chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant, refers to a patient of unknown age and gender. On 15-MAY-2013 the patient was vaccinated with the first dose of GARDASIL injection, intramuscularly (dose, lot number and expiration date not provided). On 03-JUL-2013, the patient was vaccinated with the second dose of GARDASIL injection, intramuscularly (dose, lot number and expiration date not provided). On 03-SEP-2013 the patient was vaccinated with the third dose of GARDASIL injection, intramuscularly (dose, lot number and expiration date not provided). No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a male patient with no pertinent medical history. On an unknown date the patient was vaccinated with ZOSTAVAX injection (strength, dose, route, lot number and expiration date not provided). No concomitant medication was used. On an unknown date the patient developed a baseball size welt at the injection site that lasted 3 days. No treatment was given for adverse event. None of lab diagnostics was performed. The patient did not seek a medical attention. The outcome of baseball size welt at the injection site was reported as recovered/resolved. The relatedness between vaccination with ZOSTAVAX and baseball size welt at the injection site was not reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Visual impairment
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 year old female patient with no pertinent medical history and no drug reactions or allergies. On 13-NOV-2013 the patient was vaccinated with ZOSTAVAX 0.65 ml injection, subcutaneously (lot number # J006827, expiration date 14-SEP-2013). On 16-NOV-2013 the patient experienced visual disturbances and headaches that come and go. The patient reported that she had a hair-like object in the front of her eye, that was blocking her vision and that could not be wiped away. No treatment was given and no lab diagnostics studies were performed. The outcome of visual disturbances and headaches was reported as not recovered/not resolved. The relatedness between vaccination with ZOSTAVAX and visual disturbances and headaches was not reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This spontaneous report as received from a pharmacist refer to a 65 year old male patient with a history of tetracycline use and allergy (unspecified). In November 2013 the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous) for vaccination. There were non concomitant medications. In November 2013 after receiving ZOSTAVAX the patient has developed muscle pain. The muscle pain comes and goes, and the pain goes away when he takes over-the-counter TYLENOL. The outcome of muscle pain, comes and goes is unknown. No lab diagnostics were performed. The patient sought medical attention by contacting the pharmacist. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 8 week old patient. On 31-OCT-2013, the patient was inadvertently vaccinated wiht HAEMOPHILUS B CONJUGATE VACCINE (MENINGOCOCCAL PROTEIN CONJ)) (dosages and routes of administration not provided) tha thad been improperly stored. No adverse effects were reported. Nurse informed incorrectly stored vaccine had been disposed of and she did not have lot numbers or expiration dates. She confirmed that no patient had been vaccinated with GARDASIL. This case is linked to 1311USA000343 and 1311USA011720 due to same reporter link. Additional information is not expected.
Age: 0.2
Sex: M
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, Pyrexia
Clinical narrative: This spontaneous report as received from the patient's mother refer to her 2 month old son. On an unknown date, the patient was vaccinated (route not provided) with PNEUMOVAX 23 (lot number and expiry date not provided). On an unknown date, the reporter's 2 month old son received PNEUMOVAX and was suffering from low grade fever. It was confirmed with patient's mother that the age of her son was 2 months old and he received PNEUMOVAX 23. The outcome of low grade fever and 2 month old son received PNEUMOVAX was unknown. The reporter did not assess the relationship between the low grade fever and PNEUMOVAX 23. Additional information is not expected.
Age: 0.68
Sex: M
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 8month old patient. On 31-OCT-2013, the patient was inadvertently vaccinated with HAEMOPHIUS B CONJUGATE VACCINE (MENINGOCOCCAL PROTEIN CONJ)) (dosages and routes of administration not reported) that had been improperly stored. No adverse effects were reported. Nurse informed incorrectly stored vaccine had been disposed of and she did not have lot numbers or expiration dates. She confirmed that no patient had been vaccinated with GARDASIL. The case is linked to 1311USA000343 and 1311USA011719 due to same reporter link. Additional information is not expected.
