chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Diarrhoea, Headache, Neck pain, Ocular hyperaemia, Pyrexia
Clinical narrative: Fevers from 102-104 from 12/10/04 - 12/15/04.  Also experienced painful neck and headache.  Went to ER on 12/11/04.  No tests were run.  Continued to feel bad and went back to ER with fever of 103 on 12/14/04, blood tests were taken, but no answer to results.  Also experienced bloodshot eyes and blinking alot.  On 12/15/04 had diarrhea.
Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Abscess, Erythema, Myalgia
Clinical narrative: Deep muscle pain, redness: enough to look like a start of an abcess.  Manufacturer: Aventis Pasteur.  I have previously c/o simular reactions to my TB skin test and have been told "it's nothing to worry about."  The redness has increased each year from it.  So this year I was offered an alternate "preservative" and still had a reaction.  The answer they gave my was that I was not going to have anaphlaxis.  I did not say I thought it was going to happen-I just don't want to be treated for TB because I am allergic to the preservative.
Sex: F
Vaccine: HEP
Symptoms: Drug toxicity, Medication error, Nervous system disorder
Clinical narrative: Information has been received as part of a class action suit concerning a pregnant female who was vaccinated with hepatitis B immune globulin. Subsequently, she had a son who suffered the toxic neurological effects of mercury poisoning. Upon internal review, the toxic neurological effects of mercury poisoning were considered to be other important medical events (OMIC). No further information is available. This report was received from the manufacturer's legal department on 12/13/04.
Sex: F
Vaccine: HEP
Symptoms: Drug toxicity, Medication error, Nervous system disorder
Clinical narrative: Information has been received as part of a class action suit concerning a pregnant female who was vaccinated with hepatitis B immune globulin. Subsequently, the patient's daughter experienced toxic neurological effects of mercury poisoning, considered serious. The onset date was unknown. Relevant history and concomitant medications were not provided. The outcome of the event was unknown. Toxic neurological effects of mercury poisoning was considered to be an other important medical event (OMIC). No further information is available. This report was received from the manufacturer's legal department on 12/14/04.
Sex: F
Vaccine: HEP
Symptoms: Drug toxicity, Medication error, Nervous system disorder
Clinical narrative: Information has been received as part of a class action suit concerning a pregnant female who was vaccinated with hepatitis B immune globulin. Subsequently, the patient's son experienced toxic neurological effects of mercury poisoning, considered serious. Onset date was unknown. Relevant history and concomitant medications were not provided. The outcome of the event was unknown. Toxic neurological effects of mercury poisoning was determined to be an other important medical event (OMIC). No further information is available. This report was received from the manufacturer's legal department on 12/13/04.
Sex: F
Vaccine: HEP
Symptoms: Drug toxicity, Medication error, Nervous system disorder
Clinical narrative: Information has been received as part of a class action suit concerning a pregnant female patient who was vaccinated with a dose of hepatitis B immune globulin. Subsequently, her son experienced toxic neurologic effects of mercury poisoning. Outcome is unknown. Toxic neurologic effects and mercury poisoning were considered other important medical events (OMIC). No additional information was provided. This report was received from the manufacturer's legal department on 12/13/04.
Sex: F
Vaccine: HEP
Symptoms: Drug toxicity, Medication error, Nervous system disorder
Clinical narrative: Information has been received as part of a class action suit concerning a pregnant female who was vaccinated with hepatitis B immune globulin. Subsequently, her son experienced toxic neurological effects of mercury poisoning. Outcome is unknown. Toxic neurological effects and mercury poisoning were considered other important medical events (OMIC). No additional information was provided. This report was received from the manufacturer's legal department on 12/13/04.
Sex: F
Vaccine: HEP
Symptoms: Drug toxicity, Medication error, Nervous system disorder
Clinical narrative: Information has been received as part of a class action suit concerning a pregnant female who was vaccinated with hepatitis B immune globulin. Subsequently, her son experienced toxic neurological effects of mercury poisoning. Outcome is unknown. Toxic neurological effects and mercury poisoning were considered other important medical events (OMIC). No further information was provided. This report was received from the manufacturer's legal department on 12/13/04.
Age: 50.0
Sex: M
Vaccine: MEN
Symptoms: Condition aggravated
Clinical narrative: From initial information received on 12/20/04 from a physician regarding an adverse event occurring in the USA, it was reported that an approximately 50 year old male patient received MENOMUNE A/C/Y/W-135, sometime in November 2004 (exact date was not reported). The route and site of administration were not reported and the physician reported that the lot number information was not documented. Four to five days after receiving the vaccine, the patient developed an exacerbation of multiple sclerosis. The reporting physician did not have the patient information at the time of this report, but reportedly will be able to access it at a later date. It was not reported whether the patient recovered from this event. (OMIC)
Sex: F
Vaccine: HEP
Symptoms: Drug toxicity, Medication error, Nervous system disorder
Clinical narrative: Information has been received from as part of a class action suit concerning a pregnant female who was vaccinated with hepatitis B immune globulin. Subsequently, the patient's son experienced mercury poisoning and neurological disorder. Upon internal review. neurological disorder and mercury poisoning were considered other important medical events (OMIC). No further information is available. This report was received from the manufacturer's legal department on 12/13/04.
