chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a woman in a physician's office concerning a 69 ear old male patient who on approximately 10/24/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent IM in the left deltoid (lot number 63615//1456K). Approximately 24 hours post injection on 10/25/01, the patient's left arm became red, swollen, and sore from the injection site down. The patient saw the physician and was placed on unspecified antibiotics, which resolved the symptoms. The physician stated that it was a staph infection. No culture was done for staph infection. Additional information is not expected.
Age: 0.7
Sex: M
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Sudden infant death syndrome, Unevaluable event
Clinical narrative: Came into office with head cold and was behind in immunizations, so MD's office brought him up-to-date with shots. Pt died on 7/20/02, 5 days, post vax.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Eye movement disorder, Irritability, Muscle twitching
Clinical narrative: Left office 10:30am after waiting 10 mins after shots. Baby was fine. Baby started getting irritable at noon. Daycare called mom when she saw baby twitching lower and upper extremities and eyes rolling back. Had three episodes each lasting 1 min then slept. Came to office, rechecked, referred neurologist,
Age: 25.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Influenza like illness, Pyrexia, Skin discolouration, Swelling
Clinical narrative: Within a few hours after injection, developed flu-like symptoms, joint pain, left arm swelling and discoloration, temp. Resolved with about 12 hours.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: DTaP given on 07/29/2002 came to office 7/31/02with hot red area around injection site
Age: 68.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus, Skin burning sensation
Clinical narrative: Patient was treated in Emergency department for laceration to finger.  She received dose of TD toxoid in left deltoid. Patient complained of pain at the site of injection that increased in intensity over the next few days.  The upper arm became red and swollen. The patient complained of itching  and burning. Patient sought medical attention and family physician prescribed Augmentin and Naproxin. Parent requested Medwatch report.
Age: 18.0
Sex: F
Vaccine: MEN, MEN
Symptoms: Drug administration error
Clinical narrative: Packaging of vaccine conceals the powder in the package insert. It appeared to me and my nurse that the dilutent was the entire vaccine. The pt was given only the dilutent. The error was discovered later that day and the pt is being rescheduled for reinjection with reconstituted vaccine.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Injection site oedema, Joint range of motion decreased
Clinical narrative: 48 hrs local swelling at injection site 2.5x2cm and limitation of motion on internal rotation of left upper arm at shoulder joint.
Age: 5.4
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Feeling hot, Swelling
Clinical narrative: Swelling of left arm with large knot and hot to touch. No pain. Diagnosed with cellulitis of left arm status post vaccine. Treatment with Duricet 250mg bid for 10 days. Treatment started 7/24/02.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site mass, Injection site reaction
Clinical narrative: Very red knot to her left arm with large knot and very hot to touch, knot hard and raised. Dx cellulitis and treated with Omnicef 125mg 2tsp qd x 5 days. Tx started 7/17.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Very red knot to her left arm with large knot and very hot to touch, knot hard and raised. Dx cellulitis and treated with Omnicef 125mg 2tsp qd x 5 days. Tx started 7/17.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Cellulitis, Erythema, Feeling hot, Oedema peripheral, Rash
Clinical narrative: Right arm red and edematous and hot to touch with splotchy rash noted. Diagnosed with cellulitis status post vaccine and treated with Duricef 125mg bid for 10 days.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Rash maculo-papular
Clinical narrative: Right arm red and edematous and hot to touch with splotchy rash noted. Diagnosed with cellulitis status post vaccine and treated with Duricef 125mg bid for 10 days.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Chicken pox.
Age: 17.0
Sex: M
Vaccine: TD
Symptoms: Blood pressure decreased, Heart rate increased, Musculoskeletal stiffness
Clinical narrative: After administration of Td and Tb medicine for test, RN left room only to hear noise and returned to find client lying on floor between chair and desk, body stiff, hands positioned in fist and pulled back. Heart rate rapid and weak BP (99/50) and pale. Revived quickly with ammonia inhalant. Mother stated client had eaten on grapes at noon and client required juice.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Pain in jaw, Pyrexia, Swelling
Clinical narrative: Onset of low grade fever, afternoon 07/18/02and 07/19/02 and continues today - Onset swelling jaw 07/21/02, Denies difficulty swollen and breathing.
Age: 7.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Depression, Sensory disturbance, Tic, Tremor
Clinical narrative: Through patient's vaccination schedule, she was diagnosed with problems such as a shudder spells, ticks, albiet benign; however present). Doctors ruled out seizure disorder, autism, However diagnosed with depression and dysfunction with sensory system.
