chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Barium swallow, Cerebrovascular accident, Computerised tomogram, Neurological examination, Nuclear magnetic resonance imaging
Clinical narrative: Between 5 - 7:00 AM.  My Father woke up to go to the bathroom, at that time he recalls he could not locate his left slipper.  He had experienced a stroke and his left side was not functioning.  My Mother figured it out and called 911 and he was at the hospital.  They could not determine if he fit in the 3 hour window for the Blood Clot medicine, so they did not administer it.  He was kept in the hospital and observed, then moved to rehab.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Ultrasound scan
Clinical narrative: Between 5 - 7:00 AM.  My Father woke up to go to the bathroom, at that time he recalls he could not locate his left slipper.  He had experienced a stroke and his left side was not functioning.  My Mother figured it out and called 911 and he was at the hospital.  They could not determine if he fit in the 3 hour window for the Blood Clot medicine, so they did not administer it.  He was kept in the hospital and observed, then moved to rehab.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Patient seen in ED for redness swelling at injection site and myalgia.
Age: 1.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: PT BROKE OUT IN HIVES ON FACE, LASTING FOR MORE THAN 1 DAY.
Age: 1.84
Sex: M
Vaccine: FLUN4
Symptoms: Chills, Constipation, Ear pain, Pyrexia
Clinical narrative: Fever, chills developed 10/23 AM, sought care in ER on 10/24 AM. Fever, earache, constipation developed 10/25, seen @ primary care clinic on 10/25 @ 1600. Mom reports sxs continued till 10/30 PM.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt given 36month+ dose of flu vaccine in error, 0.5mL instead of indicated 0.25mL. At time parent was notified on 10/30 PM, pt had no notable side effects or adverse reactions.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Extensive swelling of vaccinated limb, Injection site swelling, Local swelling, Pyrexia
Clinical narrative: FLUZONE quadrivalent admin 10-25-13 at approx. 0715. 10-26-13 am Severe swelling entire arm vaccinated side and entire leg same side. 10-27-13 - fever.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Erythema, Local reaction, Scar, Skin discolouration
Clinical narrative: Large local reaction. Area of redness, dark purple center, blistered center. Area now (10/31/13) is dark with white center (scar).
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Multiple sclerosis
Clinical narrative: Pt had a flare of her multiple sclerosis and will be on prednisone.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Pruritus
Clinical narrative: Next AM after injection woke up with swollen red arm and pruritis. Was given Rx for antibiotic.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Redness and swelling on arm at site of injection pain and ache in arm and legs,
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report has been received from a pharmacist who was referring to an 85 years old male patient. Information on medical history was not reported. On 12-OCT-2013 the patient was vaccinated with PNEUMOVAX 23 (lot # H022280, expiration date: 16-JUL-2014 00) 0.5 ml, intramuscular for prevention of pneumonia. Concomitant medication included blood thinner. On 13-OCT-2013, the patient's arm was sore and numb. On 14-OCT-2013, the numbness and soreness resolved but the arm was hard to lift and was hurting a little. The outcome of arm hard to lift and hurting a little was unknown. No treatment was given for the adverse experiences. The patient sought medical attention by calling pharmacist. Product Quality Complaint (PQC) was not involved. Relatedness between the adverse events and PNEUMOVAX 23 was not assess by the reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis contact, Rash erythematous, Rash generalised, Rash papular, Rash pruritic
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 60 year old female patient. On approximately 20-SEP-2013 (reported as two weeks ago) the patient was vaccinated with ZOSTAVAX in her left deltoid, in pharmacy (dose, lot number and expiration date were not reported). Concomitant therapies included aspirin. On 22-SEP-2013, two days after being administered ZOSTAVAX the patient developed a rash. The rash on her right and left hip was about 6 centimeters in width and 13 centimeters in length and it was raised, red and itchy. The rash near her left eye was red with papules. The rash was in unspecified locations on her upper extremities and looked like scratches. The nurse believed that the rash was some kind of contact dermatitis because the patient reported spending time in a wooded area on an unspecified date about 4 days after ZOSTAVAX was administered. The patient's rash was treated with ATARAX and unspecified topical hydrocortisone cream. No lab diagnostic studies were performed. The patient sought medical attention and she went to a nurse practitioner. At the time of this report the patient did not recover from her adverse events. Follow up information was received from the reporting nurse. The patient's medical history included exposure to shingles (reported as months ago). A rash did not occur at the site of injection post-vaccination. On 03-OCT-2013 the patient experienced large, raised, erythremic wheel with small papular satellite lesions over left hip. The lesions were distributed on hip, arms, chin and eyelid. Number of lesions was reported as five. The patients outcome was not reported. The relatedness between the patient's adverse events and the vaccination with ZOSTAVAX was not reported. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion, Urticaria