Sex: F
Vaccine: HEP
Symptoms: Drug toxicity, Medication error, Nervous system disorder
Clinical narrative: Information has been received as part of a class action suit concerning a pregnant female who was vaccinated with hepatitis B immune globulin. Subsequently, the patient's son experienced neurological disorder and mercury poisoning. Upon internal review, neurological disorder and mercury poisoning were considered other important medical events (OMIC). No further information is available. This report was received from the manufacturer's legal department on 12/13/04.
Sex: F
Vaccine: RAB
Symptoms: Laryngeal oedema
Clinical narrative: A female patient (age unspecified) experienced laryngeal edema following treatment with RabAvert for an unspecified indication. The dates and dosages of RabAvert, past medical history, and concomitant medications were not specified. The patient developed laryngeal edema necessitating hospitalization. The outcome was unknown at the time of this report.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Erythema, Feeling hot, Pain, Pyrexia
Clinical narrative: Very swollen, red, hot area encompassing whole upper arm from shoulder to elbow. Extreme pain, fever. Follow up: Reporter states diagnosis was cellulitis of the right arm.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Swelling
Clinical narrative: Very swollen, red, hot area encompassing whole upper arm from shoulder to elbow. Extreme pain, fever. Follow up: Reporter states diagnosis was cellulitis of the right arm.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Localized 8x9cm erythematous area at site of injection within 8 hours of administration.
Age: 29.0
Sex: M
Vaccine: FLUN3
Symptoms: Erythema, Rhinitis, Swelling
Clinical narrative: Redness and swelling around nose.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation mucosal, Dysgeusia, Paraesthesia oral, Pruritus, Tongue disorder
Clinical narrative: Metallic taste in mouth, burning/ tingling lips and tongue: intense itching.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives started day after getting shot. Then got progressively worse. Went to ER given Benadryl. Went to doctor's office and given Prednisone dose pack. Symptoms resolved.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Severe arm pain, decreased mobility of arm.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Diarrhoea, Nausea, Pain
Clinical narrative: Received Flu vaccine 12/2 at 1500: 12/2 developed chills, nausea at 20:00, 12/3 : chills, nausea, 12/4 chills, nausea, pain right hip to right knee. 12/5,12/6: vomiting/ diarrhea. 12/8: saw physician, Medrol dose pack: relief from pain. 12/9: pain right hip, right knee. Right knee replacement 2000 and right gamma rod rt femur 5/2003.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccine positive rechallenge, Vomiting
Clinical narrative: Received Flu vaccine 12/2 at 1500: 12/2 developed chills, nausea at 20:00, 12/3 : chills, nausea, 12/4 chills, nausea, pain right hip to right knee. 12/5,12/6: vomiting/ diarrhea. 12/8: saw physician, Medrol dose pack: relief from pain. 12/9: pain right hip, right knee. Right knee replacement 2000 and right gamma rod rt femur 5/2003.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site swelling, Pruritus
Clinical narrative: Patient noticed red, slightly raised area 2.5" diameter approximately 24 hours after the vaccine injection. It is less red, but slightly itchy and still 2.5" in diameter after six weeks.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Heart rate increased
Clinical narrative: Heart rate increased
Age: 1.04
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Over 25 chicken pox
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperglycaemia, Hypoaesthesia, Laboratory test abnormal, Paraesthesia
Clinical narrative: Numbness and tingling : tips of all fingers (index worst) and toes: began three days after flu vaccine. History stage 4 ovarian cancer. Treated June 02 to Nov 03 with Caneoplatinum and Taxotene (No pain history or ongoing symptoms)
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: Left arm. Thursday evening had temp of 102 x 2 inch red circle around site of injection. Fri AM more redness and by Friday afternoon around 3:30, arm was very swollen, red, hot, hard from shoulder to elbow. Treated in Emergency department with IM antibiotics. is on 10  day course of abx. On 12/14/04 mild swelling remains, but symptoms much improved.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Swelling
Clinical narrative: Left arm. Thursday evening had temp of 102 x 2 inch red circle around site of injection. Fri AM more redness and by Friday afternoon around 3:30, arm was very swollen, red, hot, hard from shoulder to elbow. Treated in Emergency department with IM antibiotics. is on 10  day course of abx. On 12/14/04 mild swelling remains, but symptoms much improved.
