chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Diet refusal, Dizziness, Hyperhidrosis, Loss of consciousness
Clinical narrative: Pt felt weak and lightheaded after vaccination.  She was seated at the time symptoms presented.  After losing consciousness, she was assisted to the floor with lower extremities elevated. Pulse 44. Within a minute she regained conscious; color remained pale with diaphoretic for approximately 5 minutes. Patient refused to eat or drink after event and planned to eat outside of facility.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor
Clinical narrative: Pt felt weak and lightheaded after vaccination.  She was seated at the time symptoms presented.  After losing consciousness, she was assisted to the floor with lower extremities elevated. Pulse 44. Within a minute she regained conscious; color remained pale with diaphoretic for approximately 5 minutes. Patient refused to eat or drink after event and planned to eat outside of facility.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Flushing, Hypoaesthesia, Mobility decreased, Musculoskeletal pain, Periarthritis
Clinical narrative: NUMBNESS AND FLUSH FEELING ON ADMINISTRATION, THEN PAIN IN SHOULDER, LIMITED MOBILITY-CURRENTLY 3 WEEKS LATER, OFFICE APPT WITH MD TODAY 11/3/14 WHO STATED I HAVE A FROZEN SHOULDER, PRESCRIBED ANTIINFLAMMITORIES AND EXERCISES, IF NOT BETTER IN 3 WEEKS I HAVE TO HAVE AN X-RAY.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Computerised tomogram head, Deafness unilateral, Ear tube insertion, Myringotomy, Vertigo
Clinical narrative: Sudden onset vertigo and left ear hearing loss, resolved in 5min. 3 more bouts of same next day. On Monday, the 27th, sudden onset of vertigo and left ear hearing loss which is still unresolved.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Deafness, Deafness unilateral, Vertigo
Clinical narrative: Sudden onset vertigo and left ear hearing loss, resolved in 5min. 3 more bouts of same next day. On Monday, the 27th, sudden onset of vertigo and left ear hearing loss which is still unresolved.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Epistaxis, Eye pain, Eye swelling
Clinical narrative: Pressure in head, dizziness shortly after receiving vaccine. By evening, rash appeared on arm and leg. Next morning eye paid and swelling, nausea. Chills, fatigue and nosebleeds. Symptoms are still present as of 11/03/2014.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Nausea, Rash
Clinical narrative: Pressure in head, dizziness shortly after receiving vaccine. By evening, rash appeared on arm and leg. Next morning eye paid and swelling, nausea. Chills, fatigue and nosebleeds. Symptoms are still present as of 11/03/2014.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizziness, leading to severe vertigo throughout the next day.   After having chiropractic treatment, it seemed to lessen and be gone, but two days after, some slight vertigo would come and go.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Myalgia, Pyrexia, Tachycardia
Clinical narrative: Patient reports a fever of 102 degrees F for 24 hours, treated with acetaminophen; patient reports tachycardia and dyspnea for 2 days and nights, with no treatment; patient reports muscle aches for about 1 week, with no treatment.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse effects noted.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient experience soreness in the arm after vaccine adminstration. Even after 10 days patient still had soreness in the arm and trouble lifting her arm.
Age: 19.0
Sex: F
Vaccine: MNQ, TYP, YF
Symptoms: Abdominal pain upper, Dyspepsia, Influenza like illness, Nausea
Clinical narrative: Client received oral typhoid, MCV4, and Yellow Fever. client took the first pill that same day (10/23/2014), then on Sat (10/25), Monday (10/27), and Wednesday (10/29). On Thursday night, after the first pill, client started feeling a stomach ache, which she describes as "horrible" and "burning" and "kind of like heartburn but lower." She states she feels "like I need to vomit" but has not had any vomiting episodes. She denies diarrhea or loose stools. Pain has been fluctuating since 10/23 until today 11/01. At its worst, pain was 6/0-10. Pain goes away then increases in a cyclical manner. She also experienced flu-like symptoms on starting Friday (10/24/14) and subsiding on Sunday (10/26/14).
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: Fever > 101-102. Chills > 8 hours. Took ibuprofen, fluids and aspirin all night.
