chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from an office manager, physician, and medical assistant concerning a female patient over 50 years old who on 06-FEB-2008 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot #658449/0989U) intramuscularly in the deltoid of the right arm. Subsequently the patient developed redness and swelling at the injection site. The patient recovered from the redness and swelling on an unspecified date. The physician stated that these reactions had not occurred at the office before and would like a lot check for pneumococcal 23v polysaccharide vaccine (Lot #658449/0989U). This is one of three reports from the same source. One of the patients also received the flu vaccine in the other arm. A standard lot investigation was performed. All in process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and research and was released. Additional information is not expected.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a physician concerning male "about 45 years old" who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient experienced "significant injection site reaction that looked like cellulitis." Subsequently, the patient recovered from significant injection site reaction after treatment with ice and NSAIDS for the pain. No further information is available.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site discolouration, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Initial and follow-up information has been received from a 61 year old female registered nurse with no known drug allergies who on 22-JAN-2008, at 8:00, was vaccinated IM in the right deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot #659203/1540U). On 22-JAN-2008, four hour post-vaccination, the patient's arm had signs of edema and became swollen and warm which started at the injection site and extended four inches across and two inches down. The patient had no fever, although, experienced bad chills. On 23-JAN-2008, at 19:00. The area four inches in diameter on the patient's arm, with the injection site in the center, became red, hot and indurated. The arm was sore to touch and the patient experienced pain with movement. She was seen by a physician at the office where she worked and the physician felt it looked like an allergic reaction. The patient was treated with diphenhydramine HCL (BENADRYL) and ibuprofen (ADVIL). The area was marked, and it was reported that it had not grown any larger, although, had not decreased in size either. It was also reported that the four inch in diameter area around the injection site remained darker in color (gray) "for several weeks." On an unspecified date, the patient recovered from the the injection site erythema, warmth, induration, and discoloration and extremity soreness and pain with movement. The outcome of the allergic reaction with chills, peripheral swelling and edema was not reported. The patient reported that in 1995 she was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and did not have a reaction. No further information is available.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Oedema peripheral, Pain in extremity
Clinical narrative: Initial and follow-up information has been received from a 61 year old female registered nurse with no known drug allergies who on 22-JAN-2008, at 8:00, was vaccinated IM in the right deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot #659203/1540U). On 22-JAN-2008, four hour post-vaccination, the patient's arm had signs of edema and became swollen and warm which started at the injection site and extended four inches across and two inches down. The patient had no fever, although, experienced bad chills. On 23-JAN-2008, at 19:00. The area four inches in diameter on the patient's arm, with the injection site in the center, became red, hot and indurated. The arm was sore to touch and the patient experienced pain with movement. She was seen by a physician at the office where she worked and the physician felt it looked like an allergic reaction. The patient was treated with diphenhydramine HCL (BENADRYL) and ibuprofen (ADVIL). The area was marked, and it was reported that it had not grown any larger, although, had not decreased in size either. It was also reported that the four inch in diameter area around the injection site remained darker in color (gray) "for several weeks." On an unspecified date, the patient recovered from the the injection site erythema, warmth, induration, and discoloration and extremity soreness and pain with movement. The outcome of the allergic reaction with chills, peripheral swelling and edema was not reported. The patient reported that in 1995 she was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and did not have a reaction. No further information is available.
Sex: M
Vaccine: PPV
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a male patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # not reported). The physician reported that the patient received the pneumococcal 23v polysaccharide vaccine and broke out in a rash all over his body. No further information was provided. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Induration, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Initial and follow up information has been received from a physician and later from a registered nurse (RN) by phone concerning a 16 year old white male child with a history of bronchitis, laryngotracheobronchitis, ear infection, pneumonia and "wheezes" who on 25-JAN-2008 was vaccinated IM with a first dose of pneumococcal 23v polysaccharide vaccine (lot # 659149/1383U). The physician reported that the patient experienced "pain, redness and soreness" at the injection site. The spot was also hard to touch. In follow up information it was reported that the patient's mother called the doctor's office and reported that on 25-JAN-2008 at PM her child's arm was red, hard, swollen and tender which lasted for several days. The child recovered several days after the injection was given. No further information expected.