Age: 7.0
Sex: F
Vaccine: FLU3, HEPA, TD
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Swelling right thigh 10x9.5 cm with erythema and warm to touch at sit of Td left thigh, Hep A right thigh, Flu vaccine right thigh given 12/15/04. Reported by parent on 12/17/04. Given Keflex and Benadryl.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Rash, Urticaria
Clinical narrative: Left arm at injection site became red and rash started 12/6 pm. Progressed to hives over body during night and through 12/7. Saw own primary care physician and obstetrician. Hives improving with Benadryl and Zantac.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Nausea, Pruritus
Clinical narrative: Right arm started itching later in day, no redness noted at site. 12/9/2004 increased itching with nickel size red area at injection site. Started nausea evening 12/9. 12/10 am injection site reddened, raised around 2.5-3cm, nausea persisted 12/10/04 3 pm denies, nausea.
Age: 1.19
Sex: F
Vaccine: DTAP
Symptoms: Feeling hot, Oedema
Clinical narrative: Left thigh edematous 9x13cm warm to touch.
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Condition aggravated, Cough, Diarrhoea, Dizziness
Clinical narrative: Has taken flu vaccine for 5-6 years with no problem. On 12/20 at 7:00pm noticed red hives around mouth area but notes that she usually gets those when weather changes. On 12/21 woke up with headache, took two Tylenol, felt more tired than normal. Fell asleep at 8:00pm for 3.5 hours which is very unusual. According to mom was coughing while sleeping. On 12/22 took two Tylenol again, felt okay during day but at night started losing voice. On 12/23 felt dizzy, weak, coughing, lost voice , started to use inhaler every four hours. Had muscle cramps (even on feet) and chills. On 12/24: coughing spasms started, muscle aches continued, sore throat, headaches coming and going, coughing phlegm. Vomiting and diarrhea started. On 12/25 : continued to throw up until it subsided on Sunday. Today 12/27 feels much better.
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Dysphonia, Fatigue, Headache, Muscle spasms, Myalgia
Clinical narrative: Has taken flu vaccine for 5-6 years with no problem. On 12/20 at 7:00pm noticed red hives around mouth area but notes that she usually gets those when weather changes. On 12/21 woke up with headache, took two Tylenol, felt more tired than normal. Fell asleep at 8:00pm for 3.5 hours which is very unusual. According to mom was coughing while sleeping. On 12/22 took two Tylenol again, felt okay during day but at night started losing voice. On 12/23 felt dizzy, weak, coughing, lost voice , started to use inhaler every four hours. Had muscle cramps (even on feet) and chills. On 12/24: coughing spasms started, muscle aches continued, sore throat, headaches coming and going, coughing phlegm. Vomiting and diarrhea started. On 12/25 : continued to throw up until it subsided on Sunday. Today 12/27 feels much better.
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria, Vomiting
Clinical narrative: Has taken flu vaccine for 5-6 years with no problem. On 12/20 at 7:00pm noticed red hives around mouth area but notes that she usually gets those when weather changes. On 12/21 woke up with headache, took two Tylenol, felt more tired than normal. Fell asleep at 8:00pm for 3.5 hours which is very unusual. According to mom was coughing while sleeping. On 12/22 took two Tylenol again, felt okay during day but at night started losing voice. On 12/23 felt dizzy, weak, coughing, lost voice , started to use inhaler every four hours. Had muscle cramps (even on feet) and chills. On 12/24: coughing spasms started, muscle aches continued, sore throat, headaches coming and going, coughing phlegm. Vomiting and diarrhea started. On 12/25 : continued to throw up until it subsided on Sunday. Today 12/27 feels much better.
Sex: U
Vaccine: DTAP, HEPA
Symptoms: Erythema, Feeling hot, Injection site induration, Swelling
Clinical narrative: hot, red, swollen, hard. The parent noticed the next morning 12/15/04. MD gave him an antibiotic and antihistamine. Keflex and Decodron.
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Patient came to office for 4 year old well child exam requiring vaccinations. She received DTaP and IPV to left deltoid and MMR to right arm. She presented the next day with other complaining of redness, swelling and pain to left upper arm.
Age: 5.0
Sex: F
Vaccine: DTP, IPV, MMR
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 0.58
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Coma, Gaze palsy, Musculoskeletal stiffness
Clinical narrative: Sudden onset stiffening while sitting in chair. Eyes back in head, unresponsive, no cyanosis. Taken to hospital via ambulance.
Sex: F
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Symptoms c/w chicken pox
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Symptoms c/w chicken pox
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Fluid retention, Injection site erythema
Clinical narrative: Pt had red fluid filled area the size of a fifty cent piece just below injection site area around  that red but not raised.
