chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site induration
Clinical narrative: Information has been received from an RN concerning a 77 year old male pt who on 21JAN2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. No other vaccinations were administered at the same time. On 22JAN2004, the pt developed induration at the injection site. Medical attention was sought. The pt was prescribed warm packs. A product quality complaint was not involved. The reporter also mentioned three other pts who developed injection site reactions post vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Injection site mass
Clinical narrative: Information has been received from a RN concerning a 60 year old male pt who on 22Jan04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. No other vaccinations were administered at the same time. Subsequently on 22Jan04. The pt developed induration at the injection site. Medical attention was sought. The pt was prescribed warm packs. A product quality complaint was not involved. The reporter also mentioned three other pt's who developed injection site reactions post vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site mass
Clinical narrative: Information has been received from a RN concerning a female pt, age in the late 50's or early 60's,  who on 21Jan04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. No other vaccinations were administered at the same time. On 22Jan04, the pt developed induration at the injection site. Medical attention was sought. The pt was prescribed warm packs. A product quality complaint was not involved. The reporter also mentioned three other pt's who developed injection site reactions post vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Oedema, Tenderness
Clinical narrative: Information has been received from a RN concerning a 66 year old female pt who on 15Dec03 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently in approx Dec03, the pt developed right arm swelling and tenderness.  Medical attention was sought. The pt was treated with ice and rest. A product quality complaint was not involved. The reporter also mentioned a male pt who experienced an adverse event post vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning himself, a 50 year old white male who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The reporter indicated that he had a painful area around the injection site about the size of the palm of his hand for a few days. He also noticed some redness. No medical attention was sought and no treatment was required. The event abated and the pt recovered. A product quality complaint was not involved.  Follow up information was received from the pharmacist who indicated that on 06Dec03 at 5:00PM he developed pain at the injection site lasting approximately 48 hours. He subsequently recovered. No further information is expected.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a LPN concerning her husband, an adult male, who several years ago was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The LPN reported that she gave her husband the vaccination with pneumococcal 23v polysaccharide vaccine and he developed redness and swelling at the injection site. No treatment was required for the adverse event. The adverse event abated and the pt recovered. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site mass
Clinical narrative: Information has been received from a physician concerning a 31 year old female who 31JAN2004 was vaccinated in the deltoid with a dose of pneumococcal 23v polysaccharide vaccine. The pt was an inpatient in the hospital at that time, and was vaccinated a few hours before being discharged from the hospital. The next day, on 01FEB2004, the pt called the hospital stating that she had a lump on her arm and was diagnosed with cellulitis by her primary physician and placed on antibiotics. It was unknown why the pt was originally hospitalized. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Feeling hot
Clinical narrative: Information has been received from an LPN concerning a 78 year old white female with hypertension, breast cancer, coronary artery disease, reflux, fatigue, hyperglycemia, high cholesterol, sulfa allergy and valsartan allergy who on 19NOV2003 at 2:00 PM was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine, IM in the right deltoid. There was no illness at the time of vaccination. On 20NOV2003 at 10:30 AM the pt developed "a large erythematous area" described as "warm to touch."The pt was diagnosed with cellulitis. The pt was treated with Keflex. Subsequently, the pt recovered from cellulitis. It was noted that the first dose of pneumococcal 23v polysaccharide vaccine was administered in 1994. Additional info has been requested.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Information has been received from an LPN concerning a 54 year old white female with bronchitis, hypertension, asthma and a smoker who on 09DEC2003 at 2:00 PM was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine, IM in the right deltoid. On 12DEC2003 at 11:00 am the pt developed swelling, redness and pain. The pt was treated with cold compresses and Benadryl , Tylenol or Advil. Subsequently, the pt recovered. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Dry skin, Erythema, Skin exfoliation
Clinical narrative: Information has been received form an LPN concerning a 64 year old white female with a hx of gastrointestinal bleeding and with cephalosporins allergy, high cholesterol and osteoarthritis who on 9DEC203 at 1:20 PM was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine, IM in the right deltoid. There was no illness at the time of vaccination. On 11DEC2003 at 10:30 Am the pt developed erythema left upper extremity described as "dry scaly." The pt was treated for signs and sxs with cold packs and Benadryl. Subsequently, the pt recovered. It was noted that the pt received the first dose of pneumococcal 23v polysaccharide vaccine on 12NOV1997. Additional info has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling
