chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Insomnia, Muscle spasms, Osteopenia, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 67 year old female with osteopenia and penicillin allergy and a history of chronic right leg injury due to motor vehicle accident, splenectomy and calculus renal who on 28-NOV-2006 was vaccinated intramuscularly in the left deltoid with the second dose of Pneumovax 23 (0.5 ml) (Lot # 655499/0988F). Concomitant therapy included ACTONEL, MAXAIR and calcium (unspecified). On 28-NOV-2006 the patient experienced pain at the injection site of the left deltoid which began a few hours after vaccination. Examination by the patient's physician on 29-NOV-2006 revealed a left deltoid muscle tenderness to palpation. Ice compresses and ADVIL was prescribed. The patient returned on 13-DEC-2006 complaining of continued pain. The physician recommended physical therapy which at the time of this report was ongoing. The patient's symptoms have improved but were not resolved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/30/2007. Initial and follow-up information has been received from a registered nurse and physical therapy notes concerning a 67 year old female with osteopenia and penicillin allergy and a history of chronic right leg injury due to motor vehicle accident, splenectomy and calculus renal who on 28-NOV-2006 at noon, was vaccinated intramuscularly in the left deltoid with the third dose of PNEUMOVAX vaccine (0.5 mL) (Lot # 655499/0988F). The patient had eczema at the time of vaccination. Concomitant therapy included ACTONEL, MAXAIR and calcium (unspecified). On 28-NOV-2006, at 4:00 PM, the patient experienced pain with any movement of the left arm which began several hours after vaccination. Examination by the patient's physician on 29-NOV-2006 revealed a left deltoid muscle tenderness to palpation. Ice compresses and ADVIL was prescribed. The patient returned on 13-DEC-2006 complaining of continued pain. The physician recommended physical therapy. Upon assessment from physical therapy, the patient complained of pain with functional range of motion less that 1/10. Diagnosis at the time included muscle spasms and joint pain. Physical therapy included ultrasound, moist heat, ice/cold pack, PROM. AROM, AAROM, strengthening, electric stim, joint mobilization, TENS, HEP, message and home exercise instructions. On 19-JAN-2007 the patient reporting that she was able to hold her hair drier better but continued to have problems reaching overhead especially dressing/grooming, and push/pull tasks. The patient also complained of being unable to get up from the floor and having sleeping difficulty. With difficulty getting comfortable and awakening 2 to 3 times per night. On 16-MAR-2007, the patient was discontinued from physical therapy after having slowly made gains, however continued to have pain with range of motion and ADL's. No further information is expected.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 67 year old female with osteopenia and penicillin allergy and a history of chronic right leg injury due to motor vehicle accident, splenectomy and calculus renal who on 28-NOV-2006 was vaccinated intramuscularly in the left deltoid with the second dose of Pneumovax 23 (0.5 ml) (Lot # 655499/0988F). Concomitant therapy included ACTONEL, MAXAIR and calcium (unspecified). On 28-NOV-2006 the patient experienced pain at the injection site of the left deltoid which began a few hours after vaccination. Examination by the patient's physician on 29-NOV-2006 revealed a left deltoid muscle tenderness to palpation. Ice compresses and ADVIL was prescribed. The patient returned on 13-DEC-2006 complaining of continued pain. The physician recommended physical therapy which at the time of this report was ongoing. The patient's symptoms have improved but were not resolved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/30/2007. Initial and follow-up information has been received from a registered nurse and physical therapy notes concerning a 67 year old female with osteopenia and penicillin allergy and a history of chronic right leg injury due to motor vehicle accident, splenectomy and calculus renal who on 28-NOV-2006 at noon, was vaccinated intramuscularly in the left deltoid with the third dose of PNEUMOVAX vaccine (0.5 mL) (Lot # 655499/0988F). The patient had eczema at the time of vaccination. Concomitant therapy included ACTONEL, MAXAIR and calcium (unspecified). On 28-NOV-2006, at 4:00 PM, the patient experienced pain with any movement of the left arm which began several hours after vaccination. Examination by the patient's physician on 29-NOV-2006 revealed a left deltoid muscle tenderness to palpation. Ice compresses and ADVIL was prescribed. The patient returned on 13-DEC-2006 complaining of continued pain. The physician recommended physical therapy. Upon assessment from physical therapy, the patient complained of pain with functional range of motion less that 1/10. Diagnosis at the time included muscle spasms and joint pain. Physical therapy included ultrasound, moist heat, ice/cold pack, PROM. AROM, AAROM, strengthening, electric stim, joint mobilization, TENS, HEP, message and home exercise instructions. On 19-JAN-2007 the patient reporting that she was able to hold her hair drier better but continued to have problems reaching overhead especially dressing/grooming, and push/pull tasks. The patient also complained of being unable to get up from the floor and having sleeping difficulty. With difficulty getting comfortable and awakening 2 to 3 times per night. On 16-MAR-2007, the patient was discontinued from physical therapy after having slowly made gains, however continued to have pain with range of motion and ADL's. No further information is expected.
