chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Influenza, Myalgia, Pyrexia
Clinical narrative: Approximately four hours after administration of flu vaccine (and concurrent pneumococcal vaccine), patient felt flu symptoms.  Within 2-3 hours, full case of flu developed with chills/fever, full-body muscle aching, eye irritation, dry cough, headache, fatigue.  Patient spent next 36 hours in bed.  Fever broke after appox. 30 hours.  Dry cough persists into fourth day after vaccination.  Treatment was bed rest, aspirin, OTC cough suppressant.  Patient is not illness-prone, has not had flu for more than five years prior.  Patient in generally strong health, except for Type II diabetes, which is well controlled by diet, medication, and exercise.  No adverse reaction with any prior influenza vaccination.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Cough, Difficulty in walking, Nasal congestion, Pain, Pharyngolaryngeal pain
Clinical narrative: Developed body aches, sore throat, cough, conjestion and weakness of lower extremities approximately 6 days after vaccination.  No photophobia or nuchal rigidity.  Patient requires assistance with ambulation due to lower extremity weakness.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure increased, Dehydration, Muscle spasms, Tremor, Vomiting
Clinical narrative: PPV at 8:15 am. 4 PM - Severe muscle cramps in arm; 7:30 PM severe body shaking, severe teeth chattering, some swelling in arm, dehydration; vomiting; no temp.; increased blood pressure.
Age: 90.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Discomfort, Injection site erythema, Injection site swelling
Clinical narrative: PT REPORTED DISCOMFORT OF LUE AND RN NOTED REDNESS AND MINIMAL SWELLING APPROX. 6"x3" BEGINNING APPROX. 1" BELOW INJECTION SITE AND EXTENDING TOWARDS ELBOW AND AROUND ARM POSTERIORLY.  ICE PACK WAS APPLIED TO SITE.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Swelling
Clinical narrative: VACCINE DTAP (RT DELTOID) AND PPD ARE GIVEN ON 12/06/05, COMES BACK 12/08/2005 FOR PPD READING AND RT UPPER ARM RED AND SWOLLEN FROM MEDIAL TO LATERAL AREA OF UPPER ARM. AREA MARKED, BENADRYL GIVEN, MOM TOLD TO CALL PCP TODAY FOR F/U. CHILD IS WITHOUT DISTRESS, NO FEVER, DOES NOT APPEAR ILL. WILL CALL MOM TOM TO F/U. MOM CALLED 12/07 REGARDING ARM AND WAS TOLD TO USE ICE AND TYLENOL FOR DISCOMFORT.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: The patient received his flu vaccine injection in the upper left deltoid muscle between 10AM and 11AM on 11/6/05.  At the time of immunization he did not complain of pain.  Later that day he experienced sharp pain in the injection area when lifting it and has had continued pain since that time associated with lifting of the arm or going through a range of motion (eg., when applying deoderant he can only lift his arm to about 90 degrees-- he cannot lift his arm any further without pain.  He does not experience pain upon touching or pressing his arm, only upon lifting or moving in a range of motion. He has not seen a physician at this point (12/8/2005).
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site induration, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Extreme swelling of her arm from shoulder to elbow.  Red, hard and very hot entire upper arm. Shot given Friday afternoon December 2.  Swelling started Saturday morning (Dec 3).  Patient seen back at the clinic Sunday evening (Dec 4) due to severe pain.  Patient started on antibotics and topical cream.  Patient seen again Monday evening Dec 5.  Swelling had become worse. Patient has continued treament and swelling has gone down.  Area is still hard, but temperature has returned to normal (Dec 8).
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Fatigue, Pyrexia, Rash, Somnolence
Clinical narrative: Baby developed rash almost immediately after receiving immunizations. Parents also reported baby acting tired and sleepy. Child's pediatrician notified 12/08/2005 rash gone, baby has low grade fever 100.
Age: 26.0
Sex: F
Vaccine: FLU3, HEPAB, TD, TYP
Symptoms: Abdominal pain, Nausea, Vomiting
Clinical narrative: 10/25/05 abdominal cramps since she had taken 1st oral typhoid 3 hours eariler. Pt also described nausea and vomiting. Oral typhoid stopped - symptoms resolved.
Age: 41.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site hypersensitivity, Injection site swelling, Muscular weakness, Pain, Pyrexia
Clinical narrative: Fever - 102.2 degrees F, large red, swollen oval shaped reaction just below inj. site approx 6 inches diameter. Muscle weakness at site of injection. ( right delt ). Patient had pain all day but really noticec Sx around 5 pm when he got home from work.
