chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Malaise, Pain, Pyrexia
Clinical narrative: Received flu shot on 10/15/10.  On 10/16/10 pt. became very ill with respiratory issues.  He had a fever for 5 days, a productive cough and body aches.  He was sick for two weeks.  On 11/11/10 he reported that he still had a non-productive cough that was not getting better.  He mentioned that he thought that he got sick from a flu shot one other time, but did not know when.  Called physician and will see him if he does not get better.  Does not have insurance.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dysstasia, Headache, Injection site pain, Pain
Clinical narrative: Profound body aches, chills, headache Began with pain at injection site around 2pm; by 7pm I couldn't stand up; used ibuprophen with no effect; took tylenol at 10pm to reduce pain enough that I could sleep. Aches persisting at lower level the following day
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness
Clinical narrative: Patient received Fluvirin in right arm on 9/13/10.  She began experiencing "pain" in right shoulder area "2-3 weeks" after immunization.  When questioned, patient described pain more as a stiffness in shoulder area and not a radiating type pain.  She states occurs approxiamtely 2-3 days per week.  Patient counseled to contact physician, and that issue may not be related to immunization, but would complete adverse event paperwork.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pruritus, Rash, Urticaria
Clinical narrative: Received influenza vaccination, approximately 20 to 30 minutes later, experienced itching, SOB, Hives/rash, first noted on arms, left than right and than located on neck and face.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chest pain, Dizziness postural, Dyspnoea, Hyperhidrosis
Clinical narrative: Sweaty, high blood pressure and dizzy upon standing, chest pain, jaw pain, back pain, can breathe but slightly short of breath. Suggested to go to Hospital ER.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Hypertension, Pain in jaw
Clinical narrative: Sweaty, high blood pressure and dizzy upon standing, chest pain, jaw pain, back pain, can breathe but slightly short of breath. Suggested to go to Hospital ER.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pruritus, Skin warm, Urticaria
Clinical narrative: Developed Hives all over body.  Warm to the touch and Itchy.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness, soreness and hot to touch at site of injection. Went to Dr.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: wheezing
Age: 0.59
Sex: M
Vaccine: DTAPHEPBIP, FLUX, HIBV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: Child brought back to clinic < 2 hours post vaccination with 3 0.5 cm hives located on left temple, no wheezing or signs of respiratory distress. Given 7.5 mg PO Benadryl by MD after complete examination. Sent home with rx for Bendaryl 7.5 mg PO q 6-8 hours until urticaria resolve and instructed to seek prompt medical attention for any worsening of condition.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood culture negative, Full blood count normal, Lethargy, Pyrexia, Urine analysis normal
Clinical narrative: PT HAD SUDDEN ONSET OF FEVER OF 103 AND WAS VERY LETHARGIC FOR 24-36 HOURS WENT TO ER. WAS ADVISED TO CONTINUE TYLENOL AND FLUIDS. THEY DID LABS WHICH WERE NORMAL. FOLLOWED UP WITH DR. THE NEXT DAY. WAS GIVEN ROCEPHIN IM AND DID BLOOD CULTURES.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: X-ray normal
Clinical narrative: PT HAD SUDDEN ONSET OF FEVER OF 103 AND WAS VERY LETHARGIC FOR 24-36 HOURS WENT TO ER. WAS ADVISED TO CONTINUE TYLENOL AND FLUIDS. THEY DID LABS WHICH WERE NORMAL. FOLLOWED UP WITH DR. THE NEXT DAY. WAS GIVEN ROCEPHIN IM AND DID BLOOD CULTURES.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Laboratory test abnormal, Pemphigus
Clinical narrative: Immediate breakout of what was appeared to be psoriasis.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Since waking up today child c/o pain in the leg at injection site with noted red hard raised area to right thigh. No fever or difficulty breathing.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Profuse sweating, dizziness.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Disturbance in attention, Dizziness, Dysphagia, Eructation
Clinical narrative: Weakness, Dizziness, Difficulty Swallowing, Lack of Concentration, Burping, Swelling of face, Paleness (all conditions began after 14 hours and continued throughout 40)
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Pallor, Swelling face
Clinical narrative: Weakness, Dizziness, Difficulty Swallowing, Lack of Concentration, Burping, Swelling of face, Paleness (all conditions began after 14 hours and continued throughout 40)
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Dry skin, Dry throat, Hyperhidrosis, Peripheral coldness
Clinical narrative: Blood Pressure 130/88, resp - non labored, chest burning, dry throat, skin cool, arms dry, face and legs sweaty, runny nose. Refused to go to hospital.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: Blood Pressure 130/88, resp - non labored, chest burning, dry throat, skin cool, arms dry, face and legs sweaty, runny nose. Refused to go to hospital.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Respiratory tract congestion, Skin discolouration
Clinical narrative: The patient called the pharmacy & reported having congestion, aches and pain all over, and that her skin was tinted orange all over including her hands, face, arms.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Abasia, Muscular weakness, Pain in extremity
Clinical narrative: pt c/o r leg weakness and pain, pt was not able to walk for the whole day
Age: 69.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Activities of daily living impaired, Chills, Fatigue, Hyperhidrosis, Impaired work ability
Clinical narrative: initial light sweat, which subsided. About 6 hours later, I noticed some aching soreness in right arm. This was the arm I received the pneumonia shot in. I was awoken about 12 midnight, with a hurting arm, I could not get back to sleep. I was also having shivers. I took 2 Advil. My rt. upper arm was to sore to move. I am a primary care giver and needed to move my patient to the bathroom in the night, which I accomplished by favoring my left arm. We were up and down most of the night, finally fell asleep about 5 AM slept till 11 am. Am listless, tired, the right arm is clearly enlarged on its upper portion near injection site as compared to the left. I failed to go to work this day. Left message for my doctor and talked with the pharmist.
