chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: Pt. stated arm was sore and itchy on Sat. Used Benadryl & ice. On Mon., Oct. 6th was seen by Nurse Practitioner at local clinic who measured site where Zostavax administered (Back of arm) 15-17 cm., area was red without blistering. No drainage noted. Keflex 500 mg ordered TID. (Shingles vaccine were public funds, Influenza was private funds)
Age: 18.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Ear discomfort, Musculoskeletal discomfort, Vomiting
Clinical narrative: Vomiting, Dizziness, Neck and Ear discomfort
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Computerised tomogram normal, Hypoaesthesia oral, Nasal congestion, Oxygen saturation decreased
Clinical narrative: Diagnosed 5 years ago with severe allergy to flu vaccine (anyphylaxis & intubated x 4 hours)has avoided since. 11/11/08 22 Co-workers received Fluzone vaccine in small, not well ventillated room, syringes were prepped in another area so minimal aerosolization occured. 20 minutes later she walked into this room and developed top lip numbness and stuffy nose, went for quick walk out of area, returned to same room & developed chest tightness and wheeze.  50mg Benadry po without relief, brought to ED.  Treated with steroids po and IV, Resp. treatments O2 sats 84%.  Improved for a while then decompensated, tach 180's.  Gastric Bypass 2 months ago with PICC line, did Chest CT with contrast to r/o PE, which was negative. Hospitalized x 48 hours, sent home on po steroids, Benadryl, Zyrtec, Albuterol inhaler.  Has epi-pen and has been educated to avoid handling of flu vaccinations, IM and nasal. 12/15/08-records received 11/118/08-presented to ED with indirect exposure to influezna vaccince which caused intense allergic reaction and after steroids became tachycardic and short of breath. Admitted for observation.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Tachycardia, Wheezing
Clinical narrative: Diagnosed 5 years ago with severe allergy to flu vaccine (anyphylaxis & intubated x 4 hours)has avoided since. 11/11/08 22 Co-workers received Fluzone vaccine in small, not well ventillated room, syringes were prepped in another area so minimal aerosolization occured. 20 minutes later she walked into this room and developed top lip numbness and stuffy nose, went for quick walk out of area, returned to same room & developed chest tightness and wheeze.  50mg Benadry po without relief, brought to ED.  Treated with steroids po and IV, Resp. treatments O2 sats 84%.  Improved for a while then decompensated, tach 180's.  Gastric Bypass 2 months ago with PICC line, did Chest CT with contrast to r/o PE, which was negative. Hospitalized x 48 hours, sent home on po steroids, Benadryl, Zyrtec, Albuterol inhaler.  Has epi-pen and has been educated to avoid handling of flu vaccinations, IM and nasal. 12/15/08-records received 11/118/08-presented to ED with indirect exposure to influezna vaccince which caused intense allergic reaction and after steroids became tachycardic and short of breath. Admitted for observation.
Age: 55.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Choking, Cough, Dysphonia, Eczema, Fatigue
Clinical narrative: On November 6, 2008 at approximately 11:40 a.m. nurses gave me a flu shot at my place of work.  In approximately five minutes I felt my throat tightening and I became hoarse.  The nurse then drove me over to facility for treatment.  By the time I go to the facility I was wheezing, coughing and choking.  Initial treatment involved administering epinephrine.  I also used my albuterol inhaler.  After the epinephrine wore off I had another attack of wheezing, coughing and choking.  At that time I was given a shot of benadryl.  A subsequent shot of a steroid was given.  At approximately 6:00 p.m. eastern that evening I had another slight attack that was treated with benadryl and my albuterol inhaler.  At one calendar week later (11/13) I still am hoarse and am taking benadryl orally daily.  Additional symptoms include flu like aches, tiredness and an activation of the eczema in my left ear.
Age: 55.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Hypersensitivity, Influenza like illness, Pain, Throat tightness, Wheezing
Clinical narrative: On November 6, 2008 at approximately 11:40 a.m. nurses gave me a flu shot at my place of work.  In approximately five minutes I felt my throat tightening and I became hoarse.  The nurse then drove me over to facility for treatment.  By the time I go to the facility I was wheezing, coughing and choking.  Initial treatment involved administering epinephrine.  I also used my albuterol inhaler.  After the epinephrine wore off I had another attack of wheezing, coughing and choking.  At that time I was given a shot of benadryl.  A subsequent shot of a steroid was given.  At approximately 6:00 p.m. eastern that evening I had another slight attack that was treated with benadryl and my albuterol inhaler.  At one calendar week later (11/13) I still am hoarse and am taking benadryl orally daily.  Additional symptoms include flu like aches, tiredness and an activation of the eczema in my left ear.