Age: 16.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Tenderness
Clinical narrative: Initial and follow up information has been received from a physician and later from a registered nurse (RN) by phone concerning a 16 year old white male child with a history of bronchitis, laryngotracheobronchitis, ear infection, pneumonia and "wheezes" who on 25-JAN-2008 was vaccinated IM with a first dose of pneumococcal 23v polysaccharide vaccine (lot # 659149/1383U). The physician reported that the patient experienced "pain, redness and soreness" at the injection site. The spot was also hard to touch. In follow up information it was reported that the patient's mother called the doctor's office and reported that on 25-JAN-2008 at PM her child's arm was red, hard, swollen and tender which lasted for several days. The child recovered several days after the injection was given. No further information expected.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Lymphadenopathy
Clinical narrative: Information has been received from a licensed practical nurse concerning a 51 year old female patient who on 03-OCT-2007, was vaccinated into the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (Lot# 659148/1382U). On 05-OCT-2007, the patient had an elevated temperature and enlarged lymph nodes. It was also reported that the patient had pneumonia at the time of vaccination. Subsequently, the patient recovered. This is one of two reports from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Lymphadenopathy
Clinical narrative: Information has been received from a physician concerning a 62 year old white female who is a heavy smoker who on 03-OCT-2007, was vaccinated into the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (Lot# 659148/1382U). On 04-OCT-2007, the patient experienced elevated temperature of 101 and enlarged lymph nodes. These symptoms lasted for approximately 4 days. No laboratory diagnostic studies were performed. Subsequently, the patient recovered. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a physician concerning a 59 year old female with some airborne allergies who on 10-NOV-2005 was vaccinated with pneumococcal 23v polysaccharide vaccine 0.5 mL. Concomitant therapy included alendronate sodium (MSD) and SYNTHORID. Soon after receiving the vaccination, the patient experienced cellulitis. A couple of weeks after vaccination, the patient recovered from cellulitis. It was noted that the patient sought medical attention. Additional information has been requested.
Age: 76.0
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: Information has been received from an RN concerning a 76 year old patient who in November or December 2007 was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine, lot #657626/1084U. The patient commented that the injection was painful and 1-2 days later developed warmth and localized hives at the injection site. The patient also reported pain from the shoulder to the breast area. Medical attention was sought. The patient was recovering. The nurse indicated that 2 additional patients had identical adverse experiences from pneumococcal 23v polysaccharide vaccine, lot #1084U, and requested a lot check to ensure the product was safe to use. 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: 65.0
Sex: U
Vaccine: PPV
Symptoms: Breast pain, Injection site pain, Injection site urticaria, Injection site warmth, Musculoskeletal pain
Clinical narrative: Information has been received from an RN concerning a 65 year old patient who in November of December 2007 was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine, lot #657626/1084U. The patient commented that the injection was painful and 1-2 days later developed warmth and localized hives at the injection site. The patient also reported pain from the shoulder to the breast area. Medical attention was sought. The patient was recovering. The nurse indicated that 2 additional patients had identical adverse experiences from pneumococcal 23v polysaccharide vaccine, lot #1084U, and requested a lot check to ensure the product was safe to use. 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 Center of Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Pain, Pyrexia, Swelling
Clinical narrative: Information has been received from a pharmacist concerning a male physician who on 12-NOV-2007 was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot# 657039/0698U). On approximately 12-NOV-2007, within 24 hours of receiving the vaccine, the patient developed cellulitis, pain, swelling, fever and was reported to have been treated with multiple antibiotics due to streaking on the skin. It was unknown if the patient recovered. It was reported that this patient may be a liver failure patient. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 74 year old female patient who on 29-NOV-2007, was vaccinated IM into the left deltoid with a first 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (Lot# 658075/0962U). Concomitant therapy included (therapy unspecified), ASPIRINE, calcium (unspecified) and vitamin D (unspecified). On 29-NOV-2007 within 6 hours of the vaccination, the patient experienced pain at the injection site. 24 hours after the vaccination the patient experienced induration, redness and warmth at the injection site. At 36 hours, 3/4th circumference of the upper arm and the middle upper arm was affected. Unspecified medical attention was sought. A diagnosis of cellulitis was reported. The patient was treated with (BACTRIM) and (DOXYCYCLINE). No laboratory diagnostic studies were performed. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a medical assistant concerning an infant who on 04-DEC-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. No treatment was required. The patient was not hospitalized. No adverse event was mentioned except that it was given to a child at an age less than indicated in the prescribing information. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Inflammation, Pain in extremity, Rash
Clinical narrative: Information has been received from a pharmacist concerning a 71 year old female patient with no medical history and a penicillin allergy who on 18-OCT-2007, was vaccinated IM into the right shoulder with a first 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (Lot# 658673/0990U). Concomitant therapy on that same day, included a dose of ZOSTAVAX given into the left arm. After receiving the pneumococcal 23v polysaccharide vaccine the patient developed an inflamed, reddened, and painful arm. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. It was reported that the rash resolved by the time the patient reported the adverse symptoms. No product complaint was involved. Additional information is not expected.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Biopsy, Blood test, Computerised tomogram, Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 69 year old male with hypertension, coronary artery disease, osteoarthritis, gastrooesophageal reflux disease, hypothyroidism and allergies to NIASPAN, NEURONTIN, statins, nitrates, cortisone who on 09-JUL-2001 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. On 18-OCT-2006 at 15:40, the patient was vaccinated IM into the deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot#651399/0486F). Concomitant therapy included atenolol, SYNTHROID, ranitidine, NITROQUICK, NEURONTIN and ECOTRIN. On 23-OCT-2006 at 10:36, the patient developed a scattered rash. The patient's scattered rash persisted. According to a letter received from the patient's wife, on 19-OCT-2006 the next day, the patient developed a rash and itch that appeared at the site of the injection and on both arms and torso. On 20-OCT-2006, the consumer contacted the doctor because the rash was much worse. The nurse  told them that it was a reaction from the shot and to take BENADRYL and call back if it was not better. On 23-OCT-2006, the patient called the doctor's office and told the nurse that the rash was much worse and has spread. The nurse advised the patient to see a dermatologist. That day an appointment was scheduled with the dermatologist. The patient was miserable and uncomfortable with the rash and itch. The patient was treated with a shot of cortisone, a topical cream. After 7 to 8 days the rash improved, but then it flared up again. On 08-DEC-2006, the patient had a biopsy and was given a new prescription. On 19-DEC-2006, the patient contacted the dermatologist and she stated that the patient should see an allergist. On 11-JAN-2007, the patient saw an allergist and was recommended for laboratory tests, to change laundry detergent, face and body soap. On 25-JAN-2007, all laboratory tests came back negative and was told to continue medications and also received new medications. On 15-FEB-2007, the patient had an allergist appointment. Some medications were changed and more blood tests were ordered. The allergist also advised the patient to go to a teaching hospital as soon as possible for test that she could not do. On 21-FEB-2007, the patient had a CAT scan of his torso. On 20-MAR-2007 and 21-MAR-2007, the patient had tests done as well as a biopsy. At the time of this report, the patient had not recovered. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Laboratory test normal, Pruritus, Rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 69 year old male with hypertension, coronary artery disease, osteoarthritis, gastrooesophageal reflux disease, hypothyroidism and allergies to NIASPAN, NEURONTIN, statins, nitrates, cortisone who on 09-JUL-2001 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. On 18-OCT-2006 at 15:40, the patient was vaccinated IM into the deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot#651399/0486F). Concomitant therapy included atenolol, SYNTHROID, ranitidine, NITROQUICK, NEURONTIN and ECOTRIN. On 23-OCT-2006 at 10:36, the patient developed a scattered rash. The patient's scattered rash persisted. According to a letter received from the patient's wife, on 19-OCT-2006 the next day, the patient developed a rash and itch that appeared at the site of the injection and on both arms and torso. On 20-OCT-2006, the consumer contacted the doctor because the rash