Age: 1.01
Sex: F
Vaccine: HEP, HIBV, MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Symptoms c/w chicken pox
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Tenderness
Clinical narrative: Left deltoid red, tender, cellulitis. Tx: Keflex 250/5 1 1/2 tab bid x 10 days.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: Client called to report that injection site on left arm began feeling itchy PM of injection and proceeded to develop swelling, redness and heat down to the elbow and on the inner upper arm. States she had a PNU vaccine 6 yrs ago at PP's. Referred to call private MD to follow up. 10/12 follow up call to client, states her arm is back to normal and redness and swelling is gone. Dr. did not put her on meds. Not able to identify previous PNU date.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Pt developed chickenpox
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Urticaria
Clinical narrative: Site red, swollen and hot, hives
Age: 70.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Feeling hot, Injection site pain
Clinical narrative: Pt received pneumococcal vaccine 12/3/04 pt called clinic with symptoms of hot spots on AM when MD spoke with pt, pt stated symptoms improved c/o sore arm Monday 12/6/04.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Injection site pain, Syncope
Clinical narrative: Pneumococcal vaccine given on 12/2/04, pt experienced extreme pain in arm, weak, dizzy, faint, symptoms in the evening of 12/02/04. Symptoms passed after half hour. Pt called office in AM noted poss. reaction to vaccine on chart.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Influenza like illness, Injection site pain, Insomnia
Clinical narrative: Pt was called by clinic to follow based on prior pt's having some symptoms related to same vaccine. Pt received pneumococcal vaccine 12/8/04 pt noted sore arm, difficulty sleeping, next day felt like stomach flu, achy sore arm, 12/10/04 arm better, slept better.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema
Clinical narrative: Received pneumococcal vaccine on 12/7/04 pt called office on Thursday c/o redness/ swelling and saw MD on Friday 12/10/04. Tx with Abx for bacterial cellulitis.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Received pneumococcal vaccine on 12/7/04 called office on Thursday c/o redness/swelling arm pain, MD treated with ABx Dx with Bacterial cellulitis.
Age: 1.26
Sex: F
Vaccine: DTPHIB, MMR
Symptoms: Viral infection
Clinical narrative: Developed varicella after vaccination. Follow up 01/19/05: Vaccination given at another facility, manufacturer unknown.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Itchy, red hives on body. Continued for several months. Treated with Benadryl, cortisone.
Age: 0.6
Sex: M
Vaccine: IPV
Symptoms: Agitation, Irritability
Clinical narrative: Began with irritability and inconsolable fussiness the evening after receiving IPV vaccine. This behavior continued into the next day.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Headache, Pharyngitis, Pyrexia, Viral infection
Clinical narrative: 11/22/04 onset severe arthralgia, fever, unrelieved by Motrin 400mg every 4-6 hours symptoms increase with T 102 F on 11/23/04. No relief with Motrin 600mg every 4 hours. c/o pharyngitis, headache, continued joint pain. Saw physician on 11/24/04. Received Dx of possible viral illness. Symptoms completely resolved by 11/28/04, returned to normal activity.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Hyperhidrosis, Hypoaesthesia, Malaise, Syncope
Clinical narrative: From initial information received on 24OCT2003 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 54 year old male patient received a dose of FLUZONE , administered IM in the left deltoid on 21OCT2003 at 9:45AM. 75 minutes later, at 11:00AM, the patient states that he was not feeling well and was feeling faint. He was diaphoretic and complained of dyspnea and numbness in this right arm. His vital signs were taken and his blood pressure was 80/60 , pulse 60 and respiration 24. The patient was taken to the ER via ambulance and his treatment included Benadryl , given IV over one minute. He stayed for observation and was later discharged. On 22OCT2003, the pt had returned to work, but stated that he did not feel that good yet. He reported that he had Benadryl to take if needed. It was reported that the patient had recovered form these events.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Cellulitis, Injection site erythema, Joint swelling, Pharyngeal oedema