Clinical narrative: Information has been received from an LPN concerning 5 female patients, all over 60 years old with some 70-80 years old, all with medical history, who 2003 were each vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. All of the pts had concomitant medications. At least two of the pts received a prior dose of pneumococcal 23v polysaccharide vaccine. Subsequently in 2001, the pts developed injection site reactions the size of a saucer that were red and inflamed. Unspecified medical attention was sought. Subsequently, all of the pts fully recovered. A product quality complaint was not involved. The reporter stated the doctor was concerned because all pts received the same lot number. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and research and was released. Three of the pts were treated with Benadryl and cold packs. Follow up information was received from the LPN concerning one of the female pts treated with Benadryl and cold packs. The pt was an 74 year old Caucasian female pt wit HTN, high cholesterol and hyperglycemia who on 05DEC2003 at 10:20 was vaccinated IM in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine, October 1996. There was no illness at the time of vaccination. On 12DEC2003 at 10:00, the pt developed a red, raised area the size of a saucer. The reporter stated that there was no treatment. Subsequently, the patient recovered. One of the other female pts was treated with Bactrim. Another one of the female pts was treated with Keflex. The remaining two female pts were treated with Benadryl and cold packs. Additional info is not expected.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning her husband who on 04DEC2003 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the pt experienced pain at the injection site, which still persists today. The pt was not hospitalized. Unspecified medical attention was sought. No additional information was provided. There was no product quality complaint. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Information has been received from an RN concerning a 70 year old female pt with allergies to escitalopram oxalate, serazone, statins and niacin who on 13JAN2004 was vaccinated IM with a second dose of pneumococcal 23v polysaccharide vaccine. There was no illness at the time of vaccination. Concomitant therapy included lisinopril, omeprazole, levothyroxine sodium, Topicort, Advil and chrondroitin sulfate sodium + glucosamine sulfate. Subsequently, the pt developed a local rxn that was very bothersome for her, including temporary loss of the full use of the arm, pain, erythema and hardness. On 14JAN2004, the pt presented to the physician because of swelling and redness where she received the dose of pneumococcal 23v polysaccharide vaccine. Physician examination revealed erythema around the area where she had the shot, diffusely extending down into the biceps area and then around to the area in the deltoid. There was moderate tenderness and increased warmth, but no lymphangitic streaking and no adenopathy. Laboratory tests were not performed. The medical assessment was a local reaction to dose of pneumococcal 23v polysaccharide vaccine with possible cellulitis. The plan was to place the pt on Clarinex for the allergic component and a short term course of Cefzil. They planned to watch for gastrointestinal side effects including diarrhea. If the pt developed that, the mediation would be discontinued. If the pt developed redness going further up or down her arm, she would call. Coolness to the area seemed to feel better, so the pt was to use cool compresses. If swelling continued to be an issue, prednisone therapy would be considered. The pt was to update them in a few days if she was not improving. Subsequently, the pt recovered. A product quality complaint was not involved. The reporter also mentioned two other pts who developed local reactions post vaccinations with dose of pneumococcal 23v polysaccharide vaccine. It was noted that all the reactions came from the same lot number, but upon inspection the vaccine appears to be fine. Additional info is not expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Pain, Tenderness
Clinical narrative: Information has been received from an RN concerning a 70 year old female pt with allergies to escitalopram oxalate, serazone, statins and niacin who on 13JAN2004 was vaccinated IM with a second dose of pneumococcal 23v polysaccharide vaccine. There was no illness at the time of vaccination. Concomitant therapy included lisinopril, omeprazole, levothyroxine sodium, Topicort, Advil and chrondroitin sulfate sodium + glucosamine sulfate. Subsequently, the pt developed a local rxn that was very bothersome for her, including temporary loss of the full use of the arm, pain, erythema and hardness. On 14JAN2004, the pt presented to the physician because of swelling and redness where she received the dose of pneumococcal 23v polysaccharide vaccine. Physician examination revealed erythema around the area where she had the shot, diffusely extending down into the biceps area and then around to the area in the deltoid. There was moderate tenderness and increased warmth, but no lymphangitic streaking and no adenopathy. Laboratory tests were not performed. The medical assessment was a local reaction to dose of pneumococcal 23v polysaccharide vaccine with possible cellulitis. The plan was to place the pt on Clarinex for the allergic component and a short term course of Cefzil. They planned to watch for gastrointestinal side effects including diarrhea. If the pt developed that, the mediation would be discontinued. If the pt developed redness going further up or down her arm, she would call. Coolness to the area seemed to feel better, so the pt was to use cool compresses. If swelling continued to be an issue, prednisone therapy would be considered. The pt was to update them in a few days if she was not improving. Subsequently, the pt recovered. A product quality complaint was not involved. The reporter also mentioned two other pts who developed local reactions post vaccinations with dose of pneumococcal 23v polysaccharide vaccine. It was noted that all the reactions came from the same lot number, but upon inspection the vaccine appears to be fine. Additional info is not expected.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Joint range of motion decreased, Pain, Skin striae