Age: 47.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Inappropriate schedule of drug administration, Injection site swelling, Neuropathy, Oedema peripheral, Skin discolouration
Clinical narrative: Information has been received from a consumer concerning his wife, and follow up information has been received a Nurse Practitioner concerning the patient, a 47 year old obese female diabetic (well-controlled) with high cholesterol, high blood pressure, fibromyalgia, an allergy to penicillin, venous insufficiency, and a Basal Metabolic Index (BMI) of 35, who in 2005 was vaccinated with a first dose of Pneumovax 23. Concomitant therapy included metformin, COREG, quinapril HCl, estradiol, simvastatin (MSD), LEXAPRO, LUNESTA, ADDERALL TABLETS, KADIAN, LASIX, cyclobenazeprine HCl (MSD), and MSIR. In December 2006, the patient received Pneumovax 23 two years in a row. An unspecified flu shot was given at the same time. Since then she has had edema of both arms and legs. The day she received Pneumovax 23 vaccine her arm began to swell around the injection site, then spread to her back, shoulders, torso and legs. She then developed edema. It was reported that her feet and legs were discolored and that "her skin is so tight it looks like it may break." The patient was seen by an endocrinologist and later by a cardiologist who ruled out congestive heart failure. The patient was treated with LASIX 80 mg TID. She was complaining of neuropathy symptoms. The patient's symptoms persisted. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Skin tightness
Clinical narrative: Information has been received from a consumer concerning his wife, and follow up information has been received a Nurse Practitioner concerning the patient, a 47 year old obese female diabetic (well-controlled) with high cholesterol, high blood pressure, fibromyalgia, an allergy to penicillin, venous insufficiency, and a Basal Metabolic Index (BMI) of 35, who in 2005 was vaccinated with a first dose of Pneumovax 23. Concomitant therapy included metformin, COREG, quinapril HCl, estradiol, simvastatin (MSD), LEXAPRO, LUNESTA, ADDERALL TABLETS, KADIAN, LASIX, cyclobenazeprine HCl (MSD), and MSIR. In December 2006, the patient received Pneumovax 23 two years in a row. An unspecified flu shot was given at the same time. Since then she has had edema of both arms and legs. The day she received Pneumovax 23 vaccine her arm began to swell around the injection site, then spread to her back, shoulders, torso and legs. She then developed edema. It was reported that her feet and legs were discolored and that "her skin is so tight it looks like it may break." The patient was seen by an endocrinologist and later by a cardiologist who ruled out congestive heart failure. The patient was treated with LASIX 80 mg TID. She was complaining of neuropathy symptoms. The patient's symptoms persisted. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 59 year old male who on an unspecified date was vaccinated with a 0.5 mL dose of Pneumovax 23. Subsequently the patient developed fever and flu like symptoms. The patient sought unspecified medical attention. On an unspecified date, the patient recovered from fever and flu like symptoms. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on 02-MAR-2007 was vaccinated with Pneumovax 23 (lot # 655152/0889F) IM.  The patient sought medical attention.  On 02-MAR-2007, the patient developed cellulitis of the arm at the injection site after immunization with Pneumovax 23.  No lab diagnostic studies were performed.  The patient was being treated with oral antibiotics.  At the time of reporting, the outcome of the cellulitis was unspecified.  The physician requested 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 met the requirements of the agency and was released by the regulatory agency.  Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local reaction, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old male patient with GERD and depression and no known drug allergies, who on 15-DEC-2006 was vaccinated with a first dose of Pneumovax 23 (lot# 655152/0889F). Concomitant therapy included PREVACID and ZOLOFT. On 16-DEC-2006, the patient experienced a local skin reaction including a 5x7 red, swelled area on the left deltoid region. It was reported that the area was pink and there was a blanchable reaction. By 18-DEC-2006, the patient was getting better. It was also reported that the patient never had any fever, chills, feeling ill or trouble breathing. No diagnostic laboratory studies were performed. On an unspecified date, the patient recovered. The patient had a similar experience following vaccination with  Zostavax (Oka/Merck) (MSD) (WAES # 0702USA00520). Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received a wholesale representative and a nurse concerning a male who on an unspecified date was vaccinated with Pneumovax 23 (lot # 655290/0959F). Subsequently the patient experienced pain, soreness to touch, redness, warmth, and swelling in the injection site arm. Unspecified medical attention was sought. At the time of this report, the outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: Information has been received a wholesale representative and a nurse concerning a female who on an unspecified date was vaccinated with Pneumovax 23 (lot # 655290/0959F). Subsequently the patient experienced pain, soreness to touch, redness, warmth, and swelling in the injection site arm. The patient also complained that she was unable to sleep. Unspecified medical attention was sought. At the time of this report, the outcome of the events was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Erythema, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old female with no illness at the time of being vaccinated and a history of penicillin allergy who on 06-MAR-2007 was vaccinated with Pneumovax 23 (lot # 655291/0985F) 0.5 ml IM into left deltoid in the morning. Concomitant medication included hormones (unspecified), BENADRYL, aspirin, and PREVACID. On 06-MAR-2007, later that day, the lower part of the patient's left arm became swollen and red. The area was warm to touch and the patient was in some discomfort. Medical attention was sought. At the time of reporting, the patient was recovering. The office requested a lot check be performed. No further information was available at the time of reporting. 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 agency and was released. Additional information was received the registered nurse. On 06-MAR-2007, the patient also experienced muscle aches and fatigue. The patient was treated with cetirizine HCl 10 mg and BIAXIN XL. On an unspecified date the patient recovered. No additional information is expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Erythema, Skin warm
Clinical narrative: Information has been received from a registered nurse concerning a 70 year old female who on 06-MAR-2007 was vaccinated with Pneumovax 23 (lot # 655291/0985F) 0.5 ml IM in left deltoid in the morning. Concomitant medication included lisinopril (MSD), ADVAIR, hydrochlorothiazide (MSD). On 06-MAR-2007, later that day, the lower part of patient's left arm below the deltoid became red. "It looks like someone grabbed her arm". The area was warm to touch and the patient had some discomfort. Medical attention was sought. At the time of reporting, the patient was recovering. The office requested a lot check be performed. No further information was available at the time of reporting. 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 agency and was released. Additional information was released from the registered nurse. On 06-MAR-2007, the patient experienced multiple areas on her left arm which were red, sore, and warm. The patient was treated with ZYRTEC 10 mg and KEFLEX 500 mg. At the time of reporting, the patient had recovered. No additional information is expected.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local reaction, Oedema peripheral, Pain in extremity
Clinical narrative: Initial and follow-up information has been received from a registered nurse and a certified medical assistant concerning a 73 year old, female patient, whose reported weight was 144 pounds and whose reported height was 64 inches, who in January 1999 was vaccinated with a first dose of Pneumovax 23. In February, 2007, the patient was vaccinated intramuscularly into the left arm with the second dose of Pneumovax 23, (lot # 655586/0881F). Subsequently the patient's arm became swollen, red and painful. The patient developed a local reaction to the vaccine. Unspecified medical attention was sought. At the time of the report, the patient had recovered. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Malaise, Oedema peripheral
Clinical narrative: Information has been received from a consumer concerning her 77 year old husband with normal pressure hydrocephalus and a lumboperitoneal shunt who on 07-MAR-2007 was vaccinated with Pneumovax 23. Concomitant therapy included LIPITOR, ARICEPT, NAMENDA, unspecified therapy ("Unithroid") and ZOLOFT. On 08-MAR-2007 the patient experienced injection site pain, warmth, blotchiness, redness, and it was reported his arm is 1.5 inches bigger around the elbow than normal. It was reported that the patient was not feeling physically well on 08-MAR-2007 but started to feel more "like himself" on 09-MAR-2007. The patient sought unspecified medical attention. At the time of this report the patient's symptoms had not resolved. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Rash macular
Clinical narrative: Information has been received from a consumer concerning her 77 year old husband with normal pressure hydrocephalus and a lumboperitoneal shunt who on 07-MAR-2007 was vaccinated with Pneumovax 23. Concomitant therapy included LIPITOR, ARICEPT, NAMENDA, unspecified therapy ("Unithroid") and ZOLOFT. On 08-MAR-2007 the patient experienced injection site pain, warmth, blotchiness, redness, and it was reported his arm is 1.5 inches bigger around the elbow than normal. It was reported that the patient was not feeling physically well on 08-MAR-2007 but started to feel more "like himself" on 09-MAR-2007. The patient sought unspecified medical attention. At the time of this report the patient's symptoms had not resolved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain, Rash macular
