chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning a pt who on an unspecified date, was vaccinated with pneumococcal vaccine 23 polyvalent (642722/0165M). Following the vaccination, the pt developed swelling, redness, and heat at the site of injection. Unspecified medical attention was sought, however, the pt did not require hospitalization. At the time of this report, the outcome of the events was unknown. 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. The LPN also reported two other patients' experiences after being vaccinated with pneumococcal vaccine 23 polyvalent (WAES0210USA00259 and 0210USA00559). No further info is expected.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 69 year old female pt who on 9/18/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (640744/0994L). The reporter indicated that within 24 hrs (approximately 9/19/02) of vaccination with pneumococcal vaccine 23 polyvalent, the pt's arm, which had been injected, developed "extreme swelling" that extended to the elbow. It is noted the pt was again seen in the physician's office the next day (approximately 9/20/02) and the swelling had "actually progressed further down the arm." The pt was treated with a 40mg IM injection of Medrol, and an unsepcified dose of IM Benadryl. The reporter expressed a concern regarding the lot number. 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: U
Vaccine: PPV
Symptoms: Medication error, Rash erythematous
Clinical narrative: Information has been received from a registered pharmacist concerning a patient who was vaccinated intradermally with a dose of pneumococcal vaccine 23 polyvalent, "believing this to be TB".  It was reported that there were "no untoward reactions at present".  Subsequently, it was reported that the only adverse experience was a "small, raised, red area" at the injection site.  Unspecified medical attention was sought.  Follow-up information indicated that the vaccination was given in error and was not the result of any "similarity of product, packaging or name".  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: MEN, PPV
Symptoms: Hypokinesia, Injection site induration, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old white asplenic (spleen removed 06/03/1994) female student, who on 10/03/2002 at 14:15 was vaccinated intramuscularly in the right deltoid with a second dose of pneumococcal vaccine 23 polyvalent (Lot # 637093/0802L).  The first dose was administered in 1994.  Concomitant therapy with the second dose included a dose of meningococcal polysaccharide vaccine and ethinyl estradiol (+) norgestimate (ortho tri-cyclen).  The reporter indicated that the second dose of pneumococcal vaccine 23 polyvalent had expired on 04/14/2002.  There was no illness at the time of vaccination.  Subsequently, the patient had a painful reaction in the arm that received the injection.  The patient stated that her "arm/armpit was very sore, hard, swollen" and that she, "could not use her arm very well".  Unspecified medical attention was sought and the patient was treated with cold/warm compresses and ibuprofen (Motrin).  No laboratory tests were performed.  One week later the patient recovered.  Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Injection site erythema
Clinical narrative: Information has been received on 10/9/02 from a medical supplier on behalf of 2 physicians concerning a female patient who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the patient developed severe redness in an area 2-3 inches around the injection site, and flu-like symptoms. The patient sought unspecified medical attention. It was reported that two other females had a similar reaction. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Joint range of motion decreased, Sleep disorder
Clinical narrative: Information has been received from a  70 year old female with no known drug allergies and borderline hypertension who on 10/8/02 was vaccinated in the right arm with pneumococcal vaccine 23 polyvalent. Concomitant therapy included omeprazole, calcium, vitamin E, vitamins, and influenza virus vaccine. The patient reported that she had received the influenza virus vaccine in her left arm on 10/8/02. On 10/8/02 the patient reported that right after she received the pneumococcal vaccine 23 polyvalent her right arm became swollen. She reported that she could not sleep because of the pain. The patient reported that on 10/9/02 the swelling took up from the top of her shoulder to her elbow and that she could barely raise her arm. At the time of this report, the patient had not sought medical attention. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Information has been received from a 72 year old Asian male physician who on 6/14/02 at 8:50am was vaccinated SC in the right thigh with 0.5ml of pneumococcal vaccine 23 polyvalent (lot # 641130/1161L). On 6/14/02 the physician reported that he gave himself a dose of pneumococcal vaccine 23 polyvalent. The physician reported that he experienced a slight reaction at the injection site with itching and slight swelling. He treated it with topical hydrocortisone. The physician also reported that his wife developed injection site swelling and peripheral swelling after being vaccinated with pneumococcal vaccine 23 polyvalent (lot # 641130/1161L). Additional information has been received from the physician. The physician reported that on 6/14/02 at 11:30am he developed redness and swelling at the injection site and had no other reaction. The physician treated the injection site reaction with a cold compress and reported that no other treatment was required. The physician reported that he recovered. No further information is expected.