chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Patient returned two to three days after the vaccination to the pharmacy.  Pharmacist on duty at the time was uncertain if rash was due to shot and suggested patient go to his physician.  Physician called pharamcy on 11/25/14 and stated rash was setermined to be vaccine related and called in a Medrol Dose for treatment.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: Patient had local reaction at site of injection the size of a tennis ball that was warm, very tender, and patient was tired. All was resolved within 24 hours using ice 4 times daily - RPh followed up with patient day after treatment with ice.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Blood culture, Central venous catheterisation, Coordination abnormal, Dyskinesia, Electroencephalogram
Clinical narrative: Guillain Barré - Fisher Miller variant; tingling, paralyzation, speech, muscle movement, coordination, respiratory failure: nerve damage/myelin damage peripheral nervous system; IVIG - intraveinous immunoglobulin.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Gastrointestinal tube insertion, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture, Miller Fisher syndrome
Clinical narrative: Guillain Barré - Fisher Miller variant; tingling, paralyzation, speech, muscle movement, coordination, respiratory failure: nerve damage/myelin damage peripheral nervous system; IVIG - intraveinous immunoglobulin.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging, Paraesthesia, Paralysis, Peripheral nerve injury, Respiratory failure
Clinical narrative: Guillain Barré - Fisher Miller variant; tingling, paralyzation, speech, muscle movement, coordination, respiratory failure: nerve damage/myelin damage peripheral nervous system; IVIG - intraveinous immunoglobulin.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Speech disorder
Clinical narrative: Guillain Barré - Fisher Miller variant; tingling, paralyzation, speech, muscle movement, coordination, respiratory failure: nerve damage/myelin damage peripheral nervous system; IVIG - intraveinous immunoglobulin.
Age: 0.17
Sex: M
Vaccine: 6VAX-F, MMRV, PER, RVX
Symptoms: Choking, Condition aggravated, Eczema, Faecal calprotectin abnormal, Gastrointestinal inflammation
Clinical narrative: My son began experiencing increased acid reflux that broke through his PPI. It was normally controlled by it. He kept spitting up profusely. Also, he had choking episodes. Lastly, the blood in his stools increased significantly as well as his eczema, which was already very bad but become uncontrollable.
Age: 0.17
Sex: M
Vaccine: 6VAX-F, MMRV, PER, RVX
Symptoms: Gastrooesophageal reflux disease, Haematochezia, Infantile spitting up
Clinical narrative: My son began experiencing increased acid reflux that broke through his PPI. It was normally controlled by it. He kept spitting up profusely. Also, he had choking episodes. Lastly, the blood in his stools increased significantly as well as his eczema, which was already very bad but become uncontrollable.
Age: 7.0
Sex: F
Vaccine: MMRV
Symptoms: Abdominal pain, Abdominal pain upper, Headache, Injection site reaction, Lymphadenopathy
Clinical narrative: Patient woke up and asked me to look at her leg. An enlarged lymph node at the growing of her right leg was observed. A red, itchy rash had also appeared at the thigh injection site on the same leg. A fever of 100.4 developed later on in the afternoon, along with a head ache and light sensitivity. The following day, 11/23/14, pain in the stomach/ spleen area developed. On 11/25/14 a light, slightly raised rash was observed at 7:30 PM, covering patient's back and trunk. A nurse at her clinic was spoken with regarding these latest symptoms.
Age: 7.0
Sex: F
Vaccine: MMRV
Symptoms: Photophobia, Pyrexia, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient woke up and asked me to look at her leg. An enlarged lymph node at the growing of her right leg was observed. A red, itchy rash had also appeared at the thigh injection site on the same leg. A fever of 100.4 developed later on in the afternoon, along with a head ache and light sensitivity. The following day, 11/23/14, pain in the stomach/ spleen area developed. On 11/25/14 a light, slightly raised rash was observed at 7:30 PM, covering patient's back and trunk. A nurse at her clinic was spoken with regarding these latest symptoms.
Age: 62.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: I was given a flu and pneumococcal vaccine, one in each arm. I developed body aches, redness and hard swelling at pneumo injection site; worsened over 48 hours to fever, chills with intermittent shivers while I was out of state at a conference. Hard red area of injection site was so painful I could not sleep on that side for 3 nights. Left conference early to return home to recover. On Monday, 11/24, I reported this to Drs office, was given a same day appt and was advised I may have cellulitis. I was given an antibiotic which has improved swelling, redness and pain.
