chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: FLUN4
Symptoms: Full blood count normal, Grand mal convulsion, Metabolic function test normal, Muscle rigidity, Myalgia
Clinical narrative: Given FLUMIST at 2pm on 11/7 - had prolonged seizure and taken to ER 4pm. Had more seizures in ER. Patient is a 16 y.o. male w/history of viral encephalitis in 2009, and known seizure disorder who presented on 11/7 with prolonged seizure. Per Dr's note (peds neuro): Mom reports that over the past 4-5 days patient has been complaining of extreme fatigue and myalgias. On day of admission he stayed home from school due to fatigue. Around 4pm yesterday mom reports patient had a seizure with unknown duration (mom feels approximately 2-3 minutes) described as generalized tonic-clonic with cyanosis. She called 911 - patient had stopped seizing by time EMS arrived. Patient had 2-3 more seizures in the ER described as bilateral arm stiffening with right leg drawn up, each lasting 1-2 minutes. Also had periods of retching/nausea in ER. Patient has had fevers with tmax of 38.1, normal CBC, CMP and CRP. ED course: VPA 1 gram load and ATIVAN 0.1 mg/kg IV x1 while in the ER. Last seizure was in December 2012 (also while ill with a virus). Prior to arrival he was taking VPA 750 mg BID. Previously taken KEPPRA but was discontinued due to side effects of anxiety and nausea.
Age: 16.0
Sex: M
Vaccine: FLUN4
Symptoms: Nausea, Pyrexia, Retching
Clinical narrative: Given FLUMIST at 2pm on 11/7 - had prolonged seizure and taken to ER 4pm. Had more seizures in ER. Patient is a 16 y.o. male w/history of viral encephalitis in 2009, and known seizure disorder who presented on 11/7 with prolonged seizure. Per Dr's note (peds neuro): Mom reports that over the past 4-5 days patient has been complaining of extreme fatigue and myalgias. On day of admission he stayed home from school due to fatigue. Around 4pm yesterday mom reports patient had a seizure with unknown duration (mom feels approximately 2-3 minutes) described as generalized tonic-clonic with cyanosis. She called 911 - patient had stopped seizing by time EMS arrived. Patient had 2-3 more seizures in the ER described as bilateral arm stiffening with right leg drawn up, each lasting 1-2 minutes. Also had periods of retching/nausea in ER. Patient has had fevers with tmax of 38.1, normal CBC, CMP and CRP. ED course: VPA 1 gram load and ATIVAN 0.1 mg/kg IV x1 while in the ER. Last seizure was in December 2012 (also while ill with a virus). Prior to arrival he was taking VPA 750 mg BID. Previously taken KEPPRA but was discontinued due to side effects of anxiety and nausea.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Rash
Clinical narrative: This spontaneous report was received from a registered nurse (age not reported) via a company representative referring on herself who on an unknown date (reproted as "several years ago) was vaccinated with a dose of ZOSTAVASX (dose and duration not reported). On an unknown date ("several years ago") the patient experienced sever pain at the injection site after administration of ZOSTAVAX. The day after administration of ZOSTAVAX, the patient developed rash on her arms. The rash subsequently resolved. Relationship between several pain in the injection site, rash and ZOSTAVAX was not reported. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient mother reports patient right thigh was very swollen, red and tender to touch. No fever. Seen in office next day after given Tylenol and ice. No signs of infection. Spoke with mom day after and significant improvement.
Age: 92.0
Sex: F
Vaccine: FLUX
Symptoms: Herpes simplex, Tonsillar disorder, Tonsillar hypertrophy, Viral infection
Clinical narrative: Herpes simplex erupted in right buttock. Added acyclovir for 10 days to daily meds. 24 hours after vaccination tonsils, right side erupted. 48 hours after vax at doctors office who specified infection was viral bcs got better without antibiotics. Tonsils never went back to normal. Tonsils were swollen, but could swallow, did not hurt or developed coating.
Age: 47.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Audiogram, Deafness unilateral, Nuclear magnetic resonance imaging brain, Vertigo, Vomiting
Clinical narrative: Pt received vaccine. On the next day he developed sudden onset of deafness of L ear, vomiting and vertigo.
Age: 35.0
Sex: F
Vaccine: FLU3, HEPA, PPV
Symptoms: Cellulitis, Pyrexia
Clinical narrative: PNEUMOVAX and flu shot given in left deltoid. Diagnosed with cellulitis, fever. Treated with Doxycycline Hyclate 100mg PO BID x 10 days.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Swelling
Clinical narrative: Swelling/redness.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Oral herpes
Clinical narrative: Outbreak of cold sores on face around mouth.
Age: 12.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Blood test normal, Idiopathic thrombocytopenic purpura, Increased tendency to bruise, Periorbital contusion, Petechiae
Clinical narrative: Petechia rash all over legs and body, spontaneous bruising with very little contact before our eyes.  Eye rub gave him black eyes.
