chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain, Tenderness
Clinical narrative: Information has been received from a health professional concerning a 63 year old white female patient who on approximately 12-JUL-2006 was vaccinated with a dose of Pneumovax 23 (lot# 651321/1036P). There was no illness at the time of vaccination. On 12-JUL-2006, twelve hours after vaccination, the patient experienced erythema, and a painful, tender, swollen upper arm. Unspecified medical attention was sought. It was noted that the pain and swelling responded to heat. The patient was also treated with oral steroids and antibiotics. No diagnostic laboratory studies were performed. At the time of this report, the patient was recovering from pain and swelling and the outcome of erythema and tenderness was unknown. The physician requested a lot check. No product quality complaint was involved. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a certified medical assistant concerning an adult male patient who on an unknown date was vaccinated (route unknown) with a dose of Pneumovax 23 (lot # 651319/1007P). After receiving the vaccine, the patient developed cellulitis starting from the injection site that went down his arm. He went to the emergency room and was hospitalized. The outcome of the patient's experience was not reported. No product complaint was involved. In follow up information, the medical assistant reported that she does not have patient information or lot number information. She reported that she can not confirm that the initial lot number reported was correct. She said "An antibiotic is sometimes ordered for a patient with cellulitis" but she does not know if the patient received an antibiotic. She has no further information to provide. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a certified medical assistant concerning an adult patient (gender unknown) who on an unknown date was vaccinated (route unknown) with a dose of Pneumovax 23 (Lot # 651319/1007P). After receiving the vaccine, the patient developed cellulitis. The outcome of the patient's experience was not reported. Unspecified medical attention was sought. No product complaint was involved. In follow up information, the medical assistant reported that she does not have patient information or lot number information. She reported that she can not confirm that the initial lot number reported was correct. She said "An antibiotic is sometimes ordered for a patient with cellulitis" but she does not know if the patient received an antibiotic. She has no further information to provide. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a certified medical assistant concerning an adult patient (gender unknown) who on an unknown date was vaccinated (route unknown) with a dose of Pneumovax (Lot # 651319/1007P). After receiving the vaccine, the patient developed cellulitis. The outcome of the patient's experience was not reported. Unspecified medical attention was sought. No product complaint was involved. In follow up information, the medical assistant reported that she does not have patient information or lot number information. She reported that she can not confirm that the initial lot number reported was correct. She said "An antibiotic is sometimes offered for a patient with cellulitis" but she does not know if the patient received an antibiotic. She has no further information to provide. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a certified medical assistant concerning an adult patient (gender unknown) who on an unknown date was vaccinated (route unknown) with a dose of Pneumovax 23 (Lot # 651319/1007P). After receiving the vaccine, the patient developed cellulitis. The outcome of the patient's experience was not reported. Unspecified medical attention was sought. No product quality complaint was involved. In follow up information, the medical assistant reported that she does not have patient information or lot number information. She reported that she can not confirm that the initial lot number reported was correct. She said "An antibiotic is sometimes ordered for a patient with cellulitis" but she does not know if the patient received an antibiotic. She has no further information to provide. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a certified medical assistant concerning an adult patient (gender unknown) who on an unknown date was vaccinated (route unknown) with a dose of Pneumovax 23 (Lot # 651319/1007P). After receiving the vaccine, the patient developed cellulitis. The outcome of the patient's experience was not reported. Unspecified medical attention was sought. No product complaint was involved. In follow up information, the medical assistant reported that  she can not confirm that the initial lot number reported was correct. She said "An antibiotic is sometimes ordered for a patient with cellulitis" but she does not know if the patient received an antibiotic. She has no further information to provide. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Incorrect route of drug administration, Injection site erythema
