chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Paraesthesia, Rash erythematous
Clinical narrative: This spontaneous report refers to  a 67 year old male patient reporting on himself. Patient's concurrent conditions included hepatitis C. Medical history was reported as none. On 14-DEC-2013, the patient was vaccinated with ZOSTAVAX for prevention of shingles (dose, lot number and concentration not reported). Concomitant medication was reported as none. Approximately on 16-DEC-2013 (reported as within a couple of days), the patient started experienced a tingling on the right side of his face around his eye. The patient developed a red rash and approximately on 17-DEC-2013 (reported as "the patient the next day") went to a clinic and was diagnosed with shingles. Patient received treatment with medications (dose unspecified). No lab diagnostics studies were performed. The outcome of the event was reported as not recovered. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist via company representative, concerning to a 64 years old, female patient. In October 2013, patient was vaccinated with a dose of ZOSTAVAX. (Route, dose number, lot and expiration date not provided). On an unspecified date, pharmacist reported that the patient developed a rash around the injection site. (No timeline was given as to how soon after receiving the vaccine that the rash appeared). The patient sought medical attention (office visit). At the time of the report the patient was recovered and the causality for the rash was unknown. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Migraine, Vomiting
Clinical narrative: Migraine headache and vomiting for about 15 hrs..
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Eye discharge, Eyelid oedema, Headache, Hypoaesthesia
Clinical narrative: hives in mouth, swollen throat, eyes swollen shut with large amounts of off white mucus coming out, fever (101 degrees) that lasted 2-3 hours (about 5 hours after vaccine given), headache, muscle aches, numbness in face and lips (lasted 48-60 hours after vaccine, shortness of breath
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia oral, Myalgia, Pharyngeal oedema, Pyrexia, Urticaria
Clinical narrative: hives in mouth, swollen throat, eyes swollen shut with large amounts of off white mucus coming out, fever (101 degrees) that lasted 2-3 hours (about 5 hours after vaccine given), headache, muscle aches, numbness in face and lips (lasted 48-60 hours after vaccine, shortness of breath
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Fatigue, Myalgia
Clinical narrative: Muscle aches, cough, fatigue
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Myalgia, Pain, Pain in extremity
Clinical narrative: Deep muscle pain.  It hurts to lift anything and patient cant even shake his right arm. (ie...after washing hands, he can't shake water off his hand)Pain hurts from below shoulder to above inside of wrist.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Burning sensation, Injection site swelling, Lymphadenopathy, Swelling
Clinical narrative: Pain and burning in left armpit and swelling right under armpit.  Swelling at injection site in left arm.  No redness at injection site or rash.  In addition to above, one week later had pain all the way down into left wrist.  Then two weeks later a rash in left crease of arm which lasted one day.  To date still swollen at injection site and under arm with a burning pain not as severe, but still present.  Went to doctor on 12/16/13 and received Prednisone  10 MG TAB take two one time.  Didn't help.  Then called doctor and on 12/20/13 was put on Cephalexin 500MG Capsules to take 3 times a day for five days.  Took last dosage on 12/24/13.  To date still swelling at injection site and under arm lymph nodes and slight burning under arm.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Insomnia, Pain in extremity
Clinical narrative: It appeared that the nurse gave my shot too high on the the left arm.  The nurse was also standing up while I was sitting down in a chair.  During the vaccine, the nurse told me to stop flexing although I did not think I was.  Within two hours of getting the shot, my left arm started to hurt with pain I hadn't felt before.  The next few days it became worse, to the point of not being able to sleep or move it.  By the middle of the week I thought it had improved, but by the following weekend it was way worse and I emailed the dr.  That next week I saw dr., she was not concerned.  Gave me Tylenol 3 which made me able to sleep.  I traveled for Christmas because it had improved slightly.  Now the pain has come back again full force.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Acoustic stimulation tests, Deafness unilateral, Dizziness, Dysstasia, Electrocochleogram
Clinical narrative: Severe onset of dizziness, then the next day as well and on the third day nov. 2 I was taken to ER with severe vomiting and vertigo and unable to stand.  Diagnosed with Viral Labyrinthitis.  3 days later lost part of my hearing in right ear.  Under treatment now for 8 weeks with ENT for Meniers disease.  Still with hearing loss and constant loud ringing in my right ear.  Waking up with severe vertigo.  Injection was mandated by mom job. Injected given in right arm.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test, Meniere's disease, Nuclear magnetic resonance imaging, Tinnitus, Vertigo
Clinical narrative: Severe onset of dizziness, then the next day as well and on the third day nov. 2 I was taken to ER with severe vomiting and vertigo and unable to stand.  Diagnosed with Viral Labyrinthitis.  3 days later lost part of my hearing in right ear.  Under treatment now for 8 weeks with ENT for Meniers disease.  Still with hearing loss and constant loud ringing in my right ear.  Waking up with severe vertigo.  Injection was mandated by mom job. Injected given in right arm.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Viral labyrinthitis, Vomiting
Clinical narrative: Severe onset of dizziness, then the next day as well and on the third day nov. 2 I was taken to ER with severe vomiting and vertigo and unable to stand.  Diagnosed with Viral Labyrinthitis.  3 days later lost part of my hearing in right ear.  Under treatment now for 8 weeks with ENT for Meniers disease.  Still with hearing loss and constant loud ringing in my right ear.  Waking up with severe vertigo.  Injection was mandated by mom job. Injected given in right arm.
