chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Chills, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a licensed practical nurse, concerning a 60 year old male patient, who on 19-SEP-2007 was vaccinated IM in the left arm with a dose, 0.5 ml, of PNEUMOVAX 23 (lot # 657525/0554U). Concomitant vaccine therapy at the visit included a dose in the left arm of FLUZONE. The following day, 20-SEP-2007, the patient called the office with symptoms of cellulitis, including redness and soreness at the injection site, and chills. Treatment with DURICEF was prescribed. The patient had a return visit scheduled to the physician on 22-SEP-2007 (future date). At the time of this report, the patient had not recovered. This is one of two reports received from the same source (WAES #0709USA03696) following vaccination with PNEUMOMAX 23 (lot #657585/0554U). The nurse a lot check. The records of testing prior to release of the lot in question, have been rechecked and found to be satisfactory. The lot complies with the standards of Center for Biologics Evaluation and Research, and was released. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Swelling, Tenderness
Clinical narrative: Information has been received from a nurse and a healthcare worker, concerning a 52 year old female patient who on an unknown date was vaccinated with a dose of PNEUMOVAX (lot # 654977/0888F), and developed cellulitis.  The symptoms were described as "redness and swelling" with a "lacy appearance and was tender to the touch."  Treatment included VICODIN.  At the time of this report, the outcome of the event was unknown.  The nurse reported that two additional patients, following vaccination with PNEUMOVAX (lot # 654977/0888F), also developed cellulitis (WAES #0709USA02720 and 0709USA03918).  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a registered nurse concerning a female who on 21-SEP-2007 was vaccinated IM, into the deltoid, with a dose of PNEUMOVAX 23 (lot #655289/0958F). Subsequently, the patient developed redness from injection site of deltoid down to the elbow. The patient was treated with KEFLEX. On 24-SEP-2007, the patient was seen in the physician's office. At the time of the report, the patient had not recovered. The registered nurse requested a lot check. Additional information has been requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the government and was released.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning four patients who were vaccinated with 0.5 ml doses of PNEUMOVAX (lot #655290/0959F).  Subsequently the patients experienced redness, swelling and pain at the injection site.  The patients contacted the physician's office.  At the time of the report, the patients outcome were unknown.  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided when available.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the research center and was released.  The medical assistant is requesting a lot check.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a registered concerning a male (age not reported) with no pertinent medical history or drug reactions/allergies who on 14-AUG-2007 was vaccinated with PNEUMOVAX 23 (lot # 655289/0958f) 0.5 mL IM into the right tricep. There was no concomitant medication. The nurse reported that a patient developed an injection site reaction after vaccination with PNEUMOVAX 23. The reaction developed gradually over the next day following vaccination with PNEUMOVAX 23. Medical attention was sought. At an office visit on 17-AUG-2007, the injection site reaction was described as a mild erythema, ill defined area 10 by 7 MM with tenderness, but no duration. The patient was given a prescription for KEFLEX 500mg three times a day for 7 days. The patient recovered on 20-AUG-2007. The registered nurse asked for a lot check for PNEUMOVAX 23 vaccine lot # 655289/0958F. There was no other information to report. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. The lot met the requirements of the government and was released. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Asthma
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 55 year old female patient with asthma, who on 12-NOV-1998 was vaccinated with a dose of PNEUMOVAX (manufacturer unspecified).  Concomitant therapy included albuterol and possibly other asthma medications.  On approximately 17-NOV-1998 ("about 5 days after injection"), the patient experienced asthmatic bronchitis.  She was seen and treated by the physician on 17, 20 and 21-NOV-1998.  At the time of this report, the outcome of the event was unknown.  Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a registered nurse concerning a male who on 21-SEP-2007 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX (lot #655289/0958F).  In September 2007, the patient developed redness at the injection site of deltoid down arm to the elbow.  The patient was treated with KEFLEX.  The patient was seen in the physician's office on 24-SEP-2007.  At the time of the report, the patient had not recovered.  The registered nurse is requesting a lot check.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the research center and was released.  Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema
Clinical narrative: Information has been received from a Registered Nurse concerning a male patient who about 2 years ago was vaccinated subcutaneous with a dose of PNEUMOVAX and developed redness at the injection site which traveled down the arm.  Patient used ADVIL and TYLENOL as treatment.  She recovered.  Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a 50 year old female registered nurse who was vaccinated subcutaneously into the right arm with a 0.5 ml dose of PNEUMOVAX.  Subsequently, she developed warmth and redness at the injection site and the redness traveled down her right arm.  She was treated with oral antibiotics for one week.  Subsequently, the patient recovered.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Information has been received from a licensed practical nurse concerning a female with shellfish and iodine allergy who was vaccinated with a dose of PNEUMOVAX 23.  Subsequently the patient developed a local injection site reaction.  The reporting licensed practical nurse did not know then extent of the reaction.  The patient was seen by the physician.  Subsequently, the patient recovered.  Additional information is not expected.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Bed rest, Chills, Malaise, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a hospital pharmacy technician via a pulmonogist concerning a 60 year old male who was vaccinated with a dose of PNEUMOVAX (Lot #658175/0856U).  Subsequently, he "got sick" and required bed rest.  He had chills over night and the arm was swollen and sore.  Treatment was not specified.  At the time of the report the patient's outcome was unknown.  Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Bed rest, Malaise
Clinical narrative: Information has been received from a hospital pharmacy technician via a pulmonologist concerning a 57 year old male who was vaccinated with a dose of PNEUMOVAX 23 (Lot #658175/0856U).  Subsequently the patient "got sick" and required bed rest.  "He felt he developed pneumonia that nearly killed him".  He was on an unspecified antibiotic for 2 weeks.  At the time of the report the patient's outcome was unknown.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Obstructive airways disorder, Refusal of treatment by patient, Spirometry abnormal
Clinical narrative: Information has been received from a physician concerning a 84 year old female patient with chronic asthma and chronic obstructive pulmonary disease and a history of hospitalization 3 times this year for pneumonia and several issues who on an unspecified date "about a week ago", was vaccinated SC with a second dose of PNEUMOVAX.  Concomitant therapy included ADVAIR.  On an unspecified date, the patient developed a cough once or twice a day since the vaccination.  It was reported that it was noticed more by the patient's husband then by herself.  It was also reported that the patient refuses to regularly use her inhaled steroids.  Laboratory diagnostic studies included Spirometry readings from 19-SEP-2007 which resulted in mild restriction, 14-MAY-2007 which also resulted in mild restriction and 20-AUG-2007 which resulted in borderline obstruction.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Body temperature increased, Erythema, Inflammation, Mobility decreased
Clinical narrative: Information has been received from a 60 year old male physician with an iodine allergy, an allergy to AUGMENTIN and morphine who "sometime in January 2007", was vaccinated with a first dose of PNEUMOVAX 23. In January 2007, the patient developed a red, swollen and stiff arm. Follow up information stated his tricep became inflamed and enlarged. He had an increase in body temperature and a decrease in energy. His arm was painful to touch or move. He also complained of being "itchy all over." All of these symptoms persisted for approximately 3 days. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. No product quality complaint was involved. Additional information is not expected.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Information has been received from a 60 year old male physician with an iodine allergy, an allergy to AUGMENTIN and morphine who "sometime in January 2007", was vaccinated with a first dose of PNEUMOVAX 23. In January 2007, the patient developed a red, swollen and stiff arm. Follow up information stated his tricep became inflamed and enlarged. He had an increase in body temperature and a decrease in energy. His arm was painful to touch or move. He also complained of being "itchy all over." All of these symptoms persisted for approximately 3 days. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician's assistant concerning a female who on an unspecified date was vaccinated with PNEUMOVAX 23 (lot # unknown).  On an unspecified date the patient was administered PNEUMOVAX 23 upon discharge from the hospital for an unspecified illness.  The patient subsequently developed severe swelling at the injection site.  Medical attention was sought in the office.  