chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Oropharyngeal pain, Pain
Clinical narrative: LESS THAN 48 HOURS AFTER IMMUNIZATION, PT DEVELOPED BODY ACHES, SORE THROAT AND NAUSEA.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Hyperhidrosis, Myalgia, Pyrexia, Respiratory tract congestion
Clinical narrative: ONSET OF FEVERS, SWEATING, CHILLS, MYALGIAS, CORYZA, SINUS CONGESTION, CHEST CONGESTION WITHIN 24 HRS OF RECEIVING VACCINE
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Rhinitis, Sinus congestion
Clinical narrative: ONSET OF FEVERS, SWEATING, CHILLS, MYALGIAS, CORYZA, SINUS CONGESTION, CHEST CONGESTION WITHIN 24 HRS OF RECEIVING VACCINE
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Lethargy, Oedema peripheral, Pain in extremity
Clinical narrative: Patient's arm was still swollen after 3 days.  She said it was about 5 inches in size and ached but is getting better by the day.  She has no other symptoms, just felt lethargic for the first 2 days.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma, Injection site pain
Clinical narrative: Patient reported a large, deep purple bruise at the site of injection that progressed in size to approximately 2 inches in diameter. She also reported pain at the injection site lasting more than 1 week.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Pain
Clinical narrative: Pt. states pain every since vaccine received. Pain in moving arm. Cannot use steering wheel. Cannot pick up 2 yr old. Had not taking anything. Recommended to take ibuprofen, ice, movement of arm and to see Dr.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Continuous pain in your upper arm, on scale of 1-10, the pain was initially an 8, but after anti-inflammatories, the pain is now a 2.
Age: 36.0
Sex: F
Vaccine: FLU3, HEP, HEPA, PPV, TDAP
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: fever of 102.5 F persisted 2 days; 3" wide band of skin that was reddened & warm to touch above left elbow persisted 4 days - looked and felt like a sunburn or fluid-less blister
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Influenza like illness, Injection site anaesthesia, Injection site reaction, Lymphadenopathy
Clinical narrative: Flu like symptoms, tingling/numbness in left arm where shot was administered, swollen lymph nodes under armpit and in my neck on the left side.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Paraesthesia
Clinical narrative: Flu like symptoms, tingling/numbness in left arm where shot was administered, swollen lymph nodes under armpit and in my neck on the left side.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Hypoaesthesia facial, Paraesthesia
Clinical narrative: Prickling "pins & needles", weakness, numbness in the face
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Body temperature increased, Convulsion, Dehydration, Electroencephalogram normal, Gaze palsy
Clinical narrative: First adverse event was my son's temperature rising to 106.3 and being in the ER to be told he was dehydrated. The following day 5/23/2010 my son had what was described to us as a seizure that caused him to go from being normal to being lifeless and not breathing with his eyes rolling in his head.  The ambulance transported us to the ER where we were told he had a seizure.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Respiratory arrest
Clinical narrative: First adverse event was my son's temperature rising to 106.3 and being in the ER to be told he was dehydrated. The following day 5/23/2010 my son had what was described to us as a seizure that caused him to go from being normal to being lifeless and not breathing with his eyes rolling in his head.  The ambulance transported us to the ER where we were told he had a seizure.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Eye discharge, Eye swelling, Feeling hot, Lip swelling, Ocular hyperaemia
Clinical narrative: Symptoms started around 2:30 - 3:00 PM.  Throat swelling, eyes red and swollen, felt hot all over, eyes draining, lips swollen.  Took Benadryl about 7 PM and in AM 10/26.  Symptoms gone within 24 hrs.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema
Clinical narrative: Symptoms started around 2:30 - 3:00 PM.  Throat swelling, eyes red and swollen, felt hot all over, eyes draining, lips swollen.  Took Benadryl about 7 PM and in AM 10/26.  Symptoms gone within 24 hrs.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Pain, Vomiting
Clinical narrative: Pt experienced severe vomiting and diarrhea, body aches, and chills.
Age: 26.0
Sex: F
Vaccine: TD
Symptoms: Acne, Chills, Fatigue, Hypersomnia, Influenza like illness
Clinical narrative: Started getting a light fever that progressed to a higher fever. Started getting chills, and my arm was hot and hard where the injection site was. The actual injection site now looks like a pimple. Started itching really really bad, accompanied by rash in various spots on my body. I generally felt like I had the flu. I was overly tired and fell asleep A LOT!
Age: 26.0
Sex: F
Vaccine: TD
Symptoms: Injection site induration, Injection site reaction, Injection site warmth, Pruritus, Pyrexia
Clinical narrative: Started getting a light fever that progressed to a higher fever. Started getting chills, and my arm was hot and hard where the injection site was. The actual injection site now looks like a pimple. Started itching really really bad, accompanied by rash in various spots on my body. I generally felt like I had the flu. I was overly tired and fell asleep A LOT!
Age: 26.0
Sex: F
Vaccine: TD
Symptoms: Rash
Clinical narrative: Started getting a light fever that progressed to a higher fever. Started getting chills, and my arm was hot and hard where the injection site was. The actual injection site now looks like a pimple. Started itching really really bad, accompanied by rash in various spots on my body. I generally felt like I had the flu. I was overly tired and fell asleep A LOT!
