chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: YF, YF
Symptoms: Renal failure, Respiratory failure, Rickets, Sepsis, Viral infection
Clinical narrative: Dehydration s/s of sepsis, multiple electrolyte abnormalities, aggressive supportive case with fluid, broad spectrum antibiotics, anti fungal, pressure. Infectious work up, Hepatitis, Ricketts, Influenza, Blood culture x 4ct, Typhoid fever, Poly Mt spotted fever, EMV, Epstein Barr were reg diagnosis, react to yellow fever vaccination or Blood work sepsis or viral sepsis from a unk agent, slow steady improvement. Discharge Diagnosis: Sepsis syndrome, Anemia, Hypotension, Respiratory Insufficiency, Multiple electrolyte abnormalities, transaminitis, Pancytopenia, Renal Insufficiency, Metabolic acidosis, admitted 11/8/04, discharged 11/18/04.
Age: 61.0
Sex: M
Vaccine: YF, YF
Symptoms: Anaemia, Electrolyte imbalance, Hypotension, Pancytopenia, Renal failure
Clinical narrative: Dehydration s/s of sepsis, multiple electrolyte abnormalities, aggressive supportive case with fluid, broad spectrum antibiotics, anti fungal, pressure. Infectious work up, Hepatitis, Ricketts, Influenza, Blood culture x 4ct, Typhoid fever, Poly Mt spotted fever, EMV, Epstein Barr were reg diagnosis, react to yellow fever vaccination or Blood work sepsis or viral sepsis from a unk agent, slow steady improvement. Discharge Diagnosis: Sepsis syndrome, Anemia, Hypotension, Respiratory Insufficiency, Multiple electrolyte abnormalities, transaminitis, Pancytopenia, Renal Insufficiency, Metabolic acidosis, admitted 11/8/04, discharged 11/18/04.
Age: 61.0
Sex: M
Vaccine: YF, YF
Symptoms: Respiratory failure, Sepsis
Clinical narrative: Dehydration s/s of sepsis, multiple electrolyte abnormalities, aggressive supportive case with fluid, broad spectrum antibiotics, anti fungal, pressure. Infectious work up, Hepatitis, Ricketts, Influenza, Blood culture x 4ct, Typhoid fever, Poly Mt spotted fever, EMV, Epstein Barr were reg diagnosis, react to yellow fever vaccination or Blood work sepsis or viral sepsis from a unk agent, slow steady improvement. Discharge Diagnosis: Sepsis syndrome, Anemia, Hypotension, Respiratory Insufficiency, Multiple electrolyte abnormalities, transaminitis, Pancytopenia, Renal Insufficiency, Metabolic acidosis, admitted 11/8/04, discharged 11/18/04.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site oedema, Laboratory test abnormal
Clinical narrative: Seen in our office 1/18/05. Received DTaP, HIB, IPV in left thigh. Mom brought back to office 1/20/05 for increasing swelling in left thigh. Admitted to hospital for cellulitis.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hearing impaired, Injection site pain, Laboratory test abnormal, Labyrinthitis
Clinical narrative: Took the flu vaccine on 12/1/04 at 10:00 AM; went back to work. Had a slight soreness in the left arm where vaccine was given. Same day at 3:00 PM, had a static noise in right ear. Lost hearing in this ear. Later had vomiting and dizziness. Follow up 03/07/05: Patient was seen in the emergency room on 12/04/04. Chief complaint was vertigo and hearing loss. Patient reported felt a little dizzy and heard staticky sound in right ear. By next am pt had severe vertigo with nausea, requiring compazine and Bonine, and noted severe hearing loss in right ear. Over the next 48 hours vertigo is lessening but hearing loss has not improved in right ear. No further tinnitus reported. Patient denies aural fullness. Patient received flu shot this week, just prior to onset of symptoms. Upon ears were found to be clear with normal appearing tympanic membrane. Eyes: no nystagmus vertical or horizontal gaze. CT of head showed not Focal Lesions and Labs normal. Impression: Acute right Labyrinthitis, prob viral, affecting both cochlear and vestibular nerves. ER summary states labyrinthitis. msv
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Tinnitus, Vomiting
Clinical narrative: Took the flu vaccine on 12/1/04 at 10:00 AM; went back to work. Had a slight soreness in the left arm where vaccine was given. Same day at 3:00 PM, had a static noise in right ear. Lost hearing in this ear. Later had vomiting and dizziness. Follow up 03/07/05: Patient was seen in the emergency room on 12/04/04. Chief complaint was vertigo and hearing loss. Patient reported felt a little dizzy and heard staticky sound in right ear. By next am pt had severe vertigo with nausea, requiring compazine and Bonine, and noted severe hearing loss in right ear. Over the next 48 hours vertigo is lessening but hearing loss has not improved in right ear. No further tinnitus reported. Patient denies aural fullness. Patient received flu shot this week, just prior to onset of symptoms. Upon ears were found to be clear with normal appearing tympanic membrane. Eyes: no nystagmus vertical or horizontal gaze. CT of head showed not Focal Lesions and Labs normal. Impression: Acute right Labyrinthitis, prob viral, affecting both cochlear and vestibular nerves. ER summary states labyrinthitis. msv
Age: 1.49
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Choking, Cough, Flushing, Lethargy, Wheezing
Clinical narrative: Wheezing, coughing, choking, flushed, lethargic. Treated with Andrenaline, Benadryl, IV fluids, oxygen at 2L /min, Solu-Medrol. Hospital admission for observation.
