chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Coxsackie virus test, Cytomegalovirus test positive, Differential white blood cell count normal, Dyspnoea exertional, Dyspnoea paroxysmal nocturnal
Clinical narrative: The patient who has a history of poorly controlled hypertension received an Influenza vaccination (FLUCELVAX) on 6/16/14. At the time of vaccination the pt. reported that he had a 2-3 day history of a dry cough and rhinorrhea (with clear discharge). He denied fever, chills, sore throat, earache, diarrhea, nausea or vomiting. He also denied an increase of symptoms or local redness, swelling or pain at the injection site after the vaccination. He did not miss any work due to his symptoms nor did it interfere with his sleep pattern, ADLs or exercise regimen (daily treadmill and weight lifting). The pt. states that the cough and runny nose had completely resolved by 7/1/14. He remained asymptomatic until 7/26/14 when he became uncharacteristically dyspneic after a light swim and walking a few blocks. That night he had 3 pillows orthopnea. He denied chest pain, chest pressure palpitations or lightheadedness. On 7/29/14 after a third night of orthopnea the pt. reported to the clinic. At that time his weight was up about 20-25 pounds and the pt. noted that his ankles were edematous. The pt. was transported by ambulance to Hospital with new onset heart failure. The pt. was diuresed with LASIX over 1-2 days with significant improvement of his symptoms. The pt. was transferred to another facility for further evaluation. The pt. has had an echocardiogram, cardiac cath, and cardiac MRI and is currently being followed by the cardiology clinic. He was recently diagnosed with myocarditis and nonischemic cardiomyopathy. The pt. is wearing a Zoll life vest; the pt. denies any discharges. The patient's current medications are: ASA 81mg qd, COREG 25mg bid, LIPITOR 40mg qd, MICARDIS 80mg qd and Spironolactone 25mg qd, LASIX 20mg qd and Potassium Chloride 20meq qd. He walks approx. 2 miles/day at a leisurely pace without symptoms. He does c/o occasional paroxysmal nocturnal dyspnea. The pt. denies chest pain/discomfort, dyspnea, palpitations, or syncope/presyncope.
Age: 38.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Echocardiogram, Eosinophil percentage increased, Herpes simplex serology negative, Herpes simplex serology positive, High density lipoprotein decreased
Clinical narrative: The patient who has a history of poorly controlled hypertension received an Influenza vaccination (FLUCELVAX) on 6/16/14. At the time of vaccination the pt. reported that he had a 2-3 day history of a dry cough and rhinorrhea (with clear discharge). He denied fever, chills, sore throat, earache, diarrhea, nausea or vomiting. He also denied an increase of symptoms or local redness, swelling or pain at the injection site after the vaccination. He did not miss any work due to his symptoms nor did it interfere with his sleep pattern, ADLs or exercise regimen (daily treadmill and weight lifting). The pt. states that the cough and runny nose had completely resolved by 7/1/14. He remained asymptomatic until 7/26/14 when he became uncharacteristically dyspneic after a light swim and walking a few blocks. That night he had 3 pillows orthopnea. He denied chest pain, chest pressure palpitations or lightheadedness. On 7/29/14 after a third night of orthopnea the pt. reported to the clinic. At that time his weight was up about 20-25 pounds and the pt. noted that his ankles were edematous. The pt. was transported by ambulance to Hospital with new onset heart failure. The pt. was diuresed with LASIX over 1-2 days with significant improvement of his symptoms. The pt. was transferred to another facility for further evaluation. The pt. has had an echocardiogram, cardiac cath, and cardiac MRI and is currently being followed by the cardiology clinic. He was recently diagnosed with myocarditis and nonischemic cardiomyopathy. The pt. is wearing a Zoll life vest; the pt. denies any discharges. The patient's current medications are: ASA 81mg qd, COREG 25mg bid, LIPITOR 40mg qd, MICARDIS 80mg qd and Spironolactone 25mg qd, LASIX 20mg qd and Potassium Chloride 20meq qd. He walks approx. 2 miles/day at a leisurely pace without symptoms. He does c/o occasional paroxysmal nocturnal dyspnea. The pt. denies chest pain/discomfort, dyspnea, palpitations, or syncope/presyncope.