Clinical narrative: Information has been received from a pharmacist concerning an adult female who on 20-JUL-2006 was vaccinated intradermally with a dose of Pneumovax 23 (lot #654593/0358F). The patient developed redness at the injection site shortly after the vaccination. Unspecified medical attention was sought. At the time of the report, redness at the injection site persisted. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant concerning an adult patient, with unknown medical history and unknown drug reaction/allergies, who on the week of 10-JUL-2006 was vaccinated intramuscularly with a dose of Pneumovax 23 (Lot # 651373/0320F). On an unspecified date, the patient developed pain, swelling, local heat, and redness around the injection site. Subsequently, on an unknown date the patient fully recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Blood culture, Cellulitis, Erythema, Full blood count normal, Injected limb mobility decreased
Clinical narrative: Information has been received from a registered nurse concerning an 82 year old male on dialysis with hypertension, enlarged prostate, chronic anaemia, trigeminal neuralgia, obesity and drug hypersensitivity to vancomycin (rash) and a history of haemorrhoidectomy who on 22-JUL-2006 was vaccinated with IM, into the right deltoid, with a 0.5 ml dose of Pneumovax 23 (lot #651373/0320F). Concomitant therapy included LASIX, TEGRETOL, baclofen, FLOMAX, atenolol, FOLBEE, TUMS, NORVASC, EPOGEN and HECTOROL. On 22-JUL-2006, the patient developed pain, redness and swelling of the right upper arm. On 23-JUL-2006, the patient presented to the emergency department with pain, redness and swelling of the right upper arm. A line was drawn around the site. On 24-JUL-2006, the patient returned to the emergency department and the affected site had grown approximately 3 inches beyond the line, down to the elbow. The patient was diagnosed with cellulitis. The patient received 2 grams of ROCEPHIN and was ordered to take CEFTIN, 500 mg for the next 14 days. At the time of the report, the cellulitis persisted and the patient was unable to use his arm. Cellulitis was considered to be disabling and an other important medical event. Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Laboratory test normal, Oedema peripheral, Pain
Clinical narrative: Information has been received from a registered nurse concerning an 82 year old male on dialysis with hypertension, enlarged prostate, chronic anaemia, trigeminal neuralgia, obesity and drug hypersensitivity to vancomycin (rash) and a history of haemorrhoidectomy who on 22-JUL-2006 was vaccinated with IM, into the right deltoid, with a 0.5 ml dose of Pneumovax 23 (lot #651373/0320F). Concomitant therapy included LASIX, TEGRETOL, baclofen, FLOMAX, atenolol, FOLBEE, TUMS, NORVASC, EPOGEN and HECTOROL. On 22-JUL-2006, the patient developed pain, redness and swelling of the right upper arm. On 23-JUL-2006, the patient presented to the emergency department with pain, redness and swelling of the right upper arm. A line was drawn around the site. On 24-JUL-2006, the patient returned to the emergency department and the affected site had grown approximately 3 inches beyond the line, down to the elbow. The patient was diagnosed with cellulitis. The patient received 2 grams of ROCEPHIN and was ordered to take CEFTIN, 500 mg for the next 14 days. At the time of the report, the cellulitis persisted and the patient was unable to use his arm. Cellulitis was considered to be disabling and an other important medical event. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: PPV
Symptoms: Abscess, Body temperature increased, Cellulitis, Injection site abscess, Injection site induration
Clinical narrative: Information has been received from a physician concerning a 9 year old female with sulfonamide allergy, and a history of recurrent sinusitis and sinobronchitis and lower respiratory tract infections, who on 10-JUL-2006 was vaccinated intramuscularly in the left deltoid with a 0.5 mL dose of Pneumovax 23 (lot # 651319-1007P). There was no concomitant medication. On 12-JUL-2006 the mother reported that the child had a fever of 101.5 and swelling at the site of injection. The patient was treated with ibuprofen. On 12-JUL-2006 it was also reported that the patient developed large sterile abscess at deltoid administration site. It was also reported that patient developed cellulitis (6" diameter). The patient was treated with cephalexin (KEFLEX) and prednisone. On 17-JUL-2006 the patient was "much better." On 26-JUL-2006 the patient had persistent induration at the site of injection. On 26-JUL-2006 it was also reported that there was a persistent induration at the site of injection 5 x 6 inches. The abscess was drained (5 cc, 15 cc, and 15 cc) pus on 3 different occasions. It was reported that there was no gas in the tissue and abscess was packed. The culture of the pus did not grow any bacteria. On 22-AUG-2006 the physician stated that the patient's mother said "the abscess gradually healed and today the patient is fine." The patient was going to follow up with the family practitioner in September 2006. The patient recovered. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, X-ray