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Asthenia, Demyelination, Fatigue, Laboratory test abnormal
Clinical narrative: Patient was in usual good state of health until 12/2003. He noted a significant change in his health after receiving anthrax vaccine #4, in 11/2003 and his flu vaccine in 12/2003 when he began feeling weak. In late 12/2003 early 01/2004, he also noted muscle and joint pain that first started with his hands, thumbs and wrist, then his elbows and shoulders. Another change in his health that was noted in 12/2003 is chronic fatigue. Since returning stateside in 06/2004, patient has noted night sweats and a decreased tolerance to cold. He often wakes up with his nightclothes and bed linens damp with perspiration. Comment: patient received anthrax vaccines 1-3 during Feb- April 2003 and denies any significant or prolonged local or systemic reactions. Patient does not recall any significant local reaction or any worsening of his systemic symptoms with vaccines subsequent to 12/2003, including anthrax vaccine #5 received in April 2004.
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Myalgia, Neuropathy peripheral, Night sweats
Clinical narrative: Patient was in usual good state of health until 12/2003. He noted a significant change in his health after receiving anthrax vaccine #4, in 11/2003 and his flu vaccine in 12/2003 when he began feeling weak. In late 12/2003 early 01/2004, he also noted muscle and joint pain that first started with his hands, thumbs and wrist, then his elbows and shoulders. Another change in his health that was noted in 12/2003 is chronic fatigue. Since returning stateside in 06/2004, patient has noted night sweats and a decreased tolerance to cold. He often wakes up with his nightclothes and bed linens damp with perspiration. Comment: patient received anthrax vaccines 1-3 during Feb- April 2003 and denies any significant or prolonged local or systemic reactions. Patient does not recall any significant local reaction or any worsening of his systemic symptoms with vaccines subsequent to 12/2003, including anthrax vaccine #5 received in April 2004.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: History of increasing pain of arm from deltoid to elbow and in armpit to breast level. No discoloration or lumps. Has pain and tenderness to touch and is afebrile. Using sports cream on left arm and taking acetaminophen. Pain described as worse when raising left arm. Had first flu shot 5 years ago via air gun with similar symptoms, therefore she wanted to file report. Pain described as worse now. (4 days later)
Age: 1.51
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Injection site warmth, Rash erythematous
Clinical narrative: Patient received DTaP and Flu shot (1st 1/2 dose) to left thigh on 01/25/05. Both immunizations in same leg D/T rash on right thigh. Reaction site is 7.5cm x 6cm, red, raised and warm to touch. No other symptoms noted. Mom called today to schedule appointment for this afternoon.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Bronchitis, Difficulty in walking, Hypokinesia
Clinical narrative: Severe pain in left hip, could not walk, was taken to ER in a wheel chair, was out of work for a week. Had an Epidural, pain lasted for 2 weeks before normal walk. Pt reported: I am a hospital employee. I have never  had a flu vaccine before. Since I am in contact with the public at the hospital my superiors insisted I have the vaccine. Since receiving the vaccine I have also had Bronchitis, which I have never had before. I never got a cold bad enough for me to miss work. Several other people at the hospital had similar problems.
Age: 75.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Pruritus, Rash
Clinical narrative: Rash back of neck, both arms. No rash at site of injections, itching of rash.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Angioneurotic oedema, Diarrhoea, Dyspnoea, Injection site pain, Wheezing
Clinical narrative: Severe pain at site, angioedema, severe diarrhea, dyspnea with wheeze, all within 4 hrs of injection
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash, Pruritus, Rash erythematous
Clinical narrative: One day after being immunized with the flu vaccine the right arm broke out with a rash. By the afternoon the rash spread to back and stomach. Referred to his doctor. Physician stated no more flu vaccine ever. The rash redness subsided by 1/8/05. C/o itching until the 8th also.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Feeling abnormal, Headache, Nausea
Clinical narrative: Within 3 hours of Flu vaccine, felt nauseous, had a headache, dizziness and chills, generally did not feel right. Slept for 3 hours after 6 hours had passed since Flu vaccine.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Somnolence
Clinical narrative: Within 3 hours of Flu vaccine, felt nauseous, had a headache, dizziness and chills, generally did not feel right. Slept for 3 hours after 6 hours had passed since Flu vaccine.
