chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Guillain Barré Syndrome. Persisting numbness in feet- Tires easily.
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Facial palsy
Clinical narrative: Hepatitis B given at hospital on 10/16/02. Developed left facial nerve problem on 11/5/02. Then he was given HB -HIb + DPTA on 12/12/02. Right sided facial nerve paralysis developed on 12/29/02. HIB + IPV on 10/16/03 and he developed left sided facial nerve paralysis on 11/15/03. Patient had recurrent facial paralysis start up on left side on 11/16/2004 and then progressed to right side, In this episode he did not receive any vaccine prior to this. He is being worked up for other etiologies of this recurrent episodes of facial paralysis by ENT, allergist, neurologist at Hospital.
Age: 1.2
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Mother reports hives approximately 30 hours later.  Legs, some trunk, arms-child asleep at time.  Mother noted hives-says 70% better next AM.  No prescription.  Did not call child's pediatrician.  No respiratory problems per mother.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Tremor
Clinical narrative: Nauseous, shaky approximately 2 hours, no treatment.
Age: 18.0
Sex: M
Vaccine: FLU3, HEPA, TYP
Symptoms: Blood pressure decreased, Syncope
Clinical narrative: Pt had brief syncopal episode immediately following completion of 3 vaccinations (Hep A, Typhoid, Flu shot) at around 10:30.  Pt was brought to ER for observation and treatment.  Pt received 1 liter of NS and released once recovered.  At 11:30 Temperature 98.5, pulse 79, RR 19, BP 119/76, Sat O2 98%.  At 15:00 Temperature 98.7, pulse 85, RR 16, BP 125/63, Sat 96%.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Pt received flu vaccine at approximately 13:30 on 01/13/04.  Mom returned to office at 16:00-child had 2 hives on right thigh 4x3cm and a "c" shaped hive approximately 2.5cm where shot was administered.  Also 1 hive on right check 1.5x1.5cm.  Benadryl 12.5mg administered per mouth.  Mom to give every 6 hours.
Age: 55.0
Sex: F
Vaccine: FLU3, HEPA, PPV
Symptoms: Injection site oedema, Injection site pain, Injection site warmth, Pruritus
Clinical narrative: Left arm noted increased swelling after 12-24 hours after shots, elbow to shoulder.  Hot and tender.  Now states itching.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Lymphadenopathy, Oedema, Urticaria
Clinical narrative: Within 3 days left arm began to swell and turn blotchy red with some bumpy (hive-like) areas.  Under left arm-swollen glands.
Age: 0.11
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Hyperhidrosis, Influenza, Laboratory test abnormal
Clinical narrative: Sweaty, runny nose, cough and fever. The ER summary received on 2/9/04 states short of breath, croup, stridor, vomiting, otitis, wheezing and viral pneumonia.
Age: 0.11
Sex: F
Vaccine: FLU3
Symptoms: Laryngitis, Otitis media, Pyrexia, Rhinorrhoea, Stridor
Clinical narrative: Sweaty, runny nose, cough and fever. The ER summary received on 2/9/04 states short of breath, croup, stridor, vomiting, otitis, wheezing and viral pneumonia.
Age: 0.11
Sex: F
Vaccine: FLU3
Symptoms: Viral infection, Vomiting, Wheezing
Clinical narrative: Sweaty, runny nose, cough and fever. The ER summary received on 2/9/04 states short of breath, croup, stridor, vomiting, otitis, wheezing and viral pneumonia.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Flushing, Palpitations, Tremor
Clinical narrative: Dizzy, shaky, trouble breathing, flushed. BP 120/86, heart pounding.  Treatment: Benadryl and inhaler.
Age: 2.0
Sex: M
Vaccine: FLU3, HEPA, PNC
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: 1 day after right thigh erythemic, itchy, slightly raised 5x6cm area.  Benadryl and Augmentin.  PCV 7 #3.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Heart rate increased, Hot flush
Clinical narrative: Pt had a flu shot and 20 minutes later got "sudden hot flash" and "felt heart racing."  Instructed him to follow up with his physician.
Age: 1.7
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Some redness and little swelling on left deltoid, painful.  Apply warm compress then cold pak RTC if not improve.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Tremor
Clinical narrative: Hands shaking, starting 5 days after injection and continuing.  No other symptoms.
Age: 32.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Injection site swelling, Urticaria
Clinical narrative: Reports after injection given 07/14/03, had welt 3x2 inch, raised in which increased size day 1, then day 6.  Took advil, cold compress.  Cephelgra occurred 1.2 days then resolved. 01/14/2003: Premed OTC claritine and acetaminophen.  Base BP 90/60.  Proceed with injection #5.
Age: 32.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Headache, Injection site swelling, Urticaria
Clinical narrative: Reports after injection given 07/14/03, had welt 3x2 inch, raised in which increased size day 1, then day 6.  Took advil, cold compress.  Cephelgra occurred 1.2 days then resolved. 01/14/2003: Premed OTC claritine and acetaminophen.  Base BP 90/60.  Proceed with injection #5.
Age: 46.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Dose #4, reports cephalogam, chills, increased temperature 101 PM.  Nausea after injection.  Problem resolved within 24 hours.