Age: 1.8
Sex: F
Vaccine: DTAP
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: 3 cm x 5 cm patchy erythematous maculo papular rash @ site of immunization.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Left arm with swelling, slight indurated , warm to touch, Cellulitis- Keflex 375 TID x 10 days.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Left arm red, warm to touch , moves hands well, Cellulitis, Keflex 250/5 (1/2 tsp ) TID X 10 days.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site swelling, Pruritus
Clinical narrative: Patient received DTaP immunization in right upper arm. Later the evening, arm turned red and swollen and itching around injection site. Patient also ran low grade fever.
Age: 0.5
Sex: M
Vaccine: DTAP, HBPV, HEP
Symptoms: Rash maculo-papular, Rash pustular
Clinical narrative: Macular/ Papular/Pusular rash over head/trunk/extremities.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm swollen, warm to touch, 5cm diameter, Cellulitis-Keflex 500 TID X 10 day.
Age: 1.08
Sex: F
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Chicken Pox
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Cluster of vesicles which resolved into an area of erythema over 3-4 days at the site of the varivax injection.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site induration
Clinical narrative: Erythema, induration, warmth over large area of right anterior/lateral thigh.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Confusional state, Dizziness, Dyspnoea, Speech disorder
Clinical narrative: Received Hep B vaccine 12pm 7/18/2002. Returned to facility 7/19/02 stating she had been to ER 7/18 pm due to dizziness, confusion, difficulty with speech, difficulty breathing. Released from ER at 630-7pm. Patient states ER DR says questionable allergic reaction to thimerosol. Follow up with private physician.
Age: 30.0
Sex: F
Vaccine: DTP
Symptoms: Feeling hot, Pain, Swelling
Clinical narrative: Arm very swollen (patient states size of softball). Very painful and warm to touch.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site induration, Urticaria
Clinical narrative: Patient received a Td vaccine 7/23/02 in her left deltoid. She noticed a welt 7/25/02 in the PM. On // she presented to our office with a 10mm induration that was red and warm at injection site. There was a large erythematous area distal to injection site. This patch was measured 100mmx70mm.
Age: 4.9
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Musculoskeletal stiffness, Oedema peripheral
Clinical narrative: Left arm swollen, red and warm to touch from shoulder to elbow. Mother also stated that patient's left leg was stiff after waking up on 7/26/02. No treatment required. Patient and mother instructed to return as needed.
Age: 2.8
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Received varicella vaccine 2/5/01. Developed large number of vesicles all over body. To MD to confirm varicella.
Age: 8.0
Sex: F
Vaccine: IPV
Symptoms: Disturbance in attention, Dizziness, Fatigue, Headache, Pallor
Clinical narrative: Patient fainted 1 to 2 minutes after immunization. Was pale, unfocused, vomited 3 times over 25 minutes. Complained of headache and dizziness. Fatigue for 5 hours after syncope.
Age: 8.0
Sex: F
Vaccine: IPV
Symptoms: Syncope, Vomiting
Clinical narrative: Patient fainted 1 to 2 minutes after immunization. Was pale, unfocused, vomited 3 times over 25 minutes. Complained of headache and dizziness. Fatigue for 5 hours after syncope.
Age: 9.0
Sex: F
Vaccine: TD, VARCEL
Symptoms: Injection site induration, Oedema peripheral, Tenderness
Clinical narrative: 7/31/02 Swelling left arm. Went to ED. Rx with Keflex. 8/1/02 office visit follow up. Left ventral upper arm red, warm, positive induration about 13cm in circumference. No fever. Rx with Keflex 500 2 times, BID for 24 hours and follow up. 8/2 no redness. Still indurated and tender.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning an approximately 57 year old female with an unspecified allergy who approximately 6 years ago was vaccinated at another health care provider's office with a dose of pneumococcal vaccine 23 polyvalent. Within a few hours of vaccination, she developed a local reaction. It was unknown if medical attention was sought. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Information has been received from a health professional concerning a 24 year old female with pulmonary fibrosis, which was reported to be stable, and recent sinusitis who on 11/8/01 was vaccinated in the left deltoid with a dose of pneumococcal vaccine 23 polyvalent (lot #636159/1070K). Concomitant therapy included sulfamethoxazole/trimethoprim (BACTRIM DS TABLETS) for recent sinusitis, hormonal contraceptives (unspecified), unspecified antihistimines and buspirone hcl (BUSPAR). On 11/9/01, the patient experienced pain, swelling and redness and was scheduled to be seen in the physician's office. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked  and found to be satisfactory. The lot complies with the standards and was released. Another patient (WAES01111206) had a similar experience following exposure to pneumococcal vaccine 23 polyvalent. Follow up information from the health care professional indicated that the patient did not have a real adverse reaction. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Psoriasis
Clinical narrative: Information has been received from a medical assistant concerning a 40 year old female patient with an allergy to amoxicillin and a history of pneumonia who on 11/15/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvent (lot # 640577/0995L). The medical assistant reported that there was a small area of psoriasis near the injection site prior to the administration of the vaccine. Within a few hours post vaccination, the patient was seen and treated in the ER for swelling, redness, and cellulitits of the left arm from the injection site to below the elbow. The area was warm to the touch. The patient was treated with diphehydramine (BENADRYL) and ibuprofen. On 11/18/2001 the patient recovered. No additional information is expected.