Clinical narrative: Information has been received from a health professional concerning a female patient (age unknown) who on 15-NOV-2006 was vaccinated with a dose of Pneumovax 23 (lot # 651406/0620F), intramuscularly.  On 09-NOV-2006 between 14:30 and 15:30 the patient was vaccinated in the other upper arm with a dose of FLUVIRIN (Lot # 72005).  Subsequently, "one hour after vaccination", the patient developed swelling and redness at the injection site, "terrible pain: worse than when I broke my arm in half!" and splotchiness in the arm in which the patient was vaccinated.  The symptoms increased over the next few days.  The patient saw the doctor and when the swelling had increased over a half inch beyond the circle he had drawn around the site, the patient was placed on KEFLEX and LORTAB for 10 days.  The symptoms went away after 5 days.  On approximately 20-NOV-2006, the patient recovered.  Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise, Rash macular
Clinical narrative: Information has been received from a health professional concerning a female patient (age unknown) who on 15-NOV-2006 was vaccinated with Pneumovax 23 (lot # 651406/0620F), intramuscularly.  On 09-NOV-2006 between 14:30 and 15:30 the patient was vaccinated in the other upper arm with a dose of FLUVIRIN (Lot # 7200).  Subsequently, "one hour after vaccination", the patient developed pain, swelling, redness at the site and splotchiness in the arm in which she was vaccinated.  The symptoms increased over the next few days.  The swelling continued and the patient complained of general malaise.  The patient alternated ibuprofen and aspirin and applied heat with some relief.  The patient did not go to the doctor.  The swelling subsided after three days.  The symptoms went away after 5 days.  On approximately 20-NOV-2006, the patient recovered.  Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Contusion, Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a female patient (age unknown) who on 15-NOV-2006 were vaccinated with Pneumovax 23 (lot # 651406/0620F), intramuscularly.  Subsequently, "one hour after vaccination", the patients developed pain, swelling and redness at the site and all around her upper arm.  The patient also developed splotchiness in the arm in which they were vaccinated.  Itching soon followed along with bruising.  The symptoms increased over the next few days.  The patient saw her doctor who stated that since she was allergic to the flu preservative she should not have been given the Pneumovax 23 since it had the same preservative.  She said she told the nurse she was allergic to the flu vaccine.  The doctor told her she had an allergic reaction and placed her on ZYRTEC.  The symptoms went away after 5 days.  Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Rash macular
Clinical narrative: Information has been received from a health professional concerning a female patient (age unknown) who on 15-NOV-2006 were vaccinated with Pneumovax 23 (lot # 651406/0620F), intramuscularly.  Subsequently, "one hour after vaccination", the patients developed pain, swelling and redness at the site and all around her upper arm.  The patient also developed splotchiness in the arm in which they were vaccinated.  Itching soon followed along with bruising.  The symptoms increased over the next few days.  The patient saw her doctor who stated that since she was allergic to the flu preservative she should not have been given the Pneumovax 23 since it had the same preservative.  She said she told the nurse she was allergic to the flu vaccine.  The doctor told her she had an allergic reaction and placed her on ZYRTEC.  The symptoms went away after 5 days.  Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Pain, Skin warm, Swelling
Clinical narrative: Information has been received from an office manager concerning a 62 year old female patient who on 08-NOV-2006 was vaccinated into the left deltoid with a first dose of Pneumovax 23 (lot# 651321/1036P).  On the morning of 09-NOV-2006, the patient experienced pain, swelling and hot to the touch (area unknown).  Subsequently, the patient developed cellulitis.  The location of the cellulitis and the patient's outcome were unknown.  The patient sought unspecified medical attention.  Additional information is not expected.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a 53 year old female physician concerning herself who in March 2002 ("5 years ago"), was vaccinated with a dose of Pneumovax 23 (Lot# not reported).  Subsequently, in March 2002, the patient developed a huge injection site reaction with redness/erythema and swelling of the upper arm.  The physician reported that she recovered (date unspecified).  Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: PPV
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant concerning a 6 month old female patient who on 07-MAR-2007, at 9:30AM, was vaccinated IM into the right thigh with a first dose of Pneumovax 23 (Lot# 655290/0959F).  The medical assistant reported that the wrong vaccine was given.  It was supposed to be PREVNAR.  There were no problems reported.  The medical assistant also noted that steps were taken to correct the problem.  The person who gave the vaccine was counseled/re-trained and visual aids were implemented.  No further information is available.