Clinical narrative: From initial information received on October 20,2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that two patients received a dose of Fluzone SV '2003-'2004 USP, lot number U1076AA, (route and site of administration not reported) on an unspecified date.  An unspecified time after administration of the vaccine, the patients developed swollen tongues and throats.  The recovery status was not reported. From additional information received on October 23,2003 from a healthcare professional, it was reported that a 53 year old female patient received Fluzone SV '2003-'2004 USP, lot number U1270AA, administered intra-muscularly in the left arm on October 07,2003 at 1:00PM.  Five hours later, the patient developed a sore arm with erythema at site of injection.  Over the next several hours, it progressed to cover the upper front half of the arm and the patient also experienced swelling to the elbow.  She also developed tongue swelling and developed small tongue blisters and upper respiratory congestion.  The patient required an emergency room/doctor visit and she was treated with Benadryl over the first 24 hours and Keflex for mild cellulitis of the upper arm.  The mouth swelling resolved within 12 hours and the respiratory congestion lasted 24 hours.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Tongue oedema, Upper respiratory tract infection
Clinical narrative: From initial information received on October 20,2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that two patients received a dose of Fluzone SV '2003-'2004 USP, lot number U1076AA, (route and site of administration not reported) on an unspecified date.  An unspecified time after administration of the vaccine, the patients developed swollen tongues and throats.  The recovery status was not reported. From additional information received on October 23,2003 from a healthcare professional, it was reported that a 53 year old female patient received Fluzone SV '2003-'2004 USP, lot number U1270AA, administered intra-muscularly in the left arm on October 07,2003 at 1:00PM.  Five hours later, the patient developed a sore arm with erythema at site of injection.  Over the next several hours, it progressed to cover the upper front half of the arm and the patient also experienced swelling to the elbow.  She also developed tongue swelling and developed small tongue blisters and upper respiratory congestion.  The patient required an emergency room/doctor visit and she was treated with Benadryl over the first 24 hours and Keflex for mild cellulitis of the upper arm.  The mouth swelling resolved within 12 hours and the respiratory congestion lasted 24 hours.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Injection site erythema, Injection site swelling, Pharyngeal oedema, Pulmonary congestion
Clinical narrative: From  initial information received on 20OCT2003, which did not contain any identifiable patient information, and additional information received on 23OCT2003 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 32 year old female patient received Fluzone 2004USP, administered IM in the left a4rm on 16OCT2003 at 12:00PM. The patient had received two previous influenza immunizations in the pat. Four hours later, the patient developed a local reaction of erythema and swelling at the site, which progressed to cover the upper third of the arm. The patient also developed selling at the back of her throat with upper respiratory congestion, which lasted approximately two days. The patient was given Benadryl for her symptoms. Her pre-existing medical conditions include asthma and hypertension. Reportedly, the patient recovered form this event. The reporter of this case is the same reporter of case 200302661
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Feeling hot, Headache, Injection site erythema, Injection site mass
Clinical narrative: Injection site cellulitis - Injection site erythema Injection site warmth Injection site mass Headache From initial information received on 10/27/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 35 year old female patient received a dose of Fluzone SV 2003-2004 USP, lot number U1270AA, administered in the left triceps on 10/22/2003 ay 11:00 AM. The following day, the patient developed a headache. She also had erythema and a wheal measuring 6cm x 4.5cm at the injection site, which was also warm to the touch. The patient applied heat to the region. She went to the emergency room where she was given antibiotics for cellulitis of the left triceps. The patient had previously received the influenza vaccine approximately five to eight times in past years. Reportedly, the patient recovered from these events.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Injection site cellulitis - Injection site erythema Injection site warmth Injection site mass Headache From initial information received on 10/27/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 35 year old female patient received a dose of Fluzone SV 2003-2004 USP, lot number U1270AA, administered in the left triceps on 10/22/2003 ay 11:00 AM. The following day, the patient developed a headache. She also had erythema and a wheal measuring 6cm x 4.5cm at the injection site, which was also warm to the touch. The patient applied heat to the region. She went to the emergency room where she was given antibiotics for cellulitis of the left triceps. The patient had previously received the influenza vaccine approximately five to eight times in past years. Reportedly, the patient recovered from these events.