Age: 69.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Injection site swelling, Listless, Pain, Pain in extremity
Clinical narrative: initial light sweat, which subsided. About 6 hours later, I noticed some aching soreness in right arm. This was the arm I received the pneumonia shot in. I was awoken about 12 midnight, with a hurting arm, I could not get back to sleep. I was also having shivers. I took 2 Advil. My rt. upper arm was to sore to move. I am a primary care giver and needed to move my patient to the bathroom in the night, which I accomplished by favoring my left arm. We were up and down most of the night, finally fell asleep about 5 AM slept till 11 am. Am listless, tired, the right arm is clearly enlarged on its upper portion near injection site as compared to the left. I failed to go to work this day. Left message for my doctor and talked with the pharmist.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Local reaction, Pain
Clinical narrative: Systemic and local reaction, fever of 102F, joint pain, body aches, swelling and redness 7x11 cm at injection site.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Systemic and local reaction, fever of 102F, joint pain, body aches, swelling and redness 7x11 cm at injection site.
Age: 0.49
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Influenza, Injection site haematoma, Nasopharyngitis, No reaction on previous exposure to drug
Clinical narrative: Flu symptoms, cold. fever, all over achiness and lack of energy.  I ended up in bed for 5 - 6 days, and I have not been this sick since I had the flu in the 80's.  I also had a large (3-4 inch bruise at the site of the injection.  I get the flu shot every year and have never had this kind of reaction.  I had not been in contact with anyone who was sick before I received the flu shot.
Age: 0.49
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pyrexia
Clinical narrative: Flu symptoms, cold. fever, all over achiness and lack of energy.  I ended up in bed for 5 - 6 days, and I have not been this sick since I had the flu in the 80's.  I also had a large (3-4 inch bruise at the site of the injection.  I get the flu shot every year and have never had this kind of reaction.  I had not been in contact with anyone who was sick before I received the flu shot.
Age: 3.0
Sex: F
Vaccine: FLUX, MMR
Symptoms: Diarrhoea, Pyrexia, Rash morbilliform
Clinical narrative: On Saturday evening fever of 103 occurred which lasted until monday morning On monday and tuesday (11/8/2010 and 11/9/2010 patient had diarhea On Tuesday and Wednesday  (11/10/2010 and 11/11/20101)patient developed horrible rash which looked like measles
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Ultrasound Doppler
Clinical narrative: Pain and erythema on right thigh after receiving vaccine.  MD first noted pain 10/3, ice applied to site.  Less painful on 10/5.  Started on rocephin and clindamycin 10/4.  Rocephin switched to vanco 10/5.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Eye pruritus, Lacrimation increased, Nasal congestion, Ocular hyperaemia
Clinical narrative: Constant raspy cough at 2:00 PM, red itchy watery eyes by 4:00 PM, nasal and sinus congestion by 5:00 PM.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Sinus congestion
Clinical narrative: Constant raspy cough at 2:00 PM, red itchy watery eyes by 4:00 PM, nasal and sinus congestion by 5:00 PM.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Fever 37.9 - 38.2 day after receiving vaccine. On rocephine previously for pneumonia.
Age: 7.0
Sex: M
Vaccine: TDAP
Symptoms: Rash generalised, Urticaria
Clinical narrative: Developed a rash over entire body one day after vaccine. Also hives on trunk and face.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Confusional state, Culture, Injection site cellulitis
Clinical narrative: Large area of cellulitis over the right shoulder.  Confusion.  Pan cultured and started empirically on vanco.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Increased tendency to bruise, Platelet count decreased
Clinical narrative: spontaneous bruising.  Low platelet count
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain
Clinical narrative: on 11/10/10 experienced body aches on 11/11/10 awakened covered in red spots on her arms, stomach and chest
Age: 1.6
Sex: F
Vaccine: DTAP
Symptoms: Choking, Cough, Dyspnoea, Erythema, Lip swelling
Clinical narrative: Choking cough, threw up mucus, intensely started scratching abdomen...suddenly blanket of hives/ welts appeared completely cover full chest/ abdomen, neck, parts of face/back. Face getting intensely red, lips swelling, trouble breathing (wheezing). Dr treated with prednisone and 2 tsp Benadryl almost gave epi pen, wanted to see how she responded to those treatments. Medicine was given within 7 minutes of initial reaction. Continuing to monitor and give same does every 6hrs for next 24 hrs.