Age: 55.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Condition aggravated, Cough, Dysphagia, Sinus operation, Throat tightness
Clinical narrative: On November 6, 2008 at approximately 11:40 a.m. nurses gave me a flu shot at my place of work.  In approximately five minutes I felt my throat tightening and I became hoarse.  The nurse then drove me over to facility for treatment.  By the time I go to the facility I was wheezing, coughing and choking.  Initial treatment involved administering epinephrine.  I also used my albuterol inhaler.  After the epinephrine wore off I had another attack of wheezing, coughing and choking.  At that time I was given a shot of benadryl.  A subsequent shot of a steroid was given.  At approximately 6:00 p.m. eastern that evening I had another slight attack that was treated with benadryl and my albuterol inhaler.  At one calendar week later (11/13) I still am hoarse and am taking benadryl orally daily.  Additional symptoms include flu like aches, tiredness and an activation of the eczema in my left ear.
Age: 55.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Wheezing
Clinical narrative: On November 6, 2008 at approximately 11:40 a.m. nurses gave me a flu shot at my place of work.  In approximately five minutes I felt my throat tightening and I became hoarse.  The nurse then drove me over to facility for treatment.  By the time I go to the facility I was wheezing, coughing and choking.  Initial treatment involved administering epinephrine.  I also used my albuterol inhaler.  After the epinephrine wore off I had another attack of wheezing, coughing and choking.  At that time I was given a shot of benadryl.  A subsequent shot of a steroid was given.  At approximately 6:00 p.m. eastern that evening I had another slight attack that was treated with benadryl and my albuterol inhaler.  At one calendar week later (11/13) I still am hoarse and am taking benadryl orally daily.  Additional symptoms include flu like aches, tiredness and an activation of the eczema in my left ear.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Musculoskeletal pain, Myalgia, Rash
Clinical narrative: Pt call on the Nov 13 complaining of severe muscle aches in the neck, back and shoulders with a pain of 7 out of 10. His symptoms began 6 days post administration. And 9 days after the shot pt develpoed a rash on the right side of his chest
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Injection site erythema, Injection site swelling, Rash erythematous
Clinical narrative: On 11-13-08 at 1755, I administered Pentacel in the right thigh, and Hep B and PCV into the left thigh.  In about 5 seconds, the patient's thighs became swollen and red.  At 1757 a nurse practitioner was called into the room to evaluate the child because the attending physician was unavailable.  At this time, three red flat splotches were noted on the patient's torso.  At 1805, the physician was brought into the room.  At this time the reddened areas on the thighs were present but had decreased in size.  The patient was monitored until 1830 and no other ASE were seen.
Age: 44.0
Sex: M
Vaccine: FLUN3
Symptoms: Dizziness, Nausea, Vertigo, Vomiting
Clinical narrative: Vaccine administered 10/05/2008. Symptoms started on 10/09/2008 with PERSISTENT NAUSEA, VOMITING AND DIZZINESS. Chlorpheniramine has reduced part of the symptoms, but the vertigo still persists, Diazepam was also prescribed.  NOTE: I am the injured-person's PCP completing this report. Patient is a pharmacist: if you need the lot number, please contact him at his place of work.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Pharyngeal oedema, Swollen tongue
Clinical narrative: Swelling of throut and tongue beginning about 3 hrs after injection, followed by full flu symptoms lasting till early next morning. Linguring effects continuing. No treatment sought, after doctor hours or I would have gone to my doctor.
Age: 10.0
Sex: M
Vaccine: VARCEL
Clinical narrative: None Stated  3/24/09 Received hospital medical records or 11/6-11/9/2008. FINAL DX: cellulitis of left arm s/p immunizations Records reveal patient experienced swelling, redness, vesicles & induration of LUE.  Had been seen in Er on 11/5, dx w/cellulitis & started on oral antibiotics.  Condition worsened & admitted.  Tx w/IV antibiotics w/significant improvement.  D/C to home on continued oral antibiotics.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness and itching around the injection site of right arm same evening she received pneumonia injection.  On 11-11-08 whole arm was swollen from the shoulder down to her hand.  Swelling getting better after Benadryl and Prednisone - Another appointment at this clinic 11-14-08 to re-check arm/site.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dermographism, Erythema, Pruritus, Urticaria
Clinical narrative: New-onset dermatographism- raised red welts on skin with minor scratching, last for 5 to 10 minutes, not pruritic
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3, FLUX
Symptoms: Chest discomfort, Cough, Hyperhidrosis, Nausea, Vision blurred
Clinical narrative: Immunization given 11/13/2008 11:40PM call placed to Take Care 11/13/2008 11:45PM c/o nausea coughing, chest tightness, sweating, blurry vision.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3, FLUX
Symptoms: Blood test, Chest pain, Cough, Dysphonia, Dyspnoea
Clinical narrative: Immunization given 11/13/2008 11:40PM call placed to Take Care 11/13/2008 11:45PM c/o nausea coughing, chest tightness, sweating, blurry vision.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3, FLUX
Symptoms: Eye discharge, Eye swelling, Hypersensitivity, Lethargy, Ocular hyperaemia
Clinical narrative: Immunization given 11/13/2008 11:40PM call placed to Take Care 11/13/2008 11:45PM c/o nausea coughing, chest tightness, sweating, blurry vision.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3, FLUX
Symptoms: Upper respiratory tract congestion, X-ray
Clinical narrative: Immunization given 11/13/2008 11:40PM call placed to Take Care 11/13/2008 11:45PM c/o nausea coughing, chest tightness, sweating, blurry vision.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Dermatitis, Rash generalised, Urticaria
Clinical narrative: Rash all over body. Dermatitis/hives - SP Flu vaccine.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: Pt reports itchy red raised blotchy rash to hand, neck and chest.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypoaesthesia, Oedema peripheral, Pain in extremity, Paraesthesia
Clinical narrative: Pain (8/10) in right upper arm, swelling, numbness & tingling.