Age: 62.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: I was given a flu and pneumococcal vaccine, one in each arm. I developed body aches, redness and hard swelling at pneumo injection site; worsened over 48 hours to fever, chills with intermittent shivers while I was out of state at a conference. Hard red area of injection site was so painful I could not sleep on that side for 3 nights. Left conference early to return home to recover. On Monday, 11/24, I reported this to Drs office, was given a same day appt and was advised I may have cellulitis. I was given an antibiotic which has improved swelling, redness and pain.
Sex: M
Vaccine: VARZOS
Symptoms: Necrotising retinitis
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a male patient of unknown age. Pertinent medical history, drug reactions or allergies were not reported. On 11-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX vial (dose number, route, dosage schedule, lot number and expiration date not provided). Concomitant medication was not reported. On an unspecified date in November 2014, after receiving ZOSTAVAX the patient developed retinal necrosis. The patient sought medical attention and was admitted at the hospital for an unspecified reason when he was diagnosed with the retinal necrosis (dates of admission and discharge were unknown). The outcome of retinal necrosis was unknown. Causality assessment was not reported. Upon internal review the event retinal necrosis was considered to be medically significant. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Neoplasm malignant
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 62 year old female patient. On unknown date in 2010 (when the patient was 58 year old), the patient was vaccinated with her first dose of PNEUMOVAX 23 (lot#, strength, dosage, frequency and route unknown). On unknown date in 2014 (reported as "now") the patient had cancer. The outcome of cancer was reported as not recovered/not resolved. Upon internal review, cancer was determined to be medical significant. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Atrial fibrillation
Clinical narrative: New onset of A-fib.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 13-NOV-2014, the patient was vaccinated with an expired dose of ROTATEQ (lot # H012974, expiry date 07-FEB-2014, dose 2 mil, oral). Concomitant medications were not reported. No adverse effect was reported. The outcome of receiving an expired dose of vaccine was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a 4 month old female patient without drug reactions and allergies. The patient did not have any relevant medical history. On 18-AUG-2014 the patient was vaccinated with ROTATEQ, oral, lot # K007243, expiration date: 13-DEC-2015 (dose was not reported). On 03-NOV-2014 the patient received another dose of ROTATEQ oral (dose and lot # not reported). There were no concomitant medications. After the ROTATEQ dose on 03-NOV-2014, the patient vomited. Thus, part of the vaccine, ROTATEQ dose may have been lost. The patient did not receive any treatment for the adverse event. There were not laboratory diagnostics studies performed. The outcome of patient vomited was reported as recovered/resolved on 03-NOV-2014. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Induration, Insomnia, Local swelling, Pain in extremity
Clinical narrative: Pt stated arm (L) was sore to where unable to sleep at noc on 11/24/14. Noticed today-11/25/14-that arm was red and swollen, and came straight to doctor office. Left arm 18x14cm induration and tenderness w/erythema 18x18xm. Denied n/v/d, fever, or any other symptoms. Rx'd-sml-tmp DS tablet x 10 day, abx cream daily.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: Pt stated arm (L) was sore to where unable to sleep at noc on 11/24/14. Noticed today-11/25/14-that arm was red and swollen, and came straight to doctor office. Left arm 18x14cm induration and tenderness w/erythema 18x18xm. Denied n/v/d, fever, or any other symptoms. Rx'd-sml-tmp DS tablet x 10 day, abx cream daily.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored ROTATEQ oral (dose and lot # were not reported). It was reported that the vaccine was exposed to 1 degree C for 48 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Numbness, tingling pain x 2 weeks (left arm).