Clinical narrative: Information has been received from a health professional concerning a 69 year old female with penicillin, codeine and sertraline hydrochloride allergies who on approximately 1/14/04 was vaccinated IM with a second dose of pneumococcal 23v polysaccharide vaccine (lot # 647724/0946N). There was no illness at the time of vaccination. Concomitant therapy included simvastatin 10mg PO QD, alendronate sodium 70mg PO Q week, vitamin E 400U PO QD, calcium (+) vitamin D 1200mg/400iu PO BID, Nefazodone HCl 75mg PO BID, hydroxyzine hydrochloride 25mg PO QD and tolterodine tartrate 4mg PO QD. Subsequently, the patient developed a local reaction which included temporary loss of full use of the arm, pain, erythema and hardness which as reported to be bothersome to the patient. On 1/16/04, the patient was seen by the physician for redness and pain in her arms. Her physical exam showed that she had a fourteen centimeter streak down towards her antecubital fossa by her basilic vein with a little warmth to it. There was no redness in the hand and no evidence of contiguous infection anywhere in the arms, including her injection site. The physician's assessment was phlebitis in the arm, etiology which was undetermined. Treatment with cephalexin 500mg QID for 7 days and then some naproxen 500mg bid was ordered. The physician also recommended using hot packs. Subsequently the patient recovered. There was no product quality complaint involved. It was also noted that 2 other patients were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647724/0946N) and had similar experiences. It was noted that all the reactions came from the same lot number but upon inspection the vaccine appears to be fine. No further information is expected.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 35 year old female with idiopathic thrombocytopenia and no known allergies who on 2/18/04 at 10:30 was vaccinated IM in the left deltoid with a first dose of pneumcococal 23v polysaccharide vaccine (lot # 647635/0864N). There was no concomitant medication. The patient had a splenectomy secondary to idiopathic thrombocytopenia at the time of vaccination. On 2/18/04, at 16:30 the patient developed redness, swelling and pain in her left (previously reported as right) arm at the injection site and a fever of 101.0 degrees F. On 2/19/04 the patient again noted a fever, swelling, pain and stiffness of the left arm. Unspecified medical attention was sought and the patient was treated with acetaminophen for her fever and warm compresses for her left arm. Subsequently, the patient recovered. No product quality complaint was involved. No further information is expected.
Age: 40.0
Sex: M
Vaccine: YF
Symptoms: Erythema, Hyperaemia, Nasal congestion, Oedema, Pruritus
Clinical narrative: Pt had nasal congestion and diffuse skin hyperemia, tachycardia, severe redness/ itching under arms: body and face, slight uvula edema (no angioedema) just after receiving injection.
Age: 40.0
Sex: M
Vaccine: YF
Symptoms: Skin reaction, Tachycardia
Clinical narrative: Pt had nasal congestion and diffuse skin hyperemia, tachycardia, severe redness/ itching under arms: body and face, slight uvula edema (no angioedema) just after receiving injection.
Age: 43.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Contusion, Injection site haemorrhage, Injection site mass, Injection site swelling
Clinical narrative: Dark purple/yellow bruising and swelling (hematoma), about one inch in diameter around injection point.  Also accompanied by a "knot" at the injection point. Condition began to recede after 7 days, though signs of swelling and bruising were still clearly visible.
Age: 33.0
Sex: F
Vaccine: ANTH, DT, FLUX, HEPA
Symptoms: Chills, Erythema, Influenza, Injection site mass, Oedema peripheral
Clinical narrative: This 34-year-old was activated November 2003 and later discharged.  During this month of activation, she received Anthrax #1, Typhoid, Hepatitis A #1, Influenza, IPV, Diphtheria, and a Tuberculin test.   She states the shot was given to the upper backside of her right arm.  That evening her arm became swollen, puffy and itched. She did complete physical training before and the morning after receiving her immunizations. She remembers having flu-like symptoms including a fever (unknown elevation), body aches, chills and a bad cold that she sought medical care for.  She states medical personnel advised her that her "cell count was down possibly due to the number of shots given". Approximately one week later, she noticed an itchy facial rash that began on her forehead spreading to her cheeks, chin and neck, as "if she had the measles or chicken-pox".  Approximately two weeks after immunization this rash now included both forearms.  There was no rash to her trunk or lower extremities.  She describes the rash as a reddened area covering her skin with scattered pimples  some with depressed centers and others with pus-like centers.  She states the rash comes and goes lasting for 3-4 days, resolved for approximately one week and then returning to the same areas.  This rash does itch and appears located to areas of skin that are not covered by clothing.  She is concerned about a reoccurring "pea-sized bump" that comes and goes at her immunization site.  This bump coincides with the rash.  Furthermore, she is concerned over the "scaring" these rashes are leaving on her skin.  She reports the scaring as a darkening pigmentation. She has treated the rash with Aveno skin toner and alcohol washes to try and dry up the rash without success.  She denies any lymphadenopathy, nausea, vomiting, abdominal pain, joint-muscular weakness or pain, or any history of skin disease.  She has not seen any medical personnel for this skin rash, prior to or since her discharge.