Age: 75.0
Sex: M
Vaccine: FLU3, TTOX
Symptoms: Injection site pain, Injection site swelling, Local swelling, Pain in extremity
Clinical narrative: Right arm to hand swollen and painful.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age (gender not reported). On 31-OCT-2013 the patient was vaccinated with a dose of GARDASIL (lot # J008423, exp. date 21-JAN-2016 (route and dose not reported) which was exposed to a low temperature of 29F for a total of 11 hours from 30-OCT-2013 until 07-NOV-2013. These excursions were not supported. No adverse effects were reported. This is one of several reports from same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age (gender not reported). On 01-NOV-2013 the patient was vaccinated with a dose of GARDASIL (lot # J008423, exp. date 21-JAN-2016) (route and dose not reported) which was exposed to a low temperature of 29F for a total of 11 hours from 30-OCT-2013 until 07-NOV-2013. These excursions were not supported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Muscular weakness, Syncope
Clinical narrative: Lower extremity weakness and syncope started 11-19-13 evening resolved on 11-22-13. No treatment.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, certified medical assistant (C.M.A) refers to a patient of unknown age and gender. In approximately November 2011 reported as about 2 years ago the patient was vaccinated with the first dose of GARDASIL, injection (strength, dose, lot number and expiration date not provided). In approximately November 2012 reported as about 1 year ago the patient was vaccinated with the second dose of GARDASIL injection (strength, dose, lot number and expiration date not provided). On 15-NOV-2013 the patient came to office to receive the 3rd dose of GARDASIL. No  adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age (gender not reported). On 05-NOV-2013 the patient was vaccinated with a dose of GARDASIL (lot # J008423, exp. date 21-JAN-2016) (route and dose not reported) which was exposed to a low temperature of 29F for a total of 11 hours from 30-OCT-2013 until 07-NOV-2013. These excursions were not supported. No adverse effects were reported. This is one of several reports from same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pustule, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX23, 0.5 ml (lot number and expiry date unknown) and (dosing regimen and frequency unknown) and AFLURIA (lot number and expiry date unknown) and (dosing regimen and frequency unknown). On an unknown date the patient developed soreness, swelling and redness at the injection site, although it is unclear which one, which then developed a pustule that traveled down the patient's arm. The field employee could not specify how far down the arm the pustule traveled or how big this lesion was. It was reported that the patient sought medical attention and visited a pharmacy. The pharmacist told the field representative that she recommended MOTRIN (manufacturer unknown) and BENADRYL (manufacturer unknown). The patient has not followed up with the pharmacist. No lab diagnostics studies were performed. The outcome of redness at the injection site, soreness at the injection site, pustule and swelling at the injection site was reported as not recovered. The relatedness of the events to the therapy with PNEUMOVAX23 and AFLURIA was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age (gender not reported). On 04-NOV-2013 the patient was vaccinated with a dose of GARDASIL (lot # J008423, exp. date 21-JAN-2016) (route and dose not reported) which was exposed to a low temperature of 29F for a total of 11 hours from 30-OCT-2013 until 07-NOV-2013. These excursions were not supported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Approx. 1530 Varicella vaccine was administered SQ on (R) thigh with 1 hive appearing within 5 minutes. BENADRYL 1/2 tsp. given immediately.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes simplex
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 09-NOV-2013, the patient was vaccinated with a dose of ZOSTAVAX (dose, strength, lot #, route and site of administration not reported). On 16-NOV-2013, the patient developed something what looked to be herpes simplex virus (HSV). The outcome of event was not reported. The relatedness between ZOSTAVAX and the event was not reported. The patient sought medical attention via a phone call to the office. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. On an unknown date approximately in NOV-2011 (also reported as 2 or 3 years ago) the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) and (dosing regimen and frequency unknown) for vaccination. On an unknown date (also reported as recently) the patient experienced shingles. It was reported that the patient sought medical attention and contacted a physician. The outcome of shingles was reported as not recovered. The relatedness of the events to the therapy with ZOSTAVAX was unknown. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: Woke with pink pinpoint rash (non raised) on chest and abd. Fever 11/15 - resolved 11-16. Rash resolved 11-17-13.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Local swelling, Pain in extremity, Vaccination complication
Clinical narrative: Pt. received PNEUMOVAX 11/26/13 at around 10 AM. She notes that on same day in the PM the arm started to swell, get red and painful. Seen in the office at 10AM 11/27/13; findings are confirmed = adverse Rx to shot with cellulitis 20 cm x 17 cm.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pain, Swelling
Clinical narrative: Localize pain at injection site. Swelling more than 72 hours. Redness at injection site.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Pain, Pruritus, Skin irritation