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 60 year old female patient. On approximately 20-SEP-2013 (reported as two weeks ago) the patient was vaccinated with ZOSTAVAX in her left deltoid, in pharmacy (dose, lot number and expiration date were not reported). Concomitant therapies included aspirin. On 22-SEP-2013, two days after being administered ZOSTAVAX the patient developed a rash. The rash on her right and left hip was about 6 centimeters in width and 13 centimeters in length and it was raised, red and itchy. The rash near her left eye was red with papules. The rash was in unspecified locations on her upper extremities and looked like scratches. The nurse believed that the rash was some kind of contact dermatitis because the patient reported spending time in a wooded area on an unspecified date about 4 days after ZOSTAVAX was administered. The patient's rash was treated with ATARAX and unspecified topical hydrocortisone cream. No lab diagnostic studies were performed. The patient sought medical attention and she went to a nurse practitioner. At the time of this report the patient did not recover from her adverse events. Follow up information was received from the reporting nurse. The patient's medical history included exposure to shingles (reported as months ago). A rash did not occur at the site of injection post-vaccination. On 03-OCT-2013 the patient experienced large, raised, erythremic wheel with small papular satellite lesions over left hip. The lesions were distributed on hip, arms, chin and eyelid. Number of lesions was reported as five. The patients outcome was not reported. The relatedness between the patient's adverse events and the vaccination with ZOSTAVAX was not reported. Additional information is not expected.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received form the healthcare worker. Patient information was updated. On 16-SEP-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, expiration date and route not reported). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 25-OCT-2013, the patient was vaccinated (route not provided) with ZOSTAVAX 19.400 plaque forming unit (PFU) lot # 0563AE, expiry date 21-MAR-2013. On 25-OCT-2013, 1 day after onset of therapy the patient received expired dose of ZOSTAVAX due to an alleged mix of ZOSTAVAX vials with a ZOSTAVAX carton. PQC filed. No adverse effect reported. The outcome of patient received expired dose of ZOSTAVAX, no adverse effect reported and pqc is unknown. The action taken with ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. On 28-OCT-2013, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot number and expiry date were reported as 671416/1241AA and 12-APR-2013 respectively, dose and route unspecified). No concomitant therapy was reported. No adverse symptoms were reported. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 3 month old patient of an unknown gender who on 22-MAR-2001 was vaccinated with the first dose of M-M-R II, lot # 640236/1214L, expiration date: 24-AUG-2003 (dose and route not reported). On 14-DEC-2004 the patient was vaccinated with the second dose of M-M-R II (lot #, dose and route not reported). No adverse effects were reported. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Gastrointestinal tube insertion
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a 6 month old male patient with Down's syndrome and congenital heart disease. There were no drug reactions or allergies. On an unknown date, the patient was vaccinated with a dose (reported as at least one dose) of ROTATEQ (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date, the patient was hospitalized. At the time of report, the patient was an in-patient in a hospital and had a Nasojejunal tube (NJ-tube) inserted approximately on an unknown date in October 2013 (reported as about a week and half ago) for an unspecified reason. It was unspecified if any treatment was given or if any lab tests were performed. The patient was not recovered. The relatedness for the event was unknown for ROTATEQ. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Allergy test positive, Oxygen saturation decreased, Pruritus, Wheezing
Clinical narrative: Child received MMRV on 10-25-13. Within 10 minutes, child itching, wheezing. Oxygen level decreased to 88%. Given EPIPEN JR, XOPENEX, DECADRON, BENADRYL, transported to ER. Child had previous severe reaction to egg, but tolerated MMR and varicella in allergist's office. Had flu vaccine also in 2010, 2011, 2012 without reaction.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site nodule, Swelling