Age: 51.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site swelling, Malaise
Clinical narrative: Information has been received from a health professional ("medical assistant") concerning an approximately 51 year old female who, on an unspecified date, was vaccinated with a dose of Pneumovax 23 (Lot# 651437/0899F).  Concomitant vaccination included a dose of influenza virus vaccine (unspecified).  Subsequently the patient developed bad swelling of the right shoulder at the injection site.  The medical assistant noted the patient was "in bad condition."  The patient was seen in the emergency room but not admitted to the hospital.  It was also reported that the patient recovered (date not reported).  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 20 year old female with no past medical history who on 08-MAR-2007 was vaccinated SC with a 0.5 ml dose of Pneumovax 23 (lot # 655152/0889F).  Concomitant therapy included YAZ.  On 09-MAR-2007 the patient developed fever and vomiting.  Three days later the fever and vomiting were resolving.  Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Injection site nodule, Injection site warmth, Nausea, Pain
Clinical narrative: Initial and follow up information has been received from a physician concerning a 45 year old female with hypothyroidism, asthma, dust and mold allergies and attention deficit disorder who on 08-MAR-2007 at 3:35pm was vaccinated SC into the left arm with a first 0.5 ml dose of Pneumovax 23 (lot # 655152/0889F).  Concomitant therapy included LEVOXYL, ADDERALL TABLETS), ADVAIR, NASAREL, WELLBUTRIN and SEROQUEL.  A few hours after vaccination, at 5:00 pm, the patient developed a "warm knot" at the injection site of her left forearm.  She also complained of terrible body aches, fever, nausea and diarrhea.  She recovered from body aches, fever, nausea and diarrhea on 12-MAR-2007.  Additional information is not expected.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Initial and follow up information has been received from a physician concerning a 45 year old female with hypothyroidism, asthma, dust and mold allergies and attention deficit disorder who on 08-MAR-2007 at 3:35pm was vaccinated SC into the left arm with a first 0.5 ml dose of Pneumovax 23 (lot # 655152/0889F).  Concomitant therapy included LEVOXYL, ADDERALL TABLETS), ADVAIR, NASAREL, WELLBUTRIN and SEROQUEL.  A few hours after vaccination, at 5:00 pm, the patient developed a "warm knot" at the injection site of her left forearm.  She also complained of terrible body aches, fever, nausea and diarrhea.  She recovered from body aches, fever, nausea and diarrhea on 12-MAR-2007.  Additional information is not expected.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a Nurse Practitioner concerning an 80 year old male patient who on 12-MAR-2007 was vaccinated with his first dose of Pneumovax 23, lot #655668/1004F.  On 12-MAR-2007 he developed an injection site reaction described as redness, swelling, heat and pain from the elbow up.  On 13-MAR-2007 the patient was seen in the office.  At the time of the report his symptoms were persisting.  The reporter indicated that two other patients developed injection site reactions after receiving Pneumovax 23, and requested a lot check be performed on lot #655668/1004F.  The records of testing prior to the release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency, and was released.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a Nurse practitioner concerning a 66 year old female patient who on 01-FEB-2007 was vaccinated with her first dose of Pneumovax 23, lot #655285/1173F.  The patient developed an injection site reaction described as redness, swelling, heat and pain from the elbow up after receiving Pneumovax 23.  The development and duration of the reaction were not clear, the patient was not observed in the office but sought medical attention.  As of the report date, the patient had recovered.  The reporter indicated that two other patients had developed injection site reactions after receiving Pneumovax 23.  Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Skin tightness, Skin warm
Clinical narrative: Information has been received from a 59 year old female health professional with a history of pneumonia who on 20-OCT-2006 was vaccinated with her second dose of Pneumovax 23 (lot# 651319/1007P).  The patient's first dose was received 10 years ago.  On 20-OCT-2006, "within hours post vaccination", the patient's left arm became red, hot and swollen from the front to middle back of arm.  The patient indicated that it "felt like a tourniquet."  The patient went to the emergency room and was given oral antibiotics and was released from the ER.  The patient was not hospitalized.  Subsequently, the patient recovered from left arm being red, hot and swollen.  No product quality complaint was involved.  Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Malaise, Pyrexia
Clinical narrative: Information has been received from a health professional concerning an adult male patient who in 2006 ("recently") was vaccinated IM with a 0.5 mL dose of Pneumovax 23 (possibly Lot# 655501/1035F).  Subsequently, (2006) the patient developed an injection site reaction to include local pain, redness, general malaise and fever up to 102 F.  At the time of the report, the reporter indicated that the patient was recovering.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Blood creatine phosphokinase, Hypokinesia, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 51 year old male who on 04-APR-2007 was vaccinated with a dose of Pneumovax 23 (lot 655500/1005F). On 04-APR-2007, 5 hours post vaccination, the patient experienced severe pain and a 14cm by 10cm area of redness involving the injection site arm. The patient sought medical attention and was treated with ice and ibuprofen. The patient was also having great difficulty raising his arm. The patient's creatine kinase level was being checked. At the time of this report, the patient was recovering. The nurse felt that the patient's severe pain, area of redness involving the injection site arm, and difficulty raising his arm were considered to be disabling. The nurse requested a lot check on lot 655500/1005F. 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: 51.0
Sex: M