Clinical narrative: Minor itching. Skin irritation below injection site. Localized pain.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Exposure during pregnancy, Headache, Nausea
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to an 18 year old female patient. The patient's pertinent medical history was reported as none. She had no drug allergies. On 26-FEB-2013 the patient was inadvertently vaccinated with GARDASIL lot # H019088,0 .5 ml (administered via intramuscular injection). She did not take any concomitant medications. At the time of the administration of the vaccine, the patient was 2 weeks pregnant. The LMP (date of last menstrual period) was calculated to be 12-FEB-2013 and EDD (estimated date of delivery) 19-NOV-2013. On an unknown date, after the administration of GARDASIL, the patient presented with diarrhea, nausea and headache. She came to the nurse for treatment on 29-MAR-2013 and was prescribed ZOFRAN on the same date. No lab diagnostics studies were performed. The reporting nurse was not sure if the patient had recovered from the diarrhea, nausea and headache and stated that she was still pregnant at this time. The reporter did not provide a causality assessment for diarrhea, nausea and headache and vaccinated with GARDASIL. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Meningitis haemophilus, Vaccination failure
Clinical narrative: Initial report was received on 19 November 2013 from a consumer from an unverified internet source, who is also the patient's parent. A female patient age two at the time of the event had received the HIB vaccine (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later, developed "hib meningitis, a rare case of vaccination failure". According to the mother, the patient was able to mount a much faster and more effective response as a result of the fact that she had been vaccinated. The patient is now 14 years old and is "bright, beautiful and healthy". The patient outcome is recovered on an unreported date. No further information was available at the time of the report. Documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Bed rest, Chest pain, Condition aggravated, Flushing
Clinical narrative: Initial report was received on 20 November 2013 from a health care professional who is also the patient. A 52 year-old female patient with a history of allergies to penicillin, DEMEROL, codeine, SUDAFED, betadine and contrast dyes had received on 30 October 2013 an intramuscular left deltoid injection of Influenza vaccine (manufacturer and lot number not reported) and 12 days later on 11 November 2013, experienced headaches and hypertensive crisis. The patient was hospitalized for several days (dates not reported). The patient also reported experiencing chest pain, pain radiating down arm and a flushed face during the "hypertensive crisis". Treatments were not reported. According to the reporter, "many lab tests and other tests" were performed but all have been negative. The patient is currently on bedrest most of the day, taking her own blood pressure every hour, self medicating as directed by physician and is able to be up after 1400 when blood pressure returns to normal. The patient received on 12 October 2012 an Influenza vaccine (manufacturer, lot number, route and site of administration not reported) and "about two weeks later", experienced headaches and hypertensive crisis. The hypertensive crisis would follow a daily pattern in which blood pressure would be elevated from about 0800 to 1400 and was elevated to as high as 280/150 but after 1400 to 1500 she would be ok until next AM. The symptoms lasted for eight weeks. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Hypertensive crisis, Laboratory test normal, Pain in extremity
Clinical narrative: Initial report was received on 20 November 2013 from a health care professional who is also the patient. A 52 year-old female patient with a history of allergies to penicillin, DEMEROL, codeine, SUDAFED, betadine and contrast dyes had received on 30 October 2013 an intramuscular left deltoid injection of Influenza vaccine (manufacturer and lot number not reported) and 12 days later on 11 November 2013, experienced headaches and hypertensive crisis. The patient was hospitalized for several days (dates not reported). The patient also reported experiencing chest pain, pain radiating down arm and a flushed face during the "hypertensive crisis". Treatments were not reported. According to the reporter, "many lab tests and other tests" were performed but all have been negative. The patient is currently on bedrest most of the day, taking her own blood pressure every hour, self medicating as directed by physician and is able to be up after 1400 when blood pressure returns to normal. The patient received on 12 October 2012 an Influenza vaccine (manufacturer, lot number, route and site of administration not reported) and "about two weeks later", experienced headaches and hypertensive crisis. The hypertensive crisis would follow a daily pattern in which blood pressure would be elevated from about 0800 to 1400 and was elevated to as high as 280/150 but after 1400 to 1500 she would be ok until next AM. The symptoms lasted for eight weeks. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a male patient of unknown age. On an unknown date in the past the patient was vaccinated with ZOSTAVAX. No concomitant medications were reported. On an unknown date, years later, the patient experienced shingles. It was reported as mild case of shingles, just a little itchy. It was reported that the patient received unspecified antiviral medication at the time the event occurred. The outcome of mild case of shingles, just a little itchy is unknown. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Corneal transplant, Transplant rejection
