chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest discomfort, Injection site erythema, Injection site warmth, Pain in extremity, Rash macular
Clinical narrative: Patient called to report previous reaction to vaccinations received on 10/31/07; patient states she developed "hot red blotches" (pneumococcal) injection site just a couple of hours after getting injections; blotches extended down to almost left wrist area on lateral aspect; later that afternoon the "blotches" were on inner aspect as well; at about 6pm she developed tightness in her throat and chest; she took 2 puffs of Maxair and Benadryl 50mg po and tightness resolved after 30-40 minutes; she stated that the pain in her upper arm was a 6-7 on a scale from 1-10, 10 being intense worst experienced) she used ice and later heat but did not take analgesics; on 11/3/2007 she states pain, redness and blotches had resolved; patient instructed to seek emergency care in the future if similar chest and throat tightness were to occur, instructed patient to discuss with doctor at her next visit to decide about vaccinations in the future; patient agreeable; will mark "alert" on Immunization record; VAERS report faxed.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Throat tightness
Clinical narrative: Patient called to report previous reaction to vaccinations received on 10/31/07; patient states she developed "hot red blotches" (pneumococcal) injection site just a couple of hours after getting injections; blotches extended down to almost left wrist area on lateral aspect; later that afternoon the "blotches" were on inner aspect as well; at about 6pm she developed tightness in her throat and chest; she took 2 puffs of Maxair and Benadryl 50mg po and tightness resolved after 30-40 minutes; she stated that the pain in her upper arm was a 6-7 on a scale from 1-10, 10 being intense worst experienced) she used ice and later heat but did not take analgesics; on 11/3/2007 she states pain, redness and blotches had resolved; patient instructed to seek emergency care in the future if similar chest and throat tightness were to occur, instructed patient to discuss with doctor at her next visit to decide about vaccinations in the future; patient agreeable; will mark "alert" on Immunization record; VAERS report faxed.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Dizziness, Nausea
Clinical narrative: 30 hrs after vaccination, pt had sudden onset of severe nausea, anxiety, and dizziness.  The dizzines persisted up to the time of reporting.
Age: 76.0
Sex: M
Vaccine: FLUX
Symptoms: Hyperhidrosis, Neck pain
Clinical narrative: Received flu vaccine on Oct. 5.  Awoke next day with severe neck pains.  Pain worsened making it difficult to lay head down on pillow or raise head.  On Oct. 15 went to Urgent Care.  Received pain med. & muscle relax. and referred to own doctor.  Saw Dr. on Oct 18, who conferred with a neurologist re: possibility of GBS.  Warned to to watch for numbing, tingling or weakness of extremities.  Provided 3 Celebrex.  Awoke Oct 19 soaking wet with sweat, but much less neck pain.  Continued slow improvement after that date.  Fine now.
Age: 45.0
Sex: M
Vaccine: ANTH
Symptoms: Hypoaesthesia, Injection site pain, Musculoskeletal stiffness, Vision blurred
Clinical narrative: Day after shot member experienced sore arm.  Following day member experienced pain in injection area followed by numbness radiating to little finger on left hand.  A few minutes later same pain radiated up into nexk area.  Within 20 minutes member experiend blurred vision.  11/07/2007 radiating pain to finger is gone.  Still a little blurred vision and stiffness in neck.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Dyspnoea, Erythema, Injection site erythema, Injection site pain
Clinical narrative: about 20 minutes post-injection, nose & cheeks became red & swollen; voice became raspy, difficulty breathing, called PMD.  took 25 mg Benadryl & within 20 minutes symptoms resolved; 3:30 pm symptoms returned - took another Benadryl (25 mg) & again symptoms resolved.  10 am on 11/7/07 - symptoms did not return; feels fine.  has had flu vaccine each year before.  10/01/2007, received PPV23 @ PMD; injection site reaction:  swelling, redness, soreness, itching; resolved over 4 days - Benadryl; in 1995 had reaction to flu vaccine (below)
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Swelling face
Clinical narrative: about 20 minutes post-injection, nose & cheeks became red & swollen; voice became raspy, difficulty breathing, called PMD.  took 25 mg Benadryl & within 20 minutes symptoms resolved; 3:30 pm symptoms returned - took another Benadryl (25 mg) & again symptoms resolved.  10 am on 11/7/07 - symptoms did not return; feels fine.  has had flu vaccine each year before.  10/01/2007, received PPV23 @ PMD; injection site reaction:  swelling, redness, soreness, itching; resolved over 4 days - Benadryl; in 1995 had reaction to flu vaccine (below)
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: The patient was given the Pneumococcal vaccine on 10/31/07 at Pharmacy. On 11/6/07 she called the pharmacy and reported her arm was swollen to the "size of an orange." The swelling was in the area on the right deltoid that the Pneumovax vaccine was given in. The patient is unable to take any OTC antiinflammatory medications due to a severe salicylate allergy, so has been using ice to treat the swelling. In speaking with the patient today, she is feeling much better, the swelling has decreased, and her only complaint is that she can't sleep on her side.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, MMRV
Symptoms: Injection site erythema, Injection site oedema, Local reaction
Clinical narrative: 11072007 @1:10pm father called and c/o redness, erythema and edema at RD injection site of DTaP given on 11-06-2007.  I explained to father like I explained to mother at the time of the injection that this localized reaction was a normal side effect of the vaccine administration of the DTaP vaccine.  father just wanted to make sure his son was going to be okay and reassurance were repeated to the father, like the mother at the time of the administation:  Ice/cold pack for 20m intervals with 10 min breaks, ibuprofen 100mg PO Q6hrs.  Explained that this was a normal but unfortunate reaction and that there was no detrimental affects to the son.
