chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from an office manager concerning a 47 year old female with iodine allergy who on 21-SEP-2007 was vaccinated SC with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot #657525/0554U). On approximately 24-SEP-2007 the patient developed cellulitis at the injection site. On 24-SEP-2007 the patient called the physician's office. The patient was treated with cephalexin (KEFLEX). At the time of the report, the patient had not recovered. The office manager is requesting a lot check. A standard lot check was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Drug Evaluations and Research and was released. Additional information has been requested.
Age: 68.0
Sex: U
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 68 year old patient who on 24-OCT-2007 was vaccinated at 12:00 pm, into the right arm with pneumococcal 23v polysaccharide vaccine, (Lot # 658555/0964U). The number of previous doses that the patient received was reportedly unknown. Subsequently the patient experienced right arm swelling, very painful and hot to touch. At the time of the report it was unknown if the patient recovered. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Information has been received from a medical assistant concerning a male patient with no known medical history who was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot #658555/0964U). The patient developed redness and inflammation at the injection site. The symptoms appeared either one or two days after the vaccination. It was reported that three patients all received the same vaccination, two females and one male, all from the same lot number and they all developed redness and inflammation. Only one of the three patients recovered from the symptoms. The other two patients are either recovering or unknown. One patient received the flu vaccine along with pneumococcal 23v polysaccharide vaccine (Lot #658555/0964) on a different arm. No further information is available. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Genital pain, Throat irritation
Clinical narrative: Information has been received from a nurse concerning a 49 year old male recent transplant patient with renal cell carcinoma stage unspecified, right ventricular hypertrophy "EF40%", hyperlipidaemia, anemia and history of pharyngitis streptococcal and pneumonia with high fevers that occur every February at the same time with similar symptoms and no known allergies or drug reactions who on 08-NOV-2007 was vaccinated via IV push with 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot# 657525/0554U). The patient had received pneumococcal 23v polysaccharide vaccine approximately 10 years ago. Concomitant therapy included cyclosporine 25mg twice daily, atorvastatin calcium (LIPITOR), sirolimus (RAPAMUNE), clonidine, nifedipine, furosemide sodium (LASIX, labetalol HCl, ascorbic acid/folic acid/vitamin B complex (NEPEROCAPS) and Mg oxide (MAG-OX 420 TABLETS). On 08-NOV-2007, 30 seconds post vaccination, the patient experienced itchy throat and throbbing in the genital area. The patient was given diphenhydramine hydrochloride (BENADRYL) 25mg and recovered. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist (Pharm D.) concerning a 72 year old female with a drug hypersensitivity to KEPPRA, diazepam, and higher doses of aspirin and a history of epilepsy who on 07-NOV-2007 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot# unknown). Secondary suspect therapy includes montelukast sodium (MSD). Other concomitant therapy included LYRICA, sertraline HCl, NASONEX, loratadine and AVAPRO. On 08-NOV-2007, the patient experienced a local injection site reaction. Medical attention was sought by the physician. The patient experienced a 4 inch diameter area of redness around the injection site associated with extreme pain and swelling. The pharmacist also noted that the area was warm to the touch. At the time of reporting the patient had not recovered. No further information was available. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 69 year old male with a history of renal transplant who on 07-NOV-2007 was vaccinated IM with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (lot #655766/0038U). On 07-NOV-2007, several hours after vaccination, the patient experienced pain and redness at the injection site and fever of 103. The patient was seen in the physician's office. At the time of the report, symptoms had improved and the patient was recovering. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Initial and follow up information has been received from a Licensed Practical Nurse concerning a 71 year old male patient who in approximately 1970 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. On 06-NOV-2007, at 09:44 AM the patient was vaccinated into left deltoid IM with a second dose of pneumococcal 23v polysaccharide vaccine lot # 658449/0989U. Concomitant therapy included lovastatin, atenolol (MSD), IBUFEN, lisinopril-HCTZ (MSD), HYTRIN, finasteride (MSD) and FLOMAX. On 08-NOV-2007 at 10:30 AM patient developed local reaction at the injection site of erythema and warmth. Patient came with his wife to the office and was examined by his physician and was prescribed KEFLEX 500 mg 1 tablet four times a day for 10 days. In follow up it was reported that improvement noted after two days and he recovered. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Rash pruritic