Age: 56.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Diarrhoea, Injection site pain, Injection site reaction, Insomnia, Local swelling
Clinical narrative: Patient reports severe muscle soreness at injection site, eight hours later could not touch site due to tenderness and pain. That night experienced one bout of loose bowels, large amount, felt bowels completely emptied, approximately 10 hours after receiving vaccine. Difficulty sleeping due to pain in arm.  By next morning, patient observed swelling in left axillary and palpated nodules in same area, also felt swelling at left groin area.  On the third day, nodule swelling at both sites, groin and axillary, had receded, no tenderness, but lateral deltoid muscle started to be tender that lead to a moderate-severe deep ache.  Pain began in lateral deltoid, wrapped around lower arm to thumb and first two fingers. Client self medicated with ibupropen 600 mg and repeated this dose every four hours with little to no relief.  On 12/23/2013, patient returned to Public Health Center to report his reactions to the PPSV23 vaccine and was on his way to the local clinic for help in achieving pain relief in his arm
Age: 56.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Myalgia, Nodule, Oedema peripheral, Pain in extremity
Clinical narrative: Patient reports severe muscle soreness at injection site, eight hours later could not touch site due to tenderness and pain. That night experienced one bout of loose bowels, large amount, felt bowels completely emptied, approximately 10 hours after receiving vaccine. Difficulty sleeping due to pain in arm.  By next morning, patient observed swelling in left axillary and palpated nodules in same area, also felt swelling at left groin area.  On the third day, nodule swelling at both sites, groin and axillary, had receded, no tenderness, but lateral deltoid muscle started to be tender that lead to a moderate-severe deep ache.  Pain began in lateral deltoid, wrapped around lower arm to thumb and first two fingers. Client self medicated with ibupropen 600 mg and repeated this dose every four hours with little to no relief.  On 12/23/2013, patient returned to Public Health Center to report his reactions to the PPSV23 vaccine and was on his way to the local clinic for help in achieving pain relief in his arm
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Erythema, Local swelling, Skin warm
Clinical narrative: Swelling, heat, redness of entire upper arm, and also repored shortness of breath starting the night after receiving the vaccine.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Chest X-ray, Chronic obstructive pulmonary disease, Cough, Influenza like illness
Clinical narrative: 8/1/2013 started with a severe sinus cold treated at home with OTC Sinus meds lasted 2 weeks. Cough never went away. 10/23-11/3 flu like symptoms went to Urgent Care on 11/3/13 diagnosed and tx for pneumonia. 12/6/13 prescribed inhaler lungs cleared up on x-ray. 12/16/13 x-ray 12/23/13 Levaquin lungs still hurt 12/26/13 Pulmonary Specialist diagnosed me with COPD prescribed Advair, doxycycline, predisone, and inhaler.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Nasopharyngitis, Non-cardiac chest pain, Pneumonia, Spirometry
Clinical narrative: 8/1/2013 started with a severe sinus cold treated at home with OTC Sinus meds lasted 2 weeks. Cough never went away. 10/23-11/3 flu like symptoms went to Urgent Care on 11/3/13 diagnosed and tx for pneumonia. 12/6/13 prescribed inhaler lungs cleared up on x-ray. 12/16/13 x-ray 12/23/13 Levaquin lungs still hurt 12/26/13 Pulmonary Specialist diagnosed me with COPD prescribed Advair, doxycycline, predisone, and inhaler.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site induration
Clinical narrative: Pt got ZOSTAVAX on 12/21/13. Came back to Pharmacy on 12/23/13 to show me her arm. It was bruised in large area around injection site with redness and hardness. I let physician know and she called her Dr. they said to ice it. I called to follow up on 12/16 and she said as of today it's looking a little better.
Age: 60.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Swelling, redness, itchiness, warm to touch 1 day post - ZOSTAVAX wife reports improvement as of 12/22/13.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Swelling, redness, itchiness, warm to touch day following ZOSTAVAX. No rxn at flu vaccine site. Improvement 12/22 - 3 days following.
Age: 42.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Abdominal pain, Asthenia, Fatigue, Menorrhagia, Nausea
Clinical narrative: Pt. developed nausea, vomiting, abdominal cramps, started menses and had large blood clots and heavy bleeding unusual for her lasted 5 days -- resolved. Currently still has tiredness and weakness. Developed hives generalized on 12/29/13 after eating salmon. Recommended follow-up with primary doctor.