Age: 1.6
Sex: F
Vaccine: DTAP
Symptoms: Pruritus, Urticaria, Vomiting, Wheezing
Clinical narrative: Choking cough, threw up mucus, intensely started scratching abdomen...suddenly blanket of hives/ welts appeared completely cover full chest/ abdomen, neck, parts of face/back. Face getting intensely red, lips swelling, trouble breathing (wheezing). Dr treated with prednisone and 2 tsp Benadryl almost gave epi pen, wanted to see how she responded to those treatments. Medicine was given within 7 minutes of initial reaction. Continuing to monitor and give same does every 6hrs for next 24 hrs.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Body temperature increased, Dysphagia, Headache, Lymphadenopathy, Malaise
Clinical narrative: Sore throat, Headache, Malaise, Submadibular and Anterior Cervical Lymphadenopathy, body aches, increasing temperature. Took motrin. by 3AM on the 10th temp was 100.6 F oral, remained above 99 F oral until 11 Nov; recieved solumedrol shot at 6:15 pm 11 Nov at MC along with oral prednisone, tessalon, mucinex D, 1:1:1 benydryl/malox/lidocaine mouthwash and codiene for "viral URI" because lymphadenopathy became so bad that swallowing liquids was very difficult.  I have a similar "viral" infection every year that I get a flu vaccine. Symptoms ongoing.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Pain, Streptococcus test negative, Viral upper respiratory tract infection
Clinical narrative: Sore throat, Headache, Malaise, Submadibular and Anterior Cervical Lymphadenopathy, body aches, increasing temperature. Took motrin. by 3AM on the 10th temp was 100.6 F oral, remained above 99 F oral until 11 Nov; recieved solumedrol shot at 6:15 pm 11 Nov at MC along with oral prednisone, tessalon, mucinex D, 1:1:1 benydryl/malox/lidocaine mouthwash and codiene for "viral URI" because lymphadenopathy became so bad that swallowing liquids was very difficult.  I have a similar "viral" infection every year that I get a flu vaccine. Symptoms ongoing.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Arthralgia, Back pain, C-reactive protein normal, Epstein-Barr virus test negative, Fatigue
Clinical narrative: Fever developed first the same day as the vaccines, to 101. The fever persisted for 4 days.  The day following vaccination he became very fatigued and this lasted for over a week.  Finally, he intermittently complained of neck, back and knee pain but there were no signs of arthiritis.  These symptoms also were intermittent for almost a week.  All symptoms self resolved eventually.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Full blood count normal, Mononucleosis heterophile test negative, Neck pain, Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: Fever developed first the same day as the vaccines, to 101. The fever persisted for 4 days.  The day following vaccination he became very fatigued and this lasted for over a week.  Finally, he intermittently complained of neck, back and knee pain but there were no signs of arthiritis.  These symptoms also were intermittent for almost a week.  All symptoms self resolved eventually.
Age: 15.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache
Clinical narrative: Patient developed occipital headache within 1 hour of receiving FLUMIST. Mild, controlled with OTC meds, but persists after 1 day.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: Patient states she had no pain, bruising or bleeding at the site after injection. Approx. 36 hrs later, several bruising presented in the lower part of the upper arm, well away from injection site. Patient presented at pharmacy for consult. Visit to patient's PCP was recommended. PCP thought a blood vessel had been nicked during injection - improvement to area in 2-3 weeks - Bruising subsiding.
Age: 10.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 8 x 7cm red, erythematous no pain or pruritis (L) deltoid.
Age: 1.0
Sex: M
Vaccine: FLUX, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: About 5 hours after receiving 6 vaccinations, patient woke up from his nap with a fever of 101.3. It progressed through the day and eventually got to 104.1 before we took him to Urgent Care at 8:30pm. We alternated between TYLENOL & MOTRIN every 4 hours to make him more comfortable but the fever never broke until the next afternoon.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Drug exposure during pregnancy, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient experiencing pain in arm 2 weeks after Influenza injection. Difficulty moving arm.
Age: 1.04
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Mom stated the child had a febrile seizure & went to ER by ambulance was cleared by ER.
Age: 14.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Confusional state, Dizziness, Loss of consciousness, Syncope
Clinical narrative: Approximately 5 minutes after administration of 2010-11 AFLURIA 0.5ml IM, pt fainted & had a LOC of about 5-10 seconds. Pt responded to verbal stimuli, but remained dizzy/confused. Was transport to ER via EMT for follow-up tx.
Age: 14.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Loss of consciousness, Pain in extremity
Clinical narrative: Approximately 5 minutes after administration of 2010-11 AFLURIA 0.5ml IM, pt fainted & had a LOC of about 5-10 seconds. Pt responded to verbal stimuli, but remained dizzy/confused. Was transport to ER via EMT for follow-up tx.