Age: 1.3
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Right leg red, swollen, tender to touch.  Warm compresses for 20 minutes every 4 hours for 24 hours.  Diagnosis: Mild reaction.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site abscess, Injection site erythema, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: Left arm red, swollen, hard and pt complained of pain.  Scant amount serous drainage at injection site.
Age: 23.0
Sex: F
Vaccine: HEPA, SMALL
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: 01/17/2004: Site became reddened, inflamed, painful and hot to touch.  Approximately 4 inch diameter left axillary, pain.  Evaluated 01/19/04, erythematous raised hot skin approximately 4 inch diameter surrounding small pox site (primary response with scab formation) (+) left axillary, lymphad malaise.
Age: 23.0
Sex: F
Vaccine: HEPA, SMALL
Symptoms: Injection site warmth, Malaise
Clinical narrative: 01/17/2004: Site became reddened, inflamed, painful and hot to touch.  Approximately 4 inch diameter left axillary, pain.  Evaluated 01/19/04, erythematous raised hot skin approximately 4 inch diameter surrounding small pox site (primary response with scab formation) (+) left axillary, lymphad malaise.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pruritus
Clinical narrative: Pt deltoid developed area of induration, redness and pruritis 12x13cm with warmth.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Crying, Pyrexia, Rash
Clinical narrative: Mom states child cried uncontrollably for over 2 hrs, had heat type rash and fever of 102 deg-she called the ER but did not take child.
Age: 1.7
Sex: M
Vaccine: PNC
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Lump at site of injection. 7x8.5cn red area around site warm to touch. Started on Keflex 250mg tid to treat possible cellulitis.
Age: 29.0
Sex: F
Vaccine: TTOX
Symptoms: Asthenia, Dizziness, Feeling hot, Hyperhidrosis, Lethargy
Clinical narrative: Dizziness, weakness, blurred vision/ spots, diaphoresis, feeling hot, tingling in toes, lethargy. Resolved in < 45 minutes.
Age: 29.0
Sex: F
Vaccine: TTOX
Symptoms: Paraesthesia, Vision blurred, Visual disturbance
Clinical narrative: Dizziness, weakness, blurred vision/ spots, diaphoresis, feeling hot, tingling in toes, lethargy. Resolved in < 45 minutes.
Age: 1.8
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: 12/30/03 mom brought child to physiican-chief c/o rash. Dx-shingles-had varicella vaccine 6/18/03 rash appeared 12/27/03.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Nausea, Pain
Clinical narrative: Wakeup with (rt) arm hurting, later woke up again with nausea, and headache.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 9mm redness, swelling right upper arm.
Age: 14.0
Sex: M
Vaccine: DT, HEPA
Symptoms: Face oedema, Oedema peripheral, Pruritus, Rash, Throat tightness
Clinical narrative: Late that night of 1/8/04 pt awoke with itching, then next day bil hands swollen and tichy with hives and rash-progressing to swollen lips and tightness on throat. Mother call center and gave Benadryl and followed up next day (Sat.) with Dr.
Age: 14.0
Sex: M
Vaccine: DT, HEPA
Symptoms: Urticaria
Clinical narrative: Late that night of 1/8/04 pt awoke with itching, then next day bil hands swollen and tichy with hives and rash-progressing to swollen lips and tightness on throat. Mother call center and gave Benadryl and followed up next day (Sat.) with Dr.
Age: 60.0
Sex: F
Vaccine: TD, TYP
Symptoms: Hypokinesia, Pain
Clinical narrative: Complains of extreme soreness in both  upper arms which began on 01/07/04 and continues today.  Unable to lift.  Using ibuprofen.  Recommend contacting her physician.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dyspnoea, Laryngospasm, Skin ulcer, Urticaria, Wheezing
Clinical narrative: Shortness of breath with wheezing.  Suspect laryngospan.  Urticarial lesions on face, trunk and extremities.  Required epinephrine x2.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: 01/03/04: Onset redness, swelling, warmth, tenderness around area on injection.  Approximately 2 inches in diameter.  Resolved over period of 4 days.  Treated with Benadryl.  No systemic adverse symptoms.
Age: 1.0
Sex: F
Vaccine: HIBV, PNC
Symptoms: Eye movement disorder, Febrile convulsion, Pyrexia
Clinical narrative: Had PRP-T and PNCV 7 this AM.  This afternoon was found febrile with yeverdited shaking eyes rolling back.  Presumed febrile seizures.  Etiology of fever vaccine reaction vs viral syndrome.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site mass
Clinical narrative: Knot in right anterior thigh.