Age: 38.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Influenza virus test, Low density lipoprotein normal, Myocarditis, Neutrophil percentage decreased, Nuclear magnetic resonance imaging
Clinical narrative: The patient who has a history of poorly controlled hypertension received an Influenza vaccination (FLUCELVAX) on 6/16/14. At the time of vaccination the pt. reported that he had a 2-3 day history of a dry cough and rhinorrhea (with clear discharge). He denied fever, chills, sore throat, earache, diarrhea, nausea or vomiting. He also denied an increase of symptoms or local redness, swelling or pain at the injection site after the vaccination. He did not miss any work due to his symptoms nor did it interfere with his sleep pattern, ADLs or exercise regimen (daily treadmill and weight lifting). The pt. states that the cough and runny nose had completely resolved by 7/1/14. He remained asymptomatic until 7/26/14 when he became uncharacteristically dyspneic after a light swim and walking a few blocks. That night he had 3 pillows orthopnea. He denied chest pain, chest pressure palpitations or lightheadedness. On 7/29/14 after a third night of orthopnea the pt. reported to the clinic. At that time his weight was up about 20-25 pounds and the pt. noted that his ankles were edematous. The pt. was transported by ambulance to Hospital with new onset heart failure. The pt. was diuresed with LASIX over 1-2 days with significant improvement of his symptoms. The pt. was transferred to another facility for further evaluation. The pt. has had an echocardiogram, cardiac cath, and cardiac MRI and is currently being followed by the cardiology clinic. He was recently diagnosed with myocarditis and nonischemic cardiomyopathy. The pt. is wearing a Zoll life vest; the pt. denies any discharges. The patient's current medications are: ASA 81mg qd, COREG 25mg bid, LIPITOR 40mg qd, MICARDIS 80mg qd and Spironolactone 25mg qd, LASIX 20mg qd and Potassium Chloride 20meq qd. He walks approx. 2 miles/day at a leisurely pace without symptoms. He does c/o occasional paroxysmal nocturnal dyspnea. The pt. denies chest pain/discomfort, dyspnea, palpitations, or syncope/presyncope.
Age: 38.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Oedema peripheral, Orthopnoea, Parvovirus B19 test positive, Troponin I increased, Weight increased
Clinical narrative: The patient who has a history of poorly controlled hypertension received an Influenza vaccination (FLUCELVAX) on 6/16/14. At the time of vaccination the pt. reported that he had a 2-3 day history of a dry cough and rhinorrhea (with clear discharge). He denied fever, chills, sore throat, earache, diarrhea, nausea or vomiting. He also denied an increase of symptoms or local redness, swelling or pain at the injection site after the vaccination. He did not miss any work due to his symptoms nor did it interfere with his sleep pattern, ADLs or exercise regimen (daily treadmill and weight lifting). The pt. states that the cough and runny nose had completely resolved by 7/1/14. He remained asymptomatic until 7/26/14 when he became uncharacteristically dyspneic after a light swim and walking a few blocks. That night he had 3 pillows orthopnea. He denied chest pain, chest pressure palpitations or lightheadedness. On 7/29/14 after a third night of orthopnea the pt. reported to the clinic. At that time his weight was up about 20-25 pounds and the pt. noted that his ankles were edematous. The pt. was transported by ambulance to Hospital with new onset heart failure. The pt. was diuresed with LASIX over 1-2 days with significant improvement of his symptoms. The pt. was transferred to another facility for further evaluation. The pt. has had an echocardiogram, cardiac cath, and cardiac MRI and is currently being followed by the cardiology clinic. He was recently diagnosed with myocarditis and nonischemic cardiomyopathy. The pt. is wearing a Zoll life vest; the pt. denies any discharges. The patient's current medications are: ASA 81mg qd, COREG 25mg bid, LIPITOR 40mg qd, MICARDIS 80mg qd and Spironolactone 25mg qd, LASIX 20mg qd and Potassium Chloride 20meq qd. He walks approx. 2 miles/day at a leisurely pace without symptoms. He does c/o occasional paroxysmal nocturnal dyspnea. The pt. denies chest pain/discomfort, dyspnea, palpitations, or syncope/presyncope.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site swelling, Pruritus generalised, Rash generalised
Clinical narrative: Itching at the injection site.  Then itching all over the body, rash on body and head.  Injection site got a large bump.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Haemorrhage, Induration, Lichenification, Papule
Clinical narrative: Persistant indurated 1cm papule with erythema, pruritus, mild hemorrhage, and lichenification still present 9 months later.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pruritus
Clinical narrative: Persistant indurated 1cm papule with erythema, pruritus, mild hemorrhage, and lichenification still present 9 months later.
