chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site oedema, Injection site reaction, Rash erythematous
Clinical narrative: Information has been received from a physician concerning a 14 year old white female with mild asthma who on 09 OCT 2001 (also reported as 10 OCT 2001) was vaccinated with a seventh dose of pneumococcal vaccine 23 polyvalent (lot # 479567, invalid) IM in the right arm and influenza virus vaccine in the left arm. Concomitant therapy included fluticasone propionate, salmeterol xinafoate, and albuterol. On 09 OCT 2001 (also reported as in the evening of 11 OCT 2001), the patient developed extreme tenderness and a blotchy, erythematous rash around the injection site of the pneumococcal vaccine. By the morning of 12 OCT 2001, the patient's right arm was so sore that hte patient could not use that arm. The physician reported that the patient subsequently recovered on 19 OCT 2001. No additional information is expected.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: Information has been receoved from a health professional concerning an 83 year old female with no known allergies who on 15 OCT 2001 was vaccinated with one dose of pneumococcal vaccine 23 polyvalent (lot #640744/0994L). Within hours post-vaccination the patient developed redness, warmth and swelling at the injection site and arm. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Information has been received from a health care professional concerning a pt who on approx. 10/10/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the pt experienced hives on the trunk of their body. As of 10/18/01, it was reported that the hives now look like a football on the pt's stomach. Unspecified medical attention was sought. The reporter indicated that the pt may have been vaccinated with pneumococcal vaccine 23 polyvalent before. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Information has been received from a health professional concerning a 72 year old female with a sulfa allergy and a history of hypertension and hypercholesterolemia who on 17 OCT 2001 was vaccinated in the right arm with a dose of pneumococcal vaccine 23 polyvalent (lot # 640576/0923L) at her well visit examination. Concomitant therapy included simvastatin, guanfacine hcl, aspirin, vitamins, calcium carbonate and naproxen 250 mg. On 17 OCT 2001, in the evening, the patient's arm was swollen and red from the shoulder to elbow. Her right arm had marked swelling with mild erythema and warmth. On 18 OCT 2001, she was rexamined and her right arm was swollen and red and no signs of infection were noted. It was reported that she was treated with loratadine and ice packs and she was instructed to call the physician's office if it worsened. No calls were received and the patient subsequently recovered. No further information is available.
Age: 53.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Erythema, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Information has been received from a health care professional concerning a 53 year old female patient with allergies to ampicillin, cephalexin and cefaclor which result in canker sores and a history of hypercholesterolemia who on 17 OCT 2001 was vaccinated in the right arm with a dose of pneumococcal vaccine 23 polyvalent (lot #636158/1456K). Concomitant therapy included a dose of influenza virus vaccine given in the left arm. On 18 OCT 2001 the patient experienced chills, sweats and a temperature of 99F. on 19 OCT 2001 the patient experienced redness, slight swelling and pain from her right scapula to elbow with blotchy patches of redness on the inner aspect of her arm. The patient sought unspecified medical attention. It was reported that the patient was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (manufacturer unknown) 8 to 10 years ago without incident. There was no evidence of discomfort on the patient's left arm where she received the influenza virus vaccine. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a health care professional concerning a 53 year old female patient with allergies to ampicillin, cephalexin and cefaclor which result in canker sores and a history of hypercholesterolemia who on 17 OCT 2001 was vaccinated in the right arm with a dose of pneumococcal vaccine 23 polyvalent (lot #636158/1456K). Concomitant therapy included a dose of influenza virus vaccine given in the left arm. On 18 OCT 2001 the patient experienced chills, sweats and a temperature of 99F. on 19 OCT 2001 the patient experienced redness, slight swelling and pain from her right scapula to elbow with blotchy patches of redness on the inner aspect of her arm. The patient sought unspecified medical attention. It was reported that the patient was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (manufacturer unknown) 8 to 10 years ago without incident. There was no evidence of discomfort on the patient's left arm where she received the influenza virus vaccine. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Injection site haemorrhage
Clinical narrative: Information has been received from a health professional via a drug wholesaler concerning a patient who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. It was reported that the patient contacted the office post vaccination and noted that he or she had streaks appearing down the arm. The patient had sought medical attention for the experience. It was also reported that another patient developed injection site ecchymosis post vaccination with pneumococcal vaccine 23 polyvalent (WAES01111508). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Rash maculo-papular
