chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site oedema, Pain, Pyrexia, Type III immune complex mediated reaction
Clinical narrative: Info has been received on 11/13/2002 from a physician's assistant concerning a pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent, in the arm. Concomitant therapy that day included a dose of influenza virus vaccine, in the opposite arm. Subsequently the pt developed a site reaction characterized by pain, swelling and redness. It was described as an Arthrus reaction with a fever of 101 to 102 degrees F. The pt sought unspecified medical attention. Additional info has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Lymphadenopathy
Clinical narrative: Info has been received from a registered nurse concerning a 48 year old female who on 11/11/2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (site and route not reported). On 11/12/2002 the pt noted redness and swelling at the injection site that spread up her arm to her neck. On 11/13/2002 on examination it was noted her lymph nodes were swollen. At this time the pt has not been re-evaluated. The pt sought unspecified medical attention. Additional info has been requested.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site oedema, Malaise, Urticaria
Clinical narrative: Info has been received from a physician concerning a 24 year old female teacher with no known allergies or prior medical history who on 01/05/2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #642722/0165M), intramuscularly in her right deltoid. The pt had no illness at the time of vaccination. On 10/07/2002, the pt developed urticaria with tender wheals and edema at the injection site followed by malaise and chills. The pt was treated with prednisone. The physician reported that no diagnostic or laboratory tests were performed. On 11/07/2002, the pt recovered. The pt sought medical attention from the reporting physician. Additional info is not expected.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Info has been received from a hospital pharmacy employee and a licensed practical nurse concerning a 33 year old female with an allergy to penicillin and type II diabetes mellitus who on 11/13/2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #642720/0172M) subcutaneously in her right arm. That same day, the pt had a reaction that involved her "left arm" becoming "swollen and red." The nurse reported that diagnostic and laboratory tests were not performed. On 11/15/2002, the pt had recovered. The hospital pharmacy employee also provided info regarding other pts' experiences (WAES #0212UA01104). The pt sought unspecified medical attention. Additional info is not expected.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: Info has been received from a licensed practical nurse concerning a 62 year disabled male pt with no known drug allergies who on 11/12/2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent intramuscularly in the bicep. On 11/13/2002 the pt's wife called the physician's office and stated that his arm was swollen, red and very painful. The pt was scheduled to be seen in the physician's office that day. Subsequently, the pt recovered. Unspecified medical attention was sought. It was also reported that a 59 year old female was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent and developed a swollen and painful arm (WAES #0211USA01408). Additional info is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Pain, Pyrexia
Clinical narrative: Info has been received from a medical assistant concerning a female who on 11/12/2002 was vaccinated with pneumococcal vaccine 23 polyvalent. Concomitant therapy included interferon alfa, albuterol sulfate (+) ipratropium bromide (COMBIVENT), bupropion HCl (WELLBUTRIN SR), chlorpheniramine maleate (+), phenylephrine hydrochloride (+), scopolamine methonitrate EXTENDRYL), budesonide (RHINOCORT), levothyroxine Na (SYNTHROID) and topiramate (TOPAMAX). On approximately 11/12/2002 the pt developed site reaction, redness, swelling, soreness, injection site induration and fever of 101.4. The pt sought unspecified medical attention. Additional info has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pain, Rash, Rash macular, Sensation of heaviness
Clinical narrative: Info has been received from a nurse concerning a 74 year old female who was vaccinated with her 1st and 2nd doses of pneumococcal vaccine 23 polyvalent in 1997 and on 11/14/2002 respectively. On 11/14/2002 the pt woke up because her arm felt heavy and sore. Upon inspection the pt discovered a blotchy red rash around her arm. The pt sought unspecified medical attention. Additional info has been requested.