Age: 55.0
Sex: F
Vaccine: TYP
Symptoms: Arthralgia, Musculoskeletal stiffness, Oedema
Clinical narrative: 1st pill taken a few hours felt aches in joints of hands and hips. Reports puffy hands and difficulty turning head. Discontinued taking
Age: 29.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Dyspnoea, Rash
Clinical narrative: 10/7/05 Rash described as 'little red spots' on trunk, stomach and back as well as thighs and calves of both legs. Rash began day after 1st oral typhoid pill pt reports rash resolved soon after completing 1 week course of oral typhoid. Pt reports taking benadryl to relieve symptoms. Mild shortness of breath was decribed.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Irritability
Clinical narrative: Vaccine given 12/5/05 - Pt fussy that day through 12/7/05 when pt very fussy. Pt taken to ED. Seen in our office 12/8 for fussiness.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site nodule, Injection site oedema, Injection site pain
Clinical narrative: Pt developed a lot of soreness and swelling at injection site a few days after. She states it has decr but there is still a nodule (golf ball sized) at injection site over 3 weeks after.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Pruritus, Pyrexia
Clinical narrative: Fever 104 degrees, chills, rigors left arm pit went to ER on 11/24/05 treated with antibiotics discharged on septra, ibupofen, zyrtec fot itching
Age: 37.0
Sex: F
Vaccine: RAB, TYP
Symptoms: Paraesthesia, Pruritus, Rash, Skin burning sensation, Urticaria
Clinical narrative: Pt describes tingling, burning in both ear lobes 8 pm 12/1/05, within 1 hour notice rash on trunk and under arms with itching. Rash progressed to raised hives on trunk 8" diameter - smaller hives under both arms. She took 50 mg benadryl around that time. By 12/2/05 7pm rash gone, all symptoms resolved.
Age: 7.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: At 03:45 pm Mom called stating that child has a rash after receiving shots ( 1 hr after ).
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Myalgia, Pyrexia, Vomiting
Clinical narrative: 10 hours after vax severe vomiting, diarrhea, myalgia and fever
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Chills, Infection, Injection site erythema, Injection site oedema
Clinical narrative: Initial report received from another manufacturer (who received information from a health care provider, report number WAES0510USA07895, on Nov 23 2005. A 68 year old female patient received a left deltoid injection of Fluzone SV 2005-2005. lot number U1811AA, on Oct 13 2005. On the same day, the patient received a subcutaneous right arm injection of Pneumovax 23,, lot number 650452/0753P. During the night on Oct 13 2005, she experienced chills and developed pain, swelling, redness and warmth of the right upper arm (not the site of Fluzone administration). There was no other known injury, fever or related symptoms of concern. On Oct 14 2005, she presented to the physicians office and upon examination, was found to have 2/4+ edema, erythema, tenderness and warmth of the posterolateral right upper arm. There was no other external evidence of injury or inflammation and no lymphangitis or local adenopathy. The local reaction at the injection site was diagnosed as cellulitis that effected the entire right upper arm and was probably secondary to the Pneumo 23 vaccine. She was given acetaminophen for fever control and cephalexin 500 mg PO TID for ten days. On Oct 15 2005, she was re examined in her physicians office as her right upper arm continued to be red, swollen and slightly tender. She had normal range of motion of joints and normal neurovascular assessment of the right arm and no lymphangitis. Home health care was required for intravenous administration of Rocephin 2 grams on Oct 15 2005 and daily for two additional days. On Oct 16 2005, she was re examined. The warmth and redness of the right arm were about the same, and pain had decreased. On Oct 17 2005, there was decrease in the swelling, redness and tenderness of the right upper arm, but increased redness to the forearm with minimal tenderness. She received additional intravenous dose of Rocephin on Oct 18 2005. upon examination on Oct 18 2005, the patients right arm was much improved. She was instructed to complete the cephalexin. The patient was reported to have recovered from this event on Oct 18 2005. Additional adverse events described by this reporter include an asymptomatic bacteriuria with negative culture (onset approximately Oct 2005), a pulled muscle on the buttock/leg (onset Oct 24 2005) and pain in the right lower chest that increased with deep breathing (onset Oct 26 2005). No additional information was provided regarding these events. At the time of this report, recovery status for these events was not reported. The reporting manufacturer considered the events to be medically significant (OMIC). Pre existing medical history included corrective lenses, allergies to amoxicillin, Augmentin, and grass and trees, hypertension, Lower extremity edema, physiologic flow murmur, coronary artery disease, hypothyroidism, GERD, Degenerative joint disease, post nasal drip, asthma, cholecystectomy, tonsillectomy, dry cough, syncope, headache, tears in the right medical and lateral menisci and sinusitis.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site pain, Injection site warmth, Tenderness
Clinical narrative: Initial report received from another manufacturer (who received information from a health care provider, report number WAES0510USA07895, on Nov 23 2005. A 68 year old female patient received a left deltoid injection of Fluzone SV 2005-2005. lot number U1811AA, on Oct 13 2005. On the same day, the patient received a subcutaneous right arm injection of Pneumovax 23,, lot number 650452/0753P. During the night on Oct 13 2005, she experienced chills and developed pain, swelling, redness and warmth of the right upper arm (not the site of Fluzone administration). There was no other known injury, fever or related symptoms of concern. On Oct 14 2005, she presented to the physicians office and upon examination, was found to have 2/4+ edema, erythema, tenderness and warmth of the posterolateral right upper arm. There was no other external evidence of injury or inflammation and no lymphangitis or local adenopathy. The local reaction at the injection site was diagnosed as cellulitis that effected the entire right upper arm and was probably secondary to the Pneumo 23 vaccine. She was given acetaminophen for fever control and cephalexin 500 mg PO TID for ten days. On Oct 15 2005, she was re examined in her physicians office as her right upper arm continued to be red, swollen and slightly tender. She had normal range of motion of joints and normal neurovascular assessment of the right arm and no lymphangitis. Home health care was required for intravenous administration of Rocephin 2 grams on Oct 15 2005 and daily for two additional days. On Oct 16 2005, she was re examined. The warmth and redness of the right arm were about the same, and pain had decreased. On Oct 17 2005, there was decrease in the swelling, redness and tenderness of the right upper arm, but increased redness to the forearm with minimal tenderness. She received additional intravenous dose of Rocephin on Oct 18 2005. upon