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 51 year old male patient with no past medical history and no known drug allergies, who on Oct 09, 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 3639394/0416L). It was noted the patient had been vaccinated with a dose of influenza vaccine the day before (Oct 08, 2002). On the night of Oct 09, 2002 the patient's arm became "extremely painful, swollen, and hard", although there was no redness around the injection site. The patient developed difficulty in raising his arm. It was noted the patient did not know whether he had ever received the pneumococcal vaccine 23 polyvalent in the past. Unspecified medical attention was sought. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Information has been received from a medical assistant concerning a patient who in a approximately Oct 2002, was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #641116/1160L). Approximately 24 hours later, the patient presented to the doctor's office with a large red welt at the injection site that extended from the deltoid to the elbow. A similar adverse experience occurred in a second patient (WAES0210USA01670) and 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 evaluation and research and was released. Aditional information has been requested.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site oedema
Clinical narrative: Information has been received from a health professional concerning a 76 year old female with no known allergies and no past medical history, who on Oct 07, 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #640981/1050L). Concomitant therapy included influenza virus vaccine (Fluzone). On the night of Oct 07, 2002 the patient developed a "local reaction", reported as "swelling at the site of injection". When the patient was seen in the physician's office the next day (Oct 8, 2002), it was reported "the entire area, from front to back of upper arm, shoulder to elbow" was red. Subsequently, the patient recovered. It was noted the patient called the physician office on Oct 11, 2002 and reported her arm was "fine and the condition resolved". Unspecified medical attention was sought. The health professional also reported another patient who had an experience following vaccination with pneumococcal vaccine 23 polyvalent (WAES0210USA01291).
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site oedema
Clinical narrative: Information has been received from a physician concerning a 69 year old female patient, who on Oct 9, 2002 was vaccinated with pneumococcal vaccine 23 polyvalent (Lot # 643783/0709M). On the next day, approximately Oct 10, 2002 the patient reported she had developed swelling in the arm that received the injection, and dizziness. Unspecified medical attention was sought. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site oedema
Clinical narrative: Information has been received from a physician concerning a 66 year old female patient, who on Oct 9, 2002 was vaccinated with pneumococcal vaccine 23 polyvalent (lot# 643783/0709M). On the next day, approximately Oct 10, 2002 the patient reported she had developed swelling in the arm that received the injection,and dizziness. Unspecified medical attention was sought. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Joint range of motion decreased
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Two hours later the patient"couldn't move that arm". The physician was concerned that he might have injected the vaccine into a tendon or a joint. Unspecified medical attention was sought. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Information has been received from a registered nurse concerning a 60 year old female with asthma who on Oct 8, 2002 was vaccinated in the right arm with a dose of pneumococcal vaccine 23 polyvalent (lot# not reported). Four hours after vaccination the patient developed severe pain in her right upper arm. The pain started to abate six days after administration. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Injection site erythema, Injection site oedema, Pain, Pyrexia
Clinical narrative: Info has been received from a 45-year-old female pt, a registered nurse with questionable drug hypersensitivity to sulfa who on 10/09/2002 in the AM was vaccinated by intramuscular injection in the right deltoid with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). Additional therapy given in the AM on 10/09/2002 included an intramuscular injection in the left deltoid with a dose of influenza virus vaccine. The reporter indicated she has a "flu vaccine every year". Concomitant therapy included "antiinflammatories". On 10/11/2002 the pt developed a reaction over half the arm between the elbow and shoulder, described as "redness 4-5 inches from mid bicep to mid tricep", she could not raise her arm, had joint aches, fever of 100.6, blister type appearance of arm, swelling of arm and severe pain. The pt went to her physician on 10/11/2002 and was treated with prednisone, and cephalexin (KEFLEX) (total daily dosage, and stop date not reported). The reporter indicated she did not have any illness at the time of vaccination, and had not experienced any adverse events following prior vaccinations. The reporter requested a lot check. It was noted the pt recovered on 10/18/2002. 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 reporter mentioned 13 other patients who also had an experience following vaccination with pneumococcal vaccine 23 polyvalent (WAES #0210USA01734, 0211USA02240, 0211USA02241, 0211USA02242, 0211USA02243, 0211USA02244, 0211USA02245, 0211USA02246, 0211USA02247, 0211USA02248, 0211USA02249, 0211USA02250 and 0211USA02251).