Age: 12.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Platelet count decreased, Rash generalised
Clinical narrative: Petechia rash all over legs and body, spontaneous bruising with very little contact before our eyes.  Eye rub gave him black eyes.
Age: 12.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Blood test, Idiopathic thrombocytopenic purpura, Immunoglobulin therapy, Increased tendency to bruise, Petechiae
Clinical narrative: Petechia rash all over legs and body, spontaneous bruising with very little contact before our eyes.  Eye rub gave him black eyes.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Decreased appetite, Diarrhoea, Stool analysis normal, Vaccination complication
Clinical narrative: Burning sensation on side of face 16 Oct13 went away and came back next afternoon. On 18 Oct I had explosive diarrhea, burning contd on face went to neck and chest. Had continuing diarrhea and burning thru wknd. Saw GP on Mon 21 Oct..she said I had reaction to flu shot..burning and diarrhea continued thru 23 Oct.....Burning stopped but totally lost appetite...cont'd to have diarrhea...on 28 Oct blood test performed....negative result....diarrhea cont'd so stool samples submitted....negative...on 6 Nov went to Gastro Dr....he said I was having affects from flu shot...I was so fed up I went to ER on 11 Nov...again Flu shot ......my bm has continued to this day 14 Nov....but now they are in the middle of the night.  I am at my wits end.......I am seeing a acupuncturist and on Monday 18 November I am going to the neurologist. Before this event I was a very active fun person......my life is now sitting in the house and maybe taking a car ride with my husband.
Age: 1.73
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Febrile convulsion
Clinical narrative: Had a febrile seizure late afternoon after her flu vaccine in the AM.  Temp @ time of seizure 101.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Rash pruritic
Clinical narrative: Itchy rash on the back, chest, face, arms and neck.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: Shingles.
Age: 57.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Aphasia, Gaze palsy, Glassy eyes, Posture abnormal, Unresponsive to stimuli
Clinical narrative: Pt became unresposive, eyes glossy and rolling backward, not able to talk, somewhat slumped over in chair. Called 911 and give 1 dose epinephrine (Epi-Pen).
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Chest discomfort, Headache, Lethargy, Sinus headache
Clinical narrative: Headache, sinus pressure behind eyes, lethargy, tight chest.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Lip swelling, Oedema mouth, Pain, Pruritus, Pyrexia
Clinical narrative: Fever and aches and pains.  Then next morning about 5:00 AM blisters under tongue and swelling in my mouth.  This continued and additional symptoms of facial swelling occured about 11/11/13.  Still have raw mouth and facial (lips) swelling and some mild itching.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Stomatitis, Swelling face, Tongue blistering
Clinical narrative: Fever and aches and pains.  Then next morning about 5:00 AM blisters under tongue and swelling in my mouth.  This continued and additional symptoms of facial swelling occured about 11/11/13.  Still have raw mouth and facial (lips) swelling and some mild itching.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: PAIN AT INJECTION SITE RADIATING TO ELBOW. CURRENT AND WORSENING PAIN AS OF 14 NOV 2013 (TODAY).
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Dyspnoea, Fatigue, Headache, Hypothyroidism
Clinical narrative: Pain in legs and joints, severe fatigue, short breath and Chronic Headaches, still experiencing all symptoms.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Pain in legs and joints, severe fatigue, short breath and Chronic Headaches, still experiencing all symptoms.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Presyncope
Clinical narrative: Near syncope episode.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: AREA OF INJECTION RED, SWOLLEN AND WARM TO TOUCH.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Bursitis, Dyspnoea, Injection site rash, Injection site swelling
Clinical narrative: Developed rash, swelling, and warmth to touch at the injection site.  2 days later awoke to pain on inspiration, difficulty breathing which was dx'd by MD as pleurisy. 1 week after pleurisy developed swelling and pain in right elbow and dx'd with bursititis for which she was hospitalized.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Joint swelling, Painful respiration, Pleurisy
Clinical narrative: Developed rash, swelling, and warmth to touch at the injection site.  2 days later awoke to pain on inspiration, difficulty breathing which was dx'd by MD as pleurisy. 1 week after pleurisy developed swelling and pain in right elbow and dx'd with bursititis for which she was hospitalized.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Lethargy
Clinical narrative: Vaccine site turned extremely red and had raised bumps; about 4 inches in diameter; redness, swelling and heat from injection site down to elbow, about 6 inches. Felt tired and lethargic for 4 days. Felt like my skin was on fire from injection site to elbow.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Vaccination site rash
Clinical narrative: Vaccine site turned extremely red and had raised bumps; about 4 inches in diameter; redness, swelling and heat from injection site down to elbow, about 6 inches. Felt tired and lethargic for 4 days. Felt like my skin was on fire from injection site to elbow.