Age: 1.0
Sex: M
Vaccine: MMR, PNC
Symptoms: Blood culture negative, CSF culture negative, Chest X-ray normal, Computerised tomogram normal, Full blood count normal
Clinical narrative: Pt developed fever to 101.4 w/ generalized tonic clonic seizure 48hours after administration.  Evaluated in emergency dept - no treatment required.  Fever resolved after this incident.  1 wk later (total of 9d following MMR administration), pt developed new fever to 101.4 w/ no focal symptoms or infectious etiology identified.  Had generalized tonic-clonic febrile sz lasting 10min.  Evaluated in emergency department - cultures of blood, urine, CSF negative.  All work-up was normal including basic metabolic panel, urinalysis, complete blood count, csf studies (glucose, protein, cell counts), CT head, chest x-ray with the exception of elevated wbc of 15.9 (poly 62,band 2, lymp 29). Pt received no treatment and was discharged home.
Age: 1.0
Sex: M
Vaccine: MMR, PNC
Symptoms: Grand mal convulsion, Metabolic function test normal, Pyrexia, Urine analysis normal, White blood cell count increased
Clinical narrative: Pt developed fever to 101.4 w/ generalized tonic clonic seizure 48hours after administration.  Evaluated in emergency dept - no treatment required.  Fever resolved after this incident.  1 wk later (total of 9d following MMR administration), pt developed new fever to 101.4 w/ no focal symptoms or infectious etiology identified.  Had generalized tonic-clonic febrile sz lasting 10min.  Evaluated in emergency department - cultures of blood, urine, CSF negative.  All work-up was normal including basic metabolic panel, urinalysis, complete blood count, csf studies (glucose, protein, cell counts), CT head, chest x-ray with the exception of elevated wbc of 15.9 (poly 62,band 2, lymp 29). Pt received no treatment and was discharged home.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Facial palsy, Hypoaesthesia oral
Clinical narrative: I recieved vaccine around 5:00pm and before i left the building {approx 5 min.} my tongue felt numb, an hour or so later my lips felt numb{all on right side}i still wasnt too concerned and tried not to think about it the next day.I awoke sat.morning and my entire right side of my face was paralysed.i thought i was having a stroke, i look like ive had a stroke but doctor says bells palsy i researched the web and found numerous reports of this reaction but have never been told that it could be caused from flu vaccine.I would rather have had the flu.It has now been a week and im not better.
Age: 80.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Physician ordered varicella vaccine for administration to 80yr old pt, vaccine was given in right arm, IM. Later discovered that the patient would have preferred Zostavax vaccine.
Age: 29.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, mild pain near injection site.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Drooling, Skin test, Swollen tongue, Urticaria
Clinical narrative: Infant received multiple parenteral vaccines as well as oral Rotateq at his 2 month visit; time administered between 10-11 am. No reaction while in the pediatricians office, but by 5 pm was noted by mother to have progressively increased drooling and prominent tongue swelling, requiring an Emergency Room visit at 7pm where he was treated with oral steroids in the ER followed by 4 daily doses of Orapred. Mother notes resolution of tongue swelling by day 2-3. No hives or local reactions at the sites of the parenteral vaccines were noted at any time. 11/27/07-records received for DOS 8/16/07-Status post possible reaction to immunization condition much improved. Evening of injection tongue protruded, lower lip swollen. Low grade fever.
Age: 0.33
Sex: F
Vaccine: DTPPHIB
Symptoms: Screaming
Clinical narrative: My daughter screamed uncontrollably for approximately 2 hours after having her 4 month vaccines.  She started this approximately 1-2 hours after having the shots.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Vomited x 1 12 hours post vaccination and vomited x 1 22 hours post vaccination
Age: 1.25
Sex: M
Vaccine: DTPHIB, FLU3, PNC
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warmth and tenderness to Right Leg.  Given Keflex 125mg/5ml 2 times per day for 10 days.