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 65 year old female with no known drug allergies who on approximately 12 OCT 2001 was vaccinated with pneumococcal vaccine 23 polyvalent. The patient subsequently developed a maculopapular rash over 20% of her body. No other symptoms were reported. The patient sought medical attention for her experience.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacist concerning a pt who on 10/16/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. On 10/19/01, the pt developed erythema of the arm. Unspecified medical attention was sought. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a physician concerning a 53 year old white female with hypertension, hypothyroidism, Sjogren's Syndrome, fibromyalgia, GERD, allergic rhinitis and menopause who on 10/10/01 at 10:30 was vaccinated IM in the left deltoid, with a dose of pneumococcal vaccine 23 polyvalent (lot 636158/1456K). Concomitant vaccination the same day included a dose of influenza virus vaccine (Fluzone) (lot U0573AA) given IM in the right deltoid. At the time of vaccination, the pt was experiencing constipation and oral thrush. On 10/11/01, at 10:15, the pt developed erythema and induration at the left deltoid injection site. The pt sought medical attention and the pt subsequently recovered. It was also reported that another pt (WAES 0112USA02132) had a similar experience following exposure to pneumococcal vaccine 23 polyvalent. No further information is available.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from an NP concerning a female pt who on approx. 10/23/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included a dose of influenza virus vaccine. Subsequently, the pt experienced nausea and vomiting. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Syncope
Clinical narrative: Information has been received from a pharmacist concerning a teenage female pt who in approx. 2001, was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the pt fainted. It was reported that the next day, the pt was fine and went to school. Unspecified medical attention was sought. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Information has been received from a physician concerning a male pt who on 10/24/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. About 4 hours, post vax, on 10/24/01, the pt developed hives over the injection site, which was red. Unspecified medical attention was sought. The pt's wife also experienced an injection site reaction (WAES 01112924) after vaccination the same week with pneumococcal vaccine 23 polyvalent. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from an RN concerning a 51 year old female pt with multiple allergies, a connective tissue disorder and osteoporosis who on 10/22/01 was vaccinated with a dose (lot 636849/0944K) of pneumococcal vaccine 23 polyvalent. Concomitant therapy included risedronate sodium (Actonel), hydroxychloroquine sulfate (Plaquenil) and bethanechol chloride (Myocholine). Subsequently, the pt reported to the physician's office that she developed localized erythema at the injection site and that it was getting worse. Unspecified medical attention was sought. The physician requested a lot check because 2 other pt's (WAES 01104569 and 01112683) also had adverse experiences with the same bottle. The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory. The lot complies with the standards of the Center of Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from an RN concerning a 51 year old male pt "construction worker" who on 10/5/01 was vaccinated with 1 dose of pneumococcal vaccine 23 polyvalent (lot 637094/0945K). Two to three days, post vax, the pt called the physician's office because his arm was so sore that he could not work. The nurse reported that the physician recommended that the pt use ibuprofen and ice and that if the arm did not improve, he should come into the office for a visit. It was also reported that the pt developed an "unduly" injection site reaction described as very severe redness, swelling and hard lumps around the injection site. It was noted that these reactions persisted for several weeks. It was also reported that the lumps took several weeks to resolve. The nurse reported that the pt never came into the office 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 the 1st use and the liquid remaining in the vial was clear. The office reported only using 3 doses from this 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 by GMP Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. It was also reported that 2 other pt's were vaccinated with 1 dose of pneumococcal vaccine 23 polyvalent from this same lot (lot 637094/0945K) and experienced similar events (WAES 01113124 and WAES 01113399). No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Hypokinesia, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a pt who was vaccinated with pneumococcal vaccine 23 polyvalent. Subsequently, the pt spiked a fever a day after the injection and developed a reaction at the injection site (red, warm area up to 7cm in diameter). The pharmacist reported that the pt's reaction continued to worsen, even after treatment with Tylenol and Benadryl to the point where the pt had trouble raising their arm. Upon internal review, the pt's injection site reaction (red, warm area 7cm in diameter) was considered an "Other Important Medical Event". The pharmacists also reported the experiences of 19 pts following vaccine with pneumococcal vaccine 23 polyvalent (WAES 01104731). Additional information has been requested.