Age: 38.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient received TDAP injection on left deltoid on 10/14/10 and came back to flu clinic 10 days later to show reaction to vaccination. TDAP site noted marked redness around injections site. Patient stated that 2 days after vaccination upper arm was very red, swollen, also with itchiness around and below injection site. Patient did seek medical attention when symptoms initially started. According to pt. symptoms were better when she came to the flu clinic to complain.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pyrexia, Swollen tongue
Clinical narrative: 10/29/2010 Patient presented at flu clinic today, reported experiencing fever of 10 degrees F, swelling of tongue and difficulty of breathing on the evening of 10/08/2010. She had received flu vaccination earlier that day on 10/08/2010. The patient did not seek medical attention on 10/08/2010 for above symptoms.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site oedema, Rash pruritic
Clinical narrative: (R) arm with pink, edematous, pruritic rash from deltoid muscle to elbow, sensation and circulation intact. Onset 24 hours after vaccine (L) deltoid measures 7 1/2" (R) 9 5/8".
Age: 10.0
Sex: M
Vaccine: FLUN3, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Red areas about 8 cm surrounding site 48 hours after administering.
Age: 1.02
Sex: M
Vaccine: FLU3, HEPA, HIBV, MMRV, PNC13
Symptoms: Chest X-ray normal, Febrile convulsion, Neutrophil count decreased, Urine analysis, White blood cell count increased
Clinical narrative: Febrile seizure approximately 8 hours after receiving immunizations. Went to emergency room & discharged home.
Age: 1.27
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Fever for 2 days then rash for 2 days per mom.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Mom states day after vaccine, leg developed 3-4" area swollen redness. Positive pain to leg, no fever, no lethargy. Now reports redness resolved, but 1" area firmness at injection site. Normal activity.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Rash erythematous, Skin warm, Swelling
Clinical narrative: Patient received the shot on Sun 11/7/10 at 12:33pm. She said her left shoulder swelled to twice the size of her shoulder very warm/hot to the touch and also gets little red bumps near the site, no fever.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Paralysis (L) side of face started Prednisone 60mg x 5 days & taper.
Age: 2.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: (L) upper extremity erythema & edema to forearm level. Fever to 103. Treated with BENADRYL, MOTRIN, & ice packs.
Sex: M
Vaccine: MNQ
Symptoms: Facial paresis, Vestibular disorder
Clinical narrative: Combined initial report received from physician via email on 29 Oct 2010 and 03 Nov 2010: This patient was vaccinated with MENVEO (batch number not known) on an unspecified date. The site and route of administration were not known. One week following vaccination, the patient experienced facial paresis and vestibular affection (NOS). The outcome and other details of the events were not provided. The physician did not report any seriousness criterion for the suspect vaccination reaction.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Vaginal haemorrhage
Clinical narrative: Pt suffered from vaginal bleeding - went to MD's office & it was confirmed she had a miscarriage. They said the baby had been dead for a while. Patient's fiance called the Rx concerned it was from flu shot.
Age: 2.0
Sex: M
Vaccine: FLU3, HEPA, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left thigh noted to have swelling, redness and tender at flu shot site.
Sex: M
Vaccine: DTAPIPV, FLUN3, MMRV
Symptoms: Injection site inflammation, Local reaction
Clinical narrative: Right deltoid large local inflammation - Local reaction only.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Rash erythematous, Rash generalised, Rash macular
Clinical narrative: 2-3 hours following administration of flu shot patient broke out in blotchy red rash starting on right leg, it then spread to right arm & face, then continued to spread to entire body, transported to ER, as clinic was closed. BENADRYL given & 12 hours following, rash has resolved.