Age: 0.55
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever 104
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Dyspnoea, Injection site pain, Tachycardia
Clinical narrative: Begin PM after injection with SOB, Tachycardia and pain in left arm in soft tissue of arm, neck, upper legs and buttocks. Pt reported this on 12/23/04. Injection received 12/20/04. Advised to go to ER. Unk if she went. Follow up 1/10/05 Pt did not go to ER
Age: 7.0
Sex: M
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Mother states date of #2 HBV child started having a rash on face, chest and back.  This rash lasted for 6-7 days.  She denies any other problem and did not bring him in for medical evaluation and treatment.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Feeling hot, Injection site erythema, Injection site mass, Rash
Clinical narrative: Pt had 8cm wide and 5cm long red square patch with sm knot at injection site, warm to touch. No generalized rash.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: 2 days post vaccine, red, painful induration 6in x 6.5in. Impression: cellulitis. Treatment: Keflex 250mg/5cc, 2 tsp BID x10days.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Skin ulcer, Viral infection
Clinical narrative: Mild varicella, only 6-10 lesions and fever for 24 hours in 12/04 vaccinated 1 year prior
Age: 1.28
Sex: M
Vaccine: DTAP, PNC
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Left thigh red, swollen, warm to touch
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Pruritus
Clinical narrative: Left arm ~4cm below site of injection warm, pink. Denies pain, SOB, or any other associated symptoms except "a lot of itching". She came into clinic 3 days after vaccination.
Age: 0.72
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Mother called 1/21 at 1:15PM to report that infant has fever between 100-102 past few days since receiving vaccinations denies cold sx. When questionably states infant has small (size of quarter) redness at vaccine sites-both thighs.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Hypoaesthesia, Injection site pain, Loss of consciousness, Oedema, Paraesthesia
Clinical narrative: 2nd day post vaccination on arm began to swell, ache with pain in upper arm and shoulder caused sleep interference. Pt used ice and heat alternating and dosed with ibuprofen, Tylenol and ASA with no relief. MD visit on 1/20/05 for eval. To ER via ambulance after passing out on 1/22. 2nd MD office visit scheduled 1/24. Still has severe pain from Left collarbone down to fingertips with burning, throbbing, tingling and numbness.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Skin burning sensation, Sleep disorder, White blood cell count increased
Clinical narrative: 2nd day post vaccination on arm began to swell, ache with pain in upper arm and shoulder caused sleep interference. Pt used ice and heat alternating and dosed with ibuprofen, Tylenol and ASA with no relief. MD visit on 1/20/05 for eval. To ER via ambulance after passing out on 1/22. 2nd MD office visit scheduled 1/24. Still has severe pain from Left collarbone down to fingertips with burning, throbbing, tingling and numbness.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site rash, Rash macular
Clinical narrative: Received DTaP, IPV, MMR and PPD 1/19/05.By that evening pt developed mild rash on both cheeks. By 1/20/05 rash had spread all over. Non pruritic lacey type rash on extremities and torso. Where pt received DTaP, rash was solid red around injection site. Rash is macular. No malaise, joint pain or neuropathy. Pt rechecked 1/24/05 and rash had resolved.
Age: 93.0
Sex: F
Vaccine: TYP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: My supervisor conveyed by telephone 01/13/05 that on 01/12/05, the daughter reported, having her mother experience local redness and swelling at site. Today 01/13/05 daughter reported symptoms subsided.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pallor
Clinical narrative: erryth. 7.2 x 8.7 cm  central palar area 3.5 x 5.8  Keflex 250 mg 3/4 tsp. TID x 10d - warm compressors
Age: 1.02
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Difficulty in walking, Injection site erythema, Injection site swelling
Clinical narrative: site red, warm and swollen
Age: 3.0
Sex: F
Vaccine: UNK
Symptoms: Viral infection
Clinical narrative: Seen 1/26/2005 with alternated chickenpox
Age: 81.0
Sex: F
Vaccine: TD
Symptoms: Myalgia
Clinical narrative: 4 - 5 days after vaccine given reset of persistent myalgias right and left arms distally. No objective findings. (transient local reaction deltoid area resolved 3 - 4 days as expected)
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Discomfort, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: MMR administered SQ in left upper thigh on 1/25/05. On 1/27/05 mom reported 3 x 2 inch area of local redness around injection site with mild tenderness.  Red, raised, warm; no limping, no fever, no specific cmplaints from child.  advised continued monitoring, Tylenol for discomfort, and compresses to leg.  On 1/28/05 erythema at injection site was measured at 10 cm diamters, raised, red, slightly warm, and slightly tender.  Afebrile.  Office Fu on Monday 1/31/05 revealed a mildly indurated, non-tender area on left upper thigh, no longer red around original injection site.  Marked areas from 1/27 and 1/28/05 were measured at 6 cm and 9 cm diameter respectively.  Pt was afebrile, without rash, joint pain, and was otherwise happy and asymptomatic.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site warmth
Clinical narrative: MMR administered SQ in left upper thigh on 1/25/05. On 1/27/05 mom reported 3 x 2 inch area of local redness around injection site with mild tenderness.  Red, raised, warm; no limping, no fever, no specific cmplaints from child.  advised continued monitoring, Tylenol for discomfort, and compresses to leg.  On 1/28/05 erythema at injection site was measured at 10 cm diamters, raised, red, slightly warm, and slightly tender.  Afebrile.  Office Fu on Monday 1/31/05 revealed a mildly indurated, non-tender area on left upper thigh, no longer red around original injection site.  Marked areas from 1/27 and 1/28/05 were measured at 6 cm and 9 cm diameter respectively.  Pt was afebrile, without rash, joint pain, and was otherwise happy and asymptomatic.