Clinical narrative: Baseball-sized knot at injection site. Redness and swelling.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pt given 36month+ dose of flu vaccine in error, 0.5mL instead of indicated 0.25mL. At time parent was notified on 10/30 PM, pt had no notable side effects or adverse reactions.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Angioedema, Chest X-ray, Generalised erythema, Local swelling
Clinical narrative: Anaphylaxis reaction:  angioedema with generalized reddened skin, urticaria, rash, and swollen hands.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Anaphylaxis reaction:  angioedema with generalized reddened skin, urticaria, rash, and swollen hands.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Eyelid margin crusting, Pyrexia
Clinical narrative: Chills and fever of 101. Eyes crusted.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: Shortness of breath, headache, cough, sore throat, exhaustion.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Nausea, headache, chills, diarrhea, fatigue.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Computerised tomogram normal, Convulsion, Culture negative, Dyskinesia, Electroencephalogram normal
Clinical narrative: During sleep our 4 month old had a seizure. Eyes rolling back, foaming mouth, body twitching and jerking. We then went to the ER and they sent us home. Once home at 11:15 pm she had another seizure. We were then admitted to another hospital.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Foaming at mouth, Gaze palsy, Lumbar puncture normal, Muscle twitching, Nuclear magnetic resonance imaging normal
Clinical narrative: During sleep our 4 month old had a seizure. Eyes rolling back, foaming mouth, body twitching and jerking. We then went to the ER and they sent us home. Once home at 11:15 pm she had another seizure. We were then admitted to another hospital.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Vaccination complication
Clinical narrative: During sleep our 4 month old had a seizure. Eyes rolling back, foaming mouth, body twitching and jerking. We then went to the ER and they sent us home. Once home at 11:15 pm she had another seizure. We were then admitted to another hospital.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Blood creatinine increased, Blood lactate dehydrogenase increased, Chills, Convulsion, Dyspnoea
Clinical narrative: TTP: decreased platelets, increased creat. and decreased kidney function, fever, hemolytic anemia, seizure requiring ICU stay and plasma pheresis.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Fibrin degradation products, Intensive care, Laboratory test, Malaise, Mental status changes
Clinical narrative: TTP: decreased platelets, increased creat. and decreased kidney function, fever, hemolytic anemia, seizure requiring ICU stay and plasma pheresis.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Microangiopathic haemolytic anaemia, Plasmapheresis, Platelet count decreased, Pyrexia, Renal impairment
Clinical narrative: TTP: decreased platelets, increased creat. and decreased kidney function, fever, hemolytic anemia, seizure requiring ICU stay and plasma pheresis.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Thrombotic thrombocytopenic purpura
Clinical narrative: TTP: decreased platelets, increased creat. and decreased kidney function, fever, hemolytic anemia, seizure requiring ICU stay and plasma pheresis.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: Redness, swelling, itching, and shingles-like blistering at injection site.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pustule
Clinical narrative: Area of erythema and induration at vaccine site with center pustules. Treated with KEFLEX.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Eye pain, Fatigue, Feeling cold
Clinical narrative: Per tele conversation with patient, she stated the following: her arm became very sore and she could hardly lift it up - approx 1:30 PM. About 7:30 PM post dinner she didn't feel well and was weak and decided to go to bed - felt "tippy" due to weakness. She soon felt very cold - added 2 down blankets to her bed, and took 2 Advil. She states she shivered and shoot all night long, her skin hurt to touch and she had a very bad headache behind her yes. Her body was achy and she did not sleep much during the night. She woke about 9:30 AM - no longer shaking continued to feel weak and achy. She stayed home from work and napped. At 2:30 PM when PHN spoke with her: H/A, shaking, body aches, skin sensitivity all gone but she feels run down, her arm soreness is gone as well. She did not take her temperature but thinks she had a fever during the night. She took 6 aspirin over a 24 hr period to help alleviate her symptoms. PHN advised she phone her physician for  his evaluation and recommendations.  10/28/13 Per tele call with pt - feels back to normal.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hyperaesthesia, Insomnia, Joint range of motion decreased, Malaise