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site inflammation, Injection site oedema, Pain
Clinical narrative: Info has been received from a registered pharmacist concerning a female registered nurse who on 10/11/2002 was vaccinated with pneumococcal vaccine 23 polyvalent (Lot #640981/1050L) intramuscularly in the deltoid. The registered pharmacist reported that he heard from a physician's office that three members of the office staff received pneumococcal vaccine 23 polyvalent and experienced swelling from the site of the injection down to almost the elbows. Follow-up info from the registered nurse indicated that 3 employees, herself included, were vaccinated with pneumococcal vaccine 23 polyvalent on 10/11/2002. (The registered nurse administered 2 vaccinations and she received her vaccination by someone else). All 3 pts experienced soreness in a few hours. The swelling appeared that night. The area was warm and inflamed. Two of the pts were treated with ice. The reactions seemed to resolve in 48 hours. Unspecified medical attention was sought. Related reports: WAES #0210USA02049 and 0210USA02050. 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.
Age: 82.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: Info has been received from a physician concerning a pt ("aged between 82-90 years") who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #641130/1161L). In October 2002 the pt experienced swelling, pain and redness at the injection site. Unspecified medical attention was sought. A product quality complaint was not involved. The physician also reported another pt that had a similar reaction after being vaccinated with a dose of pneumococcal vaccine 23 polyvalent (WAES #0306USA02634). Additional info has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Info has been received from a medical assistant concerning a pt who in approximately October 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #641116/1160L). Approx 24 hours later, the pt presented to the doctor's office with a large red welt at the injection site that extended across the arm. A similar adverse experience occurred in a second pt (WAES #0210USA01132) and 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.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Pain
Clinical narrative: Info has been received from a 50 year old female pt with no past medical history who on 09/28/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included sodium levothyroxine (SYNTHROID), pravastatin sodium (PRAVACHOL) and meloxicam (MOBIC). Subsequently, the pt stated that the injected arm "felt sore and then swollen for a few days after vaccination." The pt sought unspecified medical attention. Additional info has been requested.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site erythema, Injection site oedema, Pain
Clinical narrative: Info has been received from a licensed practical nurse (LPN) concerning a 39 year old female with an allergy to codeine and theophylline, asthma and depression and a history of a prior vaccination with pneumococcal vaccine 23 polyvalent who on 10/15/2002 was vaccinated in the deltoid (not specified) with a 2nd dose of pneumococcal vaccine 23 polyvalent (lot #643783/0709M). Concomitant therapy included amitriptyline hydrochloride (MSD), albuterol sulfate (+) ipratropium bromide (COMBIVENT), efenlafaxine HCl (EFFEXOR) and fluticasone propionate (+) salmeterol xinafoate (ADVAIR). On 10/15/2003, a few hours after administration of the vaccine, the pt developed erythema, soreness, swelling and pain around the injection site. The LPN also reported that movement of the pt's deltoid was described to be painful and limited. The pt was prescribed naproxen, 500 mg twice a day, and metaxalone (SKELAXIN) as intervention treatment. The outcome of the pt's events was unknown. The reporter expressed a concern regarding the lot number. Conflicting info has been received from the LPN. The LPN reported that on 10/16/2002 the pt was vaccinated IM in the right arm with a dose of pneumococcal vaccine 23 polyvalent (lot #643783/0709M). On 10/16/2002 the pt was unable to fully extend right arm where the injection was given. The pt's right arm became red, warm to touch, slightly edematous with much pain and the pt "couldn't sleep all night". The outcome of the pt's experience was unknown. No additional info is expected. 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.