Age: 18.0
Sex: F
Vaccine: HEP, MMR, HEP, MMR
Symptoms: Erythema, Pruritus, Rash, Rash maculo-papular
Clinical narrative: Gave MMR at approx 12:30 patient returned to clinic at approx01:30. Hands red itching rash over chest stomach and back. Face and neck splotchy. Complained of itching all over.  Benadryl 25 mg given po. Mother present. Monitored for hour and released with mother states she is feling better. BP 110/68 Pulse 80 Weight 130
Age: 18.0
Sex: F
Vaccine: HEP, MMR, HEP, MMR
Symptoms: Erythema, Feeling hot, Flushing, Pruritus, Rash erythematous
Clinical narrative: Gave MMR at approx 12:30 patient returned to clinic at approx01:30. Hands red itching rash over chest stomach and back. Face and neck splotchy. Complained of itching all over.  Benadryl 25 mg given po. Mother present. Monitored for hour and released with mother states she is feling better. BP 110/68 Pulse 80 Weight 130
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mother presented in office 1/27/2005 two days after her son received his Dtap booster. His left deltoid was red swollen and warm to touch. Mother states that she made an appointment for him to see his MD but he can't get in until tomorrow. Mother states that she used a cool compress on his arm yesterday. Instructed to continue the cool compress. Also instructed to give Benadryl elixir until he can get into MD.
Age: 24.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Mild localized reaction aeb 3"x3" area of erythema and edema
Age: 1.57
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Injection site with vesicles redness since 1/28/05.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis entire LUE, Medrol dose pak, Keflex.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis at injection site for 4 days, improved with Benadryl
Age: 46.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Pain, Paraesthesia, Sensation of heaviness, Skin burning sensation
Clinical narrative: Developed heaviness and leg pain both legs 3 wks post MMR vaccination. Lasted 3 days then gone. 2 days later pain, burning, tingling of both hands up to elbows, lasted 1 week and then gone.
Age: 0.03
Sex: M
Vaccine: HEP
Symptoms: Injury
Clinical narrative: Information has been received regarding a case in litigation concerning a male child who was vaccinated with a dose of hepatitis B virus vaccine. Subsequently the patient was diagnosed by his treating physicians as having suffered severe injury from an adverse reaction to the hepatitis B vaccine. Unspecified medical attention was sought. There was no information regarding the present status of the patient. Upon review, the severe injury was considered to be an other important medical event (OMIC). No further information is available.
Age: 1.55
Sex: F
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Coma, Convulsion, Depressed level of consciousness, Dizziness, Hemiplegia
Clinical narrative: Patient recieved the vaccine at her 18 month well visit on the 11 of January 2005 at approx. 2:30 in the afternoon. She was a bit fussy that night but I thought nothing of it I put her to bed and when I went to get her up she was having what I later found out from rescue to be a seizure. She spent 10 days in the PICU and is now in a regular room. She has her eyes open but recognizes no one she cannot sit up and she has lost use of her left side.
Age: 1.55
Sex: F
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Mental retardation severity unspecified, Oedema
Clinical narrative: Patient recieved the vaccine at her 18 month well visit on the 11 of January 2005 at approx. 2:30 in the afternoon. She was a bit fussy that night but I thought nothing of it I put her to bed and when I went to get her up she was having what I later found out from rescue to be a seizure. She spent 10 days in the PICU and is now in a regular room. She has her eyes open but recognizes no one she cannot sit up and she has lost use of her left side.
Age: 1.55
Sex: F
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Antisocial behaviour, Convulsion, Hemiplegia, Irritability
Clinical narrative: Patient recieved the vaccine at her 18 month well visit on the 11 of January 2005 at approx. 2:30 in the afternoon. She was a bit fussy that night but I thought nothing of it I put her to bed and when I went to get her up she was having what I later found out from rescue to be a seizure. She spent 10 days in the PICU and is now in a regular room. She has her eyes open but recognizes no one she cannot sit up and she has lost use of her left side.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC, DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site swelling, Pruritus
Clinical narrative: Itching and swollen right arm following immunization 2 days ago in right anterior deltoid.  ***Correction Pneumo,& (Prevnar) was accidentally entered in the Vaccines section in question 13- this was not given on that day.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC, DTAP, IPV, MMR
Symptoms: Pruritus, Swelling
Clinical narrative: Itching and swollen right arm following immunization 2 days ago in right anterior deltoid.  ***Correction Pneumo,& (Prevnar) was accidentally entered in the Vaccines section in question 13- this was not given on that day.