Age: 0.75
Sex: F
Vaccine: FLU3
Symptoms: Culture, Pyrexia, Urine analysis normal
Clinical narrative: fever of 104 via pacifier thermometer day of flu vaccine, tylenol given
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Feeling hot, Flushing, Immediate post-injection reaction, Injection site pruritus
Clinical narrative: Pt received Fluzone (single dose preservative-free vial) flu shot, immediately felt itchy and hot afterward, was taken to exam room for observation, developed generalized flush & hives within next 2 minutes, tachycardic to over 160bpm, pt then reported difficulty breathing & start of wheezing, 911 called, dyspnea dissipated as epi injection was readied, O2 @2Lpm via face mask started, pt remained alert & responsive.  Mom denied known egg allergy, reported pt to have history of multiple hypersensitivities but no prior anaphylaxis.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Oxygen supplementation, Pruritus, Tachycardia, Urticaria
Clinical narrative: Pt received Fluzone (single dose preservative-free vial) flu shot, immediately felt itchy and hot afterward, was taken to exam room for observation, developed generalized flush & hives within next 2 minutes, tachycardic to over 160bpm, pt then reported difficulty breathing & start of wheezing, 911 called, dyspnea dissipated as epi injection was readied, O2 @2Lpm via face mask started, pt remained alert & responsive.  Mom denied known egg allergy, reported pt to have history of multiple hypersensitivities but no prior anaphylaxis.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Pt received Fluzone (single dose preservative-free vial) flu shot, immediately felt itchy and hot afterward, was taken to exam room for observation, developed generalized flush & hives within next 2 minutes, tachycardic to over 160bpm, pt then reported difficulty breathing & start of wheezing, 911 called, dyspnea dissipated as epi injection was readied, O2 @2Lpm via face mask started, pt remained alert & responsive.  Mom denied known egg allergy, reported pt to have history of multiple hypersensitivities but no prior anaphylaxis.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder, Ultrasound scan
Clinical narrative: My daughter is 17 weeks pregnant, had her 2nd shot on 06/27/2007,and concieved on her next ovulation which was 07/18/2007 (about)... She recieved the Gardisil shot, We had the quad screen done because of the concerns of having the shot. Her test results came back showing Positive for Down Syndrome a ratio of 1:9 which is very high. I am very concerned that this could have been caused by this shot. Since there is no family history on either sides of ever having children born with any birth defects. We are going to see a peri-natoligist next week to confirm the diagnoses. I read were there had been studies done and showed some birth anomalies? Do you know what these anomalies may have been.
Age: 1.17
Sex: M
Vaccine: FLU3, HIBV, MMR, PNC, FLU3, HIBV, MMR, PNC
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever and febrile seizure evening after vaccines given
Age: 1.17
Sex: M
Vaccine: FLU3, HIBV, MMR, PNC, FLU3, HIBV, MMR, PNC
Symptoms: Condition aggravated, Febrile convulsion, Pyrexia
Clinical narrative: Fever and febrile seizure evening after vaccines given
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Urticaria
Clinical narrative: high fever, severe hives, and swelling and redness at injection site.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: rash knee-up; raised bumps; sometimes itches
Age: 18.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pain, Pain in extremity, Swelling
Clinical narrative: Erythema at injection site. Pain for a few Days. Resolved then 4 days Later recurrent pain with Erythema or Swelling. ? Temp (T) evening . When she has right upper arm pain right up also achy
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Rash
Clinical narrative: Patient had rash on both thighs
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site mass, Joint swelling, Musculoskeletal pain, Oedema peripheral, Skin warm
Clinical narrative: Patient developed swollen Left arm elbow - Shoulder, red, hot to touch, painful, lump felt on site of injection.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Skin warm, Swelling, Tenderness
Clinical narrative: Rt deltoid became swollen, inflamed, hot to touch, tender to touch. Affected area measures 30mm x 25 mm rt deltoid to intracubital space. Temp 99.
Age: 6.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Erythema, Oedema, Skin warm
Clinical narrative: Right deltoid warm to touch. erythematous and some mild edema
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Rash
Clinical narrative: Injection site with reddened area surrounding injection. Red raised rash
Sex: F
Vaccine: PPV
Symptoms: Lymphadenitis
Clinical narrative: Lymphandenitis - Keflex rt arm 30 hrs after injection.
Age: 1.29
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash papular, Varicella
Clinical narrative: Here 11-5-07 diagnosed chickenpox scattered pink papules with small vesicles some ex conated started on Friday 11-2-07.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Patient had history of fainting with injection received Hep B injection patient nauseated/emisis 1 time faint feeling. Satin chair, v/s assessed cool cloth to face.
Age: 48.0
Sex: F
Vaccine: DTAP
Symptoms: Medication error, Wrong drug administered
Clinical narrative: The patient was to be given a Tetanus booster.  Mistakenly she was given The Infant DTAP. The patient had no problem with the injection. Had no trouble
Age: 18.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site of vaccine became Red and Swollen mildly Painful within 24 hours - Somewhat worsened 48 hours. Patient feels Lightheaded has mild H/A and sore throat.