examination on Oct 18 2005, the patients right arm was much improved. She was instructed to complete the cephalexin. The patient was reported to have recovered from this event on Oct 18 2005. Additional adverse events described by this reporter include an asymptomatic bacteriuria with negative culture (onset approximately Oct 2005), a pulled muscle on the buttock/leg (onset Oct 24 2005) and pain in the right lower chest that increased with deep breathing (onset Oct 26 2005). No additional information was provided regarding these events. At the time of this report, recovery status for these events was not reported. The reporting manufacturer considered the events to be medically significant (OMIC). Pre existing medical history included corrective lenses, allergies to amoxicillin, Augmentin, and grass and trees, hypertension, Lower extremity edema, physiologic flow murmur, coronary artery disease, hypothyroidism, GERD, Degenerative joint disease, post nasal drip, asthma, cholecystectomy, tonsillectomy, dry cough, syncope, headache, tears in the right medical and lateral menisci and sinusitis.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Chest pain, Chills, Erythema, Feeling hot
Clinical narrative: Initial report received from another manufacturer (who received information from a health care provider, report number WAES0510USA07895, on Nov 23 2005. A 68 year old female patient received a left deltoid injection of Fluzone SV 2005-2005. lot number U1811AA, on Oct 13 2005. On the same day, the patient received a subcutaneous right arm injection of Pneumovax 23,, lot number 650452/0753P. During the night on Oct 13 2005, she experienced chills and developed pain, swelling, redness and warmth of the right upper arm (not the site of Fluzone administration). There was no other known injury, fever or related symptoms of concern. On Oct 14 2005, she presented to the physicians office and upon examination, was found to have 2/4+ edema, erythema, tenderness and warmth of the posterolateral right upper arm. There was no other external evidence of injury or inflammation and no lymphangitis or local adenopathy. The local reaction at the injection site was diagnosed as cellulitis that effected the entire right upper arm and was probably secondary to the Pneumo 23 vaccine. She was given acetaminophen for fever control and cephalexin 500 mg PO TID for ten days. On Oct 15 2005, she was re examined in her physicians office as her right upper arm continued to be red, swollen and slightly tender. She had normal range of motion of joints and normal neurovascular assessment of the right arm and no lymphangitis. Home health care was required for intravenous administration of Rocephin 2 grams on Oct 15 2005 and daily for two additional days. On Oct 16 2005, she was re examined. The warmth and redness of the right arm were about the same, and pain had decreased. On Oct 17 2005, there was decrease in the swelling, redness and tenderness of the right upper arm, but increased redness to the forearm with minimal tenderness. She received additional intravenous dose of Rocephin on Oct 18 2005. upon examination on Oct 18 2005, the patients right arm was much improved. She was instructed to complete the cephalexin. The patient was reported to have recovered from this event on Oct 18 2005. Additional adverse events described by this reporter include an asymptomatic bacteriuria with negative culture (onset approximately Oct 2005), a pulled muscle on the buttock/leg (onset Oct 24 2005) and pain in the right lower chest that increased with deep breathing (onset Oct 26 2005). No additional information was provided regarding these events. At the time of this report, recovery status for these events was not reported. The reporting manufacturer considered the events to be medically significant (OMIC). Pre existing medical history included corrective lenses, allergies to amoxicillin, Augmentin, and grass and trees, hypertension, Lower extremity edema, physiologic flow murmur, coronary artery disease, hypothyroidism, GERD, Degenerative joint disease, post nasal drip, asthma, cholecystectomy, tonsillectomy, dry cough, syncope, headache, tears in the right medical and lateral menisci and sinusitis.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Tenderness, Urine analysis abnormal
Clinical narrative: Initial report received from another manufacturer (who received information from a health care provider, report number WAES0510USA07895, on Nov 23 2005. A 68 year old female patient received a left deltoid injection of Fluzone SV 2005-2005. lot number U1811AA, on Oct 13 2005. On the same day, the patient received a subcutaneous right arm injection of Pneumovax 23,, lot number 650452/0753P. During the night on Oct 13 2005, she experienced chills and developed pain, swelling, redness and warmth of the right upper arm (not the site of Fluzone administration). There was no other known injury, fever or related symptoms of concern. On Oct 14 2005, she presented to the physicians office and upon examination, was found to have 2/4+ edema, erythema, tenderness and warmth of the posterolateral right upper arm. There was no other external evidence of injury or inflammation and no lymphangitis or local adenopathy. The local reaction at the injection site was diagnosed as cellulitis that effected the entire right upper arm and was probably secondary to the Pneumo 23 vaccine. She was given acetaminophen for fever control and cephalexin 500 mg PO TID for ten days. On Oct 15 2005, she was re examined in her physicians office as her right upper arm continued to be red, swollen and slightly tender. She had normal range of motion of joints and normal neurovascular assessment of the right arm and no lymphangitis. Home health care was required for intravenous administration of Rocephin 2 grams on Oct 15 2005 and daily for two additional days. On Oct 16 2005, she was re examined. The warmth and redness of the right arm were about the same, and pain had decreased. On Oct 17 2005, there was decrease in the swelling, redness and tenderness of the right upper arm, but increased redness to the forearm with minimal tenderness. She received additional intravenous dose of Rocephin on Oct 18 2005. upon examination on Oct 18 2005, the patients right arm was much improved. She was instructed to complete the cephalexin. The patient was reported to have recovered from this event on Oct 18 2005. Additional adverse events described by this reporter include an asymptomatic bacteriuria with negative culture (onset approximately Oct 2005), a pulled muscle on the buttock/leg (onset Oct 24 2005) and pain in the right lower chest that increased with deep breathing (onset Oct 26 2005). No additional information was provided regarding these events. At the time of this report, recovery status for these events was not reported. The reporting manufacturer considered the events to be medically significant (OMIC). Pre existing medical history included corrective lenses, allergies to amoxicillin, Augmentin, and grass and trees, hypertension, Lower extremity edema, physiologic flow murmur, coronary artery disease, hypothyroidism, GERD, Degenerative joint disease, post nasal drip, asthma, cholecystectomy, tonsillectomy, dry cough, syncope, headache, tears in the right medical and lateral menisci and sinusitis.