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Info has been received from a pharmacist concerning a female friend who in 2001 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (manufacturer unknown). Subsequently the pt developed a rash. About 2 weeks ago, the pt was vaccinated with a dose of flu vaccine and again developed a rash. The pt had also experienced a similar reaction to a steroid injection. The pt sought unspecified medical attention. Additional info has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Paraesthesia, Sensation of heaviness
Clinical narrative: Info has been received from a nurse practitioner concerning an 80-year-old female pt with osteoporosis and hypothyroidism and no reported allergies who on 11/02/2002 at approx 10:00 AM was vaccinated IM in the right deltoid with a 1st dose of pneumococcal vaccine 23 polyvalent. There was no illness at the time of vaccination. Concomitant therapy included acetaminophen (+) propoxyphene napsylate (DARVOCET-N) and levothyroxine Na (SYNTHROID). On 11/02/2002 at 2:00 PM the pt experienced tingling and heaviness in the injected arm, and reported that her arm felt "cement filled" and hardened around the injected area. There was marked improvement in herh arm and it was reported that the "arm site felt better" after taking acetaminophen (+) propoxyphene napsylate (DARVOCET-N) for the pain on 11/13/2002 and 11/14/2002. It was reported that "now" the pt is having trouble putting weight on her right leg below her knee. Unspecified medical attention was sought. Follow up info was received from a nurse practitioner indicating that the pt had tingling and pain at the injection site and her "arm felt like cement". The pt took acetaminophen (+) propoxyphene napsylate (DARVOCET-N) with relief. The pt also complained of tingling, pain and heaviness in her right leg. There was no redness or swelling noted. It was reported that the pt recovered on 11/04/2002 at 6:00 PM. No relevant diagnostic tests or laboratory data were reported. No further info is expected.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Pain, Rash, Rash macular
Clinical narrative: Info has been received from a licensed practical nurse concerning a 77 year old female pt with no new concomitant therapies reported and drug hypersensitivities to erythromycin (E-mycin) and clarithromycin (Biaxin) who on 11/13/2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent. On 11/15/2002 the pt developed a red blotchy rash at the injection site on her arm which resolved on its own. The pt complained of pain at the injection site and it was warm to the touch. Unspecified medical attention was sought. Pt was instructed by physician to call if symptoms worsen. No further info is expected.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pain
Clinical narrative: Info has been received from a medical assistant concerning a 32-year-old female principal who on 10/10/2001 (also reported by the MA as approx 11/11/2002) was vaccinated in the right deltoid with a second dose of pneumococcal vaccine 23 polyvalent (Lot #636159/1070K). Concomitant vaccines that day included influenza virus vaccine (also reported by MA as approx 11/11/2002). The MA reported that on 10/12/2001, the pt developed a local reaction of swelling, heat, pain and mild erythema (also reported as approx 11/11/2002). The pt visited her physician and subsequently recovered. Additional info is not expected.
Sex: U
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent.  Subsequently the patient had aches and pains.  The patient sought unspecified medical attention.  Additional information has been requested.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: Information has been received from a pharmacist concerning a male patient who was vaccinated in the arm with a dose of pneumococcal vaccine 23 polyvalent.  Concomitant vaccination on the same day included a dose of influenza virus vaccine in the other arm.  Subsequently, the patient developed an injection site reaction that included itching, swelling and redness on the underside of the arm that was injected with pneumococcal vaccine 23 polyvalent.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Feeling hot, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a medical assistant concerning a 22 year old female patient with asthma, which is currently under control, who on 11/13/2002 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M) in the left deltoid.  Concomitant vaccine therapy included a dose of influenza virus vaccine.  There was no illness at the time of vaccination.  Concomitant medication included montelukast sodium (MSD), fluticasone propionate (+) salmetrol xinafoate (ADVAIR), loratadine (CLARITIN), and albuterol.  On 11/14/2002 the patient presented to the physician;s office with a hot, swollen, painful rash at the injection site with a red and tender area that measured 1 3/4cm in diameter.  On 11/14/2002 a CBC revealed an elevated WBC count of 12.9 and the patient was diagnosed with cellulitis of the left deltoid.  On 11/15/2002, a raised red lesion measuring 2.5cm x 2.5cm was noted and the WBC was 16.5.  See laboratory section for additional test results.  It was noted that the patient received a second opinion about the reaction.  Additinoal information has been requested.