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (registered nurse) refers to a unspecified number of patients of unknown age. Current conditions and medical history was not reported. Since 05-NOV-2014, patient were administered with ROTATEQ injection (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On 05-NOV-2014, ROTATEQ was exposed to temperatures (9 degree for 6 hours) out of the recommended range and administered to unspecified patients. It was reported that the nurse was not aware of any adverse effects. At the time of the report, the excursion has not ended. It was reported to nurse that as per stability assessment data, ROTATEQ would not be adversely affected by this specific temperature excursion. Product quality complaint was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified amount of patients of unknown age and gender. Nurse stated that on an unknown date in 2014 within the past 2 weeks an unspecified amount of patients were vaccinated with a dose of ROTATEQ oral route which was improperly stored. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: FLU3
Symptoms: Exposure during breast feeding
Clinical narrative: This case was reported by a consumer and described the occurrence of vaccine exposure via breast milk in a infant patient who received FLUARIX TETRA. On 8th October 2014, the patient received FLUARIX TETRA. On 8th October 2014, an unknown time after receiving FLUARIX TETRA, the patient experienced vaccine exposure via breast milk. On an unknown date, the outcome of the vaccine exposure via breast mill was unknown. It was unknown if the reporter considered the vaccine exposure via breast milk to be related to FLUARIX TETRA. Additional information: Patient was nursing infant and received a FLUARIX QUADRIVALENT vaccination.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Deltoid reddened, warm to touch, raised slightly.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Administration site rash, Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Burning, pain and warmth at the site of injection firm lump. Red rash on around the area of administration.
Age: 18.0
Sex: M
Vaccine: FLUC3
Symptoms: Local swelling
Clinical narrative: Developed swelling in right armpit 2 days after vaccination. E.R. visit, no treatment required.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness
Clinical narrative: Pt became severely dizzy 3 minutes after vaccine administration and was sent to emergency room.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness
Clinical narrative: Shoulder/arm (left arm) sore/stiff MD put patient on prednisone 11-18-2014 and physical therapy.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site urticaria
Clinical narrative: Patient noticed hives around injection site the day after administration. Then bruising developed at site of injection and a red area approx. 2" round near injection site. This red area developed day after administration as well as bruising and red hives disappeared.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Anxiety, Chest X-ray, Drug screen, Dyspnoea, Electrocardiogram
Clinical narrative: Patient experienced shaking, anxiety, SOB, and fever of 102 degrees F. She went to the emergency dept where they did an EKG, urine screen, and chest x-ray. All came back normal so doctor did not do any blood work. They gave her IV fluids and she was released 5 hours later.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: Patient experienced shaking, anxiety, SOB, and fever of 102 degrees F. She went to the emergency dept where they did an EKG, urine screen, and chest x-ray. All came back normal so doctor did not do any blood work. They gave her IV fluids and she was released 5 hours later.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site joint movement impairment, Injection site pain, Pain
Clinical narrative: Injection given on right arm (1 am left-handed) way close to shoulder area. Injection site was never sore but pain and limited motion on right arm shoulder by 2nd day or so. Painful to lift arm and move pt carry things.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient contacted pharmacy on 11/19/14 to inform the pharmacy manager that his physician stated that he had an adverse reaction to the flu vaccination that he received. Patient had initial soreness after receiving vaccination that went away after a few days. Then left shoulder pain came back  got to a point where patient seeked M.D. Follow up on 10/28/14. Patient shoulder pain is where he is having trouble lifting his arm over his head. Patient went to MD again on 11/12/14. Last flu vaccination for patient was in 2012.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Allergy test negative, C-reactive protein normal, Culture throat negative, Differential white blood cell count normal, Full blood count normal
Clinical narrative: FLUMIST administered 11-12-14 at 4 pm. Mom reports child woke on 11-13-14 with congestion, headache and achiness. Mom reports child started with hives on 11-17-14 and continued with stuffy nose. 11-20-14 mom called office to report this. Advice given to observe. Mom sched appt 11-24-14 due to hives not completely resolved.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Headache, Laboratory test normal, Nasal congestion, Pain, Red blood cell sedimentation rate normal
Clinical narrative: FLUMIST administered 11-12-14 at 4 pm. Mom reports child woke on 11-13-14 with congestion, headache and achiness. Mom reports child started with hives on 11-17-14 and continued with stuffy nose. 11-20-14 mom called office to report this. Advice given to observe. Mom sched appt 11-24-14 due to hives not completely resolved.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Respiratory tract congestion, Streptococcus test negative, Urine analysis normal, Urticaria
Clinical narrative: FLUMIST administered 11-12-14 at 4 pm. Mom reports child woke on 11-13-14 with congestion, headache and achiness. Mom reports child started with hives on 11-17-14 and continued with stuffy nose. 11-20-14 mom called office to report this. Advice given to observe. Mom sched appt 11-24-14 due to hives not completely resolved.