Clinical narrative: Per tele conversation with patient, she stated the following: her arm became very sore and she could hardly lift it up - approx 1:30 PM. About 7:30 PM post dinner she didn't feel well and was weak and decided to go to bed - felt "tippy" due to weakness. She soon felt very cold - added 2 down blankets to her bed, and took 2 Advil. She states she shivered and shoot all night long, her skin hurt to touch and she had a very bad headache behind her yes. Her body was achy and she did not sleep much during the night. She woke about 9:30 AM - no longer shaking continued to feel weak and achy. She stayed home from work and napped. At 2:30 PM when PHN spoke with her: H/A, shaking, body aches, skin sensitivity all gone but she feels run down, her arm soreness is gone as well. She did not take her temperature but thinks she had a fever during the night. She took 6 aspirin over a 24 hr period to help alleviate her symptoms. PHN advised she phone her physician for  his evaluation and recommendations.  10/28/13 Per tele call with pt - feels back to normal.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Per tele conversation with patient, she stated the following: her arm became very sore and she could hardly lift it up - approx 1:30 PM. About 7:30 PM post dinner she didn't feel well and was weak and decided to go to bed - felt "tippy" due to weakness. She soon felt very cold - added 2 down blankets to her bed, and took 2 Advil. She states she shivered and shoot all night long, her skin hurt to touch and she had a very bad headache behind her yes. Her body was achy and she did not sleep much during the night. She woke about 9:30 AM - no longer shaking continued to feel weak and achy. She stayed home from work and napped. At 2:30 PM when PHN spoke with her: H/A, shaking, body aches, skin sensitivity all gone but she feels run down, her arm soreness is gone as well. She did not take her temperature but thinks she had a fever during the night. She took 6 aspirin over a 24 hr period to help alleviate her symptoms. PHN advised she phone her physician for  his evaluation and recommendations.  10/28/13 Per tele call with pt - feels back to normal.
Age: 1.91
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives - treated with BENADRYL.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: Initial information has been received from nurse practitioner as part of pregnancy registered  for GARDASIL, concerning an approximately 16 years old female patient with an unspecified pertinent medical history or drug reactions/allergies, who on 06-SEP-2012, was vaccinated with the first 0.5 ml dose of GARDASIL (lot reported as 1860AA) and on 06-NOV-2012, was vaccinated with the second 0.5 ml dose of GARDASIL (lot reported as H010123) (route was not reported). No other co-suspected were reported. Concomitant medications included: FLOVENT. Subsequently, the patient became pregnant with an last menstrual period (LMP) of 14-SEP-2012 and an estimated delivery date (EDD) of approximately 21-JUN-2013. No treatment information was reported. A urine pregnancy test was performed. It was reported that the patient sought medical attention by contacting the nurse practitioner. The patient's outcome was unknown. Follow up information was received from the same nurse practitioner on 28-OCT-2013. The reporter stated that the patient had an elective termination on an unspecified date for reasons other than the GARDASIL exposure. The reporter did not have additional information because they no longer see the patient. Upon internal review induced abortion was considered medically significant. No further information is available. Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Condition aggravated, Erythema, Psoriasis, Rash
Clinical narrative: Patient noted on flu shot form that ZOSTAVAX irritated psoriasis; following ZOSTAVAX, the next morning pt experienced blisters, redness, rash on feet/she discussed at appt w/dr. she had already made that morning and currently under her care 1 month later psoriasis flared up and currently treating w/medication and light therapy (pt stated not sure if this is due to vaccine as well) but noted it on flu shot form.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Fatigue, Swelling
Clinical narrative: C/O redness, swelling in the middle of the night on 10-18-13. Following day had mild chills and fatigue. Systemic symptoms resolved in several days. Redness and swelling started to improve a day or two ago. It was suggested to continue ibuprofen and cold compressions. Follow up of needed.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased, Pain
Clinical narrative: Soreness at injection site, difficulty lifting lingering painfulness >3 weeks. Physical therapy.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Left upper arm became very hard and very itchy. And was very red it lasted about 4 days. The redness moved from injection site the whole way around my upper arm almost to the elbow. Initial injection prick didn't hurt but just before needle was removed it really hurt. Nurse said I was the first one to say that.