Age: 63.0
Sex: F
Vaccine: HEP, TD
Symptoms: Back pain, Fatigue, Myalgia, Neck pain, Shoulder pain
Clinical narrative: Two weeks after immunizations given on 9/29/05, client experienced pain in left arm and shoulder.  No pain or redness at Td site.  Client also complained of pain in neck, spine, buttocks, and back of legs.  Client rode 10/4/-10/7 on church bus to help hurricane victims.  Patient is part of a SELECT Selenium and Vitamin E Cancer Prevention Trial - drug is Proscar.  Saw private MD for his opinion on the above left shoulder and arm pain.  MD's report states:  afebrile, BP 104/59, pulse 66.  Alert and in no distress.  Impression:  general fatigue; additional aches and muscle strains involving other areas besisde left shoulder and arm.  Diagnosis:  mild left shoulder tendonitis unrelated to Td vaccination.
Age: 63.0
Sex: F
Vaccine: HEP, TD
Symptoms: Tendonitis
Clinical narrative: Two weeks after immunizations given on 9/29/05, client experienced pain in left arm and shoulder.  No pain or redness at Td site.  Client also complained of pain in neck, spine, buttocks, and back of legs.  Client rode 10/4/-10/7 on church bus to help hurricane victims.  Patient is part of a SELECT Selenium and Vitamin E Cancer Prevention Trial - drug is Proscar.  Saw private MD for his opinion on the above left shoulder and arm pain.  MD's report states:  afebrile, BP 104/59, pulse 66.  Alert and in no distress.  Impression:  general fatigue; additional aches and muscle strains involving other areas besisde left shoulder and arm.  Diagnosis:  mild left shoulder tendonitis unrelated to Td vaccination.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cough, Dysphagia, Gastric ulcer haemorrhage, Guillain-Barre syndrome
Clinical narrative: Daughter-in-law reported that 10 days post influenza vaccination (11/04/2005) patient became paralyzed.  Was admitted to hospital and was treated for Guillian Barre Syndrome.     12/06/05: Updated report - patient remains hospitalized and has regained some feeling/movement.  Has feeding tube in place and is being treated for bleeding ulcers.   NOTE:  #13 will not allow me to enter greater than 9 previous influenza doses.  Patient has actually received 20+ doses.  Discharge summary includes cough, cold, dysphagia, parethesis, weakness, tachycardia, pneumonia, pneumoperitneum.  Medical records state reflexes decreased.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Hyporeflexia, Laboratory test abnormal, Paraesthesia, Paralysis, Pharyngitis
Clinical narrative: Daughter-in-law reported that 10 days post influenza vaccination (11/04/2005) patient became paralyzed.  Was admitted to hospital and was treated for Guillian Barre Syndrome.     12/06/05: Updated report - patient remains hospitalized and has regained some feeling/movement.  Has feeding tube in place and is being treated for bleeding ulcers.   NOTE:  #13 will not allow me to enter greater than 9 previous influenza doses.  Patient has actually received 20+ doses.  Discharge summary includes cough, cold, dysphagia, parethesis, weakness, tachycardia, pneumonia, pneumoperitneum.  Medical records state reflexes decreased.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Pneumonia, Tachycardia
Clinical narrative: Daughter-in-law reported that 10 days post influenza vaccination (11/04/2005) patient became paralyzed.  Was admitted to hospital and was treated for Guillian Barre Syndrome.     12/06/05: Updated report - patient remains hospitalized and has regained some feeling/movement.  Has feeding tube in place and is being treated for bleeding ulcers.   NOTE:  #13 will not allow me to enter greater than 9 previous influenza doses.  Patient has actually received 20+ doses.  Discharge summary includes cough, cold, dysphagia, parethesis, weakness, tachycardia, pneumonia, pneumoperitneum.  Medical records state reflexes decreased.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: At 48 hours after administration of vaccine redness of 1.5 inches diameter, swelling, warmth to the touch, and pain at the site on the right deltoid.  Patient noted this reaction about 44 hours after administration.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Abnormal sleep-related event, Unevaluable event
Clinical narrative: None Stated Received autopsy report which revealed COD as undetermined.  Patient was cosleeping w/adult.