Age: 42.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Urticaria, Vomiting
Clinical narrative: Pt. developed nausea, vomiting, abdominal cramps, started menses and had large blood clots and heavy bleeding unusual for her lasted 5 days -- resolved. Currently still has tiredness and weakness. Developed hives generalized on 12/29/13 after eating salmon. Recommended follow-up with primary doctor.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Headache, Rhinorrhoea
Clinical narrative: Pt states the day after vaccination he started with runny nose, coughing and headache from 9/29/13 - with still experiencing 12/20/13. Pt states no fever and nothing requiring a visit to MD, but believes it is directly related to the vaccine.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Youth has 3 x 4" swollen red area where he received varicella vaccine the following day.
Age: 61.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Pruritus
Clinical narrative: C/O of itching all over his torso, palms of hands and feet.
Age: 43.0
Sex: F
Vaccine: VARZOS
Symptoms: Bronchitis, Mobility decreased, Muscle spasms, Musculoskeletal pain, Neck pain
Clinical narrative: Severe pain in left side of neck, shoulder, and arm. Unable to move neck and arm for several days, muscle and nerve spasms, severe pain, still happening as of 12/27/13 given pred., cyclobenzaprine, DUEXIS 800 also respiratory issues, acute bronchitis post vac. also given Z-pack post vax on 11/29/13 I have been seen at doctor's office twice - Dr 12/5/13 and 12/10/13 - another dr and (1) ER visit on 12/9/13.
Age: 43.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Severe pain in left side of neck, shoulder, and arm. Unable to move neck and arm for several days, muscle and nerve spasms, severe pain, still happening as of 12/27/13 given pred., cyclobenzaprine, DUEXIS 800 also respiratory issues, acute bronchitis post vac. also given Z-pack post vax on 11/29/13 I have been seen at doctor's office twice - Dr 12/5/13 and 12/10/13 - another dr and (1) ER visit on 12/9/13.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash erythematous, Skin warm, Swelling, Tenderness
Clinical narrative: Evening of immunizations arm was tender. Patient did not examine arm to see if there was a rash. 12/25/13 in morning clear red rash, swollen and aching. 12/26/13 2:50pm patient came into pharmacy. Rash was irregular shaped. Approx 9cm x 5cm, still elevated, warm to touch and sore. Patient had not taken anything at this point. I recommend putting an ice compress on arm and to take ibuprofen OTC 1-2 tablets Q 4-6 hours PRN. If he did not get any relief, I suggested he contact his primary Dr. tomorrow and to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pain of skin, Paraesthesia
Clinical narrative: This spontaneous report as received from a registered nurse refers to her 61 year old husband with no pertinent medical history and no drug reactions or allergies. On 18-NOV-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot # J008434, expiration date 11-OCT-2014) (dose and route not reported). Concomitant therapies included LEVOXYL. The nurse reported that on 21-NOV-2013, 3 days after vaccination, the patient had severe pain on the scalp area and redness on right ear. He was taken to the ER and diagnosed with shingles. The "next day" on 22-NOV-2013, the patient had lesions typical of shingles. The patient continued to experience tingling on the side of his face. The patient was treated with FAMVIR. There were no Lab diagnosis or studies performed. The outcome of shingles was reported as recovered/resolved. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash (spots) developed on face on the opposite side of injection site.
Sex: U
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. On 23-DEC-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot # not reported). The pharmacist reported that on 23-DEC-2013, the patient had an immediate injection site reaction. The site of injection swelled and then bruised. The outcome of site of injection swelled and site of injection bruised was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to approximately 30 patients of unknown ages. On an unknown date, the patient were vaccinated with 0.5 ml doses of GARDASIL (Lot # reported as J00735) IM. The medical assistant stated that it was not unusual for patients to experience tenderness, soreness and or redness at the injection site after receiving GARDASIL or other unspecified vaccines. The medical assistant stated that they had 30 doses of GARDASIL lot # J00735 and all of those doses had been administered. On an unknown date, some of those 30 patients might have experienced tenderness, soreness and redness at the injection site after receiving GARDASIL lot J00735 but the medical assistant did not remember a specific adverse event associated with that lot number. The outcome of tenderness and soreness at the injection site and redness at the injection site was unknown. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash
Clinical narrative: This spontaneous report ass received from a pharmacist via field representative refers to a 60 year old patient. Approximately on an unknown date in November-2013 (reported as one and half month ago) the patient was vaccinated with ZOSTAVAX. Lot no. # and expiry date of vaccine were not provided. No other concomitant medications were reported. On an unknown date the patient experienced unspecified allergic reaction and rashes that were quarter size. No product quality complaints (PQC) were involved. The outcome of unspecified allergic reaction and rashes that were quarter size was unknown. The causality for unspecified allergic reaction and rashes that were quarter size was not provided. This case is linked to 1312USA011096 via same reporter link. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: CSF culture positive, Influenza B virus test positive, Meningitis haemophilus