Age: 33.0
Sex: F
Vaccine: ANTH, DT, FLUX, HEPA
Symptoms: Pain, Pharyngitis, Pruritus, Pyrexia, Rash maculo-papular
Clinical narrative: This 34-year-old was activated November 2003 and later discharged.  During this month of activation, she received Anthrax #1, Typhoid, Hepatitis A #1, Influenza, IPV, Diphtheria, and a Tuberculin test.   She states the shot was given to the upper backside of her right arm.  That evening her arm became swollen, puffy and itched. She did complete physical training before and the morning after receiving her immunizations. She remembers having flu-like symptoms including a fever (unknown elevation), body aches, chills and a bad cold that she sought medical care for.  She states medical personnel advised her that her "cell count was down possibly due to the number of shots given". Approximately one week later, she noticed an itchy facial rash that began on her forehead spreading to her cheeks, chin and neck, as "if she had the measles or chicken-pox".  Approximately two weeks after immunization this rash now included both forearms.  There was no rash to her trunk or lower extremities.  She describes the rash as a reddened area covering her skin with scattered pimples  some with depressed centers and others with pus-like centers.  She states the rash comes and goes lasting for 3-4 days, resolved for approximately one week and then returning to the same areas.  This rash does itch and appears located to areas of skin that are not covered by clothing.  She is concerned about a reoccurring "pea-sized bump" that comes and goes at her immunization site.  This bump coincides with the rash.  Furthermore, she is concerned over the "scaring" these rashes are leaving on her skin.  She reports the scaring as a darkening pigmentation. She has treated the rash with Aveno skin toner and alcohol washes to try and dry up the rash without success.  She denies any lymphadenopathy, nausea, vomiting, abdominal pain, joint-muscular weakness or pain, or any history of skin disease.  She has not seen any medical personnel for this skin rash, prior to or since her discharge.
Age: 33.0
Sex: F
Vaccine: ANTH, DT, FLUX, HEPA
Symptoms: Rash pruritic, Rhinitis, Skin discolouration
Clinical narrative: This 34-year-old was activated November 2003 and later discharged.  During this month of activation, she received Anthrax #1, Typhoid, Hepatitis A #1, Influenza, IPV, Diphtheria, and a Tuberculin test.   She states the shot was given to the upper backside of her right arm.  That evening her arm became swollen, puffy and itched. She did complete physical training before and the morning after receiving her immunizations. She remembers having flu-like symptoms including a fever (unknown elevation), body aches, chills and a bad cold that she sought medical care for.  She states medical personnel advised her that her "cell count was down possibly due to the number of shots given". Approximately one week later, she noticed an itchy facial rash that began on her forehead spreading to her cheeks, chin and neck, as "if she had the measles or chicken-pox".  Approximately two weeks after immunization this rash now included both forearms.  There was no rash to her trunk or lower extremities.  She describes the rash as a reddened area covering her skin with scattered pimples  some with depressed centers and others with pus-like centers.  She states the rash comes and goes lasting for 3-4 days, resolved for approximately one week and then returning to the same areas.  This rash does itch and appears located to areas of skin that are not covered by clothing.  She is concerned about a reoccurring "pea-sized bump" that comes and goes at her immunization site.  This bump coincides with the rash.  Furthermore, she is concerned over the "scaring" these rashes are leaving on her skin.  She reports the scaring as a darkening pigmentation. She has treated the rash with Aveno skin toner and alcohol washes to try and dry up the rash without success.  She denies any lymphadenopathy, nausea, vomiting, abdominal pain, joint-muscular weakness or pain, or any history of skin disease.  She has not seen any medical personnel for this skin rash, prior to or since her discharge.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Urticaria
Clinical narrative: Within 5 minutes after receiving DTAP child had a large area around injection site on left deltoid that was red, raised and welted. Child was given benadryl 1 tsp and was monitored for 30 minutes. Ice was applied to area. This was childs 4th dose of DTAP. No respiratory distress, child alert and oriented. Parent was given instructions on increased signs of distress to take child to ER. Instructed to monitor child closely for the next 24 hours. Was able to reach mother after several days of attempts on 8-5-04. Mother states child was fine, she had run a slight fever for the first 24 hours and she had given tylenol and another dose of benadryl. Area on left deltoid was now normal.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth, Pruritus
Clinical narrative: Had immunizations on 08/03/2004-Right arm deltoid region has golf-ball sized warm and red area with itching and tenderness.