Age: 0.73
Sex: M
Vaccine: HIBV
Symptoms: Ear infection, Pyrexia, Respiratory tract congestion, Sinusitis
Clinical narrative: Woke up with fever of 101.2 and congested.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: RIGHT DELTOID, EDEMA ERYTHEMA (70MM) WARM TO TOUCH.
Age: 11.0
Sex: F
Vaccine: FLUN4
Symptoms: Nasal oedema, Pharyngeal oedema, Pyrexia, Vaccination complication
Clinical narrative: Mother states child began running fever of 103.5 at bedtime.  Throat and nose was swollen.  Saw Dr. on 11-8-13.  Dr. stated her nose and throat was swollen and she felt it was a reaction to the flu mist.  Fever was still running at 102 at that time.  Child was prescribed prednisone and an antibiotic.
Age: 47.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Bone pain, Chills, Injection site reaction, Lethargy, Local reaction
Clinical narrative: Large localized reaction in arm at site of both vaccines, profound lethargy, chills and bone aches in a strong healthy male.
Age: 63.0
Sex: F
Vaccine: FLUC3
Symptoms: Pruritus
Clinical narrative: Pt came to me approx 5 min after injection complaining of significant itching. Ice was applied and pt took benadryl in her possession. I checked her every few minutes. After 20 min and still no call back from her doctor. Pt left with intent of going to see doctor. I will follow up with her through the day. Dr contacted. Per MD pt's sx have completely resolved as of 12:15 PM.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site swelling, Pain, Rash, Skin warm
Clinical narrative: Redness, sore "2-3" on scale 1-10 warmth to touch, rash like rxn. left deltoid slightly raised.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Diarrhoea, Feeling hot, Headache
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 62 year old female patient. Medical history and drug allergies were not reported. On 05-NOV-2013, the patient was vaccinated with ZOSTAVAX, lot number J005849, expiration date 17-AUG-2014, subcutaneous in the right arm, dose reported as "standard". Concomitant therapies included an unspecified tetanus toxoid vaccine and influenza virus vaccine (manufacturer unknown) administered on 30-OCT-2013 (reported as "6 days before ZOSTAVAX). On 05-NOV-2013, the patient stayed in the pharmacy after vaccination with ZOSTAVAX for 10 minutes and left without a reaction. After leaving the pharmacy the patient became warm, and had developed a headache that worsened and became very intense, the patient also developed diarrhea. On 06-NOV-2013 (reported as "the next day"), the patient experienced that her whole body felt "on fire" and "every joint ached". Patient did not seek medical attention and did not receive any treatment for the events. At the time of the report the patient was asked if she felt better and she stated that she felt "110% better but was not 100% yet". Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, PPV
Symptoms: Cellulitis, Culture negative, Local swelling, Pyrexia
Clinical narrative: Patient received influenza, MENACTRA and PNEUMOVAX 'immunization' 10/28/13. The following day, she developed cellulitis after fever, (L) arm swelling noted. Cxs (-). Given antibiotics IV with subsidence of symptoms.
Age: 57.0
Sex: M
Vaccine: HEPA, YF
Symptoms: Arthralgia, Pain
Clinical narrative: Joint pain in the left wrist especially when flexing.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Approximately 2 minutes after administration, the patient fainted in our store twice, but immediately recovered consciousness both times. His parents were with him.  We offered paramedics but they refused.  We gave him water and let him sit for 15 minutes.  Afterward, the patient felt better and they left our store.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Bone pain, Chills, Myalgia, Oropharyngeal pain, Peripheral coldness
Clinical narrative: Approximately 18 hours after vaccination developed high fevers to 102.7, rigors, severe muscle and bone pain, cold extremities, lasting 12 hours.  An additional 6-8 hours of low grade temps <100.4, sore throat.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Approximately 18 hours after vaccination developed high fevers to 102.7, rigors, severe muscle and bone pain, cold extremities, lasting 12 hours.  An additional 6-8 hours of low grade temps <100.4, sore throat.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Chills, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Began to feel flu like symptoms - fever, chills, joint and muscle aches, and the injection site hurt. On 11/07/2013 the injection site began to feel hot, the injection site turned brite red, about a 3.5" diameter area, and itched.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site warmth, Myalgia, Pyrexia
Clinical narrative: Began to feel flu like symptoms - fever, chills, joint and muscle aches, and the injection site hurt. On 11/07/2013 the injection site began to feel hot, the injection site turned brite red, about a 3.5" diameter area, and itched.
Age: 1.29
Sex: F
Vaccine: DTAP, HIBV, PNC13, VARCEL
Symptoms: Erythema, Papule, Skin plaque
Clinical narrative: Erythematous papules and plaques along a dermatome left upper arm and back.