Sex: U
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Info has been received from a health professional concerning a pt (demographics unknown) who on 10/14/2002 was vaccinated with an expired dose of pneumococcal vaccine 23 polyvalent. On 10/14/2002, the pt experienced arm pain in injected arm. The pt sought unspecified medical attention. Additional info has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Abscess
Clinical narrative: Info has been received from a health professional concerning a 59 year old "frail" female who on an unspecified date was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the pt developed a sterile abscess at the injection site. It is unknown if medical attention was sought or if intervention was required. Additional info has been requested.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pain
Clinical narrative: Info has been received from a health professional concerning a male pt who in approximately October 2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). Additional therapy at the same time in the opposite arm included a dose of influenza virus vaccine, "flu vaccine". The reporter indicated the pt had a reaction to the pneumococcal vaccine 23 polyvalent. Subsequently, in approximately October the pt developed "severe" soreness to arm, the pain was rated "10" on a pain scale of 1-10. It was noted he had to go to bed and take pain medication for 48-72 hours. 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: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: Info has been received from a consumer concerning a pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently the pt developed "swelling, redness and pain on movement of arm". Unspecified medical attention was sought. Additional info has been requested.
Age: 0.3
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Info has been received from a health professional concerning a 4 month old male with no pre-existing condition who on 10/16/2002 was vaccinated with pneumococcal vaccine 23 polyvalent (lot #641804/0035M) instead of the intended vaccine Streptococcus pneumoniae vaccine (Prevnar). Also, on approximately 10/16/2002 (also noted as 10/14/2002) the pt developed a local injection site reaction and fever for 24 hours. It was noted there was no illness at the time of vaccination, the pt did not have prior events following previous vaccinations and no diagnostic or laboratory tests were done. No medical attention was sought (also reported as serious criteria: none (required ER visit)). Subsequently, the pt recovered. Follow-up info for this report was received from Manufacturer for Streptococcus pneumoniae vaccine (Prevnar) and was assigned manufacturer report number HQ4727321OCT2002. This was originally reported by a health care professional.
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Info has been received from a physician concerning a male pt who was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent. Subsequently, the pt experienced urticaria when he was revaccinated 7 years after the 1st dose. Unspecified medical attention was sought. At the time of the report, the outcome was unknown. Additional info has been requested.
Age: 50.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Fatigue, Myalgia
Clinical narrative: Info has been received from a physician concerning an approximately 50 year old male physician with Hodgkin's disease diagnosed in 1980 and a history of splenectomy in 1980 who in 1985 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent. No adverse symptoms were noted. In 1990 the pt was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. On the same day, the pt was concomitantly vaccinated with a dose of influenza virus vaccine. Subsequently, the pt developed severe muscle pain and fatigue for 3 days. Unspecified medical attention was sought. No treatment was needed: the condition resolved and no hospitalization was required. No additional info is expected.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Info has been received from a consumer from a medical office concerning a 76-year-old female with an "unremarkable" medical history who on 10/10/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #642749/0111M). Concomitant therapy was noted to be "unremarkable." In October 2002 the pt developed injection site reactions. The pt sought unspecified medical attention. A product quality complaint was not involved. The reporter provided into regarding 3 other patients with similar experiences after vaccination with a dose of pneumococcal vaccine 23 polyvalent (WAES #0210USA02077, 0210USA02078 and 0210USA02079). Additional info has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a physician and a medical assistant concerning a 70 year old white female who "recently," in 2002, was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. The physician  reported that the vaccine was given in an "improper site." Subsequently in 2002, the patient developed a "local reaction" at the injection site including discomfort (previously reported as soreness), erythema (previously reported as redness), and edema. The patient was treated with ice and "antibiotics" (therapy unspecified) and had no sequela. The physician indicated that the patient had a previous exposure to pneumococca; vaccine 23 polyvalent or a related drug five years ago and developed a "one shot reaction" with no sequela which required no medication. The outcome was not reported. The patient sought unspecified medical attention. In follow up, the physician reported that the patient's local erythema and edema had subsided and provided no additional information. No further information is available.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema, Pain, Pruritus