Age: 1.14
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Circular reddened area approx. 3-4 cm in diameter with approx. 1-2 cm of blistered vesicular area inside of reddened area. Located on left leg at varicella injection site.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Circular reddened area approx. 3-4 cm in diameter with approx. 1-2 cm of blistered vesicular area inside of reddened area. Located on left leg at varicella injection site.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Hypoaesthesia, Pain in extremity
Clinical narrative: Headache, pain/numbness in arm, shoulder, face.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness
Clinical narrative: Right lower extremity weakness started 2 days after vaccination and getting worse.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Body temperature, Decreased appetite, Vomiting
Clinical narrative: Pt vomited, temp, decreased feeding x 24 hrs. Still had temp 9/10/14.
Sex: F
Vaccine: MNQ
Symptoms: Headache, Malaise, Musculoskeletal stiffness, Pyrexia, Rash
Clinical narrative: Received meningitis vaccine (MENVEO). Woke up next day with severe headache, stiff neck, fever, malaise (101 degrees). Rash on face and neck on 3rd day, this rash persisted for 5 days.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Was given MMR on 8/12/2014 - then received Varicella on 8/19/2014. Parent notified that the child will need to repeat Varicella.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot, Flushing, Rash macular, Vision blurred
Clinical narrative: Dizziness, blurred vision, flushing, blotchy skin, and feeling a warming sensation starting in my face then moving to my arms and hands then moving to my legs and feet.  These sympoms lasted about an hour and a half.
Age: 11.0
Sex: M
Vaccine: FLUN4, HEPA, HPV4, MNQ
Symptoms: Injection site warmth, Testicular swelling
Clinical narrative: Mom notice large hot swelling at injection site on right arm measuring 8cm by 8cm.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Incorrect route of drug administration
Clinical narrative: None.
Age: 35.0
Sex: F
Vaccine: TYP
Symptoms: Nausea
Clinical narrative: Mild to severe nausea, on and off, from around 7/25 until 8/18. No other symptoms (no fever, no diarrhea, etc - only nausea).
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Varicella immunization rash.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Erythema, Local swelling, Pain, Pruritus
Clinical narrative: 9/10/14 8:00am Patient came in with mother to report and show left upper arm redness and swelling. Pt. c/o mild pain and itching since 9/9/14 am. Dr. saw pt. and prescribed and given diphenhydramine 25mg PO qd x 5 days. Instructed pt. to apply warm compress & come back tomorrow on 09/11/14 to see Dr.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Patient returned to clinic after administration with swelling to injection site. Ice pack was applied. No erythema or hardness. Denies dizziness, nausea, headache or any other adverse effects. Swelling reduced with ice- advised to continue to ice site and take OTC analgesic if needed- stated understanding.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased, Injection site induration, Injection site mass
Clinical narrative: 100.4 temperature, hard lump at injection site.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Feeling hot, Full blood count, Localised oedema
Clinical narrative: LOCALIZED WARMTH AND EDEMA. NO OTHER SYMPTOMS. TREATMENT: TYLENOL 500 mg, 1-2 tab by mouth every 6 hours for pain # 36, no refills. MOTRIN 800 mg, 1 tab by mouth for pain or swelling with food or milk #9, No refills.
Age: 40.0
Sex: M
Vaccine: HEPA
Symptoms: Chest discomfort, Dizziness, Hypoaesthesia, Pain in extremity, Vision blurred
Clinical narrative: Arm pain and numbness; chest tightness; dizzy; blurred vision.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: None known.
Age: 0.75
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site discolouration, Injection site erythema
Clinical narrative: The skin in area of injection site remained purple-red color and raised over 2 months after the vaccine was administered.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Swelling, red and hot to touch, a little itchy on the injected arm.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Asthenia, Cough, Dizziness, Dysphonia
Clinical narrative: Dizziness, fatigue, fever, aches around the injection, weakness. Cough, headache, hoarseness. Resulted in me leaving work 4 hours early, due to not being able to stand up.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Dysstasia, Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: Dizziness, fatigue, fever, aches around the injection, weakness. Cough, headache, hoarseness. Resulted in me leaving work 4 hours early, due to not being able to stand up.
