chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling
Clinical narrative: Around 4:30 pm client noted swelling to (R) eye. Continued to get worse so the she went to the local emergency room. Was given prednisone by ER doctor.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Hyperhidrosis, Loss of consciousness, Nausea
Clinical narrative: Pt nauseous then passed out - unresponsive for 3-5 minutes - was sweating and dizziness when she awoke - after about 20-30 min felt better - still nausea and headache.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Unresponsive to stimuli
Clinical narrative: Pt nauseous then passed out - unresponsive for 3-5 minutes - was sweating and dizziness when she awoke - after about 20-30 min felt better - still nausea and headache.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Feeling abnormal, Hypotension, Pyrexia, Vomiting
Clinical narrative: Patient felt bad shortly after receiving vaccine "whole body felt lazy" then had vomiting and fever 102 degrees went to ER at 3 AM 10/11/14. Hypotensive at ER gave fluids was released afternoon of 10/12/14.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dyskinesia, Metabolic function test normal, Skin warm
Clinical narrative: Per pt mother he felt warm and she TYLENOL about 1 hour after this mom was feeding him and he had head jerking that lasted 10-15 seconds this was approx 10hrs after 4 mo immunizations.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Irritability, Pain
Clinical narrative: Mom states fussiness began evening of flu shot given. Discussed with dr. Suggested to mom to alternate ibuprofen and TYLENOL due to suspected soreness.
Age: 20.0
Sex: M
Vaccine: ANTH, FLU3, SMALL, TYP
Symptoms: Blood bilirubin increased, Pruritus, Rash generalised
Clinical narrative: Rash which began in legs and then spread to rest of body including face and hands. Some pruritis. Afebrile. Mild increase bilirubin 1.4. Given BENADRYL.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Immediate post-injection reaction, Syncope
Clinical narrative: Immediately after receiving influenza vaccine, pt had syncope episode. Became alert in seconds, layed on floor for 10 minutes with 4 RN's attending. BP WNL, O2 at 8 L applied. Pt dizzy and faint upon sitting. EMS called, had second syncope episode. Pt transferred to hospital via EMS.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Hypoaesthesia, Injection site pain
Clinical narrative: (R) shoulder down to (R) hand burning, numbing pains at time of flu shot till now. Improving daily. Has been by work comp MD, in treatment.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient received vaccine on 10/24/14. On Saturday 10/25/14, she woke up with severe pain at the injection site. There was no pain at the injection site at the time of administration or later that day. Today, on 10/29 she still has pain in the arm. Patient was taking TYLENOL for pain. Applying heat to area.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Breast swelling, Injection site swelling, Local swelling, Lymphadenopathy, Urticaria
Clinical narrative: Swelling at injection site. Welt looked like a bullseye. Swelling went into axillary lymph nodes and into the right breast and down the right arm.
Age: 1.25
Sex: M
Vaccine: FLU3, PNC13, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 36.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Asthenia, Dyspnoea, Heart rate increased, Myalgia, Pyrexia
Clinical narrative: Hives right arm, muscle soreness, fever, difficulty breathing, increased heart beat, weakness.
Age: 36.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Urticaria
Clinical narrative: Hives right arm, muscle soreness, fever, difficulty breathing, increased heart beat, weakness.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray normal, Fatigue, Hypoaesthesia, Hypoaesthesia oral, Injection site pain
Clinical narrative: Pt received Flu vaccine on 9/15/14. C/O malaise and fatigue x 4 days post vaccine. Started having severe pain in Lt shoulder 2 weeks ago from today. Pain extended to LUE x 2 days ago with numbness. Numbness on Lt side of lips today.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pain in extremity, X-ray limb normal
Clinical narrative: Pt received Flu vaccine on 9/15/14. C/O malaise and fatigue x 4 days post vaccine. Started having severe pain in Lt shoulder 2 weeks ago from today. Pain extended to LUE x 2 days ago with numbness. Numbness on Lt side of lips today.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Cellulitis, Erythema, Feeling hot, Hypersensitivity
Clinical narrative: Redness, hot in right arm. Treated at emergency room for allergic reaction/cellulitis. Prescribed antibiotic + steroid.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Pain in extremity
Clinical narrative: Patient experienced a very sore arm even at rest, she was in discomfort.
Age: 60.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Feeling hot, Induration, Injection site induration, Injection site rash, Injection site swelling
Clinical narrative: Rash, swelling, hot, large swollen area, hard especially at site. No fever. Pt given antibiotic.