Age: 10.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Urticaria
Clinical narrative: Approximately 18 hours after vaccination with Hep B and MMR, pt developed an uticarial rash.  No respiratory or systemic symptoms.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 2 1/2"x 3" area of erythema, swelling, warmth and tenderness surrounding area where shots were administered.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Hypokinesia, Injection site induration, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Mother reports left arm swollen, hot and hard. Temperature controlled with Motrin. Previous rxn with DtaP as infant where leg was red and swollen for 1 mo and resolved.   Leg unable to move or bend (no injections given in leg or buttocks at the clinic) Dr office X-ray leg with no significant findings. Client to followup with orthapedic this month
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Similar reaction on previous exposure to drug
Clinical narrative: Mother reports left arm swollen, hot and hard. Temperature controlled with Motrin. Previous rxn with DtaP as infant where leg was red and swollen for 1 mo and resolved.   Leg unable to move or bend (no injections given in leg or buttocks at the clinic) Dr office X-ray leg with no significant findings. Client to followup with orthapedic this month
Age: 0.7
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Choreoathetosis, Irritability
Clinical narrative: 24 hours following vaccine administration pt. developed irritability and choreoathetoid type movements of upper extremity
Age: 22.0
Sex: F
Vaccine: SMALL
Symptoms: Cellulitis, Chest pain, Dyspnoea, Injection site reaction, Rash
Clinical narrative: Notified that pt was admitted to hospital via ER for cellulitis, chest pain & SOB; pt discharged from hospital next day on 8 day course of duricef; main diagnosis:  cellulitis of the left arm at vaccination site; rash secondary to vaccine reaction (resolved over 24 h)
Age: 0.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Local erythema and induration around injection site immediately after injection. Erythema spread distally to approximately 12 cm. Benadryl 50 mg given orally.
Age: 4.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Feeling hot, Injection site inflammation, Medication error, Swelling
Clinical narrative: Father states patient's extremity became inflamed, swollen, and hot to the touch within 24 hours of receiving an unintended MMR vaccine.  Pt was seen at clinic by a physician and release home in his parents care.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Pruritus, Skin discolouration, Skin striae, Swelling
Clinical narrative: right deltoid red purplish discoloration, thin streaks running from the center of the swollen arm, the right deltoid is swollen to the size of a small tomato accompanied by itchyness.
Age: 81.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Hypoaesthesia, Oedema peripheral, Pain
Clinical narrative: Information has been received from a licensed practical nurse concerning an 81 year old male who on 1/21/04 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot # 262170) (IM), in the left deltoid. Concomitant therapy included meclizine hydrochloride, furosemide, potassium chloride and loratadine. Subsequently the patient developed pain, swelling and redness. The patient was seen in the emergency room and was treated with cephalexin and acetaminophen (+) tramadol hydrochloride. On 1/27/04 the patient reported that the condition was resolving. There was no product quality complaint involved. Follow up information reported that on 1/22/04 at 12:00 PM the patient developed left upper extremity swelling, pain, redness, and numbness extending from upper arm to below the elbow. The licensed practical nurse also reported the experiences of another patient vaccinated with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning an 81 year old male who on 1/21/04 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot # 262170) (IM), in the left deltoid. Concomitant therapy included meclizine hydrochloride, furosemide, potassium chloride and loratadine. Subsequently the patient developed pain, swelling and redness. The patient was seen in the emergency room and was treated with cephalexin and acetaminophen (+) tramadol hydrochloride. On 1/27/04 the patient reported that the condition was resolving. There was no product quality complaint involved. Follow up information reported that on 1/22/04 at 12:00 PM the patient developed left upper extremity swelling, pain, redness, and numbness extending from upper arm to below the elbow. The licensed practical nurse also reported the experiences of another patient vaccinated with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Injection site pain, Skin striae
Clinical narrative: Information has been received from a nursing supervisor concerning a 9 year old male with seasonal allergic rhinitis/perennial allergic rhinitis, chronic sinus disease, frequent upper respiratory tract infections, and a history of recurrent croup, bronchial hyperactivity, and diabetes mellitus juvenile onset who on 04/06/04 at 16:04 was vaccinated IM in the left deltoid with a 0.5mL first dose of pneumococcal 23v polysaccharide vaccine (Lot #647271/1138N). It was noted that the pt was stable at the time of vaccination. Concomitant therapy included albuterol (PRN), Flovent (110mcg with URI), Nasonex (ever day) and Claritin (seasonally every day). On 04/09/04 at 17:00 the pt experienced swelling at the injection site and positive erythematous "streaking" in the axillary area of the arm in which the vaccination was given. The pt had positive pain (extreme) at the site of injection and mild erythema. He was treated with nonsteroidal anti-inflammatory drugs and ice. Subsequently, the pt recovered. No diagnostic lab tests were performed. A product quality complaint was not involved. Additional information is not expected. The nurse also reported another pt that had a similar experience after therapy with pneumococcal 23v polysaccharide vaccine (WAES # 0404USA01511).