Clinical narrative: Information has been received from a female consumer (age not reported) who on 06-OCT-2007 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot # 655766/0038U). On 07-OCT-2007, at about 1 AM, the patient awakened with severe pain in the arm where the vaccine had been injected. The entire upper arm was extremely swollen and painful. There was a bright red, itchy rash around the entire upper arm. After repeated ice packs and BENADRYL were applied, the reaction finally ceased. This took about 4-5 days. To date, there were still rash marks visible on her arm. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who on approximately 02-NOV-2007 "sometime last week" was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On approximately 02-NOV-2007 the patient experienced a localized adverse experience at the injection site that involved pain and a lump. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site discolouration, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Initial and follow-up information has been received from a physician's office manager, pharmacist, and registered nurse concerning a 44 year old female patient who on 01-NOV-2007 at 08:00 was vaccinated IM in the left deltoid with a first dose of PNEUMOVAX (lot #657145/1226U). Concomitant vaccination included FLUZONE (Lot# U2466AA) administered in the right deltoid. On 01-NOV-2007, the patient experienced soreness, warmth and blotchy red discoloration at the injection site and a fever. The patient visited the school district nurse. The patient's outcome was not reported. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No additional information is requested.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injected limb mobility decreased, Injection site erythema, Pain, Pyrexia
Clinical narrative: Initial and follow-up information has been received from a physician's office manager, pharmacist, and a registered nurse concerning a 54 year old white female patient who on 01-NOV-2007 at 08:00 was vaccinated IM in the left buttocks with a first dose of pneumococcal 23v polysaccharide vaccine (lot # 657145/1226U). Concomitant vaccination included influenza virus vaccine (unspecified) (Lot# U2466AA) administered in the left deltoid. On 01-NOV-2007 the patient experienced fever with aching and chills, decreased arm mobility and redness at the injection site. The patient visited the school district nurse. The patient's outcome was not reported. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Decreased appetite, Dizziness, Hyperhidrosis
Clinical narrative: Initial and follow-up information has been received from a physician's office manager, pharmacist, and a registered nurse concerning a 58 year old female patient with a gastrointestinal illness, and allergies, who on 01-NOV-2007 at 08:00 was vaccinated IM in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot # 657145/1226U). Concomitant vaccination included influenza virus vaccine (unspecified) (Lot# U2466AA) administered in the left deltoid. The night before receiving pneumococcal 23v polysaccharide vaccine the patient experienced nausea and did not feel well in the morning. On 01-NOV-2007, the patient experienced faintness and sweating 5 hours after the injection. The patient experienced decreased food intake. It was reported that the faintness and decreased food intake were apparently related to the gastrointestinal illness. The patient visited the school district nurse. The patient recovered on 02-NOV-2007. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Feeling hot, Insomnia, Pain in extremity
Clinical narrative: Information has been received from a office manager concerning a 72 year old male who on 19-NOV-2007 was vaccinated (route and site not reported) with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot#1229). There was no concomitant medication. On 19-NOV-2007, post vaccination, the patient developed redness on the upper arm, burning, severe pain, hot sensation and was unable to sleep. The patient did receive unspecified medical attention. No diagnostic test were performed. At the time of this report the patient had not recovered. This is one of 2 reports with the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Information has been received from a health professional concerning 5-7 patients who on 12-NOV-2007 were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot# 658200/0804U). On 12-NOV-2007, the patients experienced cellulitis like reaction. The patient's entire upper arm from shoulder to elbow was red and hot to touch. Unknown medical attention was sought. At the time of report the patients had not recovered. No product quality complaint was involved. This is one of multiple patient report from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a patient who on 12-NOV-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot# 658673/0990U). Subsequently, the patient experienced injection site pain and swelling. Unknown medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. This is one of the multiple patient report from the same source. Additional information has been requested.