Age: 87.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a health professional concerning an 87 year old white male with allergies to Bactrim, sulfa, tetanus, "mairodentin" and "ERYC" and a history of positive Mantoux test who on 8/21/01 was vaccinated IM in the right deltoid, with a 1st dose of pneumococcal vaccine 23 polyvalent (lot 637095/0946K). There were no illnesses at the time of vaccination. On 8/21/01, the pt developed reddened arm, swollen to elbow with burning sensation. The pt complained of a fever on the evening of 8/21/01. He was treated with Augmentin 500mg and subsequently recovered. No further information is available.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site warmth, Pyrexia, Urinary tract infection
Clinical narrative: Information has been received from an employee in a physician's office concerning a 75 year old Caucasian female pt with allergies to penicillin, sulfa and azithromycin (Z-PAK) who on 9/6/01 was vaccinated IM in the right deltoid muscle, with a dose of pneumococcal vaccine 23 polyvalent (lot 637095/0946K). On the evening of 9/6/01, the pt went to an ER with a right deltoid induration measuring approx. 15cm which was hard and warm. No cellulitis was noted. The pt also had complaints of fever and chills and was dx'd with a UTI. The pt was treated with Levaquin and Medrol Dosepak). The pt improved the next day and recovered 1 week later. Additional information is not expected.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Information has been received from an LPN concerning a female in her 80's who in 10/01, was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. During the week of 10/15/01, while driving home from the office, the pt experienced injection site reaction of the upper arm: swollen, red, inflammed, "baseball size" area with weakness, nausea and dizziness. She went to the ER, was treated (therapy unspecified) and was released. Subsequently, the pt recovered. Upon internal review, injection site reaction, swollen, red and inflammed were considered "Other Important Medical Events". The LPN also reported that a female in her 70's experienced injection site reaction with swelling, redness and inflammation, weakness, nausea, dizziness and red rash while on therapy with pneumococcal vaccine 23 polyvalent (see WAES 0110095). Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Nausea
Clinical narrative: Information has been received from an LPN concerning a female in her 80's who in 10/01, was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. During the week of 10/15/01, while driving home from the office, the pt experienced injection site reaction of the upper arm: swollen, red, inflammed, "baseball size" area with weakness, nausea and dizziness. She went to the ER, was treated (therapy unspecified) and was released. Subsequently, the pt recovered. Upon internal review, injection site reaction, swollen, red and inflammed were considered "Other Important Medical Events". The LPN also reported that a female in her 70's experienced injection site reaction with swelling, redness and inflammation, weakness, nausea, dizziness and red rash while on therapy with pneumococcal vaccine 23 polyvalent (see WAES 0110095). Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Dyspnoea, Pruritus, Swelling, Vomiting
Clinical narrative: Information has been received from a pharmacist concerning a 67 year old female pt with no known allergies who on 10/24/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. The pharmacist reported that within 24 hours, approx. 10/27/01, the pt had trouble breathing, was itchy and swollen, had a yellow tinged arm, and was vomiting. On 10/27/01, the pt went to the ER and was monitored and then released to home on therapy with Atarax. The pt was last seen for an office visit on 10/30/01. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist and an LPN concerning a white female with asthma who was vaccinated IM, in the right deltoid, with a 0.5ml dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included a 0.5ml dose in the left deltoid of influenza virus vaccine. Other concomitant therapy included Serevent (2 puffs BID beginning on 10/12/01), Pulmicort, turbohaler (200mg QD beginning 10/12/01) and albuterol inhaler (2 puffs Q4hr PRN beginning 9/24/01. The pt reported that 2 hours after the immunization in her right arm, in the area where the shot was given, began to swell, become red and painful. The pt was seen in the physician's office the next day with a swollen, warm and red upper arm. The pt was treated with (Solu-Medrol) 125mg, prednisone 20mg, po, QD X 2 days, Benadryl 25mg, Q6 hours, PRN and instructed to use over-the-counter ibuprofen 400mg Q6 hours and to call if there was no improvement or if the condition worsened. The pharmacist reported on another pt (WAES 01110662). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Information has been received from a female with sulfa allergy who on 10/29/01 was vaccinated with pneumococcal vaccine 23 polyvalent in her right arm. Concomitant therapy included Norvasc, methotrexate, Toprol XL Tablets and Premarin. Subsequently, the pt experienced large raised red area in her right arm pit that itches and pain at the injection site. Unspecified medical attention was sought. In follow-up, the physician reported that the pt did have redness and heat at the site of the pneumococcal vaccination and it resolved spontaneously, 4 days later. The physician felt that it was "not clear to him that this was any sort of significant reaction". Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Information has been received from an LPN concerning a female in her 70's who on 10/26/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. On approx. 10/26/01, the pt experienced injection site reaction of the upper arm, swollen, red, inflammed, "baseball size" area with weakness, nausea, dizziness and a red rash at the neck line. She was treated with Benadryl. Subsequently, the pt recovered. Upon internal review, injection site reaction was considered an "Other Important Medical Events". The LPN also reported that a female in her 80's experienced injection site reaction, weakness, nausea and dizziness while on therapy with pneumococcal vaccine 23 polyvalent (see WAES 01106326). Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Rash