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Information has been received from a registered nurse concerning a 51 year old male who on 04-APR-2007 was vaccinated with a dose of Pneumovax 23 (lot 655500/1005F). On 04-APR-2007, 5 hours post vaccination, the patient experienced severe pain and a 14cm by 10cm area of redness involving the injection site arm. The patient sought medical attention and was treated with ice and ibuprofen. The patient was also having great difficulty raising his arm. The patient's creatine kinase level was being checked. At the time of this report, the patient was recovering. The nurse felt that the patient's severe pain, area of redness involving the injection site arm, and difficulty raising his arm were considered to be disabling. The nurse requested a lot check on lot 655500/1005F. 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: 91.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a Pharm. D. concerning a 91 year old male inpatient with possible bacteraemia, bladder cancer, basal cell carcinoma on his back, arteriosclerotic cardiovascular disease, and arrhythmia and a history of cardiac pacemaker insertion, and recent pneumonia and aspiration who on 04-MAR-2007 was vaccinated IM with a 0.5 mL dose of PNEUMOVAX 23 (656225/0070U). Concomitant therapy included LEVAQUIN, PHENERGAN INJECTION, sotalol hydrochloride, famotidine, LOVENOX, cefepime and TYLENOL. On 18-MAR-2007, the patient was vaccinated with another 0.5 mL dose of PNEUMOVAX 23 when he was re-admitted to the hospital. On approximately 18-MAR-2007, the patient's right arm was red and swollen at the injection site. At the time of this report, the patient's injection site redness and swelling persisted. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site streaking, Malaise
Clinical narrative: Information has been received from a health professional concerning an adult female patient who in 2006 ("recently") was vaccinated IM with a 0.5 mL dose of Pneumovax 23 (possibly Lot# 655501/1035F).  Subsequently, (2006) the patient developed an injection site reaction to include local pain, redness, general malaise and fever up to 102 F.  It was also reported that the "patient had redness that seem to radiated from the injection site in 2 lines".  At the time of the report, the reporter indicated that the patient was recovering.  The patient sought unspecified medical attention.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a health professional concerning an adult female patient who in 2006 ("recently") was vaccinated IM with a 0.5 mL dose of Pneumovax 23 (possibly Lot# 655501/1035F).  Subsequently, (2006) the patient developed an injection site reaction to include local pain, redness, general malaise and fever up to 102 F.  It was also reported that the "patient had redness that seem to radiated from the injection site in 2 lines".  At the time of the report, the reporter indicated that the patient was recovering.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 73 year old male patient who on 09-MAR-2007 was vaccinated with his first dose of Pneumovax 23, lot #655668/1004F.  After receiving the injection the patient developed an injection site reaction described as redness, swelling, heat and pain on his entire arm.  The patient reported that his arm was so painful and swollen that he could not bend the arm.  He was seen in the office on 13-APR-2007 and still had forearm and hand redness, warmth, and mild swelling.  As of the report date the patient was recovering.  The reporter indicated that 2 other patients developed injection sit reactions after receiving Pneumovax 23 and requested a lot check be performed on lot #655668/1004F.  The records of testing prior to the release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency, and was released.  Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Injection site warmth, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 73 year old male patient who on 09-MAR-2007 was vaccinated with his first dose of Pneumovax 23, lot #655668/1004F.  After receiving the injection the patient developed an injection site reaction described as redness, swelling, heat and pain on his entire arm.  The patient reported that his arm was so painful and swollen that he could not bend the arm.  He was seen in the office on 13-APR-2007 and still had forearm and hand redness, warmth, and mild swelling.  As of the report date the patient was recovering.  The reporter indicated that 2 other patients developed injection sit reactions after receiving Pneumovax 23 and requested a lot check be performed on lot #655668/1004F.  The records of testing prior to the release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency, and was released.  Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Information has been received from a nurse concerning a 73 year old male patient with a penicillin allergy (feet peeled) and an allergy to lobster, crab and shrimp, who on 04-DEC-2006 at 15:50 was vaccinated IM into the left deltoid with a first 0.5 mL dose of Pneumovax 23 (lot# 651437/0899F).  On 05-DEC-2007, the patient developed "unusually high swelling of the arm at the shot sight."  It was noted that the left upper arm was red and swollen mildly (almost to the elbow) with some warmth.  The swelling gradually receded from the shoulder but extended to the hand.  One week later, it was completely cleared.  Per the patient he had no residual difficulty.  On 11-DEC-2006, the patient recovered.  On 16-NOV-2006 at 10:18, the patient was vaccinated IM into the left deltoid with a dose of FLUVIRIN (patient has had more than 3 doses batch# 72008).  Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative, Haematology test, No adverse reaction, Vaccination failure
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a four year old female patient with immune suppression disease (state was unknown) who on 18-NOV-2004 was vaccinated with Pneumovax 23.  The patient was presenting with low titers.  In March, 2007 the physician wanted to give the patient another dose.  The nurse stated the patient reported no adverse reactions.  Unspecified medical attention was sought.  The patient's outcome was unknown.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Chest X-ray normal, Erythema, Full blood count, Injection site erythema
Clinical narrative: Initial and follow up information has been received from a physician and a Licensed Practical Nurse (L.P.N.) and concerning a 24 week old male infant (previously reported as 16 week old) with lesion on head from birth who on 05-JAN-2007 was vaccinated with Pneumovax 23 instead of Prevnar. The office was unable to determine the cause of this possible error. On 06-JAN-2007 the patient developed redness in both legs and fever and went to ER. In follow up the physician mentioned that patient developed fever 104 o and redness at site. On 07-JAN-2007 patient recovered. On 10-MAR-2007, the patient was evaluated and in his office visit and was given 2 months above without reactions noted. Additional information is not expected.
