chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Chills, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Initial and follow up information has been received from a licensed practical nurse concerning a 77 yr old retired female who on 15Oct04 at 9:50AM was vaccinated IM in the right deltoid, with a first dose of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P). Concomitant therapy included a fourth dose of influenza virus split virion 3v vaccine inactivated (Fluzone) (lot V1380AA) administered IM in the left deltoid. It was reported that the pt developed red, swollen arm at the injection site after receiving pneumococcal 23v polysaccharide vaccine. It was also reported that the pt was seen in clinic and diagnosed with cellulitis. The pt was treated with antibiotic as an intervention. The reporter indicated that cellulitis was considered to be an other important medical event (OMIC). The nurse reported that 2 other female pt's had similar experiences with pneumococcal 23v polysaccharide vaccine (WAES0410USA02650 and 0410USA03090) in the past two weeks. There was no product quality complaint involved. Follow up information from the nurse indicated that the pt developed pain, erythema and swelling in right upper arm about 2-3 hours after injection. The pt also had chills and nausea but no fever. The nurse suspected an infection or possible allergic reaction however the pt has no  history of drug allergies. It was also reported that the pt recovered (date unspecified).
Age: 78.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site reaction, Nausea
Clinical narrative: Initial and follow up information has been received from a licensed practical nurse concerning a 77 yr old retired female who on 15Oct04 at 9:50AM was vaccinated IM in the right deltoid, with a first dose of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P). Concomitant therapy included a fourth dose of influenza virus split virion 3v vaccine inactivated (Fluzone) (lot V1380AA) administered IM in the left deltoid. It was reported that the pt developed red, swollen arm at the injection site after receiving pneumococcal 23v polysaccharide vaccine. It was also reported that the pt was seen in clinic and diagnosed with cellulitis. The pt was treated with antibiotic as an intervention. The reporter indicated that cellulitis was considered to be an other important medical event (OMIC). The nurse reported that 2 other female pt's had similar experiences with pneumococcal 23v polysaccharide vaccine (WAES0410USA02650 and 0410USA03090) in the past two weeks. There was no product quality complaint involved. Follow up information from the nurse indicated that the pt developed pain, erythema and swelling in right upper arm about 2-3 hours after injection. The pt also had chills and nausea but no fever. The nurse suspected an infection or possible allergic reaction however the pt has no  history of drug allergies. It was also reported that the pt recovered (date unspecified).
Age: 0.15
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Asthma, Convulsion, Cyanosis, Dyspnoea, Hyponatraemia
Clinical narrative: An initial report was received from a health care professional on 7/26/05. A two month old male patient experienced a seizure on 5/18/05, the same day he was vaccinated exact latency was not reported. He received ActHIB, lot number Y0300 (UE3532AA), Daptacel, lot number C1996AA and Prevnar, lot number A5156A, in the left leg, routes not reported. On 5/18/05 he also received IPOL, lot number X12442, and HEPATITIS B vaccine, lot number 0607P, in the right leg, routes not reported. He had received the vaccines at another physicians office (not the reporter's). He was admitted to the hospital the same day and diagnosed with RSV. He was dicharged after ten days. Treatment or lab data was not reported. Hospital records were requested. He has recovered. Previous relevant medical history is that he wsa born prematurely.
Age: 0.15
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Lung disorder, Pyrexia, Viral infection
Clinical narrative: An initial report was received from a health care professional on 7/26/05. A two month old male patient experienced a seizure on 5/18/05, the same day he was vaccinated exact latency was not reported. He received ActHIB, lot number Y0300 (UE3532AA), Daptacel, lot number C1996AA and Prevnar, lot number A5156A, in the left leg, routes not reported. On 5/18/05 he also received IPOL, lot number X12442, and HEPATITIS B vaccine, lot number 0607P, in the right leg, routes not reported. He had received the vaccines at another physicians office (not the reporter's). He was admitted to the hospital the same day and diagnosed with RSV. He was dicharged after ten days. Treatment or lab data was not reported. Hospital records were requested. He has recovered. Previous relevant medical history is that he wsa born prematurely.