No further details were available.  Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site reaction, Injection site swelling, Injection site warmth, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a 51 year old female Licensed Practical Nurse (L.P.N.) who has allergic reactions to penicillin and sulfa, and who had drug hypersensitivity to LIPITOR, PRAVACHOL, and TYLOX and who was vaccinated subcutaneous into the left arm with a dose of PNEUMOVAX 23 lot #657525/0554U at 10:00 AM. The patient reported that she developed a fever and warm and swollen injection site arm 5 to 6 hours after vaccination at 4 PM with PNEUMOVAX 23. The patient also reported that she still had a fever on 02-OCT-2007. The patient iced the injection site reaction and it was better, but still present on 02-OCT-2007. On 29-OCT-2001, the patient received PNEUMOVAX 23 previously without any problem. The patient was recovering. No other information to report. Follow-up information was received from the physician's office. There was a large area of redness with pain extending into the underarm area. The patient had elevated temperature intermittently for 4 days and the area was also warm to touch. The patient was given antibiotics (therapy unspecified) for 10 days. The patient had no illness at the time of vaccination. On an unspecified date the patient recovered. Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a 51 year old female Licensed Practical Nurse (L.P.N.) who has allergic reactions to penicillin and sulfa, and who had drug hypersensitivity to LIPITOR, PRAVACHOL, and TYLOX and who was vaccinated subcutaneous into the left arm with a dose of PNEUMOVAX 23 lot #657525/0554U at 10:00 AM. The patient reported that she developed a fever and warm and swollen injection site arm 5 to 6 hours after vaccination at 4 PM with PNEUMOVAX 23. The patient also reported that she still had a fever on 02-OCT-2007. The patient iced the injection site reaction and it was better, but still present on 02-OCT-2007. On 29-OCT-2001, the patient received PNEUMOVAX 23 previously without any problem. The patient was recovering. No other information to report. Follow-up information was received from the physician's office. There was a large area of redness with pain extending into the underarm area. The patient had elevated temperature intermittently for 4 days and the area was also warm to touch. The patient was given antibiotics (therapy unspecified) for 10 days. The patient had no illness at the time of vaccination. On an unspecified date the patient recovered. Additional information is not expected.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Immediate post-injection reaction, Local reaction, Pain, Pruritus
Clinical narrative: Initial and follow-up information has been received from a licensed practical nurse concerning a 46 year old female officer manager with seasonal allergies who in 05-NOV-2007 was vaccinated with a first dose of PNEUMOVAX 23. On 01-OCT-2007 at 11:30 the patient was vaccinated subcutaneously into the left arm with a second dose of PNEUMOVAX 23 (Lot #657525/0554U). There was no concomitant medication. On 01-OCT-2007 the patient developed itching right immediately after vaccination with PNEUMOVAX 23. Subsequently the patient developed a large area localized reaction with redness, warmth, swelling, pain and fever. The pain went to the patient's underarm. Unspecified antibiotics was to be prescribed. There were no laboratory or diagnostic tests performed. On 08-OCT-2007 the patient recovered from localized reaction and fever. The patient was recovering from itching. Additional information is not expected.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Skin warm, Swelling
Clinical narrative: Initial and follow-up information has been received from a licensed practical nurse concerning a 46 year old female officer manager with seasonal allergies who in 05-NOV-2007 was vaccinated with a first dose of PNEUMOVAX 23. On 01-OCT-2007 at 11:30 the patient was vaccinated subcutaneously into the left arm with a second dose of PNEUMOVAX 23 (Lot #657525/0554U). There was no concomitant medication. On 01-OCT-2007 the patient developed itching right immediately after vaccination with PNEUMOVAX 23. Subsequently the patient developed a large area localized reaction with redness, warmth, swelling, pain and fever. The pain went to the patient's underarm. Unspecified antibiotics was to be prescribed. There were no laboratory or diagnostic tests performed. On 08-OCT-2007 the patient recovered from localized reaction and fever. The patient was recovering from itching. Additional information is not expected.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Local reaction
Clinical narrative: Information has been received from a licensed practical nurse concerning a 51 year old male physician with no pertinent medical history who on 05-NOV-2001 was vaccinated with a first dose of PNEUMOVAX 23. On 01-OCT-2007 at 11:30 the patient was vaccinated subcutaneously into the left arm with a second dose of PNEUMOVAX 23 (Lot # 657525/0554U). There was no concomitant medication. On 02-OCT-2007at 08:00 the physician developed a localized skin reaction at the injection site that was quarter size with redness and itching. There were no laboratory or diagnostic tests performed. Subsequently, the physician recovered. Additional information is not expected.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature, Dizziness, Fatigue, Feeling hot, Influenza like illness