Age: 18.0
Sex: F
Vaccine: UNK
Symptoms: Pharyngolaryngeal pain
Clinical narrative: Site of vaccine became Red and Swollen mildly Painful within 24 hours - Somewhat worsened 48 hours. Patient feels Lightheaded has mild H/A and sore throat.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Redness, swelling, hot to touch Right upper arm.  4" x 3" Treated with antihistamines.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Blister, Dermatitis contact, Erythema, Impetigo
Clinical narrative: This case was reported by a health professional on 05 September 2007.  An 11-year-old female patient, with a history of ADHD (attention deficit / hyperactivity disorder) and acne, received an intramuscular deltoid injection of Menactra (lot number U2386BA) on 21 August 2007.  Concomitant medications included Adderall XR and Duac Gel.  On 31 August 2007, ten days post-vaccination, the patient experienced "open sores in several areas".  She was seen by her physician on 04 September 2007, at which time the rash was noted to be on the stomach and legs.  Herpes C/S was negative, and the patient was referred to a dermatologist for follow-up.  At the time of the report, the event was resolving.  Follow-up information received from a health care provider on 23 October 2007.  On 20 July 2007, the patient received deltoid injection of Boostrix, lot number AC52B018AB, manufactured by GSK.  It was determined by the dermatologist that the open sores and rash experienced by the patient were not adverse reactions to Menactra.  The patient was evaluated by her physician on 31 August 2007.  Physical examination revealed open sores in several areas.  They were nickel sized areas of redness with vesiculation and some clear fluid in it with no induration.  The patient also complained of left knee pain when she twitched it medially.  Ceftin 250 was prescribed and the open sores cultured.  The patient returned to see the physician on 04 September 2007.  Physical examination determined that the open sores did get better over the weekend but not a whole lot better.  The patient had five to six open sores remaining, scattered around.  She also had a little maculopapular mildly vesicular rash on the side of her abdomen and the inside of her legs.  The physician noted the dermatitis was puzzling.  Impression: believed it may be an Ecthyma kind of illness but it had gotten a lot better on the Ceftin.  The patient was referred to a dermatologist for follow-up.  The patient was evaluated by the dermatologist on 10 September 2007, Lidex had been prescribed for contact dermatitis secondary to impetigo.  Office visit notes dated 20 September 2007 indicated, "Previous treatment: BX - Bite reaction, Lidex; improved.  The patient was reported as recovered from the event and no further information was provided.  Documents held by sender: Doctors notes.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Rash, Rash maculo-papular, Skin lesion, Virus culture negative
Clinical narrative: This case was reported by a health professional on 05 September 2007.  An 11-year-old female patient, with a history of ADHD (attention deficit / hyperactivity disorder) and acne, received an intramuscular deltoid injection of Menactra (lot number U2386BA) on 21 August 2007.  Concomitant medications included Adderall XR and Duac Gel.  On 31 August 2007, ten days post-vaccination, the patient experienced "open sores in several areas".  She was seen by her physician on 04 September 2007, at which time the rash was noted to be on the stomach and legs.  Herpes C/S was negative, and the patient was referred to a dermatologist for follow-up.  At the time of the report, the event was resolving.  Follow-up information received from a health care provider on 23 October 2007.  On 20 July 2007, the patient received deltoid injection of Boostrix, lot number AC52B018AB, manufactured by GSK.  It was determined by the dermatologist that the open sores and rash experienced by the patient were not adverse reactions to Menactra.  The patient was evaluated by her physician on 31 August 2007.  Physical examination revealed open sores in several areas.  They were nickel sized areas of redness with vesiculation and some clear fluid in it with no induration.  The patient also complained of left knee pain when she twitched it medially.  Ceftin 250 was prescribed and the open sores cultured.  The patient returned to see the physician on 04 September 2007.  Physical examination determined that the open sores did get better over the weekend but not a whole lot better.  The patient had five to six open sores remaining, scattered around.  She also had a little maculopapular mildly vesicular rash on the side of her abdomen and the inside of her legs.  The physician noted the dermatitis was puzzling.  Impression: believed it may be an Ecthyma kind of illness but it had gotten a lot better on the Ceftin.  The patient was referred to a dermatologist for follow-up.  The patient was evaluated by the dermatologist on 10 September 2007, Lidex had been prescribed for contact dermatitis secondary to impetigo.  Office visit notes dated 20 September 2007 indicated, "Previous treatment: BX - Bite reaction, Lidex; improved.  The patient was reported as recovered from the event and no further information was provided.  Documents held by sender: Doctors notes.
Age: 63.0
Sex: F
Vaccine: MNQ
Symptoms: Abdominal tenderness, Dizziness, Headache, Inappropriate schedule of drug administration, Myalgia
Clinical narrative: Initial report received on 02 October 2007 from a consumers husband.  A 64 year-old female patient with no concurrent illnesses, and a medical history of allergy to "Levoquin", Flagyl, and "doxicycline", and who was currently taking Cymbalta, Estrace and Xanax, had received a dose of Menactra (lot number, route and site not reported) on 26 September 2007.  Five days post-immunization, the patient experienced nausea, vomiting, abdominal tenderness, muscle aches, headache, and dizziness.  Reportedly, the patient had not experienced any fever.  No relevant diagnostic testing was performed.  Treatment received was not provided.  Seriousness criteria was ticked "none" on the submitted VAERS form.  At the time of this report, the patient had not recovered.