Age: 0.25
Sex: M
Vaccine: HIBV, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Within 12 hours, site of HIB or Pneumococcal vaccine became swollen, firm with dime size redness.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Redness, swelling and pain at injection site.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Diarrhoea, Hypotonia, Pallor, Pyrexia, Somnolence
Clinical narrative: Noted to be sleepier than normal from PM of 01/12/04, after receiving vaccines through entire day of 01/13/04 although he awoke every 4 hours to feed.  Had temperature ranging from 100.2-100.4 on 01/13/04.  At 20:30 on 01/13/04 (28 hours after receiving vaccines) mom heard noise in crib, on arrival baby had stooled and vomited.  When she picked him up he was pale and limp and although his eyes were open he seemed unresponsive as if he were staring.  Shortly after he had rapid blinking of one eye only.  No tonic extension or tonic/clonic and no cyanosis or respiratory difficulty.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Staring, Vomiting
Clinical narrative: Noted to be sleepier than normal from PM of 01/12/04, after receiving vaccines through entire day of 01/13/04 although he awoke every 4 hours to feed.  Had temperature ranging from 100.2-100.4 on 01/13/04.  At 20:30 on 01/13/04 (28 hours after receiving vaccines) mom heard noise in crib, on arrival baby had stooled and vomited.  When she picked him up he was pale and limp and although his eyes were open he seemed unresponsive as if he were staring.  Shortly after he had rapid blinking of one eye only.  No tonic extension or tonic/clonic and no cyanosis or respiratory difficulty.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Swollen, tender, red deltoid and tricep area.  No consttutroval symptoms.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever 101.4 rectally within 7 hours after shots given. Fever management ordered only.
Age: 7.0
Sex: F
Vaccine: MMR
Symptoms: Face oedema, Headache, Lymphadenitis
Clinical narrative: Swollen face, headache, right side ear, lymphadenitis.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Rash
Clinical narrative: Pt called complained of silver dollar sized raised, red and itchy area on right arm about 4 hours after injection.  24 hours after injection, complained of diffuse rash on fatty areas of body, including itching, redness.
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Thigh swollen, red, slightly indurated and slightly warm 5x4cm by shot site.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Cough, Erythema, Irritability, Lethargy, Pyrexia
Clinical narrative: 24 hours after MMR, Varivax, Prevnar given, cheeks (face), palms of hands, bottom of feet cherry red.  Temperature 102-104 for next 24 hours. Lethargic, cranky, runny nose.  Face, hands, feeet still get red and has a cough now.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Rhinorrhoea
Clinical narrative: 24 hours after MMR, Varivax, Prevnar given, cheeks (face), palms of hands, bottom of feet cherry red.  Temperature 102-104 for next 24 hours. Lethargic, cranky, runny nose.  Face, hands, feeet still get red and has a cough now.
Age: 1.0
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Pt developed generalized urticaria 7 days after receiving 7 vaccines (see below).
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site oedema, Pain, Pruritus
Clinical narrative: Give DTAP #5 on 01/12/2004 and MMR #2 on 01/13/2004.  Complained of arm "itchy and hurting" mom noticed redness around DTAP site. Seen in office today has 10x6.5cm area of redness with some swelling around injection site on left arm.
Sex: M
Vaccine: HIBV, IPV, MMR, PNC
Symptoms: Depressed level of consciousness, Pyrexia, Tremor
Clinical narrative: Temperature 101F, difficult to arouse with some questionable "shaking or seizure" per father's report. Approximately 10 hours after immunization.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Child was administered MMR#3 (#1 given too early) on 12/22/03.  Developed generalized rash on 12/25/03 and was seen by MD on 12/25/03.  Child also had been started on Amoxil prior to rash occuring.
Age: 1.92
Sex: F
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Lesioins on face, trunk and extremities x 4 days.  Afebrile.  Prescribed: Atarax.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Sneezing, Swelling face, Vomiting
Clinical narrative: Over next hour, vomiting and sneezing.  Child vomited immediately then developed increased sneezing and facial swelling but lasted for several hours. Signs stated within an hour after the vaccines were given and lasted for several hours afterwards.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Laboratory test abnormal, Oedema, Oedema peripheral, Pain
Clinical narrative: It was reported that a 49 year old female was administered Fluzone SV 2002-2003 USP (Lot # U0934BA) on 11/15/02.  Three hours after vaccination, the pt had swelling in the calves and legs.  The area from the ankle to the knee was bright red and the area from the knee to the thigh was blotchy red.  The pt also complained of extreme itchiness and burning pain in calves.  She was seen in the ER on 11/17/02 and diagnosed with vasculitis.  The treatment included IV antibiotics, IV steroids, and IV Benadryl.  She was released with oral steroids for 10 days and referred to her dermatologist.  From additional information received from the manufacturer on 04/14/03, it was reported that the pt was given Fluzone SV 2002-2003 USP vaccination in the left deltoid at 3:00PM on 11/15/02.  Pt experienced symptoms of Vasculitis three hours later on the same day.  Pt was seen in the ER on 11/17/02.  CBC, Sed. Rate, Cardiac Enzymes and Renalytes were drawn but the only abnormal lab was elevated Sed. Rate.  It was also reported that the pt, in the past, had received numerous flu shots and would get them annually.  Pt was taking Ibuprofen for an unrelated condition.  And in September 2002, pt was given Pneumovax at a doctor's office.  Pt was healthy at the time of vaccination.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash macular, Red blood cell sedimentation rate increased, Skin burning sensation, Vasculitis