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain upper, Asthenia, Body temperature increased, Chills, Diarrhoea
Clinical narrative: Severe chills although I was in bed with 2 covers, stomach pain, diarrhea, breathing shallow and at a faster rate than normal, hoarseness, I believe my heart rate was faster than normal, but I didnt take my pulse, weakness, at one point I felt I was going to faint but didn't. After a while I was very overheated (no more chills). I did had pork for dinner on Sunday 11/07/2010 I wonder if that somehow helped create the adverse reaction, took my temperature several times the highest reading was 100.1 degrees. I believe I probably was pale, but didn't look for it specifically.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Dysphonia, Feeling hot, Heart rate increased, Hypoventilation
Clinical narrative: Severe chills although I was in bed with 2 covers, stomach pain, diarrhea, breathing shallow and at a faster rate than normal, hoarseness, I believe my heart rate was faster than normal, but I didnt take my pulse, weakness, at one point I felt I was going to faint but didn't. After a while I was very overheated (no more chills). I did had pork for dinner on Sunday 11/07/2010 I wonder if that somehow helped create the adverse reaction, took my temperature several times the highest reading was 100.1 degrees. I believe I probably was pale, but didn't look for it specifically.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Pallor, Respiratory rate increased
Clinical narrative: Severe chills although I was in bed with 2 covers, stomach pain, diarrhea, breathing shallow and at a faster rate than normal, hoarseness, I believe my heart rate was faster than normal, but I didnt take my pulse, weakness, at one point I felt I was going to faint but didn't. After a while I was very overheated (no more chills). I did had pork for dinner on Sunday 11/07/2010 I wonder if that somehow helped create the adverse reaction, took my temperature several times the highest reading was 100.1 degrees. I believe I probably was pale, but didn't look for it specifically.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Decreased appetite, Erythema, Fatigue, Hypotension
Clinical narrative: Severe pain in arm, 3 hard red swollen knots, swelling in arm, fever of 102.5, low blood pressure, loss of appetite, weakness, fatigue.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Induration, Nodule, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Severe pain in arm, 3 hard red swollen knots, swelling in arm, fever of 102.5, low blood pressure, loss of appetite, weakness, fatigue.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: White blood cell count increased
Clinical narrative: Severe pain in arm, 3 hard red swollen knots, swelling in arm, fever of 102.5, low blood pressure, loss of appetite, weakness, fatigue.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site pain, Injection site swelling, Oedema peripheral, Pain in extremity
Clinical narrative: Pt noticed that she had chills over night and when she woke up in the morning, her arm was swollen and painful, from the infection site down. Pt declined an appt and decided to use home care to treat.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Headache, Hypotension, Pyrexia
Clinical narrative: chills, low BP, fever (101.8), headaches, dizzy
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Drug hypersensitivity, Injection site rash
Clinical narrative: Patient developed a red rash with raised bumps (no pustules), covering a 9cm diameter area around the injection site.  The patient recieved supportive care.  Te allergy was added to her profile.
Age: 1.04
Sex: M
Vaccine: IPV
Symptoms: Erythema, Rash pustular
Clinical narrative: Small pin-point or slightly larger pustules that appear to contain a clear fluid in patches on abdomen, chest, and back, and on inner aspect of knees and on thighs.  Randomly scattered on other parts of body also.  The bumps have white/clear heads and the skin between the bumps, where they are clustered, is pink.  They do not seem to be bothersome to the patient.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Mobility decreased, Muscular weakness, Musculoskeletal pain, Oedema peripheral
Clinical narrative: Severe pain in shoulder and shoulder blade.  Weakness in the shoulder.  Inability to move arm or do basic things such as lift, tuck in a shirt, etc. without severe pain.  Swelling in arm, chest, and shoulder area.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Swelling, X-ray
Clinical narrative: Severe pain in shoulder and shoulder blade.  Weakness in the shoulder.  Inability to move arm or do basic things such as lift, tuck in a shirt, etc. without severe pain.  Swelling in arm, chest, and shoulder area.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Diarrhoea, Rash, Wheezing
Clinical narrative: Diarrhea, Heaviness in Chest, Rash, Wheezing
Age: 0.25
Sex: F
Vaccine: DTAP
Symptoms: Crying, Hypotonia, Unresponsive to stimuli
Clinical narrative: After napping, infant received first and only vaccine, Infanrix DTaP. Baby cried for 15 seconds after vaccine and was quiet afterwards. Mother secured baby in car seat and drove three minutes to store. When she picked up baby she was limp and not responding to stimulation for about a minute. Baby opened her eyes slightly but was still limp. Mother immediately drove to doctor's and stimulated baby to wake again. She was alert when nurse saw her. Mom was told this is not a typical response but that baby appeared alert and OK now.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Headache