Age: 61.0
Sex: F
Vaccine: DTAP
Symptoms: Lymphadenopathy, Mass
Clinical narrative: Swollen gland - large round lump.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Contusion, Ear discomfort, Ear haemorrhage, Ear infection, Epistaxis
Clinical narrative: 6/5/14: pulling at her ears and took to UC Monday evening -Rx Azithromycin for otitis. Yesterday started with some dark bruising on her arms 1-1 1/2" and pinkie size bruising on legs, thighs, and buttocks. Had nosebleed this am which she has never had in the past. More bruising with light touching. GP had her in stroller and she hit the side of her head and immediately bruised- above eye and now on her tongue will f/u with hospital. 6/6/14: admitted to Hematology unit at hospital - platelet count 2 (120-150) had difficulty with IV line and she was screaming/started to bleed from her ears, gave IV immunoglobulins for 6 1/2 hrs last pm, no apparent side effects at this time, vitals every 15 min thru night - scheduled at 2pm for bone marrow biopsy - will have preliminary results later today.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Head injury, Idiopathic thrombocytopenic purpura, Immunoglobulin therapy, Increased tendency to bruise, Injection site bruising
Clinical narrative: 6/5/14: pulling at her ears and took to UC Monday evening -Rx Azithromycin for otitis. Yesterday started with some dark bruising on her arms 1-1 1/2" and pinkie size bruising on legs, thighs, and buttocks. Had nosebleed this am which she has never had in the past. More bruising with light touching. GP had her in stroller and she hit the side of her head and immediately bruised- above eye and now on her tongue will f/u with hospital. 6/6/14: admitted to Hematology unit at hospital - platelet count 2 (120-150) had difficulty with IV line and she was screaming/started to bleed from her ears, gave IV immunoglobulins for 6 1/2 hrs last pm, no apparent side effects at this time, vitals every 15 min thru night - scheduled at 2pm for bone marrow biopsy - will have preliminary results later today.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Platelet count decreased, Screaming
Clinical narrative: 6/5/14: pulling at her ears and took to UC Monday evening -Rx Azithromycin for otitis. Yesterday started with some dark bruising on her arms 1-1 1/2" and pinkie size bruising on legs, thighs, and buttocks. Had nosebleed this am which she has never had in the past. More bruising with light touching. GP had her in stroller and she hit the side of her head and immediately bruised- above eye and now on her tongue will f/u with hospital. 6/6/14: admitted to Hematology unit at hospital - platelet count 2 (120-150) had difficulty with IV line and she was screaming/started to bleed from her ears, gave IV immunoglobulins for 6 1/2 hrs last pm, no apparent side effects at this time, vitals every 15 min thru night - scheduled at 2pm for bone marrow biopsy - will have preliminary results later today.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Bursitis, Drug administered at inappropriate site, Injection site pain, Injection site reaction
Clinical narrative: At first, it felt a little bit sore like any other vaccine but as time passed the pain spread and was more intense. It has been weak and painful with certain motions ever since. I finally went to urgent care today and they said it was bursitis in the left shoulder, likely from the shot being given too high up on the shoulder. Hopefully, it will feel better after a week of steroids and high-dose ibuprofen.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Pain
Clinical narrative: At first, it felt a little bit sore like any other vaccine but as time passed the pain spread and was more intense. It has been weak and painful with certain motions ever since. I finally went to urgent care today and they said it was bursitis in the left shoulder, likely from the shot being given too high up on the shoulder. Hopefully, it will feel better after a week of steroids and high-dose ibuprofen.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Sleep disorder
Clinical narrative: Pt complains of arm pain when moves arm feels started at time of injection cannot sleep on arm or move without feeling pain.  There was and is no bruising or lump on 11-3-14 when pt reported.