Age: 11.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Redness, swelling with warmth and tenderness noted by mom next day after vaccines were given ? time, brought to child on the 11/13/2008. Prescribed Motrin and alternate warm and cold compress every 2 hours.
Age: 13.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Redness and swelling (warm, tenderness) noted by mom 2nd day after vaccines were given. Provider prescribed MOTRIN and alternate warm and cold compress every other hour.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Pain in left arm 2 weeks post FLUVIRIN given 10/27/2008. Pain and difficulty with manage of motion, continues to get worse, Per patient.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: C/O redness, pain, swelling. Seen by Dr received antibiotic and antihistamine
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Erythema, Swelling
Clinical narrative: C/o redness, discomfort, swelling. Seen by Dr received antibiotic et antihistamine
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site cellulitis, Oedema peripheral
Clinical narrative: ER visit for swollen arm 11/1. Diagnosed with Cellulitis (injection site) and given clindamycin.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Rash erythematous, Urticaria
Clinical narrative: 9/6/08 within several hours of receiving IPV + DTP, PT developed confluent rash with raised welts incompletely responsive to Benadryl received Epi & ORAPRED lasted 6-7 days + buttock rash.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Warm erythematous indurated area 5cmX5cm -treatment - warm soaks
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site pain, No reaction on previous exposure to drug
Clinical narrative: This case was received from a health professional on 25 September 2007, and is one in a cluster of three patients. The reporter is also the patient's father. A four-year-old female patient received an intramuscular deltoid injection of FLUZONE (lot number U2449AA) on 20 September 2007. Within 24 hours of vaccination, the patient developed an area of redness and soreness at the injection site, approximately two inches in diameter. The reporter diagnosed the event as cellulitis. The area was treated with antibiotic ointment, and the event resolved in "two to three days". Follow-up information received on 23-October 2007. Information concerning the patient's birth weight and number of siblings was reported. In response to a query asking if the patient had received a previous dose of FLUZONE and if there had been any reactions, it was reported that the patient had received five previous doses of FLUZONE. It was not reported whether or not the patient had any reactions to previous FLUZONE vaccinations. Date of FLUZONE vaccination, previously reported as 20 June 2007 in the structured field, has been corrected to 20 September 2007. The correct vaccination date was previously reported in the narrative field. A corrective version of the case was created using the previous receipt date for the sole purpose of correcting the FLUZONE lot number in the product screen.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a health professional in on 29 September 2007, and represents one out of three cases reported as a cluster. The reporter is also the patient's father. A nine-year-old male patient received an intramuscular deltoid injection of FLUZONE (lot number 02449AA) on 20 September. Within 24 hours of vaccination, the patient experienced redness and swelling at the injection site. The area was approximately two inches in diameter, and was diagnosed by the reporter as cellulitis. The event was treated with antibiotic ointment, and resolved within "two to three days". This reporter also noted similar events in his daughter (2007-03238) and wife (2007-03240).
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a health professional on 25 September 2007, and represents one of three cases reported as a cluster. The reporter is also the patient's husband. A 40-year-old female patient received an intramuscular deltoid injection of FLUZONE (lot number U2449AA) on 20 September 2007. Within 24 hours of vaccination, the patient experienced redness and swelling at the injection site. The area was approximately two inches in diameter, and was diagnosed by the reporter as cellulitis. The event was treated with antibiotic ointment, an resolved within "two to three days". A corrective version was created on 08 October 2007 in order to note in the narrative that the case was reported on 24 September 2007, not 25 September 2007 as previously entered. No new information was provided. The reported also noted similar events in his daughter (2007-03238) and son (2007-03239).