Clinical narrative: Information has been received from an LPN concerning a female in her 70's who on 10/26/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. On approx. 10/26/01, the pt experienced injection site reaction of the upper arm, swollen, red, inflammed, "baseball size" area with weakness, nausea, dizziness and a red rash at the neck line. She was treated with Benadryl. Subsequently, the pt recovered. Upon internal review, injection site reaction was considered an "Other Important Medical Events". The LPN also reported that a female in her 80's experienced injection site reaction, weakness, nausea and dizziness while on therapy with pneumococcal vaccine 23 polyvalent (see WAES 01106326). Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from an RN concerning a 56 year old female pt who on 11/2/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. On 11/2/01, later that same day, the pt called her physician's office and reported that she had developed site swelling, site redness, a 102F fever and experienced site soreness. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a female pt with a drug allergy to Ceftin who on 11/3/01 was vaccinated in the left deltoid with a dose of pneumococcal vaccine 23 polyvalent. On approx. 11/4/01, 24 hours post vax, the pt developed a red band around her left arm 1" below the injection site. The arm was swollen and painful. It was unknown if the pt sought medical attention. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from an RN concerning a 42 year old Caucasian male physician who on 11/1/01 at 10:00, was vaccinated SC in the right arm with the 1st dose of pneumococcal vaccine 23 polyvalent (lot 640981/1050L). Concomitant therapy that same day at 10:00, included the 1st dose IM in the left deltoid of influenza virus vaccine (Fluzone) (lot 00694AA). Subsequently, on 11/2/01 at 08:00, the pt developed red swelling, hot to touch, hard from injection, pain from injection, low-grade fever and general joint aches from right arm injection site to the elbow. The physician was treated with 2 tablets of Vicodin for the pain. The pt recovered on 11/5/01. The nurse felt that the physician's low-grade fever and joint aches were related to the flu vaccine. The nurse reported 2 other cases of injection site swelling and redness (lot 640981/1050L) (WAES 01111735 and 01111376). Additional information is not expected.
Age: 42.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Information has been received from an RN concerning a 42 year old Caucasian male physician who on 11/1/01 at 10:00, was vaccinated SC in the right arm with the 1st dose of pneumococcal vaccine 23 polyvalent (lot 640981/1050L). Concomitant therapy that same day at 10:00, included the 1st dose IM in the left deltoid of influenza virus vaccine (Fluzone) (lot 00694AA). Subsequently, on 11/2/01 at 08:00, the pt developed red swelling, hot to touch, hard from injection, pain from injection, low-grade fever and general joint aches from right arm injection site to the elbow. The physician was treated with 2 tablets of Vicodin for the pain. The pt recovered on 11/5/01. The nurse felt that the physician's low-grade fever and joint aches were related to the flu vaccine. The nurse reported 2 other cases of injection site swelling and redness (lot 640981/1050L) (WAES 01111735 and 01111376). Additional information is not expected.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site erythema, Injection site swelling, Joint swelling
Clinical narrative: Information has been received from a 56 year old female with no known allergies and no past medical history who in approx. 1997, (4 years ago), was vaccinated with a 1st dose and on 11/1/01, was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent (lot 636158/1456K). Concomitant therapy included Benadryl and (Vicodin Tablets). On 11/2/01, the pt's arm began to swell. It was 14" around and maroon red from the shoulder down to her elbow. The swelling had moved to her elbow joint and was affecting her hand movement. On 11/3/01, the pt went to the ER and was told that she might have been given a contaminated batch. On 11/4/01, the pt returned to the ER and was told that the person who gave her shot had administered the vaccine incorrectly. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complied with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypoaesthesia oral, Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 61 year old Caucasian female pt with an allergy to Duricef and a history of a local reaction to TD in 1999 who in 1995 was vaccinated with the 1st dose of pneumococcal vaccine 23 polyvalent. On 10/30/01, the pt was vaccinated with the 2nd dose of pneumococcal vaccine 23 polyvalent IM in the left thigh (1st number 637261/1067K) and influenza virus vaccine (Fluzone) IM in the right thigh (lot U0600AA). Other concomitant therapy included glucosamine, enalapril maleate, Tums, estradiol, Darvocet and an unspecified medication. Within 24 hours, on 10/31/01, the pt developed a site reaction on the left thigh about 6" in diameter with warmth, redness, swelling, inflammation and pain. The symptoms occurred only on the left thigh, which was the injection site of pneumococcal vaccine 23 polyvalent. The pt also had a swollen face and some swelling and numbness of her mouth, tongue and lips. The pt was started on prednisone 40mg X 10 days. The pt had previously tried Benadryl with little results. The pt's symptoms resolved on 11/14/01. No additional information is expected.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Swelling face
