chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: FLUN3, HPV4
Symptoms: Genital lesion, Lip blister, Oropharyngeal blistering, Pyrexia, Stevens-Johnson syndrome
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old male patient with Stevens-Johnson syndrome and no drug reaction/allergies, who on approximately on 17-NOV-2010 was vaccinated with a first dose of GARDASIL (Lot # not reported) (4 days ago, reported date as 08-DEC-2010). The nurse reported that on 04-DEC-2010 about three weeks after vaccination, the patient had a flare up of Stevens-Johnson syndrome. The patient had a fever, high white cell count, blisters on his mouth, lips and genitals and was diagnosed with a bacterial infection. He also had cardiac arrhythmias and required a cardiac monitor and evaluation of his cardiac enzymes. He was hospitalized on 05-DEC-2010 and released on 07-DEC-2010. He was prescribed with antibiotics and steroids for 6 months. At the time of the report, the patient was  recovering. Flare up of Stevens-Johnson syndrome, cardiac arrhythmia and bacterial infection were considered to be immediately life-threatening by the reporter. Upon internal review flare up of Stevens-Johnson syndrome and hospitalization were considered to be an other important medical events. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: FLUN3, HPV4
Symptoms: White blood cell count increased
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old male patient with Stevens-Johnson syndrome and no drug reaction/allergies, who on approximately on 17-NOV-2010 was vaccinated with a first dose of GARDASIL (Lot # not reported) (4 days ago, reported date as 08-DEC-2010). The nurse reported that on 04-DEC-2010 about three weeks after vaccination, the patient had a flare up of Stevens-Johnson syndrome. The patient had a fever, high white cell count, blisters on his mouth, lips and genitals and was diagnosed with a bacterial infection. He also had cardiac arrhythmias and required a cardiac monitor and evaluation of his cardiac enzymes. He was hospitalized on 05-DEC-2010 and released on 07-DEC-2010. He was prescribed with antibiotics and steroids for 6 months. At the time of the report, the patient was  recovering. Flare up of Stevens-Johnson syndrome, cardiac arrhythmia and bacterial infection were considered to be immediately life-threatening by the reporter. Upon internal review flare up of Stevens-Johnson syndrome and hospitalization were considered to be an other important medical events. Additional information has been requested.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nonspecific reaction
Clinical narrative: Information has been received from a female consumer who on 29SEP2010 received both PNEUMOVAX (dose unknown) and FLUARIX (dose unknown). It had not been identified which vaccine caused her reaction (reaction not specified) which included a hospital admission. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: Swelling of arm and injection site pain
Age: 81.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site pain, Oedema peripheral
Clinical narrative: Swelling of arm and injection site pain
Age: 17.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: Blindness cortical, Cerebral palsy, Drug exposure during pregnancy, Herpes virus infection, Microcephaly
Clinical narrative: Quadriplegic Cerebral Palsy, Microcephaly, Toxoplasmosis, Cortical Blindness, and Viral Herpes.
Age: 17.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: Nuclear magnetic resonance imaging, Scan brain, Toxoplasmosis
Clinical narrative: Quadriplegic Cerebral Palsy, Microcephaly, Toxoplasmosis, Cortical Blindness, and Viral Herpes.
Age: 17.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: Delivery, Drug exposure during pregnancy, Foetal hypokinesia, Protein urine
Clinical narrative: Quadriplegic Cerebral Palsy, Microcephaly, Toxoplasmosis, Cortical Blindness, and Viral Herpes.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC10
Symptoms: Blood test, Computerised tomogram head, Dysphagia, Headache, Nuclear magnetic resonance imaging brain
Clinical narrative: 3 days after flu vaccine and PNEUMOVAX, onset inability to swallow and severe headaches. Hospitalized x 7 days. Extensive work-up completed. Required IV nutrition as could not swallow. IV steroids given and regained some functioning of swallowing. Able to be discharged and can eat and drink but not normally or baseline. Told it was reaction to flu vaccine.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC10
Symptoms: Oesophagogastroduodenoscopy, Parenteral nutrition, Vaccination complication, X-ray
Clinical narrative: 3 days after flu vaccine and PNEUMOVAX, onset inability to swallow and severe headaches. Hospitalized x 7 days. Extensive work-up completed. Required IV nutrition as could not swallow. IV steroids given and regained some functioning of swallowing. Able to be discharged and can eat and drink but not normally or baseline. Told it was reaction to flu vaccine.
Age: 1.72
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEPA
Symptoms: Rash generalised
Clinical narrative: Diffuse body rash occurred 2 days after administration.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Red & painful & itchy lump noted at site of influenza vaccine site 2 days after vaccination.
Age: 1.26
Sex: U
Vaccine: FLU3, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site rash
Clinical narrative: On 12/15/10 mom noted red, firm bump where he received vaccine seen in office 12/17/10 approximately 1cm firm eryth nodule (R) mid/lateral thigh. Tx with KEFLEX x 7d & mupirocin.