Clinical narrative: Pt got flu shot then about 10 min, pt said she has a headache, her body heated up (she feel hot) stated by technician. RPh gave pt 1 BENADRYL (pharmacy brand). Pt came back 1/2 later & said she feels fine later & went home fine.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Amnesia, Blindness, Migraine, Mydriasis, VIIth nerve paralysis
Clinical narrative: Patient received Flu vaccine at approx 10:30 AM and at about 7:30 PM she started losing her vision and 10 min later it was completely gone, but within 10 min it started coming back - pupils dilated, memory loss of days events. Physicians checking for seizure or TIA, but now leaning toward migraine caused by flu shot. Appeared to have mild case of Bell's Palsy.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Injection site erythema, Injection site pruritus, Injection site warmth, Pyrexia
Clinical narrative: Whelp came up and popped after blistering. Skin peeling off. Fever in site. Itching and red. Warm to touch.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Skin exfoliation, Urticaria
Clinical narrative: Whelp came up and popped after blistering. Skin peeling off. Fever in site. Itching and red. Warm to touch.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Barium double contrast, Faeces discoloured, Intussusception, Pain
Clinical narrative: Patient had onset of pain and red stool late PM on 11/6/10. He was diagnosed with an intussusception which was reduced by air enema.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea
Clinical narrative: Diarrhea.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood test, Diarrhoea haemorrhagic
Clinical narrative: Bloody diarrhea 3 days after ROTATEQ vaccine given.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Diarrhoea, Headache, Injection site erythema, Injection site pain
Clinical narrative: 2.5" - 3" dia. redness with swelling, tenderness, minor itching - all at inj. site. Headache, severe backache, body ache, sick to stomach with small amt. vomiting and diarrhea.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling, Nausea, Pain, Vomiting
Clinical narrative: 2.5" - 3" dia. redness with swelling, tenderness, minor itching - all at inj. site. Headache, severe backache, body ache, sick to stomach with small amt. vomiting and diarrhea.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Pt received IM PNEUMOVAX 23 injection - 2 days later arm still painful at injection site radiating to shoulder. Pt saw primary care MD - arm still stiff and sore after 7 days pt put on prednisone and PERCOCET for pain and inflammation.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Red, hard, warm 3" circle around injections site (R) thigh. Dx. cellulitis. Tx with KEFLEX.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Eyelid oedema, Flushing
Clinical narrative: There was swelling over eyelid 15 min. after listed vaccines were given. Face was flushed. BENADRYL & prednisolone PO given as per doctors order mother was asked to go to emergency department if condition worsens 1/2 hour after child was feeling better. Follow up on 11/3/10 done. Child was stable.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Biopsy skin abnormal, Unevaluable event, Varicella virus test positive
Clinical narrative: None reported.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Joint stiffness, Musculoskeletal stiffness, Vomiting
Clinical narrative: Pt had onset of vomiting, diarrhea, chills, approximately 3-4 hrs after administration. These lasted most of the night. She had a stiff neck the next morning which progressed to other joints later that day. By the 3rd day she was feeling better.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Suffocation feeling, Swelling face
Clinical narrative: Patient said face/eyes swelled (never felt throat swell). Felt like smothering but never felt trouble breathing. Patient was going to see primary care physician.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Electrocardiogram, Fall, Loss of consciousness
Clinical narrative: 7 hours after flu shot, passed out/fell 2 times/chills for about 1 1/2 to 2 hours then gone.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient's wife called approx 4 hours after receiving vaccine. Patient developed rash on face/neck area. Patient was given BENADRYL.
Age: 13.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Concussion, Head injury, Syncope
Clinical narrative: Patient fainted, hit his head on floor. Taken to hospital by paramedics. Grandmother said he had a concussion.
Age: 13.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood pressure decreased, Concussion, Convulsion, Fall, Head injury
Clinical narrative: Patient fainted, hit his head on floor. Taken to hospital by paramedics. Grandmother said he had a concussion.
Age: 13.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Intensive care, Loss of consciousness, Syncope
Clinical narrative: Patient fainted, hit his head on floor. Taken to hospital by paramedics. Grandmother said he had a concussion.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Injection site erythema, Injection site swelling, Malaise, Nausea
Clinical narrative: Nausea; chills, fever, malaise, painful site with redness & swelling.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Nausea; chills, fever, malaise, painful site with redness & swelling.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Cough, Headache, Pain in extremity
Clinical narrative: 24 hour after imm - fever, chills, headache, vomiting, bilat hip pn, cough slight, soreness in arm but no redness or swelling
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: 24 hour after imm - fever, chills, headache, vomiting, bilat hip pn, cough slight, soreness in arm but no redness or swelling
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Faeces discoloured
Clinical narrative: Green frothy diarrhea started 1 day after administered lasting x 11 days - probiotics & hydration recommended.