Age: 39.0
Sex: M
Vaccine: HEPAB, YF
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Itchy, erythematous rash on mid-lower back... the rash and itchiness improved over course of 1 day.  No fever or any other symptoms.  No treatment given.
Age: 57.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chest pain, Injected limb mobility decreased, Local swelling, Neck pain, Vaccination complication
Clinical narrative: Pt walked in for lab draw and mentioned to Medical Assistant that he had a bad reaction to Pneumo vaccine. I was I the lab at the time and talked to Pt to indentify allergic reaction. Pt states that later on, same day as vaccine administration date, his left arm began to swell and could not lift arm. Pain then radiated to neck and chest. Decided to go to ER. Did not wait for ER MD to evaluate. Left before being seen. Pt states symptoms resolved in a couple of days. Did not return to clinic or seek medical advise.
Age: 0.18
Sex: F
Vaccine: DTPPHIB, PPV, RVX
Symptoms: Crying, Decreased appetite, Emotional distress, Fatigue, Gastrooesophageal reflux disease
Clinical narrative: Pt. received vaccine around 11:30. Slept in car seat and when in front pack 11:45-1:00. Nursed at 1:00 for briefer than typical time. Napped approximately 5 minutes before screaming. Inconsolable for 3 hours. Unable to nurse effectively at 3:00. Fell asleep again with maximum comfort techniques at 4:40. Woke herself up frequently with little squeals or screams. Back at dr. office at 5:00. Pt pale, lethargic, scream/cried at every change of position (e.g., held against parent chest vs. held cradled in arms). Pt. had worst reflux ever experienced, possibly due to intensity of crying. Given Tylenol by dr just after 6pm. Pt calmed, nursed well, still had difficulty with position changes. No fever. Started scream/crying again at 11 pm, still pale and lethargic. Given more Tylenol. Able to sleep 12-4am, able to nurse at 4am. Appeared tired and pale 11/14/13; closer to normal at 4pm.
Age: 0.18
Sex: F
Vaccine: DTPPHIB, PPV, RVX
Symptoms: Lethargy, Pallor, Screaming
Clinical narrative: Pt. received vaccine around 11:30. Slept in car seat and when in front pack 11:45-1:00. Nursed at 1:00 for briefer than typical time. Napped approximately 5 minutes before screaming. Inconsolable for 3 hours. Unable to nurse effectively at 3:00. Fell asleep again with maximum comfort techniques at 4:40. Woke herself up frequently with little squeals or screams. Back at dr. office at 5:00. Pt pale, lethargic, scream/cried at every change of position (e.g., held against parent chest vs. held cradled in arms). Pt. had worst reflux ever experienced, possibly due to intensity of crying. Given Tylenol by dr just after 6pm. Pt calmed, nursed well, still had difficulty with position changes. No fever. Started scream/crying again at 11 pm, still pale and lethargic. Given more Tylenol. Able to sleep 12-4am, able to nurse at 4am. Appeared tired and pale 11/14/13; closer to normal at 4pm.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Bone pain, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: High Fever, Severe Body Pain, Severe Head Ache, High Pain at Injection Site. The pain in my body was SO severe in my bones...almost felt like my bones were being ground up!!!
Age: 51.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site pain, Injection site reaction, Joint injury, Muscle contracture, Pain
Clinical narrative: Shoulder injury: right arm rotation pain continuing to date; right deltoid contraction pain continuing to date; sensitivity at injection point continuing to date.
Age: 51.0
Sex: M
Vaccine: DTAP
Symptoms: Pain in extremity
Clinical narrative: Shoulder injury: right arm rotation pain continuing to date; right deltoid contraction pain continuing to date; sensitivity at injection point continuing to date.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Alopecia, Condition aggravated
Clinical narrative: My hair started to fall out. Hair on top of head fell out to large area.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphagia, Dysphonia, Eye discharge, Eye swelling
Clinical narrative: Sore throat, feeling of throat closing, difficulty swallowing, hoarsness, dry cough, eyes watering and swelling shut, redness. Slight headache.  Lasted through night.  Eyes had heavy mucus on lid.  Exhausted following day.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Lacrimation increased, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Sore throat, feeling of throat closing, difficulty swallowing, hoarsness, dry cough, eyes watering and swelling shut, redness. Slight headache.  Lasted through night.  Eyes had heavy mucus on lid.  Exhausted following day.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Sore throat, feeling of throat closing, difficulty swallowing, hoarsness, dry cough, eyes watering and swelling shut, redness. Slight headache.  Lasted through night.  Eyes had heavy mucus on lid.  Exhausted following day.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: Hives covering entire torso and legs and buttocks.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Inflammation
Clinical narrative: FLARE UP BETWEEN BONE AND MUSCLE IN SHOULDER.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling, Nodule
Clinical narrative: Swelling at injection site. "Knot" on arm injected.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLUX, MMR, VARCEL
Symptoms: Asthenia, Crying, Disorientation, Headache, Hypotension
Clinical narrative: My daughter complained that her "brain hurt" and started to cry. She then fainted when she stepped in to the car. She was unresponsive for a couple of seconds. She was weak, pale, and disoriented. The nurses took her to a separate room, tested her blood pressure (which they stated was low at first) and put a cool towel on her head.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLUX, MMR, VARCEL
Symptoms: Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: My daughter complained that her "brain hurt" and started to cry. She then fainted when she stepped in to the car. She was unresponsive for a couple of seconds. She was weak, pale, and disoriented. The nurses took her to a separate room, tested her blood pressure (which they stated was low at first) and put a cool towel on her head.