Age: 18.0
Sex: F
Vaccine: HEP, MMR, HEP, MMR
Symptoms: Erythema, Pruritus, Rash, Rash maculo-papular
Clinical narrative: Pt came in with mother requesting Hepatitis B and MMR for college. Only previous vaccine was a TD in 1994. No allergies voiced. Returned to clinic approx one hour after vaccination with red flushing over face and neck and raised rash over chest, back and stomach . Complained of itching and being hot. Denied breathing difficulties, vital signs stable. Benadryl 25mg given po and monitored for one hour. Released with mother feeling better and with flushing subsiding.
Age: 18.0
Sex: F
Vaccine: HEP, MMR, HEP, MMR
Symptoms: Erythema, Feeling hot, Flushing, Pruritus, Rash erythematous
Clinical narrative: Pt came in with mother requesting Hepatitis B and MMR for college. Only previous vaccine was a TD in 1994. No allergies voiced. Returned to clinic approx one hour after vaccination with red flushing over face and neck and raised rash over chest, back and stomach . Complained of itching and being hot. Denied breathing difficulties, vital signs stable. Benadryl 25mg given po and monitored for one hour. Released with mother feeling better and with flushing subsiding.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site oedema, Injection site warmth
Clinical narrative: A report was received form a health care professional in 07/22/2002, concerning a 77 year old female patient who experienced a large red firm area at injection site after receiving Fluvirin on 10/09/2001. On 10/09/2001, the patient received Fluvirin, after which the patient experienced a red firm area at injection sit. The patient recovered in  approximately 3 days without treatment or intervention. At the time of reporting no further information was available. Update: A follow up report was received form a health care professional on 10/02/2002 concerning the 77 year old female patient who experienced redness, warmth and swelling  at injection site which lasted for 3-5 days. The patient did not need medical intervention and fully recovered. The reporter has assessed the relationship of Fluvirin to the event as probable. Update 10/14/2002: A follow up report was received on 10/14/2002 confirmed that the patient had received Fluvirin.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: A report was received from a health care professional on 09/23/2002, concerning a female patient in her 20's who experienced injection site soreness after receiving Fluvirin on 09/19/2002. On 09/19/2002 the patient received Fluvirin and experienced injection site soreness shortly after. The soreness worsened over the next couple of days, spreading throughout the entire arm. On 09/23/2003 the patient still experienced arm soreness. At the time of the report the patient had not recovered. The reporter has assessed the relationship of study medication to the event as possible and the health professional is concerned that the event may have been associated with this particular batch.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: A report was received from a health care professional on 09/23/2002, concerning a female patient in her 40's who experienced injection site soreness after receiving Fluvirin on 09/19/2002. On 09/19/2002 the patient received Fluvirin and experienced injection site soreness shortly after. The soreness worsened over the next couple of days, spreading thoughout the entire arm. On 09/23 the patient still experienced arm soreness. At the time of the report the patient had not recovered. The reporter has assessed the relationship of study medication to the event as possible and the health care professional is concerned that the event may have been associated with this particular batch.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: A report was received from a health care professional on 09/23/2002, concerning a female patient in her 60's who experienced injection site soreness after receiving Fluvirin on 09/19/2002. On 09/19/2002, the patient received Fluvirin and experienced injection site soreness shortly after. The soreness worsened over the next couple of days spreading throughout the entire arm. On 09/23 the patient still experienced arm soreness. AT the time of the report the patient had still not recovered. The reporter has assessed the relationship of study medication to the event as possible and the helath care professional is concerned that the event may have been associated to the batch.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Exfoliative rash, Rash erythematous
Clinical narrative: A report was received from a consumer on 10/03/2002 concerning a 36 year old male vaccinee who experienced raised patches on arm. abdomen, back and leg one day after receiving Fluvirin on 09/25/2002. The vaccinee had no known drug allergies nor egg allergy and was not taking any concomitant medications. The vaccinee had a past history of tinea versicolor, the vaccinee did not experience any reaction at previous flu vaccine(brand unspecified) administrations. On 09/25/2002 the vaccinee received Fluvirin intramuscularly in his upper arm. The following day the vaccinee experienced some small, non itchy "raised patches" on his arm. By the weekend, he had similar "raised patches" on his abdomen, back, and leg/ The vaccinee was not sure if the reaction was secondary to the Fluvirin, or if his past skin condition was flaring up. The rash he experienced was different than he had experienced due to the tinea versicolor. At the time of reporting the patches on his arm had almost all recovered, but the rash on his abdomen, back and leg were still persisting.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received form a health care professional on 10/07/2002, concerning a 79 year old female who inadvertently received Fluvirin subcutaneously on 03/10/2002. On 03/10/2002 the patient inadvertently received one dose of Fluvirin subcutaneously. At the time of reporting the patient did not experience any effects from the event. The reporter has assessed the relationship of study medication to the event as unclassifiable.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site oedema, Injection site pain, Injection site warmth, Overdose
Clinical narrative: A report was received from a health care professional on 10/04/2002, concerning a 29 year old female vaccinee who inadvertently received an overdose Fluvirin on 04/10/2002. On 04/10/2002 the vaccinee inadvertently received 5ml of Fluvirin. The vaccinee has received influenza vaccination (brand unspecified) for the 2000-2001 and 2001-2002 formulations without any adverse effects. At the time of reporting the vaccinee did not experience any effects from the event. There was insufficient information to determine the reporters causality assessment. Update1. 11/14/2002: The vaccinee experienced pain, throbbing, heat and swelling on the 10/04/2002. The events resolved on 10/04/2002. The reporter has assessed the relationship of the vaccine to the events as probable.