Clinical narrative: It was reported that a 49 year old female was administered Fluzone SV 2002-2003 USP (Lot # U0934BA) on 11/15/02.  Three hours after vaccination, the pt had swelling in the calves and legs.  The area from the ankle to the knee was bright red and the area from the knee to the thigh was blotchy red.  The pt also complained of extreme itchiness and burning pain in calves.  She was seen in the ER on 11/17/02 and diagnosed with vasculitis.  The treatment included IV antibiotics, IV steroids, and IV Benadryl.  She was released with oral steroids for 10 days and referred to her dermatologist.  From additional information received from the manufacturer on 04/14/03, it was reported that the pt was given Fluzone SV 2002-2003 USP vaccination in the left deltoid at 3:00PM on 11/15/02.  Pt experienced symptoms of Vasculitis three hours later on the same day.  Pt was seen in the ER on 11/17/02.  CBC, Sed. Rate, Cardiac Enzymes and Renalytes were drawn but the only abnormal lab was elevated Sed. Rate.  It was also reported that the pt, in the past, had received numerous flu shots and would get them annually.  Pt was taking Ibuprofen for an unrelated condition.  And in September 2002, pt was given Pneumovax at a doctor's office.  Pt was healthy at the time of vaccination.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: From initial info received on 10/18/02, seven female employees were vaccinated on 10/15/02 and 10/17/02 with Fluzone. They experienced local reactions of redness, swelling and itching 24 hrs post vaccination. The facility physician prescribed Tylenol. From additional info received on 11/4/02 via fax from the reporter, four of the seven employees have been identified. Pt two is a 48 year old female who received a Fluzone (U0968AA), administered IM in the left deltoid on 10/15/02 at 2 pm. Reportedly two hours later the pt experienced an edematous left arm, red from top to elbow, hot to the touch and painful; chills with headache that lasted 24 hrs. The pt reportedly recovered from these events.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral
Clinical narrative: From initial info received on 10/18/02, seven female employees were vaccinated on 10/15/02 and 10/17/02 with Fluzone. They experienced local reactions of redness, swelling and itching 24 hrs post vaccination. The facility physician prescribed Tylenol. From additional info received on 11/4/02 via fax from the reporter, four of the seven employees have been identified. Pt two is a 48 year old female who received a Fluzone (U0968AA), administered IM in the left deltoid on 10/15/02 at 2 pm. Reportedly two hours later the pt experienced an edematous left arm, red from top to elbow, hot to the touch and painful; chills with headache that lasted 24 hrs. The pt reportedly recovered from these events.
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Laboratory test abnormal
Clinical narrative: From initial info received on 2/26/03 from physician's office regarding an adverse event, it was reported that an elderly female pt received Fluzone (U0906AA). Sometime after vaccination the pt tested positive for influenza type A. No additional info is available at this time.
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Laboratory test abnormal
Clinical narrative: From initial info received on 2/26/03 from physician's office regarding an adverse event, it was reported that an elderly female pt received Fluzone (U0906AA). Sometime after vaccination the pt tested positive for influenza type A. No additional info is available at this time.
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Laboratory test abnormal
Clinical narrative: From initial info received on 2/26/03 from physician's office regarding an adverse event, it was reported that an elderly female pt received Fluzone (U0906AA), on an unspecified date. Sometime after vaccination the pt tested positive for influenza type A. No additional info is available at this time.
Sex: U
Vaccine: FLU3
Symptoms: Influenza, Laboratory test abnormal
Clinical narrative: From initial info received on 2/26/03 from physician's office regarding an adverse event, it was reported that an elderly female pt received Fluzone (U0906AA), on an unspecified date. Sometime after vaccination the pt tested positive for influenza type A. No additional info is available at this time.
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Laboratory test abnormal
Clinical narrative: From initial info received on 2/26/03 from physician's office regarding an adverse event, it was reported that an elderly female pt received Fluzone (U0906AA), on an unspecified date. Sometime after vaccination the pt tested positive for influenza type A. No additional info is available at this time.
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Laboratory test abnormal
Clinical narrative: From initial info received on 2/26/03 from physician's office regarding an adverse event, it was reported that an elderly female pt received Fluzone (U0906AA(, on an unspecified date. Sometime after vaccination the pt tested positive for influenza type A. No additional info is available at this time.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Pain, Tendonitis
Clinical narrative: From initial info received on 8/21/03 from a health care professional regarding an adverse event, it was reported that a 48 year old female pt received Fluzone (I0906AA), administered IM in the left arm on 12/19/02. 33 days later, on 1/21/03, the pt developed pain and limited movement in the left arm. She was seen by an orthopedist and consulted an infection disease specialist. An MRI done on 3/25/03 showed tendonitis. At the time of this report, the pt continued to experience intermittent shoulder pain and had not recovered from these events.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Peroneal nerve palsy
Clinical narrative: From telephone call received on 7/17/02 it was reported that a 63 year old female pt received a Fluzone vaccine administered on 11/7/01. The pt stated that she had drop foot syndrome, which occurred approximately one week after receipt of vaccine. Her physician feels this might be attributed to Fluzone. The pt told the reporter of this event that her treating physician instructed the pt to obtain as much info as she could about the vaccine. Product insert, lot # and manufacturer. Pt called this pharmacist because this is the facility where she received flu vaccination during one of the public clinics. The reporter is a pharmacist at the facility that holds public flu clinics (grocery store). She did not have any other additional info at this time.