Age: 22.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site rash, Laboratory test abnormal
Clinical narrative: Information has been received from a medical assistant concerning a 22 year old female patient with asthma, which is currently under control, who on 11/13/2002 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M) in the left deltoid.  Concomitant vaccine therapy included a dose of influenza virus vaccine.  There was no illness at the time of vaccination.  Concomitant medication included montelukast sodium (MSD), fluticasone propionate (+) salmetrol xinafoate (ADVAIR), loratadine (CLARITIN), and albuterol.  On 11/14/2002 the patient presented to the physician;s office with a hot, swollen, painful rash at the injection site with a red and tender area that measured 1 3/4cm in diameter.  On 11/14/2002 a CBC revealed an elevated WBC count of 12.9 and the patient was diagnosed with cellulitis of the left deltoid.  On 11/15/2002, a raised red lesion measuring 2.5cm x 2.5cm was noted and the WBC was 16.5.  See laboratory section for additional test results.  It was noted that the patient received a second opinion about the reaction.  Additinoal information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from nurse concerning a 66 year old female with allergies to penicillin, codeine sulfate, nitrofurantoin, hydrocortisone (WAES # 0212USA00803), phenaglycodol, cyclobenzaprine hydrochloride (WAES # 0212USA00804), and meclofenamate sodium who on 11/13/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent in the right deltoid (Lot # 641530/1351L).  The patient was well at the time of vaccination.  On 11/13/2002 the patient developed a severe site reaction.  The patient reported that her arm was painful, red and swollen at the injection site to the size of a baseball and that she could not use her arm.  The patient reported that she took diphenhydramine hydrochoride and cortisone cream.  On 11/15/2002, the patient called her physician's office and reported that she could use her arm again and the area was improving.  The physician instructed the patient to continue using the diphenhydramine hydrochloride and cortisone.  The health professional reported that as of 11/15/2002, they had not heard back from the patient so they assume she has recovered.  The reporter expressed a concern regarding the lot number.  The health professional also provided information regarding 2 other patients (WAES # 0211USA02404 AND 0211USA02405).  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 46 year old white female patient with no past medical history, who on 10/16/2002 at 10:00am was vaccinated by IM in the right deltoid with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 643783/0709M).  It was noted the patient was not ill at the time of vaccination.  On 10/16/2002 at 11:00 the patient developed swelling of right arm from shoulder down to elbow, pain, redness, and warmth.  The reporter indicated the reactions as "extreme".  It was noted the patient took acetaminophen for discomfort.  The patient recovered.  The reporter requested a lot check.  Unspecified medical attention was sought.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  The reporter mentioned that other patients also had an experience following vaccination with pneumococcal vaccine 23 polyvalent.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema, Pain
Clinical narrative: Information has been received from a pharmacist concerning a 53 year old female patient with no known medication allergies, diabetes mellitius, hypertension, a hearing aid and arthritic pain who on 11/01/2002, was vaccinated IM in the right deltoid with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 643783/0709M).  One hour post vaccination on 11/01/2002 the patient returned to the doctor's office complaining of increased swelling of her arm and pain at the injection site.  The reporter indicated there was no redness or swelling noted and there was slight pain to palpation.  The patient was treated with moist heat and over the counter nonsteroidal anti-inflammatories.  At a later point, the patient presented to the ER complaining of increased swelling and redness.  The patient was treated with antibiotics and narcotics.  On 11/04/2002, the patient recovered.  The reporter noted that the patient had no adverse events following prior vaccination.  The reporter had previously reported another adverse experience (WAES # 0211USA00944) with this same lot number and is requesting a lot check.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Additional information is not expected.