Age: 1.08
Sex: M
Vaccine: FLU3, HIBV, PNC
Symptoms: Cardiac failure, Irritability, Myocarditis
Clinical narrative: Received vaccine 11/03/2005, admitted in heart failure, myocarditis 11/10/2005, Died 11/10/2005. Increasingly cranky for 2 days procedding admission to hospital.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Coma, Hypersensitivity
Clinical narrative: Seriousness criteria: other Medically significant (OMIC). Initial report received from a health care provider on Nov 29 2005. A 61 year old female with a medical history of psycho affective disorder received an injection of Fluzone SV 2005-2006, lot number unknown, on a unspecified date in mid Nov 2005. Route and site of administration, and illness at the time of vaccination were unknown. The patient has a history of allergies to penicillin, gentamycin, latex and strawberries. No other pre existing conditions were reported, although the patient is on multiple other medication. Two weeks post vaccination, on Nov 28 2005, she became unresponsive and was examined in an ER. Per the reporter, the cause of the event was diagnosed as due to mercury derivative in the flu vaccine. The patient was released from the hospital. At the time of this report. the recovery status was not reported.
Sex: M
Vaccine: HIBV, PNC
Symptoms: Autism
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother who reported that her son is autistic. The patient received the third dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Additional suspect medication included Hib-Titer vaccine (haemophilus B conjugate vaccine diphtheria crm197 protein conjugate) injection). Concomitant medication were not reported. a mother reported that her son is autistic (autism). The reporter commented that she does not believe that the thimerosal caused her son to be autistic. Outcome is unknown. No additional information was available at the time of this report.
Age: 48.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Heart rate increased, Hypersensitivity, Injection site reaction, Malaise, Pain
Clinical narrative: Information has been received from a 48 year old male consumer with a form of lupus that affects his skin, who on Oct 12 2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included a dose of influenza virus vaccine (unspecified). It was noted that the pharmacist did not clean the site prior to administering the pneumococcal 23v polysaccharide vaccine. It was also noted that both vaccines were given in the same arm. On Oct 13 2005 at 2:00 the consumer went to the emergency room because he felt sick. and the pain in his arm was unbearable. It was noted that his pulse was 118 and his white blood cell count was over 20,000. The consumer stated that his condition was life threatening. He was admitted to the hospital and given IV antibiotics for 3 days. The first antibiotic did not work so he was given a different one for 3 more days, while he was still in the hospital. Laboratory diagnostic studies included blood test. The patient was hospitalized for 6 days. The patient was discharged with cephalexin (Keflex) but had a reaction to it and had to return to the emergency room for treatment. He was prescribed Prednisone for his reaction. The patient was recovering but he was still receiving wound care for the site of the pneumococcal 23v polysaccharide vaccine injection. It was also noted that the patients condition improved after treatment. It was also noted that the patient has never had this type of reaction to an injection before. Prior to these vaccinations, he had not been treated for his lupus for over a year. No product quality complaint was involved. Felt sick, pain in arm was unbearable, white blood cell count was over 20,000 and pulse was 118 were considered to be immediately life threatening. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: White blood cell count increased
Clinical narrative: Information has been received from a 48 year old male consumer with a form of lupus that affects his skin, who on Oct 12 2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included a dose of influenza virus vaccine (unspecified). It was noted that the pharmacist did not clean the site prior to administering the pneumococcal 23v polysaccharide vaccine. It was also noted that both vaccines were given in the same arm. On Oct 13 2005 at 2:00 the consumer went to the emergency room because he felt sick. and the pain in his arm was unbearable. It was noted that his pulse was 118 and his white blood cell count was over 20,000. The consumer stated that his condition was life threatening. He was admitted to the hospital and given IV antibiotics for 3 days. The first antibiotic did not work so he was given a different one for 3 more days, while he was still in the hospital. Laboratory diagnostic studies included blood test. The patient was hospitalized for 6 days. The patient was discharged with cephalexin (Keflex) but had a reaction to it and had to return to the emergency room for treatment. He was prescribed Prednisone for his reaction. The patient was recovering but he was still receiving wound care for the site of the pneumococcal 23v polysaccharide vaccine injection. It was also noted that the patients condition improved after treatment. It was also noted that the patient has never had this type of reaction to an injection before. Prior to these vaccinations, he had not been treated for his lupus for over a year. No product quality complaint was involved. Felt sick, pain in arm was unbearable, white blood cell count was over 20,000 and pulse was 118 were considered to be immediately life threatening. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HEP, HIBV, IPV, PPV
Symptoms: Anorexia, Irritability, Lymphocytosis, Pyrexia
Clinical narrative: Irritability 1 day later, slight fever 6 hours after, CBC 20,000, 56 % lymph, Spinal fluid 8 WBC. 82% lymphs, not eating, IV Antibiotics, R/O meningitis.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Eye movement disorder, Laboratory test abnormal, Musculoskeletal stiffness
Clinical narrative: Prior to admission, several episodes stiffening of extremities, rolling eyes for 1 hour lasting 3-5 minutes after fell asleep. A febrile.