Clinical narrative: Initial information received on 18 November 2013 from a consumer who is the patient. A female patient, age not reported had FLUZONE HD vaccine, batch, route and site of administration not reported, in September 2013. The patient had no ill effects at the time of the vaccine. Concomitant medications and medical history were not reported. On October 1st the patient had a corneal transplant. The patient began experiencing problems with rejection on an unspecified date. The patient was seen by a physician on an unspecified date. The patient outcome was not reported. No further details were available at the time of this report. Documents held by sender: None.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Cerebrovascular accident, Chest X-ray abnormal, Disorientation, Echocardiogram, Echocardiogram abnormal
Clinical narrative: 45 minutes after receiving flu shot my right arm went limp felt disoriented a short time. Day of flu shot I called Doctor's office twice. VAERS and insurance company office. Following AM numbness in my right leg went to ER. MRI with and without contrast, x-ray heart carotid arteries, transesophageal Echocardiogram. Was diagnosed as having had a stroke.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Hypotonia, Nuclear magnetic resonance imaging abnormal, Scan with contrast abnormal
Clinical narrative: 45 minutes after receiving flu shot my right arm went limp felt disoriented a short time. Day of flu shot I called Doctor's office twice. VAERS and insurance company office. Following AM numbness in my right leg went to ER. MRI with and without contrast, x-ray heart carotid arteries, transesophageal Echocardiogram. Was diagnosed as having had a stroke.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Bruising and swelling at injection site on the right deltoid. Redness below injection site on the right deltoid. Soreness in the right arm.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Blister, Furuncle, Musculoskeletal pain
Clinical narrative: 10/5/12 11A believes started with last TWINRIX. The day of the shot within 3-5 hrs a blue line from injection site to elbow. Round blisters/boil -something with fluid, size of a quarter - half dollar appeared about an hour later. Called patient - reassured would prob go away - massage, don't break blister. Eventually went down 2 days later. Shoulder area hurts to this day feels like a punch in the arm. Has sores appear and go away possibly still has a lump where shot was given. Lt arm feels different than Rt arm. 11/27/13, Records show the shot given on the left arm LD IM was the Tdap not the TWINRIX in the patient's complaint as I reported on the initial VAERS document.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Nerve injury, Pain in extremity
Clinical narrative: Had pain from neck to tips of fingers; RPh told her to go to ER or urgent care - she did and they said "fluke" thing hit a nerve. Should be ok in 2 days.
Age: 26.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling and redness at injection site on right deltoid. Soreness and stiffness at injection site on rigth deltoid. Tenderness to Palpation at injection site on right deltoid.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Feeling cold, Hyperhidrosis
Clinical narrative: Cold - teeth chattering (first night), sweating, fatigue for 4 days.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 68 year old female patient. The patient's medical history included chickenpox at 45 years of age and prior outbreak shingles. On 18-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J004267, expiration date 12-JUN-2014) 0.65 ml, subcutaneous (site of administration not reported). The pharmacist reported that on 18-NOV-2013, the patient experienced the injection site was itching, painful, red and swollen after she received ZOSTAVAX and a blister appeared on 21-NOV-2013. The patient called pharmacist but didn't received any treatment for the adverse events, but she was advised to call her healthcare professional. The outcome of blister and injection site was itching, painful, red and swollen was unknown. Healthcare professional was interested in VZV analysis. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site rash, Nausea, Pyrexia, Sensory disturbance
Clinical narrative: Nausea, rash at injection site, feels like bee sting at different places on her body, low grade fever, syncope, rash-immediate; nausea-next day. TX-phenergan, cold compress on face.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: Nausea, rash at injection site, feels like bee sting at different places on her body, low grade fever, syncope, rash-immediate; nausea-next day. TX-phenergan, cold compress on face.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Lymphadenopathy, Pyrexia, Rash
Clinical narrative: Rash, swollen inguinal nodes, fever. Onset about 5 days after vaccination.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Severe itching of palms and fingers.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Malaise, Pain, Pyrexia, Sinus congestion
Clinical narrative: Dizziness, fever, body aches, malaise, sinus congestion, took Tylenol & Claritin D.  Rest & slept.
Age: 62.0
Sex: M
Vaccine: FLUC3
Symptoms: Rash
Clinical narrative: Pt contacted this RN and described a rash that extended from right side of abdomen to left side of abdomen with 2 raised patches on each side.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Arm pain since the shot was given.  Cannot lift arm past mid body without pain.