Age: 0.15
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Blood sodium decreased, Convulsion, Hypoxia, Respiratory syncytial virus infection
Clinical narrative: An initial report was received from a health care professional on 7/26/05. A two month old male patient experienced a seizure on 5/18/05, the same day he was vaccinated exact latency was not reported. He received ActHIB, lot number Y0300 (UE3532AA), Daptacel, lot number C1996AA and Prevnar, lot number A5156A, in the left leg, routes not reported. On 5/18/05 he also received IPOL, lot number X12442, and HEPATITIS B vaccine, lot number 0607P, in the right leg, routes not reported. He had received the vaccines at another physicians office (not the reporter's). He was admitted to the hospital the same day and diagnosed with RSV. He was dicharged after ten days. Treatment or lab data was not reported. Hospital records were requested. He has recovered. Previous relevant medical history is that he wsa born prematurely.
Age: 0.15
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Blood sodium decreased, Convulsion, Dyspnoea, Hypoxia
Clinical narrative: An initial report was received from a health care professional on 7/26/05. A two month old male patient experienced a seizure on 5/18/05, the same day he was vaccinated exact latency was not reported. He received ActHIB, lot number Y0300 (UE3532AA), Daptacel, lot number C1996AA and Prevnar, lot number A5156A, in the left leg, routes not reported. On 5/18/05 he also received IPOL, lot number X12442, and HEPATITIS B vaccine, lot number 0607P, in the right leg, routes not reported. He had received the vaccines at another physicians office (not the reporter's). He was admitted to the hospital the same day and diagnosed with RSV. He was dicharged after ten days. Treatment or lab data was not reported. Hospital records were requested. He has recovered. Previous relevant medical history is that he wsa born prematurely.
Age: 0.15
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Convulsion, Respiratory syncytial virus infection
Clinical narrative: An initial report was received from a health care professional on 7/26/05. A two month old male patient experienced a seizure on 5/18/05, the same day he was vaccinated exact latency was not reported. He received ActHIB, lot number Y0300 (UE3532AA), Daptacel, lot number C1996AA and Prevnar, lot number A5156A, in the left leg, routes not reported. On 5/18/05 he also received IPOL, lot number X12442, and HEPATITIS B vaccine, lot number 0607P, in the right leg, routes not reported. He had received the vaccines at another physicians office (not the reporter's). He was admitted to the hospital the same day and diagnosed with RSV. He was dicharged after ten days. Treatment or lab data was not reported. Hospital records were requested. He has recovered. Previous relevant medical history is that he wsa born prematurely.
Age: 25.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Chills, Injection site reaction, Pyrexia, White blood cell count increased
Clinical narrative: Information has been received from a physician concerning a 25 year old male with post traumatic splenectomy and no other medical history who on 7/12/05 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (0.5ml), in the right buttock. Concomitant therapy included amoxicillin (+) clavulanate potassium. Subsequently the patient had a severe reaction to the pneumococcal 23v polysaccharide vaccine vaccination. On 7/13/05 the patient experienced temperature of 103 F, a white blood count of 23000 and what looked to be cellulitis reaction at the injection site. The symptoms all developed within 24 hours of the vaccine so possibly a hypersensitivity reaction. The patient was admitted to the hospital and given IV broad spectrum antibiotics for the fever and chills. The patient was in the hospital for 4 days for fever and chills. The diagnosis was not made initially as the patient was recovering from a trauma at the time. Additional information has been requested. (OMIC)
Age: 4.0
Sex: M
Vaccine: DTP, IPV, MMR
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male who last week (approximately 7/19/05) was vaccinated with a dose of MMR (0.5ml), SC. Concomitant therapy at the same time included diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid and poliovirus vaccine. Subsequently, ten minutes after being vaccinated, the patient developed hives and shortness of breath. The patient was given a dose of epinephrine and diphenhydramine HCl and was taken to the emergency room. The patient was observed and discharged. The patient recovered. No product quality complaint was involved. The reporter considered hives and shortness of breath to be other medical events (OMIC). Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Dyspnoea, Hypoxia, Nasal congestion
Clinical narrative: Patient was taken to hospital to receive medication for cough and congestion problems. While at the hospital, patient was given Pneumonia vaccine and complications started thus having to stay for observation and still at hospital. Patient experienced problems breathing and had to be intubated. Son states that he did not give permission for vaccine.
Age: 31.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chest pain, Hyperhidrosis, Myocarditis, Pericarditis
Clinical narrative: Acute onset chest pain occurred July 24 AM,  hospital released July 27, echocardiogram and coronary angiogram were normal. Dx. pericarditis possibly 2nd to smallpox vaccine. CP resolved in 2 hrs. 11/18/05 D/C summary states final diagnosis as acute myopericarditis. Symptoms as per VAERS form were confirmed with addition of cold sweats. 11/18/05 Medical records both pre-and post-hospital were reviewed. Admission diagnosis was confirmed as pericarditis.