Age: 1.49
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Abasia, Body temperature increased, Crying, Skin warm
Clinical narrative: 5hrs after vaccines-crying, felt warm unable to walk mom gave TYLENOL. Woke up morning after with temp 101.6 - Mom gave TYLENOL 730AM - 10AM feeling fine no temp, walking, playing. Mom using TYLENOL & ice to affected areas on legs.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: 5:30 am on 10/30 my (L) ear began ringing very loudly. When I got out of bed at 7 am, I could not hear out of my (L) ear at all.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Adverse reaction, Feeling hot, Gaze palsy, Haemorrhage, Hyperhidrosis
Clinical narrative: After the shot was administered, patient started bleeding and the area swelled up a little. She started complaining about feeling hot, sweaty, and faint. Patient said she wasn't feeling any better 30 seconds later and 911 was called. I continued monitoring the patient and at one point, her body shook and her head tilted back in the chair. I ran to put my arm under her head and saw her eyes roll back. Patient came to in around five seconds. She was alert, knew where she was and that she was having some kind of reaction to the vaccine, but she could not recall what had just happened. She reported feeling better, not as dizzy or sweaty as before. She reported that she had lost control of her bladder sometime. The EMTs arrived and took over. They checked her out and said she was fine. After they left, the patient rested for another 10 minutes before leaving.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Posture abnormal, Syncope, Tremor
Clinical narrative: After the shot was administered, patient started bleeding and the area swelled up a little. She started complaining about feeling hot, sweaty, and faint. Patient said she wasn't feeling any better 30 seconds later and 911 was called. I continued monitoring the patient and at one point, her body shook and her head tilted back in the chair. I ran to put my arm under her head and saw her eyes roll back. Patient came to in around five seconds. She was alert, knew where she was and that she was having some kind of reaction to the vaccine, but she could not recall what had just happened. She reported feeling better, not as dizzy or sweaty as before. She reported that she had lost control of her bladder sometime. The EMTs arrived and took over. They checked her out and said she was fine. After they left, the patient rested for another 10 minutes before leaving.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Differential white blood cell count, Full blood count, Head injury, Injected limb mobility decreased, Limb injury
Clinical narrative: Started 2 hrs after injection with left arm getting painful, had difficulty lifting arm. "Passed out" that night hitting head and left leg. Felt feverish the next day. Symptom mostly gone by 11/5/10. Checked below labs. No other treatment.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Metabolic function test, Pain in extremity, Pyrexia
Clinical narrative: Started 2 hrs after injection with left arm getting painful, had difficulty lifting arm. "Passed out" that night hitting head and left leg. Felt feverish the next day. Symptom mostly gone by 11/5/10. Checked below labs. No other treatment.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram, Guillain-Barre syndrome, Lumbar puncture, Muscular weakness, Nerve conduction studies
Clinical narrative: Increasing muscle weakness. MRI brain EMG/NCS MRI C spine, lumbar puncture plasmapheresis started 10-28-10. Dx Guillain-Barre Syndrome.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Plasmapheresis
Clinical narrative: Increasing muscle weakness. MRI brain EMG/NCS MRI C spine, lumbar puncture plasmapheresis started 10-28-10. Dx Guillain-Barre Syndrome.
Age: 11.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Computerised tomogram, Convulsion, Respiratory arrest
Clinical narrative: A serious spontaneous report of seizure has been received from a consumer concerning a 11-year-old female, subsequent to FLUMIST. Neither past medical history nor concomitant medications were reported for this patient. On 20-Oct-2010, patient received FLUMIST. The patient received FLUMIST at her school. On 25-Oct-2010, patient experienced a seizure at 6:30 AM. It lasted for 15 seconds with no breathing for a minute. The patient went to ER. The patient had a CT scan with results not reported. On 04-Nov-2010, patient was scheduled with neurologist. The outcome of the event seizure was unknown.
Age: 11.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Fall, Movement disorder, Nuclear magnetic resonance imaging brain, Urinary incontinence
Clinical narrative: A serious spontaneous report of seizure has been received from a consumer concerning a 11-year-old female, subsequent to FLUMIST. Neither past medical history nor concomitant medications were reported for this patient. On 20-Oct-2010, patient received FLUMIST. The patient received FLUMIST at her school. On 25-Oct-2010, patient experienced a seizure at 6:30 AM. It lasted for 15 seconds with no breathing for a minute. The patient went to ER. The patient had a CT scan with results not reported. On 04-Nov-2010, patient was scheduled with neurologist. The outcome of the event seizure was unknown.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Asthma, Nasal congestion, Oropharyngeal pain
Clinical narrative: Nasal congestion; sore throat; asthma.
Age: 1.28
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Classic shingles developed on 11/10/10, 2 1/2 months after varicella vaccine given.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Body temperature increased, Papule, Rash
Clinical narrative: Parents reported temp of 103 at 9pm. Baby given TYLENOL & no further temp c/o. Feeding well on 11/10/10 parents noted rash on legs. Client seen 11/11/10 & papules on upper thigh noted.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Beta haemolytic streptococcal infection, Culture throat positive, Listless, Local reaction, Pyrexia
Clinical narrative: Pt. had a 9 day febrile illness starting <24hrs after receiving MMR, VARIVAX and PENTACEL. Large local reaction about PENTACEL site. Grew light growth of Strep A Group on throat culture in evaluation of fever. Dr spoke with family Saturday evening - no longer febrile but still listless (11 days after vaccine). 13 days after vaccine dad reported pt. doing better since starting.
Age: 17.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood calcium, Blood creatine phosphokinase, Blood potassium, CSF cell count, CSF glucose
Clinical narrative: Headache, muscle cramping lower extremities, vasovagal reaction.
Age: 17.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: CSF protein, Differential white blood cell count, Full blood count, Headache, Muscle spasms
Clinical narrative: Headache, muscle cramping lower extremities, vasovagal reaction.
Age: 17.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Presyncope
Clinical narrative: Headache, muscle cramping lower extremities, vasovagal reaction.