Age: 60.0
Sex: U
Vaccine: FLU3
Symptoms: Herpes zoster, Pain, Pyrexia, Rash
Clinical narrative: Fever in afternoon, aching during night & into next day. Rash began after second day turning into shingles.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Mild (R) Bell's Palsy.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red & swelling around injection site. Applied ice pack, gave oral CLARITIN. Pt complained of itching. Triamcinolone spray applied, per v/o by Dr.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose normal, Convulsion, Feeling hot, Nausea, Syncope
Clinical narrative: The patient appeared to "faint" and then began to convulse upon completion of the injection. She was non-responsive for 1-2 minutes after which she began to communicate. She wished to vomit but did not. She moved to the floor and laid down complaining of being "hot". Gave BENADRYL 25mg PO then paramedics arrived and took over care. W/self transport to Urgent condition did not improve.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Unresponsive to stimuli
Clinical narrative: The patient appeared to "faint" and then began to convulse upon completion of the injection. She was non-responsive for 1-2 minutes after which she began to communicate. She wished to vomit but did not. She moved to the floor and laid down complaining of being "hot". Gave BENADRYL 25mg PO then paramedics arrived and took over care. W/self transport to Urgent condition did not improve.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Pt's mother-in-law called pharmacy to report that pt was 4-5 weeks pregnant at the time of immunization & had a miscarriage on 11/29/10.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Fatigue, Feeling abnormal, Heart rate increased, Rash macular
Clinical narrative: After 30 min slight tickle in throat a little heavy in chest and pulse increased slightly - feel a little weird all over functioning began with slight blotchy rash then became red flushed urticaria over entire body 1215 total body - 50mg BENADRYL. Needed BENADRYL x 3 over next 48 hours. Very drained x 4 days.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation, Urticaria
Clinical narrative: After 30 min slight tickle in throat a little heavy in chest and pulse increased slightly - feel a little weird all over functioning began with slight blotchy rash then became red flushed urticaria over entire body 1215 total body - 50mg BENADRYL. Needed BENADRYL x 3 over next 48 hours. Very drained x 4 days.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Throat irritation
Clinical narrative: Itching of face, throat, tongue and arms - took oral BENADRYL.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: High grade fever and swollen injection site.
Age: 26.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia, White blood cell count increased
Clinical narrative: Fever-high grade - aches all over.
Age: 1.36
Sex: M
Vaccine: DTAPIPVHIB, FLU3, MMRV
Symptoms: Injection site erythema, Injection site pain, Irritability, Rash generalised
Clinical narrative: Rash all over, irritable, reddened sore vaccine site (L) thigh where PROQUAD given.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Pain, Pain in extremity
Clinical narrative: Sore arm - aches, chills & low grade temp.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Nerve injury, Pain in extremity
Clinical narrative: Patient claims we hit a nerve in his arm with the needle causing numbness and pain since day after injection, patient went to Doctors.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Body temperature increased, Endoscopy normal, Haematemesis, Laboratory test normal
Clinical narrative: Patient had shots on 7/27/2010. He did not return to us until 12-6-10, at which time Dad told us about reaction. He states child had increased temp 103-104 and vomited blood 1-2 days after receiving shots. He took him to Dr. at hospital.  He then was transferred to hospital.  A series of tests were done - including scoping. They could find nothing wrong.
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Areflexia, Asthenia, CSF test, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: GUILLAIN BARRE Syndrome - I received Tdap 7/23/10. Symptoms began 8/4/10 with bilateral paresthesias. Symptoms progressed over next five days to ascending paresthesias, weakness, difficulty walking, headache nausea. Admitted 8/8/10 by ER - noticed to have absent reflexes. Hospitalized 8/8/10 --> 8/11/10.
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Headache, Nausea, Nerve conduction studies, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: GUILLAIN BARRE Syndrome - I received Tdap 7/23/10. Symptoms began 8/4/10 with bilateral paresthesias. Symptoms progressed over next five days to ascending paresthesias, weakness, difficulty walking, headache nausea. Admitted 8/8/10 by ER - noticed to have absent reflexes. Hospitalized 8/8/10 --> 8/11/10.
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Scan with contrast
Clinical narrative: GUILLAIN BARRE Syndrome - I received Tdap 7/23/10. Symptoms began 8/4/10 with bilateral paresthesias. Symptoms progressed over next five days to ascending paresthesias, weakness, difficulty walking, headache nausea. Admitted 8/8/10 by ER - noticed to have absent reflexes. Hospitalized 8/8/10 --> 8/11/10.
Age: 1.21
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC, VARCEL
Symptoms: Convulsion, Endotracheal intubation, Pyrexia, Tremor
Clinical narrative: Patient had a history of febrile seizures; one day after his shots (based on MD's account) he developed a fever of >101 F and he started shaking prompting 911 call, seizure persisted despite rectal & IV diazepam, phenobarbital was given, patient was intubated.
Age: 60.0
Sex: M
Vaccine: HEPAB
Symptoms: Chest discomfort, Injection site pain, Pain in extremity, Pain in jaw
Clinical narrative: The morning after receiving the injection, patient experienced severe pain in the entire left arm, radiating to jaw and down to hand. Has also experienced "some chest pressure off and on". Visited MD on 12/8/10 who ruled out cardiac incident. Pt states there has been no improvement. No swelling of arm. Instructed to return to MD if no improvement or if worsens.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 5 cm round, red, raised, hard area around injection site that was warm, very painful and lasted 1 week. She ran a low grade fever as well.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: 5 cm round, red, raised, hard area around injection site that was warm, very painful and lasted 1 week. She ran a low grade fever as well.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Pyrexia, Rash
Clinical narrative: Pt experienced low grade temperature, rash across chest.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: (L) ant lat thigh with 3 cm area in circumference of erythema and increased warmth. No induration or fluctuance.