Age: 9.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a nursing supervisor concerning a 9 year old male with seasonal allergic rhinitis/perennial allergic rhinitis, chronic sinus disease, frequent upper respiratory tract infections, and a history of recurrent croup, bronchial hyperactivity, and diabetes mellitus juvenile onset who on 04/06/04 at 16:04 was vaccinated IM in the left deltoid with a 0.5mL first dose of pneumococcal 23v polysaccharide vaccine (Lot #647271/1138N). It was noted that the pt was stable at the time of vaccination. Concomitant therapy included albuterol (PRN), Flovent (110mcg with URI), Nasonex (ever day) and Claritin (seasonally every day). On 04/09/04 at 17:00 the pt experienced swelling at the injection site and positive erythematous "streaking" in the axillary area of the arm in which the vaccination was given. The pt had positive pain (extreme) at the site of injection and mild erythema. He was treated with nonsteroidal anti-inflammatory drugs and ice. Subsequently, the pt recovered. No diagnostic lab tests were performed. A product quality complaint was not involved. Additional information is not expected. The nurse also reported another pt that had a similar experience after therapy with pneumococcal 23v polysaccharide vaccine (WAES # 0404USA01511).
Age: 11.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Abscess, Cellulitis, Erythema, Injection site mass, Laboratory test abnormal
Clinical narrative: Information has been received from a physician's assistant concerning an 11 year old Caucasian male patient with hypogammaglobulinemia and a family history of immunoglobulin deficiency who on 2/23/04 at 15:30 was vaccinated SC with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647272/0664N). There was no illness at the time of vaccination and there were no adverse events following prior vaccination. The patient received the pneumococcal 23v polysaccharide vaccine as part of an immunodeficiency work up. On 2/23/04 at 22:00 (within 12 hours of injection), the patient developed a fever of 105 degrees F and a large local reaction consisting of deep pustules at the injection site. Within 24 hours, the patient also developed soreness, redness, and warmth at the injection site. The fever did not come down during the first 24 hours. On 2/24/04, the patient's mother took him to the local emergency room due to his fever and large local reaction. In the emergency room, blood cultures were drawn. A CBC showed a high white blood cell count. The patient was treated with acetaminophen and was released. Subsequently, the patient was seen by his pediatrician. At that time, the patient's arm was noted to be red, but was not considered to be infected. On 2/27/04, the patient was again seen by his pediatrician. His arm was noted to be ok and the results of the blood cultures taken in the emergency room were confirmed to be negative. The patient's fever continued for seven days, ranging from 105 degrees to 101 degrees. On 3/1/04, the patient's mother called the reporter because the patient's arm looked horrible. The reporter recommended the patient be seen by his pediatrician. On that same day, the patient was again seen by his pediatrician. At that time, the arm was noted to be infected and a diagnosis of cellulitis was made. The pustules were drained on day seven. The patient was hospitalized for four days. The patient required plastic surgery follow up and may require a skin graft. Subsequently, according to the grandmother, the patient's arm had healed. A product quality complaint was not involved. The reporter also mentioned another patient who developed a local reaction post vaccination with pneumococcal 23v polysaccharide vaccine (lot # 647271/1138N). Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Pain, Pyrexia, Swelling, White blood cell count increased
Clinical narrative: Information has been received from a physician's assistant concerning an 11 year old Caucasian male patient with hypogammaglobulinemia and a family history of immunoglobulin deficiency who on 2/23/04 at 15:30 was vaccinated SC with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647272/0664N). There was no illness at the time of vaccination and there were no adverse events following prior vaccination. The patient received the pneumococcal 23v polysaccharide vaccine as part of an immunodeficiency work up. On 2/23/04 at 22:00 (within 12 hours of injection), the patient developed a fever of 105 degrees F and a large local reaction consisting of deep pustules at the injection site. Within 24 hours, the patient also developed soreness, redness, and warmth at the injection site. The fever did not come down during the first 24 hours. On 2/24/04, the patient's mother took him to the local emergency room due to his fever and large local reaction. In the emergency room, blood cultures were drawn. A CBC showed a high white blood cell count. The patient was treated with acetaminophen and was released. Subsequently, the patient was seen by his pediatrician. At that time, the patient's arm was noted to be red, but was not considered to be infected. On 2/27/04, the patient was again seen by his pediatrician. His arm was noted to be ok and the results of the blood cultures taken in the emergency room were confirmed to be negative. The patient's fever continued