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site pain, Injection site reaction
Clinical narrative: Five patients experienced local reactions, one pt went to ER due to large local reaction size of an orange, knot, Keflex prescribed, MD dx cellulitis, red, warm, tender to touch. Info on other 4 patients be need to be obtained. At this time, the pt that went to ER is identified as an adult female. Additional info to be provided at later time.
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: Five patients experienced local reactions, one pt went to ER due to large local reaction size of an orange, knot, Keflex prescribed, MD dx cellulitis, red, warm, tender to touch. Info on other 4 patients be need to be obtained. At this time, the pt that went to ER is identified as an adult female. Additional info to be provided at later time.
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: From telephone correspondence received on 10/14/02, it was reported that an adult male was vaccinated with Fluzone (lot # U0872AB) IM on 10/9/02. The following day, on 10/10/02, the patient experienced a red and itchy body. Benadryl was administered and helped. On 10/14/02, it was reported that the patient's hands and feet were swollen. It is not reported whether the patient recovered from these adverse events.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Hypoaesthesia, Lymph node pain, Lymphadenopathy
Clinical narrative: From telephone correspondence received on 10/14/02, it was reported that a 30 year old female received Fluzone (lot number U0904CA) on 10/10/02. The vaccination was administered IM in the right deltoid. Three hours post-vaccination, the patient complained of joint pain in the right shoulder extending to the clavicle. She was prescribed Tylenol and the event resolved by 10/11/02. On 10/12/02, the patient experienced soreness under her right arm. By 10/14/02, she was also complaining of sore lymph node in the cervical area. At the time of the report, the patient was being evaluated by a neurologist for numbness that extended from her elbow to the finger of the right upper extremity. An MRI was done and results are pending. It was not reported whether the patient recovered from these adverse events.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoglycaemia, Muscular weakness, Nausea, Paraesthesia
Clinical narrative: From telephone contact received on 10/14/02, it was reported that a 40 year old female pharmacist (DOB 2/1/1962) was administered Fluzone on 10/14/02 at 10:30AM. A short time later, she reported feeling hypoglycemic and had orange juice. Additionally, she complained of lower extremity fatigue, weakness and tingling. She also felt nauseated and went home to bed. It is not reported whether the patient recovered from these adverse events.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Nausea, Pain, Paraesthesia, Vomiting
Clinical narrative: From telephone correspondence received on 10/14/02, it was reported that a 28 year old (DOB 10/15/74) male patient, received Fluzone (lot # U0918AA) on 10/14/02. Following the administration of the dose, he experienced nausea and vomiting, severe, extreme weakness, achiness and tingling in his lower legs. Reportedly, he went home from work. It is not reported whether the patient recovered from these adverse events.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Hypoaesthesia, Nausea, Pallor, Vomiting
Clinical narrative: Information has been received from a health care professional concerning a 34 year old female who was vaccinated with a dose of Fluzone IM in the left deltoid. The date of vaccination was not reported. The lot # is U0877AA and the expiration date is 6/30/03. The patient became pale and nauseous within 2 minutes post vaccination. She also experienced vomiting (small amount), and numbness in both hands. Her lung sounds were clear and blood pressure was 140/90. She was administered with oxygen through a facemask and with Benadryl 50mg IM. She recovered two hours later.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Rash
Clinical narrative: From telephone contact received 10/17/02, it was reported that a 52 year old (DOB 01/02/1950) female was administered Fluzone (lot # U0969AA) in the right deltoid on 10/14/02. She also received a Pneumococcal vaccine (unspecified) in the left deltoid. On 10/15/02, the patient experienced a rash from, the left shoulder to the elbow. She was seen by her doctor on 10/16/02 and was given an antibiotic (unspecified) and topical hydrocortisone cream for cellulitis. Per the reporter, these adverse events are resolving.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Musculoskeletal stiffness, Pain, Pruritus
Clinical narrative: From initial information received on 10/18/02, 7 female employees were vaccinated on 10/15/02 and 10/17/02 with Fluzone. They experienced local reactions of redness, swelling and itching 24 hours post vaccination. The facility physician prescribed Tylenol. From additional information received on 11/4/02 via fax from reporter, 4 of the 7 employees have been identified. Patient 1 is a 43 year old female who received a Fluzone vaccination, lot # U0968AA, administered IM in the left arm in October 2002, exact date not specified. Sometime after receipt of vaccination, exact date not specified, the patient developed a 5cm, raised, warm erythema at the injection site on her left arm. The patient also complained of an ache in her arm, and mild systemic itching all over her body. The patient's left arm is still stiff and achy. The patient has not yet recovered from this event.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site vesicles, Pruritus