Sex: U
Vaccine: FLU3
Symptoms: Medication error, Overdose
Clinical narrative: A report was recieved from a health care profesional on 10/03/2002, concerning a child vaccinee less than 4 years old who experienced a medication error after receiving Fluvirin on an unknown date. The vacccinee experienced no adverse events at the time of the reporet. At the time of administration, the health care professional were not aware that Fluvirin was no approved for vaccinees less thanm 4 years of age. There was unsufficient information to determine the reoporters causeality assessment.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A reporte was received from a patient advocate on 10/10/2002, concerning a 12 year old female vaccinee who received Fluvirin on 10/10/2002. The vaccinee who is autistic was also receiving 400mg TID Seroquel and 5mg TID ayestin. On 10/10/2002, the vaccinee recieved 0.5ml of Fluvirin via the intramuscular route. Most of the vaccine accidentally spilled out onto the arm of the vaccinee. The vacciee had not experienced any adverse events at the time of the report.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Injection site pain, Rash, Urticaria
Clinical narrative: A report was received from a health care professional on 10/11/2002, concerning a female vaccinee in her 30's  who experienced a rash and an injection site reaction after receiving Fluvirin on 10/09/2002. On 10/09/2002, the vaccinee received a 0.5ml dose of Fluvirin. After an unknown period of time the vaccinee developed a rash, a soreness and a "knot" at the injection site. The vaccinee had not recovered at the time of the report. The reporter has assessed the relationship of the vaccine to the events as probable. Update1. 01/20/2003: A follow up report was received from a health care professioanl concerning a 31 year old female vaccinee who experienced hives after receiving Fluvirin intramuscularly in the left deltoid. The hives resolfved 1 day after vaccination on 10/10/2002/ The vaccinee had no previous exposure to Fluvirin,the vaccinee was treated with unspecified antihistamines. The reporter has assessed the relationship of the vaccine to the hives as probable.
Age: 1.47
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 10/11/02, concerning a 17 month old female vaccinee who received 0.5ml of Fluvirin on 10/09/02. The vaccinee had experienced no adverse events at the time of the report but was being monitored. The reporter has assessed the relationship of Fluvirin to the event as unclassifiable.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error, Pain
Clinical narrative: A report was received from a health care professional on 10/11/2002, concerning a 57 year old female patient who inadvertently received Fluvirin subcutaneously into her arm on 10/07/2002. The patient had experienced no adverse events at the time of the report. The reporter has assessed the relationship of Fluvirin to the event as unclassifiable. Update (1) 11/22/02: The patient experienced slight soreness. The event resolved on an unknown date.
Age: 0.59
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report received from a health care professional on 10/10/2002, concerning a 7 month old male vaccinee who inadvertently received Fluvirin on 10/09/02. On 10/09/02, the vaccinee was inadvertently administered 0.25 ml of Fluvirin, intramuscularly. The nurse was unaware of Fluvirin's indication and no adverse event was reported on the initial report. There was insufficient information to determine the reporter's causality assessment. A follow up report was  received on 11/29/02 indicating that the vaccinee was born 5 weeks premature and spent 4 weeks in neonatal ICU.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: A report was received from a health professional on 10/11/02, concerning a 48 year old female vaccinee who experienced an injection site reaction approximately 30 minutes after receiving Fluvirin on 07/10/02. He experienced a red, hot, itchy injection site swelling. There was insufficient information to determine the reporter's causality assessment. 5 other vaccinees vaccinated at the same time with the same batch had the same reaction. See PJP200200500, PHP200200501, PJP20020052, PJP20020053, and PJP200200504. Update (1) 12/10/02: A report was received from a health care professional, the  injection site reaction had resolved at the time of the report.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: A report was received from a health care professional on 10/10/02, concerning approximately 15 employees, 80 % of who developed injection site reactions after receiving Fluvirin on 10/08/02, approximately. The vaccinees developed erythema ranging from 2 to 6 inches which was hot and swollen at the site of the injection. Vaccinees were administered 0.5ml Fluvirin into the deltoid region of the arm using a tuberculin syringe. It was stated by the reporter that the vaccinees had received a different brand flu vaccine in the past. It was also reported that the reaction had not resolved in all of the vaccinees. There was insufficient information to determine the reporter's causality assessment.