Age: 63.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea, Vomiting
Clinical narrative: Initial report received on 02 October 2007 from a consumers husband.  A 64 year-old female patient with no concurrent illnesses, and a medical history of allergy to "Levoquin", Flagyl, and "doxicycline", and who was currently taking Cymbalta, Estrace and Xanax, had received a dose of Menactra (lot number, route and site not reported) on 26 September 2007.  Five days post-immunization, the patient experienced nausea, vomiting, abdominal tenderness, muscle aches, headache, and dizziness.  Reportedly, the patient had not experienced any fever.  No relevant diagnostic testing was performed.  Treatment received was not provided.  Seriousness criteria was ticked "none" on the submitted VAERS form.  At the time of this report, the patient had not recovered.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning an approximately 5 month old male (also reported a "4 months old") who on 17-JUL-2007 was vaccinated with his first dose of Rotateq (656390/0236U) and on 12-SEP-2007 with his second dose of Rotateq (657513/1052U). There were no concomitant medications. The physician reported that the patient was hospitalized for intussusception on 20-OCT-2007 (onset date also reported as 21-OCT-2007. Surgical repair was done on 20-OCT-2007. The patient was discharged on approximately the 23rd of October. The physician reported that the patient was currently "doing much better" (also reported as recovered). It was reported that the "patient did not have the same adverse experience after the 3rd dose". There was no product quality complaint. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Information has been received from a physician concerning an approximately 5 month old male (also reported a "4 months old") who on 17-JUL-2007 was vaccinated with his first dose of Rotateq (656390/0236U) and on 12-SEP-2007 with his second dose of Rotateq (657513/1052U). There were no concomitant medications. The physician reported that the patient was hospitalized for intussusception on 20-OCT-2007 (onset date also reported as 21-OCT-2007. Surgical repair was done on 20-OCT-2007. The patient was discharged on approximately the 23rd of October. The physician reported that the patient was currently "doing much better" (also reported as recovered). It was reported that the "patient did not have the same adverse experience after the 3rd dose". There was no product quality complaint. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLU3, FLUX, FLU3
Symptoms: Asthenia, Cellulitis, Intensive care, Mechanical ventilation
Clinical narrative: We received from a health care professional via the medical agencies following information on 29 OCT 2007: A 59-year-old woman, born on 01 AUG 1948, was vaccinated with Fluvirin, batch-no. 78994, i.m. on 16 OCT 2007 (18 OCT 2007) was also reported). A sore arm was reported on 18 OCT 2007. She was admitted into the hospital on 19 OCT 2007 with cellulitis of the left arm. Patient was currently in ICU on a ventilator at time of report (29 OCT 2007). Company assessment: Seriousness criterion: hospitalisation. Causality: insufficient data. Expectedness assessment according to manufacturer label: The reported symptoms, except for sore arm, are not expected after Fluvirin. On a case level, the case is considered unexpected. No change in benefit-risk-ratio. No measures necessary. NA07-005653
Age: 59.0
Sex: F
Vaccine: FLU3, FLUX, FLU3
Symptoms: Cellulitis, Influenza like illness, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: We received from a health care professional via the medical agencies following information on 29 OCT 2007: A 59-year-old woman, born on 01 AUG 1948, was vaccinated with Fluvirin, batch-no. 78994, i.m. on 16 OCT 2007 (18 OCT 2007) was also reported). A sore arm was reported on 18 OCT 2007. She was admitted into the hospital on 19 OCT 2007 with cellulitis of the left arm. Patient was currently in ICU on a ventilator at time of report (29 OCT 2007). Company assessment: Seriousness criterion: hospitalisation. Causality: insufficient data. Expectedness assessment according to manufacturer label: The reported symptoms, except for sore arm, are not expected after Fluvirin. On a case level, the case is considered unexpected. No change in benefit-risk-ratio. No measures necessary. NA07-005653
Age: 59.0
Sex: F
Vaccine: FLU3, FLUX, FLU3
Symptoms: Injection site warmth, Multi-organ failure, Surgery
Clinical narrative: We received from a health care professional via the medical agencies following information on 29 OCT 2007: A 59-year-old woman, born on 01 AUG 1948, was vaccinated with Fluvirin, batch-no. 78994, i.m. on 16 OCT 2007 (18 OCT 2007) was also reported). A sore arm was reported on 18 OCT 2007. She was admitted into the hospital on 19 OCT 2007 with cellulitis of the left arm. Patient was currently in ICU on a ventilator at time of report (29 OCT 2007). Company assessment: Seriousness criterion: hospitalisation. Causality: insufficient data. Expectedness assessment according to manufacturer label: The reported symptoms, except for sore arm, are not expected after Fluvirin. On a case level, the case is considered unexpected. No change in benefit-risk-ratio. No measures necessary. NA07-005653
Age: 59.0
Sex: F
Vaccine: FLU3, FLUX, FLU3
Symptoms: Cellulitis, Intensive care, Mechanical ventilation, Pain in extremity
Clinical narrative: We received from a health care professional via the medical agencies following information on 29 OCT 2007: A 59-year-old woman, born on 01 AUG 1948, was vaccinated with Fluvirin, batch-no. 78994, i.m. on 16 OCT 2007 (18 OCT 2007) was also reported). A sore arm was reported on 18 OCT 2007. She was admitted into the hospital on 19 OCT 2007 with cellulitis of the left arm. Patient was currently in ICU on a ventilator at time of report (29 OCT 2007). Company assessment: Seriousness criterion: hospitalisation. Causality: insufficient data. Expectedness assessment according to manufacturer label: The reported symptoms, except for sore arm, are not expected after Fluvirin. On a case level, the case is considered unexpected. No change in benefit-risk-ratio. No measures necessary. NA07-005653
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Balance disorder, Chills, Cough, Dyspnoea, Fatigue
Clinical narrative: tingling arms and legs, muscle weakness, headache, muscle pain, chills, numbness, shortness of breath, dry cough, rapid heart beat, fatigue, loss of balance