Age: 78.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Contusion, Dizziness, Erythema, Mass, Pyrexia
Clinical narrative: Patient described a large red lump and bruising underneath the injection site.  He also experienced fever and dizziness.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pruritus, Rash erythematous, Skin warm
Clinical narrative: Pt had a red spot/bruise that was warm to touch and itchy. Pharmacist recommended pt apply hydrocortisone cream to the area and take Claritin. Pt stated that the hydrocortisone cream helped with the itching but the size of the bruise continues to get bigger.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site irritation, Injection site pain, Injection site pruritus
Clinical narrative: Approx 2 inches below where my flu vaccine was administered, I got a 2X3 inch area on my lower deltoid that was red, hot, swollen and painful.  At the office, we drew a line around the edge of the redness to watch to see if the redness would get bigger.  On Thursday, 10/30/14, the area spread outside the margins that were drawn.  It increased in size on the bottom side increasing by an inch or so.  The redness had completely faded on Saturday, November 1, but left a bruised looking area for the last two days. It is no longer painful, just irritated and itchy.  I work in the clinic where the injection was administered, and one of the doctors watched the area through the day on Thursday.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Approx 2 inches below where my flu vaccine was administered, I got a 2X3 inch area on my lower deltoid that was red, hot, swollen and painful.  At the office, we drew a line around the edge of the redness to watch to see if the redness would get bigger.  On Thursday, 10/30/14, the area spread outside the margins that were drawn.  It increased in size on the bottom side increasing by an inch or so.  The redness had completely faded on Saturday, November 1, but left a bruised looking area for the last two days. It is no longer painful, just irritated and itchy.  I work in the clinic where the injection was administered, and one of the doctors watched the area through the day on Thursday.
Age: 59.0
Sex: F
Vaccine: TTOX
Symptoms: Hypersensitivity, Rash erythematous, Vaccination site reaction
Clinical narrative: Reddened area with rash, underarm where vaccine was administered and both sides of groin. Rash has spread since I first noticed it this morning. The physician this afternoon (4:15 PM) said it was a drug related allergic  reaction. The only medication I took within the last 48 hours was Ibuprofen.  I have taken this medication many times in the past without any reaction.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: VIIth nerve paralysis
Clinical narrative: I developed symptoms related to Bell's Palsy.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Muscle spasms, Pain in jaw, Paraesthesia
Clinical narrative: Cramping, soreness in left jaw. Progressed to numbness and tingling in Left side of face and tongue over next few hours.  By 11/01/2014 had partial paralysis of left side of face.  Paralysis continued to progress as of 11/03/2014, date of reporting.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Paraesthesia oral, VIIth nerve paralysis
Clinical narrative: Cramping, soreness in left jaw. Progressed to numbness and tingling in Left side of face and tongue over next few hours.  By 11/01/2014 had partial paralysis of left side of face.  Paralysis continued to progress as of 11/03/2014, date of reporting.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Headache, Vertigo
Clinical narrative: Debilitating vertigo and headache.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Patient picked at the immunization site and scratched until a cellulitis developed on that site.  The hospitalization below was to treat not only the cellulitis that developed but rule out further infection and osteomyelitis in the pre-existing hip cellulitis.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Oropharyngeal pain, Upper-airway cough syndrome
Clinical narrative: Patient states that when she got home she started to experience post nasal drip and then a sore throat.  Then she stated that she has labored breathing, but after about an hour the breathing normalized and the issue resolved on its own.
Age: 1.28
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Rash, Rash macular, Urticaria
Clinical narrative: Tiny macular rash over trunk; hives on thighs.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Posture abnormal
Clinical narrative: Patient slumped in chair, and looked to possibly have a seizure.  Then 5 minutes later patient drooped head again.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Patinet reported a small rash and redness on the upper arm that was injected. Sensitive to the toouch, no fever. Stated he felt fine.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Facial paresis, VIIth nerve paralysis
Clinical narrative: Bells Palsy; facial weakness on right side of face.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Rash, Rash erythematous
Clinical narrative: Patient reports fever/chills, red rash on arms
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Pain
Clinical narrative: Extreme discomfort and pain after administered shot. Severe pain for weeks following shot. Severe pain when lifting or moving arm forward or over head. Pain in rotator cuff area.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint range of motion decreased, Neuralgia, Pain in extremity, Rash papular
Clinical narrative: Rash (not itchy) but red bumps on arms that lasted 10 days, continuing left arm pain 2 weeks after vaccine with pain with range of motion arm movement, nerve impulse pain in left hand.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, Neuralgia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Rash (not itchy) but red bumps on arms that lasted 10 days, continuing left arm pain 2 weeks after vaccine with pain with range of motion arm movement, nerve impulse pain in left hand.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rash
Clinical narrative: Rash (not itchy) but red bumps on arms that lasted 10 days, continuing left arm pain 2 weeks after vaccine with pain with range of motion arm movement, nerve impulse pain in left hand.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported hot, red, swollen area where there was injection, no fever and was using a hot pack - advised cold pack and again on 11/3 to also include Benadryl.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Severe bruising and red swollen splotches on right upper arm. Extremely sore on same arm.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Complained of pain, itching and redness to injection site. 1/2 dollar sized raised red area noted and complaints of itching. Ice given to apply and administered Benadryl 50mg for symptoms.