Age: 63.0
Sex: F
Vaccine: RAB
Symptoms: Anxiety, Asthenia, Balance disorder, Dizziness, Feeling abnormal
Clinical narrative: Initial report received from a nurse on 27 Oct 2010: On 20 Oct 2010, the patient was commenced on RABIPUR intramuscularly (IM) on left arm for immunization. The patient did not receive any other vaccine at the same time. On 22 Oct 2010, the patient called to nurse and stated that she had not felt good since vaccination. Last night she felt hot, her heart was pounding and the injection site was red. The patient was aware of tingling sensation above injection site however the sensation radiated around to her back. The patient had no energy at all. The patient denied any swelling of lips/tongue. The patient was reassured and paracetamol was recommended for symptomatic relief. On 27 Oct 2010, the patient attended the clinic and still she was not feeling well and had unsteadiness with dizziness, headache/pressure back of head and anxiety with panic. The patient was feeling gradually better until drinking coffee and had to attend A&E last night. The patient was advised to take paracetamol and avoid coffee and alcohol. The localized problems around injection site now were not problematic. It was planned, not to continue course of RABIPUR. At the time of the report, outcome of the events was not reported. The reporter did not provide causality assessment between the event and RABIPUR.
Age: 63.0
Sex: F
Vaccine: RAB
Symptoms: Feeling hot, Headache, Injection site erythema, Injection site reaction, Palpitations
Clinical narrative: Initial report received from a nurse on 27 Oct 2010: On 20 Oct 2010, the patient was commenced on RABIPUR intramuscularly (IM) on left arm for immunization. The patient did not receive any other vaccine at the same time. On 22 Oct 2010, the patient called to nurse and stated that she had not felt good since vaccination. Last night she felt hot, her heart was pounding and the injection site was red. The patient was aware of tingling sensation above injection site however the sensation radiated around to her back. The patient had no energy at all. The patient denied any swelling of lips/tongue. The patient was reassured and paracetamol was recommended for symptomatic relief. On 27 Oct 2010, the patient attended the clinic and still she was not feeling well and had unsteadiness with dizziness, headache/pressure back of head and anxiety with panic. The patient was feeling gradually better until drinking coffee and had to attend A&E last night. The patient was advised to take paracetamol and avoid coffee and alcohol. The localized problems around injection site now were not problematic. It was planned, not to continue course of RABIPUR. At the time of the report, outcome of the events was not reported. The reporter did not provide causality assessment between the event and RABIPUR.
Age: 63.0
Sex: F
Vaccine: RAB
Symptoms: Panic reaction, Paraesthesia
Clinical narrative: Initial report received from a nurse on 27 Oct 2010: On 20 Oct 2010, the patient was commenced on RABIPUR intramuscularly (IM) on left arm for immunization. The patient did not receive any other vaccine at the same time. On 22 Oct 2010, the patient called to nurse and stated that she had not felt good since vaccination. Last night she felt hot, her heart was pounding and the injection site was red. The patient was aware of tingling sensation above injection site however the sensation radiated around to her back. The patient had no energy at all. The patient denied any swelling of lips/tongue. The patient was reassured and paracetamol was recommended for symptomatic relief. On 27 Oct 2010, the patient attended the clinic and still she was not feeling well and had unsteadiness with dizziness, headache/pressure back of head and anxiety with panic. The patient was feeling gradually better until drinking coffee and had to attend A&E last night. The patient was advised to take paracetamol and avoid coffee and alcohol. The localized problems around injection site now were not problematic. It was planned, not to continue course of RABIPUR. At the time of the report, outcome of the events was not reported. The reporter did not provide causality assessment between the event and RABIPUR.
Age: 2.0
Sex: M
Vaccine: FLU3, PNC13, PNC13
Symptoms: Diarrhoea, Injection site erythema, Injection site pain, Injection site swelling, Irritability
Clinical narrative: 1 previously filled out VAERS report with true information (please see) I wanted to make an addendum as he continued to have symptoms after I filed report. He had continued fevers 103 degrees ax 9/12 - 9/13 overhoc. T-100.2 degrees 9/13/10 am. No fever until 9/14/10 pm - 101 degrees ax. Had 2 more looser non bloody stools - no frank diarrhea. No other signs or symptoms.
Age: 2.0
Sex: M
Vaccine: FLU3, PNC13, PNC13
Symptoms: Pyrexia, Weight bearing difficulty
Clinical narrative: 1 previously filled out VAERS report with true information (please see) I wanted to make an addendum as he continued to have symptoms after I filed report. He had continued fevers 103 degrees ax 9/12 - 9/13 overhoc. T-100.2 degrees 9/13/10 am. No fever until 9/14/10 pm - 101 degrees ax. Had 2 more looser non bloody stools - no frank diarrhea. No other signs or symptoms.
Age: 2.0
Sex: M
Vaccine: FLU3, PNC13, PNC13
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: 1 previously filled out VAERS report with true information (please see) I wanted to make an addendum as he continued to have symptoms after I filed report. He had continued fevers 103 degrees ax 9/12 - 9/13 overhoc. T-100.2 degrees 9/13/10 am. No fever until 9/14/10 pm - 101 degrees ax. Had 2 more looser non bloody stools - no frank diarrhea. No other signs or symptoms.
Age: 39.0
Sex: F
Vaccine: ANTH, FLU3, SMALL, FLU3
Symptoms: Orthopoxvirus test positive, Polymerase chain reaction, Post vaccination autoinoculation
Clinical narrative: Physician at hospital refers case of 39 y/o pt, with enlarging smallpox lesions on chin from autoinoculation. Concerned pt needs VIG. Symptoms: Fever, rash, oth nonspecific skin eruption.