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Back pain
Clinical narrative: Information has been received from a doctor of pharmacy concerning a female (age unknown) who was vaccinated with a first and second dose of pneumococcal vaccine 23 polyvalent (manufacturer unknown). The patient received the vaccines within six months of reciving the first. The second dose not comply with the recommend dosages schedule. The patient reportedly was 'fine" for about a week and then she started to develop back pain and became weak. It was noted that the reporter did not know which pneumoccal vaccine the patient revealed. The patient sought unspecified medical attention. No further information is expected.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Oedema peripheral, Swelling
Clinical narrative: Information has been received from a pharmacist concerning a 72 year old male patient who on 11/12/2001 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot number 639394/0461L). Subsequently, the patient developed swelling (unspecified), swelling of the arm, redness and cellulitis. Medical attention was sought and the patient was prescribed antibiotics. At the time of reports, the outcome of the events was unknown. Per request of the pharmacist a request for a lot check has been made. The records of testing prior to release of this lot have been checked  and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested. Related WAES01112890.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot number 637369/1043L). Subsequently, the patient developed a local reaction at the injection site. Medical attention was sought. At the time of this report the outcome of the event was unknown. Additional information has been requested. Related WAES01111227.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a approximately 50 year old female who on 10/18/2001 was vaccinated with a dose (lot # 636849/0944K) of pneumococcal vaccine 23 polyvalent. Subsequently, the patient called the physician's office and reported that she had developed an injection site reaction. The patient presented to the physician's office on 10/23/2001 with a small red indurated area at the site of vaccination. She was prescribed levofloxacin (LEVAQUIN) 500 mg and was believed to have recovered as of 11/26/2001. The physician requested a lot check because three patients (WAES #'s 01104540 and 01104569 (the patient's husband)) have had adverse experiences with the same bottle. The recordes of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was release. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a 71 year old Caucasian female consumer with hypertension, sulfa allergy (rash, nausea) and degenerative joint disease who on 11/14/2001 at 14:30 was vaccinated IM in the right deltoid with the first dose (lot number 1497K reported, invalid for the product) of pneumococcal vaccine 23 polyvalent. Concomitant therapy on 11/14/2001 included a dose in her thigh of influenza virus vaccine (manufacturer not reported). Additional concomitant therapy included ramipril (ALTACE) and estrogens, conjugated (PREMARIN). On 11/14/2001 at 17:00 the patient developed pain at the injection site and her arm became swollen and painful from her shoulder to her elbow, and then down into her forearm. She reported that her arm was red, inflamed and sore. She noted that as of 11/20/2001, her arm seemed to be better. Unspecified medical attention was sought. Follow up information received from a woman in the physician's office indicated that the patient developed a localized reaction characterized by redness and swelling. She also indicated that there was soreness at the injection site in the patient's right deltoid. No further information is available.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Information has been received from a pharmacist concerning a 79 year old female who on 11/12/01 was vaccinated with pneumococcal vaccine 23 polyvalent (lot #639394/0461L). Subsequently the patient developed swelling (unspecified), swelling of the arm, redness, and cellulitis. Medical attention was sought and thepatient was prescribed antibiotics. At the time of this report, the outcome of the events were unknown. Per request of the pharmacist, a request for a lot check has been made. The records of testing prior to release of this lot have been check and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested. Related WAES01112443.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site induration, Urticaria
Clinical narrative: Information has been received from a physician concerning a female patient who on 10/22/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the patient developed hives below the injection site. It was reported that the site was red and indurated. Unspecified medical attention was sought. The patient's husband also experienced an injection site reaction (WAES01104370) after vaccination the same week with pneumococcal vaccine 23 polyvalent. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 70 year old female patient who on 10/02/01 was vaccinated with one dose of pneumococcal vaccine 23 polyvalent (lot # 637094/0945K). The patient called the physician's office 2-3 days post-vaccination because her arm was sore. It was noted that her whole arm hurt. The patient was instructed to use ibuprofen. The patient called the physician's office because the arm pain continued. It was recommended that she use ice packs and ibuprofen. It was also reported that the patient developed an unduly injection site reaction described as very severe redness, swelling and hard lumps around the injection site. It was noted that this reaction persisted for several weeks. It was also reported that the lumps took several weeks to resolve. The patient never needed to go into the office for a visit and has since recovered. The nurse and a physician reported feeling strongly that the vial was contaminated. There were no cracks in the vial, the flip off cap was intact upon first use and the liquid remaining in the vial was clear. The office reported only using these three doses from this 5 dose vial. The reporter noted that they sent a sample for testing. The patient sought unspecified medical attention. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. it was also reported that two other patients were vaccinated with one dose of pneumococcal vaccine 23 polyvalent from the same lot (lot # 637094/0945K) and experienced similar events (WAES01104576 and WAES01113399). No further information is available.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site mass, Injection site oedema, Injection site reaction, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 63 year old male patient who on 9/12/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot number 637094/0945K). The patient called the physician's office a day later because his arm was red. It was also reported that the patient developed an unduly injection site reaction described as very severe redness, swelling and hard lumps around the injection site. It was noted that this reaction persisted for several weeks. It was also reported that the lumps took several weeks to resolve. The patient never needed to go into the office for a visit and has since recovered. The nurse and a physician reported feeling strongly that the vial was contaminated. There were no cracks in the vial, the flip off cap was intact upon first use and the liquid remaining in the vial was clear. The office reported only using these three doses from the 5 dose vial. The reporter noted that they sent a sample for testing. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. It was also reported that two other patients were vaccinated with one dose of pneumococcal vaccine 23 polyvalent from the same lot (lot number 637094/0945K) and experienced similar events (WAES01104576 and WAES01113124). No further information is available.
Age: 72.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Asthenia, Chest discomfort, Chills, Erythema, Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a 72 year old Caucasian male with asthma, heart disease, a morphine allergy, an intolerance to lorezapam (Ativan), poor circulation and a history of bypass to leg. On 11/6/01 at 10:00 am the patient was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent (lot # 640744/0994L), in the right deltoid. Concomitant therapy that day included a flu vaccine. There was no illness at the time of vaccination. It was reported that on 10/11/94 the patient received the first dose. The second dose does not comply with the recommended dosage schedule. The patient reportedly within one to two hours, after the second dose, felt weak and had chills with receipt of the vaccine. The patient also had chest tightness and thought a heart attack. He took two aspirin and the chest pain went away. Later that night, his arm was very sore and swollen, also described as tightly swollen. The patient developed a severe local reaction at the injection site described as red, tender, swollen and painful. It was reproted that the symptoms started to get better the next day. However, the arm began to swell and he had more painful discomfort, described as very sore. The discomfort gradually diminished over 4 days. It was reported that the entire episode lasted for two weeks. The patient sought unspecified medical attention and recovered on 11/20/01/ It was noted that when flu shots first came out the patient became very ill after the first dose of the two dose series. No further information is expected.
Age: 72.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site swelling, Tenderness
Clinical narrative: Information has been received from a registered nurse concerning a 72 year old Caucasian male with asthma, heart disease, a morphine allergy, an intolerance to lorezapam (Ativan), poor circulation and a history of bypass to leg. On 11/6/01 at 10:00 am the patient was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent (lot # 640744/0994L), in the right deltoid. Concomitant therapy that day included a flu vaccine. There was no illness at the time of vaccination. It was reported that on 10/11/94 the patient received the first dose. The second dose does not comply with the recommended dosage schedule. The patient reportedly within one to two hours, after the second dose, felt weak and had chills with receipt of the vaccine. The patient also had chest tightness and thought a heart attack. He took two aspirin and the chest pain went away. Later that night, his arm was very sore and swollen, also described as tightly swollen. The patient developed a severe local reaction at the injection site described as red, tender, swollen and painful. It was reproted that the symptoms started to get better the next day. However, the arm began to swell and he had more painful discomfort, described as very sore. The discomfort gradually diminished over 4 days. It was reported that the entire episode lasted for two weeks. The patient sought unspecified medical attention and recovered on 11/20/01/ It was noted that when flu shots first came out the patient became very ill after the first dose of the two dose series. No further information is expected.