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Blood glucose normal, Cold sweat, Dizziness, Electrocardiogram normal
Clinical narrative: Initial report received from a health care provider on 28 September 2007. A 50-year-old male patient, who is a physician, had received an intramuscular left deltoid injection of FLUZONE, lot number U2441AA on 26 September 2007 and 24 hours later, experienced dizziness, lightheadedness, pallor and felt clammy. Blood pressure - pulse readings: lying - 110/70, 56, sitting - 118/70, 60 and standing - 130-90, 72. He was unable to continue seeing patients and was driven home. Five hours after the onset of symptoms, the patient stated they felt 80 percent better. The patient was reported to have received their flu vaccinations annually and had no prior events with prior flu vaccinations received. The patient had not been ill at the time of vaccination and had no pre-existing medical conditions. The patient had recovered from the event on 28 September 2007. No further information was provided.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Full blood count normal, No reaction on previous exposure to drug, Pallor
Clinical narrative: Initial report received from a health care provider on 28 September 2007. A 50-year-old male patient, who is a physician, had received an intramuscular left deltoid injection of FLUZONE, lot number U2441AA on 26 September 2007 and 24 hours later, experienced dizziness, lightheadedness, pallor and felt clammy. Blood pressure - pulse readings: lying - 110/70, 56, sitting - 118/70, 60 and standing - 130-90, 72. He was unable to continue seeing patients and was driven home. Five hours after the onset of symptoms, the patient stated they felt 80 percent better. The patient was reported to have received their flu vaccinations annually and had no prior events with prior flu vaccinations received. The patient had not been ill at the time of vaccination and had no pre-existing medical conditions. The patient had recovered from the event on 28 September 2007. No further information was provided.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Headache, Palpitations, Tremor
Clinical narrative: Initial report received from a health care professional on 03 October 2007. A 64-year-old female patient with a medical history of a doxycycline allergy complained of dizziness, vertigo, headache, hives, heart palpitations, shakiness and weakness two to three days after she had received an intramuscular left deltoid injection of FLUZONE, lot number U2454AA. The reporter stated that the patient was "feeling a little sick" at the time of vaccination. It was unknown if the patient had received any vaccinations during the four weeks prior to vaccination or if the patient had been taking any concomitant medications. The patient was not evalutated by their physician and corrective treatments had not been reported. The patient had not experienced any adverse events following receipt of prior doses of FLUZONE. The patient's recovery status was listed as not recovered at the time of the report. Follow-up informatio was received from a health care professional on 07 January 2008. According to the reporter, they reviewed the case and had no additional information to provide at this time. The patient's recovery status remained as not recovered fromthe event. The reporting facility in this case is the same as in case 2007-03356.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria, Vertigo
Clinical narrative: Initial report received from a health care professional on 03 October 2007. A 64-year-old female patient with a medical history of a doxycycline allergy complained of dizziness, vertigo, headache, hives, heart palpitations, shakiness and weakness two to three days after she had received an intramuscular left deltoid injection of FLUZONE, lot number U2454AA. The reporter stated that the patient was "feeling a little sick" at the time of vaccination. It was unknown if the patient had received any vaccinations during the four weeks prior to vaccination or if the patient had been taking any concomitant medications. The patient was not evalutated by their physician and corrective treatments had not been reported. The patient had not experienced any adverse events following receipt of prior doses of FLUZONE. The patient's recovery status was listed as not recovered at the time of the report. Follow-up informatio was received from a health care professional on 07 January 2008. According to the reporter, they reviewed the case and had no additional information to provide at this time. The patient's recovery status remained as not recovered fromthe event. The reporting facility in this case is the same as in case 2007-03356.
Sex: U
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chills, Pyrexia
Clinical narrative: A cluster of three adult patients, with no illness at the time of vaccination, had received intramuscular injections of FLUZONE SV 2007-2008, lot number U2438AA, on 18 October 2007. In the evening of the same day, the patients experienced fevers of 102 degrees Farenheit, stomach pain, and chills. Treatment included ibuprofen and liquid diet. At the time of this report, the event was still resolving, and the patient had not recovered. A corrective version was created with the same latest received date as the previous version (19 October 2007) for the sole purpose of adding to the narrative and the main screen (linked cases structure field) that the reporter for this case is the same as for cases 2007-03588, 2007-03589, and 2007-03590. No other relevant medically significant information was added to this case.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chest pain, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: Initial report received from a health care providers on 22 October 2007. A female patient with no pre-existing medical conditions, had received an intramuscular left deltoid injection of FLUZONE, lot number US444AA on 18 October 2007 and within 24 hours, she experienced chest pain which radiated to her back. The patient had no difficulty breathing. The patient was evaluated by her physician and diagnostic testing was performed. "Echo and EKG - WNL"; dates of testing were not provided. The reporter stated the patient had recovered from the evnet and no further information was provided at the time of the report. Follow-up information received on 26 November 2007 from a health care provider. There was no illness at the time of vaccination although other medications included ibuprofen. The date of the echocardiogram and electrocardiogram was 19 October 2007. The patient had a history of congenital absent pericardium of the left side of the heart and cardiomegaly secondary to absent pericardium (previously reported as no past medical history). The reporting facility in this case is the same as in case 2007-03559.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain
Clinical narrative: Initial report received from a health care provider on 22 October 2007. An adult female patient with no pre-existing medical conditions, had received an intramuscular left deltoid injection of FLUZONE, lot number U2444AA on 18 October 2007 and within 24 hours, she experienced chest pain. The event resolved and no medical attention was required. Concomitant medicatons and illness at the time of vaccination were not reported. The reporter stated the patient had recovered from the event. No further information was provided. Follow-up information received on 28 November 2007 from a health care provider. Other medications included birth control pills. No diagnostic testing was performed. The patient had no illness at the time of vaccination. Additional medically relevant information was not provided. The reporting facility in this case is the same as in case 2007-03558.