Clinical narrative: Information has been received from a physician concerning a 66 year old female who on 16-JUN-2006 was vaccinated subcutaneously with a 0.5mL dose of Pneumovax 23 (lot 651357/0391F). The physician reported that after receiving Pneumovax 23, the patient developed a swollen arm that shifted down to her elbow. The patient sought medical attention, and an x-ray was performed. At the time of this report, the patient was recovering. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning an approximately 60 year old male who on an unspecified date was vaccinated with Pneumovax 23 (0.5 ml) (lot # 651328/1046F). Subsequently, the "day after receiving the vaccination", the patient developed swelling and redness at the injection site. Unspecified medical attention was sought. The patient subsequently recovered from the swelling and redness at the injection site on an unspecified date. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV
Symptoms: Wrong drug administered
Clinical narrative: Initial and follow-up information has been received from a certified medical assistant concerning a 16 week old hispanic male who on 21-JUL-2006 was inadvertently vaccinated IM with a 0.5 ml dose of Pneumovax 23 (lot #653283/0001F) instead of PREVNAR. Concomitant therapy included ACTHIB (lot #UE693AA) and PEDIARIX (lot #AC21B0G3AA). No symptoms of adverse event were noted. On an unspecified date the patient returned to the office for vaccination with PREVNAR. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site necrosis
Clinical narrative: Information has been received from a certified medical assistant concerning a 68 year old Caucasian male smoker with prostate cancer and a history of hernia and bone cyst, who on 31-JUL-2006 in the AM was vaccinated subcutaneously in the left arm with a first dose of Pneumovax 23 (Lot #651374/0485F) (0.5 mL). Concomitant therapy included ZYBAN and possibly VENTOLIN. On 01-AUG-2006 the patient contacted the clinic and reported that the injection site was red and the "area is hard". The patient was given AUGMENTIN as intervention or to prevent serious criteria. Additional information from the certified medical assistant indicated that the patient's experiences were considered other important medical events since the patient required antibiotics. She indicated that the experiences were serious enough to require medication but was not sure if they would have been life threatening or would have required hospitalization without the antibiotic treatment, although at the time of reporting she felt that way. She stated the patient's symptoms were diagnosed as cellulitis. No product quality complaint was involved. The patient's experiences were considered to be other important medical events. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a certified medical assistant concerning a 59 year old female with cluster headache, memory loss, hearing aid user, depression, hypertension and rosacea, and drug reactions/allergies to penicillin (unspecified), hydrochlorothiazide ("hydrochlorothiazide"), and esomeprazole magnesium (NEXIUM), who on 31-JUL-2006 was vaccinated subcutaneously in the left arm with a first dose of Pneumovax 23 vaccine (Lot # 651374/0485F) (0.5 ml). Concomitant therapy included acitretin (SORIATANE), fluocinonide (LIDEX), albuterol (VENTOLIN (albuterol)), propranolol HCl, paroxetine HCl (PAXIL), amlodipine besylate (NORVASC), lisinopril (LISINOPRIL-BC), aspirin, omega-3 marine triglycerides and vitamins (unspecified). The medical assistant reported that the patient experienced an adverse reaction after being vaccinated. The patient called the clinic 2 days later, and reported that her arm was red and swollen at the injection site and down past the elbow. The patient happened to see her dermatologist the next day and he placed her on antibiotics (unspecified). Additional information received from the certified medical assistant indicated that the patient's experience were considered other important medical events since the patient required antibiotics. The medical assistant indicated that the experiences were serious enough to require medication but was not sure if they would have been life threatening or would have required hospitalization without the antibiotic treatment, although at the time of reporting she felt that way. The medical assistant stated that patient's symptoms had been diagnosed as cellulitis. No product quality complaint was involved. The patient's experiences were considered to be other important medical events. Additional information has been requested.