Clinical narrative: This spontaneous report as received from a physician refers to a currently 5 month old (former 29 week preemie) patient with gastroesophageal reflux disease. The patient was one of twins born at 29 weeks gestation. The patient's medical history included intraventricular hemorrhage. In 2013 the patient received 2 doses of Hib (manufacturer unknown) (exact dates unspecified, doses and route unknown). Concomitant therapies included ZANTAC. In 2013 the patient experienced haemophilus influenzae b meningitis, considered as potential vaccine failure. On unknown date in 2013 the lab test were performed and results were provided as: positive CSF culture; HIB positive by latex agglutination on cerebrospinal fluid (CSF). The patient was hospitalized in 2013. At the time of this report the patient was recovering but remained hospitalized. The causality between Hib vaccine (manufacturer unknown) and Haemophilus influenzae meningitis was unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site infection, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 61 years old female. Her medical history included obesity. On an unspecified date, the patient developed redness and swelling at the injection site after receiving a second dose of PNEUMOVAX23 injection 25/0.5Y (lot# J006242, expiry date: 03-AUG-2014) (intramuscularly, dose and location unspecified) on 31-OCT-2013. Patient received the first dose of PNEUMOVAX23 on an unspecified date in 2005. Other suspect therapy included a dose of AFLURIA (lot# unspecified) (route, dose and location unspecified), on 31-OCT-2013. The reporter stated that the patient stated the injection site was infected, but this was not confirmed by the physician. Concomitant therapies included PROTONIX, levothyroxine sodium (manufacturer unknown), ASTEPRO, atenolol and vitamins (unspecified). Clindamycin as treatment was given for the events. The patient had sought medical attention via office visit. At the time of report, the outcome of the events was unknown. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 48 year old female patient. On an unknown dates the patient was vaccinated with 2 doses of VARIVAX (Merck) (lot#, expiration date, dose, route and indication not reported) in the past. A recent titer showed the patient was with no immunity to varicella in 2013. The outcome of the event was reported as not recovered. It was not reported if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This spontaneous report as received from an unspecified healthcare professional, as part of a marketing research program "ZSOTAVAX specialty insights research (reference # RH-12-5437)", refers to a patient of unknown age with no concomitant therapy and no relevant medical history. On an unknown date the patient was vaccinated with ZOSTAVAX (dose and lot # unknown). About a year ago on an unknown date in December 2012 the patient experienced non efficacy and patient mentioned developed shingles after being vaccinated. The outcome of adverse events was unknown. The reporter considered the events to be not related with the vaccination. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a treating pharmacist via company representative refers to multiple, unspecified patients, during the past three days, had received ZOSTAVAX (Lot# unspecified) single dose injection (dose and location unspecified), and returned to the pharmacy within three days post-vaccination, with symptoms of "cellulitis" at the injection site and surrounding areas. The patient did not reintroduce the therapy, the patient had sought medical attention via contacted pharmacist. At the time of report, the outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: This spontaneous report as received from a pharmacist refers to a over 60 years old female patient. On 13-DEC-2013 (reported as 3 days ago) the patient was vaccinated with a standard dose of ZOSTAVAX, 0.65 ml, subcutaneously (lot number and site of administration were not reported). On 16-DEC-2013, the patient came back to the pharmacy and presented with egg shaped lump at the injection site. There was no treatment given for the adverse event. The patient sought medical attention via coming back to the pharmacy. The outcome of egg shaped lump at the injection site was reported as not recovered. The relatedness between vaccination with ZOSTAVAX and egg shaped lump at the injection site was not reported. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 77 year old patient. On 18-FEB-2013 the patient was vaccinated with ZOSTAVAX vial (lot number and expiry date, dose unknown), subcutaneously for unknown indication. It was reported that physician prescribed ZOSTAVAX on two separate occasions over the past year, and the patient received ZOSTAVAX on 18FEB-2013 and 21-DEC-2013. No adverse effect has been reported. It was reported that patient haven't sought medical attention. The outcome of event was unknown. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Maternal exposure before pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse practitioner concerning a female patient of unknown age. The patients pertinent medical history, drug reactions/allergies were not provided. On 18-SEP-2013 (start date also reported as 18-SEP-2013 or 19-SEP-2013), the patient was vaccinated with a dose of VARIVAX (Merck) (lot # and expiration date were not provided, dose and route not reported). No concomitant medications were reported. It was reported that the patient conceived around 08-OCT-2013 three weeks later. The last menstrual period was approximately on 24-SEP-2013 and estimated delivery date would be approximately on 01-JUL-2014. No adverse effects were reported. The patient sought medical attention by consulting a health care professional. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Syncope, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age with drug reaction/allergies to ZITHROMAX. Medical history and concurrent conditions were not reported. On 15-SEP-2013, the patient was vaccinated with a first dose of GARDASIL intramuscular, for the indication "recommended". Dose and lot number were not reported. No co-suspect therapies were reported. Concomitant therapies included FLONASE. The pharmacist stated that after the patient received the first dose of GARDASIL, he fainted "right away". The pharmacist stated the patient was "fine after a little while". The patient had the second dose of GARDASIL (lot #, dose and expiration date not reported) intramuscular, "a week after 14-NOV-2013", approximately on 21-NOV-2013, and then developed hives all over his body. The pharmacist stated that the patient's father is a physician, who prescribed prednisone (manufacturer unknown) for the reaction on an unspecified date. The pharmacist stated the patient would discontinue the GARDASIL series and would not receive the third dose "based on his father's recommendation and his reaction to the vaccine". The pharmacist stated that patient's hives are still present. The therapy was discontinued. The adverse event did not improve. The patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to patient of unknown age and gender. On 09-DEC-2013, the patient inadvertently vaccinated with a dose of VARIVAX (Merck) (VIAL 1350 U (lot #, expire date and indication not reported), 0.5 ml, subcutaneous) instead of ZOSTAVAX. The reporter stated that this was staff error and not related to product confusion. No adverse effect reported. It was unspecified whether the patient sought medical attention or not. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from approximately 71 years male patient with "borderline" diabetic, refers to himself. The patient had no drug reactions or allergies. On an unknown date, 2-3 years ago, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose, frequency and route of administration not reported). Concomitant therapies included metoprolol tartrate, losartan potassium (manufacturer unknown), omeprazole (manufacturer unknown), COLCRYS, ULORIC, metformin, pravastatin sodium, terazosin hydrochloride and warfarin sodium (manufacturer unknown). In February or March 2013, the patient developed shingles on his face. It was a "pimply" rash on one side of face near eye. Caller said that it "seems like" he had shingles prior to receiving vaccine but wasn't sure. In addition, the patient stated that he had developed a "possible problem" with his kidney while taking metformin and discontinued that medication. None lab diagnostics studies were performed. The patient did seek medical attention, he visited office but he was not hospitalized. No treatment was given for shingles. The outcome of shingles were reported as recovered/resolved on an unspecified date in 2013. The outcome of "possible problem" with kidney was unknown at the time of the report. The relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: This spontaneous report as received from a consumer regarding her granddaughter a 17 year old female patient with AUGMENTIN allergy. In the middle of October 2013, patient receive her first dose of GARDASIL (dose, concentration, and lot number not reported). On 18-NOV-2013, the patient was vaccinated with her second dose of GARDASIL (dose, concentration and lot number not provided). No concomitant therapy was reported. Approximately on November 2013, the patient experienced headache after received the second shot of GARDASIL. The reporter stated that the patient has not yet received a third shot of GARDASIL. The outcome of headache was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Hair disorder
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 84 year old female patient. Pertinent medical history and drug reactions were reported as none. On 16-DEC-2013, the patient was vaccinated with ZOSTAVAX (lot # J007858, expiration date 28-SEP-2013, single dose, subcutaneous). No concomitant therapy was reported. On December 2013, the patient had a permanent wave process on her hair performed at a beauty salon that was not effective. Patient called pharmacist. No lab diagnostics studies were performed. Patient had not received any treatment. The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: FLUR3
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Patient years ago had a flu shot which resulted in her arm burning very reddened swelling. On 12/20/13 received FLUBLOK 24 hrs later redness, swelling 4-5 c area peaked at 48 hrs. Redness/pain severe about 6-7 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 36 hrs post vaccine -> (L) arm swelling/redness/itching. Seen about 40-48 hours in ER and dx'd with cellulitis/treated with KEFLEX PO.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event, Simplex virus test positive
Clinical narrative: This spontaneous report as received from a physician refers to two patients of unknown age. This field representative noted that this physician stated he "administered ZOSTAVAX (lot/batch  # and dose were not provided) to two unspecified patients with active recurrent herpes simplex virus infections on unspecified dates." No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. The patient's medical history was not reported. On 04-DEC-2013, reported as about a week ago, the patient was vaccinated with ZOSTAVAX (dose, lot number, expiration date were not reported). Concomitant medications were not reported. On an unknown date in December 2013 the patient experienced swelling at injection site.The outcome of swelling at injection site and relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Viral titre decreased
Clinical narrative: This spontaneous report was received from a consumer who is the patient's mother, referring to a female patient of unknown age. No concurrent conditions were reported. On an unknown date in 2002, about eleven years ago, the patient was vaccinated with VARIVAX (Merck) for prevention of varicella. Dose, route and lot number were not reported. No co-suspect and concomitant therapies were reported. On an unknown date, years later to vaccination, the patient had titers drawn while she was pregnant. The reporter stated that "the titers showed that the vaccine did not take". At the time of this report the outcome was unknown. The causality was not reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Eyelid oedema, Swelling face
Clinical narrative: Parent reports 40 mins post injection of 1st Gardasil immunization, pt developed swelling of face and eyelids.  Parent reports administering Benadryl with effectiveness.