Age: 0.2
Sex: M
Vaccine: PPV
Symptoms: Laboratory test, Pyrexia, Urine analysis, Wrong drug administered
Clinical narrative: Initial and follow up information has been received from a physician and a Licensed Practical Nurse (L.P.N.) and concerning a 24 week old male infant (previously reported as 16 week old) with lesion on head from birth who on 05-JAN-2007 was vaccinated with Pneumovax 23 instead of Prevnar. The office was unable to determine the cause of this possible error. On 06-JAN-2007 the patient developed redness in both legs and fever and went to ER. In follow up the physician mentioned that patient developed fever 104 o and redness at site. On 07-JAN-2007 patient recovered. On 10-MAR-2007, the patient was evaluated and in his office visit and was given 2 months above without reactions noted. Additional information is not expected.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site rash
Clinical narrative: Information has been received from a registered nurse concerning a 35 year old female who on 15-MAR-2007 was vaccinated IM in the right deltoid with a 0.5 mL dose of Pneumovax 23 (lot #655588/0883F). Concomitant therapy included REYATAZ. On approximately 15-MAR-2007, after receiving the vaccination, the patient developed a rash on the injection site of the right upper deltoid arm. The rash was described as two separate bands that went around the arm. It was also reported that the patient had been experiencing headaches since vaccination. The headaches were treated with ADVIL. Subsequently, the injection site rash resolved completely, although, the headaches have persisted. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Influenza like illness, Pain, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a 20 year old female who on 12-MAR-2007 was vaccinated with a dose of Pneumovax 23.  Within 48 hours, on approximately 14-MAR-2007 the patient developed hip and leg pains and on 16-MAR-2007 the symptoms were getting worse and she reported she felt like she had the flu.  She reportedly had flu like symptoms, fever and body aches.  She was instructed to contact her primary care doctor.  Additional information was not available.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Chills, Erythema, Headache, Oedema peripheral
Clinical narrative: Information has been received from a 66 year old female with high blood pressure, mitral valve prolapse, sulfonamide allergy and drug hypersensitivity to erythromycin and saccharin would make her chest palpitate.  Illness at the time of vaccination included a sinus infection.  The patient was seen by a dentist on 16-MAR-2007 who said her "sinus looked cloudy."  On 16-MAR-2007 the patient was vaccinated, into the left arm, with a dose of Pneumovax 23.  Concomitant therapy included NORVASC, AVELOX and hydrochlorothiazide (manufacturer unknown).  On approximately 17-MAR-2007 the patient experienced headache that comes and goes.  On 17-MAR-2007, at 01:30 her "chest was pounding."  The patient noticed a butterfly rash across nose, underneath eye and under the cheek on 17-MAR-2007.  The patient discontinued therapy with AVELOX due to the advice of her pharmacist.  At 8:00 pm, her left arm started to burn intensely.  Her left arm swelled up and looked like a bullseye, and was red and about 3 inches long and 2 inches wide.  The area was very tender.  The consumer iced the area all night and took ADVIL for the pain.  On 18-MAR-2007, the butterfly rash spread to the forehead.  On the afternoon of 18-MAR-2007, the patient started to shake and had chills which later subsided.  The patient also developed heart palpitations and cold hands.  The patient discontinued taking ADVIL and was taking aspirin.  At the time of the report, the patient rash on her forehead was better but the butterfly rash was still on her face.  Her arm continued to hurt and she still had palpitations.  The consumer felt that headache might have been due to her sinus infection.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Palpitations, Peripheral coldness, Rash, Skin burning sensation, Tenderness