Age: 0.56
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Redness warmth after getting shots (PCV 13) slight fever.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt came in to store the back side of the arm is swollen and pink. We told pt he needed to see a doctor but pt said he had no insurance. Told pt to try BENADRYL but will need to see MD. ASAP if continues.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: 11-22-10 patient reported to daughter tremors (shakes) to hands & feet. Treated with TYLENOL PM. Daughter administered 25mg BENADRYL & checked in at E.R. While waiting in ER, symptoms cleared up. Patient left E.R. untreated - patient is doing fine.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Flushing
Clinical narrative: 12-14-10 4:20 pm patient states he felt fine - RN told him after waiting 15" that he looked "flushed", (red in the face) but he felt okay. BP 152/98 P 92 R 16 Temp 98.5. Nurse called Dr office and he was seen 4:50pm. 6:45 pm pt called by telephone states he is fine but still flushed & given BENADRYL/CLARITIN by MD if he needs it. BP at Dr's office 123/73. 12/16/10 10:30 spoke with pt this AM, states he feels fine but went back to MD yesterday for follow-up (12-15-10). States flushing is resolving and he feels fine - BP remains elevated - states Dr changed his BP meds yest. to Trandolapril 4mg & Verapamil ER 240mg continues the same. Denies taking any other supplements or vitamins. States occ. uses ADVIL but none on 12-14-10. To follow-up for hypertension with Dr in 2-3 wk per pt.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Redness, swelling, warmth of entire arm: shoulder to elbow local reaction is cellulitis -> SEPTRA DS bid x 10d -> resolved.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever 104 for 24 hours; redness, erythema, and swelling at injection site
Age: 33.0
Sex: M
Vaccine: TD
Symptoms: Rash, Urticaria
Clinical narrative: Rash, urticaria
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Local swelling
Clinical narrative: SWELLING IN LEFT NECK AREA WITH LYMPHEDEMA NOTED IN SHOULDER AREA.  BY 10/10/2010, SITE OF INJECTION BECAME RED AND PUFFY.  CONTINUED TO SWELL AND BECOME LARGER IN SIZE BY 10/13/2010 TO APPROX 10 MM OUTER CIRCUMFERENCE AND A BRIGHT RED SPOT INSIDE THE AREA THAT MEASURED APPROX 7 MM IN DIAMETER.  ENTIRE AREA ITCHED AND WAS PAINFUL TO TOUCH. PATIENT VISITED FAMILY DOCTOR ON 10/11/10 AND WAS PRESCRIBED AN ANTIBIOTIC FOR 2 DAYS.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphoedema
Clinical narrative: SWELLING IN LEFT NECK AREA WITH LYMPHEDEMA NOTED IN SHOULDER AREA.  BY 10/10/2010, SITE OF INJECTION BECAME RED AND PUFFY.  CONTINUED TO SWELL AND BECOME LARGER IN SIZE BY 10/13/2010 TO APPROX 10 MM OUTER CIRCUMFERENCE AND A BRIGHT RED SPOT INSIDE THE AREA THAT MEASURED APPROX 7 MM IN DIAMETER.  ENTIRE AREA ITCHED AND WAS PAINFUL TO TOUCH. PATIENT VISITED FAMILY DOCTOR ON 10/11/10 AND WAS PRESCRIBED AN ANTIBIOTIC FOR 2 DAYS.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Headache, Impaired work ability, Lethargy, Nausea
Clinical narrative: FEVER, NAUSEA, HEADACHE, EXTREME LETHARGY. The feelings were so severe that she was unable to work for 2 days following the vaccination, and she was still feeling lethargic 4 days later. Tmax >102F.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: FEVER, NAUSEA, HEADACHE, EXTREME LETHARGY. The feelings were so severe that she was unable to work for 2 days following the vaccination, and she was still feeling lethargic 4 days later. Tmax >102F.
Age: 19.0
Sex: F
Vaccine: FLUX, MEN
Symptoms: Convulsion, Dizziness, Loss of consciousness
Clinical narrative: As we left the office started feeling light headed.  Quickly passed out and seizing.
Age: 10.0
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: PATIENT DEVELOPED A REACTION AT THE SITE OF INJECTION.  WARM TO TOUCH, INFLAMMED, AND RED.  37CM X 37CM.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Slight raised, redness, warm to touch, softball sized area at injection site. Patient instructed to take TYLENOL prn and pharmacist states recommended not to receive any TD vaccines within 10 years. Per 2nd conversation w/RN - area originally described as round, elevated, softball sized area on arm. Upon follow-up conversation - pt's arm had no elevation or nodule. Only reddened & warm to touch.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: Difficulty breathing, weakness, fast heart beat, and dizziness.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Inability to lift arm without pain. Narrow range of motion.
Age: 2.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, red, & warm to touch (L) thigh.
Age: 1.56
Sex: F
Vaccine: FLU3, MMR, PNC13, VARCEL
Symptoms: Rash, Varicella
Clinical narrative: Patient has red rash across chest/back/groin/hair line Dx Chicken pox Treatment anti-itch cream
Age: 0.38
Sex: M
Vaccine: DTAPIPVHIB, PPV
Symptoms: Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Intussusception
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Injection site swelling, Paraesthesia
Clinical narrative: left arm swelling to the elbow and had a tingling sensation
Age: 19.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Syncope
Clinical narrative: Pt had syncope episode after vaccination administration
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Presyncope, Unresponsive to stimuli
Clinical narrative: Vasovagal event after receiving HPV vaccine - nonresponsive 5 seconds.  No fall, no injury.