Age: 1.28
Sex: M
Vaccine: DTAP, HBHEPB, MMR
Symptoms: Dysphonia, Dyspnoea, Hypersensitivity, Rash, Urticaria
Clinical narrative: Red rash area on stomach and cheeks on 7/22/05. Saw MD 7/23 for idiopathic urticaria; given steroids and told to give one dose if rash went away, stop steroid which parents did. Later that day they were at a restaurant. Child developed hoarseness, wheezing, airway problems. Taken to ER and admitted for 24 hours observation. Mother states when steroid wears off; hives return. To see allergist 7/28/05.
Age: 1.28
Sex: M
Vaccine: DTAP, HBHEPB, MMR
Symptoms: Wheezing
Clinical narrative: Red rash area on stomach and cheeks on 7/22/05. Saw MD 7/23 for idiopathic urticaria; given steroids and told to give one dose if rash went away, stop steroid which parents did. Later that day they were at a restaurant. Child developed hoarseness, wheezing, airway problems. Taken to ER and admitted for 24 hours observation. Mother states when steroid wears off; hives return. To see allergist 7/28/05.
Age: 1.37
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Blood urea increased, Cellulitis, Erythema, Feeling hot, Hypersensitivity
Clinical narrative: Pt afebrile but with AOM and Otitis Externa and superficial cellulitis on foot. Rocephin x1 + vaccines or below. Keflex ordered but not started. 20-24 hrs later mom noticed rapidly increasing swelling and erythema warmth at upper arm, under rash. 1hr later swelling, induration, erythema and tender further to to ante and now arm to elbow. Given Benadryl, Keflex continued admitted. Benadryl alone (Keflex too but developed problem on Rocephin 5hrs later the induration had decrease, still warm and red, hard, but burdens has not extended further. The following morning on Benadryl (+ Keflex) there was complete resolution and the pt was discharged. Medical record recieved 08/17/05 states allergic reaction.
Age: 1.37
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site mass, Oedema, Tenderness
Clinical narrative: Pt afebrile but with AOM and Otitis Externa and superficial cellulitis on foot. Rocephin x1 + vaccines or below. Keflex ordered but not started. 20-24 hrs later mom noticed rapidly increasing swelling and erythema warmth at upper arm, under rash. 1hr later swelling, induration, erythema and tender further to to ante and now arm to elbow. Given Benadryl, Keflex continued admitted. Benadryl alone (Keflex too but developed problem on Rocephin 5hrs later the induration had decrease, still warm and red, hard, but burdens has not extended further. The following morning on Benadryl (+ Keflex) there was complete resolution and the pt was discharged. Medical record recieved 08/17/05 states allergic reaction.
Age: 14.0
Sex: F
Vaccine: MNQ, TD
Symptoms: Swelling, Urticaria
Clinical narrative: Urticaria within 30-60 minutes of vaccine, swollen lips and hives.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Feeling hot, Injection site induration, Pain, Pyrexia
Clinical narrative: 40mm induration and erythema, hot to touch, pain and temperature 99 degrees.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Coma, Convulsion
Clinical narrative: Child accompanied by mother for varicella vaccine for school entry.  Screening questions asked to mother, denied any allergies, medical conditions, fever, or previous reactions.  States child has not had chickenpox disease.  Vaccine re-constituted with 0.7ml stenlediluent and administered subcutaneously to left upper outer deltoid.  Tolerated injection well except stated it burns several times.  After approximately 5-6 minutes while mother was talking to nurse, patient states "I feel funny", face appeared pale.  Assisted to chair by nurse and mother when child suddenly slumped over and became unresponsive.  Immediately assisted to floor when child convulsed and back arched into a c-position with eyes closed and jerked several times.  Ambulance notified at this time incident lasted approximately 30-45 seconds.  No apnea or loss of bowel/bladder occurred.  Patient became responsive with no memory of incident and confusion.  Remained on floor in supine position - vs BP 80/60, p-48, r-16-20 uneven.  Color pale, skin remained warm and dry.  Ambulance arrived approximately 09:35AM.  Patient answered questions appropriately, transported to hospital via ambulance with mother.  Copy of vaccine label provided with lot number.  07/19/2005 Mom back in clinic today for TB med refill.  Inquired about child's  status.  States patient was released from hospital in stable condition with appointment for EEG and to see a neurologist RE: seizure.  Mom states she thinks this has been going on for a while, reports she just found out from patients friend that child had similar incident while hit in head while playing.  States child did vomit once at home and Mom states reported this to ER doctor.  States patient is fine however now.  Encouraged Mom to keep us informed on patient's status.