Age: 1.11
Sex: M
Vaccine: DTAP, FLUX
Symptoms: Autism, Epilepsy, Immediate post-injection reaction
Clinical narrative: AUTISM SYMPTOMS OCCURRED RIGHT AFTER VACCINATION, WE DIDNT FIND OUT HE HAD AUTISM UNTIL 2011-2012.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Dyspnoea, Pruritus, Throat irritation, Urticaria
Clinical narrative: Pt called 3 day after receiving FLULAVAL injection stating she had developed a hive like rash and itching on her arms and legs several hours after receiving injection. She also c/o mild throat irritation and hoarseness, but no SOB, difficulty breathing. Rash was beginning to clear no fever noted.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling
Clinical narrative: After FLUZONE HD inj (Monday) pt came in w/ arm red and swelling. Pt is doing fine and will monitor if it gets worse. Pt was instructed to go to ER if it worsens. Pt taking antihistamine.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fall, Syncope
Clinical narrative: Patient received vaccine at workplace at 10:20 am and returned to desk. At 10:30 am patient collapsed at desk and fell to the floor. Patient stated that she felt dizzy prior to fainting. Patient laid on back in chair for about 15 minutes until she felt normal.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with RECOMBIVAX HB. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The medical assistant reported that doses of RECOMBIVAX were improperly stored and were administered (on an unknown date). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Induration, Nodule, Pain
Clinical narrative: 48 hr post-vaccination, patient experienced red, painful, hard knot approximately 1/2 dollar size. Spoke with him 9/10/14 and knot has reduced in size and redness. Patient improving.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 04-SEP-2014, the patient was vaccinated with ZOSTAVAX. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. On 04-SEP-2014, the patient improperly stored ZOSTAVAX during transport to physician office. Patient received that dose of improperly stored ZOSTAVAX on 04-SEP-2014. No adverse effects were noted. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Swollen arm, red to touch, itching from shoulder to wrist. Reported some swelling first on 9/8/2014. Advised to take BENADRYL and observe. Visited emergency room on 9/9 and given antibiotic.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with PEDVAXHIB. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The medical assistant reported that doses of PEDVAXHIB were improperly stored and were administered (on an unknown date). NO adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a unspecified number of patients of unkonwn age and gender. On an unknown date the patients were vaccinated with ROTATEQ. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The medical assistant reported that doses of ROTATEQ were improperly stored and were administered (on an unknown date). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Herpes zoster, Musculoskeletal pain
Clinical narrative: This spontaneous report was received from a 63 year old female consumer with chronic obstructive pulmonary disease (COPD), drug reactions/allergy to sulfa and angiotensin-converting-enzyme inhibitor (ACE inhibitors), pelvic nerve damage and sarcoidosis. The patient's medical history included shingles on middle August 2014. In August 2014 (reported as around third week of August), the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number, lot number, expiration date and route were not reported) for prevention of shingles (also reported as prevent subsequent shingles). Concomitant therapies included LYRICA, cyclobenzaprine hydrochloride and tramadol hydrochloride. Historical drugs included sulfa and ACE inhibitors. Consumer reported that she was diagnosed with shingles in middle of August 2014, and received a dose of ZOSTAVAX to prevent subsequent shingles around third week of August. Consumer reported that shingles rash was gone but she still felt burning pain around left breast and left shoulder, where shingles rashes were, and reported that when she smokes, burning pain felt worse. Consumer noticed worsening of burning pain with smoking after receiving ZOSTAVAX. At the time of report the outcome was reported as not recovered. Patient seek medical attention at the office visit, but she did not received treatment for the event. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The medical assistant reported that doses of GARDASIL were improperly stored and were administered (on an unknown date). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria, pruritus.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: Vaccine for Varicella given to patient early in pregnancy. LMP 7/17/14. Vaccine given 8/14/14.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Breast pain, Erythema, Swelling
Clinical narrative: Redness, swelling, and pain on left breast. Began day after vaccine and continues today.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Vaccination complication
Clinical narrative: Pt received vaccine at 10:30am on 9/7/14. She experienced extreme stomach pain and was taken to hospital at 1:30pm. Pt was given 3 doses of morphine and was released at 8:30pm. MD told her that her stomach was about to ulcerate had she delayed coming in. She was told it was a rxn to shot and not to get another for 2 yrs.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Feeling cold, Injection site erythema, Injection site swelling, Pain, Tremor
Clinical narrative: Pt developed red raised bump at injection site. He started having shakes and could not get warm he then started into severe pain. He went to ER and was treated with PERCOCET.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Patient experienced muscle tenderness on her upper arm. Also pain on that area followed by fever for a couple days.