Clinical narrative: Information has been received from a pharmacist concerning a 61 year old Caucasian female pt with an allergy to Duricef and a history of a local reaction to TD in 1999 who in 1995 was vaccinated with the 1st dose of pneumococcal vaccine 23 polyvalent. On 10/30/01, the pt was vaccinated with the 2nd dose of pneumococcal vaccine 23 polyvalent IM in the left thigh (1st number 637261/1067K) and influenza virus vaccine (Fluzone) IM in the right thigh (lot U0600AA). Other concomitant therapy included glucosamine, enalapril maleate, Tums, estradiol, Darvocet and an unspecified medication. Within 24 hours, on 10/31/01, the pt developed a site reaction on the left thigh about 6" in diameter with warmth, redness, swelling, inflammation and pain. The symptoms occurred only on the left thigh, which was the injection site of pneumococcal vaccine 23 polyvalent. The pt also had a swollen face and some swelling and numbness of her mouth, tongue and lips. The pt was started on prednisone 40mg X 10 days. The pt had previously tried Benadryl with little results. The pt's symptoms resolved on 11/14/01. No additional information is expected.
Age: 76.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dizziness, Fatigue, Injection site reaction, Injection site swelling, Nausea
Clinical narrative: Information has been received from a physician concerning a 76 year old female who on 11/1/01 was vaccinated SC with pneumococcal vaccine 23 polyvalent. Concomitant vaccination included influenza virus vaccine. On 11/5/01, the pt developed a swollen arm and on 11/6/01, the pt became nauseated and vomited. It was also reported that on an unspecified date, the pt became lightheaded and dizzy and felt tired. The pt sought unspecified medical attention. At the time of this report, the outcome of the events was unknown. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 76 year old female who on 11/1/01 was vaccinated SC with pneumococcal vaccine 23 polyvalent. Concomitant vaccination included influenza virus vaccine. On 11/5/01, the pt developed a swollen arm and on 11/6/01, the pt became nauseated and vomited. It was also reported that on an unspecified date, the pt became lightheaded and dizzy and felt tired. The pt sought unspecified medical attention. At the time of this report, the outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Pain, Swelling
Clinical narrative: Information has been received from an RN concerning a pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 637369/1043L). Subsequently, the pt developed swelling and pain at the injection site and in the non-injected arm. Medical attention was sought. At the time of this report, the outcome of the events was unknown. Additional information has been requested. Related WAES 01112519.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Initial and follow-up information has been received from an RN concerning  an 83 year old retired Caucasian female pt with insulin-dependent diabetes mellitus and no known allergies who on 11/2/01 at 14:00, was vaccinated SC in the right arm, with the 1st dose of pneumococcal vaccine 23 polyvalent (lot 640981/1050L). Concomitant therapy that same day at 14:00, included the 1st dose IM in the left deltoid, of influenza virus vaccine (Fluzone) (lot U0694AA). There were no illnesses at the time of vaccination. Subsequently, on 11/4/01 at 11:00, the pt developed red, hot, hard swelling 3"-4" from the elbow to site of injection. The event was described as erythema 3"-4" below the injection site (around elbow area) that was hot to the touch. It was noted that there was no pain and that the pt was afebrile. Cellulitis was suspected and antibiotics were prescribed. On 11/4/01, therapy with erythromycin, 500mg po every 6 hours was started for 24 hours. Therapy with dicloxacillin 250mg po every 6 hours for 7 days was also started. An X-ray of the right elbow was performed on 11/5/01, which showed no fracture. The pt recovered on 11/8/01. The nurse reported 2 other cases of injection site swelling (lot 640981/1050L) (WAES 01110500, 011111376). Additional information is not expected.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth
Clinical narrative: Initial and follow-up information has been received from an RN concerning  an 83 year old retired Caucasian female pt with insulin-dependent diabetes mellitus and no known allergies who on 11/2/01 at 14:00, was vaccinated SC in the right arm, with the 1st dose of pneumococcal vaccine 23 polyvalent (lot 640981/1050L). Concomitant therapy that same day at 14:00, included the 1st dose IM in the left deltoid, of influenza virus vaccine (Fluzone) (lot U0694AA). There were no illnesses at the time of vaccination. Subsequently, on 11/4/01 at 11:00, the pt developed red, hot, hard swelling 3"-4" from the elbow to site of injection. The event was described as erythema 3"-4" below the injection site (around elbow area) that was hot to the touch. It was noted that there was no pain and that the pt was afebrile. Cellulitis was suspected and antibiotics were prescribed. On 11/4/01, therapy with erythromycin, 500mg po every 6 hours was started for 24 hours. Therapy with dicloxacillin 250mg po every 6 hours for 7 days was also started. An X-ray of the right elbow was performed on 11/5/01, which showed no fracture. The pt recovered on 11/8/01. The nurse reported 2 other cases of injection site swelling (lot 640981/1050L) (WAES 01110500, 011111376). Additional information is not expected.
