Pyrexia
Clinical narrative: Malaise & lymph node swelling 2-3 days after MMR & Zoster vaccinations. Fever, morbilliform rash, pharyngeal lesions 21 days after vaccination.
Age: 29.0
Sex: F
Vaccine: MMRV
Symptoms: Rash morbilliform
Clinical narrative: Malaise & lymph node swelling 2-3 days after MMR & Zoster vaccinations. Fever, morbilliform rash, pharyngeal lesions 21 days after vaccination.
Age: 28.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site pain, Injection site warmth, Rash pruritic, Tenderness
Clinical narrative: The rash is described as moderately pruritic and markedly sensitive to touch. Warmth and tenderness surrounding injection site w/ o appearance of cellulitis.
Age: 68.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Injected limb mobility decreased, Injection site discharge, Injection site erythema, Injection site joint effusion
Clinical narrative: 40C temperature, chills, swollen upper arm, deep red upper arm skin, painful triceps, excess fluid around elbow and upper arm, inability to bend or use arm. Fever/chills subsided 8/31/2012 around 3:30 AM. Redness, pain, edema progressively decreased into      09/03/2012. No fever or edema treatment.
Age: 68.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Injection site swelling, Oedema, Pyrexia
Clinical narrative: 40C temperature, chills, swollen upper arm, deep red upper arm skin, painful triceps, excess fluid around elbow and upper arm, inability to bend or use arm. Fever/chills subsided 8/31/2012 around 3:30 AM. Redness, pain, edema progressively decreased into      09/03/2012. No fever or edema treatment.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Rash at injection site. Pain in arm where injection was given.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: A few hours after improper administration technique, had severe pain and loss of range of motion.  Had taken pain medication and NSAIDS as well as cold compress.  After one week of continued pain and decreased ROM, notified my nurse manager.  After two weeks, had been seen at corporate health office.
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Client received Flu vac. at 2:30 PM 8/31/12. On 9/1/12 she noticed a 3 inch area below the bandaid was red and warm. On 9/2/12 she called b/c area was still red. No treatment offered. Told to watch area.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Erythema, rash, pruritis.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hypersensitivity, Paraesthesia oral, Vaccination complication
Clinical narrative: Patient said that her lips felt tingly/funky and that she was having some difficulty breathing. Pharmacist was alerted who assessed the situation and 911 was called. EMT checked out patient and said her pulse ox and vitals were OK and it was up to her if she wanted to go to the ER. Patient went to ER and was told she had an allergic reaction to the flu shot and was discharged later that day.
Age: 7.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Computerised tomogram, Electromyogram, Laboratory test, Lethargy, Listless
Clinical narrative: Listless, lethargic, high temp. vomiting.
Age: 7.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Listless, lethargic, high temp. vomiting.
Age: 72.0
Sex: M
Vaccine: DTAP
Symptoms: Arthropathy, Dyskinesia, Limb injury, Suture insertion
Clinical narrative: Knees buckled, less than 5 minutes; on several separate occasions, involuntary jerking of hands & arms, less than 5 minutes; result on 08/21/2012: 3 fingers into table saw, taken to ER, 30 stitches, several visits to hand therapist.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Few hours after receiving shot - swelling, redness, heat around the whole upper arm, pain.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Reddened area ~3"-4" long ~2" wide warm to touch.
Age: 66.0
Sex: U
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Malaise
Clinical narrative: Patient called complaining of redness that started at ZOSTAVAX inj. site (back of left arm). Started approx. size of penny day of inj. On day 3 pt. says redness is size of silver dollar & complains of generally not feeling well. Instructed pt to see MD. Pt did not want to go today. Wants to follow up Tues.
Age: 6.0
Sex: M
Vaccine: HEPA, VARCEL, VARCEL
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Redness, swelling & fever.
Age: 6.0
Sex: M
Vaccine: HEPA, VARCEL, VARCEL
Symptoms: Cellulitis, Erythema, Infection, Pain, Pruritus
Clinical narrative: Redness, swelling & fever.