Clinical narrative: Information has been received from a medical assistant concerning a 67 year old female who on Oct 15, 2002, was vaccinated with pneumococcal vaccine 23 polyvalent (lot# 643782/0675M), in the right arm. On Oct 18, 2002, she presented to her physician's office with swelling of right arm (3x5 or 4x4area), redness of right arm and itching of right arm. The patient experienced no pain. The medical assistant did not know what interventions were recommended by the physician. The medical assistant also reported that two other patients were vaccinated with pneumococcal vaccine 23 polyvalent (lot# 643782/0675M). One patient experienced pain, left arm swelling, redness and itching (WAES0210USA02231). The medical assistant reported that the physician expressed a concern regarding the lot number and 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 standards of the evaluation and research and was released. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site oedema, Nausea
Clinical narrative: Information has been received from a registered pharmacist and a registered nurse concerning a patient who on Oct 11, 2002, was vaccinated by a registered nurse with a dose of pneumococcal vaccine 23 polyvalent (lot#640981/1050L), intramuscularly in the deltoid. The registered pharmacist reported that he heard from a physician's office that three members of the office staff received pneumococcal vaccine 23 polyvalent and experienced swelling from the site of the injection down to almost the elbows. The registered nurse reported that three employees were vaccinated with pneumococcal vaccine 23 polyvalent on Oct 11, 2002. All three patients experienced soreness in a few hours. The swelling appeared that night. The area was warm and inflamed. This patient also had nausea the next day. Two of the patients were treated with ice. The reactions seemed to resolve in 48 hours. Unspecified medical attention was sought. Related reports: WAES0210USA01548 and WAES0210USA02050. 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 evaluation and research and was released. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site oedema
Clinical narrative: Information has been received from a registered pharmacist and a registered nurse concerning a patient who on Oct 11, 2002, was vaccinated by the registered nurse with a dose of pneumococcal vaccine 23 polyvalent, intramuscularly (lot #640981/1050L expiration date May 16, 2003), intramuscularly in the deltoid. The registered pharmacist reported that he heard from a physician's office that three members of the office staff received pneumococcal vaccine 23 polyvalent and experienced swelling from the site of the injection down to almost the elbows. The registered nurse reported that three employees were vaccinated with pneumococcal vaccine 23 polyvalent on Oct 11, 2002. All three patients experienced soreness in a few hours. The swelling appeared that night. The area was warn and inflamed. Two of the patients were treated with ice. The reactions seemed to resolved in 48 hours. Unspecified medical attention was sought. The records of testing priori to release of this lot have been checked by compliance and found to be satisfactory. The lot complies with the standards of the evaluation and research and was released. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: FLUX, PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning an approximately 60 year old patient who in approximately Oct 2002, was vaccinated in the arm with a dose of pneumococcal vaccine 23 polyvalent (lot# 642722/0165M). Concomitant therapy, that same day, included a dose of influenza virus vaccine in the opposite arm. Within hours of vaccination, in approximately Oct 2002, the patient developed a "big time reaction" from the deltoid to the elbow. The reaction persisted for 3 to 5 days. The patient received palliative treatment. The physician reported that the patient had priori vaccination with pneumococcal vaccine 23 polyvalent over 5 years ago. 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 evaluation and research and was released. The patient sought unspecified medical attention. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a consumer from a medical office concerning a 75 year old male who on Oct 10, 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #642749/0111M). In Oct 2002, the patient developed injection site reaction. The patient sought unspecified medical attention. The reporter provided information regarding three other patients (WAES0210USA01938, 0210USA02077 and 0210USA02079). Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a consumer from a medical office concerning a 74 year old female who on Oct 15, 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot# 642749/0111M). In Oct 2002, the patient developed injection site reaction. The patient sought unspecified medical attention. The reporter provided information regarding three other patients (WAES0210USA01938, 0210USA02077 and 0210USA02078). Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Skin disorder