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: Information has been received from a pharmacist concerning a nurse who in approximately 2001 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the patient developed a local erythema and warmth. Unspecified medical attention was sought. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning his 65 year old wife who was recently diagnosed with diverticulitis and was vaccinated with pneumococcal vaccine 23 polyvalent. On approximately 11/28/01, the physician's wife had developed pain at the injection site and a mild fever. Unspecified medical attention was sought. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a licensed practical nurse concerning a 47 year old female patient who on 10/12/01 was vaccinated in the left arm with a dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy on 10/12/01 included an injection of phytonadione (dose not reported) in the right arm and a dose of influenza virus vaccine (manufacturer not reported) in the left arm. It was unknown if there were any other concomitant therapies. It was reported that the patient was treated for abut 17 days by her primary physician (event onset approximately 11/12/01), and that cellulitis was ruled out. The patient presented to the reporters office on 11/29/01 with a red rash on her left arm. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a registered nurse (director of nursing at administering facility) concerning a 51 year old male with alcoholism and no known drug allergies and a history of pneumonia, malnutrition and hypokalemia who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (0.5 ml), in the left upper forearm. The patient developed a local reaction 5x4 cc red raised area which was reported as red, warm, and painful. There were no additional details provided. The patient sought unspecified medical attention. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site reaction, Injection site swelling, Pain
Clinical narrative: Information has been received from a medical assistant concerning a 63 year old Caucasian male patient with sulfa allergy, chronic obstructive pulmonary disease, hyperglycemia, and hypercholesterolemia who on 11/30/01 was vaccinated with the first dose of pneumococcal vaccine 23 polyvalent IM in the left deltoid *(lot number 641350/1351L). On 12/31/01, the patient developed a local site reaction. The patient's arm was red, swollen, hot to the touch and painful. The patient used ice and took diphenhydramine and ibuprofen. Unspecified medical attention was sought. On 12/5/01, the patient recovered. The reporter requested a lot check on lot 641530/1351L. The records of testing prior to release of this lot had been checked and found to be satisfactory. The lot complied with the standards  and was released. The patient's wife also developed injection site swelling, warmth, and ecchymosis post vaccination with pneumococcal vaccine 23 polyvalent (WAES0201USA00493). No additional information is expected.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Paraesthesia, Pruritus, Skin burning sensation
Clinical narrative: Information has been received from a woman in a doctor's office concerning a 66 year old female with no known allergies who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot # 636846/0801L). The patient developed swelling in her hand. The area was described as red and has a burning sensation. The swelling lasted for about 48 hours. After the swelling subsided the patient stated area is itchy/tingly with red dots. There were no other details available. The patient sought unspecified medical attention. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Feeling hot, Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 44 year old White female who on 12/5/01 at 5:00 pm was vaccinated IM with pneumococcal 23 polyvalent (lot # 640744/0994L). On 12/6/01 at 3:00 pm, the patient developed a fever of 100 degrees F, and an injection site reaction that included erythema to the left deltoid, edema, warmth, and cellulitis. It was also reported that the area was tender to touch. The patient subsequently recovered from the erythema, edema, tenderness, and fever. The outcome of the injection site warmth and cellulitis was unknown. Unspecified medical attention was sought. No further information is expected.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Tenderness
Clinical narrative: Information has been received from a physician concerning a 44 year old White female who on 12/5/01 at 5:00 pm was vaccinated IM with pneumococcal 23 polyvalent (lot # 640744/0994L). On 12/6/01 at 3:00 pm, the patient developed a fever of 100 degrees F, and an injection site reaction that included erythema to the left deltoid, edema, warmth, and cellulitis. It was also reported that the area was tender to touch. The patient subsequently recovered from the erythema, edema, tenderness, and fever. The outcome of the injection site warmth and cellulitis was unknown. Unspecified medical attention was sought. No further information is expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Information has beenr eceived from a registered nurse concerning a patient who on 12/4/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #641116/1160L). Subsequently on 12/6/01, the patient called the office complaining that her left arm where she received the injection was red, edematous and painful. The patient was seen in the office on 12/7/01 and her arm was fine. The RN reported that there was nothing there. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. No further information is expected. The RN also reported that another patient experienced cellulitis and SOB and was hospitalized after vaccination with pneumococcal vaccine 23 polyvalent (see WAES01120796).