Age: 38.0
Sex: F
Vaccine: YF
Symptoms: Injection site reaction, Rash, Rash pruritic
Clinical narrative: Itchy rash at injection site followed by rash on arms, chest, back.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: LIGHTHEADED AND DIZZY RIGHT AFTER SHOT WAS GIVEN, GAVE HER SOME WATER TO SIP AND SHE SAT FOR ABOUT 15 MINUTES AT THE PHARMACY
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, RV5
Symptoms: Convulsion, Febrile convulsion, Pyrexia
Clinical narrative: Mother of the patient called our advise nurse at 10:37 PM on 12/23/2013 reporting the child had a fever and that she thought patient had a seizure. The child had a fever of 100.3 underarm. The advise nurse advised mother to take child to the ER. The ER determined the child had a febrile seizure. The patient was discharged and advised by ER to take tylenol and ibuprofen PRN for the fever.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin irritation
Clinical narrative: Patient has redness/irritation that has lingered for almost a month. Doctor is aware. She has been prescribed Triamcinolone topically.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: 12/13 Pt had large knot at injection site - then developed shingles on side of face days later. 12/10 - swelling, heated, knot at injection site.
Age: 7.0
Sex: M
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Asthenia, Dizziness
Clinical narrative: 12/18/13 2:15 pm T.C. from (M) stating patient became dizzy and weak within 1/2 hour of receiving the vaccinations. He had not eaten breakfast prior to vaccinations. He took a nap when he went home and required bathroom assistance with ambulation. She has since given him something to eat and MOTRIN - he is now feeling better. 12/18/13 4:25 pm - T.C. to friend/unable to reach (M). Client feeling better.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort
Clinical narrative: Arm had reflex reaction after injection was administered and patient has had discomfort in the arm off and on since.
Age: 23.0
Sex: U
Vaccine: FLU3
Symptoms: Feeling hot, Scab, Skin exfoliation, Swelling
Clinical narrative: Pt states, "8 days after I had vaccine, I felt a small bump on my arm and during the next few days it got bigger and hot, then started peeling and now scab.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Eye pruritus, Heart rate increased, Idiosyncratic drug reaction, Influenza like illness
Clinical narrative: Swollen upper lip. Red and itchy eyes. Scratchy throat. Low grade fever. Shaking and chills. Elevated heart rate of 152. Flu like symptoms for 3 days. Swollen upper limb went away on its own within 4 hours. Treatment: IV fluids and TYLENOL.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Ocular hyperaemia, Pyrexia, Throat irritation, Tremor
Clinical narrative: Swollen upper lip. Red and itchy eyes. Scratchy throat. Low grade fever. Shaking and chills. Elevated heart rate of 152. Flu like symptoms for 3 days. Swollen upper limb went away on its own within 4 hours. Treatment: IV fluids and TYLENOL.
Age: 19.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Headache, Rash, Rash pruritic
Clinical narrative: Rash started on face spread to torso, legs, palms and soles. No fever, sore throat - mild, mild headache. Rash mildly itchy, no pain or discharge from rash.
Age: 74.0
Sex: U
Vaccine: FLUX
Symptoms: Chills, Pharyngeal oedema, Vomiting
Clinical narrative: Swelling in throat. Vomiting, extreme chills.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pain all the way down arm - was advised to seek medical assistance if pain persists.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to several patients of unknown gender in their seventies. On an unknown date the patients were vaccinated with ZOSTAVAX (lot number, expiration date, dose, route of administration, strength and indication were not reported). The reporter stated that she has known of several instances in which a person received ZOSTAVAX and later (date not specified) developed shingles. She stated that the people were older, in their 70s. The outcome of shingles was unknown. Relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Viral titre decreased
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 65 year old female patient. The nurse reported that a patient had a low varicella titer and may have received a dose of VARIVAX (Merck). The nurse was not sure that the patient received a dose of VARVIAX (Merck) only that the patient had a titer test and was determined to have a low varicella titer. No adverse event reported other than the low varicella titer. The outcome of viral titer decreased is unknown. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Rash began on arms during the night of the 11th.  Started on arms then moved to chest, neck and face.  Tried cortisone cream-no relief.  Took Zyrtec--no relief. Saw PCP on day 5 and he prescribed Atarax-no relief.  Rash spread to legs, stomach, back, ear lobes and saw PCP again on day 8 (day after Christmas.  Put me on Prednisone 60 mg for 4 days, 1 Zyrtec daily, 1 Zantac daily and 2 Benadryl (25 mg) as needed.  Much relief today after starting steroids.  Still have rash everywhere and still itches quite a bit but significantly better.