Age: 17.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Myalgia, Presyncope
Clinical narrative: Headache, muscle cramping lower extremities, vasovagal reaction.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Injection site swelling, induration & tenderness left deltoid area.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Full blood count normal, Injection site swelling, Pyrexia, Rash
Clinical narrative: Pt developed fever, chills, swelling at the injection and purpura like rash on lower legs.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Eye oedema, Oedema mouth, Pruritus, Rash macular
Clinical narrative: Edema of eyes and mouth and itchy skin in axilla and blotchy rash right chest, voice hoarse.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Abscess, Cellulitis, Injection site erythema, Injection site induration, Injection site infection
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of injection site infection in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On 15 September 2010 the subject received a dose of FLUARIX (.5 ml, unknown, unknown arm). On 16 September 2010, 1 day after vaccination with FLUARIX, the subject experienced injection site infection. The subject received FLUARIX on 15 September 2010 and returned to the office the next day due to an infection in their arm at injection. The subject may have required medical treatment. At the time of the report no further information was available. At the time of reporting the outcome of the injection site infection was unspecified. The physician reported two subjects were given FLUARIX and returned to the office the next day due to an infection in their arm at injection. Please see case A0882998 for the second subject. Follow-up information was received on 05 November 2010 via physician. The injection site infection with onset date of 16 September 2010 was described as red, hard and hot; the subject was given Doxy 100 mg twice daily. On 17 September 2010 the subject was diagnosed with cellulitis and abscess. On 21 September 2010 the event were noted to be resolving. At the time of this report the injection site infection, cellulitis and abscess resolved. No biopsy was performed. The patient had not experienced any adverse events following previous vaccinations.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, No reaction on previous exposure to drug
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of injection site infection in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On 15 September 2010 the subject received a dose of FLUARIX (.5 ml, unknown, unknown arm). On 16 September 2010, 1 day after vaccination with FLUARIX, the subject experienced injection site infection. The subject received FLUARIX on 15 September 2010 and returned to the office the next day due to an infection in their arm at injection. The subject may have required medical treatment. At the time of the report no further information was available. At the time of reporting the outcome of the injection site infection was unspecified. The physician reported two subjects were given FLUARIX and returned to the office the next day due to an infection in their arm at injection. Please see case A0882998 for the second subject. Follow-up information was received on 05 November 2010 via physician. The injection site infection with onset date of 16 September 2010 was described as red, hard and hot; the subject was given Doxy 100 mg twice daily. On 17 September 2010 the subject was diagnosed with cellulitis and abscess. On 21 September 2010 the event were noted to be resolving. At the time of this report the injection site infection, cellulitis and abscess resolved. No biopsy was performed. The patient had not experienced any adverse events following previous vaccinations.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Abscess, Cellulitis, Injection site infection, No reaction on previous exposure to drug, Oedema peripheral
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of injection site infection in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On 15 September 2010 the subject received a dose of FLUARIX (.5 ml, unknown, unknown arm). On 16 September 2010, 1 day after vaccination with FLUARIX, the subject experienced injection site infection. The subject received FLUARIX on 15 September 2010 and returned to the office the next day due to an infection in their arm at injection. The subject may have required medical treatment. At the time of the report no further information was available. At the time of reporting the outcome of the injection site infection was unspecified. The physician reported two subjects were given FLUARIX and returned to the office the next day due to an infection in their arm at injection. Please see case A088299BA for the second subject. Follow-up information was received on 05 November 2010 via physician. The subject's injection site infection had an onset date of 14 September 2010 (previously reported as 16 September 2010) been diagnosed as cellulitis with abscess and swelling of arm. On an unspecified date the injection site infection, cellulitis, abscess and swelling of arm resolved. The patient had no experience any adverse events following previous vaccinations.