Age: 60.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site warmth, Rash, Swelling
Clinical narrative: Rash, swelling, hot, large swollen area, hard especially at site. No fever. Pt given antibiotic.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Developed significant size rash on the arm in which the vaccine was given. Patient went to urgent care and received OTC cream.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site bruising, Injection site inflammation
Clinical narrative: FLUVIRIN and PNEUMOVAX were administered to the patient on the same arm (left arm).  The area where the vaccines were administered started to get an inflammation and a bruise formed.  She was administered BENADRYL 50mg/ml and the inflammation decreased.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Nausea, Somnolence, Syncope
Clinical narrative: This year had thimerosal free flu vaccine. Within 40 min had fainting spell, sweating, blurred vision, nausea, ringing in ears, dizzy, had to lay down 1 hr. Drove home slept 10 hr.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Tinnitus, Vision blurred
Clinical narrative: This year had thimerosal free flu vaccine. Within 40 min had fainting spell, sweating, blurred vision, nausea, ringing in ears, dizzy, had to lay down 1 hr. Drove home slept 10 hr.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Urticaria
Clinical narrative: Customer called and wanted FLUZONE HD lot # and expiration date because got hives from this. She has a history of chronic urticaria as well so it was hard to tell. Had to see MD due to this.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: 3 inch erythema and warmth 1 inch below injected area.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Contusion, Dehydration, Diarrhoea, Dyspnoea
Clinical narrative: Blood pressure dropped, vision blurred, ringing in ears, difficulty breathing, then nausea, vomiting, diarrhea, fell against sink and bruised leg/hip, severe dehydration followed.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Nausea, Tinnitus, Vision blurred, Vomiting
Clinical narrative: Blood pressure dropped, vision blurred, ringing in ears, difficulty breathing, then nausea, vomiting, diarrhea, fell against sink and bruised leg/hip, severe dehydration followed.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysstasia, Hyperhidrosis, Hypersomnia, Nausea
Clinical narrative: This year had thimerosal free vaccine. Within 30 min had fainting spell, sweating, blurred vision, ringing in ears, nausea, dizzy, couldn't stand up. Finally drove home and slept 12 hours.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Reaction to previous exposure to any vaccine, Syncope, Tinnitus, Vision blurred
Clinical narrative: This year had thimerosal free vaccine. Within 30 min had fainting spell, sweating, blurred vision, ringing in ears, nausea, dizzy, couldn't stand up. Finally drove home and slept 12 hours.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head normal, VIIth nerve paralysis
Clinical narrative: Bell's palsy started day after vaccination.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Dyspnoea, Erythema, Fatigue
Clinical narrative: Inj. around noon; afternoon felt tired and moving slow with gradual worsening, peaking around 6 pm with intermittent HA, 4/10, lightheaded, ears/eyes red, ears ringing, pulse low, BP fine. Throat started to have tingling feeling around 8 pm and difficult to breathe that lasted 1-2 mins; felt as though may pass out. At 9 pm started with cold chills. Couldn't sleep - arm sore x 1 day.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Heart rate decreased, Insomnia, Ocular hyperaemia, Pain in extremity
Clinical narrative: Inj. around noon; afternoon felt tired and moving slow with gradual worsening, peaking around 6 pm with intermittent HA, 4/10, lightheaded, ears/eyes red, ears ringing, pulse low, BP fine. Throat started to have tingling feeling around 8 pm and difficult to breathe that lasted 1-2 mins; felt as though may pass out. At 9 pm started with cold chills. Couldn't sleep - arm sore x 1 day.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Tinnitus
Clinical narrative: Inj. around noon; afternoon felt tired and moving slow with gradual worsening, peaking around 6 pm with intermittent HA, 4/10, lightheaded, ears/eyes red, ears ringing, pulse low, BP fine. Throat started to have tingling feeling around 8 pm and difficult to breathe that lasted 1-2 mins; felt as though may pass out. At 9 pm started with cold chills. Couldn't sleep - arm sore x 1 day.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Pain, Rash erythematous, Rash pruritic
Clinical narrative: Two days after receiving FLUMIST, patient developed red rash on face and trunk. This rash was painful and itchy which caused concern and child was taken to the ER.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Fever, nausea, body aches.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Headache, Pyrexia, Tremor
Clinical narrative: Approx. 30 minutes after injection developed 103 degree Fever, was weak and shakey. Next am woke with headache; temp was down to 99 degrees.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling
Clinical narrative: Patient had a lot of redness around the arm and some swelling in the area with a good amount of swelling around the elbow.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Pain, Rash erythematous, Rash pruritic
Clinical narrative: Two days after receiving FLUMIST patient developed red rash on all four extremities. Rash was painful and itchy which caused concern and patient was taken to ER.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Had flu shot at 2pm 10/28/2014. Went home took a nap then at 5pm when individual woke up notice itching, looked at legs noticed hives. Took BENADRYL. Symptoms are resolving.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Fall, Headache
Clinical narrative: Pt received flu vaccine, following day reported HA, weakness, "falling down" x 4 but no syncope or seizure.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Rash
Clinical narrative: FLUZONE High Dose injection given in Rt. deltoid 10/4/14 - next day bruise developed on lower elbow - day after that 10/6 rash occurred - pt went to hospital.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Headache, Injection site pain, Injection site rash, Photophobia
Clinical narrative: Vaccine given at 0930 on 10/27. By 1130 patient had loss of bladder control, blinding headache, vomiting, photophobia, dizziness. Diffuse, painful rash to injection site erupted 10/28. Patient has no hx of migraines.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Urinary incontinence, Vomiting
Clinical narrative: Vaccine given at 0930 on 10/27. By 1130 patient had loss of bladder control, blinding headache, vomiting, photophobia, dizziness. Diffuse, painful rash to injection site erupted 10/28. Patient has no hx of migraines.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Insomnia
Clinical narrative: Initial flu vaccine injection was uneventful. Severe right upper arm pain about 5 1/2 hrs post injection; Rated pain 5 on 1-10 scale initially. Currently pain is 5 during the day and 8 at night. Severe pain at injection site. Unable to sleep at night. Appt. with PCP 10/29/14, who recommended contact of pharma. company. Right hand numbness.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: Given FLUMIST w/reported history of egg allergy - Pt observed for 30 minutes and released w/no symptoms.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Fatigue, Pain in extremity
Clinical narrative: Fatigue, very painful whole arm. Painful elbow and wrist - unable to find comfortable position. Lasted 10 days.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dysphagia, Dyspnoea, Eye swelling, Nasal congestion
Clinical narrative: Started with coughing, then throat constricted, so difficulty breathing and swallowing, continued up the head w/nasal and sinus congestion, red, swollen, bloodshot eyes.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Ocular hyperaemia, Sinus congestion, Throat tightness
Clinical narrative: Started with coughing, then throat constricted, so difficulty breathing and swallowing, continued up the head w/nasal and sinus congestion, red, swollen, bloodshot eyes.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Local swelling, Malaise
Clinical narrative: Patient had arm swelling - all hand didn't feel well for 2 days.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Insomnia, Pain in extremity, Peripheral coldness
Clinical narrative: Pain during injection process from site of fingers. Pain rated 8 on 1-10 scale for remainder of day and into day 3. Since the injection, pain is from upper arm to fingers. It is a continuous dull ache, with severe pain upon use. Unable to sleep on left side. Appt. with PCP on Oct 20, 2014 and was treated with ice and ibuprofen and has a follow up appt. 11/7/14. Left hand coldness.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Insomnia, Pain
Clinical narrative: Upon injection, felt needle and vaccine enter her arm. Soreness and pain from shoulder to elbow. Numb, dull ache continues during the day. Minimal relief with ibuprofen during the day and TYLENOL PM at night. Unable to sleep on either side. Pain 6 during day and 10 during night on 1-10 scale.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Pain in extremity
Clinical narrative: 30 min to 1 ht after getting flu shot, pt reported be sweaty for 1-2 min, being lightheaded, and weak (had to sit down), went to bed. Arm extremely sore, but resolved per pt.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Infection, Pyrexia
Clinical narrative: Patient said red ring formed about 3-4 inches out, fever of 105, went to doctor and doctor said was infected, patient remembers vaccinator using gloves and swabbing, (suspect pneumo shot).
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Administration site reaction, Flushing, Local reaction, Rash
Clinical narrative: Large localized reaction at vaccine administration site. Flushing and rash on chest. Treatment with BENADRYL - 2 office visits in Employee Health.