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Pyrexia, Swelling, Tenderness
Clinical narrative: Information has been received from a pharmacist concerning a 73 year old female who on 12/5/01 was vaccinated in the right arm with the second dose (lot number 639394/0461L) of pneumococcal vaccine 23 polyvalent (P1: 1992). On 12/6/01 the patient developed a fever and a swollen tender area on her right upper arm. On 12/7/01 the patient developed cellulitis of the site. The pharmacist referred to the symptoms as an injection site reaction. The patient sought unspecified medical attention, and was treated with 4 doses of nafcillin sodium and one dose of fluprednidene acetate (DECODERM SINE GENTAMYCIN). No information was available on the route of the treatment medications. Subsequently after treatment the patient recovered. No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a woman in a physician's office concerning a female who on approximately 12/11/01 was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent (lot #640577/0995L). The patient was well at the time of the vaccination. It was reported that the patient was previously vaccinated with pneumococcal vaccine polyvalent years ago (exact date and lot # unknown). Following the December 2001 vaccination the patient subsequently developed a severe reaction to the vaccine and on 12/12/01 was seen in her physician's office and was diagnosed with cellulitis. It was reported that the cellulitis went from her shoulder to her elbow in the injected arm. The patient was treated with unspecified oral antibiotics and subsequently recovered. The patient did not require hospitalization. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Screaming
Clinical narrative: Screamed x 3 days after vaccines - not consolable. Also had local reaction at Prevnar site. Red hot thigh.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Injection site hypersensitivity, Injection site induration, Oedema
Clinical narrative: 2 days after injection, site became red, indurated, warm and swollen
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Chills, Headache, Malaise, Myalgia
Clinical narrative: muscle aches, joint aches, headaches, malaise, chills and nausea
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Nausea
Clinical narrative: muscle aches, joint aches, headaches, malaise, chills and nausea
Age: 0.7
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Vaccinated on 05/10/01. Died-apparent SIDS 06/11/01. Was totally normal. Put down to nap and found dead two hours later. Mom requesting VAERS be notified.
Sex: F
Vaccine: MMR
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a consumer concerning a female who was vaccinated on an unknown date with a dose of MMR II (lot not given). The reporter stated "a little girl up the street died after an allergic reaction to MMR." It was also indicated that it was unknown if the pt sought medical attention. Additional info has been requested.
Age: 3.5
Sex: F
Vaccine: DTP
Symptoms: Choking, Cough, Drug ineffective, Laboratory test abnormal, Lymphoedema
Clinical narrative: A 3 1/2 year old white female presented with a 2 day history of cough and fever. Her parents had similarly been ill with the father having a cough for the past 10 weeks, severe enough to produce paroxysms with retching and hypoxia. He was receiving home oxygen therapy and aerosolized bronchodilator medication. The child's exam was remarkable for erythematous tonsils and palpable cervical adenopathy. She was dx'd with a viral illness and placed on combination cough and cold medication. The child returned in 2 weeks, with worsening coughing and choking on mucus. Her exam was remarkable for stridor over her airway with erythematous throat palate. She was current on her immunizations, having received 4 DPT vaccinations. The child was started on aerosolized albuterol every 4 hours as needed, azithromycin 12/mg/kg/day for 5 days and Pediapred 1.0mg/kg/day for 5 days. The father was subsequently screened for pertussis by his physician and found to have a (+) IgM antibody titer. The child continued to have paroxysms of coughing over the next 6 weeks that gradually diminished. Most recent exam shows her to be healthy and thriving with no sequelae. Case linked with U2002-00570.
Age: 3.5
Sex: F
Vaccine: DTP
Symptoms: Pharyngitis, Pyrexia, Stridor, Viral infection
Clinical narrative: A 3 1/2 year old white female presented with a 2 day history of cough and fever. Her parents had similarly been ill with the father having a cough for the past 10 weeks, severe enough to produce paroxysms with retching and hypoxia. He was receiving home oxygen therapy and aerosolized bronchodilator medication. The child's exam was remarkable for erythematous tonsils and palpable cervical adenopathy. She was dx'd with a viral illness and placed on combination cough and cold medication. The child returned in 2 weeks, with worsening coughing and choking on mucus. Her exam was remarkable for stridor over her airway with erythematous throat palate. She was current on her immunizations, having received 4 DPT vaccinations. The child was started on aerosolized albuterol every 4 hours as needed, azithromycin 12/mg/kg/day for 5 days and Pediapred 1.0mg/kg/day for 5 days. The father was subsequently screened for pertussis by his physician and found to have a (+) IgM antibody titer. The child continued to have paroxysms of coughing over the next 6 weeks that gradually diminished. Most recent exam shows her to be healthy and thriving with no sequelae. Case linked with U2002-00570.