Clinical narrative: Initial and follow-up information has been received from a licensed practical nurse concerning a 39 year old female homemaker with no medical history and allergies to erythromycin and codeine-GI upset only, who on 01-OCT-2007 was vaccinated intramuscularly in the right arm with a first dose of PNEUMOVAX 23 vaccine (Lot# 658555/0964U). There was no concomitant medication. On 02-OCT-2007 at 08:40 (previously reported as 01-OCT-2007) the patient developed a 100F temperature, experienced generalized body aches, flu-like symptoms, a hot arm, dizziness, fatigue, and the injection site of the right arm became swollen and painful. The patient notified the physician's office by phone and was instructed to apply ice and to take BENADRYL. No laboratory diagnostics were performed. A follow up examination was scheduled for 04-OCT-2007. The patient recovered on approximately 10-OCT-2007. No product quality complaint was involved. Additional information is not expected.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: Initial and follow-up information has been received from a licensed practical nurse concerning a 39 year old female homemaker with no medical history and allergies to erythromycin and codeine-GI upset only, who on 01-OCT-2007 was vaccinated intramuscularly in the right arm with a first dose of PNEUMOVAX 23 vaccine (Lot# 658555/0964U). There was no concomitant medication. On 02-OCT-2007 at 08:40 (previously reported as 01-OCT-2007) the patient developed a 100F temperature, experienced generalized body aches, flu-like symptoms, a hot arm, dizziness, fatigue, and the injection site of the right arm became swollen and painful. The patient notified the physician's office by phone and was instructed to apply ice and to take BENADRYL. No laboratory diagnostics were performed. A follow up examination was scheduled for 04-OCT-2007. The patient recovered on approximately 10-OCT-2007. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a female with no pertinent medical history or drug reactions/allergies who on 04-SEP-2007 was vaccinated intramuscularly in the left arm with PNEUMOVAX 23 (0.5 ml) (lot # 657039/0698U) There was no concomitant medication. In September 2007 (exact onset date unknown), the patient's left arm became swollen from the shoulder to the elbow. The patient sought treatment at her physician's office on 06-SEP-2007. Conservative treatment with BENADRYL and ice failed and the patient was given an intramuscular injection of KENALOG and oral steroids in a dose pack. The patient fully recovered (date unspecified). Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a 72 year old female with an allergy to penicillin and VISTARIL who on approximately 11-OCT-2007 was vaccinated SC in the left arm with a 0.5 mL dose of PNEUMOVAX 23 (lot #656233/0200U) and a dose of  influenza virus vaccine (site unspecified). It was reported that the patient was previously vaccinated with a dose of PNEUMOVAX 23 in November 1996 and "may have had an earlier prior vaccination." On 11-OCT-2007, the patient developed swelling and redness at the injection site. The patient treated the injection site with cool compresses and took BENADRYL. On 12-OCT-2007, the patient was seen in the physician's office. The injection site reaction was described as an indurated, erythematous swollen reaction at the injection site. The patient was prescribed therapy with MEDROL DOSEPAK and Z-PAK. As of 16-OCT-2007, the injection site swelling and redness were "going down." The patient was reported as recovering. A concern regarding the lot was reported. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the government and was released. The medical assistant reported another patient who developed an adverse experience after vaccination with PNEUMOVAX 23 (lot #656233/0200U) (WAES#0710USA03557). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Cellulitis, Erythema, Pain, Skin warm
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old female nurse with allergies to most antibiotics, who on 13-OCT-2007 was vaccinated intramuscularly in the left deltoid with a dose of PNEUMOVAX 23 (Lot# 655765/0061U). On 12-OCT-2007, concomitant therapy included influenza virus vaccine (unspecified), administered in the right arm. On 13-OCT-2007 the patient experienced pain, redness, swelling, an area that was hot to the touch, and a temperature over 101F. The patient was seen at the physician's office and was diagnosed with cellulitis. The patient was treated with penicillin. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional has been requested has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old female nurse with allergies to most antibiotics, who on 13-OCT-2007 was vaccinated intramuscularly in the left deltoid with a dose of PNEUMOVAX 23 (Lot# 655765/0061U). On 12-OCT-2007, concomitant therapy included influenza virus vaccine (unspecified), administered in the right arm. On 13-OCT-2007 the patient experienced pain, redness, swelling, an area that was hot to the touch, and a temperature over 101F. The patient was seen at the physician's office and was diagnosed with cellulitis. The patient was treated with penicillin. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional has been requested has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Information has been received from a Licensed Visiting Nurse (L.V.N) concerning a 68 year old female patient with intravenous (IV) iodine allergy, codeine allergy, allergic to "TALWIN", sulfonamide allergy and allergic reaction to antibiotic "CEFTIN" and allergic to steroids who on 13-SEP-2007 was vaccinated IM with a dose of PNEUMOVAX 23 lot #657525/0554U. On 13-SEP-2007 the nurse reported that patient developed a "cellulitis like" injection site reaction after receiving a dose of PNEUMOVAX 23. The patient reported that on the day of the vaccination, the injection site was red, so she took some BENADRYL, the next day, she noticed that the injection site was swollen and inflamed. The inflammation eventually spread from deltoid down to her elbow. The patient was sent to an emergency room and released. Caller was requesting a lot check of this vaccine due to the patient having adverse experiences. No further information is available. The patient was recovering. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. The lot met the requirements of the government and was released. Additional information is not expected.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Angioedema, Complement factor C3, Complement factor C4
Clinical narrative: Information has been received from a physician concerning a 54 year old male with diabetes and no drug allergies, who on 20-SEP-2007 was vaccinated with a dose of PNEUMOVAX 23 (Lot# 657628/0556U). Concomitant therapy included metformin and aspirin. On 22-SEP-2007 the patient developed angioedema of the lips. The patient was treated with BENADRYL. The angioedema resolves but recurs every time BENADRYL is discontinued. The patient was seen in the office. Laboratory diagnostic were performed with the following results: complement 3 and 4 levels. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discolouration, Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 47 year old female with no pertinent medical history, penicillin and sulfonamide allergies and no other drug allergies, who on 17-OCT-2007 was vaccinated IM with a 0.5 ml PNEUMOVAX 23 (lot# 658555/0964U). There was no concomitant medication. On that same day the patient experienced an injection site reaction that was very itchy at the injection site. The patient was treated with BENADRYL. Also located at the injection site was a white spot with a red, swollen area about the size of 50 cent coin. The inflammation eventually spread from deltoid down to the elbow. The patient called the physician's office for medical attention. No labs or diagnostic studies were performed. The patient was not recovered at the time of reporting. A lot check was requested by the reporter. This is one of several reports from the same source. Additional information has been requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the government and was released.
Age: 64.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 64 year old female with no medical history and a sulfonamide allergy, who on 04-OCT-2007 was vaccinated intramuscularly with a 0.5mL first dose of PNEUMOVAX 23 (Lot# 658555/0964U). Concomitant therapy included influenza virus vaccine (unspecified). Subsequently, the patient developed an injection site reaction with pain, swelling, and inflammation. The inflammation spread from the deltoid down to the elbow. The patient called the office. No laboratory diagnostics were performed. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. This is one of three cases from the same source. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the government and was released. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse, concerning a female patient (age not specified), who on 15-OCT-2007 was vaccinated IM with a dose of PNEUMOVAX 23 (lot # not provided). Concomitant vaccine therapy included influenza virus vaccine (manufacturer unspecified). On 15-OCT-2007, following the vaccination the patient developed an injection site reaction of redness and swelling. The nurse added that the patient had also received a dose of PNEUMOVAX 23 last year. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a female "65 years or older", who in October 2007, was vaccinated intramuscularly with a 0.5mL dose of PNEUMOVAX 23. Subsequently, the patient developed swelling in the arm that encompassed most of the upper outer arm. The area was red and very painful. The patient also developed a low grade fever. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Anorexia, Bone pain, Pyrexia