Age: 9.0
Sex: M
Vaccine: FLUN4
Symptoms: Abdominal pain, Cough, Diarrhoea, Frequent bowel movements, Respiratory tract congestion
Clinical narrative: Received Flu Mist vaccine in flu shot clinic (known what time he received it).  Mom states that he developed abdominal pain and then frequent nonbloody, nonbilious diarrhea 5-10 times per day. Maybe some congestion and cough also seen after flu mist.
Age: 1.27
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Dyskinesia, Electroencephalogram, Fatigue, Lethargy, Posture abnormal
Clinical narrative: Patient had a fever, was very lethargic, fatigued, started head jerking movements which happened several times a day for two weeks, and occasionally she will have the head jerk movements now three months later.  Patient broke out in a rash all over her body.
Age: 1.27
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Patient had a fever, was very lethargic, fatigued, started head jerking movements which happened several times a day for two weeks, and occasionally she will have the head jerk movements now three months later.  Patient broke out in a rash all over her body.
Age: 51.0
Sex: F
Vaccine: FLUN4
Symptoms: Heart rate increased, Pruritus generalised, Urticaria
Clinical narrative: Large hives on torso. Itching on torso, arms, head, back. Faster heartbeat, but not extreme. I told the pharmacist where I went to pick up a prescription. He said if I had trouble breathing to go to the E.R. I have not had swelling in my throat or trouble breathing, so I have not sought medical attention for the reaction.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site movement impairment, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of falling asleep suddenly in a 61-year-old female subject who was vaccinated with Influenza quadrivalent vaccine unspecified (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included osteoporosis spine. Concurrent medications included OPANA ER, Oxymorphone and NEURONTIN. On 14 October 2013 at 16:00 the subject received a dose of Influenza quadrivalent vaccine unspecified (unknown details, left arm). The subject did know which GSK quadrivalent vaccine for influenza she received. On the morning of 16 October 2013, 2 days after vaccination with Influenza quadrivalent vaccine unspecified, the subject experienced pain around injection site. The subject stated that "the pain at injection site has spread down near her elbow, then up to her shoulder, and then into her neck." In October 2013, at an unknown time after vaccination with Influenza quadrivalent vaccine unspecified, the subject experienced falling asleep suddenly (described as "spontaneously falls asleep", headache-daily and intolerance to sun (without any cutaneous reaction) (described as "cannot stand to be in the sunlight"), and injection site movement impairment (described as "cannot hardly use that arm"). The subject reported "having headaches almost every day". She remarked that "she has been poisoned." The subject reported that "if she sleeps on her arm it hurts so bad that she cannot hardly use that arm." The subject did not clarify what she meant by "cannot stand to be in the sunlight." The subject reported experiencing "all of these symptoms every day." In the subject's opinion, the events were disabling. This case was assessed as medically serious by GSK. The subject considered the events to be disabling. At the time of reporting the events were worse. At the time of reporting, the subject had an appointment planned with her physician.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Photosensitivity reaction, Sudden onset of sleep
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of falling asleep suddenly in a 61-year-old female subject who was vaccinated with Influenza quadrivalent vaccine unspecified (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included osteoporosis spine. Concurrent medications included OPANA ER, Oxymorphone and NEURONTIN. On 14 October 2013 at 16:00 the subject received a dose of Influenza quadrivalent vaccine unspecified (unknown details, left arm). The subject did know which GSK quadrivalent vaccine for influenza she received. On the morning of 16 October 2013, 2 days after vaccination with Influenza quadrivalent vaccine unspecified, the subject experienced pain around injection site. The subject stated that "the pain at injection site has spread down near her elbow, then up to her shoulder, and then into her neck." In October 2013, at an unknown time after vaccination with Influenza quadrivalent vaccine unspecified, the subject experienced falling asleep suddenly (described as "spontaneously falls asleep", headache-daily and intolerance to sun (without any cutaneous reaction) (described as "cannot stand to be in the sunlight"), and injection site movement impairment (described as "cannot hardly use that arm"). The subject reported "having headaches almost every day". She remarked that "she has been poisoned." The subject reported that "if she sleeps on her arm it hurts so bad that she cannot hardly use that arm." The subject did not clarify what she meant by "cannot stand to be in the sunlight." The subject reported experiencing "all of these symptoms every day." In the subject's opinion, the events were disabling. This case was assessed as medically serious by GSK. The subject considered the events to be disabling. At the time of reporting the events were worse. At the time of reporting, the subject had an appointment planned with her physician.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Oropharyngeal pain, Pain in extremity, Pyrexia, Respiratory tract congestion
Clinical narrative: Pain at injection site, expanding and radiating down arm. Pt. also has intermittent fevers (low grade), chest congestion and throat pain.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Loss of consciousness
Clinical narrative: Patient returned about 15 min after IM flu shot feeling funny. A few minutes later she lost consciousness for about 5 sec. 911 was called. Paramedics found nothing. Patient went home with husband.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Blood culture, Full blood count, Injection site pain, Injection site warmth, Red blood cell sedimentation rate
Clinical narrative: Pain and warmth @ injection site approx 10 day after vaccination. Possible local reaction vs. early cellulitis.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Bacterial infection, Injection site pain, Injection site swelling
Clinical narrative: Pt developed swelling and pain at injection site. Pt's Dr initiated treatment for bacterial infection (prednisone and cephalexin).