Age: 62.0
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Body temperature increased, Chills, Fatigue
Clinical narrative: About 3 hours after receiving vaccinations I got the chills really bad for about 4-5 hours. Could not get warm for all this time and then felt exhausted for the next day. Temp. 100.5 degrees afterwards.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Decreased appetite, Dizziness
Clinical narrative: Patient came in and said the day after he received the flu shot he felt dizzy, lightheaded, and weak. He reported to having no appetite. The symptoms were gone 24 hours later.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash, Rash
Clinical narrative: Itchy rash on right leg and left arm at injection site.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy, Rash
Clinical narrative: Received FLUZONE High Dose, which I was not aware that the pharmacist was giving me. Just wanted regular flu shot. Beside all the regular problems from the shot. 6 day later, broke out with a rash.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Mass
Clinical narrative: Localized painful mass/swelling. Recommended BENADRYL and Ibuprofen. If no relief, see physician.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: Developed rash or hives on right side of face/neck within a couple hours of vaccination. That evening arm was sore. Developed low grade fever, aches, chills x 2 days. No treatment. Called in sick to work on 10/4/13 - next day. Resolved spontaneously.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Developed rash or hives on right side of face/neck within a couple hours of vaccination. That evening arm was sore. Developed low grade fever, aches, chills x 2 days. No treatment. Called in sick to work on 10/4/13 - next day. Resolved spontaneously.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Crying, Cyanosis, Musculoskeletal stiffness, Pallor
Clinical narrative: 4 vaccines administered. After 4th injection child stiffened, eyes squeezed closed. Assisted to exam table, alert, crying, circumoral cyanosis, Dr summoned. O2 0.5 l face mask applied. Pulse Ox 98% R.A, conversing appropriately throughout. Offered rice cakes and water, child ate and enjoyed. Pallor and cyanosis resolved. Observed for 25 min, then DR discharged to home.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain, Pain in extremity, Skin warm
Clinical narrative: Received PNEUMOVAX in left deltoid. Client stated it felt like "a burst" in her arm. Three hours after the immunization client felt "severe pain" from shoulder to elbow. Area quite reddened and hot. Client unable to put pressure on area or move area without pain. Per client within 24 hours of symptoms it had improved.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Headache, Local swelling, Rhinorrhoea
Clinical narrative: Starting getting swelloning in (R) arm pit, neck, some weakness in neck, headache and runny nose.
Age: 63.0
Sex: F
Vaccine: DTAP, FLU3, PPV
Symptoms: Erythema, Local swelling, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Swollen, feverish left arm. Red, sore. Tried warm and cold compresses, TYLENOL, BENADRYL. No relief.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling cold, Injected limb mobility decreased, Musculoskeletal stiffness, Pain in extremity, Vomiting
Clinical narrative: Got my pneumonia shot at 9:00 am. My arm was stiff by 2:30 PM and severe pain in arm. Got very cold all over till 10:00 pm. Threw up at 10:30 pm. Called hospital about 10:30 pm and asked if I should came in. They connected me with dr who said the ER couldn't do anything for me. My arm has had bad pain now for six days but I can move it more now. It was stiff at my side for two to three days. Around 10:00 am on 10-21-13, I went to hosp and got a flu shot. That arm never got sore. P.S. Today is 10-27-13 and my arm is still some what stiff and painful.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown umber of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following  information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 13-SEP-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot #, expiration date and route not reported). This is one of the several reports from the same source. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown umber of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following  information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 17-SEP-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot #, expiration date and route not reported). This is one of the several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: ANTH, FLUN4, SMALL, ANTH, FLUN4, SMALL
Symptoms: Bundle branch block left, ECG signs of ventricular hypertrophy, Electrocardiogram T wave amplitude decreased, Troponin I increased, Ventricular hypertrophy
Clinical narrative: This study case was received from the investigator in a trial on 17 October 2013 with additional information received on 25 October 2013. A female subject with no reported past medical history had received on 30 September 2013 the following vaccinations: ACAM2000 (lot number, route and site not reported), Anthrax (lot number, route and site) and FLUMIST (lot number, route and site) and 10 days later on 10 October 2013, experienced possible myopericarditis. The subject had no cardiac symptoms and was currently being worked up by cardiology. ECG on 10 October 2013 was abnormal with left posterior hemiblock, flat T waves and right ventricular hypertrophy. Troponin I on 10 October 2013 was 6.10 ng/mL. Repeated attempts to contact the subject have failed. No further information regarding work-up or treated was expected to become available. Outcome was reported as not recovered. According to the investigator, the event of possible myopericarditis was possibly related to vaccination and severity of the event was mild. Documents held by sender: none.