Age: 61.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site pain, Skin discolouration
Clinical narrative: Patient noticed discoloration of skin on both the arms on 9/8/14. Feel sore in arms.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Inflammation, Oral herpes, Pruritus, Rash erythematous
Clinical narrative: Developed red rashes on the left ankle and blotch on inside of upper right thigh 10 min after the shot. Inflamed and red and itchy. Next morning, got cold sores in the mouth, and more rashes on the leg, the rashes are now climbing up. Used little bit of cortisone cream - by night time, rash had spread on both legs and arms. Affecting her joints now. Took 1 tab of ZYRTEC.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Rash macular
Clinical narrative: Developed red rashes on the left ankle and blotch on inside of upper right thigh 10 min after the shot. Inflamed and red and itchy. Next morning, got cold sores in the mouth, and more rashes on the leg, the rashes are now climbing up. Used little bit of cortisone cream - by night time, rash had spread on both legs and arms. Affecting her joints now. Took 1 tab of ZYRTEC.
Age: 30.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Right arm pain from site of injections down to fingertips, and up to neck. Pain rated 7/10.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Pt states she has pain/dull ache since receiving vaccine on 8/19/14.
Age: 4.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Urticaria
Clinical narrative: Hives day 6-8 after MMR. Symptom treatment with antihistamines.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The pharmacist reported that on 25-AUG-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 inj (lot # J006921, expiration date 09-AUF-2014), 0.5 ml, intramuscular. No adverse effects were reported. This case is linked to case MARRS # 1408USA015595 (same reporter link). Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Injection site reaction, Swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 4 year old patient of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 19-AUG-2014 the patient was vaccinated with PROQUAD, 0.5 ml, subcutaneous in the right thigh, lot number J015595, expiration date 05-JUN-2015, (dose number were unspecified). On an unknown date in August 2014, the patient experienced injection site reactions, and swelling after an injection PROQUAD (merck). The patient did not seek medical attention. The outcome of the events was unknown. The relatedness between PROQUAD and the events was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. No pertinent history, drug reactions or allergies were reported. On 27-AUG-2014 (Oka/Merck) PROQUAD (dose, dose number, route, anatomical location lot number and expiration date were unspecified) and (Oka/Merck) VARIVAX (dose, dose number, route,anatomical location lot number and expiration date were unspecified) were administered concomitantly to the patient. No adverse effect reported. No other concomitant therapies were reported. The outcome of the event was unknown. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Pain, Skin warm
Clinical narrative: This spontaneous report as received from a 71 year old female patient reporting on herself. The patient's medical history included shingles three time over the years (in 1990, 2004 and 2007). The patient had no known drug reactions or allergies. On 05-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX lot # K000325, expiration date 27-FEB-2015 (route was not provided) for prevention of shingles. Concomitant therapies included ZETIA, amlodipine besylate and calcium. On 05-SEP-2014, in the evening after receiving ZOSTAVAX at her local pharmacy, the patient experienced a red, warm, painful, raised, after receiving ZOSTAVAX. No treatment was given for the adverse event. The patient did not seek medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The pharmacist reported that on 09-SEP-2014 a patient was administered a dose of ZOSTAVAX, 0.65 ml, subcutaneously (lot number not reported), that was improperly stored. No adverse events were reported. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from registered nurse refers to a 41 year old female patient with anxiety, depression, vaccination, myofascial pain syndrome and drug allergy to sulfonamide. Patient had an allergic reaction with sulfonamide on an unknown date. On 03-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 injection, (dose unknown) single dose with lot # K004281 and expired date 22-MAR-2014. Concomitant therapies included VENTOLIN, XANAX, atenolol (manufacture unknown), BENTYL and furosemide (manufacturer unknown). On the same day after administration of PNEUMOVAX 23 patient developed severe pain in right arm, from shoulder to elbow. Patient self treated the events with analgesics. Patient called office for medical attention to the events. No laboratory test was performed for diagnosis of events. The outcome of severe pain in right arm, from shoulder to elbow was reported as not recovered/not resolved. The outcome of 41 years patient received PNEUMOVAX 23 was unknown. The reporter did not provide the causality of severe pain in right arm, from shoulder to elbow to PNEUMOVAX 23. No further information was provided. Additional information has been requested. This is one of several reports from the same source (MARRS 1409USA003160 and 1409USA002618).