Age: 1.31
Sex: M
Vaccine: DTAP, FLU3, HIBV, MMR, VARCEL
Symptoms: Ataxia, CSF test, Febrile convulsion, Intensive care
Clinical narrative: Febrile seizure and ataxia.  Patient admitted on 12/8/2010 to Hospital 12/8/10-12/17/10, epidural fluid collection.  Pt in PICU x 3 days for concern of possible compression of thecal sac.  No compression occurred and neuro surgery did not intervene.  Patient still ataxic and is to get out patient physical therapy.
Age: 17.0
Sex: M
Vaccine: MNQ, TD
Symptoms: Dizziness, Fall, Loss of consciousness, Syncope
Clinical narrative: He started feeling dizzy then fainted (and fell off the table onto the floor). He was unconscious for a few minutes (long enough for the nurse to take his pulse, leave the room and get the dr. out of another room and return and take his pulse again.  The Dr. said his name a few times before he came to and responded).
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Eye swelling, Swelling face, Urticaria, Vomiting, Wheezing
Clinical narrative: Emesis, hives, facial/eye swelling, wheezing.  All symptoms within 10 minutes of reaction (by 3:50 PM). Benadryl (po), albuterol nebulizer given, transported by MEDIC 5 to ED for Epinephrine and monitoring
Age: 31.0
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Mastication disorder, Oral discomfort, Pain in jaw
Clinical narrative: Soreness in left jaw with popping while chewing or opening/closing mouth.  Same side as TDaP vaccine given 12/15/10 on left arm. Got progressively worse 12/16/10-12/17/10 and improved 12/18/10-12/19/10.  Limited ability to eat solid food 12/16/10 and 12/17/10. No treatment sought.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash papular
Clinical narrative: Mild itching and appearance of three 5-6 mm pink papules (nearly vesicular) in L antecubital fossa, ipsilateral side of injection; no pain
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Large Red, warm, elevated and hard area on the right deltoid. Benadryl given at 8 AM on Friday October 22, 2010. Area remained warm, elevated and hard for 2-3 days. No other signs or symptoms noted. Benadryl seemed to control the swelling and firmness of the area.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Skin tightness
Clinical narrative: Developed swelling, tightness, slight warmth of left arm, no redness, no fever, child was "ornery".  Swelling was from just below the elbow to the shoulder, "3/4 the way down the shoulder blade."  Woke up in morning with these symptoms.  Was worse the first 1-2 days, gone after 4-5 days. Took Tylenol for discomfort, ice to arm, child was encouraged to keep moving the arm.  This was the child's 5th DTaP and 4th IPV.
Age: 12.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Burning sensation, Chest X-ray abnormal, Dehydration, Headache, Hypoaesthesia
Clinical narrative: Uncontrollable muscle spasms all over body. Most of the activity was in the legs, stomach, chest and shoulder muscles. There was no pain associated with the spasms. Did have tenderness and redness at injection site. Also experienced Nausea, vomiting, burning sensation in the eyelids and a weakness and stiffness in the left arm. Also numbness/dissociated feeling in his toes and a fever that ranged from 100.9 to 103. Tremors lasted a little while then headaches to left side of head started. Was taken to the ER and diagnosed with Pneumonia and dehydration. Went home and recovered after sleeping off and on for the next 24 hours.
Age: 12.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Injection site erythema, Injection site pain, Laboratory test, Muscle spasms, Muscular weakness
Clinical narrative: Uncontrollable muscle spasms all over body. Most of the activity was in the legs, stomach, chest and shoulder muscles. There was no pain associated with the spasms. Did have tenderness and redness at injection site. Also experienced Nausea, vomiting, burning sensation in the eyelids and a weakness and stiffness in the left arm. Also numbness/dissociated feeling in his toes and a fever that ranged from 100.9 to 103. Tremors lasted a little while then headaches to left side of head started. Was taken to the ER and diagnosed with Pneumonia and dehydration. Went home and recovered after sleeping off and on for the next 24 hours.
Age: 12.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Musculoskeletal stiffness, Nausea, Pneumonia, Pyrexia, Rhinorrhoea
Clinical narrative: Uncontrollable muscle spasms all over body. Most of the activity was in the legs, stomach, chest and shoulder muscles. There was no pain associated with the spasms. Did have tenderness and redness at injection site. Also experienced Nausea, vomiting, burning sensation in the eyelids and a weakness and stiffness in the left arm. Also numbness/dissociated feeling in his toes and a fever that ranged from 100.9 to 103. Tremors lasted a little while then headaches to left side of head started. Was taken to the ER and diagnosed with Pneumonia and dehydration. Went home and recovered after sleeping off and on for the next 24 hours.