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 10/11/02, concerning a vaccinee of unknown demography who experienced a medication error after receiving Fluvirin on an unreported date. On an unreported date, a vaccinee was inadvertently administered Fluvirin subcutaneously. No adverse reactions were noted.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: A report was received from a health professional on 10/11/2002, concerning a 23 year old female vaccinee who experienced an injection site reaction approximately 30 minutes after receiving Fluvirin on 07/10/02. She experienced a red, hot, itchy injection site swelling. There was insufficient information to determine the reporter's causality assessment. 5 other vaccinees vaccinated at the same time with the same batch, had the same reaction. See PJP20020497, PJP200200501, PJP200200502, PJP200200503 and PJP200200504. Update (1) 12/10/02: A report was received from a health care professional, the injection site reaction had resolved at the time of the report.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: A report was received from a health professional on 10/11/02, concerning a 38 year old male vaccinee who experienced an injection site reaction approximately 30 minutes after receiving Fluvirin on 07/10/02. He experienced a red, hot, itchy injection site swelling. There was insufficient information to determine the reporter's causality assessment. 5 other vaccinees vaccinated at the same time with the same batch, had the same reaction. See PJP200200497, PJP200200500, PJP200200502, PJP200200503, and PJP200200504. Update (1) 12/10/02: A report was received from a health care professional, the injection site reaction had resolved at the time of the report.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: A report was received from a health professional on 10/11/02, concerning a 48 year old female vaccinee who experienced an injection site reaction approximately 30 minutes after receiving Fluvirin on 07/10/02. The patient experienced a red, hot, itchy injection site swelling. There was insufficient information to determine the reporter's causality. Five other vaccinees vaccinated at the same time with the same batch, had the same reaction. See PJP200200500, PJP20200501, PJP200200497, PJP200200503 and PJP200200504. Update (1) 12/10/2002: A report was received from a health care professional, the injection site reaction had resolved at the time of the report.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: A report was received from a health professional on 11Oct02, concerning a 58 year old female vaccinee who experienced an injection site reaction approx 30 minutes after receiving Fluvirin on 10Jul02. On 10Jul02, the vaccinee received Fluvirin. Approximately 30 minutes later the vaccinee experienced a red, hot, itchy injection site swelling. There was insufficient information to determine the reporter's causality assessment. 5 other vaccinees vaccinated at the same time with the same batch, had the same reaction. See PJP200200500, PJP200200501, PJP200200502, PJP200200503, and PJP200200497. Update 1 10Dec02, a report was received from a health care professional, the injection site reaction had resolved at the time of the report.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Feeling hot, Flatulence, Similar reaction on previous exposure to drug
Clinical narrative: A report was received from a 43 year old female vaccinee on 04Nov02 who experienced warmth, diarrhea and gas soon after receiving Fluvirin on 31Oct02. On 31Oct02 the vaccinee experienced warmth (temp 99) diarrhea, and gas soon after receiving 0.5ml Fluvirin IM. It was reported that the vaccinee usually develops flu-like symptoms when she gets an annual flu vaccination. The symptoms had not abated at the time of the report.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: A report was received from a health professional on 22Oct02 concerning a 60 year old male vaccinee who experienced fever, chills, and aches after receiving Fluvirin vaccine on 21Oct02. The vaccinee has a thyroid condition and a history of heart and lung complications. On 22Oct02 the vaccinee experienced fever (103 F) chills and muscle aches after receiving Fluvirin 24 hours previously. The vaccinee contacted his physician who instructed the vaccinee to go to the local emergency room for evaluation. At the time of reporting the vaccinee had not recovered. The reporter has assessed the relationship of study medication to the event as possible.
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health professional on 11Oct02, concerning 3 vaccinees who were inadvertently admin Fluvirin from a partially frozen vial on an unk date. On an unk date, 3 vaccinees were inadvertently administered Fluvirin from a partially frozen vial: no adverse events were observed. There was insufficient information to determine the reporters causality assessment.
Sex: U
Vaccine: FLU3
Symptoms: Diarrhoea
Clinical narrative: A report received from a health professional on 22Oct02 concerning 3 vaccinees of unk demography who experienced diarrhea after receiving the Fluvirin vaccine on an unk date. The diarrhea persisted for about 24 hours. The event was reported as resolved. There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200200625.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Medication error, Urticaria
Clinical narrative: A report was received from a health professional on 28Oct02, concerning a 30 year old pt who experienced welt formation and redness at injection site after an inadvertent administration of Fluvirin on 22 and 28Oct02. The pt received an initial Fluvirin injection on 22Oct02 IM. On 28Oct02 received the pt inadvertently a second dose of Fluvirin SC in the right forearm. Initially the welt measured approx 16mm in diameter, at the time of reporting the welt was decreased to 4mm in diameter but had not resolved and subsequently experienced redness and formation of a welt at the injection site. The pt was administered a dose of Benadryl as treatment. The reporter has assessed the relationship of study medication to the injection site as probable. (OMIC)