Age: 60.0
Sex: M
Vaccine: TDAP
Symptoms: Monoplegia
Clinical narrative: Day after Rdap paralysis of (L) 3-5 digits (within 24 hrs post vaccine). 2 day after complete (L) arm paralysis which is still present.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Pityriasis
Clinical narrative: Pityviasis like rash that began after vaccination.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Nausea, Vomiting
Clinical narrative: Patient with nausea and vomiting post vaccine while still in the room.
Age: 0.38
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Crying, Rash generalised, Tremor
Clinical narrative: At the 4 month vaccine visit on 7/30/14, PENTACEL, PCV and ROTA were administered in a.m. Later in the afternoon ( few hours after vaccines given)-> pt developed 'shaking' like body movement, and full body rash and increased crying.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Patient received flu shot on 10/16/14, developed hives on 10/17, treated with antihistamines on 10/17. Went to ER on 10/18 due to "spreading rash and itchiness" kept overnight for observation, given prednisone, antihistamine and an IV. 10/23: pt. re-evaluated by provider, no rash, feeling well.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local reaction, Skin warm
Clinical narrative: Localized reaction red/warm.
Age: 74.0
Sex: U
Vaccine: FLU3
Symptoms: Blood pressure increased
Clinical narrative: After a Flu shot, my blood pressure rose to 210. After 3 weeks, I am still on Lisinopril -10 mg daily. My normal blood pressure is 120/70 app.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Herpes zoster
Clinical narrative: Developed herpes zoster one day after receiving influenza vaccine. Concern for herpes zoster ophthalmicus. He presented for care 10/27/14.
Age: 9.0
Sex: F
Vaccine: FLUN4, HEP, IPV, MMR, TD
Symptoms: Dizziness, Hypotonia, Presyncope
Clinical narrative: At 2:05 AM, vaccines administered. Approximately 2 minutes later, pat complained of feeling dizzy. Stabilized pt to avoid fall. Pt then went limp, had vagal response. Called for hep from co-worker. Gave water and cool compress. Stayed with pt and family until felt better.
Age: 1.03
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Patient developed fever of 106 for 2 full days after the vaccine was administered.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Lymph node pain, Neck mass, Neck pain, Pain, Torticollis
Clinical narrative: X 4 days lump left lower neck, painful to move neck to left. Tender left supraclavicular lymph node, torticollis. Rx tramadol, OV needed for pain.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Acne, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Swelling, pimple-like, redness at site of injection.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Patient is still experiencing arm pain. Called before but said it was a little better at first but i snow hurting again. She is doing ice and heat therapy. Numbness
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain in extremity, Vaccination site discolouration, Vaccination site induration, Vaccination site warmth
Clinical narrative: Discoloring where vaccination occurred skin felt hard and warm to touch. Bad bruising start 12-15 hours after immunization. Soreness within arm.  Bruising still present on 10-31-2014.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Severe chill and fever, felt overall lousy.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Syncope
Clinical narrative: syncopal episode 8 hrs after vaccine administration with stated elevated HR. Seen at local hospital. R/O DVT.
Age: 0.84
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX given to 10 month old.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Pruritus
Clinical narrative: Erythema and pruritis of right bicep. Temporary itching relief from topical steroid. Improved when added cetirizine 10mg QD.
Age: 80.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Injection site erythema, Injection site rash, Rash
Clinical narrative: Pat reported rash or redness around the injection site and spreading down the arm.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth, Swelling
Clinical narrative: Redness, rash inside of left arm; sensitive and warm to the touch. 10/18/14 pt states he is feeling better and redness and swelling had gone down.