Age: 73.0
Sex: U
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Feeling hot, Pain
Clinical narrative: Information has been received from an office manager concerning a 73 year old patient (gender not reported) who on 20-NOV-2007 was vaccinated (route and site not reported) with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (Lot#655765/1229F). Post vaccination, the patient developed redness on the upper arm, burning, severe pain and hot sensation. It is unknown if the patient received medical attention and if the patient recovered. This is one of 2 reports with the same source. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a 59 year old female who in approximately 1997 "over 10 years ago" was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot# unknown). On an unspecified date the patient was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot# 657042/1347U). On 21-NOV-2007, the patient's right arm was swollen, painful and developed red streaks after being administered her second dose of pneumococcal 23v polysaccharide vaccine. Medical attention was sought. The patient was examined in the Emergency Room on 22-NOV-2007 and was not admitted. The patient was released that day after an injectable antibiotic was administered and oral antibiotics were prescribed. On 23-NOV-2007, the patient's arm was not as painful and the swelling had improved in the upper region of her arm but increased in the lower region of the arm. No further information was available. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 68 year old female who on 21-NOV-2007 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot# 658555/0964U) 0.5 mL IM. Concomitant therapy included LIPITOR, COUMADIN, enalapril maleate (MSD), digoxin and PREMARIN. On 22-NOV-2007, the patient developed hives, itching, severe swelling on the whole upper arm, redness, pain and inability to use arm. Medical attention was sought. Subsequently, the patient is recovering; most symptoms have resolved other than the pinkness on the arm. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 68 year old female who on 21-NOV-2007 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot# 658555/0964U) 0.5 mL IM. Concomitant therapy included LIPITOR, COUMADIN, enalapril maleate (MSD), digoxin and PREMARIN. On 22-NOV-2007, the patient developed hives, itching, severe swelling on the whole upper arm, redness, pain and inability to use arm. Medical attention was sought. Subsequently, the patient is recovering; most symptoms have resolved other than the pinkness on the arm. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Injection site streaking, Musculoskeletal chest pain, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning a male (age unknown) with no medical history and no drug allergies, who on 21-NOV-2007 was vaccinated intramuscularly with a 0.5mL first dose of pneumococcal 23v polysaccharide vaccine (Lot# 658555/0964U). Concomitant therapy included carvaedilol (COREG), candesartan cilexetil (ATACAND) and clopidogrel bisulfate (PLAVIX). On 22-NOV-2007 the patient developed severe swelling on the whole upper arm, redness, pain, and inability to use the arm. The patient experienced tingling and pain at the arm and ribs. The patient developed reddish vertical streaks that were observed on the arm near or at the injection site. The patient contacted the office. No laboratory diagnostics were performed. The patient recovered after several days on an unspecified date. No product quality complaint was involved. This is one of two reports from the same source.