Age: 28.0
Sex: M
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Severe shoulder pain and restricted range of motion.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Impaired work ability, Injection site pain, Pain, X-ray
Clinical narrative: I received the influenza vaccine (Fluzone/NDC 49281-013-88, lot UH890AB, in my upper left shoulder on 09/10/2013. Approximately one week later I began to experience severe, sharp pain (9 out of 10) with movement in my left shoulder and arm that radiated to my back. A dull, achy, constant pain was also present in the shoulder, but far less severe (2/10).  I visited an orthopedic doctor on 09-25-2013 who examined my shoulder and took x-rays. The doctor diagnosed me with: "Left Shoulder Pain likely is result of influenza shot sequelae." I was unable to work from 9/25/13 to 10/7/13. My shoulder pain eventually disappeared around the end of October 2013.
Age: 0.48
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 1st dose of Rotavirus vaccine given at greater than 104 days of age.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Abnormal behaviour, Cough, Decreased appetite, Influenza virus test positive, Lethargy
Clinical narrative: I brought him to the after hours care clinic, he was very lethargic, wasn't eating, had a high fever and a runny nose with a cough. They performed a flu test it came back negative. I came back to the ER 2 hours later and they ran another flu test it came back postive and then they sent him home saying there was nothing they could do. I later took him back and he was wheezing. I told them something was wrong that this wasn't how my son acts. They later admitted him and he was diagnosed with pneumonia and was put on oxygen.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Pneumonia, Pyrexia, Rhinorrhoea, Wheezing
Clinical narrative: I brought him to the after hours care clinic, he was very lethargic, wasn't eating, had a high fever and a runny nose with a cough. They performed a flu test it came back negative. I came back to the ER 2 hours later and they ran another flu test it came back postive and then they sent him home saying there was nothing they could do. I later took him back and he was wheezing. I told them something was wrong that this wasn't how my son acts. They later admitted him and he was diagnosed with pneumonia and was put on oxygen.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Inner ear disorder, Nausea
Clinical narrative: Experienced: "excessive" dizziness, "sick to my stomach"; no treatment; called her doctor and "the doctor thought I had inner ear problems"; "I did not have any inner ear problems before that".
Age: 32.0
Sex: F
Vaccine: TD
Symptoms: Injection site pruritus, Local swelling, Oedema, Oedema peripheral, Rash erythematous
Clinical narrative: Adverse reation: itching where injection was, swelling in entire arm, raised red rash on forearm. Treatment: 50mg of Benadryl and prior to ER. While waiting to be seen in ER: experienced edema in arm, back and chest. Treatment: icepack, oxycodine, and 50 mg of Benadryl. Monitored in ER for several hours.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Rash erythematous, Swelling
Clinical narrative: Pharmacy was notified of the adverse event on 12/26/2013.  Patient had redness, swelling, and heat approximately 24 hours after administration of vaccine.  Now, patient is asymptomatic with a red oval shaped rash.  It is not raised or hot to the touch.  Patient stated that it has reduced in size.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Burning sensation, Chest discomfort, Chills, Diarrhoea
Clinical narrative: 10/13/13 Pt states she woke up the morning after the vaccine feeling "BLEH" and had not slept well, experiencing chills and diarrhea. 10/14/13 states she had swollen sinuses and c/o lungs, and nose burning as if she "had a sniff of chemicals".  She experienced her whole body as if in "a vice grip with SOB and tight chest" after which she "either fell asleep or passed out". In the middle of the night she sat up and couldn't breathe with the "sensation of impending doom", and was "wiped out for days and days afterwards".  Returned to work 10/18/13 and still felt "rundown", experiencing a bout of dizziness and not being able to "get fresh air".  Reported to the ER.   She reported to employee health 12/9/13.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Fatigue, Feeling abnormal, Nasal discomfort
Clinical narrative: 10/13/13 Pt states she woke up the morning after the vaccine feeling "BLEH" and had not slept well, experiencing chills and diarrhea. 10/14/13 states she had swollen sinuses and c/o lungs, and nose burning as if she "had a sniff of chemicals".  She experienced her whole body as if in "a vice grip with SOB and tight chest" after which she "either fell asleep or passed out". In the middle of the night she sat up and couldn't breathe with the "sensation of impending doom", and was "wiped out for days and days afterwards".  Returned to work 10/18/13 and still felt "rundown", experiencing a bout of dizziness and not being able to "get fresh air".  Reported to the ER.   She reported to employee health 12/9/13.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Poor quality sleep, Swelling
Clinical narrative: 10/13/13 Pt states she woke up the morning after the vaccine feeling "BLEH" and had not slept well, experiencing chills and diarrhea. 10/14/13 states she had swollen sinuses and c/o lungs, and nose burning as if she "had a sniff of chemicals".  She experienced her whole body as if in "a vice grip with SOB and tight chest" after which she "either fell asleep or passed out". In the middle of the night she sat up and couldn't breathe with the "sensation of impending doom", and was "wiped out for days and days afterwards".  Returned to work 10/18/13 and still felt "rundown", experiencing a bout of dizziness and not being able to "get fresh air".  Reported to the ER.   She reported to employee health 12/9/13.