Age: 0.7
Sex: F
Vaccine: DTAPHEPBIP, PPV
Symptoms: Wrong drug administered
Clinical narrative: Initial and follow-up information has been received from a certified medical assistant concerning a 9 month old hispanic female who on 21-JUL-2006 was inadvertently vaccinated IM with a 0.5 ml dose of Pneumovax (lot # 653283/0001F) instead of PREVNAR. Concomitant therapy included PEDIARIX. No symptoms of adverse event were noted. The patient was advised to return to the office in 2 months for vaccination with PREVNAR. As of 23-OCT-2006, the patient has not returned to the office. Additional information is not available.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Rash, Skin warm
Clinical narrative: Initial information has been received from a whole sale representative, as told by a customer, and follow up information has been received from a healthcare worker, concerning a 65 year old male, with unknown medical history, who on 27-JUN-2006 was vaccinated (route unknown) with a first dose (0.5mL) of Pneumovax 23 (Lot # 651328/1046P). Concomitant therapies may have included ROCEPHIN. Initial information received from the whole sale representative reported that the customer indicated that "we heard the patient reacted to Pneumovax 23 and that the patient had a rash." Initially the clinical outcome of the patient was not provided. Follow up information from the healthcare worker indicated that the next day, on 28-JUN-2006, the patient's arm was swollen and then became swollen, red and warm from shoulder to the elbow. He was treated with warm compresses and the red, swollen, warm arm resolved within 1 week. The reporter indicated that all serious criteria was no. However, she requested that a lot check be done on the lot, because she was not using it on any other patients. She also noted that she was "afraid this might happen to other patients". A lot check has been requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a medical biller in a physician's office concerning a female patient who was vaccinated with her first dose of Pneumovax 23. Subsequently, the patient "had a reaction". Her outcome was not reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a physician concerning a 50 year old female with a history of splenectomy who "6 years ago" was vaccinated with a dose of Pneumovax. When she was vaccinated the patient experienced local redness at the injection site. No other symptoms were noted. Subsequently, the patient recovered. Additional information has been requested.
Age: 86.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Rash
Clinical narrative: Initial information has been received from a whole sale representative, as told by a customer, and follow up information has been received from a healthcare worker, concerning a 87 year old male, with unknown medical history, who on 25-JUL-2006 was vaccinated (route unknown) with a second dose (0.5 mL) of Pneumovax 23 (Lot # 651328/1046P. Concomitant therapy may have included ROCEPHIN. Initial information received from the whole sale representative reported that the customer indicated that "we heard the patient reacted to Pneumovax 23 and that the patient had a rash." Initially the clinical outcome of the patient was not provided. Follow up information from the healthcare worker indicated that the same day, on 25-JUL-2006, the patient called the office because his arm was swollen. He started to treat the arm with warm compresses but the arm became swollen from the shoulder to the fingers with a "blood collection" at the end of the arm. The patient was treated with KEFLEX and injections of DEPO-MEDROL. The patient recovered on 31-JUL-2006. The reporter indicated that all serious criteria was no. However, she requested that a lot check be done on the lot, because she was not using it on any other patients. She also noted that she was "afraid this might happen to other patients". A lot check has been requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. Additional information has been requested.
Age: 54.0
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a healthcare worker concerning a 54 year old male patient, with no medical history reported, who in the past 2 weeks was vaccinated subcutaneously with a 0.5 mL dose of Pneumovax 23 (Lot #651357/0391F). Subsequently within a few days of receiving the vaccine, the patient developed a local injection site reaction. The patient possibly was seen in the office for symptoms. No product quality complaint was involved. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Inappropriate schedule of drug administration, Injected limb mobility decreased, Injection site swelling, Oedema peripheral
Clinical narrative: Information has been received from a 74 year old male and his wife, with no known medical history or drug reactions/allergies reported, who on 15-AUG-2006 was vaccinated subcutaneously with another dose of Pneumovax 23. Concomitant therapy included baby aspirin. The patient had been hospitalized for chest pains and when he was discharged the hospital asked him if he had been vaccinated for pneumonia. The wife confirmed that the patient was not hospitalized as a result of the vaccination, but rather received it upon discharge as part of the hospital's policy. The patient count not remember if had received it and he got a shot. That evening, on 15-AUG-2006, the injection site got swollen. The following morning, on 16-AUG-2006, the patient's arm was bright red. It was reported that he could not bend his left upper arm, and his whole arm was swollen and red. When the patient called his doctor, he stated that he had received the shot last November. The patient's clinical outcome was reported as not recovered. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count, Injection site reaction, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Information has been received from a certified medical assistant concerning a 19 year old female, with no known medical history reported, who on 16-AUG-2006 was vaccinated intramuscular with a 0.5 mL dose of Pneumovax 23 (Lot# unknown). Concomitant therapy included fluticasone propionate (FLONASE), ethinyl estradiol/mestranol/norethindron (ORTHO-NOVUM), albuterol and fluticasone propionate (+) salmeterol xinafoate (ADVAIR). The medical assistant reported that the patient had an injection site reaction. On the day of the vaccination, 16-AUG-2006, the patient developed nausea, vomiting, and fever 102.6 degrees F. There was also 5 inches in diameter of swollen area at the injection site. It was also reported that she went to work for a half a day. The medical assistant and the doctor felt that the patient's experience was serious because she did have to miss some work due to her symptoms. The clinical outcome was reported as recovering. No product quality complaint was involved. The patient's experience, injection site reaction, nausea, vomiting, and fever 102.6 degrees F, and 5 inches in diameter of swollen area at the injection site, were considered to be an other important medical event by the reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Information has been received from a certified medical assistant concerning a 19 year old female, with no known medical history reported, who on 16-AUG-2006 was vaccinated intramuscular with a 0.5 mL dose of Pneumovax 23 (Lot# unknown). Concomitant therapy included fluticasone propionate (FLONASE), ethinyl estradiol/mestranol/norethindron (ORTHO-NOVUM), albuterol and fluticasone propionate (+) salmeterol xinafoate (ADVAIR). The medical assistant reported that the patient had an injection site reaction. On the day of the vaccination, 16-AUG-2006, the patient developed nausea, vomiting, and fever 102.6 degrees F. There was also 5 inches in diameter of swollen area at the injection site. It was also reported that she went to work for a half a day. The medical assistant and the doctor felt that the patient's experience was serious because she did have to miss some work due to her symptoms. The clinical outcome was reported as recovering. No product quality complaint was involved. The patient's experience, injection site reaction, nausea, vomiting, and fever 102.6 degrees F, and 5 inches in diameter of swollen area at the injection site, were considered to be an other important medical event by the reporter. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Information has been received from a nurse concerning a male patient who on an unspecified date was vaccinated with Pneumovax 23 (lot # 651328/1046P). Subsequently, the patient developed swelling and redness at the injection site which spread all over his arm. IT was reported that the patient had previously received vaccination with Pneumovax and did not experience any reaction. 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 erythema, Injection site pain, Injection site reaction, Injection site swelling, Lymphadenopathy
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated in the "past week" with a dose of Pneumovax 23 (0.5 ml) (lot # 651148/0087F or 651173/1211R), intramuscularly. Subsequently, the patient experienced an injection site reaction. The patient experienced redness, pain, swelling and lymphadenopathy. The patient experienced the reaction "right away or a few days later." The patient may have been treated with warm compresses and an unnamed analgesics. Unspecified medical attention was sought. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated with Pneumovax 23. Concomitant therapy included an allergy shot in the same arm. The patient was seen in the office. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated in the "past week" with a dose of Pneumovax 23 (lot # 651148/0087F or 651173/1211R), intramuscularly. Subsequently, the patient experienced an injection site reaction. The patient experienced redness, pain, swelling and had "an affected area approximately 4-6 inches." The patient experienced the reaction "right away or a few days later." The patient may have been treated with warm compresses and unnamed analgesic. Unspecified medical attention was sought. Additional information is not expected.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a registered nurse concerning an 86 year old female, with an allergy to codeine and history of a recent hip fracture who on 25-AUG-2006 was vaccinated, most likely via intradermal route, in the right forearm with a 0.5 mL dose of Pneumovax 23 (Lot # 651356/0089F). Concomitant therapy included several unspecified medications (therapy unspecified). On 25-AUG-2006 the patient developed a red raised area around the site. The physician has ordered the patient cephalexin (KEFLEX). No product quality complaint was involved. The patient's experience, red raised area around the site, was considered to be an other important medical event by the reporter. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: PPV
Symptoms: Cold compress therapy, Contusion, Injection site erythema, Injection site nodule, Pain in extremity
Clinical narrative: Initial and follow up information has been received from a parent and from a certified medical assistant, respectively, concerning a 6 month old male (birth weight 6#, 13 oz.), with no known drug allergies, who on 08-AUG-2006 (previously reported as 25-AUG-2006), was vaccinated with a 0.5 mL dose of Pneumovax 23 (Lot # unknown) instead of PREVNAR. It was initially reported by the parent, that the infant had no adverse effect, however the certified medical assistant reported in follow up that the mother called the office the next day and reported that the patient developed a small knot at the injection site, as well as injection site redness. The parent was instructed to put a warm pack on the injection site first, and then follow with ice pack applications. As of 05-SEP-2006, the patient had since recovered (date not specified). The certified medical assistant reported that the inadvertent vaccination with Pneumovax 23 "was a mistake made by one of the staff members, who had been counseled regarding the event". Follow-up information has been received on 06-OCT-2006. The physician's office reported that on 11-AUG-2006 at 15:15, the patient's right leg was hurting, bruised, had a hard knot and was swollen. The physician prescribed TYLENOL, PRN and warm compress as treatment. Additional information is not expected.