Age: 90.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Syncope
Clinical narrative: Severe dizzy, fainting, nausea - ambulance to hospital. 10/17/14 more moderate attack. No hospitalization.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Flu vaccine administered 10/22. Next day started pain, redness and has increased in size from plum size to now size of orange with increased warmth. OMNICEF started.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Diarrhoea, Malaise, Vomiting
Clinical narrative: Patient felt sick in evening. Chills possible fever, vomiting, diarrhea. Next day ok but "felt weak as a kitten".
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Joint swelling, Weight bearing difficulty, X-ray normal
Clinical narrative: (R) ankle swelling next morning after receiving Influenza unable to weight bear.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Flushing, Nausea, Pyrexia
Clinical narrative: Fever, nausea, face flushed.
Age: 1.5
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient had fever and was given TYLENOL at 1am on 10/29/14. At 4am mother noticed child had vomited and was again running fever. Patient was taken to local ED with rectal temp of 40.8 at 4:28am. Treated with 100mg ibuprofen and 2mg ondansetron and sent home with instructions to alternate TYLENOL and MOTRIN every 3 hours. Child was not given any medication after discharge and arrived at our clinic at 9:45 with fever of 105.5. Given 80mg ibuprofen and covered with ice packs and wet towels to reduce fever. EMS was called when child's fever 15 minutes later was 106.4. At time of EMS arrival 16 minutes later temperature had dropped to 104.9. Child is currently being evaluated at the hospital.
Age: 59.0
Sex: F
Vaccine: FLUX, VARZOS, FLU4, VARZOS
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: This spontaneous report as received a 59 year old female patient with asthma, and high blood pressure. The patient's medical history included allergic to MOBIC, allergic to penicillin and allergic to BACTRIM. On 17-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX in the left arm (strength, dose, dose number and route unspecified), lot # reported as K009771, expiry date reported: October 2015. Other suspect therapies included influenza virus vaccine (manufacturer unknown), which was vaccinated on 17-OCT-2014, in her right arm, (strength, dose, dose number, route and lot # unspecified). Concomitant therapies included lisinopril (manufacturer unknown) and SINGULAIR. On 25-OCT-2014, the patient had one blister on her left chest, a whole big cluster under her left armpit and two small spots on her left forearm. She sought medical attention and was seen by a physician's assistant to address her symptoms and was diagnosed as having shingles. Patient was prescribed with "valcyclovir" and started taking it on 26-OCT-2014 to treat the symptoms. The outcome of events was reported as not recovered/not resolved. The causal relationship was not reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLUX, VARZOS, FLU4, VARZOS
Symptoms: Diarrhoea, Herpes zoster, Injection site reaction, Pyrexia
Clinical narrative: This spontaneous report as received a 59 year old female patient with asthma, and high blood pressure. The patient's medical history included allergic to MOBIC, allergic to penicillin and allergic to BACTRIM. On 17-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX in the left arm (strength, dose, dose number and route unspecified), lot # reported as K009771, expiry date reported: October 2015. Other suspect therapies included influenza virus vaccine (manufacturer unknown), which was vaccinated on 17-OCT-2014, in her right arm, (strength, dose, dose number, route and lot # unspecified). Concomitant therapies included lisinopril (manufacturer unknown) and SINGULAIR. On 25-OCT-2014, the patient had one blister on her left chest, a whole big cluster under her left armpit and two small spots on her left forearm. She sought medical attention and was seen by a physician's assistant to address her symptoms and was diagnosed as having shingles. Patient was prescribed with "valcyclovir" and started taking it on 26-OCT-2014 to treat the symptoms. The outcome of events was reported as not recovered/not resolved. The causal relationship was not reported. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Cold sweat, Dizziness, Hyperhidrosis
Clinical narrative: 15 min following administraiton of vaccines, felt dizzy was returned to exam room, cool compress was used, small about , was clammy and sweaty. BP 88/68, 66 pulse, drank cranberry juice and pretzels. 2:25 - 90/72; 2:30 98/67 pulse 76. States feels fine and able to drive self home. 2:35 BP 98/67 69 was 100/67 prior to immunization. Was released at 2:45 PM.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 13-OCT-2014 the patient was vaccinated with RECOMBIVAX HB lot # H014029, which was expired on 07-SEP-2014. No adverse effects reported. No further information. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 37 year old female patient. There was no pertinent medical history, drug reactions or allergies reported. On an unknown date (the nurse presumed that the patient was inoculated when she was an infant, but had no records or definite information), the patient was vaccinated with a dose of M-M-R II injection (dose, dose number, lot/batch number, expiration date and route of administration were not reported). There was no concomitant medication reported. On an unknown date, the patient had the titers drawn because she was changing jobs and her titer results were negative for mumps and rubella. It was reported that the patient had not any adverse effects and had never had mumps or rubella. No product quality complaint (PQC) reported. No treatment was given for the events. The patient did not seek medical attention. The outcome of the event was unknown. The relatedness between the events and M-M-R II was not reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Pain
Clinical narrative: 6in x 3in redness around injection site and warm to the touch with body aches.