Age: 91.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from an RN concerning a 91 year old Caucasian female pt with a sulfa and penicillin allergy who on 11/2/01 at 14:00, was vaccinated SC, in the right arm, with a 1st dose of pneumococcal vaccine 23 polyvalent (lot 640577/0995L). Concomitant therapy that same day, at 14:00, included the 1st dose IM in the left deltoid, of influenza virus vaccine (Fluzone) (lot U0694AA). Subsequently on 11/3/01, at 10:00, the pt developed a 5cm circular erythema about 48 hours post vax. The pt recovered from the erythema on 11/6/01. Unspecified medical attention was sought. The nurse reported 2 other cases of injection site swelling (lot number 640577/0995L) (WAES 01110500 and 011111375). Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a woman in a doctor's office and an RN concerning a 59 year old Caucasian female RN who on 11/8/01, at 18:00, was vaccinated in the left deltoid with a dose (1st number 635892/1197K) of pneumococcal vaccine 23 polyvalent. There were no illnesses at the time of vaccination. On 11/10/01, sometime in the AM, (also reported as within 12 hours of administration of the vaccine), the pt developed an injection site reaction with an enlarged, raised, reddened area, that was hot to the touch and very painful (12" X 4", deltoid to elbow, also reported as 10" X 4"). The pt was treated with ice and acetaminophen (+) caffeine (Excedrin). The pharmacist who supplied the physician's office with the pneumococcal vaccine 23 polyvalent was worried about using the last vial. Follow-up information received from the female RN indicated that although there was no visible evidence, the area of injection was still painful to the touch. She reported the outcome of the events as recovered. The records of testing prior to release of this lot (635892/1197K) have been checked by GMP Compliance and found to be satisfactory. This lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 31.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Contusion, Injection site mass, Injection site reaction
Clinical narrative: Information has been received from a health professional concerning a 31 year old female who was vaccinated with pneumococcal vaccine 23 polyvalent (dose unknown) (lot 636158/1456K). Concomitant therapy, that day, included influenza virus vaccine. On 11/7/01, the pt developed signs of bruising and a large nodule at the injection site. The pt did not complain of pain. The pt was monitored for 10 minutes while an ice park was applied and ibuprofen administered. At that time, the pt's nodule "went down a little bit". As of 11/12/01, the pt's nodule was still present and there was still a small amount of bruising. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Contusion, Injection site mass, Injection site pain
Clinical narrative: Information has been received from an MA concerning a 67 year old male who on 11/12/01 was vaccinated with the 1st dose of pneumococcal vaccine 23 polyvalent (lot 637487/1071K) in the arm. Concomitant therapy that day, in the opposite arm, included a flu vaccine. At the pneumococcal vaccine 23 polyvalent injection site, the pt had pain, bruising and a nodule about 20 minutes after being vaccinated. The pt sought unspecified medical attention. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning an 82 year old white female pt with no known medical history who on 11/6/01, at 09:30, was vaccinated SC, in the left arm, with the 1st dose of pneumococcal vaccine 23 polyvalent (lot 641115/1159L). There was no illness at the time of vaccination. On 11/6/01 (previously reported as 11/7/01), the pt experienced a bad reaction which included severe swelling and redness. The pt was seen in the ER. There was no relevant diagnostic tests or lab data. The reporter expressed a concern with the lot number. The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The pt's husband (WAES 01111065) had a similar experience following exposure to pneumococcal vaccine 23 polyvalent. F/U information received on 5/9/02, stated that the pt recovered, on an unspecified date. There was no disability or long-term adverse effect noted. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Contusion, Injection site reaction
Clinical narrative: Information has been received from a health professional via a drug wholesaler concerning a pt who was vaccinated with pneumococcal vaccine 23 polyvalent. It was reported that the pt contacted the office, post vax, and stated that his or her arm had begun to bruise. The pt had sought medical attention for the experience. It was reported that a pt had developed injection site erythema, post vax, with pneumococcal vaccine 23 polyvalent (see WAES 01102743). Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Pruritus, Rash
Clinical narrative: Itching and Rash/hives appeared on all over approx 4hrs after the vaccination. No other abnormal symptom appeared. The patient ate well and played as usual. The Patient was given only one 25mg of Benadryl at 6.15PM. The itching and rash/hives disappeared before the night and the next day no itching or rash.