Sex: M
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning a male (age unknown) with no medical history and no drug allergies, who on 21-NOV-2007 was vaccinated intramuscularly with a 0.5mL first dose of pneumococcal 23v polysaccharide vaccine (Lot# 658555/0964U). Concomitant therapy included carvaedilol (COREG), candesartan cilexetil (ATACAND) and clopidogrel bisulfate (PLAVIX). On 22-NOV-2007 the patient developed severe swelling on the whole upper arm, redness, pain, and inability to use the arm. The patient experienced tingling and pain at the arm and ribs. The patient developed reddish vertical streaks that were observed on the arm near or at the injection site. The patient contacted the office. No laboratory diagnostics were performed. The patient recovered after several days on an unspecified date. No product quality complaint was involved. This is one of two reports from the same source.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot #655291/0985F). The patient developed an injection site reaction which included swelling, pain and redness. No other information was provided. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a female who in November 2007, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The arm was red and swollen after vaccination. As of the report date, the patient's symptoms persisted. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria, Joint range of motion decreased
Clinical narrative: Information has been received from a nurse practitioner concerning a 35 year old white female LPN with asthma and penicillin allergy, who on 12-NOV-2007 was vaccinated in the left deltoid with pneumococcal 23v polysaccharide vaccine (lot # 657529/0993U). There were no illnesses at time of vaccination. On 12-NOV-2007, the patient noticed redness to the injection site with some swelling. On 13-NOV-2007, the patient developed raised confluent hive to the left deltoid and was very painful to the touch. The redness and swelling remained the same, however, the pain was worse and the patient experienced achiness down to the left lower arm. The patient also experienced pain with raising the left arm above the shoulder and decreased range of motion to the left arm and left shoulder. The patient denied numbness or tingling sensation. The patient was treated with a sling to keep the left arm up as much as possible and cephalexin 250 mg, one table four times a day times x10 days, and MEDROL-DOSEPAK. The patient subsequently recovered from the raised confluent hive and decreased range of motion to left arm and left shoulder on 18-NOV-2007. No further information is expected.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 35 year old white female LPN with asthma and penicillin allergy, who on 12-NOV-2007 was vaccinated in the left deltoid with pneumococcal 23v polysaccharide vaccine (lot # 657529/0993U). There were no illnesses at time of vaccination. On 12-NOV-2007, the patient noticed redness to the injection site with some swelling. On 13-NOV-2007, the patient developed raised confluent hive to the left deltoid and was very painful to the touch. The redness and swelling remained the same, however, the pain was worse and the patient experienced achiness down to the left lower arm. The patient also experienced pain with raising the left arm above the shoulder and decreased range of motion to the left arm and left shoulder. The patient denied numbness or tingling sensation. The patient was treated with a sling to keep the left arm up as much as possible and cephalexin 250 mg, one table four times a day times x10 days, and MEDROL-DOSEPAK. The patient subsequently recovered from the raised confluent hive and decreased range of motion to left arm and left shoulder on 18-NOV-2007. No further information is expected.
Sex: U
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a health professional via a Pharmacist concerning a patient who on an unspecified date was vaccinated with pneumococcal 23v polysaccharide vaccine (lot# unknown). Subsequently the patient experienced an unspecified reaction. Medical attention was sought. No other information was available. At the time of reporting it was unknown if the patient had recovered.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Information has been received from a physician concerning a 65 year old female patient with hypothyroidism, osteoarthritis, depression, menopause, asthma and allergy to AUGMENTIN who on 02-NOV-2007 was vaccinated IM with her first dose of pneumococcal 23v polysaccharide vaccine, lot #655152/0889F. Concomitant therapy included influenza virus vaccine (unspecified) given the same day in the other arm, SYNTHROID, estradiol, LEXAPRO, and AMBIEN. The patient developed redness and rash at injection site and sought medical attention in office, but no treatment was required. Subsequently, she recovered. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a physician concerning a male (age not reported) who in October 2007, "2 to 3 weeks ago" was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. In October 2007, the patient experienced erythema, warmth, and swelling localized to his arm. The patient sought medical attention. The patient was treated with cephalexin (KEFLEX). After a week, the patient recovered. No additional information is available.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Skin warm