Age: 0.98
Sex: M
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an 11-month-old male patient. Current conditions and other relevant history were not reported. On 21-OCT-2014 the patient was vaccinated with the first dose of M-M-R II (subcutaneous injection, dose 1, 0.5 ml, subcutaneous; batch/lot # and expiration date not reported). Concomitant therapies were not reported. The reporter informed that he patient received the first dose of M-M-R II on 21-OCT-2014, 8 days before the patients 12 month birthday. No adverse effects were reported. No further information was provided. Additional information is not expected because the reporter did not consent to be contacted for further follow-up.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old patient of unknown gender. Current conditions and other medical history were not reported. On 21-OCT-2014 the patient was vaccinated with ZOSTAVAX (Subcutaneous injection, 0.65 ml, subcutaneous, batch # reported as K00888, lot # not reported, expiration date reported as 20-SEP-2015, anatomical location not reported). Concomitant therapies were not reported. The reporter informed that the patient, on 21-OCT-2014, received ZOSTAVAX that was stored at 5 (units not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician, via a company representative, refers to an unspecified number of patients. The physician reported that the number of patients was "in the teens". No demographics or information on their medical history, concurrent conditions or concomitant drugs were provided. On unknown dates the patients were vaccinated with doses of ZOSTAVAX, 0.65 ml, subcutaneously (sites of administration, lot# and expiration dates not reported). On unknown dates the patients developed shingles at unspecified time post vaccination. The patient sought medical attention via contacting the physician. Reportedly the patients were not treated. The outcome of shingles was unknown. Relatedness between use of ZOSTAVAX and the adverse event was not reported. Additional information is not expected, as there was no consent to contact the reporting physician.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 22-OCT-2014 the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous) that had expired in September 2014 (lot # not reported). No adverse events were reported. Additional information is not expected as there was no consent to contact physician.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Swelling
Clinical narrative: Swelling.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a healthcare worker via company representative refers to a male patient of unknown age. No pertinent medical history was reported. On 09-OCT-2014, the patient was vaccinated with ZOSTAVAX (dose, route, lot# were not reported). Concomitant medications were not reported. On 10-OCT-2014, the patient experienced herpes zoster within 24 hours of the vaccination. Patient sought medical attention by an office contact. No Product Quality Complaint (PQC) was involved. The outcome of herpes zoster was unknown. Causality was not provided by the reporter. Additional information has been requested.
Age: 1.34
Sex: M
Vaccine: HEPA
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Immediate reaction to Hep A within seconds site of inj. became red, warm and some spotting red dots.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt received Zostavax on 10/6/14. 1-2 days later noted some soreness and warmth at site. Yesterday increased pruritis, warmth, swelling at site. Today at work nurse looked at arm and told her to come be seen. No fevers, chills, sweats. Patient treated for allergic reaction and possible cellulitis. Antihistamines and antibiotics in process.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Erythema, Local reaction
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 20 year old female patient. Current conditions and other relevant medical history were not reported. On 12-AUG-2014 the patient was vaccinated with the first dose of VARIVAX (Merck) (Subcutaneous injection, dose 1, 0.5 ml; route, anatomical location, batch/lot # and expiration date not reported). Concomitant therapies were not reported. The physician informed that after the first dose of VARIVAX (Merck), on an unspecified date in 2014, the patient experienced extended local reaction with redness. The physician also stated that after the blood work test, performed on an unspecified date in 2014, the patient's titer showed no response to VARIVAX (Merck). The patient sought medical attention. The outcome of the events was not reported. Causality assessment was not provided by the reporter. Additional information is not expected because the physician did not consent to be contacted for further follow-up.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Crying, Emotional disorder, Syncope