Age: 11.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Rash erythematous
Clinical narrative: Itching and Rash/hives appeared on all over approx 4hrs after the vaccination. No other abnormal symptom appeared. The patient ate well and played as usual. The Patient was given only one 25mg of Benadryl at 6.15PM. The itching and rash/hives disappeared before the night and the next day no itching or rash.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Ecchymosis, Erythema, Injection site induration, Injection site oedema
Clinical narrative: 16 month old male seen on 7/31/02 after two day history of right thigh swelling and induration at the site of his dTaP vaccination on 7/9/02.  The site had two 2 mm papules with some ecchymosis, and a surrounding area of erythema 10.5 x 8 cm involving the entire anterior right thigh.  60 Day follow up states that pt recovered.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PPV
Symptoms: Coma, Crying, Hypotonia, Pallor, Screaming
Clinical narrative: She received 4 shots at 4:30 on Tuesday 7/9/02 in the afternoon: DTaP, Hib, IPV, and PCV.  Within 3 hours of the vaccinations, she became very limp, pale and non-responsive.  She began crying in a very high pitched manor that came and went as she slipped in and out of sleep.  She never did fully wake and open her eyes during this time.  This lasted for three to four hours.  At approx 11 pm that evening, about six hours after the shot, her body, head and arms began trembling.  This shaking episode may have lasted 15-30 minutes.  I don't recall exactly.  She felt cold, clamy, yet feverish, but I never took her temperature.  Following this episode, she fell back to sleep.  The remainder of the night she slept very restlessly, and woke frequently.  The shaking, limp, and crying symptoms had subsided by midnight that evening, but she remained fussy for the rest of the week.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PPV
Symptoms: Somnolence, Tremor
Clinical narrative: She received 4 shots at 4:30 on Tuesday 7/9/02 in the afternoon: DTaP, Hib, IPV, and PCV.  Within 3 hours of the vaccinations, she became very limp, pale and non-responsive.  She began crying in a very high pitched manor that came and went as she slipped in and out of sleep.  She never did fully wake and open her eyes during this time.  This lasted for three to four hours.  At approx 11 pm that evening, about six hours after the shot, her body, head and arms began trembling.  This shaking episode may have lasted 15-30 minutes.  I don't recall exactly.  She felt cold, clamy, yet feverish, but I never took her temperature.  Following this episode, she fell back to sleep.  The remainder of the night she slept very restlessly, and woke frequently.  The shaking, limp, and crying symptoms had subsided by midnight that evening, but she remained fussy for the rest of the week.
Age: 0.9
Sex: F
Vaccine: MMR
Symptoms: Abasia, Asthenia, Blood glucose increased, Dyspnoea, Irritability
Clinical narrative: Information has been received from a legal firm regarding a case in litigation concerning an 11 month old ("361 days old") female, with no known allergies, birth defects or medical conditions, who on 6/3/99 was vaccinated with the 1st of MMRII (lot 627849/1009H), administered SC, in the left arm. This does not comply with the recommended dose schedule. There was no concomitant medication or illness at the time of vaccination. The child had "developed normally" from the time of birth to the date of her vaccination. From that date through 6/14/99, she had an immediate and increasing change in her mood. She became irritable, lethargic and increasingly would not eat. This was reportedly unusual, as the child was normally active in the morning. It was noted that this took place in a public place with a lot of stimulation. On the night of 6/11/99, the child fell asleep in the middle of breakfast, in a restaurant and wakened agitated. She refused to crawl, play or walk. She had no appetite and was increasingly lethargic. On the morning of 6/14/99, she could not stand up in her crib and was panting. She appeared to be very weak. She was irritable and difficult to comfort. She was taken to the hospital, where a spinal tap was performed. She had a temperature of 100.3F, high blood sugar of 305 and extremely high levels of acidosis. She was treated with insulin and transferred to another hospital, by ambulance. She arrived at the 2nd hospital at 12:11 PM. She was dx'd with advanced diabetic ketoacidosis and was admitted to ICU. She was stabilized and discharged on 6/19/99. Since then, she has followed a diabetic regimen consisting of 4 insulin shots per day. One of the source documents received, indicated that as of 7/3/99, the pt was on insulin. That same source document indicated a death date of 7/3/99, with no additional details. However, additional information received, indicated that as of 11/12/01, the child was not deceased. It was noted that there is no history of Type I diabetes in either parental family. Teething was considered to be an incidental finding. This report may have also been filed directly to FDA and subsequently, may be a duplicate report. No further information is available.