Age: 39.0
Sex: F
Vaccine: ANTH, FLU3, SMALL, FLU3
Symptoms: Polymerase chain reaction, Post vaccination autoinoculation, Pyrexia, Rash, Smallpox
Clinical narrative: Physician at hospital refers case of 39 y/o pt, with enlarging smallpox lesions on chin from autoinoculation. Concerned pt needs VIG. Symptoms: Fever, rash, oth nonspecific skin eruption.
Age: 39.0
Sex: F
Vaccine: ANTH, FLU3, SMALL, FLU3
Symptoms: Vaccinia test positive
Clinical narrative: Physician at hospital refers case of 39 y/o pt, with enlarging smallpox lesions on chin from autoinoculation. Concerned pt needs VIG. Symptoms: Fever, rash, oth nonspecific skin eruption.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Rhinorrhoea, Throat irritation, Wheezing
Clinical narrative: This case was reported by a  healthcare professional and described the occurrence of feeling hot in a 47-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included lupus and premenstrual syndrome. The subject was not allergic to eggs. She has had the flu shot previously and did not experience any reactions with previous flu shots. Concurrent medications included LEXAPRO for premenstrual syndrome, administered for one week per month. On 16 September 2010 at 12:15 the subject received unspecified dose of FLULAVAL (.5 ml, unknown, right arm). On 16 September 2010, within 30 minutes after vaccination with FLULAVAL, the subject experienced feeling hot as if flushed, throat burning, nausea, wheezing and difficulty breathing. Medical attention was required at the emergency room. The healthcare professional considered the events were disabling and clinically significant (or requiring intervention). The subject was treated with SOLU MEDROL and a nebulizer treatment of Albuterol and prednisolone. On 23 September 2010, the events were resolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Feeling hot, Nausea, Throat irritation, Wheezing
Clinical narrative: This case was reported by a  healthcare professional and described the occurrence of feeling hot in a 47-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included lupus and premenstrual syndrome. The subject was not allergic to eggs. She has had the flu shot previously and did not experience any reactions with previous flu shots. Concurrent medications included LEXAPRO for premenstrual syndrome, administered for one week per month. On 16 September 2010 at 12:15 the subject received unspecified dose of FLULAVAL (.5 ml, unknown, right arm). On 16 September 2010, within 30 minutes after vaccination with FLULAVAL, the subject experienced feeling hot as if flushed, throat burning, nausea, wheezing and difficulty breathing. Medical attention was required at the emergency room. The healthcare professional considered the events were disabling and clinically significant (or requiring intervention). The subject was treated with SOLU MEDROL and a nebulizer treatment of Albuterol and prednisolone. On 23 September 2010, the events were resolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Grand mal convulsion
Clinical narrative: Pt did not respond to her name and was foaming at the mouth and was exchanging air.  Pt had a blank stare and was clenching at times and was combative at times.  Upon nurse arrival seizure lasted one minute. Pt did get responsive, but incoherent and could not follow directions.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Aggression, Convulsion, Foaming at mouth, Gliosis, Incoherent
Clinical narrative: Pt did not respond to her name and was foaming at the mouth and was exchanging air.  Pt had a blank stare and was clenching at times and was combative at times.  Upon nurse arrival seizure lasted one minute. Pt did get responsive, but incoherent and could not follow directions.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mouth breathing, Muscle tightness, Nuclear magnetic resonance imaging brain abnormal, Staring, Unresponsive to stimuli
Clinical narrative: Pt did not respond to her name and was foaming at the mouth and was exchanging air.  Pt had a blank stare and was clenching at times and was combative at times.  Upon nurse arrival seizure lasted one minute. Pt did get responsive, but incoherent and could not follow directions.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Migraine
Clinical narrative: Migrain and difficulty breathing onset. Pt. also had cold symptoms and thought that maybe the cold was the cause of the symptoms.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Confusional state, Dizziness, Hypoaesthesia, Hypoaesthesia facial, Muscular weakness
Clinical narrative: First - severe nausea, then numbness in throat, face, arms and hands.  Weakness in arms and hands, dizziness, confusion.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pharyngeal hypoaesthesia
Clinical narrative: First - severe nausea, then numbness in throat, face, arms and hands.  Weakness in arms and hands, dizziness, confusion.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Ataxia, Cough, Dyspnoea, Endotracheal intubation, Extubation
Clinical narrative: 10/6/10:  weakness of upper and lower extremities.  10/7/10 weak cough, trouble breathing but good pulse ox readings.  Noted to have ataxia by neurologist and transferred to PICU for probable Guillian-Barre Syndrome.  Intubated and treated with IVIG (5 doses, each with 400 mg/kg).    Extubated 10/14/2010).  Transferred from ICU to rehab inpatient unit.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Intensive care, Muscular weakness
Clinical narrative: 10/6/10:  weakness of upper and lower extremities.  10/7/10 weak cough, trouble breathing but good pulse ox readings.  Noted to have ataxia by neurologist and transferred to PICU for probable Guillian-Barre Syndrome.  Intubated and treated with IVIG (5 doses, each with 400 mg/kg).    Extubated 10/14/2010).  Transferred from ICU to rehab inpatient unit.