Sex: U
Vaccine: FLUX, MMR, VARCEL
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a registered  nurse refers to a patient of approximately 1 year old. On 08-OCT-2014, the patient was vaccinated with a dose of M-M-R II (dose, route and lot # not reported) in the right leg for and a dose of (Oka/Merck) VARIVAX (dose, route and lot # not reported) in the right leg and influenza virus vaccine (unspecified) in the left leg.  The nurse reported that on an unspecified date in October 2014, the patient developed a pretty impressive rash where the M-M-R II was given in the right leg.  There were no lab diagnosis or studies performed. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Significant redness, pain and swelling at injection site of right deltoid.
Age: 78.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Injection site erythema, Injection site rash, Rash
Clinical narrative: Pt reproted rash or redness around the injeciton site and spreading down the arm.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red, swelling, itching at injection site.
Age: 1.02
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC13
Symptoms: C-reactive protein normal, Erythema, Full blood count normal, Injection site erythema, Injection site swelling
Clinical narrative: On 10/28/14 - developed red ears. On 10/31-11/1/14 developed red, hot, swollen legs and brief fever (labs CBC, CRP normal). On 11/3/14 developed scattered urticaria.
Age: 1.02
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC13
Symptoms: Injection site warmth, Pyrexia, Red blood cell sedimentation rate increased, Urticaria
Clinical narrative: On 10/28/14 - developed red ears. On 10/31-11/1/14 developed red, hot, swollen legs and brief fever (labs CBC, CRP normal). On 11/3/14 developed scattered urticaria.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Joint range of motion decreased, Pain
Clinical narrative: Pt experienced pain upon receiving vaccine, stated more pain than experienced in the past. Within the hour she was experiencing greater pain and marked decrease in range of motion. These symptoms have persisted since the vaccination on 10/11/14. Pain is relieved by IBU 600mg every 12 hours, but discomfort increases when not taking. Range of motion issues stated above are limited to left arm/shoulder.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and gender. On an unknown date, patients were vaccinated with improperly stored ROTATEQ (dose, frequency, route of administration and indication were not provided). No concomitants were reported. No adverse events were reported. The outcome of events was unknown. No further information ws provided.  This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Vomiting
Clinical narrative: Vomiting-11/1/14. Reaction ? ROTARIX.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Hyperhidrosis, Injection site erythema, Pain in extremity, Pyrexia
Clinical narrative: Vaccine administered 10/30/14 - AM. Patient started c/o symptoms 10/30/14 PM - which include fever, chills, sweats, arm pain - RT. Upon PE on 11/3/14 - vaccination site significantly swollen, red, hot to touch, very painful to touch. Treatment - BACTRIM, BACTROBAM, naproxen. Call if worsens.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Vaccine administered 10/30/14 - AM. Patient started c/o symptoms 10/30/14 PM - which include fever, chills, sweats, arm pain - RT. Upon PE on 11/3/14 - vaccination site significantly swollen, red, hot to touch, very painful to touch. Treatment - BACTRIM, BACTROBAM, naproxen. Call if worsens.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, RV1
Symptoms: Abnormal behaviour
Clinical narrative: At 4 mo PE, pt's mother stated that, pt stopped cooing after receiving the PENTACEL and ROTARIX vaccines 8/13/14. Pt was also noted not to smile as much. This change continued until 9/7/14.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to 2 different unspecified patients of unknown demographics. On 20-OCT-2014 the patient was vaccinated with PNEUMOVAX23 lot # J004747, expiry: 20-JUL_2014 (dosing regimen unspecified). No concomitant medications were reported. Healthcare worker stated that an expired doses of PNEUMOVA23 were administered to 2 different unspecified patients on 20-OCT-2014. No adverse effects reported. The outcome of the medication error and no adverse effects reported is unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Local swelling, Yellow skin
Clinical narrative: This spontaneous report as received from   a pharmacist refers to a 66 year old male patient. No information reported regarding medical history and concurrent conditions. On 15-OCT-2014 the patient was vaccinated with ZOSTAVAX lot # K003597, expire date: 12-MAR-2015, 0.65 ml, subcutaneous (dose number, anatomical locations not reported). No concomitant medications reported. On 17-OCT-2014, (also reported that around 17-OCT-2014 or 18-OCT-2014) the patient experienced yellow raised bump close to injection site after receiving ZOSTAVAX. No treatment was given for adverse event. The patient had visited into the pharmacy on 23-OCT-2014, and sought medical attention. The outcome of yellow raised bump close to injection site was unknown. This is one of two report received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Pt received HPV x3 each month received got menses x2.