Age: 43.0
Sex: M
Vaccine: FLUX
Symptoms: Chest discomfort, Cough, Hypokinesia, Influenza, Nasal congestion
Clinical narrative: About 1 1/2days after injection of FluMist, go the flu, runny nose, congestion, minor cough, aches, and tight chest-every time I inhale to max it hurts in my chest.  Some movement hurts in my chest/heart area.
Age: 43.0
Sex: M
Vaccine: FLUX
Symptoms: Rhinorrhoea
Clinical narrative: About 1 1/2days after injection of FluMist, go the flu, runny nose, congestion, minor cough, aches, and tight chest-every time I inhale to max it hurts in my chest.  Some movement hurts in my chest/heart area.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Urticaria
Clinical narrative: Within hrs of vaccine child developed urticaria, eyes shut swollen-Benadryl given
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Injection site erythema, Pruritus, Pyrexia, Vomiting
Clinical narrative: Following info given by mother: 11-17-05 c/o fever, vomiting & diarrhea, 11-18-05 no further fever, vomiting or diarrhea, 11-19-05 Left arm swollen with red blotches from deltoid to elbow, 11-21-05 symptoms have diminished slight itching called PMD office.  Not seen.
Age: 1.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Eye swelling, Pyrexia, Rash, Serum sickness
Clinical narrative: Rash began AM of 11/16/05 noted 1st on nape as small dots various sizes then 11/17 spread to arms, legs, chest, head, scalp increased number of spots, size remained same ~5mm diam some with a "target" on nape; concentrated in warm area of body (axilla, scalp), some with pinpoint central vesicle; on 11/18/05 Pt awoke with swollen eyelids L almost closed, swollen hands and feet.  Fever to 100 F rectal & diffuse rash 1-2 cm diam macular with central vesicle-Pt given 20mg oral prednisone in office and 1mg 1cc/dose every 12 hrs for 3 days-until rash disappeared on 11/21/05.  EM-serum sickness
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Lymph node pain
Clinical narrative: On 11-12-05 in AM noted a painful lump in armpit.  On 11-16-05 was worse and was seen by second physician who put her on Keflex 500mg qid x 10 days.  Resolved as of 12-5-05.
Sex: M
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Fever 105, chills, vomiting, diarrhea x 24-48hr then resolved
Age: 0.54
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: Fluirin by Chiron is indicated for patients older than 4yrs.  Inadvertently given to this 6 month old child.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Around 5 pm the day of getting the flu vaccine began to feel wheezing and SOB.  These symptoms did progress somewhat.  Normal peak flow is 400 at 7pm that evening my peak flow was 250.  Used Albaterol inhaler and steam bath to help symptoms which elected to pass about 9pm.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Herpes zoster, Hypoaesthesia, Injection site pain, Pruritus
Clinical narrative: c/o numbness and pain in left arm at the site of the flu vaccine immediately after administration.  For the next two days after the vaccine, she felt tired and slept.  The third day after the vaccine (11/5) the patient had a rash and itching on her left arm and felt ill.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: c/o numbness and pain in left arm at the site of the flu vaccine immediately after administration.  For the next two days after the vaccine, she felt tired and slept.  The third day after the vaccine (11/5) the patient had a rash and itching on her left arm and felt ill.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Chest discomfort, Diarrhoea, Dry throat, Dyspnoea
Clinical narrative: Pt received Pneumovax 23 in the right deltoid by intramuscular injection on 11/21/2005 and influenza in the left deltoid. The time was around 4pm. Pt reports having shortness of breath and experiencing "tightness" in her chest as she traveled up a flight of stairs to her garage apartment later that day. the episode lasted about ten minutes. During the night, other symptoms appeared. around 9:30 pm to 10 pm, pt had "shooting pain" in her arm, experienced severe shaking of the head and body for 5-10 minutes, throat and nose became "dry" for about 45 minutes, felt warm and appeared flushed. She also experienced nausea and diarrhea through the night. Pt presented to the health department for further evaluation on 11/22/2005. The nausea had subsided and had a decrease in episodes of diarrhea. She also reported malaise. She did not have a thermometer to measure her body temperature when whe experienced feeling warm the previous night. Pt evalutaed by nurse and upper left arm tenderness and swelling into left axilla was noted. Arm was also warm to the touch, but no paralysis noted. Pt has no drug allergies or food allergies and is currently on three meds: Zoloft 50 mg every day, Diovan HCT, and Verelan. Pt was to report to us if symptoms did not resolve in a 48 hour period or if symptoms worsened, to follow up with primary care doctor or emergency room. Pt contacted health department of 11/23/2005 and stated that swelling had not resolved and that pain had extended into left breast. Pt was advised to follow up with a medical provider and went to an urgent care that day where she was diagnosed with cellulitis and received Keflex 500mg qid for 7 days and Vicoden 500mg for pain. Will continue to follow up with pt until fully resolved.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Malaise, Nasal dryness, Nausea, Pain