Age: 69.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a 69 year old male patient, who on 11/18/2002 was vaccinated in the right arm with a dose of pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M).  Concomitant vaccination included a dose of influenza virus vaccine in the left arm.  On 11/20/2002, the patient called the doctor's office reporting that he had developed a rash from his elbow to his shoulder on his right arm.  No other symptoms were reported.  The patient was expected to be seen at the doctor's office.  Subsequently, the patient fully recovered.  The reporter indicated that two other patients (WAES #'s 0212USA01969 & 0212USA01970) received pneumococcal vaccine 23 polyvalent from the same lot and also experienced "worse than usual local reactions".  The reporter also noted that "This office has given [pneumococcal vaccine 23 polyvalent] for over 10 years and we have never had the type of reactions that these 3 (and subsequent) patients experienced" (WAES # 0303USA00344).  The reporter stated that she was "uncomfortable using the rest of the vial or other vials from the same lot".  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Additional information is not expected.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a health care professional concerning a 49 year old male patient who on 11/15/2002 was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent.  His first dose was reported as being given on 10/02/2001.  On 11/20/2002 the patient complained of a red, swollen, hot and painful area at the injection site.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Malaise, Pyrexia, Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 68-year-old female patient with no known allergies who on 11/20/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent.  The patient had previously received a dose of the vaccine five years ago.  Concomitant therapy included alendronate sodium, lansoprazole, levothyroxine Na, and sertraline HC1.  On 11/21/2002 the patient developed "serum sickness", which was described as fever, malaise, and urticarial redness in the upper arm.  Unspecified medical attention was sought.  Follow up information indicated that, on further "interrogation", it was discovered that the patient had received the vaccination 2-3 years prior to the one given on 11/20/2002.  Her mild symptoms of serum sickness resolved over 1-2 weeks.  The reporter indicated that "she is fine".  No further information is expected.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a health professional concerning a female patient who in approximately October 2002, was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M); additional therapy included a dose of influenza virus vaccine "flu vaccine", which was given in the opposite arm.  The reporter indicated the patient had a reaction to the pneumococcal vaccine 23 polyvalent.  In approximately October 2002, the patient developed soreness at the injection site.  The pain was described as a "4" on the pain scale and lasted 48-72 hours.  The reporter requested a lot check.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Unspecified medical attention was sought.  Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Rash erythematous
Clinical narrative: Information has been received from a health professional concerning a female patient who was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M).  Additional therapy given at the same time, in the opposite arm included a dose of influenza virus vaccine, "flu vaccine".  The reporter indicated the patient had a reaction to the pneumococcal vaccine 23 polyvalent, which was described as a "silver dollar size" raised red area at the injection site, and injection site soreness, rated "4" on a pain scale.  It was noted the raised red area lasted 72 hours.  The reporter requested a lot check.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Unspecified medical attention was sought.  Additional information has been requested.  The health professional mentioned 13 other patients who also had an experience following vaccination with pneumococcal vaccine 23 polyvalent (WAES #'s: 0210USA01524, 0210USA01734, 0211USA02240, 0211USA02242, 0211USA02243, 0211USA02244, 0211USA02245, 0211USA02246, 0211USA02247, 0211USA02248, 0211USA02249, 0211USA02250, 0211USA02251).
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Hypokinesia, Oedema, Pain, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a female patient who in approximately October 2002 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M).  Additional therapy given at the same time, in the opposite arm included a dose of influenza virus vaccine, "flu vaccine".  The reporter indicated the patient had a reaction to the pneumococcal vaccine 23 polyvalent.  In approximately October 2002 the patient developed redness with swelling to inside of arm, joint aches, fever-101.2, pain rated "5" on a scale of 1-10 and was unable to raise her arm.  The reporter requested a lot check.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Unspecified medical attention was sought.  Additional information has been requested.  The health professional mentioned 13 other patient's who also had an experience following vaccination with pneumococcal vaccine 23 polyvalent (WAES#'s:  0210USA01524, 0210USA01734, 0211USA02240, 0211USA02241, 0211USA02243, 0211USA02244, 0211USA02245, 0211USA02246, 0211USA02247, 0211USA02248, 0211USA02249, 0211USA02250, 0211USA02251).