Age: 52.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt came back to pharmacy the day after getting vaccine and has pain, redness, and swelling at injection site. Pt states she is going to MD 11/15/13 to get evaluated. Also advised pt to put ice pack on site and to take ibuprofen for pain.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain
Clinical narrative: Pain, bruises, per patient.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Right arm is red, hot and swollen from injection site to below the elbow and it itching.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Nausea, Palpitations
Clinical narrative: Heart palpitations, weakness, nausea. No treatment necessary, resolved overnight.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Immediate swelling at injection site of Hib vaccine. Cold compress applied in office. She call that night, still red at site, not painful will recheck at next appt. No mention of swelling or symptoms at next visit 11/12/13.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Local swelling
Clinical narrative: Left leg swelling (previous knee joint replacement) has bilateral leg swelling left slightly.
Age: 55.0
Sex: F
Vaccine: FLUC3
Symptoms: Arthralgia, Aspiration joint, Gait disturbance, Joint swelling, Muscle spasms
Clinical narrative: Received call from pt on 11/14/13. She reports receiving flu vaccine on 10/31/13 around 2 PM. That evening around 5 PM states her ears started ringing. Around 8 PM that evening, she experienced sharp spasms in both shoulders which traveled to middle back, to butt, to both thighs and to both  knees. Then felt "charley horse" type cramps in both forearms. She awakened during the night that same night with the cramping spasms again as described earlier with the worst pain seeming to be in the knees. The next day 11/1/13, states her knees "felt like they were gelled up" and noticed swelling in both knees, which has continued to get a little worse each day since then. On Sunday, 11/3/13, she noticed blurriness in the "lower 1/3" of her right eye which persists through today. On 11/8/13, she went to clinic and saw nurse practitioner. She suggested steroids, but pt said she does not tolerate steroids well so they suggested ibuprofen and Benadryl. The swelling and pain in her knees has continued to get worse, making it difficult for pt to walk. She saw a rheumatologist today and he aspirated 22 cc of fluid from the left knee and 23 cc of fluid from the right knee which he is sending to be tested. She has a follow-up appt in 2 weeks unless symptoms become worse or she feels she needs to see him sooner than that. The muscle spasms have been very intermittent since that first night with the most recent being 3 days ago in the left forearm. Knee swelling and pain has increased as described above, and the blurriness in the right eye has remained unchanged since it started.
Age: 55.0
Sex: F
Vaccine: FLUC3
Symptoms: Tinnitus, Vision blurred
Clinical narrative: Received call from pt on 11/14/13. She reports receiving flu vaccine on 10/31/13 around 2 PM. That evening around 5 PM states her ears started ringing. Around 8 PM that evening, she experienced sharp spasms in both shoulders which traveled to middle back, to butt, to both thighs and to both  knees. Then felt "charley horse" type cramps in both forearms. She awakened during the night that same night with the cramping spasms again as described earlier with the worst pain seeming to be in the knees. The next day 11/1/13, states her knees "felt like they were gelled up" and noticed swelling in both knees, which has continued to get a little worse each day since then. On Sunday, 11/3/13, she noticed blurriness in the "lower 1/3" of her right eye which persists through today. On 11/8/13, she went to clinic and saw nurse practitioner. She suggested steroids, but pt said she does not tolerate steroids well so they suggested ibuprofen and Benadryl. The swelling and pain in her knees has continued to get worse, making it difficult for pt to walk. She saw a rheumatologist today and he aspirated 22 cc of fluid from the left knee and 23 cc of fluid from the right knee which he is sending to be tested. She has a follow-up appt in 2 weeks unless symptoms become worse or she feels she needs to see him sooner than that. The muscle spasms have been very intermittent since that first night with the most recent being 3 days ago in the left forearm. Knee swelling and pain has increased as described above, and the blurriness in the right eye has remained unchanged since it started.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal hypoaesthesia, Throat irritation
Clinical narrative: Patient had throat symptoms including numbness and felt itchy.