Age: 0.19
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site nodule
Clinical narrative: 1cm nodule on right lateral thigh for 2 months after injection.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Mom calls today, stating she took patient to urgent care on Sunday, 07/24.  Saturday patient woke with red area localized, swelling on left arm, by evening was more swollen.  Gave Benadryl, no benefit.  By Sunday area was swollen from shoulder to elbow, red, hot to touch and hard.  Advised to use Advil, cool compresses.  Follow up if symptoms don't resolve.
Age: 16.0
Sex: U
Vaccine: MEN
Symptoms: Abdominal pain, Anorexia, Asthenia, Hypoaesthesia, Nausea
Clinical narrative: Approx 15 mins after receiving vaccine became faint color pale skin cool to touch. Placed head low between legs. In about 10 mins she states she was fine. On the way home. C/o tingling in arms and numbness. Had abd pain with nausea and loss of appetite c/o extreme weakness started feeling better at 2PM.
Age: 16.0
Sex: U
Vaccine: MEN
Symptoms: Pallor, Paraesthesia, Syncope
Clinical narrative: Approx 15 mins after receiving vaccine became faint color pale skin cool to touch. Placed head low between legs. In about 10 mins she states she was fine. On the way home. C/o tingling in arms and numbness. Had abd pain with nausea and loss of appetite c/o extreme weakness started feeling better at 2PM.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Redness, swelling of left thigh, site of Dtap, IPV improving.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Blister, Injection site erythema, Injection site oedema
Clinical narrative: Large swelling and erythema L upper arm, shoulder with 2-3cm round small vesicles at site of injection.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Pyrexia, Rash morbilliform, Rash pustular, Viral infection
Clinical narrative: Developed system morbilliform type rash within 2 days after vaccine. 5 days after vaccine T 103 (R) with vomiting adn 1 lesion, chicken pox criteria and vesicles pustule and scab.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Developed system morbilliform type rash within 2 days after vaccine. 5 days after vaccine T 103 (R) with vomiting adn 1 lesion, chicken pox criteria and vesicles pustule and scab.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Contusion, Dermatitis bullous, Irritability, Petechiae
Clinical narrative: 24 hrs after MMR was given mom noticed chicken pox type rash which faded overnight and then noted bruising and linear petechial (1 cm long, scratches on right thigh where MMR was injection. Pt was irritable but consolable on 2nd night after injection. Fussy with exam but alert and smiling with mom.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Anorexia, Crying, Screaming, Somnolence
Clinical narrative: Pt woke up from nap at 3PM same day and started screaming (non stop) x 30 mins and was given Tylenol with stopping of crying but began to sleep and difficult to wake up and refused to feed for next 12 hrs. Pt finally started to drink Pedialyte next morning.
Age: 0.49
Sex: F
Vaccine: HEP, PNC
Symptoms: Rash
Clinical narrative: After vaccine given pt went home, child fell asleep. Awoke at 1:30PM with rash all over body.
Age: 41.0
Sex: M
Vaccine: TD
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Reaction began soon after Td given. Swelling, redness (indurated area left deltoid: about 10x15cm), area warm to touch and painful. Treatment: rest, ice, NSA meds
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Skin ulcer, Viral infection
Clinical narrative: 07/30/05 Child developed 10-20 lesions over trunk by 8/1/05 has 40 chicken pox lesions. No fever, no other symptoms.
Age: 11.0
Sex: M
Vaccine: MMR
Symptoms: Dermatitis, Hypersensitivity, Oedema, Urticaria
Clinical narrative: Hypersensitive dermatitis where touched, swelling, hives. Created egg allergy causing hives still occurring.