Sex: M
Vaccine: DTAP, FLUX, MMR
Symptoms: Pyrexia, Rash, Rash morbilliform
Clinical narrative: This spontaneous report was received from a consumer refers to a her son, a male patient of unknown age. On 07-NOV-2014 the patient was vaccinated with M-M-R II, DTAP (manufacturer unknown) and influenza virus vaccine (Manufacturer unknown). On 14-NOV-2014 the patient had a low grade fever (around 101), on the evening of 15-NOV-2014, his fever increased around midnight to around 103 (temperature was not taken-because she could not find thermometer at the time but body temperature was extremely high and consistent with previous fevers in this range). In the morning the fever had broken 16-NOV-2014, but her son had a face rash (concentrated on forehead and around his eyes) and torso rash (neck to diaper area) that was slightly raised, spread out, and reminiscent of a measles rash. She read known side effects for MMR vaccinations and her son's symptoms seem to align with reported side effects. She worked Tuesday-Thursday (hence the delay in reporting). The patient's rash was fading and temperature has remained normal since them. The patient was recovering from the rash and recovered from fever. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse on 27-OCT-2014, who stated that it would take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and date of vaccine administration) together and that she might send the information at a later time. Follow up information has been received from the registered nurse on 13-NOV-2014, concerning a patient (age reported as 5, units not reported) of unknown gender. On 29-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report as received from registered nurse (who worked in a health clinic) refers to unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with M-M-R II (dosing details and lot number unknown). On an unknown date, a routine titer testing was done and an unspecified number of patients had negative titers for MMR. The patients came back to receive a booster dose of M-M-R II. The outcome of the negative MMR titers was unknown. No product quality complaint was involved. Causality assessment was not provided. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 27-OCT-2014, the patient was vaccinated with a dose of PROQUAD lot # K009894, expiry date: 11-JAN-2016 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 29-OCT-2014, the patient was vaccinated with a dose of PROQUAD (Merck) lot # K009894, expiry date: 11-JAN-2016 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. 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 pharmacist refers to a female patient of unknown age. On unknown date in 2006 (reported as: "8 years ago") the patient was vaccinated with first dose of GARDASIL (dose, route and lot # not reported) and on 06-NOV-2014 (reported as: "today") the patient received a second dose of GARDASIL (dose, route and lot # not reported). No adverse event was reported. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Musculoskeletal pain
Clinical narrative: (R) shoulder pain
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date of 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse on 27-OCT-2014 who stated that it would take some time to get the  VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she might send the information at a later time. Follow up information has been received from the registered nurse on 13-NOV-2014, concerning a patient (age reported as 6, units not provided) of unknown gender. On 28-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Age: 49.0
Sex: M
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (also reported as the physician) refers to a 49 year old male patient. Medical history and current conditions were not reported. On 07-AUG-2014, the patient was vaccinated with (Oka/Merck) PROQUAD, 0.5 ml, subcutaneous, at age 49, because he was never vaccinated as a child.  No adverse effect was reported. Concomitant medication was not reported. Additional information has been requested.
Age: 1.95
Sex: M
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Urticaria
Clinical narrative: Gave DTAP, Hep A #2, and 1st CPOX. Approx 4 hrs later mother returned to clinic and pt had hives over face, neck, and abdomen. BENADRYL given.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Convulsion, Syncope
Clinical narrative: Syncope and brief seizure (see ER report)
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Nodule, Swelling
Clinical narrative: Swelling, knot, redness, shoulder to elbow.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Arm swelling; fever; pain in arm. MD called manufacturer and prescribed clindamycin accordingly. Pt ended up on IV antibiotics.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Hyperhidrosis, Peripheral swelling, Pyrexia