Age: 0.55
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 6 month old given KINRIX.
Age: 9.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Epstein-Barr virus test negative, Full blood count normal, Lymphadenopathy, Red blood cell sedimentation rate normal, Streptococcus test negative
Clinical narrative: Swollen, lymph nodes behind ears and axillae - mom noticed they started 2 days after vaccines.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain, Skin warm
Clinical narrative: Very red, hot, hard area about 2 inches in cir painful.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient received ZOSTAVAX and showed up 4 days later with red area around injection site.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report was received from a nurse refers to a 64 year old female patient with left breast cancer, allergic to DARVON, hypertension, hypothyroidism, sarcoidosis and hyperlipidemia.  On 27-OCT-2014 the patient was vaccinated with ZOSTAVAX vial 19400 PFU, lot # K008884, expiration date: 20-SEP-2014, (route and dosage were not reported). Concomitant therapies included SYNTHROID, DEXILANT, LOSARTAN POTASSIUM, ZOCOR and ALLEGRA. The nurse informed that on 29-OCT-2014, the patient developed tenderness, redness and warmth at the injection site following administration of ZOSTAVAX., Also informed the patient had a red area that was approximately 3 cm by 4 cm in size around the injection site. The adverse events were treated ibuprofen, there were not laboratories studies performed. The patient sought medical attention by an office visit. The outcome of the event was not recovered. Additional information has been requested.
Age: 41.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 41 year old patient. Medical history and concurrent conditions were not reported. On 08-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose number, lot number and expiration date were not reported) (dose reported as 1 single shot), subcutaneous. Co -suspect and concomitant therapies were not reported. The pharmacist reported, patient was scheduled to receive (Oka/Merck) VARIVAX but was accidentally given ZOSTAVAX, on 08-OCT-2014, and now she had to wait even longer to try to conceive a child. No adverse effects were reported.  Additional information has been requested.
Sex: M
Vaccine: HIBV
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a health care worker refers to a male patient of unknown age. The patient's pertinent medical history and current condition was not reported. On an unknown date the patient was vaccinated with LIQUID PEDVAXHIB (strength, dose and frequency was not provided). On an unknown date the child was vaccinated with LIQUID PEDVAXHIB at 2, 4, and 6 months of age and no adverse effects reported. Product quality complaint was not involved. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients. On unknown dates the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot #, expiration date, dose and route unspecified). No adverse effects were reported. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician assistant through the field representative refers to a 89 year old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX. Patient sought medical attention through trip to ER visit. Patient was treated with acyclovir and lyrica for the adverse event. No product quality complaint was involved. The outcome of event was reported as not recovered. The reporter causality was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia oral
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's medical history and current conditions were not reported. On an unknown darte the patient was vaccinated with ZOSTAVAX (unknown strength, dose and frequency) (lot # and expiry date not provided). Other co-suspects and concomitant medicaiton was not reported. The pharmacist reported that every time he prepare and administre ZOSTAVAX to a patient, he experienced tingling of lips. The pharmacist states the lip tingling resolves within 30 minutes without requiring medical treatment. The pharmacist also reported that he wears gloves while preparing and administering the ZOSTAVAX. Cancer and overdose was not reported. The outcome of the event was reported as recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other healthcare worker refers to a patient of unknown age. On 02-OCT-2014 the patient was vaccinated with expired does of PNEUMOVAX23 lot # J009827, expiry 10-OCT-2014 0.5 ml. No concomitant medication was reported. On an unknown date the patient received expired dose of PNEUMOVAX23. No adverse effects were reported. Product quality complaint was not reported. The outcome of events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown demographics. The patient has received a dose of ZOSTAVAX 19400 PFU (dose, site of administration unknown) at an unspecified date in the past and inadvertently was vaccinated with ZOSTAVAX on 28-OCT-2014. No concomitant medications were reported. No adverse effects were reported. Product quality complaint was not reported. The outcome of patient received a dose of ZOSTAVAX at an unspecified date in the past and inadvertently received a second dose was unknown. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding an approximately 67 year old female patient. There was no information  on pertinent medical history and drug reactions or allergies. On 29-OCT-2014, the patient was vaccinated with ZOSTAVAX, product lot # J007208, expiry date: 20-SEP-2014, dose 0.65 ml (milliliter), subcutaneously in the right arm, which expired on 20-SEP-2014. No adverse effects were reported. There was no product quality involved. The outcome of the event was unknown. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 56 year old asplenic male patient. On an unknown date the patient was vaccinated with PNEUNMOVAX23 (dosing regimen and frequency unknown) (lot number and expiry date unknown at the age of 40. On an unknown date the patient was vaccinated with another dose of PNEUMOVAX23 (dose regimen and frequency unknown) (lot number and expiry date unknown) at the age of 46. No concomitant medications were reported. No adverse events were reported. The outcome of the events and action taken with the therapy with PNEUMOVAX23 was unknown. The relatedness of the events to the therapy with PNEUNMOVAX23 was unknown. There was no product quality issue reported.  Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to her children of unknown age. On an unknown date, the patient was vaccinated with the second and third dose of RECOMBIVAX HB, subcutaneous (dose, frequency, lot number, not provided) 5 weeks apart and wanted to know if the 3rd dose was going to still be effective. No adverse event reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and gender. On an unknown date, patients were vaccinated with improperly stored M-M-R II (dose, frequency, route of administration and indication were not provided). No concomitants were reported. No adverse events were reported. The outcome of events was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an adult patient of unknown gender. On 22-OCT-2014, the patient was inadvertently administered a does of RECOMBIVAX HB (lot # J014312) intramuscularly which expired on 07-SEP-2014. This was supported. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and gender. On an unknown date, patients were vaccinated with improperly stored LIQUID PEDVAXHIB (dose, frequency, route of administration and indication were not provided). No concomitants were reported. No adverse events were reported. The outcome of events was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 51 year old female patient with no pertinent medical history or drug reaction/allergies. On 21-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number, date and route were not reported) lot # K007986, expiration date 03-SEP-2015 with no concomitant therapies. The pharmacist reported that on 23-OCT-2014, the patient came to the pharmacy with a red, warm, 2.5 to 3 inch in diameter circle around the of ZOSTAVAX injection site. Pharmacist reported that red area was not raised and there was no rash present. At the time of the report the outcome was reported as not recovered. Patient sought medical attention at the pharmacy visit and was advised to administer ice packs to the injection site for treatment. No lab diagnostics test were performed. 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 nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, patients were vaccinated with improperly stored GARDASIL (dose, frequency, route of administration and indication were not provided. No concomitants were reported. No adverse events were reported. The outcome of events was unknown. No further information was provided. There is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Vaccine administered 10.9.14. On 11-3-14 patient presented to pharmaciy and stated he had 5 red spots on left arm between elbow and wrist.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning a patient of an unknown age and gender. Medical history and concurrent conditions were not reported. On 21-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (frequency reported as once) lot # K000996 expiration date 13-MAR-2014, 0.65 ml, subcutaneous. Co-suspect and concomitant therapies were not reported. The licensed practical  nurse stated patient received ZOSTAVAX that was exposed to 1C for 31 hours (supported by stability data). No adverse effects reported. This is one (1) of two (2) reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (registered nurse) refers to a female patient of unknown age. Current conditions and medical history was not reported. On 30-OCT-2014, the patient was vaccinated with PNEUMOVAX23 injection for an unknown indication (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On 30-OCT-2014, the patient was accidentally administered PREVNAR13 for an unknown indication (dose, route, lot number ad frequency were not reported) as well. No adverse effects noted. Product quality complaint was not reported. Additional information has been requested.