Sex: U
Vaccine: FLUX, PPV
Symptoms: Hypokinesia, Pain
Clinical narrative: Information has been received from a health professional concerning a patient who in approximately October 2002 was vaccinated in the left arm with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M).  Additional therapy given at the same time, in the opposite arm included influenza virus vaccine, "flu vaccine".  The reporter indicated the patient had a reaction to pneumococcal vaccine 23 polyvalent.  In approximately October 2002 the patient developed "severe" pain in the left arm, and could barely lift the arm.  The reporter requested a lot check.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Unspecified medical attention was sought.  Additional information has been requested.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Feeling hot, Lymphadenopathy, Pain
Clinical narrative: Info has been received from a health professional concerning a pt who in approx Oct 2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot 3643251/0445M). Additional therapy given at the same time, in the opposite arm included influenza virus vaccine, "flu vaccine". The reporter indicated the pt had a reaction to the pneumococcal vaccine 23 polyvalent. Subsequently, in approx Oct 2002, the pt developed soreness in the arm, and it was warm to touch 6 days after the injection. It was also noted, the pt had enlarged axillary lymph node with soreness. The reporter requested a lot check. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Unspecified medical attention was sought. Additional info has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Lethargy, Pain, Pharyngolaryngeal pain
Clinical narrative: Info has been received from a health professional concerning a female pt who on 10/09/2002 was vaccinated in the left arm with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). Additional therapy given on 10/09/2002 in the opposite arm included influenza virus vaccine, "flu vaccine". The reporter indicated the pt had a reaction to the pneumococcal vaccine 23 polyvalent. Subsequently on 10/10/2002 (also reported as the next day) the pt developed soreness in the left arm at the injection site, on 10/15/2002 she developed a sore throat. On 10/17/2002, she called "sick" with a sore throat, lethargy and head cold. It was noted the pt had not had a cold or flu in 5 years. The reporter requested a lot check. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Unspecified medical attention was sought. Additional info has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Feeling hot, Hypokinesia, Injection site oedema, Pain
Clinical narrative: Info has been received from a health professional concerning a female pt who on 10/09/2002, was vaccinated in the arm with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). Additional therapy on 10/09/2002 given in the opposite arm included a dose of influenza virus vaccine, "flu vaccine". The reporter indicated the pt had a reaction to pneumococcal vaccine 23 polyvalent . Subsequently on approx 10/09/2002 the pt developed "severe" pain in arm and under arm, and she was unable to lift her arm for 3 days (approx 10/12/2002). It was noted, the arm was warm and a little swollen, but felt better by Tuesday, 10/14/2002. It was noted the pt rated the pain "8" on a pain scale, and took ibuprofen (ADVIL) for the pain. The reporter requested a lot check. The records of pain testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested. The health professional 13 other pts who also had an experience following vaccination with pneumococcal vaccine 23 polyvalent (WAES #0210USA01524, 0210USA01734, 0211USA02240, 0211USA02241, 021USA02242, 0211USA02243, 0211USA02244, 0211USA02245, 0211USA02247, 0211USA02248, 0211USA02249, 0211USA02250, and 0211 USA02251.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Pain
Clinical narrative: Info has been received from a health professional concerning a female pt who in approximately Oct 2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). Additional therapy given at the same time, in the opposite arm, included a dose of influenza virus vaccine, "flu vaccine". Subsequently, in approx Oct 2002 and pt developed chills that night after receiving the vaccine, and small amount of soreness in both arms. The reporter requested a lot check. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Unspecified medical attention was sought. Additional info has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Hypokinesia, Oedema, Pain
Clinical narrative: Info has been received from a health professional concerning a female pt, who in approx Oct 2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot 3643251/0445M). Additional therapy given at the same time, in the opposite arm included a dose of influenza vaccine, "flu vaccine". The reporter indicated the pt had a reaction to the pneumococcal vaccine 23 polyvalent. Subsequently in approx Oct 2002, the pt developed "severe" pain, "very" swollen armpit with throbbing, "sore to the bone" and she could not raise her hand. It was noted the soreness lasted for 2 days. The reporter requested a lot check. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Unspecified medical attention was sought. Additional info has been requested. The health professional mentioned 13 other pts who also had an experience following vaccination with pneumococcal vaccine 23 polyvalent (WAES #0210USA01524, 0210USA01734, 0211USA02240, 0211USA02241, 0211USA02242, 0211USA02243, 0211USA02244, 0211USA02245, 0211USA02246, 0211USA02247, 0211USA02249, 0211USA02250 and 0211USA02251).
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain
Clinical narrative: Info has been received from a health professional concerning a female pt who was vaccinated with a 1st dose pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). Additional therapy given at the same time in the opposite arm, included a dose of influenza virus vaccine, "flu vaccine". Subsequently in approx Oct 2002, the pt developed a sore arm, and pain under right armpit. It was noted she could not lay on that side for a couple of days. The reporter requested a lot check. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Unspecified medical attention was sought. Additional info has been requested.