Age: 1.04
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: Child presented with cough and rash day of vaccines, no fever 11/13/2013. 11/14/13 first time event, child began to vomit at 10:00 AM consistently throughout the day 11/14/13 ran a low grade fever (100.9) mother stated child arms and legs began shaking uncontrollably approx, 02:30 PM. This happened almost 24 hrs after vaccinations. Child transported via ambulance to ER.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Crying, Headache, Ocular hyperaemia, Pharyngeal oedema
Clinical narrative: Swelling in throat. Red eyes and weeping. Headache.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: This spontaneous report was received via field employee from a female nurse in her 50's, referring on herself. On an unknown date, the patient was vaccinated with ZOSTAVAX (vial) dose reported as "standard" single dose, route reported as "injection" (lot number was not provided). No concomitant medications were reported. On an unknown date, reported as "within one day after receiving ZOSTAVAX", the patient experienced rash, redness and soreness around the injection site. Treated with acyclovir, the "anti-viral medication", the reaction improved "within a few days." On an unknown date, the patient was recovered. Additional information is not expected.
Age: 0.47
Sex: M
Vaccine: IPV, PNC13
Symptoms: Urticaria
Clinical narrative: At 2 mo PE received Pentacel; Prevnar and Rotarix - had hives all over after 2r hrs on 11/7/13. Receive red Prevnar 13 and IPV.  36 hours later hives all over again.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Contusion, Erythema, Local swelling
Clinical narrative: Localized red raised area 8cm in diameter including 2cm bruise. Returned to doctor's visit 11/15/13. Instructed to apply cold pack and take TYLENOL.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Chest pain, Dizziness, Dyspnoea, Fatigue
Clinical narrative: This spontaneous report as received from a consumer, mother of  the patient, who refers a 16 year old male patient with migraines and with no allergies or drug reactions. In "may or June 2013", the patient was vaccinated with the first dose of GARDASIL (dose, indication, route and lot were not reported). On 15-OCT-2013, the patient was vaccinated with the second dose of GARDASIL, route reported as "injection" (dose, and lot were not reported). Concomitant therapies included amitriptyline hydrochloride (manufacturer unknown). On 15-OCT-2013, the patient experienced shortness of breath, woke up this morning feeling very fatigued, his chest hurt and felt like he was going to pass out. The patient was went to the physician to see medical attention. No treatment was given. Lab diagnostics were not performed. The outcome of shortness of breath, woke up this morning feeling fatigued, felt like he was going to pass out and his chest hurt was reported as not recovered/not resolved. Therapy with GARDASIL was continued. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Pt. came in the following day c/o pain in arm, redness. There was noticeable redness/swelling in entire upper arm (L). Pt. was advised to see MD ASAP. Pt. saw her PCP and was put on 7 day regimen of Cephalexin 500 mg. Dx: cellulitis.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Skin warm
Clinical narrative: Patient received Fluzone HD on 11/11/13 on 11/13/13 patient experienced an episode of shaking (chills) of lasted from Noon till 9 PM. Spouse felt his head and thought he had a fever. Called the pharmacy on 11/14. I asked him to take his temp it was 101.4. She called again and 5 PM his fever was 101.7. MD recommended Tylenol.