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Accidental exposure to product, Exposure during pregnancy, Exposure via direct contact, Eye irrigation, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received form a 23 year old female patient (also nurse) reporting on herself. On 26-AUG-2014 the patient splashed less than 0.1ml of M-M-R II in her face and possibly her eyes when drawing up the vaccine. The patient/nurse immediately washed her face and flushed her eyes with sterile saline. She was concerned since she was pregnant with 28 weeks of gestation. The patient's last menstrual period (LMP) was 11-FEB-2014 with estimated date of delivery (EDD) of 18-NOV-2014. The pregnancy outcome was outcome pending. Patient contacted her OB/GYN physician. No adverse effects reported. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: MMR
Symptoms: Measles antibody, Mumps antibody test negative, Rubella antibody positive
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 40 year old male patient with none pertinent medical history and drug allergies. On an unknown date the patient was vaccinated with one dose of M-M-R II, (lot#, expiration date, dose and route not reported). On 13-AUG-2014, blood titer was performed and the titer was drawn, which was negative for mumps antibodies, equivocal for measles antibodies, and positive for rubella antibodies. No treatment was given for the events. The patient's present status was unspecified. The outcome of the events was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a healthcare worker via field employee refers to a now 22 year old female patient. The patient was vaccinated with the first dose of GARDASIL, injection, (dose, route, lot # and expired date were not reported) on 04-AUG-2008. Concomitant therapy was not reported. The patient was performed pap smear. The patient was diagnosed with an unspecified strain of human papillomavirus (HPV) on an unspecified date prior to receiving the 2nd and 3rd doses of GARDASIL. The patient had a physician office visit for medical attention. Therapy with GARDASIL was continued. The outcome of adverse event was unspecified. On 30-JUN-2014, the patient was vaccinated with the second dose of GARDASIL. On 12-AUG-2014, the patient was vaccinated with the third dose of GARDASIL. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Laser therapy, Rash, Skin papilloma
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with the first dose of GARDASIL (lot#, strength, dosage and route unknown for prevention of HPV). The patient was vaccinated with the second dose of GARDASIL (lot#, strength, dosage and route unknown in the left arm for prevention of HPV) series on unspecified date. On an unknown date the patient experienced "20 to 25 bumps" on the back of her arm following the 2nd dose GARDASIL that was administered. The patient was administered the 2nd dose of GARDASIL in her left arm and experienced the "bumps" on her right arm. The patient was seen by an unspecified dermatologist on an unspecified date and was informed by the dermatologist that the "bumps" were actually "warts caused by the GARDASIL vaccine." The dermatologist lasered to 20 to 25 bumps which the unspecified dermatologist stated were warts caused by the GARDASIL vaccine. The outcome of the events was recovered on an unknown date. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Chest pain, Nausea, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to an 11 year old male patient. On 15-APR-2014 the patient was vaccinated with his first dose of GARDASIL intramuscular. The physician reported that on 15-APR-2014 "the patient experienced nausea, vomiting and substernal chest pains, lasting for 15 minutes, after receiving the initials dose of GARDASIL." The reporter also reported that the patient received MENACTRA (unspecified dose/frequency and manufacturer) and T-DAP (unspecified dose/frequency and manufacturer) concomitantly, with the dose of GARDASIL. Patient sought medical attention by office visit on 15-APR-2014 and was given no treatment for AEs. The outcome of substernal chest pains, vomiting and nauseas was unknown. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Injection site reaction, Swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 1 year old patient of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 07-AUG-2014 the patient was vaccinated with (Oka-Merck) PROQUAD, 0.5 ml, subcutaneous in the left thigh, lot number K006770, expiration date 07-NOV-2015, for prevention (dose number were unspecified). On an unknown date in August 2014, the patient experienced injection site reactions and swelling after an injection (Oka-Merck) PROQUAD. The patient did not seek medical attention. The outcome of the events was unknown. The relatedness between (Oka-Merck) PROQUAD and the events was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse who refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with GARDASIL. The patient received dose of GARDASIL that was stored improperly. No adverse effects reported. The outcome of the patient received dose of GARDASIL that was stored improperly was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse, reporting on a female patient of unknown age. Medical history and concurrent conditions were not reported. The patient was vaccinated with GARDASIL (dose, lot number and expiration date were not reported) intramuscular route. Patient received first dose of GARDASIL on 01-OCT-2013, second dose on 01-MAY-2014, and would received her third dose on 03-SEP-2014. No known adverse effects. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 6 patients of unknown age and unknown gender. No pertinent medical history, drug reactions or allergies were reported. On unspecified dates, 6 patients were inadvertently vaccinated with GARDASIL, that had been improperly stored (dose, dose number, route, anatomical location lot number and expiration date were unspecified). No adverse effects reported. No concomitant therapies were reported. The outcome of the events was unknown. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Injection site reaction, Swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 1 year old patient of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 25-AUG-2014 the patient was vaccinated with (Oka-Merck) PROQUAD, 0.5 ml, subcutaneous in the left thigh, lot number K006770, expiration date 07-NOV-2015, for prevention (dose number were unspecified). On an unknown date in August 2014, the patient experienced injection site reactions and swelling after an injection (Oka-Merck) PROQUAD. The patient did not seek medical attention. The outcome of the event was unknown. The relatedness between (Oka-Merck) PROQUAD and the events was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Erythema, Gait disturbance, Incomplete course of vaccination, Injection site erythema