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Heart rate increased, Hypoaesthesia, Muscular weakness, Myalgia
Clinical narrative: tingling arms and legs, muscle weakness, headache, muscle pain, chills, numbness, shortness of breath, dry cough, rapid heart beat, fatigue, loss of balance
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Paraesthesia
Clinical narrative: tingling arms and legs, muscle weakness, headache, muscle pain, chills, numbness, shortness of breath, dry cough, rapid heart beat, fatigue, loss of balance
Age: 81.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a certified medical assistant concerning an 81 year old female who on 29-OCT-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (lot# 657767/0740U) in the right deltoid. Concomitant vaccination administered on that day included a dose of Pneumovax 23 (MSD) in the left arm. Other concomitant drug therapy included alendronate sodium (MSD), valsartan (DIOVAN), warfarin sodium (COUMADIN), enalapril maleate (VASOTEC) and atorvastatin calcium (LIPITOR). On that same day, the patient experienced pain, redness and swelling in her right arm. The patient was seen by the physician. The patient was noted to be recovering. There was no product quality complaint. Pain, redness and swelling were considered to be disabling by the reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blindness
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female patient, who on 02-NOV-2007 was vaccinated with the first dose of Gardasil (lot # not provided). On 02-NOV-2007, following the vaccination and while the patient was cheerleading, she developed blindness and was unable to see anything." She was taken to the hospital via ambulance, but it was unknown if she was admitted. At the time of this report, the outcome of the event was unknown. The nurse considered developed blindness to be disabling/incapacitating. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain
Clinical narrative: Information has been received from a physician concerning a 20 year old female with diabetes (unspecified) who on an unspecified date was vaccinated with her second dosage of Gardasil. Since July 2007 the patient has had abdominal and periumbilical pain, possible gastroenteritis since she was given her second dosage of Gardasil. It was reported that the patient sought medical attention and was hospitalized (duration not reported). As of 01-NOV-2007, the patient had not recovered from the events. The patient's abdominal pain and periumbilical pain were considered to be disabling by the reporting physician. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea, Paraesthesia, Vomiting
Clinical narrative: Information has been received from a physician's assistant concerning a 15 year old female who on approximately 17-OCT-2007 was vaccinated with a 0.5 ml dose of Gardasil. On approximately 17-OCT-2007 the patient experienced headache, extreme nausea, vomiting and tingling in fingers and toes. It was reported that the patient missed 2 days of school. At the time of the report, the patient was recovering. The reporting physician's assistant considered headache, extreme nausea, vomiting and tingling in fingers and toes to be disabling. Additional information has been requested.  11/27/07 Received vax record from pcp.  2/8/08 Reviewed pcp medical records which reveal patient experienced URI s/s, cough, sore throat, bronchitis, otitis media & otitis externa approx 2 wks prior to vax & was on antibiotics.  Seen in office 10/16 c/o HA & nausea beginning 48 hr s/p vax.  Improved when seen next on 10/23 but bilat otitis externa had recurred.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Disturbance in attention, Dizziness, Lethargy
Clinical narrative: This case was reported by a consumer and described the occurrence of lethargy in a 61-year-old male subject who was vaccinated with (Flulaval, GlaxoSmithKline) for prophylaxis. The reporter is the subject. A physician or other health care professional has not verified this report. The subject's medical history included deafness in one ear, heart attack and high blood pressure. The subject reported that 10 years ago he had a flu shot and had a cold all that winter. Since then, the subject has had a flu shot yearly and has not had any problems. Concurrent medications included Omeprazole (Prilosec), Aspirin (Baby ASA), Atorvastatin calcium (Lipitor) and Clopidogrel bisulphate (Plavix). On 18 October 2007 at 5:00 p.m. the subject received unspecified dose of Flulaval (.5 ml, unknown). A few hours later, on 18 October 2007, less than one day after vaccination with Flulaval, the subject experienced lethargy, tightness in his throat and a dry cough. At 3:30 a.m. on 19 October 2007, the subject experienced night sweats and chills. On 04 November 2007 the subject experienced dizziness and noise in his ears. On an unspecified date, less than one month after receipt of Flulaval, the subject experienced difficulty with mental focusing. The subject was seen at a physician's office. The subject considered the events to be disabling. At the time of reporting the outcome of the events were was unspecified.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Mental impairment, Night sweats, Throat tightness, Tinnitus
Clinical narrative: This case was reported by a consumer and described the occurrence of lethargy in a 61-year-old male subject who was vaccinated with (Flulaval, GlaxoSmithKline) for prophylaxis. The reporter is the subject. A physician or other health care professional has not verified this report. The subject's medical history included deafness in one ear, heart attack and high blood pressure. The subject reported that 10 years ago he had a flu shot and had a cold all that winter. Since then, the subject has had a flu shot yearly and has not had any problems. Concurrent medications included Omeprazole (Prilosec), Aspirin (Baby ASA), Atorvastatin calcium (Lipitor) and Clopidogrel bisulphate (Plavix). On 18 October 2007 at 5:00 p.m. the subject received unspecified dose of Flulaval (.5 ml, unknown). A few hours later, on 18 October 2007, less than one day after vaccination with Flulaval, the subject experienced lethargy, tightness in his throat and a dry cough. At 3:30 a.m. on 19 October 2007, the subject experienced night sweats and chills. On 04 November 2007 the subject experienced dizziness and noise in his ears. On an unspecified date, less than one month after receipt of Flulaval, the subject experienced difficulty with mental focusing. The subject was seen at a physician's office. The subject considered the events to be disabling. At the time of reporting the outcome of the events were was unspecified.