Sex: U
Vaccine: MMR, VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant, refers to a patient of unknown age and gender. On 04-NOV-2013 the patient was vaccinated with VARIVAX (Merck) (dose, route and lot number were not provided) measles, mumps, and rubella (Wistar Ra 27-3) virus vaccine live (manufacturer unknown) (dose, route and lot number were not provided) and ZOSTAVAX (dose, route and lot number were not provided). The healthcare worker reported that the patient should have received VARIVAX (Merck) and measles, mumps, and rubella (Wistar Ra 27-3) virus vaccine, live (manufacturer unknown) vaccines, however, after the patient received VARIVAX (Merck), the patient got ZOSTAVAX instead of measles, mumps and rubella (Wistar Ra 27-3) virus vaccine, live (manufacturer unknown) due to human error. The patient received measles, mumps, and rubella (Wistar Ra 27-3) virus vaccine live (manufacturer unknown) after the error was detected. No adverse effect reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Diarrhoea, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: PNEUMOVAX site - L arm - erythema 13x18 cm, central induration (welt) 3x3 cm. ZOSTAVAX site - R arm = welt x 2x2cm, significant warmth, erythema, 9x7 cm. (+) axillary lymphadenopathy (R). Reports significant itching/burning at site. Also c/o slight nausea and low grade fever and loose stools.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site urticaria, Injection site warmth, Lymphadenopathy, Nausea, Pyrexia
Clinical narrative: PNEUMOVAX site - L arm - erythema 13x18 cm, central induration (welt) 3x3 cm. ZOSTAVAX site - R arm = welt x 2x2cm, significant warmth, erythema, 9x7 cm. (+) axillary lymphadenopathy (R). Reports significant itching/burning at site. Also c/o slight nausea and low grade fever and loose stools.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Red, painful, swellinig on R arm. Started 11-13-13.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 16-FEB-2011 the patient was vaccinated with the first dose of GARDASIL (lot# unspecified). Late on 29-AUG-2013 the patient was vaccinated with the second dose of GARDASIL (lot# unspecified). Early on 24-OCT-2013 the patient was vaccinated with the third dose of GARDASIL (lot# unspecified). No adverse effects were reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On 07-NOV-2013 the patient was vaccinated an expired first dose of GARDASIL (lot# 1073AA, expiry date: 11-OCT-2013) intramuscularly (dose and location unspecified). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product quality issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified patients of unknown age. When he reconstituted an unspecified number of ZOSTAVAX vials, the total volume of reconstituted product withdrawn is approximately 0.6mL. Pharmacist stated that these doses have been administered to an unspecified number of unspecified patients on unspecified dates. PQC filed. This is one of the reports from the same source. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Gait disturbance, Injection site rash
Clinical narrative: Next day after injection right upper arm rash present. Day three both arms joint pain and lower back. Having problems with walking.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Skin tightness
Clinical narrative: (R) upper arm tense red swollen nl ROM, nl strength.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Pain, Pain in extremity
Clinical narrative: I had severe sharp pain at the time of flu vaccination. My Rt arm has been hurting ever since and have pain with normal daily activities.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 99.0 Temp, swollen (R) deltoid, red diameter 70 mm, pain from injection site to under her arm pit. Continue to monitor, advised, ice, MOTRIN and or TYLENOL. Made circle around reddened area.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified patients of unknown age. Pharmacist mentioned that an unspecified number of patients after receiving ZOSTAVAX (lot # was not reported) on unspecified dates had experienced injection site reactions of swelling and inflammation. This is one of the reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to an unknown age and gender patient. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). Concomitant medication was not reported. On an unknown date, the patient developed shingles post vaccination. The outcome of patient developing shingles was unknown. Causality was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy healthcare student, refers to a 65 year old patient of unknown gender. On 31-OCT-2013 the patient was vaccinated with ZOSTAVAX (lot # J001729, expiration date 20-OCT-2013) (dose, indication and route were not reported), which was approximately 10 days after the expiration. Concomitant medications were not reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown ages and genders. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date, at 12 months of age the patients were vaccinated with VAQTA, 0.5 ml, intramuscular and again at 15 months of age with the same dose. Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age with heart disease. On 25-OCT-2013 the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous). There was none drug reactions. Concomitant drug included aspirin. The pharmacist reported that the patient was administered ZOSTAVAX on 25-OCT-2013 and on an unspecified date a few years ago the patient developed pain and weakness from the elbow to the shoulder on the arm of the ZOSTAVAX injection. The patient called the pharmacist for medical attention and none treatment was given and none diagnostics studies were performed. The outcome of the adverse events was not reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Hypotension, Type 2 diabetes mellitus, Vertigo
Clinical narrative: Had flu shot on 10/8/2013. Began having low BP. Extreme dizziness/vertigo overnight and for 1-3 hours after awakening.
Sex: U
Vaccine: FLU3
Symptoms: Laceration, Syringe issue
Clinical narrative: I had a FLUZONE PF syringe NDC49281-0013-88 break apart in my hand while preparing for an immunization. The syringe was glass, and the broken glass cut my thumb with a deep laceration.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Erythema, Infection, Swelling
Clinical narrative: Swelling and infection w/redness 4" total, at 2 inch wide infection within 4" redness. Given KEFLEX for the infection and had a severe reaction to the KEFLEX. I am still on meds for the reacton and seeing an allergist.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Vomiting lasting for several days after vaccination received, starting about 6 h after shot.
Age: 71.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Malaise
Clinical narrative: My partner and I were getting our FLUZONE HD INJ this past Saturday October 12-2013. After a few hours we became extremely sick with all the symptoms describe as side effects. For older people (that we are) 74 and 71 weight just a little above 150 pounds, that dosage was much to strong.
Age: 71.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: My partner and I were getting our FLUZONE HD INJ this past Saturday October 12-2013. After a few hours we became extremely sick with all the symptoms describe as side effects. For older people (that we are) 74 and 71 weight just a little above 150 pounds, that dosage was much to strong.