Age: 32.0
Sex: F
Vaccine: IPV, RAB, YF
Symptoms: Hypoaesthesia, Hyporeflexia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Post yellow fever vaccination: Severe shooting sciatic nerve pain and numbness/tingling reaching through leg and to left foot (same side as injection). Also 2 inch diameter raised, red bump at injection site hot and painful to touch. Urgent care clinic resulted in use of pain medications, tordal injection and musle relaxants which all greatly helped. Majority of nerve pain resolved after 3 days, complete resolution of nerve pain after 2 months. Injection site reaction resloved in 2 weeks. Subsequent MD visits noted loss of reflex in left ankle indicating nerve damage.
Age: 32.0
Sex: F
Vaccine: IPV, RAB, YF
Symptoms: Injection site warmth, Nerve injury, Paraesthesia, Sciatica
Clinical narrative: Post yellow fever vaccination: Severe shooting sciatic nerve pain and numbness/tingling reaching through leg and to left foot (same side as injection). Also 2 inch diameter raised, red bump at injection site hot and painful to touch. Urgent care clinic resulted in use of pain medications, tordal injection and musle relaxants which all greatly helped. Majority of nerve pain resolved after 3 days, complete resolution of nerve pain after 2 months. Injection site reaction resloved in 2 weeks. Subsequent MD visits noted loss of reflex in left ankle indicating nerve damage.
Age: 0.4
Sex: F
Vaccine: RVX
Symptoms: Injection site erythema, Injection site mass, Insomnia, Irritability, Poor quality sleep
Clinical narrative: Redness and lump at the injection site lasting for 6 weeks, 10/17/13 afternoon low grade fever 100.6 degrees, restless sleep/inability to sleep and irritablility for 4 days following.
Age: 0.4
Sex: F
Vaccine: RVX
Symptoms: Pyrexia
Clinical narrative: Redness and lump at the injection site lasting for 6 weeks, 10/17/13 afternoon low grade fever 100.6 degrees, restless sleep/inability to sleep and irritablility for 4 days following.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Influenza like illness, Pyrexia
Clinical narrative: Experienced severe shortness of breath 2 hours after her flu shot. She also has a fever today with flu like symptoms.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Headache, Hyperhidrosis, Malaise
Clinical narrative: Chills, sweats, temperature of 100, and headache about 10 hours after receiving flu vaccine didn't feel well for a day afterward.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pain, Pharyngeal oedema, Pruritus
Clinical narrative: Pt waited ~15 minutes after receiving half dose of flu vaccine and left. After leaving pt reports feeling itchy and achy. Pt decided to rest and take a nap and woke up at 5:30 PM feeling like her throat was swelling and general malaise. Pt then took a Benadryl and states symptoms were resolved.
Age: 75.0
Sex: F
Vaccine: FLUX
Symptoms: Contusion, Swelling
Clinical narrative: Swelling and large bruise.
Age: 46.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Chest discomfort, Injection site pain, Lethargy, Neck pain, Pain in extremity
Clinical narrative: PT STATED THAT SHE FELT A PAIN IN HER LEFT ARM AT SIGHT OF INJECTION WHICH TRAVELED UP THE OUTSIDE OF HER NECK.  SHE STATED THAT SHE STILL CONTINUES TO HAVE THIS PAIN AT TIMES.  SHE STATED THAT HER INJECTION ARE FELT VERY HEAVY AND LETHARGIC FOR THE DAYS AFTER THE INJECTION AND THAT SHE HAS TIGHTNESS IN THE SAME SIDE IN HER CHEST. SHE FEELS PAIN RADIATE DOWN HER LEFT ARM AS WELL.  DID NOT FEEL ANY OF THIS UNTIL SHE WAS GIVEN THE INJECTION. PATIENT INTENDS TO MAKE A DOCTOR VISIT.
Age: 46.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Sensation of heaviness
Clinical narrative: PT STATED THAT SHE FELT A PAIN IN HER LEFT ARM AT SIGHT OF INJECTION WHICH TRAVELED UP THE OUTSIDE OF HER NECK.  SHE STATED THAT SHE STILL CONTINUES TO HAVE THIS PAIN AT TIMES.  SHE STATED THAT HER INJECTION ARE FELT VERY HEAVY AND LETHARGIC FOR THE DAYS AFTER THE INJECTION AND THAT SHE HAS TIGHTNESS IN THE SAME SIDE IN HER CHEST. SHE FEELS PAIN RADIATE DOWN HER LEFT ARM AS WELL.  DID NOT FEEL ANY OF THIS UNTIL SHE WAS GIVEN THE INJECTION. PATIENT INTENDS TO MAKE A DOCTOR VISIT.