Age: 12.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Tremor, Urine analysis, Vomiting, Wheezing
Clinical narrative: Uncontrollable muscle spasms all over body. Most of the activity was in the legs, stomach, chest and shoulder muscles. There was no pain associated with the spasms. Did have tenderness and redness at injection site. Also experienced Nausea, vomiting, burning sensation in the eyelids and a weakness and stiffness in the left arm. Also numbness/dissociated feeling in his toes and a fever that ranged from 100.9 to 103. Tremors lasted a little while then headaches to left side of head started. Was taken to the ER and diagnosed with Pneumonia and dehydration. Went home and recovered after sleeping off and on for the next 24 hours.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Pain in extremity, Rash
Clinical narrative: Whole upper arm (shoulder joint) sore and ached until 12/20/10 then the pain moved to my elbow joint and began to ache and pain set in. On 12/21/10 the went away, ache still in the elbow, but now a rash about on bicep just under injection site.
Age: 37.0
Sex: F
Vaccine: DTAP
Symptoms: Rash generalised, Urticaria
Clinical narrative: Severe rash/ hives all over my body
Age: 21.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Chills, Lacrimation increased, Malaise, Nasal congestion, Oropharyngeal pain
Clinical narrative: Sunday evening I wasn't feeling well, woke up Monday morning with a terrible stuffy nose, cold chills and a painful sore throat. I decided to drink some green tea in the morning before work and thought I would feel better. Today, Tuesday, I'm feeling worse than I did yesterday; and my eyes are watering and my throat is still in severe pain. Prior to having my flu shot I was never once since, with the exception of catching a mild cold in 7th grade I never had once had my flu shot. Now, this year I decide to get my flu shot and I am terrible sick and I wash my hands consistently and eating proper and adequate nutrition.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Acute disseminated encephalomyelitis, CSF cell count increased, Diplopia, Encephalitis, Hyperaesthesia
Clinical narrative: Progressive neuropathic/encephilitis?/hyperalgesia, urinary retention, diplopia decrease LE reflexes. A.D.E.M.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Hyporeflexia, Neuropathy peripheral, Urinary retention, White blood cell count increased
Clinical narrative: Progressive neuropathic/encephilitis?/hyperalgesia, urinary retention, diplopia decrease LE reflexes. A.D.E.M.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Acute disseminated encephalomyelitis, Aphasia, Asthenia, Balance disorder, Computerised tomogram
Clinical narrative: Pt began with slurred speech, balance problems, weakness - MRI's, LP done given IV Solumedrol, Plasmaphoresis, then pt unable to speak, mental status decreased ? ADEM.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Dysarthria, Lumbar puncture abnormal, Mental status changes, Nuclear magnetic resonance imaging, Plasmapheresis
Clinical narrative: Pt began with slurred speech, balance problems, weakness - MRI's, LP done given IV Solumedrol, Plasmaphoresis, then pt unable to speak, mental status decreased ? ADEM.
Age: 23.0
Sex: F
Vaccine: FLU3, HPV4, TDAP, VARCEL
Symptoms: Drug exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: Client received vaccines on 11-30-10; pregnancy test performed 11-30-10 was negative; on 12-17-10 pregnancy test performed during a physical exam - result was positive. Possibility of being pregnant at the time she received vaccines (1st trimester?).
Age: 2.0
Sex: F
Vaccine: DTAP, FLU3, HEP, IPV
Symptoms: Incorrect dose administered
Clinical narrative: None. Patient was given wrong dose of flu on 11/2/10. Lot: UT3574BA.
Age: 36.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Hypoaesthesia facial, Migraine
Clinical narrative: 2 days after FLUMIST, woke up with headache and left side face numbness, lasted 3-5 days. Went to Urgent Care & PCP, who treated for migraine with EXCEDRIN with relief.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Within 5-10 minutes after receiving injectable influenza, became short of breath went for inhaler, & EPIPEN administered by RN, vital signs, recovered without incident.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Herpes zoster, Rash, Viral test
Clinical narrative: Pt with IM flu shot in (R) hip on 12/13/10. Later same day with hip pain. TMS progressed to hip/back pain. Then noted rash. Pt came for OV 12/20/10 & noted Zoster in same distribution over L1 dermatome on (R).
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chest discomfort, Injection site induration, Injection site warmth, Pain
Clinical narrative: The pt called PAC 12/20 and spoke to LPN. She related after 10" of leaving the office she had shooting pain up her legs with heaviness in her chest. About a hr later she had a 101 temp on 12/17/10. 12/18 site felt warm & hard.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: The pt called PAC 12/20 and spoke to LPN. She related after 10" of leaving the office she had shooting pain up her legs with heaviness in her chest. About a hr later she had a 101 temp on 12/17/10. 12/18 site felt warm & hard.