Age: 15.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Vaccination site erythema
Clinical narrative: Area of erythema 12cm x 10cm left bicep. Occurred after patient was grabbed by a class mate at area vaccinated.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt called saying she received PNEUMOVAX yesterday and her (L) arm is hot and red and swollen from shoulder to elbow. Told to come in for check.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Nausea
Clinical narrative: Initial report was received on 29 September 2009 from a health care professional. An 80-year-old female patient with a history of asthma, had received an intramuscular arm injection of FLUZONE, lot number U3200AA and an unspecified amount of time later, she developed shortness of breath, nausea and a heavy, tight chest. The patient received her influenza vaccinations yearly and according to the reporter, she experienced this same adverse event following receipt of FLUZONE when she was 79 years of age. The patient had no illness at the time of vaccination and the reporter had no concomitant medications on file. The patient had not received any other vaccines within four weeks of FLUZONE. Corrective treatments consisted of unspecified over the counter medications. According to the reporter, the event did not require a doctor's visit and the patient recovered. Follow-up information received on 20 October 2009 from a health care professional. Per the reporter, it is unknown if the patient was taking any concomitant medications for asthma. The adverse events noted in the above narrative with FLUZONE administered at age 79 were mild. Regarding the current adverse events, the symptoms were also of mild severity lasting several hours and were treated with BENADRYL. The patient recovered within 24 hours of onset of symptoms. No etiology was determined. Follow-up information received on 16 November 2009 from a health care professional. The patient did not see a physician. The patient took BENADRYL and had recovered by the following day. Previous event (year before) was very similar. No further information is expected. The reporter for this case is the same as case numbers 2009-04130 and 2009-04132. Documents held by sender: None.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site papule
Clinical narrative: Initial report received from a consumer on 29 September 2009; the consumer is also the patient's mother. A five-year-old male patient experienced injection site papules after receiving FLUZONE (lot number U3191AA) on 19 September 2009. Medical history included an allergy to penicillin, and the patient was taking SINGULAIR, FLOVENT, NASONEX, Albuterol, and MIRALAX concomitantly. On 20 September 2009, one day post-vaccination, the patient developed a circle of papules three inches in diameter at the injection site. The patient's mother had contacted the clinic where the patient had received the vaccine, and no treatment was administered at that time. Outcome was not reported. Documents held by sender: None.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Areflexia, Asthenia, Atrial fibrillation, Death
Clinical narrative: Initial case received from the Centers for Disease Control and Prevention (CDC) on 08 January 2010, under VAERS ID number 359602-1. A 75-year-old male patient received an injection of FLUZONE SV 2009-2010 (lot number U3192AA) on 24 September 2009. The patient had a history of polio with post-polio syndrome (including kyphoscoliosis and atrophy of the left lower extremity and arm); prostate cancer, hyperlipidemia, smoker, emphysema, diverticulitis, hemorrhoids, ventral hernia, osteoarthritis, and skin cancer. Three days post-vaccination, on 27 September 2009, the patient experienced difficulty navigating to the bathroom on two separate occasions and was unable to walk on his own. He experienced profound, progressive and generalized weakness; numbness of the toes, feet and fingers; peripheral edema; and bilateral rhonchi. He was subsequently intubated, and an EMG showed denervation distally. He underwent a lumbar puncture and was diagnosed with severe Guillain-Barre Syndrome. Treatment included IVIG. He was found to have hematuria with clots, a gallbladder polyp, renal cyst, atrial fibrillation, sinus bradycardia, and left ventricular hypertrophy. He was unresponsive to voice or touch, and deep tendon reflexes were absent. Due to increased neuronal injury and poor prognosis, coupled with post-polio syndrome, his family made the decision to extubate the patient on 12 October 2009. Final diagnosis was death secondary to Guillain-Barre Syndrome. Documents held by sender: None.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Denervation atrophy, Electromyogram abnormal, Endotracheal intubation, Extubation, Gait disturbance
Clinical narrative: Initial case received from the Centers for Disease Control and Prevention (CDC) on 08 January 2010, under VAERS ID number 359602-1. A 75-year-old male patient received an injection of FLUZONE SV 2009-2010 (lot number U3192AA) on 24 September 2009. The patient had a history of polio with post-polio syndrome (including kyphoscoliosis and atrophy of the left lower extremity and arm); prostate cancer, hyperlipidemia, smoker, emphysema, diverticulitis, hemorrhoids, ventral hernia, osteoarthritis, and skin cancer. Three days post-vaccination, on 27 September 2009, the patient experienced difficulty navigating to the bathroom on two separate occasions and was unable to walk on his own. He experienced profound, progressive and generalized weakness; numbness of the toes, feet and fingers; peripheral edema; and bilateral rhonchi. He was subsequently intubated, and an EMG showed denervation distally. He underwent a lumbar puncture and was diagnosed with severe Guillain-Barre Syndrome. Treatment included IVIG. He was found to have hematuria with clots, a gallbladder polyp, renal cyst, atrial fibrillation, sinus bradycardia, and left ventricular hypertrophy. He was unresponsive to voice or touch, and deep tendon reflexes were absent. Due to increased neuronal injury and poor prognosis, coupled with post-polio syndrome, his family made the decision to extubate the patient on 12 October 2009. Final diagnosis was death secondary to Guillain-Barre Syndrome. Documents held by sender: None.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Gallbladder polyp, Guillain-Barre syndrome, Haematuria, Haemorrhage urinary tract, Hypoaesthesia