Clinical narrative: Arm swelling; fever; pain in arm. MD called manufacturer and prescribed clindamycin accordingly. Pt ended up on IV antibiotics.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 2 children under the age of 5 years. Medical history was not reported. On an unknown date the patients were vaccinated with expired doses of M-M-R II injection, lot # J012083, expiration date 27-JUL-2014 (route and dosage were not reported). No adverse effects reported. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified amount of patients of unknown age and gender. Nurse stated that on an unknown date in 2014 within the past 2 weeks an unspecified amount of patients were vaccinated with a dose of VAQTA which was improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 02-OCT-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K008185, expiry date: 05-DEC-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication ws not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 29-SEP-2014, the patient was vaccinated with a dose of PROQUAD (Merck) lot # K008185, expiry date: 05-DEC-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse on 27-OCT-2014, who stated that it would take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she might send the information at a later time. Follow up information has been received from the registered nurse on 13-NOV-2014, concerning a patient (age reported as 8, units not reported) of unknown gender. On 29-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (registered nurse) refers to a unspecified number of patients of unknown age. Current conditions and medical history was not reported. Since 05-NOV-2014, patients were administered with RECOMBIVAX HB injection (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On 05-NOV-2014, RECOMBIVAX HB vaccine was exposed to temperatures (9 degree for 4 hours) out of recommended range and administered to unspecified patients. It was reported that the nurse was not aware of any adverse effects. At the time of this report, the excursion has not ended. It was reported to nurse that as per stability assessment data, RECOMBIVAX HB would not be adversely affected by this specific temperature excursion. Product quality complaint was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 26-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K008185, expiry date: 05-DEC-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 13-NOV-2014, the patient was vaccinated with improperly stored ZOSTAVAX (19400 PFU). Concomitant medications were not provided. No adverse symptoms were reported. The temperature excursion with ZOSTAVAX was found to be supported with in-house stability data. Outcome of patient receiving improperly stored ZOSTAVAX was unknown. No product quality complaint was involved. Causality assessment was not provided. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to an unspecified female patient of unknown age with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated with (Merck) VARIVAX (lot number, expiry date, route and site not reported) on 13-FEB-2013 and then on 25-MAR-2013. There was no concomitant medication. On 25-MAR-2013, a pregnancy test done in the office prior to the administration of the second dose of (Merck) VARIVAX noted that the patient was not pregnant. The patient came back for an office visit on 09-APR-2013 and a pregnancy test was done then as well and it was determined the patient was six weeks pregnant. The LMP was approximately 26-FEB-2013 and EDD 03-DEC-2013. The pregnancy outcome was pending. The outcome of the patient was unknown. Follow up information was received on 24-NOV-2014. All telephone attempts to obtain follow-up information has been unsuccessful. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Eyelid oedema, Swelling face
Clinical narrative: Immediate swelling of (L) eyelid progressing to (L) side of nose and (L) side of lip. Mom applied ice on eye. The swelling was gone in the next morning.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Received call from parent with c/o starting 11/23/14 noticed redness, swelling and whensite touched child pulled away, signifying "pain" site R thigh.
Age: 1.01
Sex: U
Vaccine: VARCEL, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 months old infant patient and unknown gender. On 02-SEP-2014 the patient was vaccinated with a dose of an improperly stored VARIVAX (Merck) (lot J009002, expiration date 19-JUL-2015) (dose, route, were not reported. No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several report received from the same source. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: VARCEL, MMR
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 months old infant patient and unknown gender. On 02-SEP-2014 the patient was vaccinated with a dose of an improperly stored VARIVAX (Merck) (lot J009002, expiration date 19-JUL-2015) (dose, route, were not reported. No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several report received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from licensed practical nurse refers to a patient of unknown age and gender. On 06-NOV-2014, the patient was vaccinated with improperly stored GARDASIL (does: 0.5 ml, intramuscular, lot # K004205, expiration date 12-JAN-2017, anatomical location not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Injection site erythema, Urticaria
Clinical narrative: Hepatitis B vaccine admin IM to LAT. Within one minute of administration patient broke out in hives on his face and some milk erythema at site of injection. Tx with 1 1/2 tsp of BENADRYL.
Sex: M
Vaccine: VARZOS
Symptoms: Parkinson's disease
Clinical narrative: This spontaneous report as received from a consumer (patient's sister) refers to a male patient of unknown age with lymphoma. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, expiration date, dose, route were not reported). Concomitant therapies included unspecified chemotherapy. On an unknown date, shortly after injected with ZOSTAVAX (also reported as "some time ago") the patient showed signs of Parkinson's Disease. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected due to lack of patient and physician's contact information.