Age: 42.0
Sex: M
Vaccine: FLU(H1N1), FLUN3
Symptoms: Pruritus, Rash pruritic, Urticaria
Clinical narrative: Pruritic truncal eruption/Hives on abdomen extending around to the sides and back. Extremely itchy.
Age: 42.0
Sex: M
Vaccine: FLU(H1N1), FLUN3
Symptoms: Pruritus, Rash pruritic, Urticaria
Clinical narrative: Pruritic truncal eruption/Hives on abdomen extending around sides and back. Extremely itchy.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Blood test normal, Discomfort, Fatigue, Gait disturbance
Clinical narrative: Began to experience flu like s/s sore and feeling "sore all over"  Very tired. C/O pain in lt arm (client had vaccine in rt arm) pain that over a period of days spread to lt shoulder, back, hip area.  Client claims she had difficulty walking.  Pain eventually spread to rt arm and shoulder.  Client saw MD.  Blood tests were run, however, client states tests were normal.  MD unable to find cause.  Client feels her discomfort is due to flu shot.  She did discuss this with the MD.  She claims he told her it might be due to flu shot. MD told her if s/s get worse to call.  Client has not talked to MD in 1wk.  Advised client to call MD to give update on condition.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Pain, Pain in extremity
Clinical narrative: Began to experience flu like s/s sore and feeling "sore all over"  Very tired. C/O pain in lt arm (client had vaccine in rt arm) pain that over a period of days spread to lt shoulder, back, hip area.  Client claims she had difficulty walking.  Pain eventually spread to rt arm and shoulder.  Client saw MD.  Blood tests were run, however, client states tests were normal.  MD unable to find cause.  Client feels her discomfort is due to flu shot.  She did discuss this with the MD.  She claims he told her it might be due to flu shot. MD told her if s/s get worse to call.  Client has not talked to MD in 1wk.  Advised client to call MD to give update on condition.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Diarrhoea, Fatigue, Injection site pain, Laboratory test normal, Myalgia
Clinical narrative: fevers, fatigue, mylagias, diarrhea, pain at injection site
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: fevers, fatigue, mylagias, diarrhea, pain at injection site
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Eye irritation, Headache, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Headache; four days, mild and occasional hives; two days, burning and redness of eyes; five days, pain swelling and burning of injection site to include the majority of the upper arm; five days, occasional nausea; three days.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Urticaria
Clinical narrative: Headache; four days, mild and occasional hives; two days, burning and redness of eyes; five days, pain swelling and burning of injection site to include the majority of the upper arm; five days, occasional nausea; three days.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site urticaria, Rash, Urticaria
Clinical narrative: Broke out in a rash with hives. Injection site red and with hive; at urgent care center given injection of Benadryl.
Age: 56.0
Sex: M
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Chills, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: High Fever, chills, and awoke at 3:00 AM with sweating and fever/chills. Body aches and did not go to work. First time ever after a flu shot.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram abnormal, Dysgeusia, Hypoaesthesia, Hypoaesthesia oral, Immediate post-injection reaction
Clinical narrative: I spent many many hours talking to the FDA (they were wonderful) talking to the pharmacy (where my husband & I received the flu shot), talking to doctors & nurses, waiting 5 hours in Emergency to get a CT; visiting a neurologist (which our family doctor, a fabulous doctor recommended) etc that I would prefer not to fill out any more forms right now. Both my husband & I had an immediate negative response to the flu shot (or following - beginning that evening, the flu shot) that I would prefer to just send you a photocopy of some of the medical records, and, with my permission, you may request any information from any doctor, that might help you, or others, to avoid this complication. Just as an update, I believe I am suffering from a second round of Bell's palsy (as noted on doctor's report). My left side - lip & toes are going numb again. I'm losing weight, I think because I don't taste foods the way I used to, due to the partial paralysis of my tongue. I believe I may have had a negative to the mercury in the flu shot, so next year, I will request a preservative free shot. Diagnosis: Transient cerebral ischemia.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Paralysis, Transient ischaemic attack, VIIth nerve paralysis
Clinical narrative: I spent many many hours talking to the FDA (they were wonderful) talking to the pharmacy (where my husband & I received the flu shot), talking to doctors & nurses, waiting 5 hours in Emergency to get a CT; visiting a neurologist (which our family doctor, a fabulous doctor recommended) etc that I would prefer not to fill out any more forms right now. Both my husband & I had an immediate negative response to the flu shot (or following - beginning that evening, the flu shot) that I would prefer to just send you a photocopy of some of the medical records, and, with my permission, you may request any information from any doctor, that might help you, or others, to avoid this complication. Just as an update, I believe I am suffering from a second round of Bell's palsy (as noted on doctor's report). My left side - lip & toes are going numb again. I'm losing weight, I think because I don't taste foods the way I used to, due to the partial paralysis of my tongue. I believe I may have had a negative to the mercury in the flu shot, so next year, I will request a preservative free shot. Diagnosis: Transient cerebral ischemia.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Respiratory tract congestion
Clinical narrative: Patient reported that approx 4-5 days after vaccination complaints of chest congestion noted green sputum. Reported evaluated by heart and lung doctors for flu. Reported 11-8-10 s/s have resolved. To f/u with physician for appt 12/10.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Muscle injury, Pain in extremity
Clinical narrative: Patient complains about pain around injection site. Concerned about damage to muscle area. States pain is fairly constant. No visible marks. On follow up call says pain on arm area and is fairly constant. Told patient to see her family doctor and contact us with results.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Atrial fibrillation, Blood culture, Chest X-ray, Infection
Clinical narrative: 10-10-10 Received flu shot PP23 (LD) about 1130 am. 2 A 10-11-10 woke up feeling weak. At 4 pm 10-11-10 went to hosp. Hospitalized for COPD and atrial fib. Currently being worked up for an infection. Still not feeling well
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Myositis, Pain in extremity
Clinical narrative: At 530pm 9/29/2010 arm very sore; by evening whole shoulder are very painful. 9/30 AM unable to raise arm or reach backward. Used ice compresses to relieve pain. Finally went to P.P. 10/11/2010.