Clinical narrative: From initial information received via telephone on 10/21/02, it was reported that a 54 year old female patient had been vaccinated with Fluzone on 10/11/02. The patient developed a red area, 2cm in diameter, with tiny blisters and itching. The patient went to her doctor's office on 10/14/02. No other signs or symptoms reported. It was not reported whether the patient recovered.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: From telephone correspondence received on 10/22/02, it was reported that a 38 year old female was vaccinated with Fluzone, lot U0982AA, on 10/8/02. She developed a rash approximately 12 hours after vaccination. She denied any respiratory problems and was not seen by a physician. It was reported that the patient fully recovered. This case is closed.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: From telephone correspondence received on 10/22/02, it was reported that a 28 year old female was vaccinated with Fluzone, lot # U0982AA, on 10/8/02. She developed a rash approximately 12 hours after vaccination. She denied any respiratory problems and was not seen by a physician. It was reported that the patient fully recovered.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: From telephone contact received on 10/28/02, it was reported that a 27 year old adult female was vaccinated with Fluzone, lot # U0913AA, on 10/21/02. Eight hours later, the patient experienced nausea, vomiting, and diarrhea. She was told to see her own physician on 10/23/02. It was not reported whether the patient recovered.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Nasal congestion, Pharyngolaryngeal pain, Pyrexia, Rash
Clinical narrative: From telephone contact received on 10/28/02, it was reported that a 53 year old adult female was vaccinated with Fluzone, lot # U0913AA, on 10/21/02. By 10/24/02, she complained of being tired with a low grade fever of 37.4C, sore throat, and sinus congestion. On 10/26/02, she developed a peppery roseolla-like rash that did not itch as she does with fever. Patient called to report, but was not seen. It was not reported whether the patient recovered.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Roseola
Clinical narrative: From telephone contact received on 10/28/02, it was reported that a 53 year old adult female was vaccinated with Fluzone, lot # U0913AA, on 10/21/02. By 10/24/02, she complained of being tired with a low grade fever of 37.4C, sore throat, and sinus congestion. On 10/26/02, she developed a peppery roseolla-like rash that did not itch as she does with fever. Patient called to report, but was not seen. It was not reported whether the patient recovered.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site mass
Clinical narrative: From telephone contact received on 10/28/02, it was reported that a 78 year old male patient vaccinated with Fluzone on 10/17/02 in the left deltoid. Two days later, the patient developed a hard nodule the size of a quarter. No loss of arm use, pain, or itching occurred. The nodule is still persisting at this time. The patient was advised by his pharmacist, who administered the Fluzone, to see his physician.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Arthritis, Pain, Pharyngolaryngeal pain
Clinical narrative: From telephone contact received on 10/29/02, it was reported that a 50 year old male patient vaccinated with Fluzone (lot # U0933AA) on 10/22/02. On 10/25/02, the patient reported having arthritis like symptoms with achiness and a sore throat. These symptoms were resolved within 24 hours.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site pain, Joint range of motion decreased
Clinical narrative: From faxed correspondence received on 11/1/02, it was reported that an 81 year old elderly female was vaccinated with Fluzone (lot # U0888AA) IM in the deltoid on 10/11/02. She complained of pain at injection site, severe bruising, and decreased range of motion the next day. She was seen on 10/28/02 without bruises, or abscess, but with loss of shoulder motion. Reportedly the patient recovered. This case is closed.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Bursitis, Cellulitis
Clinical narrative: From telephone correspondence received on 10/30/02, it was reported that a 43 year old female adult received Fluzone, lot # U0918AA, on 10/16/02. She later complained of a sore elbow and was seen by her doctor who diagnosed it as bursitis. On 10/30/02, her arm developed red streaks at the injection site, which her physician described as cellulitis. She received 7 Rocephin IM injections and was placed on antibiotics. It was not reported whether the patient recovered.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pruritus, Rash
Clinical narrative: From telephone contact received on 10/30/02, it was reported that a 55 year old female had been vaccinated with Fluzone (lot number U0913AA) in the left deltoid. The date of vaccination was not reported. 3 to 4 days after vaccination, the patient complained of her elbow being sore. The patient also developed an area of rash that was itchy on the top of her left foot. These symptoms reportedly resolved within one week without any treatments.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Dyskinesia, Hypoaesthesia, Muscle twitching, Paraesthesia, Restlessness
Clinical narrative: From telephone correspondence received on 11/1/02, it was reported that an adult female received Fluzone on 10/25/02., Approximately 2 to 3 days post vaccination, she began to experience sensations of muscle twitching, which the patient described as a numbness and tingling of the upper and lower extremities. Per the physician, the patient was experiencing paresthesias and restlessness. She has a history of psychiatric episodes and was seen by the physician to get her influenza vaccine. On 10/31/02, the patient was seen by her psychiatrist, who noted marked facial dyskinesia. The patient is currently taking several psychiatric medications for bi-polar disorder. Reportedly, the symptoms are still persisting, although the patient states they are starting to improve. From additional information received on 4/3/03 from the reporting physician, it was reported that the patient was 39 year old at the time of the administration of Fluzone, lot number is U0904CA and was given IM in her deltoid. Reportedly, the patient was seen by the physician on 10/29/02 and recovered from the adverse reactions. No further information is anticipated, this case is closed.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypokinesia, Muscular weakness, Pain