Clinical narrative: Information has been received from a 66 year old female with high blood pressure, mitral valve prolapse, sulfonamide allergy and drug hypersensitivity to erythromycin and saccharin would make her chest palpitate.  Illness at the time of vaccination included a sinus infection.  The patient was seen by a dentist on 16-MAR-2007 who said her "sinus looked cloudy."  On 16-MAR-2007 the patient was vaccinated, into the left arm, with a dose of Pneumovax 23.  Concomitant therapy included NORVASC, AVELOX and hydrochlorothiazide (manufacturer unknown).  On approximately 17-MAR-2007 the patient experienced headache that comes and goes.  On 17-MAR-2007, at 01:30 her "chest was pounding."  The patient noticed a butterfly rash across nose, underneath eye and under the cheek on 17-MAR-2007.  The patient discontinued therapy with AVELOX due to the advice of her pharmacist.  At 8:00 pm, her left arm started to burn intensely.  Her left arm swelled up and looked like a bullseye, and was red and about 3 inches long and 2 inches wide.  The area was very tender.  The consumer iced the area all night and took ADVIL for the pain.  On 18-MAR-2007, the butterfly rash spread to the forehead.  On the afternoon of 18-MAR-2007, the patient started to shake and had chills which later subsided.  The patient also developed heart palpitations and cold hands.  The patient discontinued taking ADVIL and was taking aspirin.  At the time of the report, the patient rash on her forehead was better but the butterfly rash was still on her face.  Her arm continued to hurt and she still had palpitations.  The consumer felt that headache might have been due to her sinus infection.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Tremor, Urine analysis abnormal, White blood cells urine positive, X-ray abnormal
Clinical narrative: Information has been received from a 66 year old female with high blood pressure, mitral valve prolapse, sulfonamide allergy and drug hypersensitivity to erythromycin and saccharin would make her chest palpitate.  Illness at the time of vaccination included a sinus infection.  The patient was seen by a dentist on 16-MAR-2007 who said her "sinus looked cloudy."  On 16-MAR-2007 the patient was vaccinated, into the left arm, with a dose of Pneumovax 23.  Concomitant therapy included NORVASC, AVELOX and hydrochlorothiazide (manufacturer unknown).  On approximately 17-MAR-2007 the patient experienced headache that comes and goes.  On 17-MAR-2007, at 01:30 her "chest was pounding."  The patient noticed a butterfly rash across nose, underneath eye and under the cheek on 17-MAR-2007.  The patient discontinued therapy with AVELOX due to the advice of her pharmacist.  At 8:00 pm, her left arm started to burn intensely.  Her left arm swelled up and looked like a bullseye, and was red and about 3 inches long and 2 inches wide.  The area was very tender.  The consumer iced the area all night and took ADVIL for the pain.  On 18-MAR-2007, the butterfly rash spread to the forehead.  On the afternoon of 18-MAR-2007, the patient started to shake and had chills which later subsided.  The patient also developed heart palpitations and cold hands.  The patient discontinued taking ADVIL and was taking aspirin.  At the time of the report, the patient rash on her forehead was better but the butterfly rash was still on her face.  Her arm continued to hurt and she still had palpitations.  The consumer felt that headache might have been due to her sinus infection.  Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Erythema, Incorrect dose administered, Myalgia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 65 year old retired male with no illness at the time of vaccination, polyarthritis, peripheral vascular disorder, hypertension and a history of non-specific abnormal liver function studies related to hyperlipidemia who on 19-MAR-2007 was vaccinated with a first dose of Pneumovax 23 (lot # 655290/0959F) 0.75 to 0.8 ml subcutaneously in the right tricep area at 10:30 AM. Concomitant therapy included enalapril maleate (MSD), warfarin, DEMADEX, amitriptyline hydrochloride (MSD), OMACOR, meclizine and VIAGRA. The nurse withdrew 1 ml. from a multi-dose vial of Pneumovax 23. During administration, the nurse realized the recommended dose, stopped administration of the 1 ml dose and 0.75 to 0.8 ml was administered to the patient. On 20-MAR-2007 (previously reported as 19-MAR-2007), the patient experienced chills and fever. At the time of reporting, the patient had not recovered. No further information was available at the time of reporting. Follow-up information was received from the licensed practical nurse. On 20-MAR-2007, the patient experienced fever, chills, muscle aches, and erythema of the right tricep. No diagnostic tests were performed. The patient was treated with rest, fluids, and TYLENOL. On 23-MAR-2007, the patient reported feeling much better and had recovered. No additional information is expected.