Age: 12.0
Sex: F
Vaccine: FLUX
Symptoms: Muscle twitching, Painful respiration, Paraesthesia
Clinical narrative: Tingling in both feet. Twitchy muscles in both legs. Painful breathing in diaphragm area. Took her to the ER, where she was examined and released.  We were told to watch her over the next couple of weeks and seek medical attention if the symptoms returned.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local reaction, Pain, Swelling
Clinical narrative: Large local reaction, swelling redness, pain.
Age: 59.0
Sex: F
Vaccine: FLUX, PPV, TDAP
Symptoms: Chest X-ray, Local swelling, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Pain in left arm; by 2 PM left arm could not be moved; by 4 PM extreme pain; swelling; treated swelling with ice packs; pain with Tylenol; by 11/27/13 most but not all swelling has subsided; still residual pain with some movements of left arm.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Dizziness, Injection site pain, Myalgia, White blood cell count increased
Clinical narrative: Local pain at injection site, diffuse joint and muscle pain, elevated WBC, dizziness. Required hospitalization x 3 days.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: 14 year old female received the GARDASIL/FLUMIST vaccine on 6 Nov 13. She states that 48 hours later she developed a ring lesion over her left arm surrounding the vaccine. She states her arm was swollen and sore feeling initially. The rash was very itchy at the site only. She went to her PCM and they gave her a steroid cream. It did not help much. She then developed a generalized rash that started on 25 Nov 13. The rash began on her chest and spread to her arms/legs. The rash is described as little itchy bumps everywhere. She denies any other systemic symptoms. She is being followed by dermatology for this condition as well.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Rash generalised, Rash pruritic, Skin lesion
Clinical narrative: 14 year old female received the GARDASIL/FLUMIST vaccine on 6 Nov 13. She states that 48 hours later she developed a ring lesion over her left arm surrounding the vaccine. She states her arm was swollen and sore feeling initially. The rash was very itchy at the site only. She went to her PCM and they gave her a steroid cream. It did not help much. She then developed a generalized rash that started on 25 Nov 13. The rash began on her chest and spread to her arms/legs. The rash is described as little itchy bumps everywhere. She denies any other systemic symptoms. She is being followed by dermatology for this condition as well.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Headache, Lumbar puncture normal, Pyrexia
Clinical narrative: Fever, headache.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Paraesthesia, Swelling, Urticaria
Clinical narrative: Administered to an LPN at the Personnel Health on 11/20/2013. Area became red & puffy. Showed the area to a PA on 11/23. He said it was a hive. 11/23 Took diphenhydramine 25 mg po X1. 11/27 Area still sore & has tingling in fingers.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Myalgia, Pyrexia
Clinical narrative: 12 hr after vaccine, pt had temp of 40 C. Myalgia, dizziness, and generalized weakness. F/up call in morning - fever cleared.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood glucose increased, Blood pressure increased, Bursitis, Condition aggravated, Injected limb mobility decreased
Clinical narrative: On 10/19/2012 claimant entered pharmacy for the purpose of obtaining an influenza vaccine which was administered and injected in claimant's upper left arm. Within 48 hours claimant experienced itching and hives of the left arm. In the next 48 hours claimant experienced pain which became excruciating. I could not move the fingers of my left hand nor move my left arm. I had to obtain emergency care at hospital. X-rays revealed a swelling and inflammation of a fluid-filled sac that overlies and protect the elbow. Follow up care indicated a rise in blood pressure, Laboratory data indicated a significant rise in toxins and glycemic levels. Periodic assessment of glaucoma tests indicated significant rise in optic pressure. To date claimant continues to experience weakness and throbbing of the left hand.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Intraocular pressure increased, Intraocular pressure test abnormal, Mobility decreased, Muscular weakness, Pain