Clinical narrative: It was reported that a 73 year old adult female, received dose of Fluzone (lot # U0879AA) IM in the right arm and Pneumovax 23 (lot # 0923L) IM in the left arm on 10/18/03. The patient developed weakness in her right hand with difficulty grasping. The right hand grasp was reported weaker than the left hand. Additionally, she experienced soreness in upper arm after injection was given and the soreness has increased over the last two weeks. No site swelling or redness was reported. The patient treated with Tylenol and warm compresses to the upper arm. Per the reporting nurse, the physician feels this isn't related to the dose of Fluzone received. A copy of this report was submitted by the reporter.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Injection site pain
Clinical narrative: From faxed correspondence on 11/1/02, it was reported that a 70 year old elderly female received Fluzone (lot # 40888AA) IM in the deltoid on 10/10/02. She felt normal the next day except soreness at injection site. But then she experienced progressive loss of motor control of her left shoulder. Reportedly she recovered.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: From telephone contact received at manufacturer on 11/04/02, it was reported that a 79 year old female pt was vaccinated with Fluzone SV 2002-2003 USP (Lot # U0882AA) in the left arm on 10/19/02.  Two days after the vaccination, on 10/21/02, the pt complained of pain in her left arm. She was seen in her MD office on 11/04/02.  Her entire arm aches from her shoulder to her fingers. Treatment prescribed with Ibuprofen 800mg three times a day for 10 days.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Blood cholesterol increased
Clinical narrative: From telephone contact received at manufacturer on 11/05/02, it was reported that a 49 year old female pt had been vaccinated with Fluzone on 10/24/02.  The pt's liver function tests are abnormal.  The pt started taking cholesterol-lowering medications 6 months ago.  Her liver function tests were normal until last week.  No systemic symptoms after receipt of dose.  The pt's doctor did not locate the lot number of the product while reporting this event, but will provide it when completing a VAERS form for the manufacturer.  The MD also stated that she felt most likely that this event was not due to the Fluzone vaccine, but because it occurred in such close proximity to the receipt of dose, she felt it should be reported.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Mouth ulceration
Clinical narrative: From telephone correspondence received at manufacturer on 11/05/02, it was reported that a 42 year old female received Fluzone SV 2002-2003 USP (Lot # U0882AA) on 10/29/02.  The pt reported to employee health nurse on 10/31/02 that she developed sores in her mouth, which resolved in less than 24 hours after self-treatment with Listerine mouthwash. She was not evaluated by a physician when these sore erupted; therefore the cause is unknown per reporter. This case is closed.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Oedema peripheral, Pain
Clinical narrative: From faxed correspondence received at manufacturer on 10/07/02, it was reported that a 31 year old female received Fluzone SV 2002-2003 USP vaccine (Lot # E31882CA) in the left arm and pneumonia vaccine (manufacturer Merck, Lot # 0165M) in the left arm on 10/02/03.  She reportedly developed a swelling of the left arm, painful and warm to touch. She applied an ice pack 10 minutes on and 15 minutes off, and was advised to call physician to order antihistamines.  It was not reported whether the pt recovered.  See case # U2002-00952 with the same reporter.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: From telephone correspondence received at manufacturer on 11/06/02, it was reported that a 7 year old male child was vaccinated with Fluzone SV 2002-2003 USP (Lot # U0930FA). The pt experienced chills, temperature 99.9F, and body aches for a period of 2 days after vaccination.  He had not previously been immunized with Flu vaccine. The pt recovered.
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Pt received dose of Fluzone 11/05/02, within 2 hours reported generalized rash and hives head to toe except for their face.  No difficulty breathing and no throat/lip swelling. No other events reported for this person.  There are a total of 3 similar reports from this facility.  A second person reported hives, generalized rash that occurred 4 days after vaccination, follow up with allergist. The third pt is employee in health center.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Thought blocking
Clinical narrative: Information has been received concerning a 38 year old male who was administered Fluzone SV 2002-2003 USP (Lot # U0944aa) on 11/06/2002.  Approximately 6 hours after vaccination, the pt experienced difficulty in verbalizing thoughts, which lasted for 2 to 3 hours.  He was fully recovered.  It was also reported that he had received influenza vaccine in the past with no problems.  From additional information received on 04/10/03, from a nurse, it was reported that the pt, vaccine administrator and physician's information be updated.  No further information is anticipated, this case is closed.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash macular, Rash pruritic
Clinical narrative: From telephone correspondence received at manufacturer on 11/08/02, it was reported that a 59 year old adult female was vaccinated with Fluzone SV 2002-2003 USP (Lot # U0928AA) on 11/06/2002.  The next day she developed generalized itchy rash with red blotches.  Pt's condition remained unresolved at the time of report.
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: From telephone correspondence received at manufacturer on 11/06/02, it was reported that an adult female pt received Fluzone SV 2002-2003 USP (Lot # U0932AA) on 11/01/2002.  The next day, she developed numbness and tingling in her left arm.  At the time of the report, her condition remained unresolved.  See case # U2002-00958 with same reporter.