Sex: M
Vaccine: FLU3
Symptoms: Back pain
Clinical narrative: Initial report received on 18 October 2007 from a health care professional in the United States. A male patient (demographics unknown), with unknown medical history, had received a right deltoid dose of FLUZONE SV 2007-2008 (lot number U2439AA) ON 16 October 2007. Two hours post-vaccination, the patient developed severe back pain. At the time of this report, the patient's pain was persisting and he was to be evaluated by a physician on 18 October 2007. Treatments received and diagnostic testing performed were not provided. At the time of this report, it was unknown it the patient had recovered.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Muscle twitching
Clinical narrative: Initial report received on 31 October 2007 from a health care professional. A 57-year-old- female patient , with no illness at the time of vaccination, had received a left deltoid injection of FLUZONE SV 2007-2008, lot number U2464AA, on 19 October 2007. Needle used was a 27 gauge with a 1.5 inch length. The following day, the patient developed soreness at the injection site and intermittent twitching of the left arm. The event did not required medical examination. At the time of this report, the patient had recovered. The reporter in this case is the same as in case 2007-03693.
Sex: F
Vaccine: FLU3
Symptoms: Muscle twitching
Clinical narrative: A female patient of reported unknown age had received a left deltoid, intramuscular injection of FLUZONE SV 2007-2008, lot number U2464AA, on 29 October 2007. Needle used was a 27 gauge with a 1.5 inch length. On the same day, the patient developed spontaneous, intermittent twitching of the left arm. There was no pain or soreness. The event did not require medical examination. At the time of this report, the patient had not recovered. The reporter in this case is the same as in case 2007-03692.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Tongue discolouration
Clinical narrative: A 21 year old, female patient (with no medical history) experienced her tongue turn brown, a dark brown, approximately 2 hours after she received FLUZONE (lot number U2529AA) intramuscularly in the left deltoid on 10 November 2007. There was no swelling and no other symptoms were reported. Benadryl was given. She did not have any illness at the time of vaccination and was not on any medications. At the time of the report, the patient's recovery status was unknown.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a consumer on 15 November 2007. A 47 year-old female patient with a history of a penicillin allergy, had received an intramuscular left deltoid injection of FLUZONE (lot number not reported) on 13 November 2007 and the evening of vaccination developed warmth, redness, itching and swelling at the injection site; reported to be the size of a softball. The patient had not received any vaccines during the four weeks prior to receipt of FLUZONE. The patient reportedly experienced this same type of event in the past after receipt of Lovenox and heparin. The patient had not been evaluated by a physician and had not received any doses of FLUZONE in the past. At the time of the report, the patient had not recovered from the event. Follow-up information received on 11 January 2008 from a physician. The patient was taking "Lovaxil" at the time of the vaccination on 13 November 2007. The FLUZONE was reported as U2531AA and the vial had an expiration date of 30 June 2008. The adverse events that was previously reported started at 1:30 p.m., one hour post-vaccination with FLUZONE vaccine on 13 November 2007. At the time of this report, the patient had recovered. No further information is expected.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Stomatitis
Clinical narrative: A 56-year-old with a history of recent stem cell transplant one month prior, had received a left deltoid injection of FLUZONE SV 2007-2008, lot number U2493AA, on 08 November 2007. Two days later, the patient developed mouth sores. Other medications included Ambien, Crestor, Diovan, metolazone, and Lasix. The event did not required examination by a physician. Recovery status was unknown.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure decreased, Dizziness, Hyperhidrosis, Immediate post-injection reaction, Tinnitus
Clinical narrative: A 30-year-old male patient, with no illness at the time of vaccination, had received a left arm, intramuscular injection of FLUZONE SV 2007-2008, lot number U2526AA, on 15 November 2007. Two minutes post-vaccination, the patient stood up, began walking, and felt lightheaded and dizzy. He also experienced sweating and ringing in his ears. The patient's blood pressure was checked and found to be 90/72, sitting. He was provided to glasses of water to drink after which his symptoms began to subside. Subsequent blood pressure readings were 102/78, 100/78 and 110/89. After 30 minutes, the patient completely recovered. Follow-up information received on 20 November 2007 from a health care professional. The reporter confirmed that the patient had not died and that the death date was filled out in error on the VAERS form.