Sex: F
Vaccine: FLUX, RUB
Symptoms: Hypokinesia, Pain
Clinical narrative: Info has been received from a health professional concerning a female pt who in approx Oct 2002 was vaccinated in the left arm with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). Additional therapy given at the same time in the opposite arm included a dose of influenza virus vaccine, "flu vaccine". Subsequently in approx Octo 2002, the pt developed soreness in her left arm, and she couldn't raise her arm. It was noted she took antiinflammatories for the pain. The soreness and inability to raise her left arm lasted for 2 days. The reporter requested a lot check. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Unspecified medical attention was sought. Additional info has been requested. The health professional mentioned 13 other patients who also had an experience following vaccination with pneumococcal vaccine 23 polyvalent (WAES #0210USA01524, 0210USA01734, 0211USA02240, 0211USA02241, 0211USA02242, 0211USA02243, 0211USA02244, 0211USA02245, 0211USA02246, 0211USA02247, 0211USA02248, 0211USA02249 and 0211USA02251).
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site oedema, Pain
Clinical narrative: Info has been received from a health professional concerning a female pt who in approx Oct 2002, was vaccinated in the right arm with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). The reporter indicated the pt had a reaction to pneumococcal vaccine 23 polyvalent. Subsequently in approx Oct 2002, the pt developed right arm soreness and mild edema. The reporter requested a lot check. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Unspecified medical attention was sought. Additional info has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: Info has been received from a Pharm. D. concerning a female who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot number not reported). On the same day, the pt was vaccinated in the opposite arm with a dose of concomitant therapy influenza virus vaccine. Subsequently the pt developed itching, swelling and redness on the underside of her arm that was injected with pneumococcal vaccine 23 polyvalent. The outcome of the pt's itching, swelling and redness was unknown. The Pharm. D. reported that the pt sought unspecified medical attention. Additional info has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: Info has been received from a Pharm. D. concerning a pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot number not reported). Subsequently the pt developed itching, swelling and redness on the underside of the arm that was injected with pneumococcal vaccine 23 polyvalent. The outcome of the pt's itching, swelling and redness was unknown. The Pharm. D. reported that the pt sought unspecified medical attention. Additional info has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Info has been received from a health professional concerning a 65 year old female with diabetes, dyslipidaemia and hypertension who on 11/20/2002 was revaccinated with pneumococcal vaccine 23 polyvalent (lot #640576/0923L). On 11/21/2002 the pt experienced a severe site reaction which the physician called cellulitis. The pt sought medical attention and was treated with cephalexin (Keflex). Additional info has been requested. The health professional also reported that the pt's sister received pneumococcal vaccine 23 polyvalent (MSD) (WAES #0305USA00506) and developed cellulitis.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site erythema, Injection site oedema, Malaise
Clinical narrative: Info has been received from a white pt with allergies to penicillin and mangos and a history of asthma who on 11/19/2002 in the PM, also reported as 11/20/2002, was vaccinated IM in the right deltoid with a 1st dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI-CYCLEN) and vitamins (unspecified). There was no illness at the time of vaccination. The pt developed a welt on her arm, a fever of 101 degrees Fahrenheit, chills, malaise, fatigue and erythema, pain and swelling at the injection site. Unspecified medical attention was sought. On 11/26/2002, the pt recovered. No further info is expected.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia, Urticaria
Clinical narrative: Info has been received from a white pt with allergies to penicillin and mangos and a history of asthma who on 11/19/2002 in the PM, also reported as 11/20/2002, was vaccinated IM in the right deltoid with a 1st dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI-CYCLEN) and vitamins (unspecified). There was no illness at the time of vaccination. The pt developed a welt on her arm, a fever of 101 degrees Fahrenheit, chills, malaise, fatigue and erythema, pain and swelling at the injection site. Unspecified medical attention was sought. On 11/26/2002, the pt recovered. No further info is expected.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Pain