Clinical narrative: On 10/19/2012 claimant entered pharmacy for the purpose of obtaining an influenza vaccine which was administered and injected in claimant's upper left arm. Within 48 hours claimant experienced itching and hives of the left arm. In the next 48 hours claimant experienced pain which became excruciating. I could not move the fingers of my left hand nor move my left arm. I had to obtain emergency care at hospital. X-rays revealed a swelling and inflammation of a fluid-filled sac that overlies and protect the elbow. Follow up care indicated a rise in blood pressure, Laboratory data indicated a significant rise in toxins and glycemic levels. Periodic assessment of glaucoma tests indicated significant rise in optic pressure. To date claimant continues to experience weakness and throbbing of the left hand.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Pruritus, Toxicologic test abnormal, Urticaria, X-ray limb abnormal
Clinical narrative: On 10/19/2012 claimant entered pharmacy for the purpose of obtaining an influenza vaccine which was administered and injected in claimant's upper left arm. Within 48 hours claimant experienced itching and hives of the left arm. In the next 48 hours claimant experienced pain which became excruciating. I could not move the fingers of my left hand nor move my left arm. I had to obtain emergency care at hospital. X-rays revealed a swelling and inflammation of a fluid-filled sac that overlies and protect the elbow. Follow up care indicated a rise in blood pressure, Laboratory data indicated a significant rise in toxins and glycemic levels. Periodic assessment of glaucoma tests indicated significant rise in optic pressure. To date claimant continues to experience weakness and throbbing of the left hand.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood glucose increased, Blood pressure increased, Bursitis, Intraocular pressure increased, Mobility decreased
Clinical narrative: On 10/19/2012 claimant entered pharmacy for the purpose of obtaining an influenza vaccine which was administered and injected in claimant's upper left arm. Within 48 hours claimant experienced itching and hives of the left arm. In the next 48 hours claimant experienced pain which became excruciating. I could not move the fingers of my left hand nor move my left arm. I had to obtain emergency care at hospital. X-rays revealed a swelling and inflammation of a fluid-filled sac that overlies and protect the elbow. Follow up care indicated a rise in blood pressure, Laboratory data indicated a significant rise in toxins and glycemic levels. Periodic assessment of glaucoma tests indicated significant rise in optic pressure. To date claimant continues to experience weakness and throbbing of the left hand.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscular weakness, Pain, Pain in extremity, Pruritus, Swelling
Clinical narrative: On 10/19/2012 claimant entered pharmacy for the purpose of obtaining an influenza vaccine which was administered and injected in claimant's upper left arm. Within 48 hours claimant experienced itching and hives of the left arm. In the next 48 hours claimant experienced pain which became excruciating. I could not move the fingers of my left hand nor move my left arm. I had to obtain emergency care at hospital. X-rays revealed a swelling and inflammation of a fluid-filled sac that overlies and protect the elbow. Follow up care indicated a rise in blood pressure, Laboratory data indicated a significant rise in toxins and glycemic levels. Periodic assessment of glaucoma tests indicated significant rise in optic pressure. To date claimant continues to experience weakness and throbbing of the left hand.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Toxicologic test abnormal, Urticaria, X-ray limb abnormal
Clinical narrative: On 10/19/2012 claimant entered pharmacy for the purpose of obtaining an influenza vaccine which was administered and injected in claimant's upper left arm. Within 48 hours claimant experienced itching and hives of the left arm. In the next 48 hours claimant experienced pain which became excruciating. I could not move the fingers of my left hand nor move my left arm. I had to obtain emergency care at hospital. X-rays revealed a swelling and inflammation of a fluid-filled sac that overlies and protect the elbow. Follow up care indicated a rise in blood pressure, Laboratory data indicated a significant rise in toxins and glycemic levels. Periodic assessment of glaucoma tests indicated significant rise in optic pressure. To date claimant continues to experience weakness and throbbing of the left hand.