Age: 34.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Initial report received on 21 November 2007 from a health care professional. A 34-year-old female patient had received a left deltoid injection of FLUZONE, lot number U2486AA, and a right deltoid injection of PNEUMOVAX, manufacturer Merck, lot number 1417U; on 20 November 2007. Later that evening, the patient experienced left arm pain extending into the left axilla and left neck and a fever of 101.0 degrees Fahrenheit. At the time of this report, the patient had not recovered.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Initial information was received from a health care professional on 19 December 2007. Follow up information was received from a health care professional in the on 20 June 2008. Based upon this new information a narrative has been created for this case. A two year old-male patient with no past medical history received a fourth injection of FLUZONE (lot number U2476GA), on 04 November 2007. According to the patient's mother approximately six hours after vaccination, the patient began experiencing edema of hands and feet and hives. The day after vaccination he was seen by his physician and treated with Benadryl. The treating physician suspected "a viral illness vs. a vaccine reaction". The patients symptoms resolved within 2 days.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Drug exposure during pregnancy, Hyperventilation, Tremor
Clinical narrative: Initial information received on 26 October 2007 from a health care professional.  A 28-year-old female patient, with a history of panic attacks and who was pregnant (33 weeks gestation), had received a left deltoid, intramuscular injection of Fluzone SV 2007-2008, lot number U2469AA on 24 October 2007. Fifteen minutes post-vaccination the patient experienced an anxiety attack with hyperventilation, anxiety and trembling. She refused transport to an emergency room. The patient was contacted one hour later following the event and "was fine." The patient recovered from the event. Follow-up informaion was received from a health care professional on 16 January 2008. The reporter stated that the vaccine had been administered in a retail pharmacy setting and indicated that they have no access to the patient's medical records or information. According to the consent form completed by the patient prior to immunization, the patient had no egg allergies and no prior reactions to any vaccines in the past requiring medical care. The reporter provided a copy of the patient's consent form which contained contact information for the patient's physician. No futher information was provided.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Injection site warmth, Oedema peripheral
Clinical narrative: Initial report received on 29 October 2007 and follow-up received on 07 January 2008 from a health care provider. The initial information received contained listed events; and, upon follow-up, the final diagnosis was an unlisted event. A 58-year-old female patient, with no illness at the time of vaccination, had received a left deltoid, intramuscular injection of FLUZONE SV 2007-2008, lot number U2464AA, on 26 October 2007. Twenty-four hours post-vaccination, the patient experienced redness and swelling of approximately half of the area between the shoulder and elbow, and the injection site was warm to touch. The diameter of the area was approximately three inches. The final diagnosis of the event was aseptic cellutitis. Treatment included TYLENOL and KEFLEX. The patient subsequently recovered on 05 November 2007. The reporter for this case is the same as for case 2007-03679.
Sex: U
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site discolouration
Clinical narrative: Initial report received from a health care professional on 30 October 2007. Cluster of 50 cases of dark grey dots appearing instantly after injection out of an unspecified number vaccinees who had received an intramuscular deltoid injection of FLUZONE, lot number U2488AA. The reporter stated that they use B-D regular syringes, 25 gauge, one inch. The injection site had been prepped with Kendall Curity alcohol wipes. The dark grey mark appeared after all doses withdrawn from the vials and appeared instantly following injection. The reporter had not checked to observe it the dots disappeared later on and did not know how long the dots remained at the injection site. The reported event had been observed by all of the health care workers providing FLUZONE immunizations this year but had not been observed in prior years. The reporter stated they used FLUZONE and the same syringes in prior years. All 50 of the reported patients had recovered from the event.