Age: 6.0
Sex: M
Vaccine: HEPA, VARCEL, VARCEL
Symptoms: Pyrexia, Swelling
Clinical narrative: Redness, swelling & fever.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Inflammation, Swelling
Clinical narrative: Small raised bump initially, became red, & inflamed to size of silver dollar. Raised area became prominent. BENADRYL treatment site improved later in day.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Injection site erythema
Clinical narrative: Shot administered approx. 5:10 pm on 8/24/12, approx 20 mins later pt. felt to dizzy to drive or walk. Daughter came to pick her up. Pt. sat in waiting area for approx 1 hr. Also had headache in front. After approx. 3 hrs. pt. states HA went away and at 11 pm that night dizziness subsided. Next day noticed 2 inch radius of redness at inj site and gone in the afternoon.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Mass, Oedema peripheral
Clinical narrative: Patient presented 2 days after immunization with swelling and hard mass (small) in her arm. Told to take Ibuprofen & BENADRYL and go to MD if getting worse.
Age: 15.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 15 years old female patient with asthma. The patient was vaccinated with lot # (669796/0840AA) dose 1 GARDASIL, right deltoid and with lot # (669842/0931AA) dose 2 VARIVAX (Merck), SC, left deltoid on 22-DEC-2011 at 15:14. Concomitant medications included HAVRIX and FLUZONE. It was reported that the patient was administered an immunization that was stored at invalid temperatures, the immunization was stored at a temperature of 32 degrees F or less. No adverse reaction occurred. This is one of several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a female consumer refers to herself. The patient was vaccinated with first dose of GARDASIL (lot# not reported) in 2006 and the last two doses in 2012. It was unknown if the patient sought medical attention. The consumer stated her physician stated she did not have to start the series of vaccines. Additional information is not expected.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 14 years old male patient with no illness at time of vaccination and no known drug allergies. The patient was vaccinated with lot # (670048/0963AA) dose 1 GARDASIL, IM, right deltoid on 28-DEC-2011 at 10:14 AM. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient received above vaccine during time of refrigerator failure. Temps found to be <32 degrees. The patient was re-vaccinated due to vaccine compromise. No adverse reaction reported. There was no lab studies performed. This is one of several reports from the same source. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Computerised tomogram, Headache, Road traffic accident
Clinical narrative: This spontaneous report as received from a consumer refers to her 15 years old (reported as "16 years old") daughter with no drug reactions/allergies. The patient was vaccinated with dose 1, 2 and 3, 0.5 ml GARDASIL (lot# not reported) on 03-JUN-2011, 15-AUG-2011 and 27-SEP-2011, respectively. No other co-suspects were reported. Concomitant medications included unspecified headache medication. The consumer reported that around the "second week of September", the patient started to experience headaches. The patient was also involved in an automobile accident on 01-SEP-2011. Ever since "the second week of September", the patient had had a headache every day. The patient had seen a neurologist but the physician had not confirmed a specific diagnosis for the headaches. Unspecified headache medication was given for the adverse event. CAT scans and blood work was performed for the patient. The outcome of automobile accidents is unknown. The outcome of headaches was reported as not recovered/not resolved. The patient believed that the headaches my be due to the administration. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 12 years old female patient with no preexisting allergies, birth defects or medical conditions. The patient was vaccinated with lot # (670048/0963AA) dose 3 GARDASIL, right deltoid on 04-JAN-2012 at 03:39 PM. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient was administered an immunization that was stored at invalid temperatures, the immunization was stored at a temperature of 32 degrees F or less. No adverse reaction occurred. This is one of several reports from the same source. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a other health professional refers to a 12 years old female patient patient with no illness at time of vaccination. The patient was vaccinated with lot # (669796/0840AA) dose 2 GARDASIL, IM on 21-DEC-2011 at 14:34. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient received immunization that was stored at an improper temp <32 degrees. There were not adverse reactions to vaccine. This is one of several reports from the same source. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 year old male patient with no illness at time of vaccination and no known drug allergies. The patient was vaccinated with lot # (670048/0963AA) dose 1 GARDASIL, IM, right deltoid on 28-DEC-2011 at 10:11 AM. No other co-suspects were reported. No concomitant medication were reported. It was reported that the patient received above vaccine during time of refrigerator failure. Temps found to be <32 degrees. The patient was re-vaccinated due to vaccine compromise. No adverse reaction reported. There was no lab studies performed. This is one of several reports from the same source. Additional information is not expected,.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 11 years old female patient with no illness at time of vaccination, no adverse events following prior vaccination and no preexisting allergies, birth defects or medical conditions. The patient was vaccinated with lot # (669796/0840AA) dose 2 GARDASIL, IM. left deltoid on 21-DEC-2011 at 10:07 AM. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient was administered an immunization that was stored at invalid temperatures, the immunization was stored at a temperature of 32 degrees F or less. No adverse reaction occurred. There was no labs diagnostic performed. This is one of several reports from the same source. Additional information is not expected.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an 80 years old male patient. The patient was vaccinated intramuscularly with a 1.0 ml dose of PNEUMOVAX 23 (lot number 1947AA, expiration date 20-OCT-2013) rather than 0.5ml dose on 10-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. It was unspecified if the patient sought medical attention. Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 54 years old female patient with allergy to IV contrast dye and no pertinent medical history. The patient was vaccinated SC with a dose of ZOSTAVAX (lot # not reported) on 22-AUG-2012. No concomitant medications were taken. On 23-AUG-2012 the patient experienced "a red, swollen, warm, and painful area the size of a 5-cent piece at the site of ZOSTAVAX injection." The patient came into the office to seek medical attention. No treatment was given for the events. No laboratory tests were done. The patient's present status is not recovered. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a consumer refers to her 5 years old daughter. The consumer called to reported that her 5 year old daughter received ZOSTAVAX (Lot# and route not reported) instead of VARIVAX (Merck) as a booster to her initial VARIVAX (Merck) injection. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin mass
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a 69 years old female patient. The patient was vaccinated subcutaneously with ZOSTAVAX (lot number unknown) on 12-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. Six days later, on 18-JUL-2012 the patient noticed a lump beneath her skin. The reporter did not specify the size of the lump, but it had been getting smaller. The patient denied rash, itching or pain at the injection site. No treatment was given for adverse event. The patient consulted pharmacist for medical attention. The outcome of lump beneath her skin was reported as recovering. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Biopsy site unspecified abnormal, Borrelia test negative, Henoch-Schonlein purpura, Rash
Clinical narrative: This spontaneous report as received from a 58 years old pharmacist refers to herself with drug reactions/allergies to sulfa and sulfamethoxazole, MICROBID and no pertinent. The patient was vaccinated with a dose of ZOSTAVAX (Lot# not reported) SQ on 29-MAR-2012. No other co-suspects were reported. Concomitant medications included ALTACE, NEXIUM, SYNTHROID and LAMICTAL. The pharmacist was reporting that she was diagnosed with "Henoch Schonlein Purpura" after receiving ZOSTAVAX. She developed "dots" on skins and joint pain on her ankles, feet, hands, and wrists. She was first treated with doxycycline thinking that it might be lyme disease but the blood test was negative. A biopsy was done and it was confirmed that it was Henoch Schonlein Purpura. The patient sought medical attention. Prednisone and cortisone injection were given for treatment. The AE onset date was in April 2012, "within 3 weeks of vaccination". At the time of reporting, the patient was not recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Erythema, Herpes zoster, Hypersensitivity