Age: 1.05
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Rash papular, Viral infection
Clinical narrative: Rash: red papular with some vesicles on arms, legs and face and spreading. Prob. chicken pox post vaccine.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Hypersensitivity, Injection site hypersensitivity, Injection site reaction, Pyrexia
Clinical narrative: Information has been received from a female consumer in her 50's with a mold allergy, a dust allergy, pollen allergy, many food allergies, sulfa drug allergy, terbinafine (Lamisil) allergy, itraconazole (Sporanox) allergy, celecoxib (Celebrex) allergy, Saldine allergy and an allergy to adhesive strips and medical tapes and a history of high cholesterol, unspecified thyroid condition, high blood pressure, severe migraines and bronchitis who on May 27 2004 was vaccinated IM in the right hip with a 0.5 dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included estrogens, conjugated (Premarin), simvastatin (Zocor), cetirizine hydrochloride (Zyrtec), Valsartan (Diovan), zolpidem tartrate (Ambien), Cilan and levothyroxine Na (Levoxyl). On May 28 2004 the patient developed an injection site reaction described as a red circle six inches in circumference. She also developed a reddish streak along her thigh that was near the the injection site. The streak was one inch wide and six inches long. the patient also reported joint pain and fever. She consulted with her physician who administered a shot of triamcinolone acetonide (Kenalog) to compensate for symptoms. The patient also increased her use of cetirizine hydrochloride (Zyrtec) from one a day to three times daily. Symptoms have abated and the patient is recovering. It was also reported that the patient was recovering with Sequa lea. No product quality complaint was involved. No other information was available. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The pharmacist reported a physician requested specific treatment that is recommended for an injection site reaction following vaccination with pneumococcal 23v polysaccharide vaccine. No other patient or lot information was available, There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a pharmacist concerning a female who on Oct 09 1999 was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine (there is no record of lot number). In 1999, the patient developed a scab on the arm in which she received the injection, It was reported that the scab was not at or near the injection site, The patient indicated that the scab has been recurring ever since. The reporter could not be sure what was meant by..... Has been occurring ever since. The pharmacist did not know if that meant that the scab recurred annually or seasonally, or fit it occurred in 1999 and has been there in some form ever since. The event first occurred in 1999. The patient indicated that she showed it to her physician but he did not think it was from the vaccine. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Information has been received from a certified medical assistant concerning a 75 year old retired white female with chronic obstructive pulmonary disease, hypertension, and Ca++ Granuloma LUL, who on Jun 02 2004 was vaccinated IM with a 0.5ml third dose of pneumococcal 23v polysaccharide vaccine (lot 648139/0009P). It was noted that the patient received a dose of pneumococcal 23v polysaccharide vaccine in both 1991 and 1998, and had no reaction at that time. On June 02 2004 the patient developed cellulitis, It was noted that the patient experienced a local reaction within an hour of injection and developed cellulitis in the arm, The patient was seen again on June 03 2004 and is currently being treated with oral antibiotic therapy. Additional information is expected.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Information has been received from a pharmacist concerning a patient who last week, on approximately June 08 2004, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Now, the patient presents to the ER with cellulitis at the injection site. The patient was not admitted, but was placed on oral anitibiotics and sent home. No product quality complaint was involved. No additional information was available.
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Injection site hypersensitivity
Clinical narrative: Information has been received from a registered pharmacist concerning a patient who on June 15 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The reported stated the patient was due for another vaccine intradermally and instead received an intradermal dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the injection site became red and warm. Unspecified medical attention was sought. A product quality complaint was not involved. No further information is expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Headache, Injection site hypersensitivity, Injection site oedema, Myalgia
Clinical narrative: Information has been received from a certified medical assistant concerning an approximately 65 year old female who on Apr 09 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 646711/180N). Subsequently, 24 to 48 hours after the vaccination, the patient returned to the doctor's office with myalgia, diarrhea, headaches and a low grade fever, It was also reported that the patient's upper arm she got the injection in was red and swollen. Unspecified medical attention was sought. No product quality complaint involved. It was also reported that another patient had similar symptoms (WAES0406USA01943). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a certified medical assistant concerning an approximately 65 year old female who on Apr 09 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 646711/180N). Subsequently, 24 to 48 hours after the vaccination, the patient returned to the doctor's office with myalgia, diarrhea, headaches and a low grade fever, It was also reported that the patient's upper arm she got the injection in was red and swollen. Unspecified medical attention was sought. No product quality complaint involved. It was also reported that another patient had similar symptoms (WAES0406USA01943). Additional information has been requested.