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchospasm, Hypoaesthesia oral, Injection site pain, Pain, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site soreness in a female subject of unspecified age who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis. On 5 October 2007 the subject received unspecified dose of Flulaval (.5 ml, unknown, unknown arm). On 5 October 2007, less than one day after vaccination with Flulaval, the subject experienced injection site soreness that was considered to be extreme. The reporter also noted that the arms continued to be tender. Pharmaceutical product complaint was also identified. It was not reported of the subject had previously received any influenza injections. Also any previous reactions following vaccinations was also not reported. At the time of reporting the events were improved. The healthcare professional considered the events were probably related to vaccination with Flulaval. Follow-up was received by the healthcare professional on 07 November 2007. At the time of the events, the subject was 54 years of age. Medical history included tobacco use of one-half pack daily and alcohol use reported as "few weekends." On 5 October 2007, the subject received an injection of Flulaval in the left arm. On 5 October 2007, less than one day after vaccination with Flulaval, the subject experienced tingling and numbness of the lips and tongue, body aches, bronchospasm, injection site soreness, arm tenderness and product complaint. Review of a hospital bill indicated that the subject was transported via ambulance to an emergency room on 5 October 2007 and hospitalized. The hospital bill indicated that the subject received Ketoralac tremetamol, Betamethasone acetate + betamethasone sodium phosphate, Ipratropium bromide + salbutamol sulphate and respiratory therapy. The events resolved with sequelae on 11 October 2007. The healthcare professional considered the events were probably related to vaccination with Flulaval.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia oral, Pharmaceutical product complaint, Tenderness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site soreness in a female subject of unspecified age who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis. On 5 October 2007 the subject received unspecified dose of Flulaval (.5 ml, unknown, unknown arm). On 5 October 2007, less than one day after vaccination with Flulaval, the subject experienced injection site soreness that was considered to be extreme. The reporter also noted that the arms continued to be tender. Pharmaceutical product complaint was also identified. It was not reported of the subject had previously received any influenza injections. Also any previous reactions following vaccinations was also not reported. At the time of reporting the events were improved. The healthcare professional considered the events were probably related to vaccination with Flulaval. Follow-up was received by the healthcare professional on 07 November 2007. At the time of the events, the subject was 54 years of age. Medical history included tobacco use of one-half pack daily and alcohol use reported as "few weekends." On 5 October 2007, the subject received an injection of Flulaval in the left arm. On 5 October 2007, less than one day after vaccination with Flulaval, the subject experienced tingling and numbness of the lips and tongue, body aches, bronchospasm, injection site soreness, arm tenderness and product complaint. Review of a hospital bill indicated that the subject was transported via ambulance to an emergency room on 5 October 2007 and hospitalized. The hospital bill indicated that the subject received Ketoralac tremetamol, Betamethasone acetate + betamethasone sodium phosphate, Ipratropium bromide + salbutamol sulphate and respiratory therapy. The events resolved with sequelae on 11 October 2007. The healthcare professional considered the events were probably related to vaccination with Flulaval.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Autoimmune disorder, Blood test normal, Erythema, Lumbar puncture, Nuclear magnetic resonance imaging normal
Clinical narrative: Initial report received from a health care professional on 30 October 2007. An 18-year-old male with no known allergies received a first, right deltoid, Intramuscular injection of Adacel (lot number C2759AA) on 14 August 2007 and two weeks later (approximate date 30 August 2007), he developed a generalized rash with red pustules. During approximately the third week in September, the patient complained of problems with cloudiness in his central vision area. No problems were reported with his peripheral vision. The patient was hospitalized for three days and received treatment with steroids. Results of MRI, blood tests and spinal tap were reported to be negative. The patient was diagnosed with having an autoimmune response affecting the optic nerve secondary to vaccine. At the time of the report, the condition continued to persist without improvement. The patient felt it necessary to withdraw from school. No additional information was provided at the time of this report.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Optic nerve disorder, Rash generalised, Rash pustular, Vision blurred
Clinical narrative: Initial report received from a health care professional on 30 October 2007. An 18-year-old male with no known allergies received a first, right deltoid, Intramuscular injection of Adacel (lot number C2759AA) on 14 August 2007 and two weeks later (approximate date 30 August 2007), he developed a generalized rash with red pustules. During approximately the third week in September, the patient complained of problems with cloudiness in his central vision area. No problems were reported with his peripheral vision. The patient was hospitalized for three days and received treatment with steroids. Results of MRI, blood tests and spinal tap were reported to be negative. The patient was diagnosed with having an autoimmune response affecting the optic nerve secondary to vaccine. At the time of the report, the condition continued to persist without improvement. The patient felt it necessary to withdraw from school. No additional information was provided at the time of this report.