Age: 61.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain
Clinical narrative: From initial information received on 10/11/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 60 year old male patient received FLUZONE SV '2003-'2004 USP, lot number U1148CA, administered intramuscularly in left deltoid, and a first dose of PNEUMOVAX 23, lot number 0988N, administered in the right deltoid on 10/29/2003 at 10:00 AM, 14 hours later, at midnight on 10/30/2003, the patient developed a very large area of erythema (redness) measuring approximately 14 inches to 16 inches long and approximately four to five inches wide. The area extended from in front of the armpit tp below the elbow on the inner aspect of the arm. There was no itching, but the arm was a little sore. The patient was seen by a physician on 10/31/2003 and was treated with Allegra, Tylenol and ice to the area. The patient recovered from this event as of 10/31/2003. No other information was reported.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Cellulitis, Neuroma, Pain in extremity, Phlebitis
Clinical narrative: From initial information received on 11/13/2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 28 year old female patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1097AA, administered intra-muscularly in the right deltoid on 10/16/2003 at 10:00AM.  10 days later, on 10/26/2003 at 7:00AM, the patient awok with pain in her foot.  She did not have any known injuries.  Three days later, on 10/29/2003, the pain had moved from her foot into her ankle.  A neuroma vs cellulitis/phlebitis was suspected.  She was prescribed unspecified antibiotics.  On 11/03/2003, the fourth day of being on the antibiotics, she had a positive tendon range of motion and her legs were stable.  She did have pain in the anterior tibial tendon (described as a third of the way up), as well as pain upon palpation of the arch of her foot (plantar and dorsal).  The patient was referred to another physician, where her symptoms were diagnosed as viral synovitis.  The patient's recovery status is currently unknown at the time of the report.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Synovitis
Clinical narrative: From initial information received on 11/13/2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 28 year old female patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1097AA, administered intra-muscularly in the right deltoid on 10/16/2003 at 10:00AM.  10 days later, on 10/26/2003 at 7:00AM, the patient awok with pain in her foot.  She did not have any known injuries.  Three days later, on 10/29/2003, the pain had moved from her foot into her ankle.  A neuroma vs cellulitis/phlebitis was suspected.  She was prescribed unspecified antibiotics.  On 11/03/2003, the fourth day of being on the antibiotics, she had a positive tendon range of motion and her legs were stable.  She did have pain in the anterior tibial tendon (described as a third of the way up), as well as pain upon palpation of the arch of her foot (plantar and dorsal).  The patient was referred to another physician, where her symptoms were diagnosed as viral synovitis.  The patient's recovery status is currently unknown at the time of the report.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Syncope
Clinical narrative: From initial information received on 11/13/2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 71 year old female patient received Fluzone SV'2003-'2004 USP, lot number U1095AA, administered intra-muscularly in the left deltoid on 10/20/2003 at 1:20PM.  Five minutes later, the patient told her husband the she was 'going to pass out'.  At 1:30PM, the patient was not responsive to sternal rub.  She was put on the floor with her legs in the air.  She became responsive and was alert and oriented to person, place and time.  The patient was flushed.  At 1:35PM, she was sitting up and nausea was noted.  She was transferred to a stretcher at 1:37PM.  Her blood pressure was 156/90 at that time.  At 2:04PM the patient was ambulatory and refused to use a wheelchair.  She was instructed to call her primary care physician.  The patient recovered from these events. The reporter of this case is the same reporter of case 2003-02988.
Age: 25.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Rash
Clinical narrative: From initial information received on 11/14/2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 24 year old male patient received his second dose of Fluzone SV '2003-'2004 USP, lot number U1255AA, administered intra-muscularly in the right deltoid, and a second dose of Hepatitis A vaccine, lot number 0981M, administered intra-muscularly in the left deltoid on 11/10/2003 at 6:00PM.  Approximately one to one and a half hours later, the patient developed a raised rash on his neck, back, flank, and thighs.  Nothing was noted at the immunization sites.  The patient's mother gave him Benadryl and the rash vanished later that evening with no recurrence.  Reportedly, the patient recovered from these events.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site oedema, Injection site pain, Pain, Skin discolouration
Clinical narrative: Injection site reaction - injection site discoloration - injection site edema - injection site pain From initial information received on 11/25/2003 from a registered nurse regarding an adverse event occurring in the U.S.A., it was reported that a 49 year old female patient received a dose of FLUZONE SV '2003-'2004 USP, lot number U1081AA, administered intra-muscularly in the left deltoid on 10/21/2003 at 3:00 PM. 16.5 hours later, on 10/22/2003 at 7:30 AM, the patient developed an injection site reaction consisting of discoloration, edema and soreness. The soreness extended under her arm. Treatment included ice packs and Benadryl 50 mg every four to six hours as necessary. Reportedly, the patient recovered from these events. The reporter of this case is the same as for case U2002-01131.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Pyrexia
Clinical narrative: From initial information received on 13Nov03 from a health care professional regarding an adverse event occurring, it was reported that a 73 year old male pt received a dose of Fluzone SV 2003-2004 USP, lot number U1076AA, administered IM in the left arm on 21Oct03. Four days later, the pt developed a fever (no temp provided) and general malaise. The pt was hospitalized with a diagnosis of fever, etiology to be determined. The pt was hospitalized for eight days and was discharged on 02Nov03. The pt's recovery status is currently unk. 22Sep04: Despite continued attempts to obtain follow up, no further information was provided. No further information is anticipated, this case is considered closed.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Injection site erythema, Injection site rash