Clinical narrative: Information has been received from a medical assistant concerning a male who was revaccinated with pneumococcal vaccine 23 polyvalent six years after previous dose of pneumococcal vaccine 23 polyvalent. Subsequently the patient developed a local site reaction. The medical assistant reported that the patient told her that he "felt like his skin was coming off". The patient was treated with diphenhydramine HCL (Benadryl). The outcome of the patient's events was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a pharmacy student concerning a patient who on approximately Oct 14, 2002, about one week ago, was vaccinated with pneumococcal vaccine 23 polyvalent. On approximately Oct 14, 2002, the patient developed anaphylaxis and was hospitalized. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Information has been received from a woman in a physician's office concerning a 72 year old male patient with no past medical history and no known allergies, who on Oct 18, 2002 was vaccinated with the second dose of pneumococcal vaccine 23 polyvalent. It was reported that 24 hours of receiving the vaccination, on approximately Oct 19, 2002, the patient developed a swollen right arm. It was also reported that the patient developed redness, and an unspecified site was hot to touch. Unspecified medical attention was sought. At the time of this report, the outcome of the events was unknown. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain, Pruritus
Clinical narrative: Information has been received from a medical assistant concerning an 81 year old female who on 10/17/02, was vaccinated with pneumococcal vaccine 23 polyvalent (643782/0675M), in the left arm. On 10/18/02, in the morning, she called the physician's office with complaints of pain, left arm swelling, left arm redness and left arm itching. The medical assistant reported that the physician expressed a concern regarding the lot number and 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. Additional info has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain
Clinical narrative: Information has been received from a registered nurse concerning a female pt who on 10/16/02 was vaccinated with pneumococcal vaccine 23 polyvalent (643783/0709M). On approximately 10/16/02 she developed pain, redness and a "swollen circumference around her arm." It was noted the registered nurse described it as an "extreme reaction." Unspecified medical attention was sought. The reporter expressed concern and is requesting 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. Additional info has been requested.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a medical assistant concerning a pt who recently, in 2002 was vaccinated with pneumococcal vaccine 23 polyvalent. Concomitant therapy possibly included infleunza virus vaccine. In 2002, the pt developed a local site reaction after vaccination with pneumococcal vaccine 23 polyvalent. This is one of two reports concerning a total of four patients. It was noted that this pt was "a re-vaccinee." It was also reported that three of the patients possibly received "a flu vaccine" in the opposite arm on the same day (WAES0210USA02648). The pt sought unspecified medical attention. Additional info has been requested.
Age: 84.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Feeling hot, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning an 84 year old female pt with no allergies and no medical history, who on 10/21/02 was vaccinated IM in the right deltoid with a first dose of pneumococcal vaccine 23 polyvalent (640981/1050L). Concomitant vaccination included a first dose of influenza virus vaccine (Fluvirin) (E34722HA) IM in the left deltoid. The pt stated to the nurse that she had received both vaccines in the left arm. However, the nurse confirmed that pneumococcal vaccine 23 polyvalent was administered in the right deltoid. There was no illness at the time of vaccination. On 10/22/02, the pt developed a "10 1/2 by 7 1/2 centimeter area, left arm erythematous, which developed  into mild case of cellulitis, warm to touch." The area was also described as "red, raised with induration" and swelling was also reported. The pt sought unspecified medical attention and was treated with cephalexin 250mg orally three times a day for 10 days. Subsequently, the pt recovered. 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. It was also reported that a second pt experienced an adverse event following vaccination with pneumococcal vaccine 23 polyvalent (640981/1050L) WAES0210USA02516 and a third pt experienced an adverse event following vaccination with pneumococcal vaccine 23 polyvalent (637345/1449K) WAES0210USA02517. Additional info is not expected.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Oedema
Clinical narrative: Information has been received from a pharmacist concerning a pt who on approximately 10/21/02 was vaccinated in the left arm with a dose of pneumococcal vaccine 23 polyvalent. Concomitant vaccination included a dose of influenza virus vaccine in the right arm. Post vaccination the pt developed swelling of the left arm. Unspecified medial attention was sought. Additional info has been requested.