for seven days, ranging from 105 degrees to 101 degrees. On 3/1/04, the patient's mother called the reporter because the patient's arm looked horrible. The reporter recommended the patient be seen by his pediatrician. On that same day, the patient was again seen by his pediatrician. At that time, the arm was noted to be infected and a diagnosis of cellulitis was made. The pustules were drained on day seven. The patient was hospitalized for four days. The patient required plastic surgery follow up and may require a skin graft. Subsequently, according to the grandmother, the patient's arm had healed. A product quality complaint was not involved. The reporter also mentioned another patient who developed a local reaction post vaccination with pneumococcal 23v polysaccharide vaccine (lot # 647271/1138N). Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Information has been received from a physician's assistant concerning an 11 year old Caucasian male patient with hypogammaglobulinemia and a family history of immunoglobulin deficiency who on 2/23/04 at 15:30 was vaccinated SC with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647272/0664N). There was no illness at the time of vaccination and there were no adverse events following prior vaccination. The patient received the pneumococcal 23v polysaccharide vaccine as part of an immunodeficiency work up. On 2/23/04 at 22:00 (within 12 hours of injection), the patient developed a fever of 105 degrees F and a large local reaction consisting of deep pustules at the injection site. Within 24 hours, the patient also developed soreness, redness, and warmth at the injection site. The fever did not come down during the first 24 hours. On 2/24/04, the patient's mother took him to the local emergency room due to his fever and large local reaction. In the emergency room, blood cultures were drawn. A CBC showed a high white blood cell count. The patient was treated with acetaminophen and was released. Subsequently, the patient was seen by his pediatrician. At that time, the patient's arm was noted to be red, but was not considered to be infected. On 2/27/04, the patient was again seen by his pediatrician. His arm was noted to be ok and the results of the blood cultures taken in the emergency room were confirmed to be negative. The patient's fever continued for seven days, ranging from 105 degrees to 101 degrees. On 3/1/04, the patient's mother called the reporter because the patient's arm looked horrible. The reporter recommended the patient be seen by his pediatrician. On that same day, the patient was again seen by his pediatrician. At that time, the arm was noted to be infected and a diagnosis of cellulitis was made. The pustules were drained on day seven. The patient was hospitalized for four days. The patient required plastic surgery follow up and may require a skin graft. Subsequently, according to the grandmother, the patient's arm had healed. A product quality complaint was not involved. The reporter also mentioned another patient who developed a local reaction post vaccination with pneumococcal 23v polysaccharide vaccine (lot # 647271/1138N). Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Information has been received from a physician's assistant concerning an 11 year old Caucasian male patient with hypogammaglobulinemia and a family history of immunoglobulin deficiency who on 2/23/04 at 15:30 was vaccinated SC with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647272/0664N). There was no illness at the time of vaccination and there were no adverse events following prior vaccination. The patient received the pneumococcal 23v polysaccharide vaccine as part of an immunodeficiency work up. On 2/23/04 at 22:00 (within 12 hours of injection), the patient developed a fever of 105 degrees F and a large local reaction consisting of deep pustules at the injection site. Within 24 hours, the patient also developed soreness, redness, and warmth at the injection site. The fever did not come down during the first 24 hours. On 2/24/04, the patient's mother took him to the local emergency room due to his fever and large local reaction. In the emergency room, blood cultures were drawn. A CBC showed a high white blood cell count. The patient was treated with acetaminophen and was released. Subsequently, the patient was seen by his pediatrician. At that time, the patient's arm was noted to be red, but was not considered to be infected. On 2/27/04, the patient was again seen by his pediatrician. His arm was noted to be ok and the results of the blood cultures taken in the emergency room were confirmed to be negative. The patient's fever continued for seven days, ranging from 105 degrees to 101 degrees. On 3/1/04, the patient's mother called the reporter because the patient's arm looked horrible. The reporter recommended the patient be seen by his pediatrician. On that same day, the patient was again seen by his pediatrician. At that time, the arm was noted to be infected and a diagnosis of cellulitis was made. The pustules were drained on day seven. The patient was hospitalized for four days. The patient required plastic surgery follow up and may require a skin graft. Subsequently, according to the grandmother, the patient's arm had healed. A product quality complaint was not involved. The reporter also mentioned another patient who developed a local reaction post vaccination with pneumococcal 23v polysaccharide vaccine (lot # 647271/1138N). Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Cellulitis, Injection site reaction, Pyrexia