Age: 16.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Vertigo
Clinical narrative: Student c/o vertigo after receipt of FLUMIST. Kept in observation area with legs elevated. State she felt condition improved 15'' later. Went to school nurse at 10AM - c/o "pressure in head". Vitals within normal range. Left & came back at 11:30, c/o HA - nurse gave her 2 ADVIL, BP 124/78 T98.3. Nurse asked her if she wanted to go home. Student said "no". Student texted parent sometime later. Parent picked student up & student signed self out of school.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Client stated he was breaking out with hives and felt itchy. Given 2 Tabs 12.5 BENADRYL by mouth condition improved B/P 120/80 - 72 - 14.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Face injury, Pallor, Syncope
Clinical narrative: Pt appeared to have fainted after the nasal vaccine was administered. Pt was placed on floor with feet elevated, vitals checked, pt was feeling better juice given, pt went to be observed and was playing games upon observation pt's color was very pale, rescue called, vitals checked 92/62, P64 6:05pm. Pt bumped chin, ice applied BP 94/62 P64 at 6:20pm.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Fall, Pallor, Skin warm, Vertigo
Clinical narrative: Pt appeared pale, c/o vertigo, skin was warm & moist. Parents stated she had a fall on way into observation room, but did not faint & had no c/o pain from fall. ROH WNL. BP 104/60, P 68 at 5:45pm. BP 102/68, P 68 at 5:53pm. Pt appeared to recover, was given cool liquids to drink & went home with parents.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Tremor
Clinical narrative: 515 Injection given. 525 She was complaining of feeling shaky (none noticed) color pink - skin warm & dry alert & oriented - she ate pasta - chicken just before she arrived - not on meds - BP/Diabetes. 530 Apple juice given (refused orange) resting - no improvement BP 160/100 - 80 ? accurate - she had a very Lg arm - I did not have a Lg BP cuff - she did not know what her normal BP was no diff breathing - swallowing - hives - or even a local reaction I asked her to lie flat - could help - she declined. 545 - Supervisor called. 600 They brought her to a provider room to rest - not be around the "shots being given" quite area. At the same time we called "Supervisor" she told "admin" only the plan - treatment is to call 911. I was not comfortable with her symptoms - They could have been related to many other conditions. 645 We saw rescue arrive at the back door - I went to that area. Supervisor stated they called 911 as she also was c/o nausea no meds given to hospital ? family notified.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Patient began to have a headache within 1 hr after 1st Hep B vaccination.  She continued to have "bad" headache thoughout afternoon. She also had nausea and vomiting in the evening. She feels better today 11/10/10, but continues to have a dull headache. Patient received 2 pediatric doses of 0.5ml to equal 1 adult dose of 1.0ml because pharmacy was unable to secure adult doses from manufacturer.
Age: 72.0
Sex: M
Vaccine: PPV, TD
Symptoms: Dyspnoea, Heart rate increased, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Muscle aches, fever, swelling and redness at injection site and surrounding areas, fast heart beat, and difficulties breathing.