Clinical narrative: Initial case received from the Centers for Disease Control and Prevention (CDC) on 08 January 2010, under VAERS ID number 359602-1. A 75-year-old male patient received an injection of FLUZONE SV 2009-2010 (lot number U3192AA) on 24 September 2009. The patient had a history of polio with post-polio syndrome (including kyphoscoliosis and atrophy of the left lower extremity and arm); prostate cancer, hyperlipidemia, smoker, emphysema, diverticulitis, hemorrhoids, ventral hernia, osteoarthritis, and skin cancer. Three days post-vaccination, on 27 September 2009, the patient experienced difficulty navigating to the bathroom on two separate occasions and was unable to walk on his own. He experienced profound, progressive and generalized weakness; numbness of the toes, feet and fingers; peripheral edema; and bilateral rhonchi. He was subsequently intubated, and an EMG showed denervation distally. He underwent a lumbar puncture and was diagnosed with severe Guillain-Barre Syndrome. Treatment included IVIG. He was found to have hematuria with clots, a gallbladder polyp, renal cyst, atrial fibrillation, sinus bradycardia, and left ventricular hypertrophy. He was unresponsive to voice or touch, and deep tendon reflexes were absent. Due to increased neuronal injury and poor prognosis, coupled with post-polio syndrome, his family made the decision to extubate the patient on 12 October 2009. Final diagnosis was death secondary to Guillain-Barre Syndrome. Documents held by sender: None.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Left ventricular hypertrophy, Lumbar puncture abnormal, Nerve injury, Oedema peripheral
Clinical narrative: Initial case received from the Centers for Disease Control and Prevention (CDC) on 08 January 2010, under VAERS ID number 359602-1. A 75-year-old male patient received an injection of FLUZONE SV 2009-2010 (lot number U3192AA) on 24 September 2009. The patient had a history of polio with post-polio syndrome (including kyphoscoliosis and atrophy of the left lower extremity and arm); prostate cancer, hyperlipidemia, smoker, emphysema, diverticulitis, hemorrhoids, ventral hernia, osteoarthritis, and skin cancer. Three days post-vaccination, on 27 September 2009, the patient experienced difficulty navigating to the bathroom on two separate occasions and was unable to walk on his own. He experienced profound, progressive and generalized weakness; numbness of the toes, feet and fingers; peripheral edema; and bilateral rhonchi. He was subsequently intubated, and an EMG showed denervation distally. He underwent a lumbar puncture and was diagnosed with severe Guillain-Barre Syndrome. Treatment included IVIG. He was found to have hematuria with clots, a gallbladder polyp, renal cyst, atrial fibrillation, sinus bradycardia, and left ventricular hypertrophy. He was unresponsive to voice or touch, and deep tendon reflexes were absent. Due to increased neuronal injury and poor prognosis, coupled with post-polio syndrome, his family made the decision to extubate the patient on 12 October 2009. Final diagnosis was death secondary to Guillain-Barre Syndrome. Documents held by sender: None.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Renal cyst, Rhonchi, Sinus bradycardia, Unresponsive to stimuli
Clinical narrative: Initial case received from the Centers for Disease Control and Prevention (CDC) on 08 January 2010, under VAERS ID number 359602-1. A 75-year-old male patient received an injection of FLUZONE SV 2009-2010 (lot number U3192AA) on 24 September 2009. The patient had a history of polio with post-polio syndrome (including kyphoscoliosis and atrophy of the left lower extremity and arm); prostate cancer, hyperlipidemia, smoker, emphysema, diverticulitis, hemorrhoids, ventral hernia, osteoarthritis, and skin cancer. Three days post-vaccination, on 27 September 2009, the patient experienced difficulty navigating to the bathroom on two separate occasions and was unable to walk on his own. He experienced profound, progressive and generalized weakness; numbness of the toes, feet and fingers; peripheral edema; and bilateral rhonchi. He was subsequently intubated, and an EMG showed denervation distally. He underwent a lumbar puncture and was diagnosed with severe Guillain-Barre Syndrome. Treatment included IVIG. He was found to have hematuria with clots, a gallbladder polyp, renal cyst, atrial fibrillation, sinus bradycardia, and left ventricular hypertrophy. He was unresponsive to voice or touch, and deep tendon reflexes were absent. Due to increased neuronal injury and poor prognosis, coupled with post-polio syndrome, his family made the decision to extubate the patient on 12 October 2009. Final diagnosis was death secondary to Guillain-Barre Syndrome. Documents held by sender: None.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Erythema, Herpes virus infection, Injection site erythema, Injection site vesicles
Clinical narrative: Initial report received on 29 September 2009 from a health care professional. A 63 year old male patient with no reported past medical history developed redness at the site which blistered within 24 hours of receiving FLUZONE SV 2009-2010 (lot number U3216AA) intramuscularly in the left deltoid on 23 September 2009. One year prior, the patient had a influenza vaccine, but did not experience any reactions to the vaccine. Concomitant therapy included blood pressure and cholesterol medication (name of medication was not specified). On 24 September 2009, the patient also experienced redness to the left side of his chest, forehead, shoulders, and armpits which also turned to blisters. The patient was advised by the reporter to contact his primary care provider for treatment. The patient was seen in the emergency room on 29 September 2009 and was diagnosed with herpes virus outbreak. The patient was prescribed antiviral medication. No further information was provided. The patient did not recover. Follow-up information was received 06 August 2010 from a health care professional. The patient had been taking blood pressure and cholesterol medications which consisted of Atenolol and "Simvastin". He had no known history of chickenpox or similar outbreaks, and it was unknown if he had been ill or under stress at the time of the event. The patient had been immunized as 09:00 am on 23 September 2009 and he was seen at the emergency room on 28 September 2009 (previously reported as 29 September 2009). According to the reporter, the patient was not treated at their facility; therefore, prescribed treatments, their treating physician's contact information, and their recovery status were unknown. List of Documents held by Sender: none.