Sex: F
Vaccine: ANTH, FLUN4, SMALL, ANTH, FLUN4, SMALL
Symptoms: Cardiac imaging procedure abnormal, Echocardiogram normal, Electrocardiogram normal, Myocarditis, Nuclear magnetic resonance imaging abnormal
Clinical narrative: This study case was received from the investigator in a trial on 17 October 2013 with additional information received on 25 October 2013. A female subject with no reported past medical history had received on 30 September 2013 the following vaccinations: ACAM2000 (lot number, route and site not reported), Anthrax (lot number, route and site) and FLUMIST (lot number, route and site) and 10 days later on 10 October 2013, experienced possible myopericarditis. The subject had no cardiac symptoms and was currently being worked up by cardiology. ECG on 10 October 2013 was abnormal with left posterior hemiblock, flat T waves and right ventricular hypertrophy. Troponin I on 10 October 2013 was 6.10 ng/mL. Repeated attempts to contact the subject have failed. No further information regarding work-up or treated was expected to become available. Outcome was reported as not recovered. According to the investigator, the event of possible myopericarditis was possibly related to vaccination and severity of the event was mild. Documents held by sender: none.
Sex: F
Vaccine: ANTH, FLUN4, SMALL, ANTH, FLUN4, SMALL
Symptoms: Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 17 October 2013 with additional information received on 25 October 2013. A female subject with no reported past medical history had received on 30 September 2013 the following vaccinations: ACAM2000 (lot number, route and site not reported), Anthrax (lot number, route and site) and FLUMIST (lot number, route and site) and 10 days later on 10 October 2013, experienced possible myopericarditis. The subject had no cardiac symptoms and was currently being worked up by cardiology. ECG on 10 October 2013 was abnormal with left posterior hemiblock, flat T waves and right ventricular hypertrophy. Troponin I on 10 October 2013 was 6.10 ng/mL. Repeated attempts to contact the subject have failed. No further information regarding work-up or treated was expected to become available. Outcome was reported as not recovered. According to the investigator, the event of possible myopericarditis was possibly related to vaccination and severity of the event was mild. Documents held by sender: none.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: On 10/30/13 patient contacted coordinator of off site clinic and had been experiencing pain and inability to have full function of left arm since inoculation. He ask his regular RPh and was advised to ice arm and take ibuprofen. An email was sent to pharmacy supervisor who contacted patient who complaines of pain and wanted to see MD supervisor forwarded to processing pharmcy to file and open insurance claim for patient.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pain, upper (R) arm red, warm.
Age: 23.0
Sex: M
Vaccine: ANTH, FLUN4
Symptoms: Injection site swelling
Clinical narrative: Swelling of affected admin site, right bicep. 5cm difference between biceps. 125 Solumedrol IM and 25mg Benadryl Q 6 hr. PO. Follow up in 24 hrs.
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Abscess, Culture, Erythema, Staphylococcal infection, Swelling
Clinical narrative: Developed MRSA infection (swollen red abscess). Received medical attention on 10/14, 10/15 and 10/17. BACTRIM used to treat infection.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: Developed Guillain Barre syndrome approx 1 week after flu shot.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 25-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J001694, expiration date 08-MAY-2014, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hypoaesthesia, Hypoaesthesia oral, Lip swelling, Nausea
Clinical narrative: Received flu shot at 10:20AM.  At 1:20 PM, I felt dizzy and nauseous, my lips were numb and swelling, as was the rest of my face. I drove to Urgent Care, where I was given prednisone and epinephrine.  I went home to rest around 5:00 PM. I felt better around 8:00 PM that evening.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Received flu shot at 10:20AM.  At 1:20 PM, I felt dizzy and nauseous, my lips were numb and swelling, as was the rest of my face. I drove to Urgent Care, where I was given prednisone and epinephrine.  I went home to rest around 5:00 PM. I felt better around 8:00 PM that evening.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Injection site erythema, Injection site warmth, Urticaria
Clinical narrative: Started with diarrhea the night of the vaccination. Then by morning developed hives in several areas. The injection site was warm to touch and erythmatic. She was seen by a physician. She was advised to take Benadryl and rest.