Clinical narrative: From initial information received on 15Dec03 from a physician regarding an adverse event occurring, it was reported that a 60 year old male pt received a dose of Influenza vaccine, lot number 765666, administered IM in the left arm. Reportedly, the lot number does not match that of the manufacturer's Influenza vaccine. Immediately after immunization, the pt developed a red rash on the left side from elbow to shoulder, which lasted one week and arthralgias, which started eight hours after vaccination and have persisted since. Reportedly, the pt is improving. No other information was provided at this time.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: From initial information received on 12/12/03, from a health care professional regarding an adverse event occurring in the USA, it was reported a 3 year old male patient received his first dose of Fluzone SV '2003-'2004 USP, lot number U1260AA, administered in the right leg (route of administration not reported), on 12/03/03 after 1-3 PM. Three days later at 8:00 AM of 12/06/03, the patient developed clear liquid vomiting. There was no fever, chills or diarrhea. The patient was in the emergency room twice and then was seen in another room. Reportedly, the patient recovered from this event.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: From initial information received on 11/24/03 from the patient's parents regarding an adverse event occurring in the USA, it was reported that a 6 year old male patient received a dose of Fluzone SV '2003-'2004 USP, lot number, route and site of administration not reported, on 11/13/03. Two days later, on 11/15/03, the patient developed a rash over his body. He was treated with Benadryl orally every 6 hours and steroids. The patient's recovery status is currently unknown. His past medical history is significant for allergies to penicillin, sulfa and cephalosporins, for which he develops a rash.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Influenza like illness, Pain, Pyrexia
Clinical narrative: From initial information received on 11/12/2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 70 year old female patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1260AA, on 09/30/2003.  The route and site of administration were not reported.  Seven days after receiving the vaccine, the patient developed muscle weakness.  The patient's recovery status is currently unknown. From additional information received on 02/23/2004 from a physician, the patient's full name and address as well as her date of birth were provided.  The reporter's fax number was also provided.  The patient received the vaccine in Los Angeles county on 09/30/2003 at 11:00AM, administered intra-muscularly in her right deltoid.  The following day, the patient developed muscle aches, flu-like symptoms, fever and weakness in her arms and legs.  She was treated with Neurontin, Vicodin and vitamin B6 therapy.  At the time of vaccination, the patient also took Cozaar 50mg twice daily, Mevacor 20mg once a day, Prilosec 20mg once a day, Amitriptyline daily, Catapres, Neurontin and Cipro 50mg twice daily for 10 days for urinary tract infection.  Reportedly the patient received two previous doses of the Fluzone vaccine, one in 2001 and one in 2002.  The patient's past medical history includes allergic rhinitis and she has allergies to penicillin, all sulfa drugs, Valium, iodine, Propulsid, aspirin, theophylline, estrogen, zaroxolyn, procardia and prednisone.  Reportedly, the patient did not recover from these events. From additional information received on 07/07/2004 from the reporting facility, it was reported that the information has been reviewed on 06/28/2004 and no additional information is available at this time. Further information is not anticipated.  This cases is considered closed.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Influenza like illness, Muscular weakness, Myalgia, Pyrexia, Urinary tract infection
Clinical narrative: From initial information received on 11/12/2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 70 year old female patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1260AA, on 09/30/2003.  The route and site of administration were not reported.  Seven days after receiving the vaccine, the patient developed muscle weakness.  The patient's recovery status is currently unknown. From additional information received on 02/23/2004 from a physician, the patient's full name and address as well as her date of birth were provided.  The reporter's fax number was also provided.  The patient received the vaccine in Los Angeles county on 09/30/2003 at 11:00AM, administered intra-muscularly in her right deltoid.  The following day, the patient developed muscle aches, flu-like symptoms, fever and weakness in her arms and legs.  She was treated with Neurontin, Vicodin and vitamin B6 therapy.  At the time of vaccination, the patient also took Cozaar 50mg twice daily, Mevacor 20mg once a day, Prilosec 20mg once a day, Amitriptyline daily, Catapres, Neurontin and Cipro 50mg twice daily for 10 days for urinary tract infection.  Reportedly the patient received two previous doses of the Fluzone vaccine, one in 2001 and one in 2002.  The patient's past medical history includes allergic rhinitis and she has allergies to penicillin, all sulfa drugs, Valium, iodine, Propulsid, aspirin, theophylline, estrogen, zaroxolyn, procardia and prednisone.  Reportedly, the patient did not recover from these events. From additional information received on 07/07/2004 from the reporting facility, it was reported that the information has been reviewed on 06/28/2004 and no additional information is available at this time. Further information is not anticipated.  This cases is considered closed.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal distension, Herpes zoster, Pain, Rash