Age: 0.5
Sex: M
Vaccine: PPV
Symptoms: Skin nodule, Swelling, Wrong drug administered
Clinical narrative: Initial and follow up information has been received from a parent and from a certified medical assistant, respectively, concerning a 6 month old male (birth weight 6#, 13 oz.), with no known drug allergies, who on 08-AUG-2006 (previously reported as 25-AUG-2006), was vaccinated with a 0.5 mL dose of Pneumovax 23 (Lot # unknown) instead of PREVNAR. It was initially reported by the parent, that the infant had no adverse effect, however the certified medical assistant reported in follow up that the mother called the office the next day and reported that the patient developed a small knot at the injection site, as well as injection site redness. The parent was instructed to put a warm pack on the injection site first, and then follow with ice pack applications. As of 05-SEP-2006, the patient had since recovered (date not specified). The certified medical assistant reported that the inadvertent vaccination with Pneumovax 23 "was a mistake made by one of the staff members, who had been counseled regarding the event". Follow-up information has been received on 06-OCT-2006. The physician's office reported that on 11-AUG-2006 at 15:15, the patient's right leg was hurting, bruised, had a hard knot and was swollen. The physician prescribed TYLENOL, PRN and warm compress as treatment. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Malaise
Clinical narrative: Information has been received from a physician concerning a female with a history of splenectomy prior to vaccination who "last week" (August 2006) was vaccinated subcutaneously with a 0.5 ml dose of Pneumovax 23. The physician reported that a day following the Pneumovax 23, the patient reported that she was not feeling very well. The patient developed cellulitis at the injection site that spread to her lymph nodes and then to her neck. The patient was hospitalized for three days but the physician did not provide dates. The physician felt as though the patient was near death at one point during her hospitalization. At the time of the report, it was unknown if the patient recovered. The physician felt that the patient's not feeling very well, cellulitis at the injection site which spread to her lymph nodes and then to her neck were considered to be immediately life-threatening. A lot check of concern has been requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a health professional concerning a 65 year old female patient who on 25-AUG-2006 was vaccinated with a dose of Pneumovax 23 (lot # 651399/0486F). On 25-AUG-2006 the patient developed cellulitis at the injection site. She was treated with an antibiotic. Subsequently, the patient recovered from cellulitis at the injection site. It was reported that the patient's cellulitis was considered an other important medical event. Additional information is not available.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Initial and follow up information has been received from a health professional concerning a 66 year old white female patient (186.5 pounds) with hyperlipidemia, gastrooesophageal reflux disease, "possible" sjogren's syndrome and drug allergy to Codeine and lindane who on 21-AUG-2006 was vaccinated IM into the right deltoid with a first dose of Pneumovax 23 (lot # 651319/1007P). Concomitant therapy included NEXIUM, "merulax", EFFEXOR, PAMELOR and lovastatin (manufacturer unknown). On 21-AUG-2006 at night the patient experienced right arm pain, redness, tenderness and erythema at the injection site. She was seen in the office and was treated with ice, ADVIL and DARVOCET. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning 4 elderly patients who on 29-AUG-2006 were vaccinated with a dose of Pneumovax 23 (lot # 651321/1036F). On 29-AUG-2006 the patient developed swelling, redness and heat in their injection site arms. The patients are being treated with diphenhydramine hydrochloride (BENADRYL), and acetaminophen (TYLENOL). It was reported that the physician "is very concerned" about the lot number and therefore has requested a lot check. No further information was available. The reporter considered the patient's experience to be other important medical events. In follow up information the health professional confirmed that the patient had developed swelling, redness and heat in the injection site arm after receiving a dose of Pneumovax 23 (lot # 651321/1036F). She stated that she had no information regarding each patient and stated she was not able to get that information. She said that the doctor had told her that all 4 patients (WAES #'S 0609USA05102, 0609USA05103, and 0609USA05104) had been seen in the office and have since recovered from the swelling, redness and heat in their injection site arms. The patients are being treated with diphenhydramine hydrochloride (BENADRYL) and acetaminophen (TYLENOL). It was reported that the physician "is very concerned" about the lot number and therefore has requested a lot check. No further information was available. The reporter considered the patient's experiences to be other important medical events. In follow up information the health professional confirmed that the patient had developed swelling, redness and heat in the injection site arm after receiving a dose of Pneumovax 23 (lot # 651321/1036F). She stated that she had no information regarding each patient and stated she was not able to get that information. She said that the doctor had told her that all 4 patients (WAES # 0609USA05102, 0609USA05103, and 0609USA005104) had been seen in the office and have since recovered from the swelling, redness and heat in their injection site arms after treatment with diphenhydramine hydrochloride (BENADRYL) and acetaminophen (TYLENOL0. The health professional was aware that a lot check of concern had been initiated and she stated that she had no further information. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the office of Biologics Research and Review and was released by the regulatory agency. Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant concerning a male patient who in August 2006, was vaccinated with a 0.5 ml dose of Pneumovax 23 (lot# 651356/0089F). In August 2006, the patient experienced redness, soreness and swelling at the injection site. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. A lot check was requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Nausea, Pyrexia, Skin warm
Clinical narrative: Initial and follow-up information has been received from a health care worker and a medical assistant concerning a 44 year old, white female with no drug reactions, with seasonal allergies, whose reported weight was 152 pounds, who on 29-AUG-2006 at her annual physical with reportedly no illness was vaccinated subcutaneously, in the left upper arm with a 0.5 ml dose of Pneumovax 23. Concomitant therapy included ibuprofen and ALLEGRA, as needed. Subsequently the patient developed a red, raised, feverish area approximately 2 1/2 inches wide to her left upper arm. It was reported the patient ran a fever and felt nauseous times 2 days. The physician was informed. The patient sought unspecified medical attention. The patient was told to take ibuprofen, and instructed to apply ice to the affected area an if "resp" issues occurs. At the time of the report, the patient recovered. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a licensed practical nurse concerning a 55 year old female with hypothyroidism, chronic obstructive pulmonary disease, penicillin allergy and drug hypersensitivity to erythromycin and KEFLEX who on 30-AUG-2006 was vaccinated IM with a 0.5 ml dose of Pneumovax 23.. Concomitant therapy included SYNTHROID, CLARITIN, albuterol and calcium (+) vitamin D (unspecified). On 31-AUG-2006 the patient developed swelling and soreness of left upper arm and nausea. Unspecified medical attention was sought. There were no laboratory or diagnostic tests. The patient's outcome was unknown. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Body temperature increased, Chest X-ray abnormal, Chills, Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 74 year old Caucasian male with a benign calcified nodule in right mid lung and no unknown drug allergies who on 25-JUL-2006 was vaccinated with a second dose of Pneumovax 23 (o.5 ml) (IM), in the right deltoid. It was noted that the patient originally received Pneumovax 23 "10 years ago." The physician decided to revaccinate the patient. Subsequently, the patient developed a fever of 102 degrees and lost 10 pounds. On 26-JUL-2006 the patient developed "chills with rigors, temperature 101, erythema at injection site, severe weakness, tremors, diarrhea, nausea, and vomiting." The physician put the patient on steroids. The patient was given PHENERGAN. It was reported that the patient "may take" TYLENOL as directed for fever if needed. The patient was reportedly "getting better". No further information is available.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Lung neoplasm, Nausea, Pyrexia, Tremor
Clinical narrative: Information has been received from a physician concerning a 74 year old Caucasian male with a benign calcified nodule in right mid lung and no unknown drug allergies who on 25-JUL-2006 was vaccinated with a second dose of Pneumovax 23 (o.5 ml) (IM), in the right deltoid. It was noted that the patient originally received Pneumovax 23 "10 years ago." The physician decided to revaccinate the patient. Subsequently, the patient developed a fever of 102 degrees and lost 10 pounds. On 26-JUL-2006 the patient developed "chills with rigors, temperature 101, erythema at injection site, severe weakness, tremors, diarrhea, nausea, and vomiting." The physician put the patient on steroids. The patient was given PHENERGAN. It was reported that the patient "may take" TYLENOL as directed for fever if needed. The patient was reportedly "getting better". No further information is available.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Vomiting, Weight decreased