Clinical narrative: Pt received Pneumovax 23 in the right deltoid by intramuscular injection on 11/21/2005 and influenza in the left deltoid. The time was around 4pm. Pt reports having shortness of breath and experiencing "tightness" in her chest as she traveled up a flight of stairs to her garage apartment later that day. the episode lasted about ten minutes. During the night, other symptoms appeared. around 9:30 pm to 10 pm, pt had "shooting pain" in her arm, experienced severe shaking of the head and body for 5-10 minutes, throat and nose became "dry" for about 45 minutes, felt warm and appeared flushed. She also experienced nausea and diarrhea through the night. Pt presented to the health department for further evaluation on 11/22/2005. The nausea had subsided and had a decrease in episodes of diarrhea. She also reported malaise. She did not have a thermometer to measure her body temperature when whe experienced feeling warm the previous night. Pt evalutaed by nurse and upper left arm tenderness and swelling into left axilla was noted. Arm was also warm to the touch, but no paralysis noted. Pt has no drug allergies or food allergies and is currently on three meds: Zoloft 50 mg every day, Diovan HCT, and Verelan. Pt was to report to us if symptoms did not resolve in a 48 hour period or if symptoms worsened, to follow up with primary care doctor or emergency room. Pt contacted health department of 11/23/2005 and stated that swelling had not resolved and that pain had extended into left breast. Pt was advised to follow up with a medical provider and went to an urgent care that day where she was diagnosed with cellulitis and received Keflex 500mg qid for 7 days and Vicoden 500mg for pain. Will continue to follow up with pt until fully resolved.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Swelling, Tremor
Clinical narrative: Pt received Pneumovax 23 in the right deltoid by intramuscular injection on 11/21/2005 and influenza in the left deltoid. The time was around 4pm. Pt reports having shortness of breath and experiencing "tightness" in her chest as she traveled up a flight of stairs to her garage apartment later that day. the episode lasted about ten minutes. During the night, other symptoms appeared. around 9:30 pm to 10 pm, pt had "shooting pain" in her arm, experienced severe shaking of the head and body for 5-10 minutes, throat and nose became "dry" for about 45 minutes, felt warm and appeared flushed. She also experienced nausea and diarrhea through the night. Pt presented to the health department for further evaluation on 11/22/2005. The nausea had subsided and had a decrease in episodes of diarrhea. She also reported malaise. She did not have a thermometer to measure her body temperature when whe experienced feeling warm the previous night. Pt evalutaed by nurse and upper left arm tenderness and swelling into left axilla was noted. Arm was also warm to the touch, but no paralysis noted. Pt has no drug allergies or food allergies and is currently on three meds: Zoloft 50 mg every day, Diovan HCT, and Verelan. Pt was to report to us if symptoms did not resolve in a 48 hour period or if symptoms worsened, to follow up with primary care doctor or emergency room. Pt contacted health department of 11/23/2005 and stated that swelling had not resolved and that pain had extended into left breast. Pt was advised to follow up with a medical provider and went to an urgent care that day where she was diagnosed with cellulitis and received Keflex 500mg qid for 7 days and Vicoden 500mg for pain. Will continue to follow up with pt until fully resolved.
Age: 1.3
Sex: M
Vaccine: DTAP, FLU3, VARCEL
Symptoms: Blister
Clinical narrative: Parent states child has four blister type rash marks.  Physician verified Chicken Pox total of 6 pox on child-no other S/S, well and dried pox 12-5-04.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: L arm red and hot entire L arm
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Cough, Injection site induration, Injection site oedema, Pyrexia, Wheezing
Clinical narrative: Induration and swelling 7x8cm on L deltoid noted on 28-30 H after injection.  Q fever given Robitussin and Albuterol for associated cough and wheezing noted as 32 Hp.
Age: 1.51
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash, Skin irritation
Clinical narrative: red ear with itching, blotchy rash. Rash treated with Rx Benadryl 1/4 tsp every 4 hours- completey cleared in 6-8 hrs. Was not seen in office.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Shoulder pain, Swelling
Clinical narrative: Events reported on 12/6/05. Following flu shot to left deltoid, patient complained of swelling and pain to left shoulder. Patient stated it was so painful I had to take Vicodin for a couple of weeks. Duration of severe pain approximately 2 weeks, though very painful for 4 weeks total. Seen by personal physician, MRI completed - normal. Full ROM to left shoulder.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Infection, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Eyrthema and swelling around site of shots on left arm - 2 x 2 cm induration 2.5 x 3.5 cm - mother  Rx possible infection.