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Nausea
Clinical narrative: Information has been received from a certified medical assistant concerning an 85 year old male who on Apr 15 2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 646711/1180N). Subsequently, on Apr 17 2004, the patient returned to the office complaining of myalgia and nausea. the patient was advised to use ice and acetaminophen (Tylenol). Unspecified medical attention was sought. No product quality complaint involved. It was also reported that another patient had similar symptoms (WAES0406USA01890). Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site reaction, Injection site swelling, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 38 year old female patient who on Nov 14 2003 at 10:00am was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 643249/0358M), in the right arm intramuscularly. Concomitant therapy that day included an influenza virus vaccine (unspecified) (lot 765876), in the left arm intramuscularly. There was no illness at the time of vaccination. It was reported that several hours post vaccination, the patient developed an injection site reaction of redness and swelling. This initial reaction resolved within days. Once a month since the vaccination, the patient develops an itchy papule at the same site that lasts for a day or so and then resolves. It was also reported that day after shot patient had redness, swelling and itching at injection site. This reportedly subsided after approximately one week. it was also reported that since then monthly same injection site area becomes raised, red and itchy. Unspecified medical attention was sought, but treatment was not required. A product quality complaint was not involved. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash papular
Clinical narrative: Information has been received from a registered nurse concerning a 38 year old female patient who on Nov 14 2003 at 10:00am was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 643249/0358M), in the right arm intramuscularly. Concomitant therapy that day included an influenza virus vaccine (unspecified) (lot 765876), in the left arm intramuscularly. There was no illness at the time of vaccination. It was reported that several hours post vaccination, the patient developed an injection site reaction of redness and swelling. This initial reaction resolved within days. Once a month since the vaccination, the patient develops an itchy papule at the same site that lasts for a day or so and then resolves. It was also reported that day after shot patient had redness, swelling and itching at injection site. This reportedly subsided after approximately one week. it was also reported that since then monthly same injection site area becomes raised, red and itchy. Unspecified medical attention was sought, but treatment was not required. A product quality complaint was not involved. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Information has been received from a physician concerning a 68 year old male who on June 03 2004 was vaccinated with pneumococcal 23v polysaccharide vaccine. On June 05 2004 the patient developed pain and swelling of most joints. At the time of the report, the patient was considered as not recovered. Medical attention was sought. the patient was treated with celecoxib (Celebrex) for pain. No product quality complaint involved. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Pyrexia
Clinical narrative: Information has been received from a woman in a medical office concerning a male patient over 50 years old who on June 21 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 648139/0009P). Subsequently that week on approximately June 21 2004, the patient called the medical office and reported redness around the injection site and fever, Unspecified medical attention was sought. A product quality complaint was not involved. the reported also mentioned two female patients who had a similar experiences post vaccination with pneumococcal 23v polysaccharide vaccine (WAES0406USA02561). Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Gastrointestinal haemorrhage, Injection site hypersensitivity, Injection site oedema, Pruritus
Clinical narrative: Information has been received from a pharmacist concerning an 80 year old healthy female who on June 14 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant vaccines given. It was reported that the patient was hospitalized with gastrointestinal bleeding at the time of vaccination. About two hours after the injection the patient experienced an injection site reaction described as a red, swollen and itching arm, Medical attention was sought, but no treatment was required. No product quality complaint was involved. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: Information has been received from a medical assistant concerning an 82 year old female who on June 23 2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (0.5ml) (lot 647028/0564N) (IM). Concomitant therapy included an unspecified medication. On June 24 2004 the patient developed injection site rash. Unspecified medical attention was sought. No product quality complaint involved. Follow up information from the medical assistant reported that there has been no adverse reaction. No further information is expected.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: Information has been received from a 49 year old female consumer with no medical history and no allergies who in 1999 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included doxycycline. In 2002 the patient contracted pneumonia. She reported that she went to the doctor when she contracted this, but the doctor sent her home. No lob studies were performed. No treatment was required. No product quality complaint was involved. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Hypersensitivity, Oedema, Pain, Tenderness