Clinical narrative: Information has been received from a physician and a consumer concerning her 48 year old husband with no medical history and an allergy to penicillin, who on 17-OCT-2007 at 09:35 in the am, was vaccinated into the left arm with a first dose of PNEUMOVAX 23. Concomitant medication included a dose of influenza virus vaccine (unspecified) also administered into the left arm. On 18-OCT-2007, the patient experienced a high fever, achy bones, and loss of appetite. The patient sought unspecified medical attention. No laboratory diagnostics studies were performed. Subsequently, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 68 year old female with no drug reactions or allergies with hypothyroidism, hypercholesterolaemia and depression who on 04-OCT-2007 was vaccinated intramuscularly with the first dose of PNEUMOVAX 23, (Lot # 657525/0554U). Concomitant therapy SYNTHROID, ZOLOFT, ezetimibe (MSD) and LOVAZA. The physician reported that the patient developed erythema, pain and swelling at the injection site of the left arm after receiving her first dose of PNEUMOVAX 23. The physician examined the patient on 09-OCT-2007 and prescribed warm compresses and TYLENOL. No further details were available. This is case 1 of 2. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Skin warm
Clinical narrative: Initial and follow-up information has been received from a physician and a health care professional concerning a 71 year old retired female with asthma and an allergy to the Tetanus vaccine, who on 22-AUG-2007 (previously reported as 15-OCT-2007) was vaccinated intramuscularly in the right deltoid with a first dose of PNEUMOVAX (Lot# 657143/0380U) (previously reported as Lot# 658555/0964).  Concomitant therapy included influenza virus vaccine (unspecified), administered into a different site.  Subsequently, the patient developed pain, swelling, and redness at the injection site.  On 24-AUG-2007 the patient developed 2 reddened areas below the injection site.  The patient experienced pain, soreness, and the area was warm to touch.  The patient reported that the symptoms resolved within 3 days and that he had had 2 or 3 vaccinations with PNEUMOVAX in the past.  The patient had an office visit.  The patient recovered on 25-AUG-2007.  No product quality complaint was involved.  Additional information is not expected.
Age: 86.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Information has been received from a certified medical assistant concerning an 86 year old male patient with cardiac failure congestive, coronary artery disease, hypertension, peripheral vascular disease and an allergy to codeine who on 17-OCT-2007 at 10:00 am, was vaccinated IM into the right deltoid with a first 0.5ml dose of PNEUMOVAX 23 (Lot#655766/0038U). Concomitant therapy included influenza virus vaccine (unspecified) given on the same day but in a different arm. On 17-OCT-2007 at night, the patient experienced a reaction that was 1 or 2 inches below the injections site that went down the arm to the elbow. This area was red, swollen and warm to the touch. The patient woke up during the night because the arm was hurting. On 18-OCT-2007 at 13:00, the patient experienced from the injection site on his shoulder down to his elbow was red and warm to the touch. It was also reported that he had some pain but it had improved before he was seen at the office. The patient never took any meds for the pain but he applied a cold pack to the site. On 19-OCT-2007, the patient notified the office that the reaction was not better. No laboratory diagnostic studies were performed. On 20-OCT-2007, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 69 year old male patient who on 04-OCT-2007, was vaccinated IM with a 0.5ml dose of PNEUMOVAX 23. Concomitant suspect therapy included influenza virus vaccine (unspecified) administered into the same site. Subsequently, the patient developed pain, swelling and redness at the injection site. Unspecified medical attention was sought. At the time of this report, the patient recovered. No product quality complaint involved. This is one two reports from the same source. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site induration, Rash, Skin test
Clinical narrative: Information has been received from an 82 year old female consumer with allergies and hypothyroidism and a history of gastrooesophageal reflux who "about 2 to 3 years ago" (October 2002) had been skin tested for the PNEUMOVAX 23. Concomitant therapy included ASTELIN, CYTOMEL, SYNTHROID and NEXIUM. On 22-OCT-2002, the patient developed a severe reaction described as red streak and rash. It was also described as erythema and induration at the testing site. Follow up information reported that the consumer developed an erythema reaction in the arm and hand within 24 hours. The consumer was not seen after the injection. Laboratory diagnostic studies included a skin test for allergies. It was reported that the patient required no treatment and the rash resolved in an unspecified period of time. No other symptoms and no other information was reported. No product quality complaint was involved. Additional is not expected.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant concerning a 66 year old female patient with no medical history who on 10-OCT-2007, was vaccinated into the left arm with a dose of PNEUMOVAX 23. Subsequently the patient developed redness, swelling and pain at the injection site. The area affected was from just below her shoulder to her elbow of her left arm. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information is not expected.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Injection site swelling, Lethargy