Age: 56.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: Info has been received from a pharmacist concerning a 56 year old female who on 10/15/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #641531/1352L). Concomitant therapy included a dose of the influenza virus vaccine (manufacturer unknown). On approx 10/15/2002, the pt developed a local reaction at the injection site and a fever of 100F. Unspecified medical attention was sought. Additional info has been requested.
Age: 76.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: Info has been received from a registered nurse concerning a 76 year old female pt with multiple allergies who on 10/10/2002 was vaccinated in the left arm with a dose of pneumococcal vaccine 23 polyvalent (Lot #643249/0358M). Concomitant vaccination included a dose of influenza virus vaccine in the right arm. Post vaccination the pt developed a swollen left arm from her elbow to her shoulder, "with 3 inch swollen diameter, itchy, red". Subsequently, the pt was treated with methylprednisolone sodium succinate benzyl alcohol (SOLU-MEDROL). Additional info has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: Info has been received from a registered nurse concerning a 63 year old (previously reported as approx 50 year old) female who on 10/23/2002 at 14:00 was vaccinated with the 1st dose of pneumococcal vaccine 23 polyvalent given in the right arm (lot #640578/0996L). On 10/24/2002, 24 hours after receiving the vaccine, the pt experienced a painful injection site, and her arm was tender, red and swollen for a couple of days. After 6 days, on 10/29/2002, the pt recovered and had no more symptoms. No further info is available.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Injection site erythema
Clinical narrative: Info has been received from a registered nurse concerning a 69 year old female pt who on 10/17/2002 was vaccinated with the "first documented" dose of pneumococcal vaccine 23 polyvalent (lot #641531/1352L). Subsequently the pt had a local reaction at injection from shoulder to elbow, red and blister-like. The pt sought medical attention and was treated with dephenhydramine HCl (Benadryl). It was reported that the symptoms resolved. It was also reported that 2 other patients (WAES #0211USA01411 and 0211USA01412) experienced symptoms after vaccination with pneumococcal vaccine 23 polyvalent. Additional info has been requested.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Laboratory test abnormal
Clinical narrative: Info has been received from a physician concerning a 40 year old female who in 2001 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Following her vaccination in 2001, the pt found that in approx March 2002 her titer was negative. The physician reported that titers were drawn several times, the earliest in approx March 2002 and latest in Sept 2002. The physician indicated that the pt had told her that she had been immunized at another practice, but there were no records of the vaccination. The physician further indicated that the pt was a "pretty reliable" historian. As of 10/24/2002, the physician was trying to determine whether to re-immunize the pt who was soon to be started on intravenous immunoglobulin (IVIG) if a titer was negative following a dose of pneumococcal vaccine 23 polyvalent in 2001. In follow-up, the physician indicated that she did not give the original immunization. The physician further indicated that she did not have nor can she get any additional info. The pt sought unspecified medical attention. Additional info is not expected.
Sex: F
Vaccine: PPV
Symptoms: Oedema
Clinical narrative: Info has been received from an office manager concerning a female pt who on 10/21/2002 was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent. The pt had received a 1st dose of pneumococcal vaccine 23 polyvalent approx 5 to 6 years "with no problems". Post vaccination with the 2nd dose, the pt developed swelling from her shoulder to her elbow. The reporter indicated that a pt was treated with antibiotics, but did not specify if it was this pt or a 2nd pt (WAES #0210USA02676) that experienced an adverse event post pneumococcal vaccine 23 polyvalent vaccination. Unspecified medical attention was sought. Additional info has been requested.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Info has been received from a woman in a physician's office concerning a 73 year old male pt with no past medical history and no known allergies, who on 10/18/2002 was vaccinated with the 2nd dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included moexipril hydrochloride (UNIVASC) and morniflumate (FLOMAX). It was reported that 24 hours after receiving the vaccination, on approx 10/19/2002, the pt developed a swollen right arm. It was also reported that the pt developed redness, and an unspecified site was hot to touch. At the time of this report, the outcome of the events was unknown. Unspecified medical attention was sought. Additional info has been requested.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: Info has been received from a registered nurse concerning a 48 year old male pt with no allergies and no medical history, who on 03/25/2002 was vaccinated intramuscularly in the left deltoid with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #640981/1050L). There were no concomitant vaccinations and there was no illness at the time of vaccination. On 03/27/2002, the pt developed a 3cm in diameter raised, red and swollen area of the left arm. Unspecified medical attention was sought and the pt was treated with cetirizine hydrochloride (ZYRTEC) 10 mg daily, orally. Subsequently, the pt recovered. 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. It was also reported that another pt experienced an adverse event following vaccination with pneumococcal vaccine 23 polyvalent (lot #640981/1050L) (WAES #0210USA02350) and a 3rd pt experienced an adverse event following vaccination with pneumococcal vaccine 23 polyvalent (lot #637345/1449K) (WAES #0210USA02517). Additional info is not expected.