Clinical narrative: Information has been received from a pharmacy technician and a licensed practical nurse concerning a female patient (age not reported) who on 29-NOV-2007 was vaccinated with a dose of pneumococcal 23v Polysaccharide vaccine (Lot#659226/1419U). On 30-NOV-2007, the patient experienced warmth and redness at the injection site and a very warm feeling from shoulder down arm, arm felt hot. The licensed practical nurse reported that the patient called the doctor's office and stated that she had pneumococcal 23v polysaccharide vaccine before and never experienced these symptoms. The pharmacy technician noted that "it seemed like more patients had this experience this year than patients who received the vaccine last year." At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: Information has been received from a registered pharmacist concerning a female (age not reported) who in November 2005, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. In November 2005, the patient had a reaction after receiving pneumococcal 23v polysaccharide vaccine. The pharmacist reported that the patient was seen by her physician and the physician told her that she should never get another dose of pneumococcal 23 v polysaccharide vaccine. The pharmacist did not know what kind of reaction the patient had experienced. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: PPV
Symptoms: Allergy test positive, Injection site erythema, Skin reaction
Clinical narrative: Information has been received from a consumer, concerning her 17 year old son with a penicillin and CECLOR allergy, sulfonamide allergy, drug hypersensitivity to FLUVIRIN (involving an anaphylactic reaction, 02-OCT-2007), latex allergy, and multiple food allergies, who on 15-NOV-2007 had a skin allergen test performed prior to vaccination with a dose of pneumococcal 23v polysaccharide vaccine (lot #658555/0964U). Concomitant therapy included ZYRTEC. Her son's skin "flared up and became red" at the injection site, and he consequently was not administered a full dose of the vaccine. At the time of this report, her son had recovered from the event (duration not specified). The patient had a history of a positive allergy skin test when exposed to varicella virus vaccine live (MSD) (WAES #0801USA05565). Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity, Ultrasound scan
Clinical narrative: Information has been received from a health care worker concerning a 73 year old female with no pertinent medical history or concomitant medication use and an allergy to penicillin who on 09-OCT-2007 was vaccinated (site and route not reported) with pneumococcal 23v polysaccharide vaccine (lot# 658074/0961U). On 10-OCT-2007, the patient developed severe arm pain, numbness and developed weakness in the injection site arm. There was no redness or swelling at the injection site. The patient had an ultrasound done (outcome not reported) and received unspecified medical attention. The severe arm pain, numbness and weakness in the injection site arm lasted for 10 days and then resolved. This is one of several reports with the same source. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity
Clinical narrative: Information has been received from a health care worker concerning a 72 year old male who on 08-OCT-2007 was vaccinated (site and route not reported) with a dose of pneumococcal 23v polysaccharide vaccine (lot#658074/0961U). On 09-OCT-2007, post vaccination, the patient developed arm pain, numbness and weakness. There was no redness or swelling at the injection site. The arm pain, numbness and weakness lasted for 5-7 days and then resolved. The patient received unspecified medical attention and recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Cough, Crying, Injection site cellulitis, Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning a 34 month old female with no known allergies and a history of pulmonary disease who on 13-NOV-2007 was vaccinated with her first dose of pneumococcal 23v polysaccharide vaccine (Lot #658175/0856U) subcutaneously in the left arm. Concomitant therapy included an influenza vaccine intramuscularly in the right arm (Lot #U7459PA) on the same day. On 13-NOV-2007, the patient developed redness, warmth, swelling, pain and a splotchy rash at pneumococcal 23v polysaccharide vaccine site. The diagnosis was cellulitis. The mother reported that the patient received pneumococcal 23v polysaccharide vaccine on 13-NOV-2007, cried all night, complained of left arm hurting, woke up with a half dollar size lesion on the arm as well. The rash spread to cover most of the upper left arm. The patient had a fever of 102 and started a cough. The patient has treated with clindamycin 75 mg/5 mL PO - 5 mL PO TID, ADVIL 100 mg/5mL - 5 mL PO for pain and fever. Additional information is not expected.