Age: 16.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Fatigue, Nausea, Pain in extremity, Pallor
Clinical narrative: Pain in arm- paleness - nausea - fatigue approximately 22 hrs after vaccines & lasted for 24 hours.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Abdominal pain, Abdominal pain upper, Asthenia, Blood test
Clinical narrative: I was given on Oct 31 2010 the Seasonal Flu vaccine as well as the H1N1 vaccine - FLUVIRIN MULTIDOSE vial at the pharmacy. The side effects are a skin rash itching, hot feeling and red pimples that burn and sting. Waking up in the night to the feeling of: burning hot itching feeling. Along with weakness, dizziness and sick to my stomach, nausea discomfort and headache as well as constipation with a black stool. I have pain in my stomach and continued digestive problems and a well as red rash. Which I have seen my primary care doctor to improve my condition. Which requires additional medicine and cost to myself and my family. The ill effect continue with a skin rash itching, hot feeling and red pimples that burn and sting. Along with weakness, dizziness and sick to my stomach, nausea discomfort and headache as well as pain in my abdomen and stomach.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Constipation, Discomfort, Dizziness, Dyspepsia
Clinical narrative: I was given on Oct 31 2010 the Seasonal Flu vaccine as well as the H1N1 vaccine - FLUVIRIN MULTIDOSE vial at the pharmacy. The side effects are a skin rash itching, hot feeling and red pimples that burn and sting. Waking up in the night to the feeling of: burning hot itching feeling. Along with weakness, dizziness and sick to my stomach, nausea discomfort and headache as well as constipation with a black stool. I have pain in my stomach and continued digestive problems and a well as red rash. Which I have seen my primary care doctor to improve my condition. Which requires additional medicine and cost to myself and my family. The ill effect continue with a skin rash itching, hot feeling and red pimples that burn and sting. Along with weakness, dizziness and sick to my stomach, nausea discomfort and headache as well as pain in my abdomen and stomach.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Faeces discoloured, Feeling hot, Headache, Nausea, Pain
Clinical narrative: I was given on Oct 31 2010 the Seasonal Flu vaccine as well as the H1N1 vaccine - FLUVIRIN MULTIDOSE vial at the pharmacy. The side effects are a skin rash itching, hot feeling and red pimples that burn and sting. Waking up in the night to the feeling of: burning hot itching feeling. Along with weakness, dizziness and sick to my stomach, nausea discomfort and headache as well as constipation with a black stool. I have pain in my stomach and continued digestive problems and a well as red rash. Which I have seen my primary care doctor to improve my condition. Which requires additional medicine and cost to myself and my family. The ill effect continue with a skin rash itching, hot feeling and red pimples that burn and sting. Along with weakness, dizziness and sick to my stomach, nausea discomfort and headache as well as pain in my abdomen and stomach.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Ultrasound scan
Clinical narrative: I was given on Oct 31 2010 the Seasonal Flu vaccine as well as the H1N1 vaccine - FLUVIRIN MULTIDOSE vial at the pharmacy. The side effects are a skin rash itching, hot feeling and red pimples that burn and sting. Waking up in the night to the feeling of: burning hot itching feeling. Along with weakness, dizziness and sick to my stomach, nausea discomfort and headache as well as constipation with a black stool. I have pain in my stomach and continued digestive problems and a well as red rash. Which I have seen my primary care doctor to improve my condition. Which requires additional medicine and cost to myself and my family. The ill effect continue with a skin rash itching, hot feeling and red pimples that burn and sting. Along with weakness, dizziness and sick to my stomach, nausea discomfort and headache as well as pain in my abdomen and stomach.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Ataxia, Dizziness, Opsoclonus myoclonus, Tremor
Clinical narrative: Developed tremors, progressive ataxia, dizziness dx - Opsoclonus Myoclonus.
Age: 38.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthma, Blindness, Blindness unilateral, Bronchial hyperreactivity, Bronchitis
Clinical narrative: She reported receipt of a FLUMIST vaccination (MED 500549) on 9/4/2008. Approximately 2 days later (Sunday) she awoke stating she was "blind" in her left eye. She vaguely remembers some clear discharge and redness to the eye. She had no light/dark visibility, pain, itching, trauma, headaches or nasal discharge/sinus pressure. She denied any other symptoms at this time. She advised she contacted a HCP who prescribed an eye drop and was seen in his office 24 hours later (Monday) with return of vision but blurry. (Review of ophth records show pt seen in Sept 2007 for similar c/o being diagnosed with chemical keratitis with use contact lens...no blindness in 2007 or 2008). Approximately one week later (9/11/2008) she complained of cold like s/s (PND, congestion, cough, nauseated) that progressed into bronchitis. She denied any fever, headache, myalgia/arthralgia, or visual disturbance). These symptoms persisted on and off over the next 5-6 months (fall/winter with unknown duration either for symptoms or between episodes with five evaluations with PCP from 11/11/2009 to 12/4/2009 and 1/13/2010 for bronchitis/asthma exacerbation). She advised symptoms peaked during the week of 2/28/2009 with subjective fevers (101), worsening dry cough and PND. She saw her PCP (3/4/09 & 4/1/2009) being diagnosed with RAD and bronchitis. Temperature was 98.8F. She was treated with a MEDROL dose pack, ALLEGRA, albuterol and Z-PAK with resolution of symptoms. On 9/3/2009 she was evaluated for neck and sinus pain with positive oropharyngeal inflammation. She was diagnosed with chronic sinusitis treated with NASONEX and ZYRTEC. She received an intramuscular influenza 9/11/2009 (AVP 05549111a) complaining of above URI-like symptoms stating symptoms persisted intermittently thru Feb 2010 when diagnosed with asthma by a pulmonologist. She denied any swelling, rashes, hives or anaphylactic like symptoms. She eats eggs regularly with no adverse event reported.