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: A report was received from a health professional concerning a 37 year old pt, who is a nurse and who experienced an allergic reaction after receiving a Fluvirin vaccine on 16Oct02. The pt has a medical history of latex allergy, no other allergies are known, is not allergic to eggs. On 16Oct02 the pt experienced an allergic reaction after receiving Fluvirin vaccine in the left arm. Within 10 minutes the pt developed general edema, redness from the elbow to shoulder and itching that spread to the torso. The pt was diaphoretic without shortness of breath, RR 20, HR 90, BP 142/68 mmHg. The pt medicated herself with 25mg of diphenhydramine and was seen in the ER, where 60mg of prednisone was administered. The symptoms gradually dissipated that day. The pt had received flu vaccine in previous  years and received about 3 months ago a diphtheria/tetanus vaccination. At the time of reporting the pt had recovered. The reporter has assessed the relationship of study medication to the event as probable. (OMIC)
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Skin burning sensation
Clinical narrative: A report was received from a health professional on 25Oct02, concerning seven pt who experienced red, burning, hard nodules at the site of injection, after receiving Fluvirin on 22Oct02. On 22Oct02, seven out of 68 employees who received Fluvirin at a community hospital experienced red, burning, hard nodules at the site of injection within a few hours. The pt's were seen in the ER. The vaccine was administered using a TB syringe with a prefixed needle. It was unk if the pt's recovered. The reporter provided no information on pt specific details. The reporter suspects that these adverse experiences are probably associated with this particular batch of Fluvirin. The following day, additional employees received Fluvirin from a different batch and no adverse experiences were noted. Update 1 20Feb03: A report was received from a health care professional concerning a 60 year old male vaccinee who experienced raised red induration at the injection site 15 minutes after receiving Fluvirin on 20Oct02. The vaccinee was observed in the ER and recovered on 23Oct02. Three other vaccinees had the same reaction to the same batch. See ref: PJP200300088, PJP200300089, PJP200300090.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Anorexia, Back pain, Chills, Fatigue, Insomnia
Clinical narrative: A report was received from a healthcare professional on 31Oct02, concerning a 48 year old female vaccinee who experienced back pain, lethargy, loss of appetite, insomnia, feet pain, hand pain and arm pain, approximately 72 hours after receiving Fluvirin on 25Oct02. On 28Oct02, the vaccinee experienced left arm pain (the injection arm) and then right arm pain. The pain continued in her arms and later included the palms of her hands. As a result of the pain, the vaccinee sought medical care at a local ER on 27Oct02 at 11:00PM. The feet, hand and arm pain resolved on an unspecified date. The vaccinee continued to experience back pain, lethargy, loss of appetite and insomnia up to 31Oct02. The vaccinee was scheduled for a follow up visit with her physician on 31Oct02. The reporter has assessed the relationship of the vaccine to the event as possible. Update 1, 22Jan03, A report received from a health care professional indicated that the vaccinee also experienced flu-like muscular aches and chills on 25Oct02, neuritis or nerve pains on 27Oct02, fatigue, muscle weakness, aches and stiffness on 29Oct02 and an upper respiratory infection on approx 09Nov02. The flu-like muscular aches and chills resolved on 26Oct02. The vaccinee was treated with an anti-inflammatory Naprosyn and amoxicillin, salbutamol, loratadine and fluticasone propionate for the respiratory infection. The neuritis or nerve pains, fatigue, muscle weakness, aches and stiffness had not resolved at the time of the report but had much improved. The upper respiratory infection had not resolved at the time of the report. The reporter has assessed the relationship of the vaccine to the flu-like muscle aches and chills, neuritis or nerve pains, fatigue, muscle weakness, aches and stiffness as probable and the upper respiratory infection to be presumed secondary to the compromised immune status of the vaccinee.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Lethargy, Muscular weakness, Musculoskeletal stiffness, Myalgia, Neuralgia
Clinical narrative: A report was received from a healthcare professional on 31Oct02, concerning a 48 year old female vaccinee who experienced back pain, lethargy, loss of appetite, insomnia, feet pain, hand pain and arm pain, approximately 72 hours after receiving Fluvirin on 25Oct02. On 28Oct02, the vaccinee experienced left arm pain (the injection arm) and then right arm pain. The pain continued in her arms and later included the palms of her hands. As a result of the pain, the vaccinee sought medical care at a local ER on 27Oct02 at 11:00PM. The feet, hand and arm pain resolved on an unspecified date. The vaccinee continued to experience back pain, lethargy, loss of appetite and insomnia up to 31Oct02. The vaccinee was scheduled for a follow up visit with her physician on 31Oct02. The reporter has assessed the relationship of the vaccine to the event as possible. Update 1, 22Jan03, A report received from a health care professional indicated that the vaccinee also experienced flu-like muscular aches and chills on 25Oct02, neuritis or nerve pains on 27Oct02, fatigue, muscle weakness, aches and stiffness on 29Oct02 and an upper respiratory infection on approx 09Nov02. The flu-like muscular aches and chills resolved on 26Oct02. The vaccinee was treated with an anti-inflammatory Naprosyn and amoxicillin, salbutamol, loratadine and fluticasone propionate for the respiratory infection. The neuritis or nerve pains, fatigue, muscle weakness, aches and stiffness had not resolved at the time of the report but had much improved. The upper respiratory infection had not resolved at the time of the report. The reporter has assessed the relationship of the vaccine to the flu-like muscle aches and chills, neuritis or nerve pains, fatigue, muscle weakness, aches and stiffness as probable and the upper respiratory infection to be presumed secondary to the compromised immune status of the vaccinee.