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 34 month old female with no known allergies and a history of pulmonary disease who on 13-NOV-2007 was vaccinated with her first dose of pneumococcal 23v polysaccharide vaccine (Lot #658175/0856U) subcutaneously in the left arm. Concomitant therapy included an influenza vaccine intramuscularly in the right arm (Lot #U7459PA) on the same day. On 13-NOV-2007, the patient developed redness, warmth, swelling, pain and a splotchy rash at pneumococcal 23v polysaccharide vaccine site. The diagnosis was cellulitis. The mother reported that the patient received pneumococcal 23v polysaccharide vaccine on 13-NOV-2007, cried all night, complained of left arm hurting, woke up with a half dollar size lesion on the arm as well. The rash spread to cover most of the upper left arm. The patient had a fever of 102 and started a cough. The patient has treated with clindamycin 75 mg/5 mL PO - 5 mL PO TID, ADVIL 100 mg/5mL - 5 mL PO for pain and fever. Additional information is not expected.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a pharmD concerning a 59 year old male with no pertinent medical history and no drug reactions/allergies who on 01-OCT-2007 was vaccinated intramuscularly (site not reported) with a dose of pneumococcal 23v polysaccharide vaccine (lot#657526/0555U). On 02-OCT-2007, post vaccination, the patient developed severe pain in the right arm and had trouble moving his arm. The patient rated his pain as 10 out of 10. The pharmD did not know if the patient had been administered pneumococcal 23v polysaccharide vaccine prior to this dose. The patient did receive unspecified medical attention and it is unknown if the patient recovered. This is one of several reports with the same source. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Rash, Staphylococcal infection
Clinical narrative: Information has been received from a pharmD concerning a 65 year old male with no pertinent medical history, no concomitant medication usage and allergies to penicillin, sulfa, iodine, nystatin, aspirin and tetracycline who on 04-OCT-2007 was vaccinated intramuscularly (site not reported) with a dose of pneumococcal 23v polysaccharide vaccine (Batch# 658075/lot# 0962U). Post vaccination, (date not reported) the patient developed a rash, erythema and a staph infection. The pharmD did not know if the patient had been administered pneumococcal 23v polysaccharide vaccine prior to this dose. Patient did receive unspecified medical attention and at the time of this report it is unknown if the patient recovered. This is one of several reports with the same source. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Pain
Clinical narrative: Information has been received from a pharmD concerning a 61 year old male with no pertinent medical history, drug reactions/allergies or concomitant medication use who on 05-OCT-2007 was vaccinated intramuscularly (site not reported) with a dose of pneumococcal 23v polysaccharide vaccine (lot # 658075/0962U). On 06-OCT-2007, post vaccination, the patient developed severe pain and a swollen arm. The patient rated his pain as between 4 to 5 out of 10 at rest and 9 out of 10 during movement. No lab diagnostic test were performed. The pharmD did not know if the patient had been administered pneumococcal 23v polysaccharide vaccine prior to this dose. The patient received unspecified medical attention and recovered on 10-OCT-2007. This is one of several reports with the same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information has been received from a 68 year old female consumer who in 2006 (exact date not reported) was vaccinated (site and route not reported ) with pneumococcal 23v polysaccharide vaccine (lot# not reported). Concomitant therapy included influenza virus vaccine (unspecified) given in the opposite arm. In 2006 (exact date not reported), post vaccination, the patient's whole arm swelled and got red. No lab diagnostic test were performed. The patient did receive unspecified medical attention and recovered. No additional information is expected.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 46 year old female with no known allergies and no reported medical history who on 10-NOV-2007 was vaccinated with pneumococcal 23v polysaccharide vaccine intramuscularly in the right deltoid. There was no concomitant medication. Within a few hours the patient developed a red spot the size of a silver dollar at the injection site. The next evening, on 11-NOV-2007 the patient reported the area was very warm and itchy and felt better when ice was applied. On 12-NOV-2007, the patient had a fever and the injection site area got bigger. When the patient went in to see the physician on 13-NOV-2007 there was no fever but the area was 13 X 15 cm irregular erythema that was warm to the touch and slightly raised at the injection site. The patient was given topical chloroxine (+) triamcinolone acetonide (Triamcinolone 0.1%) applied three times daily and KEFLEX, 500 mg 4 times daily for 1 week. The patient was seen again on 16-NOV-2007 and the area had almost completely resolved. That was the first time the patient received pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a pharmacist as reported by a physician concerning a patient with no reported medical history who "last year" in 2006 was vaccinated with pneumococcal 23v polysaccharide vaccine. The patient developed erythema and pain at injection site. The patient sought medical attention by having an exam in the office. No further details are available. Additional information has bee requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity
Clinical narrative: Information has been received from a health care worker concerning a 73 year old female who on 08-OCT-2007 was vaccinated (site and route not reported) with a dose of pneumococcal 23v polysaccharide vaccine (lot#658074/0961U). On 09-OCT-2007, post vaccination, the patient developed arm pain, numbness and weakness. There was no redness or swelling at the injection site. The arm pain, numbness and weakness lasted for 5-7 days and then resolved. The patient received unspecified medical attention and recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old male with no reported medical history who on approximately 14-NOV-2007 was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot #655291/0985F). On 14-NOV-2007 the patient developed an injection site reaction which included pain, swelling and redness. This was the patient's second dose of pneumococcal 23v polysaccharide vaccine. The patient sought medical attention with an office visit and recovered on an unspecified date. This is one of several reports received from the same source. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a male patient "in his 70's" who on 20-NOV-2007 was vaccinated with 0.5 mL of pneumococcal 23v polysaccharide vaccine (lot #658447/1132U). There was no concomitant medication. On 20-NOV-2007, the patient could not move his arm due to pain after he received the vaccination. He had pain in his arm and shoulder. There was no redness or swelling. No further information was available. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 44 year old female who on 16-NOV-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot #655291/0985F). On 16-NOV-2007, the patient experienced an injection site reaction with swelling, pain and redness. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant concerning a less than 18 month old male who on 05-OCT-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine instead of PREVNAR. There was no adverse event report. No product quality complaint was involved. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant concerning a less than 18 month old male who on 05-OCT-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine instead of PREVNAR. There was no adverse event reported. No product quality complaint was involved. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a pharmacist concerning a male in his sixties who on unspecified dates in September 2007 during a vaccination clinic, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included influenza virus vaccine (unspecified). In September 2007 one or two days following vaccination with pneumococcal 23v polysaccharide vaccine the patient present to his physician with injection site reaction described as a cellulitis. The patient was given a prescription for antibiotic (name unspecified). The relationship of the event to therapy with pneumococcal 23v polysaccharide vaccine was report as unknown. The outcome of the event was not reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site infection
Clinical narrative: Information has been received from a pharmacist concerning a female (age not reported) who on an unspecified date in September 2007 during a vaccination clinic, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included influenza virus vaccine (unspecified). In September 2007 one or two days following vaccination with pneumococcal 23v polysaccharide vaccine the patient developed an injection site reaction described as a infection and was referred to her physician. The patient was given a prescription for CIPRO and BACTRIM antibiotics. The physician considered hospitalizing the patient but had not hospitalized her yet. The relationship of the event to therapy with pneumococcal 23v polysaccharide vaccine was reported as unknown. The outcome of the event was not reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pruritus, Skin warm, Wrong drug administered
Clinical narrative: Initial and follow up information has been received from an RN and a practice manager concerning a female patient, aged between 35-50, who on 18-SEP-2007 was inadvertently vaccinated in the right deltoid with a dose of pneumococcal 23v polysaccharide vaccine, lot #655765/0061U; instead of the flu vaccine. On 18-SEP-2007, the flu vaccine was to be given to elementary school teachers and their spouses. Due to human error (not product confusion), pneumococcal 23v polysaccharide vaccine, lot #655765/0061, was brought to the school and administered instead of the flu vaccine. The patient developed symptoms similar to cellulitis. Her right arm, the inner aspect toward the elbow, was red, swollen, warm, and itchy. She was advised to take an antihistamine. As on 21-SEP-2007, she was "ok." The nurse also reported on additional patients who received pneumococcal 23v polysaccharide vaccine, lot #655765/0061U, instead of the flu vaccine; some of whom had adverse reactions. The practice manager stated "is anything wrong with this lot?" and a lot check was requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Pain in extremity, Wrong drug administered