Age: 2.0
Sex: F
Vaccine: DTP
Symptoms: Bacterial infection, Cough, Cyanosis, Laryngospasm, Lymphocyte morphology abnormal
Clinical narrative: A nearly 2 year old white female had a 10 day history of cough and congestion. She was initially treated symptomatically. She was current on her immunizations and had received 4 doses of pertussis vaccination. Two days prior to hospitalization, her cough had progressed resulting in paroxysms severe enough to produce laryngeal spasm and episodes of perioral cyanosis. Exam showed her to have an erythematous pharynx, palpable cervical adenopathy and reduced air flow in all lung fields with basilar rales. She was dx'd with a pneumonic process and given 50,000 units/kg of LA Bicillin. Her 13 year old sister was concurrent ill with cold symptoms and paroxysms of cough. Over the next 3 days, her symptoms intensified with paroxysm of cough causing choking on respiratory secretions. Her mother noted that the episodes would produce apnea and cyanosis. Her temperature ranged from 39C to 39.5C. Exam was remarkable for reduced airflow in the right lung with basilar rales. She was admitted for further evaluation and treatment of pneumonitis. She was placed on humidified 30% oxygen by tent and started on IV fluids. Her oximeter reading was 95%-98%. She was started on ampicillin 100mg/kg/day IV divided every 6 hours. She was taken out of the mist. Choking episodes were reduced but still several occurred each day. Gradually, they became less severe. She was feeling well. A repeat Bordetella FA was negative after 4 days of treatment and culture showed no Bordetella growth. She was discharged home with instructions to take azithromycin 12mg/kg/day for 5 days. She continues to do well at routine follow-up. Her sister had no testing performed and seemed to return to normal without sequelae. Linked with case U2002-00574.
Age: 2.0
Sex: F
Vaccine: DTP
Symptoms: Lymphoedema, Nasal congestion, Pharyngitis, Pulmonary function test decreased, Pyrexia
Clinical narrative: A nearly 2 year old white female had a 10 day history of cough and congestion. She was initially treated symptomatically. She was current on her immunizations and had received 4 doses of pertussis vaccination. Two days prior to hospitalization, her cough had progressed resulting in paroxysms severe enough to produce laryngeal spasm and episodes of perioral cyanosis. Exam showed her to have an erythematous pharynx, palpable cervical adenopathy and reduced air flow in all lung fields with basilar rales. She was dx'd with a pneumonic process and given 50,000 units/kg of LA Bicillin. Her 13 year old sister was concurrent ill with cold symptoms and paroxysms of cough. Over the next 3 days, her symptoms intensified with paroxysm of cough causing choking on respiratory secretions. Her mother noted that the episodes would produce apnea and cyanosis. Her temperature ranged from 39C to 39.5C. Exam was remarkable for reduced airflow in the right lung with basilar rales. She was admitted for further evaluation and treatment of pneumonitis. She was placed on humidified 30% oxygen by tent and started on IV fluids. Her oximeter reading was 95%-98%. She was started on ampicillin 100mg/kg/day IV divided every 6 hours. She was taken out of the mist. Choking episodes were reduced but still several occurred each day. Gradually, they became less severe. She was feeling well. A repeat Bordetella FA was negative after 4 days of treatment and culture showed no Bordetella growth. She was discharged home with instructions to take azithromycin 12mg/kg/day for 5 days. She continues to do well at routine follow-up. Her sister had no testing performed and seemed to return to normal without sequelae. Linked with case U2002-00574.
Age: 5.08
Sex: U
Vaccine: VARCEL
Symptoms: Convulsion
Clinical narrative: Information has been received from a vaccine specialist concerning a 12 year old pt who on 05/25/95 was vaccinated with a first dose of varicella virus vaccine live (lot 608320/0405B). It was reported that on 05/17/02 the pt experienced seizure and was taken to a hospital. A physician at the hospital felt that the seizure was related to therapy with varicella virus vaccine live. No other info was available at this time. Upon internal review, the pt's experience was considered an other important medical event. Additional info has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Febrile convulsion, Hypersensitivity, Lethargy, Urinary incontinence, Vomiting
Clinical narrative: Child had a febrile seizures occurring the following day (am) after receiving DTaP, Polio, MMR and varicella at immunization clinic on 7/18/02. Discharge summaries state vomiting, urinary incontience, allergic reaction and lethergy. msv
Sex: M
Vaccine: LYME
Symptoms: Polyarthritis
Clinical narrative: Report number A0375263A describes arthritic type condition of joints in a male (age unspecified) who received Lyme disease vaccine recombinant OspA (LYMErix). This report was received as part of the litigation proceedings. The personal injury claims of April 2002 noted the injury sustained was arthritic type condition of joints, which occurred in June 2000. The claim classified this injury as a permanent injury. The claim denied that hospitalization or surgery were required for this injury. As of 19 July 2002, the outcome of the adverse event was unknown. The adverse event of arthritic type condition of joints is labeled per the USPI. The adverse event does not meet ICH serious criteria but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Age: 57.0
Sex: M
Vaccine: LYME
Symptoms: Polyarthritis
Clinical narrative: Report number A0375266A describes arthritic type condition of joints in a 57 year old male who received Lyme disease vaccine recombinant OspA (LYMErix). This report was received as part of the litigation proceedings. The personal injury claim of April 2002 noted the injury sustained was arthritic type condition of joints; vision problems which occurred in July 2000. The claim classified this injury as a permanent injury. The claim denied that hospitalization or surgery were required for this injury. As of 19 July 2002, the outcome of the adverse events was unknown. The adverse event of arthritic type condition of joints is labeled per the USPI. The adverse event did not meet ICH serious criteria, but is being submitted as an expedited report by special FDA requests per the June 28, 2000 letter.