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Nausea, Pruritus
Clinical narrative: Initial report received on 30 November 2007 from a health care professional. A female patient (age unknown) had received an injection of FLUZONE SV 2007-2008, lot number unknown, and route and site of administration unknown, on an unknown date. Within one hour post-vaccination, the patient developed anxiety, nausea, and itching. The event did not require medical examination. The subject subsequently recovered. The reporter in this case is the same as in case 2007-04123. In that case events were reported following administration of Tubersol 5 TU.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Staphylococcal infection
Clinical narrative: Initial report received on 10 January 2008 from a health care professional. A 39-year-old male patient, who had no concurrent illness, pre-existing medical conditions, or use of other medications had received a dose of FLUZONE SV 2007-2008 (lot number U2464AA) on 18 October 2007. The route and site of administration was not provided. The following day, after receiving the FLUZONE vaccine. the patient experienced a "staph infection." No relevant diagnostic tests, or laboratory data were performed to confirm the diagnosis of "staph infection". At the time of this report, the patient had recovered. No other relevant medically significant information was provided. Follow-up information was received 08 August 2008 from a health care professional. The reporter reviewed the case information and had no new relevant medically significant information to provide at the time of the report. The reporter for this case is the same for case 2007-03565, which is a case for a 55-year-old female who developed a "staph infection" after administration of the FLUZONE SV2007-2008 on 16 October 2007.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Electrophoresis protein, Fatigue, Full blood count, Myalgia, Red blood cell sedimentation rate
Clinical narrative: This case was received from a health professional on 17 January 2008. A 58-year-old female patient received an injection of FLUZONE (lot number U2444AA) on 12 December 2007. The patient had a history of allergies to egg, penicillin, pollen, and  other food. On 16 December 2007, four days after vaccination, the patient developed constant muscle aches, which she described as being worst in her arms and legs. She also complained of extreme fatigue. She was treated with prednisone, with little effect, and was later seen in the emergency department. Laboratory work-up, including CBC and ESR, were performed in the emergency department, but results were not provided. She was seen by an ENT (ear, nose and throat specialist) and diagnosed with a sinus infection. On 17 January 2008, she underwent protein electrophoresis testing, the results of which were not provided. At the time of the report, the events had not resolved. Per the reporter, the patient had experienced a "similar event following last flu vaccine". Concomitant medication included PROZAC, Avista, Vitamins, Calcium, and monthly flu shots. In addition to allergy history, the patient also had a medical history of osteoporosis.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Sinusitis
Clinical narrative: This case was received from a health professional on 17 January 2008. A 58-year-old female patient received an injection of FLUZONE (lot number U2444AA) on 12 December 2007. The patient had a history of allergies to egg, penicillin, pollen, and  other food. On 16 December 2007, four days after vaccination, the patient developed constant muscle aches, which she described as being worst in her arms and legs. She also complained of extreme fatigue. She was treated with prednisone, with little effect, and was later seen in the emergency department. Laboratory work-up, including CBC and ESR, were performed in the emergency department, but results were not provided. She was seen by an ENT (ear, nose and throat specialist) and diagnosed with a sinus infection. On 17 January 2008, she underwent protein electrophoresis testing, the results of which were not provided. At the time of the report, the events had not resolved. Per the reporter, the patient had experienced a "similar event following last flu vaccine". Concomitant medication included PROZAC, Avista, Vitamins, Calcium, and monthly flu shots. In addition to allergy history, the patient also had a medical history of osteoporosis.
Age: 3.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: Initial report was received from a health care professional on 18 January 2008. A 3-year-old child with no past medical history, had received an intramuscular, left deltoid injection of FLUZONE SV (lot number invalid). On an unspecified date and approximately two days later, the child developed a fever of 103.5 degrees Fahrenheit and their left arm became very reddened and swollen from the shoulder and axillary areas down to their mid arm and hard at the injection site. The needle size utilized had been 25 gauge, 5/8 inch length. Corrective treatments included TYLENOL, BENADRYL, and an antibiotic. The patient had no known allergies and had not received any other vaccines during the four weeks prior to receipt of FLUZONE SV. At the time of the report, the patient had not recovered from the event.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site discolouration
Clinical narrative: Initial report received 29 April 2008 from a health care professional. A seven-year-old female patient had received an intramuscular left deltoid injection of FLUZONE, lot number U2440AA (0.5mL) on 31 October 2007 and immediately following vaccination. a black dot appeared at the injection site. According to the reporter, the recovery status of the patient was unknown at the time of the report. The reporter received a cluster of reports of black dots at the injection site from multiple satellite locations who were all affiliated with the reporter. The facilities used McKesson alcohol wipes and syringes which included safety glide and vanish point with 25 gauge needles. Some of the black dots were reported to have appeared immediately with some present two months post immunization. This event had been noticed by all health care worker at the facilities and had not been noticed in the past. The reporter indicated follow-up information would be provided as it is obtained. The reporter for this case is the same as for case number 2008-01333 (IPOL and ActHIB), 2008-01334 (IPOL), 2008-01335 (IPOL), 2008-01336 (IPOL and DTaP) and 2008-01339 (IPOL). These events occurred at multiple satellite locations which are all affiliated with the reporter.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration
Clinical narrative: Initial report received on 14 May 2008 from a health care provider. A four year old female patient received on 21 November 2007 a third right deltoid intramuscular injection of FLUZONE (lot number U2452AA). On February 2008 84, days post vaccination, the patient had a white "peace sign" type ring, measuring 3.5 cm by 2.5 cm, on the deltoid injection site. The patient had no medical history, except for an allergy to amoxicillin (urticaria), and had no illness at the time of vaccination. Corrective treatment was not reported. At the time of the report, the patient had not recovered.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Alpha 1 foetoprotein, Anaemia, Drug exposure during pregnancy, Eye pruritus, Foetal disorder
Clinical narrative: Initial report received on 29 July 2008 from a health professional under reference number 0712041488. A 31-year-old pregnant female had received an injection of ADACEL (lot number and route/site of administration not reported) on 10 September 2007 and an injection of FLUZONE (lot number and route/site of administration not reported) on 01 November 2007. It was also reported that the patient had exposure to Varicella-Zoster Immune Globulin injection on 11 March 2008 (manufacturer not reported). Date of conception was reported as 22 August 2007. On 03 November 2007, the patient experienced a respiratory infection (cold, no fever). On 11 February 2008, the patient developed a sinus infection that was treated with Zithromax 500mg on 25 February 2008 and Zithromax 250mg from 26-29 February 2008. The patient experienced anemia and received treatment with iron 65mg from 05 November 2007 to 13 March 2008 and with an increased iron dose of 130mg from 14 March 2008 to 14 May 2008. For headaches, the patient received treatment with Tylenol and ibuprofen. The patient received Visine drops for red, itchy eyes. On 14 May 2008, the pregnancy resulted in a live birth. On 03 June 2008, the baby was diagnosed with patent foramen ovale and peripheral pulmonic stenosis. The reporter of this case is the same as case 2008-02469, which is a report of congenital anomaly (patent foramen ovale and peripheral pulmonic stenosis) for the above-mentioned baby.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Glucose tolerance test, Headache, Ocular hyperaemia, Respiratory tract infection, Sinusitis
Clinical narrative: Initial report received on 29 July 2008 from a health professional under reference number 0712041488. A 31-year-old pregnant female had received an injection of ADACEL (lot number and route/site of administration not reported) on 10 September 2007 and an injection of FLUZONE (lot number and route/site of administration not reported) on 01 November 2007. It was also reported that the patient had exposure to Varicella-Zoster Immune Globulin injection on 11 March 2008 (manufacturer not reported). Date of conception was reported as 22 August 2007. On 03 November 2007, the patient experienced a respiratory infection (cold, no fever). On 11 February 2008, the patient developed a sinus infection that was treated with Zithromax 500mg on 25 February 2008 and Zithromax 250mg from 26-29 February 2008. The patient experienced anemia and received treatment with iron 65mg from 05 November 2007 to 13 March 2008 and with an increased iron dose of 130mg from 14 March 2008 to 14 May 2008. For headaches, the patient received treatment with Tylenol and ibuprofen. The patient received Visine drops for red, itchy eyes. On 14 May 2008, the pregnancy resulted in a live birth. On 03 June 2008, the baby was diagnosed with patent foramen ovale and peripheral pulmonic stenosis. The reporter of this case is the same as case 2008-02469, which is a report of congenital anomaly (patent foramen ovale and peripheral pulmonic stenosis) for the above-mentioned baby.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Ultrasound scan
Clinical narrative: Initial report received on 29 July 2008 from a health professional under reference number 0712041488. A 31-year-old pregnant female had received an injection of ADACEL (lot number and route/site of administration not reported) on 10 September 2007 and an injection of FLUZONE (lot number and route/site of administration not reported) on 01 November 2007. It was also reported that the patient had exposure to Varicella-Zoster Immune Globulin injection on 11 March 2008 (manufacturer not reported). Date of conception was reported as 22 August 2007. On 03 November 2007, the patient experienced a respiratory infection (cold, no fever). On 11 February 2008, the patient developed a sinus infection that was treated with Zithromax 500mg on 25 February 2008 and Zithromax 250mg from 26-29 February 2008. The patient experienced anemia and received treatment with iron 65mg from 05 November 2007 to 13 March 2008 and with an increased iron dose of 130mg from 14 March 2008 to 14 May 2008. For headaches, the patient received treatment with Tylenol and ibuprofen. The patient received Visine drops for red, itchy eyes. On 14 May 2008, the pregnancy resulted in a live birth. On 03 June 2008, the baby was diagnosed with patent foramen ovale and peripheral pulmonic stenosis. The reporter of this case is the same as case 2008-02469, which is a report of congenital anomaly (patent foramen ovale and peripheral pulmonic stenosis) for the above-mentioned baby.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site erythema, No reaction on previous exposure to drug
Clinical narrative: This case was received form a health professional on 05 October 2007.  An eight-year-old male patient with an allergy to penicillin received an intramuscular injection of FLUZONE (lot number U2461BA) on 22 September 2007.  Within two days he developed redness at the site, which subsequently turned into a " 15 cm brown spot".  The patient had not been seen by a physician.  Per the reporter, the patient had received FLUZONE in 2006, and had not experienced any adverse events following vaccination.  At the time of report, the events remained ongoing.  Follow-up information received on 08 January 2008 from a physician.  Per the reporter, the patient suffered no ill effect from the adverse events, and was subsequently re-evaluated by a physician and found to have no symptoms.  The date of re-evaluation was not reported.  It was not reported whether the patient received any other treatments.  The patient recovered.  No further information is expected.