Age: 38.0
Sex: F
Vaccine: FLUN3
Symptoms: Chronic sinusitis, Cough, Eye discharge, Nasopharyngitis, Nausea
Clinical narrative: She reported receipt of a FLUMIST vaccination (MED 500549) on 9/4/2008. Approximately 2 days later (Sunday) she awoke stating she was "blind" in her left eye. She vaguely remembers some clear discharge and redness to the eye. She had no light/dark visibility, pain, itching, trauma, headaches or nasal discharge/sinus pressure. She denied any other symptoms at this time. She advised she contacted a HCP who prescribed an eye drop and was seen in his office 24 hours later (Monday) with return of vision but blurry. (Review of ophth records show pt seen in Sept 2007 for similar c/o being diagnosed with chemical keratitis with use contact lens...no blindness in 2007 or 2008). Approximately one week later (9/11/2008) she complained of cold like s/s (PND, congestion, cough, nauseated) that progressed into bronchitis. She denied any fever, headache, myalgia/arthralgia, or visual disturbance). These symptoms persisted on and off over the next 5-6 months (fall/winter with unknown duration either for symptoms or between episodes with five evaluations with PCP from 11/11/2009 to 12/4/2009 and 1/13/2010 for bronchitis/asthma exacerbation). She advised symptoms peaked during the week of 2/28/2009 with subjective fevers (101), worsening dry cough and PND. She saw her PCP (3/4/09 & 4/1/2009) being diagnosed with RAD and bronchitis. Temperature was 98.8F. She was treated with a MEDROL dose pack, ALLEGRA, albuterol and Z-PAK with resolution of symptoms. On 9/3/2009 she was evaluated for neck and sinus pain with positive oropharyngeal inflammation. She was diagnosed with chronic sinusitis treated with NASONEX and ZYRTEC. She received an intramuscular influenza 9/11/2009 (AVP 05549111a) complaining of above URI-like symptoms stating symptoms persisted intermittently thru Feb 2010 when diagnosed with asthma by a pulmonologist. She denied any swelling, rashes, hives or anaphylactic like symptoms. She eats eggs regularly with no adverse event reported.
Age: 38.0
Sex: F
Vaccine: FLUN3
Symptoms: Neck pain, Night blindness, Ocular hyperaemia, Oropharyngeal discomfort, Pyrexia
Clinical narrative: She reported receipt of a FLUMIST vaccination (MED 500549) on 9/4/2008. Approximately 2 days later (Sunday) she awoke stating she was "blind" in her left eye. She vaguely remembers some clear discharge and redness to the eye. She had no light/dark visibility, pain, itching, trauma, headaches or nasal discharge/sinus pressure. She denied any other symptoms at this time. She advised she contacted a HCP who prescribed an eye drop and was seen in his office 24 hours later (Monday) with return of vision but blurry. (Review of ophth records show pt seen in Sept 2007 for similar c/o being diagnosed with chemical keratitis with use contact lens...no blindness in 2007 or 2008). Approximately one week later (9/11/2008) she complained of cold like s/s (PND, congestion, cough, nauseated) that progressed into bronchitis. She denied any fever, headache, myalgia/arthralgia, or visual disturbance). These symptoms persisted on and off over the next 5-6 months (fall/winter with unknown duration either for symptoms or between episodes with five evaluations with PCP from 11/11/2009 to 12/4/2009 and 1/13/2010 for bronchitis/asthma exacerbation). She advised symptoms peaked during the week of 2/28/2009 with subjective fevers (101), worsening dry cough and PND. She saw her PCP (3/4/09 & 4/1/2009) being diagnosed with RAD and bronchitis. Temperature was 98.8F. She was treated with a MEDROL dose pack, ALLEGRA, albuterol and Z-PAK with resolution of symptoms. On 9/3/2009 she was evaluated for neck and sinus pain with positive oropharyngeal inflammation. She was diagnosed with chronic sinusitis treated with NASONEX and ZYRTEC. She received an intramuscular influenza 9/11/2009 (AVP 05549111a) complaining of above URI-like symptoms stating symptoms persisted intermittently thru Feb 2010 when diagnosed with asthma by a pulmonologist. She denied any swelling, rashes, hives or anaphylactic like symptoms. She eats eggs regularly with no adverse event reported.
Age: 38.0
Sex: F
Vaccine: FLUN3
Symptoms: Respiratory tract congestion, Sinus headache, Upper-airway cough syndrome, Vision blurred
Clinical narrative: She reported receipt of a FLUMIST vaccination (MED 500549) on 9/4/2008. Approximately 2 days later (Sunday) she awoke stating she was "blind" in her left eye. She vaguely remembers some clear discharge and redness to the eye. She had no light/dark visibility, pain, itching, trauma, headaches or nasal discharge/sinus pressure. She denied any other symptoms at this time. She advised she contacted a HCP who prescribed an eye drop and was seen in his office 24 hours later (Monday) with return of vision but blurry. (Review of ophth records show pt seen in Sept 2007 for similar c/o being diagnosed with chemical keratitis with use contact lens...no blindness in 2007 or 2008). Approximately one week later (9/11/2008) she complained of cold like s/s (PND, congestion, cough, nauseated) that progressed into bronchitis. She denied any fever, headache, myalgia/arthralgia, or visual disturbance). These symptoms persisted on and off over the next 5-6 months (fall/winter with unknown duration either for symptoms or between episodes with five evaluations with PCP from 11/11/2009 to 12/4/2009 and 1/13/2010 for bronchitis/asthma exacerbation). She advised symptoms peaked during the week of 2/28/2009 with subjective fevers (101), worsening dry cough and PND. She saw her PCP (3/4/09 & 4/1/2009) being diagnosed with RAD and bronchitis. Temperature was 98.8F. She was treated with a MEDROL dose pack, ALLEGRA, albuterol and Z-PAK with resolution of symptoms. On 9/3/2009 she was evaluated for neck and sinus pain with positive oropharyngeal inflammation. She was diagnosed with chronic sinusitis treated with NASONEX and ZYRTEC. She received an intramuscular influenza 9/11/2009 (AVP 05549111a) complaining of above URI-like symptoms stating symptoms persisted intermittently thru Feb 2010 when diagnosed with asthma by a pulmonologist. She denied any swelling, rashes, hives or anaphylactic like symptoms. She eats eggs regularly with no adverse event reported.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain
Clinical narrative: Eleven days later pt still complains of sore muscle in arms. No heat or redness present. Just painful to move arm.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Injection site induration, Pain, Pyrexia
Clinical narrative: Fever, chills pain & erythema & induration at injection site.