Age: 1.26
Sex: F
Vaccine: DTAP, FLU3, HIBV, VARCEL
Symptoms: Autopsy, Cardiac arrest, Death
Clinical narrative: Cardiac arrest < 12 hours following administration. Prelim autopsy with unknown cause of death.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Blood pressure increased, Dizziness, Syncope
Clinical narrative: Pt experienced Z dizziness and syncope in office after vaccination. Occurred at approx 7:45 pm, held pt due to elevated BP until 9:00 pm. No treatment necessary, record BP for 10 days and report to us.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Pain
Clinical narrative: 11/24/13 called reported soreness, pain at injection site. 11/26/13 came in shown red rash at injection site pain better rash dissipating. Applied ice pak and aspirin, ALEVE.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Aura, Convulsion, Faecal incontinence, Headache, Urinary incontinence
Clinical narrative: This case was reported by a healthcare professional (medical assistant) and described the occurrence of seizure in a 21-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included autism and seizure. Concurrent medications included CELEXA, KEPPRA and LAMICTAL. The subject had a history of seizures but seizures were under control with medications. On 7 October 2013 at 13:00 the subject received a dose of FLULAVAL (.5 ml, unknown route, right arm). On 8 October 2013, 1 day after vaccination with FLULAVAL, the subject experienced "one" seizure. Per the reporter, the subject did not receive any new medication or treatment of other than the flu vaccine. This case was assessed as medically serious by GSK. On 8 October 2013, the event was resolved. Follow-up information was received on 19 November 2013 via healthcare professional. Additional concurrent medical conditions included seizure disorder and "non-verbal". The healthcare professional reported the seizure was witnessed and occurred on 08 October 2013. The subject did not lose consciousness. It was unknown if the subject remembered the event. The subject is non-verbal so it was unknown if the seizure was preceded by an aura or headache. The subject experienced urine/fecal incontinence during the seizure. No evidence that symptoms were due to withdrawal of alcohol or other psychotropic substances. There was no evidence of neurological lesion, infection or abnormal serum electrolytes. The subject has not received any medication known to reduce the seizure threshold. The subject has a history of seizures as well as a history with cerebral palsy, neurological handicap or congenital abnormality; specific details not provided. The healthcare professional indicated that there was no planned follow-up. The reporting healthcare professional did not consider the seizure serious. The reporting healthcare professional attributed the seizure to medical history/concurrent illness of seizure disorder. No action was taken with FLULAVAL vaccine.
Age: 84.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chest X-ray abnormal, Cough, Pneumonia
Clinical narrative: This case was reported by a consumer (patient) and described the occurrence of pneumonia in a 84-year-old female subject who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified), pneumonia vaccine (non-gsk). A physician or other health care professional has not verified this report. Concurrent medical conditions included chronic obstructive pulmonary disease and pulmonary hypertension. Co-suspect medication included ADVAIR HFA-CFC Free Inhaler for chronic obstructive pulmonary disease. In September 2013 the subject received a dose of Influenza vaccine unspecified (unknown), unspecified dose of Pneumonia vaccine (Non-GSK) (unknown). On an unknown date in 2013 within months of vaccination with Influenza vaccine unspecified and Pneumonia vaccine (Non-GSK), the subject experienced pneumonia and coughing hard. The subject was prescribed ADVAIR HFA for an off label use (chronic obstructive pulmonary disease). This case was assessed as medically serious by GSK. At the time of reporting the pneumonia was unresolved and the outcome of coughing hard was unknown. The subject reported that she "doesn't think the flu shot did what it was supposed to do". She explained that she got a flu shot in September 2013 and the pneumonia shot and has had pneumonia for the past two weeks [2013]. She informed that she "got the flu shot but still got whatever you want to call it". She stated that she does not have a diagnosis of the flu, she was diagnosed with pneumonia. The subject reported that she went to the urgent care because she was coughing hard. The subject stated that she had an X-ray and was diagnosed with pneumonia. The subject indicated she has COPD and pulmonary hypertension and was given a sample of ADVAIR HFA recently. The subject did not state whether she had taken any ADVAIR HFA. It was unclear if she ever used the ADVAIR HFA. At the time of the report, the subject noted that her pharmacist was calling her physician so that she could get the inhaler (COMBIVENT) she had used in the past since she read ADVAIR HFA is not indicated for COPD.
Age: 41.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Arthralgia, Asthenia, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: This case was reported by a pharmacist, who is also the subject and described the occurrence of possible Stevens Johnson syndrome in a 41-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included seasonal allergy. Historic vaccination included Td vaccine (non-gsk); unknown given in 2001. Concurrent vaccination included HepA vaccine; manufacturer unspecified; unknown; unknown given on 15 November 2013. Concurrent medications included CLARITIN. On 15 November 2013 at 10:00 the subject received 1st dose of BOOSTRIX (.5 ml, unknown, right deltoid). On 15 November 2013, within hours of vaccination with BOOSTRIX, the subject experienced injection site redness, swelling injection site and generalized weakness. On 16 November 2013, one day after vaccination with BOOSTRIX, the subject experienced generalized myalgia, generalized arthralgia and sore throat. On 17 November 2013, two days after vaccination with BOOSTRIX, the subject experienced rash on trunk. On 18 November 2013, three days after vaccination with BOOSTRIX, the subject experienced "disperse rash to include extremities". The subject sought medical attention at the emergency department (ED). The pharmacist reported receiving BOOSTRIX on 15 November 2013, since then he has had weakness, redness and swelling at injection site, myalgia and sore throat. Also reported dispersed rash currently controlled by BENADRYL and prednisone as prescribed by emergency department (ED) physician he saw on 18 November 2013. It was reported that the managing physician is also considering a diagnosis of Steven Johnson. The pharmacist reported this was his first Tdap vaccine, previously he received a Td vaccine in 2001. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the injection site redness, swelling injection site, generalized weakness, myalgia, arthralgia, sore throat, spreading rash, rash on trunk and possible Stevens Johnson syndrome were unspecified.