Age: 1.3
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Injection site erythema, Injection site warmth
Clinical narrative: From telephone contact received at manufacturer on 11/12/02, it was reported that a 15 month old male had been vaccinated with Fluzone SV 2002-2003 USP on 11/01/02 in the right deltoid.  The mother of the pt reported a 4x3 inch area of bruising and warmth at the site.  Initially, there had been only redness prior to bruising.  No other symptoms were noted.  The pt has no bleeding disorders.  The reporting physician received this information via a telephone call from the pt's mother; the child did not have an office visit for this event.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Eye irritation, Eye oedema, Face oedema, Urticaria
Clinical narrative: From telephone correspondence received at manufacturer on 11/13/02, it was reported that a 60 year old adult female received Fluzone SV 2002-2003 USP (Lot # U0930FA) on 11/06/02.  The following morning the pt broke out in hives and a generalized rash, and experienced swollen lips and itchy eyes.  There was no reported difficulty with breathing. She was administered Allegra 10mg and Benadryl.  Pt had received Fluzone for the past 5 years with no history of allergic reactions or egg allergies.  It was not reported whether the pt recovered.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Laboratory test abnormal, Transient ischaemic attack
Clinical narrative: It was reported that a 66 year old female received Fluzone SV 2002-2003 USP (Lot # U0953AA), administered on 11/08/02.  Within 24 hours of dose received, on 11/09/02, the pt experienced a transient ischemic attack and weakness in left leg while driving.  No accident was involved.  The episode resolved quickly. The pt was seen in the ER and the event was diagnosed as a possible transient ischemic attack.  She was released from the ER the same day.  From additional information received on 04/10/03 from a health care facility it was reported that the pt received Fluzone SV 2002-2003 USP (Lot # U0953AA) IM in the right deltoid on 11/08/02 sometime between 8:00 and 9:00 AM.  On 11/09/02 at 12:12PM, the pt experienced a transient ischemic attack and weakness in left leg while driving.  An echocardiogram showed trace MR and Holter monitoring revealed rare SVT.  An ultrasound of the carotids and CT of the head were normal.  The pt did not have any illness at the time of vaccination.  Pre-existing medical conditions included increased lipids, hypertension, psoriasis , TMJ and spinal stenosis. Concomitant medications included calcium, carisoprodol, diclofenac, dovonex, lipitor, nexium and psorcon.  No other medically significant information was provided.  No further information is anticipated, this case is considered closed.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Abnormal dreams, Anxiety, Chest discomfort, Disorientation, Dizziness
Clinical narrative: From telephone contact received at manufacturer on 11/14/02, it was reported that a 47 year old male was vaccinated with Fluzone SV 2002-2003 USP (Lot # U0927AA) on 11/13/02.  Immediately after the vaccination, the pt felt chest tightness and lung congestion.  He felt no further respiratory distress after the use of inhaler, but felt disoriented and anxious.  After 1 hour, he drove home where he experienced muscle aches, joint stiffness and extremity tingling.  He also reported a restless night sleep, with vivid dreams.  He felt fine in the morning.  He drove to work, but felt dizzy so he returned home.  He will see his physician today at 14:00 11/14/02.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Insomnia, Joint stiffness, Nasal congestion, Pain, Paraesthesia
Clinical narrative: From telephone contact received at manufacturer on 11/14/02, it was reported that a 47 year old male was vaccinated with Fluzone SV 2002-2003 USP (Lot # U0927AA) on 11/13/02.  Immediately after the vaccination, the pt felt chest tightness and lung congestion.  He felt no further respiratory distress after the use of inhaler, but felt disoriented and anxious.  After 1 hour, he drove home where he experienced muscle aches, joint stiffness and extremity tingling.  He also reported a restless night sleep, with vivid dreams.  He felt fine in the morning.  He drove to work, but felt dizzy so he returned home.  He will see his physician today at 14:00 11/14/02.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chest pain
Clinical narrative: It was reported that a 57 year old female patient was vaccinated with Fluzone on 11/4/02. The patient reported to the nurse that she developed chest pain and chest tightness on 11/5/02. The symptoms resolved without physician evaluation.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chest pain
Clinical narrative: From information received on 11/14/02, it was reported that a 40 year old female was vaccinated with FLUZONE on 11/6/02 and reported to the nurse that she developed chest pain and chest tightness. The patient was not evaluated by a physician. The patient reported persistence of symptoms and was advised to seek medical attention. It was not reported whether the patient recovered.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Rash vesicular
Clinical narrative: From faxed correspondence on 11/12/02, it was reported that an 8 year old female child received FLUZONE, lot # U0886AA, on 10/21/02. That same day, the patient developed a possible vesicular rash on top of ear. The patient recovered. No further information was provided from correspondence received on 4/14/03. This case is closed.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Contusion, Injection site pain, Tendonitis
Clinical narrative: From telephone contact on 11/19/02, it was reported that a 48 year old female received Fluzone (lot number U0929AA) at a pharmacy on 10/22/02. The patient had immediate pain at injection site along with a large bruise. The patient was seen by her primary care doctor on 11/15/02 and was diagnosed with Tendonitis and bursitis.