Age: 0.74
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Wheezing
Clinical narrative: Itching within 12 hour post shot wheezing that evening - wheeze persists - on albuterol and pulmacort via nebulizer
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Eye disorder, Eye oedema, Feeling cold, Headache
Clinical narrative: Vaccine 11 am 12/08/05. Ill around 5 pm. Cold back, face warm, hot itchy eyes and head, headache, puffy eyes. All symptoms x 2 days, weakness and swollen throat. Did not go to ER/doctor. All resolving except still feeling weak.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Pruritus, Skin warm
Clinical narrative: Vaccine 11 am 12/08/05. Ill around 5 pm. Cold back, face warm, hot itchy eyes and head, headache, puffy eyes. All symptoms x 2 days, weakness and swollen throat. Did not go to ER/doctor. All resolving except still feeling weak.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Diarrhoea, Eye pain, Fatigue
Clinical narrative: Received immunization at 3 pm. Adverse reaction started at 7 pm following a work out. Cough, sore throat, chills, burning in both eyes, low grade fever, body aches, whole body trembling. Lasted until 11 pm. Next day had headache and very fatigued, diarrhea began and has not stopped.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain, Pharyngolaryngeal pain, Pyrexia, Tremor
Clinical narrative: Received immunization at 3 pm. Adverse reaction started at 7 pm following a work out. Cough, sore throat, chills, burning in both eyes, low grade fever, body aches, whole body trembling. Lasted until 11 pm. Next day had headache and very fatigued, diarrhea began and has not stopped.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Diplopia, Dizziness, Headache, Heart rate increased, Nausea
Clinical narrative: Approximately 5 hours after vaccination pt experienced Double vision, Dizziness, Nausea, Headache and "Racing Heart". Pt called Health Dept and was referred to PMD. Pt states PMD diagnosed "viral syndrome" and prescribed Naproxen.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Viral infection
Clinical narrative: Approximately 5 hours after vaccination pt experienced Double vision, Dizziness, Nausea, Headache and "Racing Heart". Pt called Health Dept and was referred to PMD. Pt states PMD diagnosed "viral syndrome" and prescribed Naproxen.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Paraesthesia
Clinical narrative: Patient stated that within 2-3 minutes following injection began experiencing dizziness, sweating, and "tingling everywhere". Prior to injection told nurse that she was petrified of needles. She did not indicate that she was experiencing anything until about 7-8 minutes following injection.  She was placed on the floor in Trendelenburg position and given coke to drink.  Her color was good, pulse normal, and was not diaphoretic.  She remained on the floor for about 10 minutes.  Left clinic site with no complaints.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Difficulty in walking, Dyspnoea, Fatigue, Headache, Myalgia
Clinical narrative: Headache, muscle aches, trouble breathing, could not eat for 3+ days, had trouble walking. Because of the anthrax shot I have/had leukemia.  I ended up having a bone marrow transplant in Aug 2006 with the hope of going into remission.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Myeloid leukaemia, Night sweats, Oral intake reduced
Clinical narrative: Headache, muscle aches, trouble breathing, could not eat for 3+ days, had trouble walking. Because of the anthrax shot I have/had leukemia.  I ended up having a bone marrow transplant in Aug 2006 with the hope of going into remission.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Dyspnoea, Hypersensitivity
Clinical narrative: Ten minutes after receiving vaccination alerted nurse she had breathing issues, nurse observed rapid breathing, anxious; sent to urgent care and was transported via ambulance to where she received treatment (benadryl & epinepherine) for an "allergic reaction", chest x-ray, respiratory work-up.  Prescribed prednisone.
Age: 1.01
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Rash
Clinical narrative: RASH ON BACK AND CHEST.
Age: 33.0
Sex: F
Vaccine: TTOX
Symptoms: Chills, Headache, Nausea, Pyrexia, Tremor
Clinical narrative: 12 hours after injection, patient with low grade fever, severe shaking chills, nausea, and headache.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: RECEIVED PNEUMOCOCCAL VACCINE 12/0/05 IN RIGHT DELTOID. 12/09/05 INJECTION SITE EDEMATOUS AND ERYTHEMATOUS TO ELBOW.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Herpes zoster, Rash
Clinical narrative: Developed erythematous vesicular lesion/rash in L2-L3 dermatomal distribution of right leg consistent with herpes zoster 3 months after vaccination for varicella.
Age: 1.68
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Injection site warmth, Swelling
Clinical narrative: Swollen, red, warm thigh-approx. 7 by 4 inches in size.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling over right deltoid area 24hrs after vaccination.  Upon evaluation, symptoms spontaneously resolving; expect complete spontaneous recovery.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site warmth, Swelling
Clinical narrative: Patient notified us regarding rt. arm redness, swelling in upper arm 3x5 area, warm to touch. 8-10 hours after injection.  Took tylenol, took it easy.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Hyperreflexia, Hypertonia, Hypoaesthesia, Laboratory test abnormal
Clinical narrative: 1 week following flu vaccine started to feel tingling numbness in toes/fingertips. LE weakness which is progressively worsening over past 4 weeks, increased reflexes. Medical records state Hypertonia, pain. msv
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Paraesthesia
Clinical narrative: 1 week following flu vaccine started to feel tingling numbness in toes/fingertips. LE weakness which is progressively worsening over past 4 weeks, increased reflexes. Medical records state Hypertonia, pain. msv
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Contusion, Erythema
Clinical narrative: On 10-21, notified us of Lt arm red 1 inch in diam.  Rt arm bruised.  Patient is on Plavix. Noticed the redness 24 hours after shot.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Erythema, Swelling
Clinical narrative: On 10-17 patient notified us of redness/swelling of upper right arm.  The discomfort began 2-3 hours shot..then redness. Notified her physician...physician advised her to give it 72 hours..apply ice and take tylenol.
Age: 43.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chest pain, Pyrexia, Tenderness
Clinical narrative: Temperature during 3 days. Sunday am severe chest pain. Shot went through arm pit extreme pain. Rash outlined like bulb, under arm pit and chest areas very tender
Age: 69.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Chills, Erythema, Hyperhidrosis, Phlebitis
Clinical narrative: At night, chills and sweats began and fever of 101 took aspirin. On Wednesday symptoms on and off. Red blotch appeared 2 inches below injection sites, a streak appearred on one side. Today, doctor diagnosed it as phebotis type reaction. Red and hard in certain areas. Prescribed cephalexin for next 2 weeks. (500 mg, 3 x day)