Clinical narrative: Initial and follow-up information has been received from a pharmacist concerning a 39 (also reported as 35) year old female patient, who on 10-OCT-2007 (also reported as 12-OCT-2007), was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (Lot# 657040/0859U). Concomitant therapy given in the same deltoid, about 2 to 3 inches from the first site, included a dose of influenza virus split virion 3v vaccine inactivated (Lot# "U2453AA"), administered intramuscularly. There were no illness at the time of the vaccinations. On 12-OCT-2007, the patient developed swelling up to 4 times the baseline at the injection site within 24 hours from the time of vaccination. It was reported that the patient felt lethargic and "like she was about to die." The patient went to the hospital and was diagnosed with cellulitis at the site of the PNEUMOVAX 23, which spread to the rest of her body. The emergency room doctor stated that the cellulitis was due to the vaccination with PNEUMOVAX 23. She was put on Cephalexin and sent home. On 14-OCT-2007, the patient was reported to be feeling much better. On 15-OCT-2007, it was reported that the patient was going to see a physician at a Hospital. The reporter is requesting a lot check for PNEUMOVAX 23 (Lot# 657040/0859U). A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Diarrhoea, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a consumer, 61 year old female who on 05-OCt-2007 was vaccinated with a 0.5 mL dose of PNEUMOVAX 23 (Lot # unknown). Concomitant therapies included LIPITOR, TOPROL XL TABLETS, furosemide, PREVACID, aspirin and influenza virus vaccine (unspecified). On 05-OCT-2007 the patient experienced swollen arm and pain at injection site about three hours later. The patient went to ER but was not admitted to the hospital. The patient also had severe diarrhea and weakness. The patient's status was reported as recovering. There was no product quality complaint. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Rash macular, Swelling
Clinical narrative: Information has been received from a health professional concerning a 54 year old female who on 05-OCT-2007 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX.  Concomitant therapy included SYNTHROID.  On approximately 06-OCT-2007 (during the week end) the patient developed fever of 103 F, swelling of the entire left arm and red blotches on the arm.  The patient had a hard time getting the fever down with OTC medications during the day but the fever did break over the night.  On Monday 08-Oct-2007, the patient still nursed a low grade temperature.  Unknown medical attention was sought.  The patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Hyperventilation, Injection site pain, Injection site warmth, Laboratory test
Clinical narrative: Information has been received from a 58 year old male consumer with asthma, high blood pressure, and an allergy to penicillin, coconut weed and egg, who on approximately 11-OCT-2007 was vaccinated with a dose of PNEUMOVAX 23 (lot # not provided). There was no concomitant medication. One hour after the vaccination, the patient experienced pain on his arm in the injection site that it felt like someone hit him on his arm and it was sore and hot. The patient also reported that his heart beats faster then normal, his breathing was heavy and he started coughing with phlegm after receiving the vaccine. According to the patient, a day after the administration of vaccine he developed pain in the other arm which was not the injection site. Unknown medical attention was sought. According to patient the soreness and pain in the injection site was gone but his breathing was still heavy. No product quality complaint was involved. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Local swelling
Clinical narrative: Information has been received from a medical office manager concerning a 58 year old female with type 2 diabetes mellitus, hypothyroidism, goitre, alopecia, hypertension, allergy to aspirin and penicillin allergy who on 12-OCT-2007 was vaccinated in the right arm with the first dose of PNEUMOVAX 23 (0.5 ml) (lot # 655766/0038U).  Concomitant vaccination included influenza virus vaccine (unspecified) in the left arm.  On 13-OCT-2007 the patient developed swelling underneath her armpit and redness on the injection site on the right arm.  It was reported that the patient did not have any reaction on the left arm where the influenza virus vaccine (unspecified) was administered.  Unspecified medical attention was sought.  At the time of this report, the patient was recovering.  Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Accidental exposure, Eye pain