Age: 72.0
Sex: M
Vaccine: PPV, TD
Symptoms: Pyrexia
Clinical narrative: Muscle aches, fever, swelling and redness at injection site and surrounding areas, fast heart beat, and difficulties breathing.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Bed rest, Chills, Diarrhoea, Dyspnoea, Malaise
Clinical narrative: Trouble Breathing, Body aches, Chills, Mild Fever, General Malaise, Diarrhea, Vomiting
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Trouble Breathing, Body aches, Chills, Mild Fever, General Malaise, Diarrhea, Vomiting
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Pain in extremity, Pyrexia
Clinical narrative: Patient called Wed (11/10/10) said Monday night she ran a low fever, felt weak and had a sore arm.  As of the next day (Tues) she was already feeling better.  Fever and weakness is gone, just has a sore arm.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Injected limb mobility decreased, Injection site pain, Nausea, Pain
Clinical narrative: Started to experience mild pain at the injection site that increased to extreme pain that radiated to fingertips and back up to jaw line. Started experiencing chest pains approx. 40 minutes post injection. Pain continued to radiate from jawline to fingertips for 5 1/2 hours post injection. Tylenol was administered 10 minutes post injection. Pain became so intense that patient reported unable to lift or move arm and began to experience nausea. Pt did not go to ER as pt is a nurse and did not feel there was any indiacated treatment options.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Pain in jaw
Clinical narrative: Started to experience mild pain at the injection site that increased to extreme pain that radiated to fingertips and back up to jaw line. Started experiencing chest pains approx. 40 minutes post injection. Pain continued to radiate from jawline to fingertips for 5 1/2 hours post injection. Tylenol was administered 10 minutes post injection. Pain became so intense that patient reported unable to lift or move arm and began to experience nausea. Pt did not go to ER as pt is a nurse and did not feel there was any indiacated treatment options.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Oedema peripheral
Clinical narrative: Swelling under the left arm (Injection given in left arm) about the size of a quarter.  Was sore 12 hours later.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Chills, Dizziness, Headache, Myalgia
Clinical narrative: High fever, chills, extreme pain in all joints and muscles, especially legs, knees and ankles; dizziness, headache.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: High fever, chills, extreme pain in all joints and muscles, especially legs, knees and ankles; dizziness, headache.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Balance disorder, Diplopia, Ear pain, Immunoglobulin therapy, Miller Fisher syndrome
Clinical narrative: About 1 week after receiving the flu vaccine at her private doctors office the patient had loss of balance, double vision, ear pain and tingling in hands and feet. She was diagnosed with C Miller Fisher variant of Guillain Barre that affects mainly the cranial nerves. She was admitted to Hospital on 11/01/10 for treatment with IVIG and was discharge on 11/10/10 with approximately 80% improvement in symptoms.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Paraesthesia
Clinical narrative: About 1 week after receiving the flu vaccine at her private doctors office the patient had loss of balance, double vision, ear pain and tingling in hands and feet. She was diagnosed with C Miller Fisher variant of Guillain Barre that affects mainly the cranial nerves. She was admitted to Hospital on 11/01/10 for treatment with IVIG and was discharge on 11/10/10 with approximately 80% improvement in symptoms.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Neck pain, Pyrexia
Clinical narrative: Fever (up to 100.4), severly painful arm where injection was given, pain up into L side of neck.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, X-ray
Clinical narrative: Patient came to store 10/29/10 -he stated he had pain after immunization that night & by next day it was "excruciating" and "above a 10" on scale of 1-10. He stated he had no local site redness or warmth. He was seen by his primary care MD the following day. The doctor performed xrays & exam with no result. Patient also went to chiro. Dr. who is having pt use immoblizer.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Pain, Rash erythematous, Stevens-Johnson syndrome
Clinical narrative: Pt received FLULAVAL 0.5mL IM LD - within the hour pt c/o stinging on Right Deltoid - noted 1 1/2 x 2 1/2 red raised rash with water blisters noted - FNPC stated Stevens Johnson syndrome. Pt given: BENADRYL elixir 50mg po, DEPO-MEDROL 40mg IM.
Age: 1.7
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Immunology test, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning her approximately 19 months old grand-daughter, with gastrooesophageal reflux disease and a history of premature birth at 32 weeks of gestation, who on unspecified dates had received three doses of ROTATEQ (Lot # unknown) PO. Concomitant therapy included ranitidine and PREVACID. The nurse reported that on an unspecified date the patient was subsequently diagnosed with rotavirus gastroenteritis. Child was hospitalized for 1 week. The patient had an ELISA performed for identification of rotavirus. The patient was treated with intravenous fluid replacement for vomiting and diarrhea. Patient was discharged and recovered fully on an unspecified date. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray, Flank pain, Hepatic function abnormal, Injected limb mobility decreased, Injection site abscess
Clinical narrative: Information was received from a field employee, who reported that a clinic administrator spoke on behalf of the physician, regarding an 81-year-old female. On 28-SEP-2010, the patient received PNEUMOVAX 23 (syringe PRF 25 Y), 0.5 mg, via injection, for the treatment of pneumococcal disease. On 29-SEP-2009, the patient experienced pain in her upper-left extremity (injection site), non-specific whole body pain and vomited after receiving the injection. Her shoulder became dysfunctional but was moving properly. On 01-OCT-2010, during a follow-up visit, the patient was assessed with cellulitis and an "abyss" at the injection site at which time the patient was treated with SEPTRA-VID. The patient's symptoms were still not resolved, so her arm was put in a sling. On 28-OCT-2010, the patient went to the emergency room complaining of "flamk." She underwent a chest x-ray for possible pneumonia (results not specified) and also had elevated liver function. She was released the same day from the emergency room (ER). The patient was not recovered. The events were considered disabling/incapacitating by the reporter. Additional information is expected.