Age: 41.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Raised area at vaccine site of 50mm long X 40mm wide, red and warm with itching noted per patient.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on torso. Treated with Caladryl, antihistamines, cortisone cream. I still have hives erupting daily.
Age: 24.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Myalgia, Pruritus
Clinical narrative: Muscle soreness, redness, itchiness.
Age: 1.58
Sex: F
Vaccine: FLU3
Symptoms: Coxsackie viral infection, Irritability, Rash vesicular, Viral rash
Clinical narrative: Cranky with a diffuse vesicular rash  over her right arm abd right leg almost resembling variola rather than varicella. On 10/17/13 she developed vesicular papable lesions close to coxsakie viral exanthem on hands, feet, mouth.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEPA
Symptoms: Body temperature increased, Breath sounds abnormal, Crying, Dyspnoea, Gaze palsy
Clinical narrative: At 11:50PM pt whimpered once. At 12:15AM pt cried 2 times an odd cry, mom got up and went into room, left light off. Tried to pick pt. up, but was unable because he was so rigid. Mom said pt. sounded like he was struggling to breath, but couldn't tell if it was just his stuffy nose he had had over the weekend. She moved her arm to get a tissue and pt's head fell back and he went limp. She turned on the light and his eyes were open slightly with eyes looking down and to the right. He felt very hot per mom, and was doing "odd breathing" like he was trying to cry, but breathing only out of nose. Did not respond to parents. Dad put Tylenol in pts mouth, it sat there, then he swallowed it and opened his eyes. His eyes then looked downwards and to the left. They drove pt. to emergency room, and pt was now focusing on parents. Temp at hosp. was 103.4 rectally. They gave pt Motrin, a popsicle, and monitored him for 2 hrs. He was acting normally within 45 min of arriving at hospital. Has been fine and afeb. since.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEPA
Symptoms: Hypotonia, Muscle rigidity, Posture abnormal, Skin warm
Clinical narrative: At 11:50PM pt whimpered once. At 12:15AM pt cried 2 times an odd cry, mom got up and went into room, left light off. Tried to pick pt. up, but was unable because he was so rigid. Mom said pt. sounded like he was struggling to breath, but couldn't tell if it was just his stuffy nose he had had over the weekend. She moved her arm to get a tissue and pt's head fell back and he went limp. She turned on the light and his eyes were open slightly with eyes looking down and to the right. He felt very hot per mom, and was doing "odd breathing" like he was trying to cry, but breathing only out of nose. Did not respond to parents. Dad put Tylenol in pts mouth, it sat there, then he swallowed it and opened his eyes. His eyes then looked downwards and to the left. They drove pt. to emergency room, and pt was now focusing on parents. Temp at hosp. was 103.4 rectally. They gave pt Motrin, a popsicle, and monitored him for 2 hrs. He was acting normally within 45 min of arriving at hospital. Has been fine and afeb. since.
Age: 42.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Erythema, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Erythema the size of a 50 cent piece in the center of the right deltoid, however, no induration noted.  Patient stated the area was sore and he noticed swelling yesterday morning.  The area also felt warm to touch and noted mild swelling radiating down from right deltoid down to right hand as compared to left arm.  Patient stated that he had no other symptoms to report such as throat swelling, difficulty swallowing or breathing.  Patient confirms that Dr. has prescribed a steroid and antibiotic.  Instructed patient to use ice pack to affected site for swelling and cortisone cream to affected injection site if needed for itching/irritation, start steroid and antibiotic prescriptions as soon as possible and continue to monitor site and physical symptoms.  Instructed patient to go to ER for evaluation for any worsening symptoms.  Patient verbalized understanding.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Blood pressure increased, Confusional state, Headache, Laboratory test normal, Malaise
Clinical narrative: Headaches, mild confusion, elevated blood pressure, malaise- began about a week after.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Vaccine administered on 10/25/2013. On 10/26/2013, patient reports that his Right Arm was numb and sore. Also reports experiencing a fever with uncontrollable shaking the previous evening.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site pruritus, Local swelling, Pain in extremity
Clinical narrative: Severe pain in arm from shoulder to hands and around injection site, itching at injection site. Swelling of arm. Pain did not respond to medication. Slight improvement with heat therapy and non usage of arm. Doctor suggest antihistamines and anti inflammatory meds.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Malaise, Mobility decreased, Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: Patient reported arm stiffness, muscle aches, general malaise. Patient also reported pain and lack of movement.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: Patient has a bruise on right arm the size of "silver dollar".