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site oedema, Pain
Clinical narrative: Info has been received from a registered nurse concerning a male pt who on 12/11/2001 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #637345/1449K), administered in the left arm. Subsequently, the pt developed swelling of left arm "distal to the injection site downward", pain, edema, and warmth. The reporter expressed concern with the lot. Unspecified medical attention was sought. 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. It was also reported that 2 additional pts experienced an adverse event following vaccination with pneumococcal vaccine 23 polyvalent (lot #640981/1050L) (WAES #0210USA02350 and 0210USA02517). Additional info has been requested.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Injection site oedema, Pyrexia
Clinical narrative: Info has been received from a pharmacist concerning a pt who on approximately 10/21/2002 was vaccinated in the left arm with a dose of pneumococcal vaccine 23 polyvalent. Concomitant vaccination included a dose of influenza virus vaccine in the right arm. Subsequently, the pt developed a "high fever" and swelling of the left arm. Unspecified medical attention was sought. Additional info has been requested.
Sex: U
Vaccine: PPV
Symptoms: Arthralgia, Myalgia
Clinical narrative: Info has been received from a health professional concerning a pt who on an unspecified date was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently the pt developed arthralgia and myalgia. It was noted that a nurse from office told the pt the dose received must have been from a "bad batch". A lot check was requested by the physician. No lot info on the pneumococcal vaccine 23 polyvalent (MSD) had been provided. It was noted that the pt reported to the clinic in this report as follow-up and did not receive the vaccine there. It was also noted that the reporter could not recall the first or last name of the pt and could not provide any more info. Unspecified medical attention was sought. No further info has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site erythema, Injection site oedema, Pain
Clinical narrative: Info has been received from a licensed practical nurse (LPN) concerning a 56 year old female with an allergy to sulfa and quinine sulfate (QUINAMM), hypertension, vascular (circulatory) insufficiency and stasis dermatitis who on 10/15/2002 was vaccinated IM in the left deltoid with a dose of pneumococcal vaccine 23 polyvalent (lot #643783/0709M). Concomitant therapy included metoclopramide hydrochloride (REGLAN), cetirizine hydrochloride (ZYRTEC), esomeprazole magnesium (NEXIUM), furosemide (LASIX), verepamil, irbesartan (AVAPRO), ibuprofen (MOTRIN), diltiazem hydrochloride (CARDIZEM CD), iron (unspecified) and estrogens, conjugated (+) medroxyprogesterone acetate (PREMPRO). On 10/15/2002 a few hours after administration of the vaccine, the pt developed erythema, soreness, swelling and pain around the injection site. The LPN also reported that movement of the pt's deltoid was described to be painful and limited. In follow-up, the LPN reported that the pt developed redness and swelling in the left upper arm, nausea and slight diarrhea. The pt's intervention treatment included methylprednisolone acetate (DEPO-MEDROL), promethazine HCl (PHENERGAN), and a "Pred-Pak". In follow-up, the LPN reported that the pt was treated with methylprednisolone acetate (DEPO-MEDROL), 80 mg IM, and was told to put ice on the arm. The outcome of the pt's events was unknown. The reporter expressed a concern regarding the lot number. No additional info is expected. 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.