Clinical narrative: Info has been received from a health professional concerning a pt who on 11/15/2002 was vaccinated with pneumococcal vaccine 23 polyvalent (lot #644105/0820M) subcutaneously into the left deltoid. Subsequently the pt developed local injection site reactions involving swelling, redness and soreness. According to the pt's physician the reaction was severe and the pt developed cellulitis. The pt went to the ER and was treated with cephalexin (Keflex). The pt was not hospitalized. The reporter also described the experiences of two other pts who were also vaccinated with pneumococcal vaccine 23 polyvalent (WAES #0212USA00646 and 0212USA00647). Additional info has been received from a physician concerning this 64-year-old male pt who is HIV positive "with a good T cell count and a low viral load." It was reported that the pt was not ill at the time of vaccination. Within 24 hours, on 11/16/2002, it was reported that the pt developed marked swelling, erythema, tenderness of the entire left arm extending from the site of the injection to the elbow. The pt was seen in the ER and was diagnosed with a reaction and a question of cellulitis. The pt recovered from his experiences on 11/19/2002. It was reported that the pt has never had an adverse event following prior vaccinations. Additional info is not expected.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site warmth, Pain
Clinical narrative: Info has been received from a nurse concerning an 80 year old female with allergies to iodine, codeine, epinephrine and mycins who on 11/15/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent in the right deltoid (lot #641530/1351L). The pt was well at the time of vaccination. On 11/15/2002 the pt developed a severe site reaction. The pt reported that her right arm was hot, red, swollen in a 3 inch diameter, and painful to the touch. On 11/16/2002 the pt went to the ER where she was diagnosed with cellulitis. She was treated with cephalexin, 500 mg, and was told to use moist heat on the area. On 11/21/2002 the pt reported that the cephalexin was giving her diarrhea. The area was still painful but not as red. The physician instructed the pt to discontinue the cephalexin. The health professional reported that they had not heard back from the pt since 11/21/2002, so they were assuming that she recovered. The reporter expressed a concern regarding the lot number. The health professional also provided info regarding other pts (WAES #0211USA01894 and 0211USA02405). The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The pt sough unspecified medical attention. Additional info has been requested.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site erythema, Injection site oedema, Pain
Clinical narrative: Info has been received from a nurse concerning an 86-year-old female, with allergies to codeine sulfate, sulfa, ciprofloxin (CIPRO), lidocaine (XYLOCAINE) and acetaminophen (+) propoxyphene napsylate (DARVOCET N-100), who on 11/18/2002 was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent, in the right deltoid (lot #641530/1351L). She was reported to be well at the time of vaccination. On 11/18/2002 the pt developed a severe site reaction. The pt experienced pain in arm, lost use of the arm, and developed swelling in armpit and redness. She called to report the events to the physician's office on 11/19/2002. She reported that she put ice on the arm "that night". The physician instructed her to put heat on the arm and prescribed cephalexin (KEFLEX) 500 mg TID for 7 days. The office personnel had not heard back from the pt, after 11/19/2002 and "assume she recovered" (also reported as "After a few days the pt recovered"). It was noted that the pt had received a 1st dose of pneumococcal vaccine 23 polyvalent on 11/07/1995. The nurse also reported 2 other pts' experiences (WAES #0211USA02404 and 0211USA01894). One of the 3 patients reported to the ER but was not hospitalized. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Info has been received from a physician concerning a female pt who in approx Sept 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. In approx Sept 2002 the pt developed cellulitis at the injection site. The pt was treated with antibiotics. It was also reported that one male pt developed cellulitis at the injection site (WAES #0212USA00380), one female pt developed cellulitis at the injection site in the left arm for 2 days (WAES #0302USA00556) and one female pt developed cellulitis at the injection site (WAES #0306USA02587). The symptoms of 2 of the pts cleared up without event. Two pts were seen over the weekend within "a day or two of injection" and at the time of this report follow up had not occurred. Additional info has been requested.