Age: 3.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Crying, Erythema, Injection site erythema, Injection site haematoma, Injection site pain
Clinical narrative: (R) leg with red, itching rash (4 x 2" rash) with pain & bruising. Started with red & swollen leg, next AM had bumpy rash. No fever. Slightly warm to touch. Cried x 1 hour with pain. Took almost a week to clear rash red & pain. Cried x 1 hr solid.
Age: 3.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Injection site pruritus, Injection site rash, Oedema peripheral, Rash, Skin warm
Clinical narrative: (R) leg with red, itching rash (4 x 2" rash) with pain & bruising. Started with red & swollen leg, next AM had bumpy rash. No fever. Slightly warm to touch. Cried x 1 hour with pain. Took almost a week to clear rash red & pain. Cried x 1 hr solid.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Headache, Pain
Clinical narrative: HA started 5-6 hours after injections - worsened over next 4 hours (at worst 9/10 on pain scale). Pt took Ibuprofen at that time then was able to sleep. At worst point, pt unable to turn head secondary pain. ER visit strongly recommended but pt declined. When seen in office next day pain 3/10.
Sex: F
Vaccine: MNQ
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: (R) deltoid 5x2cms of cellulitis & erythema after the MENVEO injection, placed on AUGMENTIN/placed on - warm compress, patient did well.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Secondary transmission of adverse event. I administered the vaccine to pt on 12/8/2010 I wore gloves while mixing vaccine & administering vaccine. 12 day after I have come down with shingles. (I am on steroids for chronic condition). This also happened to me last year - which I considered coincidental and did not report.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient was given an injection of ZOSTAVAX into the (R) arm (upper). 24-48 hours later a 2.1cm x 1.8cm raised, erythemic area was noted at the location site of injection. Patient stated that it was warm, not painful, but itching.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Dizziness, Injection site warmth, Swelling, Vomiting
Clinical narrative: Swelling; hot to touch at vaccine site, dizziness, vomiting.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Injection site erythema, Injection site urticaria, Nausea, Pain in extremity
Clinical narrative: Within 12 hrs pt had an exquisitely painful (L) arm. Couldn't sleep it was so painful. There were 2 welts along with 3" diameter red area around site. Improved after 24-36 hrs, gone after 3 days. Nausea started 24 hours after injection lasted 2-3 days. Diarrhea started 12-14 hrs after the nausea.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Fall, Injection site erythema, Injection site swelling
Clinical narrative: Seen 11/30/10, received pneumonia vaccine, had stated she received at some point in past but didn't know when, seen 12/1/10, she had fallen during the night,  fell in (L) arm, had been started on LEXAPRO visit prior and Z-PAK for sinus, was dizzy. Noted next AM (L) arm red, slightly swollen & warm, 3-4" below injection site.
Age: 0.43
Sex: F
Vaccine: FLU3, PNC13, FLU3, FLU3
Symptoms: Death, Decreased appetite, Diarrhoea, Insomnia, Malaise
Clinical narrative: Initial report received from a consumer's parent on 10 December 2010. A 5-month-old female infant received on 10 November 2010 at 11:00 AM an intramuscular right thigh injection of INFLUENZA VACCINE, manufacturer provided as sanofi pasteur (lot number not reported) and died eight days later. The patient had no medical history, took no concomitant medications, no previous illness and had no illness at the time of vaccination. On 10 November 2010 in the evening, the patient developed a fever which was as high as 102 (units not provided). Over the next few days, the patient developed irritability, lethargy, diarrhea and loss of appetite. The patient was seen by a physician four days after the vaccination. The patient died on 18 November 2010. The outcome was reported as fatal. Documents held by sender: None.
Age: 0.43
Sex: F
Vaccine: FLU3, PNC13, FLU3, FLU3
Symptoms: Pyrexia
Clinical narrative: Initial report received from a consumer's parent on 10 December 2010. A 5-month-old female infant received on 10 November 2010 at 11:00 AM an intramuscular right thigh injection of INFLUENZA VACCINE, manufacturer provided as sanofi pasteur (lot number not reported) and died eight days later. The patient had no medical history, took no concomitant medications, no previous illness and had no illness at the time of vaccination. On 10 November 2010 in the evening, the patient developed a fever which was as high as 102 (units not provided). Over the next few days, the patient developed irritability, lethargy, diarrhea and loss of appetite. The patient was seen by a physician four days after the vaccination. The patient died on 18 November 2010. The outcome was reported as fatal. Documents held by sender: None.