Clinical narrative: This spontaneous report was received from a other health professional via a company representative refers to a 14 year old female patient. Concurrent condition included: very emotional and crying. On 14-OCT-2014 the patient was vaccinated with GARDASIL dose 1, (dose, route and frequency unspecified) intramuscular. No concomitant medications were reported. On 14-OCT-2014, the patient experienced syncopal episode. It was reported that after receipt of this dose, patient had a syncopal episode in the office and was slumped over in the chair - although she was easily aroused and sent home with her mother (this was considered resolved). The reporter stated that on 15-OCT-2014, the patient came back to the office along with her mother. The mother reported to the reporter that her daughter (the patient) has been very emotional and crying since receipt of the vaccine, although patient states she has been emotional and crying for one week (which began prior to receipt of the vaccine). Treatment given was none. On 14-OCT-2014, the outcome of syncopal episode was reported as resolved. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 32 year old male patient. On 15-MAR-2014, the 32 years old patient was vaccinated with his first dose of GARDASIL lot # K007360, expiration date: 02-FEB-2017, 0.5 ml, intramuscular. On 23-MAY-2014, the patient received second dose of GARDASIL and on 19-OCT-2014, 7 months after his first dose, he received third dose of GARDASIL, both lot # K007360, expiration date: 02-FEB-2017, 0.5 ml, intramuscular. No adverse effects were noted by the patient. The patient did not seek medical attention. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Experienced red rash, hot to touch next day. Went to urgent care, received abx thought to be possible infection.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: At about 7PM, patient reported having chills, site of shot was red, swollen, hot and painful to touch.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Tenderness to touch at sire of vaccine x 13 weeks - no treatment.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old non-pregnant female patient. The patient's chart listed allergy to horse serum in an unspecified tetanus vaccine, allergy to penicillin and acetaminophen, VICODIN. No other pertinent medical history was reported. On 23-OCT-2014, the patient was vaccinated with ZOSTAVAX ( lot # K008883, exp. date: 20-SEP-2015)0.65 ml, subcutaneously (anatomical location was not reported). There were not concomitant medications. On an unspecified date, approximately in October 2014, the patient experienced a warm pink area, a little bit larger than a 50 cent piece, surrounding the injection site. The pharmacist stated that the patient reported that it seemed to have gotten larger in circumference from the date she first noticed it, which date was unspecified(approximately in October 2014). There was not treatment given for the adverse events, the patient did not seek for medical attention, no laboratory tests were performed. The outcome of the events was unknown. The relatedness between vaccination with ZOSTAVAX and the events was not reported. There was not product quality complaint reported for this case. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to an approximately 14 year old male patient. Current conditions and medical history was not reported. On an unknown date in November 2013, February 2014 and May 2014, patient was vaccinated with first, second and third dose of GARDASIL injection, respectively for an unknown indication (dose and route were not reported). Concomitant medications were not reported. On 13-OCT-2014 the patient was vaccinated with GARDASIL additional fourth dose. Lot number was reported as J010668 and expiry date was 29-APR-2016. No adverse effects reported. Patient did not seek medical attention. Product quality complaint was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dyskinesia, Eye movement disorder, Seizure like phenomena, Speech disorder, Syncope
Clinical narrative: Vaccine admin. and within seconds had what appeared, at the time, to be a seizure, with jerking, garbled speech, eye rolled back. Did recover in seconds but could not stabilize BP - squad called and transported without further incidence. Later dx as syncope.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 15-OCT-2014 the patient was vaccinated with an expired dose of 0.65 ml ZOSTAVAX (lot # J003806, expiration date 03-JUL-2014), subcutaneous. Dose supported. No adverse experience reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to a patient of unknown demographics. No current condition was reported. No historical medication was reported. On 24-OCT-2014, the patient was vaccinated with ZOSTAVAX  lot # J007854, expiration date- 28-SEP-2014, 0.65 ml, subcutaneous. No concomitant medication was reported. The nurse reported that on 24-OCT-2014, expired dose of ZOSTAVAX was administered. No adverse effect was reported. The outcome of expired dose of ZOSTAVAX was administered was unknown. No further information was provided. 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. Information about concurrent conditions, concomitant medication and medical history was not provided. On unknown dates the patients were vaccinated with improperly stored VARIVAX (Merck) (injection, lot#, dose and route were not provided). No adverse symptom was reported. The temperature excursion with VARIVAX (Merck) was found to be a supported excursion with in-house stability data. Additional information has been requested.