Clinical narrative: From initial information received on 2/18/04 from the patient, regarding an adverse event occurring in the USA, it was reported that the 65 year old female received a dose of Fluzone, lot number U1256AA, administered in the right deltoid on 11/5/03. Two days later, the patient developed severe pain in the upper right quadrant, which extended to the spine upon going in to a sitting position or turning. She also described a feeling of fullness like a balloon inside. She stated that the pain was less severe when walking. Reportedly, the patient also developed shingles on an unspecified date. She was seen by a physician and treated with unspecified medication for shingles, as well as pain medication. Reportedly, the patient did not recover from these events and was still experiencing the feeling fullness at the time of this report. From additional information received on 6/28/04 from the patient, it was reported that the patient started to experience symptoms two days after immunization. Symptoms were treated with a total of five shots of Toradol administered IM. Reportedly, the patient continues to occasionally experience a feeling of fullness in the lower and upper abdomen, but it is less frequent and no longer feels like a balloon. At the time of vaccination, the patient was taking Fosamax for osteoporosis, Lotensin for high blood pressure and Lipitor for high cholesterol. She was still experiencing a pain in her left leg from a fracture. Pre-existing medical conditions include osteoporosis, elevated blood pressure, and elevated cholesterol. In addition, the patient provided the name and address of the physician who treated the symptoms.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal distension, Abdominal pain upper, Herpes zoster
Clinical narrative: From initial information received on 2/18/04 from the patient, regarding an adverse event occurring in the USA, it was reported that the 65 year old female received a dose of Fluzone, lot number U1256AA, administered in the right deltoid on 11/5/03. Two days later, the patient developed severe pain in the upper right quadrant, which extended to the spine upon going in to a sitting position or turning. She also described a feeling of fullness like a balloon inside. She stated that the pain was less severe when walking. Reportedly, the patient also developed shingles on an unspecified date. She was seen by a physician and treated with unspecified medication for shingles, as well as pain medication. Reportedly, the patient did not recover from these events and was still experiencing the feeling fullness at the time of this report. From additional information received on 6/28/04 from the patient, it was reported that the patient started to experience symptoms two days after immunization. Symptoms were treated with a total of five shots of Toradol administered IM. Reportedly, the patient continues to occasionally experience a feeling of fullness in the lower and upper abdomen, but it is less frequent and no longer feels like a balloon. At the time of vaccination, the patient was taking Fosamax for osteoporosis, Lotensin for high blood pressure and Lipitor for high cholesterol. She was still experiencing a pain in her left leg from a fracture. Pre-existing medical conditions include osteoporosis, elevated blood pressure, and elevated cholesterol. In addition, the patient provided the name and address of the physician who treated the symptoms.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Anorexia, Arthralgia, Chills, Diarrhoea, Dizziness
Clinical narrative: From initial information received on 02/25/04 from a county health service regarding an adverse event occurring in the USA, it was reported that a 49 year old female patient received a Fluzone SV '2003-'2004 USP vaccination, lot number U194AA, administered intramuscularly in the left deltoid, and a Pneumovax 23 vaccination, lot number 0029N, administered intramuscularly in the right deltoid on 11/10/03 at 5:00 PM. Thirty minutes later the patient noted dizziness at home. At 8:00 PM, the patient went to bed with soreness of both arms with the left on being worse that the right. She experienced absolute fatigue, headache and sinus feeling pressure. She took Tylenol, Ibuprofen and another medication for relief. The patient " had a rough night up six times to get relief of pain, aches in knees in the night". On 11/12/03, the symptoms "kind of lifted". Her left arm was still sore, shoulder joint to knuckles stiff and could not be used, muscles felt sore and injection site was hot. Her right arm had minimal soreness. She felt miserable and had no appetite. Her sinus headache went to a migraine in the afternoon. She took a long nap, couldn't quite put her knees together and she ached. In the afternoon, she felt chilled. At 6:00 Pm she began shivering under three quilts, vomited and diarrhea started. She was taking a lot of Ibuprofen. On 11/13/03, the headache resolved, but she couldn't bend her elbow. She slept in the afternoon and felt better so she went to work. As she was driving she became hot and could no longer drive. She felt like " I had run a marathon". She went to the doctor for another reason and the doctor noted a fast heart rate. On 11/14/03, her arm began to bend. Her stomach was upset and she didn't want to eat. She began to have a sinus headache, more diarrhea and noted dark stools. She experienced a nosebleed and dizziness at intervals. It was at this time the patient called the county health service and was encouraged to seek medical attention and to report the above events at which time she refused. On 11/15/03, the patient did not eat breakfast, did not have an appetite and had a nervous stomach. She denied any headache and migraine and can now move her fingers. Her knee aches and elbow aches have subsided. On 11/20/03, her shoulder to elbow was stiff. On 11/30/03, she experienced stiffness and aches. The patient has stated "I have had 4 bouts of flu like symptoms about every 10 days following my shot". The patient did not seek medical evaluation from her medical provider because she has had reactions in the past and reportedly physician thinks she is somewhat of a hypochondriac. The patient has completely recovered from these events. From additional information received on 09/13/04 from the initial reporter, the patient was not on any other medications at the time of vaccination. The patient refused to go to a medical provider. The reporter stated that the case was reviewed and that there is no additional information at this time. No further information is anticipated, this cause is considered closed.