Sex: U
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Info has been received from a consumer concerning a client who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the client developed hives. Additional info has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Erythema nodosum, Injection site inflammation, Injection site oedema, Injection site warmth, Pain
Clinical narrative: Info has been received from a 55 year old female registered nurse with allergies to sulfa medications, codeine and tetanus toxoid who on 10/22/2002 at 1600 was vaccinated intramuscularly in the left deltoid with a 0.5 ml 2nd dose of pneumococcal vaccine 23 polyvalent (lot #643251/0445M). There was no illness at the time of vaccination. Concomitant medication included vitamins, calcium, sertraline hydrochloride (ZOLOFT), hyoscyamine sulfate (LEVBID), and diphenhydramine hydrochloride (BENADRYL) prn. On 10/22/2002 at 1630 the pt developed a localized reaction with swelling pain, inflammation, "hot to the touch" and had blotches of red from the shoulder to the elbow on the left upper arm. On 11/26/2002, it was reported by a health care professional that the pt developed a local reaction which was diagnosed as erythema nodosum to the medial aspect of her humerus. No intervention was reported. Unspecified medical attention was sought. The pt recovered on 10/29/2002. Additional info is not expected.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Rash macular
Clinical narrative: Info has been received from a 55 year old female registered nurse with allergies to sulfa medications, codeine and tetanus toxoid who on 10/22/2002 at 1600 was vaccinated intramuscularly in the left deltoid with a 0.5 ml 2nd dose of pneumococcal vaccine 23 polyvalent (lot #643251/0445M). There was no illness at the time of vaccination. Concomitant medication included vitamins, calcium, sertraline hydrochloride (ZOLOFT), hyoscyamine sulfate (LEVBID), and diphenhydramine hydrochloride (BENADRYL) prn. On 10/22/2002 at 1630 the pt developed a localized reaction with swelling pain, inflammation, "hot to the touch" and had blotches of red from the shoulder to the elbow on the left upper arm. On 11/26/2002, it was reported by a health care professional that the pt developed a local reaction which was diagnosed as erythema nodosum to the medial aspect of her humerus. No intervention was reported. Unspecified medical attention was sought. The pt recovered on 10/29/2002. Additional info is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Info has been received from a health professional concerning a pt who was vaccinated with pneumococcal vaccine 23 polyvalent (Lot #641027/1051L). Subsequently the pt experienced arm swelling from shoulder to elbow, heat and erythema. The experience "lasted 2 to 3 days and resolved without intervention". The pt sought unspecified medical attention. The health professional also described the experience of another pt who was vaccinated with pneumococcal vaccine 23 polyvalent (lot #641027/1051L, exp. 05/18/2003), WAES #0211USA01918. Additional info has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema nodosum, Injection site reaction, Oedema peripheral, Pain
Clinical narrative: Information has been received from a 61 year old female RN who in the early afternoon of 10/18/02 (previously reported as 10/22/02) was vaccinated IM with a first dose of PNEUMOVAX 23 (643251/0445M). On 11/26/02 it was reported by a health professional that the pt had subsequently developed a local reaction which was diagnosed as erythema nodosum to the medial aspect of her humerus. No intervention was reported and the reaction had dissipated with no visible reaction. Unspecified medical attention was sought. On 3/2/03, the pt reported that on 10/18/02 her arm had swollen up 2x the normal size and was very hard and painful. The pain lasted for 3 days. The pt reported that she had recovered on 10/23/02. It was also reported that one other nurse was vaccinated with PNEUMOVAX 23 and also developed an adverse reaction (WAES0211USA02568). No further info is expected.
Age: 77.0
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a pharmacist concerning a 77 year old hospitalized pt who was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent. The pt experienced a "cellulitis-like" reaction spreading from the injection site that started almost a week after the injection. Unspecified medical attention was sought. Additional info has been requested.
Sex: U
Vaccine: PPV
Symptoms: Nausea, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent for the first time. Subsequently the pt experienced "sore arm/ underarm" and nausea and developed swelling, induration, and fever. After "at least 4 days," the pt's symptoms subsided. The pt sought unspecified medical attention. A product quality complaint was not involved.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Laboratory test abnormal, Renal failure
Clinical narrative: Information has been received from a consumer concerning a 65 year old female who in July 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Approximately 2 to 3 weeks later the pt experienced extreme fatigue. It was reported that blood work suggested symptoms associated with renal failure. Unspecified medical attention was sought. Additional info has been requested.
Sex: F
Vaccine: PPV
Symptoms: Anaphylactic reaction, Throat tightness, Urticaria
Clinical narrative: Information has been received from a physician concerning a female patient with a history of asthma and no known drug allergies, who on Nov 22, 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. There was no concomitant medication. On Nov 22, 2002 one hour after the administration of pneumococcal vaccine 23 polyvalent the patient experienced an anaphylactic reaction, described as "hives and her throat started to close". It was noted the patient was taken to the emergency room and she was treated with diphenhydramine hydrochloride (Benadryl) epinephrine, and methylprednisolone sodium succinate (Solu-Medrol). No further data was provided. Anaphylactic reaction was considered to be immediately life threatening. Additional information has been requested.