Age: 89.0
Sex: M
Vaccine: FLU3
Symptoms: Death
Clinical narrative: We received from a health care professional via the agency following information on 29 OCT 2007: A 89-year-old man, born on 15 JUL 1918, was vaccinated with Fluvirin, batch-no. 78428, i.m. on 23 OCT 2007. The patient died shortly after the vaccination after he left the facility and walked down the hall. Caller felt that individual was properly screened, reported no allergies to any component, and filled out the waiver for the vaccine prior to administration, and had prior flu vaccinations. The reporter felt the death was coincidental based on the age and history of the patient. Company assessment: Seriousness criterion: death. Causality: insufficient data. Expectedness assessment according to manufacturer label: Death after Fluvirin is not expected. No change in benefit-risk-ratio. No measure necessary. Addendum We received from a health care professional via the medical agencies additional information on 29 OCT 2007: The batch-no. was 78478 (and not 78428 as previously reported). No change in assessment. NA07-005622
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Bacteria urine, Cellulitis, Full blood count, Haematocrit decreased, Haematuria
Clinical narrative: (1) Cellulitis Rt arm (2) Local Reaction Lt arm 11/13/07-records received for DOS 10/11/07-DX: Acute allergic reaction and cellulitis of right upper limb. Slight reaction to flu vaccine, more reaction to pneumonia vaccine. Gastric bezoar, having problems with eating. Developed swelling and tenderness and pain with painful movement of right shoulder. Swelling and pain right upper arm around injection site and extending to right axilla.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Haemoglobin decreased, Local reaction, Mean cell haemoglobin normal, Metabolic function test normal, Proteinuria
Clinical narrative: (1) Cellulitis Rt arm (2) Local Reaction Lt arm 11/13/07-records received for DOS 10/11/07-DX: Acute allergic reaction and cellulitis of right upper limb. Slight reaction to flu vaccine, more reaction to pneumonia vaccine. Gastric bezoar, having problems with eating. Developed swelling and tenderness and pain with painful movement of right shoulder. Swelling and pain right upper arm around injection site and extending to right axilla.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Red blood cell count decreased, Urine analysis abnormal, White blood cell count normal
Clinical narrative: (1) Cellulitis Rt arm (2) Local Reaction Lt arm 11/13/07-records received for DOS 10/11/07-DX: Acute allergic reaction and cellulitis of right upper limb. Slight reaction to flu vaccine, more reaction to pneumonia vaccine. Gastric bezoar, having problems with eating. Developed swelling and tenderness and pain with painful movement of right shoulder. Swelling and pain right upper arm around injection site and extending to right axilla.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Clinical narrative: death.  12/17/07 Reviewed autopsy report which states COD as SIDS.  Patient found in crib lying on back & unresponsive. 12/17/07 Received vax record & medical records which confirm vax dose & lot #s as reported.  Patient had thrush & was constipated during office visit 10/29/07, otherwise, healthy.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: Had Flu vaccine 10-18-07, Fluarix A310AA lot #. On 10-22-07 developed rash over sternum to (R) rib cage area, that is clearly shingles with vesicular lesions. No prior case of shingles. Hx chickenpox in past. 11/14/07-patient not hospitalized, recovering from shinges.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Radiculitis brachial
Clinical narrative: Symptoms of brachial neuritis on side of injection. 11/13/07-office notes for DOS 10/25/06-received-DX: allergic rhinitis.  11/14/07-records received for DOS 10/26-11/1/07-office notes-presented on 10/26/07 with pain left arm, shooting pain shoulder to elbow, elbow to 5th finger. Dull pain. No swelling, warm, or tenderness. No weakness. DX: brachial neuritis secondary to vaccination. 11/1/07-brachial neuritis resolved.
Age: 1.1
Sex: M
Vaccine: FLU3, HEPA, HIBV, PNC
Symptoms: Body temperature increased, Full blood count normal, Influenza serology negative
Clinical narrative: temperature of 104.2 after immunizations
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site haemorrhage, Injection site swelling, Pain in extremity
Clinical narrative: after shot given arm (at injection site) swelled to size of golf ball and began bleeding. Swelling decreased after several hours - forearm and wrist have pain difficulty rotating wrist very painful - pain continues after 2 weeks.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain, Dizziness, Headache, Nausea
Clinical narrative: 1-2 Hours after vaccine given went Home with Nausea/dizziness Unproved next 2 days with Headache and abdominal pain and dizziness.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Staring, Vitreous floaters
Clinical narrative: five minutes after administration child began to stare became dizzy with severe HA and eye felt funny with lights floating. Lights continued to float with severe HA and pallor. Pupils equal and pearla. Stable. Continued to have H/A 30 minutes after.
Age: 14.0
Sex: M
Vaccine: IPV, MMRV, TDAP
Symptoms: Unevaluable event
Clinical narrative: "None stated"