Clinical narrative: The spontaneous report as received from a physicoan refers to a  21 year old female patient with no drug reactions or allergies. Medical history included some "ortho" problems (not specified) in her past (also reported as no pertinent medical history). On 27-JUN-2011, the patient was vaccinated with the first dose of GARDASIL 0.5 ml once, intramuscular, lot #1569Z (expiration date not availaable). The patient developed redness and swelling at injection site. This reactions lasted only a day (recovered on 28-JUN-2011). On 29-AUG-2014, the patient was vaccinated with the second of GARDASIL, 0.5 ml once, intramuscular dose lot #668819/0477AA, expiration date 29-JUN-2013, in the arm. Within a day of the second dose (on 30-AUG-2011) the patient developed mild swelling, redness in the upper arm along with arthralgia or as the patient called it  "severe muscle aches in her knees and legs along with a log of soreness with trouble walking lasting 2 days".  Physician stated that the patient had decided not to administered third dose of  GARDASIL. Physician stated that the patient wsa on the pill (unspecified birth control medication). The outcome of mild swelling and redness in the upper arm was not reported. The outcome of arthralgia was recovered on 01-SEP-2011. Physician stated TYLENOL was recommended to patient but no other treatment. No labs diagnostic studies performed. It was reported that the patient contacted the office. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Local swelling, Myalgia
Clinical narrative: The spontaneous report as received from a physicoan refers to a  21 year old female patient with no drug reactions or allergies. Medical history included some "ortho" problems (not specified) in her past (also reported as no pertinent medical history). On 27-JUN-2011, the patient was vaccinated with the first dose of GARDASIL 0.5 ml once, intramuscular, lot #1569Z (expiration date not availaable). The patient developed redness and swelling at injection site. This reactions lasted only a day (recovered on 28-JUN-2011). On 29-AUG-2014, the patient was vaccinated with the second of GARDASIL, 0.5 ml once, intramuscular dose lot #668819/0477AA, expiration date 29-JUN-2013, in the arm. Within a day of the second dose (on 30-AUG-2011) the patient developed mild swelling, redness in the upper arm along with arthralgia or as the patient called it  "severe muscle aches in her knees and legs along with a log of soreness with trouble walking lasting 2 days".  Physician stated that the patient had decided not to administered third dose of  GARDASIL. Physician stated that the patient wsa on the pill (unspecified birth control medication). The outcome of mild swelling and redness in the upper arm was not reported. The outcome of arthralgia was recovered on 01-SEP-2011. Physician stated TYLENOL was recommended to patient but no other treatment. No labs diagnostic studies performed. It was reported that the patient contacted the office. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Respiratory arrest
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of 74 years of age. The patient's medical history included asthma and hypertension. The patient's drug reactions/allergies were reported for penicillin, prednisone, ZANTAC, TAGAMET, PEPCID, PREVACID, DILAUDID. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent 23 (unknown manufacturer). Concomitant therapies included TOPROL XL, CLARITIN, FLOVENT and hydrocodone. On an unknown date the patient developed a localized reaction after receiving an pneumococcal vaccine, 23 (unknown manufacturer). The patient sought medical attention. The outcome of event was reported as resolved on an unknown date. No PQC, overdose and cancer was reported. On an unknown date, the patient experienced respiratory arrest after receiving hepatitis b vaccine (manufacturer unknown) (entered in MARRS# 1409USA003641). Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Local reaction
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of 74 years of age. The patient's medical history included asthma and hypertension. The patient's drug reactions/allergies were reported for penicillin, prednisone, ZANTAC, TAGAMET, PEPCID, PREVACID, DILAUDID. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent 23 (unknown manufacturer). Concomitant therapies included TOPROL XL, CLARITIN, FLOVENT and hydrocodone. On an unknown date the patient developed a localized reaction after receiving an pneumococcal vaccine, 23 (unknown manufacturer). The patient sought medical attention. The outcome of event was reported as resolved on an unknown date. No PQC, overdose and cancer was reported. On an unknown date, the patient experienced respiratory arrest after receiving hepatitis b vaccine (manufacturer unknown) (entered in MARRS# 1409USA003641). Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling abnormal, Throat tightness
Clinical narrative: Pt states she felt "funny" and throat felt "tight". Physician and pharmacy notified, pt medicated with Benadryl and observed for 2 hours at which point she felt fine and was discharged home.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Extreme shoulder pain. Very limited range of motion.