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Bone pain, Chills, Fatigue, Headache, Irritability
Clinical narrative: Fatigue, chills, fever, nausea, aching bones, headache, shivering, irritability.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Pyrexia
Clinical narrative: Fatigue, chills, fever, nausea, aching bones, headache, shivering, irritability.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash generalised, Rash pruritic, Urticaria
Clinical narrative: Itchy red rashes appeared initially on the scalp, upper back, neck, and chest. Rashes then spread to low back, arms, groin, and thighs by the following day, 24 hours after administration of the vaccine. Currently raised welts consistent with hives are visible on 60% of the body.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram, Dizziness, Gait disturbance, Mental impairment, Metamorphopsia
Clinical narrative: Visual distortion, unsteady walking, severe dizziness with spinning of the room, difficulty trying to call EMS, difficulty forming thoughts.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Vertigo
Clinical narrative: Visual distortion, unsteady walking, severe dizziness with spinning of the room, difficulty trying to call EMS, difficulty forming thoughts.
Age: 1.87
Sex: M
Vaccine: DPP, FLUX, MMR
Symptoms: Affective disorder, Autism, Convulsion
Clinical narrative: Seizure and autistic like behavior next day.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Dysstasia
Clinical narrative: Dizziness. Extreme, could not stand, began after awaking from a nap. Still occurring 12 hrs after vaccination.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Sore left arm, red area below injection site, red area is warm to touch.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Altered visual depth perception, Diplopia, Dizziness, Injection site erythema, Injection site swelling
Clinical narrative: Case number PHEH2013US019053 is an initial spontaneous report received from a pharmacist on 09 Sep 2013 and a follow up report from the pharmacist received on 16 Oct 2013. This report refers to a 69-year-old female patient. Her medical history included fall and trauma to head or eyes. Concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1308401) at a dose of 0.5ml intramuscularly in the arm on 06 Sep 2013 (11:00 AM). On the same day after vaccination, she experienced redness and swelling at the injection site and disturbances with vision, such as depth perception and dizziness. Her ophthalmic examination determined that her recent fall caused visual issues. She also had blurred vision and double vision. Injection site reactions had improved since initial presentation but the visual disturbances still persisted. Seriousness and causality of the events were not reported. Follow up report from the pharmacist received on 16 Oct 2013: Medical history, vaccination site and dose of FLUVIRIN, events (double vision and blurred vision) and lab data were updated.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Ophthalmological examination abnormal, Vision blurred, Visual impairment
Clinical narrative: Case number PHEH2013US019053 is an initial spontaneous report received from a pharmacist on 09 Sep 2013 and a follow up report from the pharmacist received on 16 Oct 2013. This report refers to a 69-year-old female patient. Her medical history included fall and trauma to head or eyes. Concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1308401) at a dose of 0.5ml intramuscularly in the arm on 06 Sep 2013 (11:00 AM). On the same day after vaccination, she experienced redness and swelling at the injection site and disturbances with vision, such as depth perception and dizziness. Her ophthalmic examination determined that her recent fall caused visual issues. She also had blurred vision and double vision. Injection site reactions had improved since initial presentation but the visual disturbances still persisted. Seriousness and causality of the events were not reported. Follow up report from the pharmacist received on 16 Oct 2013: Medical history, vaccination site and dose of FLUVIRIN, events (double vision and blurred vision) and lab data were updated.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 26-AUG-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J001694, expiration date 08-MAY-2014, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. 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 registered nurse refers to a patient of unknown age and gender. On 10-AUG-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J001694, expiration date 08-MAY-2014, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.