Sex: U
Vaccine: MMR
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 18-OCT-2014 the patient was vaccinated with an expired dose of M-M-R II, lot # H018947, expiry date: 18-OCT-2014/reported: 17-OCT-2014, dose/frequency: 0.5 ml (dose number, route not reported). No adverse effects reported. The outcome of event was unknown. Additional information has been requested.
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Dry mouth, Headache
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old patient of unknown gender. The patient was not pregnant and had drug reactions/allergies to SULFA. On 24-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot# was reported as K000945, expiry date 06-MAR-2015, dose and route were not provided). Concomitant medications were not provided. Beginning on an unknown date (in approximately October 2014), the patient developed dry mouth and on 27-OCT-2014 the patient developed headaches. The adverse events remained ongoing at the time of report. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Pruritus
Clinical narrative: This spontaneous report as received from a male consumer of unknown age regarding himself. On 16-OCT-2014 the patient was vaccinated with ZOSTAVAX dose 1, 1 time vaccine. On 16-OCT-2014 the patient's hand had come in contact with the ZOSTAVAX. On 17-OCT-2014, the patient experienced itchiness at the site of exposure. The outcome of itchiness was reported as not recovered/not resolved. The outcome of his hand had come in contact with the ZOSTAVAX is unknown. The reporter considered his hand had come in contact with the ZOSTAVAX to be not related to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a patient of unknown age. On 22-OCT-2014 the patient was vaccinated with a dose of expired ZOSTAVAX, dose, route not reported, lot # J008433, expiration date 11-OCT-2014. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. Medical history, current conditions and drug allergies were not reported. On 22-OCT-2014, the patient was vaccinated with ZOSTAVAX single dose, lot # K007988, expiration date 03-SEP-2015) subcutaneous in the right arm. No concomitant medication was reported. On an unspecified date in October 2014, the patient developed redness, warmth, swelling, and tenderness at the injection site. The patient sought for pharmacist attention. The outcome of redness, warmth, swelling, and tenderness at the injection site was not reported. The relatedness between the ZOSTAVAX and the events was not provided. Additional information is not expected because there was no consent to further contact.
Age: 0.9
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 11 month old patient. The patient's medical history was not reported. On 16-OCT-2014 the patient was vaccinated with first dose of M-M-R II and VARIVAX (Merck) (dose, frequency and lot # were not reported). No adverse symptoms were reported. No product complaint was reported for M-M-R II and VARIVAX (Merck). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to unspecified number of patients of unknown age. Current conditions and medical history was not reported. On an unknown date, patients were vaccinated with PNEUMOVAX 23 injection (route, lot number and frequency were not reported). Concomitant medications were not reported. On an unknown date, patients were administered PNEUMOVAX 23 which measures slightly more than 0.5 milliliter (ml) (such as 0.52 ml or 0.51 ml). No adverse effects were reported. Product quality complaint (PQC) was filed for this case, but it was determined that the caller was reporting feedback and user error rather than a PQC. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy test positive, Eye disorder
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient with neomycin allergy. On 08-JUN-2012 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously (LOT and batch numbers were not provided). Concomitant therapies included SINGULAIR, estradiol (manufacturer unknown), unspecified allergy and antibiotics eye drops, unspecified nasal sprays and unspecified antibiotics. In approximately December 2013 (reported as: 6 months later) the patient began experiencing unspecified eye symptoms. The patient had recently, on an unspecified date, allergy testing completed that has shown neomycin allergy. The patient was treated with unspecified steroids at the moment of this report. The patient sought medical attention via contacting the physician's and was under physician's treatment. The outcome of unspecified eye symptoms was reported as not recovered/not resolved. The relatedness between unspecified eye symptoms and ZOSTAVAX was not reported. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a male patient of unknown age. On 23-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 injection, dose 2 (dose and route unspecified). No concomitant medications were reported. The nurse reports that the patient, who received his 1st dose of PNEUMOVAX 23 on an unspecified date "last year", was inadvertently administered a 2nd dose of PNEUMOVAX 23 on 23-OCT-2014. No adverse effect reported. The outcome of the medication error inadvertently administered a second dose of PNEUMOVAX 23 on 23-OCT-2014 is unknown. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients (gender and age not reported). Since October 2014, improperly stored PROQUAD (Merck) (dose, lot number and route not provided) were administered to patients. No adverse effects were noted. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a female physician of unknown age refers to herself. "About one week ago", on approximately 25-SEP-2014 the patient was vaccinated with ZOSTAVAX (strength and dose was not reported), lot # K003601, expiration date: 19-MAR-2015), administered subcutaneously in the tricep area of the upper arm rather than the deltoid region by the pharmacist. 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 registered nurse refers to an unknown number of patients (gender and age not reported). Since October 2014, improperly stored VARIVAX (Merck) (dose, lot number and route not provided) were administered to patients. No adverse effects were noted. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, HPV4, HEPA, HPV4
Symptoms: Blood glucose, Electrocardiogram, Electroencephalogram, Metabolic function test, Tonic convulsion
Clinical narrative: This case was reported by a physician and described the occurrence of seizure in a 12-year-old male subject who was vaccinated with HAVRIX pediatric (GlaxoSmithKline), (non-gsk) GARDASIL. The subject's medical history included seizure when he was in kindergarten but none since that time. Concurrent medical conditions included allergic rhinitis and migraine (no migraine in the past year). Subject's mother had migraines. On 22 August 2014, the subject received 1st dose of HAVRIX pediatric (unknown route, right deltoid), unspecified dose of GARDASIL (unknown route, left arm). On 22 August 2014, almost immediately after vaccination with GARDASIL and HAVRIX pediatric, the subject experienced seizure. This case was assessed as medically serious by GSK. The subject was referred to the emergency room. At the time of reporting the outcome of the event was unspecified. Follow-up information received on 16 October 2014: This case was reported to the regulatory authority under reference VAERS E-81734. The patient had no history of movement disorder, head injury, central nervous system disorder, cerebral palsy, neurological handicap, congenital anomaly, diabetes or renal failure. The patient didn't receive any medication which was known to reduce the seizure threshold. During the vaccination with GARDASIL, the needle removed from the syringe. Almost immediately after vaccination with HAVRIX pediatric, the subject experienced generalized tonic seizure (serious criteria GSK medically significant), loss of consciousness (serious criteria GSK medically significant) and trembling for 30 seconds and then regained consciousness. The patient did not experience urine or fecal incontinence. Thereafter the patient was drowsy and disoriented without headache and generalized both upper extremities and both lower extremities weakness. The patient could not remember the event. The event was witnessed but not preceded by an aura or headache. On 22 August 2014, the following tests were performed electrocardiogram (normal), blood serum (normal) and serum electrolytes (normal). On 3 September 2014, an electroencephalogram showed an abnormal sleeping pattern.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, HPV4, HEPA, HPV4
Symptoms: Convulsion, Headache, Muscular weakness
Clinical narrative: This case was reported by a physician and described the occurrence of seizure in a 12-year-old male subject who was vaccinated with HAVRIX pediatric (GlaxoSmithKline), (non-gsk) GARDASIL. The subject's medical history included seizure when he was in kindergarten but none since that time. Concurrent medical conditions included allergic rhinitis and migraine (no migraine in the past year). Subject's mother had migraines. On 22 August 2014, the subject received 1st dose of HAVRIX pediatric (unknown route, right deltoid), unspecified dose of GARDASIL (unknown route, left arm). On 22 August 2014, almost immediately after vaccination with GARDASIL and HAVRIX pediatric, the subject experienced seizure. This case was assessed as medically serious by GSK. The subject was referred to the emergency room. At the time of reporting the outcome of the event was unspecified. Follow-up information received on 16 October 2014: This case was reported to the regulatory authority under reference VAERS E-81734. The patient had no history of movement disorder, head injury, central nervous system disorder, cerebral palsy, neurological handicap, congenital anomaly, diabetes or renal failure. The patient didn't receive any medication which was known to reduce the seizure threshold. During the vaccination with GARDASIL, the needle removed from the syringe. Almost immediately after vaccination with HAVRIX pediatric, the subject experienced generalized tonic seizure (serious criteria GSK medically significant), loss of consciousness (serious criteria GSK medically significant) and trembling for 30 seconds and then regained consciousness. The patient did not experience urine or fecal incontinence. Thereafter the patient was drowsy and disoriented without headache and generalized both upper extremities and both lower extremities weakness. The patient could not remember the event. The event was witnessed but not preceded by an aura or headache. On 22 August 2014, the following tests were performed electrocardiogram (normal), blood serum (normal) and serum electrolytes (normal). On 3 September 2014, an electroencephalogram showed an abnormal sleeping pattern.