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning a 59 year old patient of an unknown gender. Medical history and concurrent conditions were not reported. On 21-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (frequency reported as once) lot # K000996, expiration date 13-MAR-2014, 0.65 ml, subcutaneous. Co-suspect and concomitant therapies were not reported. The licensed practical nurse stated patient received ZOSTAVAX that was exposed to 1C for 31 hours (supported by stability data). No adverse effects reported.  This is (1) of two (2) reports from the same source. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 56 year old female patient. Medical history was not reported. On 28-OCT-2014 the patient was vaccinated with the second dose of ZOSTAVAX vial, 0.65 ml, subcutaneous, lot # K009772, expiration date: 09-OCT-2015. Concomitant therapy was not reported. The pharmacist informed that on 29-OCT-2014, the patient experienced a raised, red swollen area, about one inch in diameter, at the injection site after receiving ZOSTAVAX. Also informed that the patient had inadvertently received the second does of ZOSTAVAX. It was not known when patient received the first dose of ZOSTAVAX. The patient did not receive treatment for the adverse event. There were not laboratories studies performed. The patient sought medical attention calling the pharmacist. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker/office manager via a company representative refers to a patient of unknown age and gender. Healthcare worker reported that the patients had received the first three doses of GARDASIL on a schedule that was outside the prescribing information and also a fourth dose of GARDASIL (strength, dose, route and lot # unspecified). Patient was administered doses on 16-MAY-2012, 08-AUG-2013, 12-AUG-2014 and 22-OCT-2014. No adverse events were reported. The outcome of event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.11
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC13
Symptoms: Eye swelling, Irritability, Pyrexia, Rash
Clinical narrative: Fever, fussy, rash, swollen eyes. Symptoms mild lasted about 2 days. Mother of infant called family physician. Her thought it was related to the shot MMR.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker/office manager via a company representative refers to a patient of unknown age and gender. Healthcare worker reported that the patients had received the first three doses of GARDASIL on a schedule that was outside of the prescribing information and also a fourth dose of GARDASIL (strength, dose, route and lot # unspecified). Patient was administered doses on 24-APR-2012, 08-AUG-2013, 12-AUG-2014 and 13-OCT-2014. No adverse events were reported. The outcome of event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. No information reported regarding medical history and concurrent conditions. On an unknown date the patient was vaccinated with ZOSTAVAX, subcutaneus (lot#, dose number, anatomical location  not reported). No concomitant medications reported. The pharmacist reported that she has seen an unspecified amount of patients develop unspecified rashes around the injection site and rashes around other unspecified areas after receiving ZOSTAVAX. The outcome of unspecified amount of patients develop unspecified rashes around the injection site and rashes around other unspecified areas after receiving ZOSTAVAX was unknown. This is one of the two report received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Cyanosis, Incorrect route of drug administration
Clinical narrative: This spontaneous report as received from a other health professional (registered nurse) refers to a female patient of unknown age. Patient was not pregnant. Current conditions and medical history was not reported. On an unknown date approximately in 2012 (reported as 2 years ago), the patient was vaccinated with ZOSTAVAX, intramuscular (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On an unknown date, the patient experienced a blue arm from the deltoid down to her elbow. On an unknown date approximately in 2012, patient received ZOSTAVAX by the intramuscular route rather than the subcutaneous. The outcome of blue arm from the deltoid down to her elbow was unknown. Causality assessment was not reported. Product quality complaint was not reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient with drug reaction/allergies to tetanus vaccine and drug reaction/allergies to sulfa. On 13-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 lot # J005068, expiration date 18-JAN-2015, 0.5 ml, intramuscular. No co-suspect and concomitant therapies were reported. Pharmacist reported that the patient developed a slight fever and an injection site reaction of redness, swelling and a "lump" (approximately in October 2014). At the time of this report, the patient no longer had the fever, redness and swelling but the patient still had a lump at the injection site. The outcome of injection site reaction was reported as recovering. The patient sought medical attention, called the pharmacist. No treatment was given for the adverse events. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The nurse reported that since 17-OCT-2014, the patient was vaccinated with a dose of PROQUAD (Merck) (dose and lot # not reported) subcutaneously that was improperly stored. This was supported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.