Clinical narrative: Initial and follow up information has been received from an RN and a practice manager concerning a female patient between the ages of 35-50 who on 18-SEP-2007 was inadvertently vaccinated with a dose of pneumococcal 23v polysaccharide vaccine, lot #655765/0061U; instead of the flu vaccine. On 18-SEP-2007, the flu vaccine was to be given to elementary school teachers and their spouses. Due to human error (not product confusion), pneumococcal 23v polysaccharide vaccine, lot #655765/0061, was brought to the school and administered instead of the flu vaccine. The patient had pain down her entire arm (unspecified), which "settled in the wrist." Medical attention was sought. As of 21-SEP-2007, the patient "was ok." The nurse also reported on additional patients who received pneumococcal 23v polysaccharide vaccine, lot #655765/0061U, instead of flu vaccine; some of whom developed adverse reactions. The practice manager stated "is there anything wrong with this lot?" and a lot check was requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from an RN concerning a patient who on 04-OCT-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine, lot #655765/0061U. The patient developed a cellulitis-like reaction: redness, swelling, and warmth in the arm from the upper arm to lower arm. As of 05-OCT-2007 the patient's outcome was unknown. The nurse also reported additional patients who had adverse reactions after receiving pneumococcal 23v polysaccharide vaccine, lot #655765/0061U. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Skin reaction
Clinical narrative: Information has been received from a certified medical assistant concerning two patient's who were vaccinated with pneumococcal 23v polysaccharide vaccine. Subsequently, the patients experienced cellulitis-like reactions. The patients were treated with an antibiotic. At the time of the report it was unknown if the patients recovered. 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. In follow-up it was reported by the physician that a patient with no pre-existing allergies, birth defects, or medical conditions was vaccinated intramuscularly in the a.m., on approximately 31-JAN-2007, with pneumococcal 23v polysaccharide vaccine, (Lot # 651046/0620F). It was reported that the patient had a localized cellulitic-like reaction. The patient had a clinical exam only. It was reported that the patient recovered. The reporter stated that there were three other patients that had localised cellulitic-like reactions after receiving the pneumococcal 23v polysaccharide vaccine, (WAES # 0702USA03808, #0711USA03297, 0711USA03298). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Skin reaction
Clinical narrative: Information has been received from a certified medical assistant concerning two patients who were vaccinated with pneumococcal 23v polysaccharide vaccine. Subsequently, the patients experienced cellulitis-like reactions. The patients were treated with an antibiotic. At the time of the report it was unknown if the patients recovered. 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. In follow-up it was reported by the physician that a patient with no pre-existing allergies, birth defects, or medical conditions was vaccinated intramuscularly in the a.m., on approximately 08-FEB-2007, with pneumococcal 23v polysaccharide vaccine, (Lot # 651406/0620F). It was reported that the patient had a localized cellulitic-like reaction. The patient had a clinical exam only. It was reported that the patient recovered. The reporter stated that there were three other patients that had localised cellulitic-like reactions after receiving the pneumococcal 23v polysaccharide vaccine, (WAES # 0702USA03808, #0711USA03296, 0711USA03298). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Skin reaction
Clinical narrative: Information has been received from a certified medical assistant concerning two patients who were vaccinated with pneumococcal 23v polysaccharide vaccine. Subsequently, the patients experienced cellulitis-like reactions. The patients were treated with an antibiotic. At the time of the report it was unknown if the patients recovered. 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. In follow-up it was reported by the physician that a patient with no pre-existing allergies, birth defects, or medical conditions was vaccinated intramuscularly in the a.m., on approximately 16-FEB-2007, with pneumococcal 23v polysaccharide vaccine, (Lot # 651406/0620F). It was reported that the patient had a localized cellulitic-like reaction. The patient had a clinical exam only. It was reported that the patient recovered. The reporter stated that there were three other patients that had localised cellulitic-like reactions after receiving the pneumococcal 23v polysaccharide vaccine, (WAES # 0702USA03808, #0711USA03296, 0711USA03297). Additional information has been requested.