Clinical narrative: Information has been received from a licensed practical nurse concerning a 72 year old Caucasian female with hyperlipidemia, metabolic syndrome, hypothyroidism, seasonal allergies and no known allergies who on June 23 2004 at 16:40 was vaccinated in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647724/0946N). Concomitant therapy included fluticasone propionate (Flonase), fexofenadine hydrochloride (Allegra), levothyroxine Na (Synthroid), estradiol (Estraderm), calcium (unspecified) (+) vitamin D (unspecified), vitamins (unspecified) and Foltex. There was no illness at the time of vaccination. On June 24 2004 in the am, the patient's right arm was red and sore. She was seen in the office on June 25 2004 with red band around the upper arm that was painful and warm to touch. There were no diagnostic laboratory tests performed. Treatment received was warm compresses. The outcome was recovered on approximately June 27 2004. There was no product quality complaint involved. Follow up information from a health professional indicated that on June 24 2004 the patient's right upper extremity was swollen and red. described as a 6 inch wide red band around the arm. The arm was warm to the touch and tender according to the patient. No further information has been requested.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Urticaria
Clinical narrative: Information has been received from a consumer who is a 43 year old female licensed visiting nurse with a concurrent condition of diabetes who on July 06 2004 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 648139/0009P). Concomitant medication included insulin. It was noted that the patient received the first vaccination about five years ago. On Jul 06 2004, the patient developed a large welt at the injection site that was painful and lasted for two days. Subsequently, the patient recovered. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter also mention a few calls from other patients who have had similar reactions after receiving pneumococcal 23v polysaccharide vaccine (WAES0407USA02583). Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a male who on Jul 09 2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 648139/0009P). Subsequently, the patient developed redness, warmth, soreness and a raised area at injection site. the patient was recommended ice and acetaminophen (Tylenol) for treatment. The patient recovered. No product quality complaint involved. No further complaints were reported. it was also reported the another patient had a similar reaction (WAES0407USA01676). Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a male patient who in September 2003, was vaccinated IM with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 647681/0986N). It was reported that currently the patient had experienced pneumonia infection. Unspecified medical attention was sought.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Information has been received from a Pharm D. concerning a 54 year old male with bronchitis, pneumonia, hepatic cirrhosis, pancytopenia, long nodule and diabetes and a history of biopsy lung (May 2004) who was hospitalized on Jul 02 2004 for a pre existing medical condition (details not reported). On approximately Jul 06 2004, the patient was vaccinated in the upper left arm intramuscularly with a dose of pneumococcal 23v polysaccharide vaccine (lot # not reported). On Jul 15 2004, the patient was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine in the left arm (lot 645255/1212M). Concomitant Therapy included prednisone. The patient was scheduled for a splenectomy on Jul 16 2004. There was no redness or swelling at the injection site but the patient experienced a sore arm. Unspecified medical attention was sought. The outcome of the sore arm was not reported. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Drug hypersensitivity, Hypersensitivity, Inflammation, Local reaction, Myalgia
Clinical narrative: Information has been received from a Registered Nurse concerning a 74 year old white female patient with a penicillin allergy who on Jul 12 2004 at 10:00 am was vaccinated into the right arm with a first dose of )PNEUMOVAX 23 (lot 647029/0460F). Within 48 hours, the patient developed a local reaction at the site of her injection. On Jul 14 2004, the patient was seen by her physician and was instructed to use ice on the involved area. On Jul 16 2004, the patient returned to the physicians office and the reaction appeared to be worse. The patient was to be treated with Omnicef. Follow up information from a registered nurse indicated that the patient developed swelling and redness of the right deltoid (approximate 2cm x 2cm area) on Jul 12 2004. There was no purulence or fluctuance and no neuro vascular compromise. There were no diagnostic studies on laboratory tests done. There was no illness at the time of vaccination. It was reported that the patient had recovered. It was also reported by the patients husband that the patient who has a history of diabetes was vaccinated with an adult dose of PNEUMOVAX 23 on Jul 07 2004 (reported by the nurse as Jul 12 2004). He reported that the day after she was vaccinated she developed swelling and redness. The husband noted that the patients experiences caused her significant disability or incapacity but she was recovering as of Dec 27 2004. There were no labs or diagnostic studies performed. Follow up information was received from the physician who stated that the patient was not disabled. The physician did report that the patient did have a long recovery and a lot of inflammation. She reported that although the patient had recovered, she did have occasional muscle pain in her arm which she could predict the weather with. Additional information is not expected.  Additional follow up information received from the patient's husband indicated that he believes that the specific lot (lot 647029/0460F) caused the reaction. The records of testing prior to release of this lot have been checked by Quality Assurance and found to satisfactory. The lot complies with the standards of the Center for Biological Evaluation and Research and was released. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Oedema