Age: 52.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Influenza like illness, Malaise, Memory impairment, Pain
Clinical narrative: Knee pain (bilateral) from 3/95 to 12/95; hand pain from 6/95 to present; short-term memory problems from 3/95 to present; persistent flu-like symptoms and malaise. When not taking ? 100mg taken in AM and 1300mg of ? medication, HS. The 2nd Lymerix/IM given on 3/17/95 and the 3rd Lymerix/IM given on 2/16/96.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site rash
Clinical narrative: Splotches, rash around right IM leg area.  Follow up: treated with benadryl.
Age: 25.0
Sex: M
Vaccine: HEPA, TTOX, TYP, YF
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Pt came in about 15 minutes after receiving shots complaining of shortness of breath and tightness in his chest. O2 @ 10 LPN per non-rebreather mask was placed and an IV of NS @ 150ml/hr with an 18g IV was started. 911 was notified. MD gave 0.3cc epinephrine IV. SOB.
Age: 0.3
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: 4 X 6cm swelling in AM; non-tender left leg.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site urticaria
Clinical narrative: Developed urticaria, 2 days after receiving vaccines. It included his face, trunk and extremities.
Age: 0.5
Sex: F
Vaccine: DTAP, PNC
Symptoms: Convulsion
Clinical narrative: Probable seizure.  follow up: child treated in ER.
Age: 2.08
Sex: M
Vaccine: HBHEPB, PNC
Symptoms: Pyrexia
Clinical narrative: 106F fever post Prevnar; 104F in clinic; 106F at home.
Age: 1.2
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL, DTAP, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Child seen in doctor's office today for red and swollen right thigh. Had DTAP in right thigh, 2 days ago. No fever, not tender and walks ok. Thigh is red and swollen from hip to knee and around leg. Told to apply ice and to give Benadryl and ibuprofen.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Crying, Hypersensitivity, Injection site mass, Muscle contractions involuntary, Urticaria
Clinical narrative: Immediately after vaccination, "shrill, fierce cry" and 20 minutes later had hives over both legs and on face and right arm and right leg contracted. Sent to ER (minutes away) and was given Benadryl, Tylenol, Codeine and contraction resolved. Hives became "pinhead dots". After ER visit child slept and woke up fine. On 7/22/02, he has "knot" where DTAP was given and cried longer than usual last night. Relieved by Tylenol. ER doctor noted "allergic reaction".
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: Area of erythema left arm
Age: 5.5
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: Large area of erythema right upper arm. Warm to touch. Nontender.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Pruritus
Clinical narrative: Large area of itchy erythema on left arm.
Age: 2.2
Sex: M
Vaccine: UNK
Symptoms: Autism, Contusion, Erythema, Injection site mass, Pruritus
Clinical narrative: Has a very large, hard, hot spot on his shoulder. Bruise around injection site. Looks like injection has been trapped. Itches, red and swollen. The annual follow up received 7/14/03 states pt continues to suffer from autism spectrum disorder.
Age: 2.2
Sex: M
Vaccine: UNK
Symptoms: Swelling
Clinical narrative: Has a very large, hard, hot spot on his shoulder. Bruise around injection site. Looks like injection has been trapped. Itches, red and swollen. The annual follow up received 7/14/03 states pt continues to suffer from autism spectrum disorder.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: Redness left upper arm and around;Around arm 2 hour shots DTaP, IPV
Age: 5.6
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt in clinic for mtx reading of c/o itching to her legs. Mother noticed and had daughter had hive on her legs only. It was about 3pm 08/01/02. Pt saw MD. Dx hives. Benadryl 12.5mg tid as needed. Hives are disappearing and no itching.