Clinical narrative: Information has been received from a 31 year old female registered nurse with no pertinent medical history, drug reactions or allergies, who reported that on 15-OCT-2007 while withdrawing PNEUMOVAX 23 she splashed some in her eye. The nurse flushed the affected eye with contact solution, however reported that "it still hurt little bit". The nurse was wearing contacts at the time. She did not seek medical treatment from a physician, she self  treated her self herself. At the time of this report, the nurse had not recovered. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Initial and follow up information has been received from a pharmacist concerning a 67 year old female patient who on 13-OCT-2007 (previously reported as 12-OCT-2007) was vaccinated IM into right deltoid muscle with the first dose of PNEUMOVAX 23 (lot #658075/0962U).  Concomitant therapy included a dose, IM in the left shoulder, of FLUZONE (lot #U2493AA).  There was no illness at the time of the vaccination.  On 14-OCT-2007 (previously reported as 13-OCT-2007), the patient came into the pharmacy with a red, painful and swollen area on the inside surface of the right arm near the elbow, remote from the injection site.  Cool compresses and TYLENOL were recommended.  The symptoms lasted for "several days" after the vaccination.  Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a healthcare professional, concerning a 5 year old female patient who on 09-OCT-2007 was vaccinated with a dose of PNEUMOVAX 23 (lot #658075/0962U).  On the day of vaccination, the patient developed cellulitis.  At the time of this report, the outcome of the event was unknown.  Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a nurse concerning a 29 old female patient who on 11-OCT-2007 was vaccinated with a dose of PNEUMOVAX 23 lot 3 658447/1132U. On 11-OCT-2007 the patient developed "cellulitis" after getting the PNEUMOVAX 23. No other information was available. The outcome was unknown. The physician has requested A lot check for PNEUMOVAX 23 #658447/1132U. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site reaction
Clinical narrative: Information has been received from a consumer concerning her mother who on 12-OCT-2007 was vaccinated with a dose of PNEUMOVAX.  The reporter reported that her mother received the injection and developed an allergic reaction at the injection site.  It was unknown if patient sought medical attention.  The outcome was unknown.  Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered nurse, concerning a female patient (age not specified), who on 15-OCT-2007 was vaccinated IM with a dose of PNEUMOVAX 23 (lot # not provided).  Concomitant vaccine therapy included influenza virus vaccine (manufacturer unspecified).  On 15-OCT-2007, following the vaccination the patient developed cellulitis located 4 1/2 inches below the injection site.  At the time of this report, the outcome of the event was unknown.  Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning an 82 year old female patient with hypertension, hyperlipidaemia, osteopenia, gastrooesophageal reflux disease, and sulfa allergy who on 22-OCT-2007 was vaccinated IM into the right deltoid with a second 0.5ml dose of PNEUMOVAX 23 (lot # 658074/0803U).  On 22-OCT-2007, the patient experienced redness, soreness, and swelling of her shoulder where the vaccine was administered.  It was also noted that the patient has had limited movement of the affected arm and that the injection site was warm to touch.  The patient sought medical attention and was seen by the physician.  On 23-OCT-2007 in the am, it was reported that the patient developed soft tissue swelling in the right shoulder region.  At the time of this report, the patient recovered.  No product quality complaint was involved.  Additional information is not expected.
Age: 1.0
Sex: U
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning a 12 month old patient who on 24-OCT-2007 was vaccinated with a dose of PNEUMOVAX 23. The PharmD reported that there was a lack of clarity with request from the nurse regarding what needed. The nurse stated they needed a pneumococcal vaccine, but did not state the age of the patient. Therefore, the incorrect vaccine was administered to the patient. No problems were reported. The corrective action at the site was to ask the age of the patient who would need the vaccine. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a female medical office manager who on 22-OCT-2007 was vaccinated with a "normal single dose" of PNEUMOVAX 23.  Concomitant vaccination on 22-OCT-2007 included influenza virus vaccine (unspecified) in the same arm.  On 22-OCT-2007, "right after vaccination", the patient developed red, swelling in a three inch diameter around the injection site.  It was reported that the rash became raised and hard and hot to touch.  The physician at the office administered the vaccine.  Unspecified medical attention was sought.  At the time of this report, the patient had not recovered.  Additional information has been requested.