Clinical narrative: Information has been received from a Licensed Practical Nurse, concerning a 60 year old female patient with coronary artery disease, hypertension, hyperthyroidism, allergy to CIPRO, codeine, DEMEROL, MACROBID and Sulfa(unspecified), who on 14-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck)(Lot #: 6695331/1383Z, Exp: May-2012) (dose and route not reported). Licensed practical nurse reported that on 15-APR-2011, the day after vaccination with ZOSTAVAX (Merck), patient developed swollen joints, chills, painful arms and hands and shingles on her left arm. Prednisone and VALTREX were given as treatment for the events. No lab/diagnostic studies were performed. At the time of the report, the patient's outcome was unknown. Patient sought medical attention through office visit. Follow up information was received from the physician's office concerning the 60 year old female patient with allergies (unspecified) who on 14-APR-2011 was vaccinated into left deltoid with a dose of ZOSTAVAX (Lot #: 6695331/1383Z, Exp: May-2012) (dose and route not reported). On 15-APR-2011, the patient experienced allergy erythema with several minutes of wheezing, serious shaken. The patient also developed myalgia and arthralgia. The patient's symptoms have resolved. The patient was treated with short term prednisone. No lab/diagnostic studies were performed. The events was considered to be serious as an other important medical event as it required medical/surgical intervention to prevent one of the serious criteria. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Myalgia, Pain in extremity, Tremor, Wheezing
Clinical narrative: Information has been received from a Licensed Practical Nurse, concerning a 60 year old female patient with coronary artery disease, hypertension, hyperthyroidism, allergy to CIPRO, codeine, DEMEROL, MACROBID and Sulfa(unspecified), who on 14-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck)(Lot #: 6695331/1383Z, Exp: May-2012) (dose and route not reported). Licensed practical nurse reported that on 15-APR-2011, the day after vaccination with ZOSTAVAX (Merck), patient developed swollen joints, chills, painful arms and hands and shingles on her left arm. Prednisone and VALTREX were given as treatment for the events. No lab/diagnostic studies were performed. At the time of the report, the patient's outcome was unknown. Patient sought medical attention through office visit. Follow up information was received from the physician's office concerning the 60 year old female patient with allergies (unspecified) who on 14-APR-2011 was vaccinated into left deltoid with a dose of ZOSTAVAX (Lot #: 6695331/1383Z, Exp: May-2012) (dose and route not reported). On 15-APR-2011, the patient experienced allergy erythema with several minutes of wheezing, serious shaken. The patient also developed myalgia and arthralgia. The patient's symptoms have resolved. The patient was treated with short term prednisone. No lab/diagnostic studies were performed. The events was considered to be serious as an other important medical event as it required medical/surgical intervention to prevent one of the serious criteria. Additional information is not expected.
Age: 0.35
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Band neutrophil percentage, Basophil percentage decreased, Blood culture negative, Culture urine negative, Decreased appetite
Clinical narrative: This spontaneous report as received from a physician refers to a 2 months old patient. The patient was vaccinated with ROTATEQ (lot # was unknown) on an unknown date. Other suspect therapies included Hib (manufacturer unknown). Concomitant medications included Hib (manufacturer unknown), PEDIARIX and PREVNAR. On an unknown date the patient developed a "high" fever after receiving ROTATEQ. The patient was hospitalized. During the hospitalization the patient had a "radiograph" and was diagnosed with intussusception. The physician reported that the intussusception spontaneously resolved. Patient current status was recovered. Additional information has been requested.
Age: 0.35
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Differential white blood cell count normal, Dyskinesia, Emotional distress, Eosinophil percentage decreased
Clinical narrative: This spontaneous report as received from a physician refers to a 2 months old patient. The patient was vaccinated with ROTATEQ (lot # was unknown) on an unknown date. Other suspect therapies included Hib (manufacturer unknown). Concomitant medications included Hib (manufacturer unknown), PEDIARIX and PREVNAR. On an unknown date the patient developed a "high" fever after receiving ROTATEQ. The patient was hospitalized. During the hospitalization the patient had a "radiograph" and was diagnosed with intussusception. The physician reported that the intussusception spontaneously resolved. Patient current status was recovered. Additional information has been requested.
Age: 0.35
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Flatulence, Full blood count, Gastritis, Irritability, Monocyte percentage
Clinical narrative: This spontaneous report as received from a physician refers to a 2 months old patient. The patient was vaccinated with ROTATEQ (lot # was unknown) on an unknown date. Other suspect therapies included Hib (manufacturer unknown). Concomitant medications included Hib (manufacturer unknown), PEDIARIX and PREVNAR. On an unknown date the patient developed a "high" fever after receiving ROTATEQ. The patient was hospitalized. During the hospitalization the patient had a "radiograph" and was diagnosed with intussusception. The physician reported that the intussusception spontaneously resolved. Patient current status was recovered. Additional information has been requested.