Clinical narrative: Information has been received from a physician concerning a 74 year old Caucasian male with a benign calcified nodule in right mid lung and no unknown drug allergies who on 25-JUL-2006 was vaccinated with a second dose of Pneumovax 23 (o.5 ml) (IM), in the right deltoid. It was noted that the patient originally received Pneumovax 23 "10 years ago." The physician decided to revaccinate the patient. Subsequently, the patient developed a fever of 102 degrees and lost 10 pounds. On 26-JUL-2006 the patient developed "chills with rigors, temperature 101, erythema at injection site, severe weakness, tremors, diarrhea, nausea, and vomiting." The physician put the patient on steroids. The patient was given PHENERGAN. It was reported that the patient "may take" TYLENOL as directed for fever if needed. The patient was reportedly "getting better". No further information is available.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, PPV
Symptoms: No adverse effect, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a 2 month old male with jaundice at the time of vaccination who on 24-JUL-2006 was inadvertantly vaccinated with a dose of Pneumovax 23 (lot #650456/0974P), instead of a dose of Prevnar. On 24-JUL-2006 the patient was concomitantly vaccination intramuscularly in the right thigh with a first dose of DTaP (lot AC143032), intramuscularly in the right thigh with a first dose of Hib (unspecified carrier) (lot UE816AC), and intramuscularly in the left thigh with a first dose of poliovirus vaccine inactivated (unspecified) (lot 2000). At the time of report, no symptoms had been reported. The medical assistant also reported that the Risk Management Department of her organization, which includes 30 clinics, was working on an company-wide program to develop a standardized protocol for vaccine administration. Some of the issues it was addressing included identifying the correct patient and rechecking the vaccine with another person. She noted that it was to protect both the patient and the health care professional who was administering the vaccine. Her office also sent a letter to the parents of the children who was administering the vaccine. Her office also sent a letter to the parents of the children who had received the Pneumovax 23 (lot #650456/0974P), instead of a dose of Prevnar. No product quality complaint was involved. No additional information is expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a physician via a wholesaler employee concerning a patient who was vaccinated with a dose of Pneumovax (lot # 651373/0320F). Subsequently the patient experienced firm area of redness at the injection site. Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV, TTOX
Symptoms: Cellulitis, Chills, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 65 year-old male with hypertension, hyperlipidemia and cardiac arrhythmias and no known allergies who on 08-SEP-2006 was vaccinated with Pneumovax 23 (lot 651374/0485F) (dose not reported). Concomitant therapy on 8-SEP-2006 included tetanus toxoid vaccination (dose not reported). On 9-SEP-2006, the patient experienced chills, fever, cellulitis, redness and warmth at injection site. The patient was seen in the physician's office and treated with KEFLEX. No laboratory diagnostics were performed. The patient's chills and fever and cellulitis and redness and warmth at injection site persisted. Chills, fever, cellulitis and redness and warmth at injection site were considered other important medical events. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 72 year old female with drug hypersensitivity to sertraline (ZOLOFT) who on 07-SEP-2006 was vaccinated with Pneumovax 23 (Lot number 651374/0485F). Concomitant therapy on 7-SEP-2007 included tetanus toxoid "in the same arm". On 08-SEP-2006 the patient experienced red area, cellulitis and warmth at injection site. The patient was not seen in the physician office. Ice, acetaminophen (TYLENOL) and ibuprofen (MOTRIN) were recommended as treatment. No laboratory studies were performed. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information was received from an office manager concerning six children who were vaccinated with a dose of Prevnar. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 0.2
Sex: F
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Initial and follow-up information has been received from a medical assistant concerning a 15 month old female, whose reported birth weight was 7 pounds (lbs) and 5 ounces (oz) with no preexisting allergies, birth defects, medical conditions and no illness at the time of vaccination, who on 10-AUG-2006 was inadvertently vaccinated with a dose of Pneumovax 23 9lot #650456/0974P), instead of a Prevnar. It was reported that the patient had received the following vaccinations (date not reported) DTaP (manufacturer Adventis) Hib (HIB) (manufacturer Adventis) and poliovirus vaccine (manufacturer Adventis). At the time of report, no symptoms had been reported. The medical assistant also reported that the Risk Management Department of her organization, which includes 30 clinics, was working on a company-wide program to develop a standardized protocol for vaccine administration. Some of the issues it was addressing included identifying the correct patient and rechecking the vaccine with another person. She noted that it was to protect both the patient and the health care professional who was administering the vaccine. Her office also sent a letter to the parents of the children who had received the Pneumovax 23 (lot #650456/09974P), instead of a dose of Prevnar. No product quality complaint was involved. Additional information has been requested.