Clinical narrative: Information has been received from a Registered Nurse concerning a 74 year old white female patient with a penicillin allergy who on Jul 12 2004 at 10:00 am was vaccinated into the right arm with a first dose of )PNEUMOVAX 23 (lot 647029/0460F). Within 48 hours, the patient developed a local reaction at the site of her injection. On Jul 14 2004, the patient was seen by her physician and was instructed to use ice on the involved area. On Jul 16 2004, the patient returned to the physicians office and the reaction appeared to be worse. The patient was to be treated with Omnicef. Follow up information from a registered nurse indicated that the patient developed swelling and redness of the right deltoid (approximate 2cm x 2cm area) on Jul 12 2004. There was no purulence or fluctuance and no neuro vascular compromise. There were no diagnostic studies on laboratory tests done. There was no illness at the time of vaccination. It was reported that the patient had recovered. It was also reported by the patients husband that the patient who has a history of diabetes was vaccinated with an adult dose of PNEUMOVAX 23 on Jul 07 2004 (reported by the nurse as Jul 12 2004). He reported that the day after she was vaccinated she developed swelling and redness. The husband noted that the patients experiences caused her significant disability or incapacity but she was recovering as of Dec 27 2004. There were no labs or diagnostic studies performed. Follow up information was received from the physician who stated that the patient was not disabled. The physician did report that the patient did have a long recovery and a lot of inflammation. She reported that although the patient had recovered, she did have occasional muscle pain in her arm which she could predict the weather with. Additional information is not expected.  Additional follow up information received from the patient's husband indicated that he believes that the specific lot (lot 647029/0460F) caused the reaction. The records of testing prior to release of this lot have been checked by Quality Assurance and found to satisfactory. The lot complies with the standards of the Center for Biological Evaluation and Research and was released. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a female who on Jul 09 2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 648139/009P), intramuscularly in the left upper arm. Subsequently, on Jul 10 2004, the patient developed redness, warmth, soreness, raised area at injection site and discomfort at injection site. the patient recommended ice and ibuprofen (Motrin) for treatment. The patient recovered. No product quality complaint involved. no further complaints were reported. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth, Tenderness
Clinical narrative: information has been received from a physician concerning a 69 year old white female patient with a pertinent medical history ( no details provided) who on Jul 19 2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 646322/0530N), in the deltoid. Subsequently, the patient developed a red, swollen arm at injection site. Ice and analgesic treatment was reported. The reporting physician requested a lot check. No product quality complaint. Follow up information reported that the patient developed a red, tender, hot upper arm, The patient recovered. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory, the lot complies with the standards of the Center for Biologics Evaluation and Research and was released. It was also reported that two other patients had a similar reaction (WAES0407USA02326, WAES0407USA02327). Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site pain, Rash, Rash maculo-papular
Clinical narrative: Initial and follow up information has been received from a nurse practitioner concerning a 44 year old white female patient with a concurrent condition of allergic to some antibiotics who on Jul 20 2004 (previously reported as Jul 03 2004) was vaccinated IM into the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 646494/1201N). Concomitant therapy included montelukast sodium and many other medications including acetaminophen (+) propoxyphene napsylate (Darvocet-N), albuterol (Proventil inhaler), cetirizine hydrochloride (Zyrtec) and lansopraxole (Prevacid). It was noted that on Jul 20 2004 the patient felt immediate pain, and a couple of hours later developed a red rash with warmth, burning and pain at the injection site, Today on Jul 22 2004 the patient had a splotchy rash, warmth and tenderness at the injection site. Unspecified medical attention was sought. The patient was told to follow up it there was no improvement. It was unknown if the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Initial and follow up information has been received from a nurse practitioner concerning a 44 year old white female patient with a concurrent condition of allergic to some antibiotics who on Jul 20 2004 (previously reported as Jul 03 2004) was vaccinated IM into the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 646494/1201N). Concomitant therapy included montelukast sodium and many other medications including acetaminophen (+) propoxyphene napsylate (Darvocet-N), albuterol (Proventil inhaler), cetirizine hydrochloride (Zyrtec) and lansopraxole (Prevacid). It was noted that on Jul 20 2004 the patient felt immediate pain, and a couple of hours later developed a red rash with warmth, burning and pain at the injection site, Today on Jul 22 2004 the patient had a splotchy rash, warmth and tenderness at the injection site. Unspecified medical attention was sought. The patient was told to follow up it there was no improvement. It was unknown if the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth, Tenderness
Clinical narrative: Information has been received from a physician concerning an 83 year old female patient with a pertinent medical history (no details provided) who on Jun 10 2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 646322/0530N), in the right deltoid. Subsequently, the patient developed a red, swollen arm at injection site. Ice and analgesic treatment was reported. The reporting physician requested a lot check. No product quality complain. follow up information reported that the patient developed red, hot, swollen shoulder tender, The patient recovered. the records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for biologics Evaluation and Research and was released. It was also reported that two other patients had a similar reaction (WAES0407USA01800, WAES0407USA02327). Additional information is not expected.