Age: 52.0
Sex: F
Vaccine: HEPAB
Symptoms: Eye swelling, Feeling hot, Flushing
Clinical narrative: Flushing and feeling warm after vaccine received on 10/30/14. Around 9 pm that evening, pt c/o eyes swelling. She took BENADRYL with relief.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 27-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # J003528, expiry date: 25-MAR-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. on 18-NOV-2014, the patient was vaccinated with a dose of VARIVAX, 0.5 ml, subcutaneous (lot number and expiration date were not reported) that underwent a supported temperature excursion. No adverse experience reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient. The patient had no pertinent medical history or drug reactions/allergies. On 19-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J011339 with expiration date 13-DEC-2014, single dose, subcutaneously). There were no concomitant medications. On 21-NOV-2014 the patient developed two "quarter sized" red spots at the injection site. No treatment was given for the event. No lab diagnostics studies were performed. The patient had sought medical attention via calling pharmacy. The outcome of the event was reported as not recovered. Additional information is not expected as there was no consent to contact the physician.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Dyspnoea, Rash, Stress
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient, whose current conditions included asthma, hypertension and type 2 diabetes. On an unknown date the patient was vaccinated with ZOSTAVAX (refrigerated vial, lot # K008881, expiry date 20-SEP-2015). Concomitant medications were not reported. On an unknown date the patient experienced a very bad rash on her forehead within two and a half hours of vaccine administration. Patient also reported shortness of breath but mentioned that the symptoms may have been anxiety related to the stress of developing the rash. Patient sought medical attentions and was treated with BENADRYL and hydrocortisone. Outcome of the events was reported as recovering/resolving (events improved in about a week). Shortness of breath was not related to ZOSTAVAX while causality of the other events was not provided. No product quality complaint was filed. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site rash
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 69 year old male patient. On 10-NOV-2014 the patient was vaccinated with PNEUMOVAX 23, (dose 0.5 ml, intramuscular route, lot number reported as K008409k, expiry date 04-MAR-2016). Concomitant medications were not reported. On 11-NOV-2014, the patient experienced rash and cellulitis surrounding the injection site that extended to the elbow. The patient sought medical attention. No treatment was prescribed by the physician. No laboratory studies were performed. There was no hospitalization required, no significant disability and experience was not life threatening. The outcome of the events was reported as not recovered/not resolved. No product quality complaint was involved. Causality assessment was not provided. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a female patient of unknown age reporting on herself. On 08-NOV-2014 the patient was vaccinated with ZOSTAVAX (dose, route of administration and lot # were not reported). In November 2014 the patient experienced swelling, lump, itchiness, redness and warmth at the injection site. The patient sought medical attention (she called her pharmacist) and received TYLENOL as treatment for the adverse events. The outcome of the events was unknown. Additional information has been requested.
Age: 1.06
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 months old infant patient and unknown gender. On 03-SEP-2014 the patient was vaccinated with a dose of MMRII (lot H020255, expiration date not reported) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker refers to a patient of unknown age and gender. No relevant medical history of the patient was reported. On 17-NOV-2014 the patient was vaccinated with an expired dose of PEDVAXHIB (lot number reported as H0125270, expiration date reported as 24-OCT-2014) (strength, dose, and route of administration were not reported). There were no concomitant medications reported. The patient experienced no adverse effects. There was no product quality complaint involved. The outcome was unknown. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 months old infant patient and unknown gender. On 02-SEP-2014 the patient was vaccinated with a dose of MMRII (lot H020255, expiration date not reported) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patient were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received 27-OCT-2014 from the registered nurse who stated that it will take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received on 13-NOV-2014 from the registered nurse concerning a patient (age range reported as 17, units not reported) of unknown gender. On 07-NOV-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Age: 1.03
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 months old infant patient and unknown gender. On 02-SEP-2014 the patient was vaccinated with a dose of MMRII (lot H020255, expiration date not reported) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant on 20-NOV-2014 refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, expiration date and route unspecified) that has been improperly stored. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to unspecified patients of unknown age. It was reported doses of VARIVAX (Merck) (lot# unspecified) that were exposed to supported temperature excursions from "September 2014" and had been administered to unspecified patients on unspecified dates in 2014 since the excursion on an unspecified date in "September 2014." No adverse experience had been observed or reported. No PQC(product quality issue) involved. Action taken and outcome were not provided. Additional information has been requested.
Age: 1.09
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 13 months old child patient and unknown gender. On 29-AUG-2014 the patient was vaccinated with a dose M-M-R II (lot H020255, expiration date not reported) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 6 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.09
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 13 months old child patient and unknown gender. On 29-AUG-2014 the patient was vaccinated with a dose M-M-R II (lot H020255, expiration date not reported) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 6 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.