Age: 41.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Oropharyngeal pain, Rash, Stevens-Johnson syndrome
Clinical narrative: This case was reported by a pharmacist, who is also the subject and described the occurrence of possible Stevens Johnson syndrome in a 41-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included seasonal allergy. Historic vaccination included Td vaccine (non-gsk); unknown given in 2001. Concurrent vaccination included HepA vaccine; manufacturer unspecified; unknown; unknown given on 15 November 2013. Concurrent medications included CLARITIN. On 15 November 2013 at 10:00 the subject received 1st dose of BOOSTRIX (.5 ml, unknown, right deltoid). On 15 November 2013, within hours of vaccination with BOOSTRIX, the subject experienced injection site redness, swelling injection site and generalized weakness. On 16 November 2013, one day after vaccination with BOOSTRIX, the subject experienced generalized myalgia, generalized arthralgia and sore throat. On 17 November 2013, two days after vaccination with BOOSTRIX, the subject experienced rash on trunk. On 18 November 2013, three days after vaccination with BOOSTRIX, the subject experienced "disperse rash to include extremities". The subject sought medical attention at the emergency department (ED). The pharmacist reported receiving BOOSTRIX on 15 November 2013, since then he has had weakness, redness and swelling at injection site, myalgia and sore throat. Also reported dispersed rash currently controlled by BENADRYL and prednisone as prescribed by emergency department (ED) physician he saw on 18 November 2013. It was reported that the managing physician is also considering a diagnosis of Steven Johnson. The pharmacist reported this was his first Tdap vaccine, previously he received a Td vaccine in 2001. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the injection site redness, swelling injection site, generalized weakness, myalgia, arthralgia, sore throat, spreading rash, rash on trunk and possible Stevens Johnson syndrome were unspecified.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal chest pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist and described the occurrence of radiating pain in arm in a 32-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 24 October 2013 the subject received a dose of FLUARIX Quadrivalent (.5 ml, unknown). On 26 October 2013, 2 days after vaccination with FLUARIX Quadrivalent, the subject experienced pain radiating down the back of the arm (triceps) to rib cage and deltoid tenderness. The pharmacist reported there was no redness, but the subject experienced pain radiating down the back of the arm (triceps) to rib cage and tenderness in the deltoid. It was noted that the subject consulted a healthcare professional. The pharmacist considered the events were disabling. At the time of reporting the radiating pain in arm and deltoid tenderness were unresolved.
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Injection site reaction, Joint range of motion decreased
Clinical narrative: This case was reported by a healthcare professional (nurse, subject) via sales representative and described the occurrence of pain in left arm around injection site in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 25 October 2013 the subject received a dose of FLUARIX (unknown details, left arm). On 25 October 2013, immediately after vaccination with FLUARIX, the subject experienced pain in left arm around injection site. Per the nurse, "it was immediately painful with a sharp pain that extended all the way down my arm." The nurse also reported that "it was extremely painful that night." Over the next week, the nurse reported that the pain "eased up." The nurse described the pain in left arm around injection site as "left shoulder muscle is 'stiff' and painful" and "worse in the mornings." In 2013, within a month after vaccination with FLUARIX, the subject experienced arm heaviness (post injection site reaction) and injection site reaction (difficulty in moving arm). The nurse described her arm as feeling "heavy and" the nurse has "limited range of motion." The nurse decided to seek medical attention from a doctor. At the time of reporting, the nurse had not yet seen a doctor. The healthcare professional considered the events were disabling. At the time of reporting the events were unresolved. At the time of reporting, "it has been 3 weeks" and the nurse considered the events as "becoming more of a chronic problem." The healthcare professional considered the events were probably related to vaccination with FLUARIX. The nurse stated that her symptoms were "absolutely 100 percent caused by the flu shot."