Clinical narrative: Information has been received from a physician's assistant concerning an 11 year old Caucasian male patient with hypogammaglobulinemia and a family history of immunoglobulin deficiency who on 2/23/04 at 15:30 was vaccinated SC with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647272/0664N). There was no illness at the time of vaccination and there were no adverse events following prior vaccination. The patient received the pneumococcal 23v polysaccharide vaccine as part of an immunodeficiency work up. On 2/23/04 at 22:00 (within 12 hours of injection), the patient developed a fever of 105 degrees F and a large local reaction consisting of deep pustules at the injection site. Within 24 hours, the patient also developed soreness, redness, and warmth at the injection site. The fever did not come down during the first 24 hours. On 2/24/04, the patient's mother took him to the local emergency room due to his fever and large local reaction. In the emergency room, blood cultures were drawn. A CBC showed a high white blood cell count. The patient was treated with acetaminophen and was released. Subsequently, the patient was seen by his pediatrician. At that time, the patient's arm was noted to be red, but was not considered to be infected. On 2/27/04, the patient was again seen by his pediatrician. His arm was noted to be ok and the results of the blood cultures taken in the emergency room were confirmed to be negative. The patient's fever continued for seven days, ranging from 105 degrees to 101 degrees. On 3/1/04, the patient's mother called the reporter because the patient's arm looked horrible. The reporter recommended the patient be seen by his pediatrician. On that same day, the patient was again seen by his pediatrician. At that time, the arm was noted to be infected and a diagnosis of cellulitis was made. The pustules were drained on day seven. The patient was hospitalized for four days. The patient required plastic surgery follow up and may require a skin graft. Subsequently, according to the grandmother, the patient's arm had healed. A product quality complaint was not involved. The reporter also mentioned another patient who developed a local reaction post vaccination with pneumococcal 23v polysaccharide vaccine (lot # 647271/1138N). Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Abscess, Cellulitis, Erythema, Injection site mass, Laboratory test abnormal
Clinical narrative: Information has been received from a physician through a wholesaler who reported on an 11 year old male pt who on 23Feb04 was vaccinated with pneumococcal 23v polysaccharide vaccine. In 12 hours, the pt developed a fever of 105 degrees and cellulitis at the injection site. The pt was hospitalized for three days and then released. The injection site was cultured but nothing was found. The office retained the vial and  was reportedly sending it back . Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Pain, Pyrexia, Swelling, White blood cell count increased
Clinical narrative: Information has been received from a physician through a wholesaler who reported on an 11 year old male pt who on 23Feb04 was vaccinated with pneumococcal 23v polysaccharide vaccine. In 12 hours, the pt developed a fever of 105 degrees and cellulitis at the injection site. The pt was hospitalized for three days and then released. The injection site was cultured but nothing was found. The office retained the vial and  was reportedly sending it back . Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Information has been received from a physician through a wholesaler who reported on an 11 year old male pt who on 23Feb04 was vaccinated with pneumococcal 23v polysaccharide vaccine. In 12 hours, the pt developed a fever of 105 degrees and cellulitis at the injection site. The pt was hospitalized for three days and then released. The injection site was cultured but nothing was found. The office retained the vial and  was reportedly sending it back . Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Information has been received from a physician through a wholesaler who reported on an 11 year old male pt who on 23Feb04 was vaccinated with pneumococcal 23v polysaccharide vaccine. In 12 hours, the pt developed a fever of 105 degrees and cellulitis at the injection site. The pt was hospitalized for three days and then released. The injection site was cultured but nothing was found. The office retained the vial and  was reportedly sending it back . Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Cellulitis, Injection site reaction, Pyrexia
Clinical narrative: Information has been received from a physician through a wholesaler who reported on an 11 year old male pt who on 23Feb04 was vaccinated with pneumococcal 23v polysaccharide vaccine. In 12 hours, the pt developed a fever of 105 degrees and cellulitis at the injection site. The pt was hospitalized for three days and then released. The injection site was cultured but nothing was found. The office retained the vial and  was reportedly sending it back . Additional information has been requested.