Age: 27.0
Sex: M
Vaccine: DTAP
Symptoms: Condition aggravated, Depression, Fatigue, Feeling abnormal, Irritability
Clinical narrative: Woke up the next morning felt strange and left hand swollen badly. Shot was in left arm. Have been depression free for 2 years no meds. Ever since shot depression has returned with a vengeance. I have been very irritable. But I can't shake myself out this depression I'm constantly tired in bed by 7pm every night. It has seriously affected my life.
Age: 27.0
Sex: M
Vaccine: DTAP
Symptoms: Local swelling
Clinical narrative: Woke up the next morning felt strange and left hand swollen badly. Shot was in left arm. Have been depression free for 2 years no meds. Ever since shot depression has returned with a vengeance. I have been very irritable. But I can't shake myself out this depression I'm constantly tired in bed by 7pm every night. It has seriously affected my life.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Skin warm
Clinical narrative: Patient had rash, warm to touch radiating down arm.
Age: 1.67
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Abnormal behaviour, Decreased eye contact, Mood altered, Staring, Toe walking
Clinical narrative: One month after vaccine given mother presented to the office with report that 6-7 days after the shots (MMR and Varicella) that the pt was moody, unresponsive like he was staring off into space.  He wouldn't look at anyone, in the church nursery he stood up in the same spot and did not move, even when other children bumped into him, like he was in a "trance"  He behaved like this for 3-4 days then started to act more normally again.  He would also say the same sound over and over.  He is doing some toe walking too.  Mom didn't call me sooner because she and the dad weren't sure what the cause was.
Age: 1.67
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Trance, Unresponsive to stimuli
Clinical narrative: One month after vaccine given mother presented to the office with report that 6-7 days after the shots (MMR and Varicella) that the pt was moody, unresponsive like he was staring off into space.  He wouldn't look at anyone, in the church nursery he stood up in the same spot and did not move, even when other children bumped into him, like he was in a "trance"  He behaved like this for 3-4 days then started to act more normally again.  He would also say the same sound over and over.  He is doing some toe walking too.  Mom didn't call me sooner because she and the dad weren't sure what the cause was.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Very severe pain in right arm unrelieved by taking two Advil or Tylenol and pain persisted unrelieved for 12 hours, unable to move or lift right arm for almost 12 plus hours.  Continue to have some limited movement of arm.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Chills, Fatigue, Hyperhidrosis, Malaise
Clinical narrative: Patient states he started feeling tired and ill around 8:00PM on 9/8/2014. Went to bed and felt he had a fever, chills, sweats and nausea. States he vomited around 9:00PM on 9/8/2014 but then was able to sleep through the night. Reported feeling tired and weak on 9/9/2014. No other symptoms reported.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Patient states he started feeling tired and ill around 8:00PM on 9/8/2014. Went to bed and felt he had a fever, chills, sweats and nausea. States he vomited around 9:00PM on 9/8/2014 but then was able to sleep through the night. Reported feeling tired and weak on 9/9/2014. No other symptoms reported.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever 101-102 day after vaccines administered.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Pt reports that he had pna vaccine morning of 08/26. In the afternoon, arm was sore and tender to touch. No swelling or redness. No warmth or sxs of infection.  Took Advil qhs with relief of sxs.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Soreness, redness at injection site, "Rock Hard Bump".
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Henoch-Schonlein purpura, Urine analysis normal
Clinical narrative: Henoch-Schonlein purpura.
Age: 1.25
Sex: F
Vaccine: HEP, HEPA
Symptoms: Autism spectrum disorder, Convulsion, Electroencephalogram, Laboratory test, Nuclear magnetic resonance imaging
Clinical narrative: Seizures, autism (autism spectrum disorder (ASD)).
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Back pain, Headache, Neck pain, Pyrexia, Rash
Clinical narrative: Severe headache, subjective fever, neck, back pain, multiple coin rash that coalesced to become a plaque 6 x 3 inches.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Skin plaque
Clinical narrative: Severe headache, subjective fever, neck, back pain, multiple coin rash that coalesced to become a plaque 6 x 3 inches.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Oedema, Pruritus, Skin warm
Clinical narrative: 3 in redness, hot to touch, 6mm edema, itchy.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Fatigue, Lethargy
Clinical narrative: DIARRHEA, MALAISE, LETHARGY, WEAKNESS, FATIGUE, LOSS OF APPETITE, SWOLLEN GLANDS, ROSACEA.