Age: 0.9
Sex: F
Vaccine: MMR
Symptoms: Ketoacidosis, Lethargy, Mood altered, Oral intake reduced, Pyrexia
Clinical narrative: Information has been received from a legal firm regarding a case in litigation concerning an 11 month old ("361 days old") female, with no known allergies, birth defects or medical conditions, who on 6/3/99 was vaccinated with the 1st of MMRII (lot 627849/1009H), administered SC, in the left arm. This does not comply with the recommended dose schedule. There was no concomitant medication or illness at the time of vaccination. The child had "developed normally" from the time of birth to the date of her vaccination. From that date through 6/14/99, she had an immediate and increasing change in her mood. She became irritable, lethargic and increasingly would not eat. This was reportedly unusual, as the child was normally active in the morning. It was noted that this took place in a public place with a lot of stimulation. On the night of 6/11/99, the child fell asleep in the middle of breakfast, in a restaurant and wakened agitated. She refused to crawl, play or walk. She had no appetite and was increasingly lethargic. On the morning of 6/14/99, she could not stand up in her crib and was panting. She appeared to be very weak. She was irritable and difficult to comfort. She was taken to the hospital, where a spinal tap was performed. She had a temperature of 100.3F, high blood sugar of 305 and extremely high levels of acidosis. She was treated with insulin and transferred to another hospital, by ambulance. She arrived at the 2nd hospital at 12:11 PM. She was dx'd with advanced diabetic ketoacidosis and was admitted to ICU. She was stabilized and discharged on 6/19/99. Since then, she has followed a diabetic regimen consisting of 4 insulin shots per day. One of the source documents received, indicated that as of 7/3/99, the pt was on insulin. That same source document indicated a death date of 7/3/99, with no additional details. However, additional information received, indicated that as of 11/12/01, the child was not deceased. It was noted that there is no history of Type I diabetes in either parental family. Teething was considered to be an incidental finding. This report may have also been filed directly to FDA and subsequently, may be a duplicate report. No further information is available.
Age: 0.9
Sex: F
Vaccine: MMR
Symptoms: Tooth disorder
Clinical narrative: Information has been received from a legal firm regarding a case in litigation concerning an 11 month old ("361 days old") female, with no known allergies, birth defects or medical conditions, who on 6/3/99 was vaccinated with the 1st of MMRII (lot 627849/1009H), administered SC, in the left arm. This does not comply with the recommended dose schedule. There was no concomitant medication or illness at the time of vaccination. The child had "developed normally" from the time of birth to the date of her vaccination. From that date through 6/14/99, she had an immediate and increasing change in her mood. She became irritable, lethargic and increasingly would not eat. This was reportedly unusual, as the child was normally active in the morning. It was noted that this took place in a public place with a lot of stimulation. On the night of 6/11/99, the child fell asleep in the middle of breakfast, in a restaurant and wakened agitated. She refused to crawl, play or walk. She had no appetite and was increasingly lethargic. On the morning of 6/14/99, she could not stand up in her crib and was panting. She appeared to be very weak. She was irritable and difficult to comfort. She was taken to the hospital, where a spinal tap was performed. She had a temperature of 100.3F, high blood sugar of 305 and extremely high levels of acidosis. She was treated with insulin and transferred to another hospital, by ambulance. She arrived at the 2nd hospital at 12:11 PM. She was dx'd with advanced diabetic ketoacidosis and was admitted to ICU. She was stabilized and discharged on 6/19/99. Since then, she has followed a diabetic regimen consisting of 4 insulin shots per day. One of the source documents received, indicated that as of 7/3/99, the pt was on insulin. That same source document indicated a death date of 7/3/99, with no additional details. However, additional information received, indicated that as of 11/12/01, the child was not deceased. It was noted that there is no history of Type I diabetes in either parental family. Teething was considered to be an incidental finding. This report may have also been filed directly to FDA and subsequently, may be a duplicate report. No further information is available.