was much worse. The nurse  told them that it was a reaction from the shot and to take BENADRYL and call back if it was not better. On 23-OCT-2006, the patient called the doctor's office and told the nurse that the rash was much worse and has spread. The nurse advised the patient to see a dermatologist. That day an appointment was scheduled with the dermatologist. The patient was miserable and uncomfortable with the rash and itch. The patient was treated with a shot of cortisone, a topical cream. After 7 to 8 days the rash improved, but then it flared up again. On 08-DEC-2006, the patient had a biopsy and was given a new prescription. On 19-DEC-2006, the patient contacted the dermatologist and she stated that the patient should see an allergist. On 11-JAN-2007, the patient saw an allergist and was recommended for laboratory tests, to change laundry detergent, face and body soap. On 25-JAN-2007, all laboratory tests came back negative and was told to continue medications and also received new medications. On 15-FEB-2007, the patient had an allergist appointment. Some medications were changed and more blood tests were ordered. The allergist also advised the patient to go to a teaching hospital as soon as possible for test that she could not do. On 21-FEB-2007, the patient had a CAT scan of his torso. On 20-MAR-2007 and 21-MAR-2007, the patient had tests done as well as a biopsy. At the time of this report, the patient had not recovered. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 64 year old female with no allergies or drug reactions who on 03-DEC-2007 was vaccinated (site and route not reported) with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot#658200/0804U). On the same day the patient was concomitantly vaccinated (site and route not reported) with a influenza virus vaccine (unspecified). On 05-DEC-2007, the nurse reported that the patient developed redness and pain at injection site and fever 48 hours post vaccination. The patient sought medical attention and was prescribed antibiotic by the physician. No further information available. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Sensation of heaviness, Skin warm
Clinical narrative: Information has been received from a medical assistant concerning a 69 year old female with allergies to epinephrine, sulfa and influenza vaccine who on 06-DEC-2007 was vaccinated (route and site not reported) with a dose of pneumococcal 23v polysaccharide vaccine (lot# 657626/1084U). Post vaccination (date not reported), the patient developed a swollen, hot and heavy arm. The patient went to the physician's office and received unspecified medical attention. No further information available. Additional information has been requested.
Sex: M
Vaccine: DT, PPV
Symptoms: Abscess, Cellulitis, Chills, Pyrexia, Swelling
Clinical narrative: Information has been received from a health professional concerning a male patient with food allergy to "tuna" who on 18-JUN-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included poliovirus vaccine and diphtheria toxoid/tetanus toxoid on same day. The reporter reported that the patient experienced fever, chills, sterile abscess, swelling in area of vaccine and cellulitis for which emergency room visit was required. It was reported that several days later on an unspecified day patient recovered. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 70 year old female. The physician reported that the patient had a reaction to either FLUVAX or pneumococcal 23v polysaccharide vaccine (MSD). It was a hive like reaction. As of 30-NOV-2007, the out come was unknown. Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: FLUN3, PPV, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 6 year old Caucasian male with gastrooesophageal reflux disease, chronic sinusitis, reactive airways disease and food allergies, who on 12-NOV-2007 was vaccinated intramuscularly with pneumococcal 23v polysaccharide vaccine into the right arm (lot# 656222/0381U). Concomitant therapy included FLUMIST and varicella virus vaccine live (unspecified) (manufacturer unknown), into the opposite arm. Other concomitant therapies included PREVACID and SINGULAIR. On 12-NOV-2007, the patient experienced a significant injection site reaction, edema and erythema almost immediately following the pneumococcal 23v polysaccharide vaccination. The injection site arm was affected from the shoulder area down the arm 2/3 of the way to the elbow. The area was warm, erythematous, and swollen. The patient was given steroids and diphenhydramine as treatment and the reaction resolved in a couple of days. Medical attention was sought, treated for the injection site reaction. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a nurse concerning a 46 year old female with hypothyroidism, hypoglycaemia, migraine headaches, cortisol increased, and an allergic reaction to Solanaceae, sugar substitutes and MAXALT, who on 26-MAR-2008 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot# 659148/1382U). Concomitant therapy included ARMOUR THYROID, clobetasol propionate (topical), RETINOL cream and hormonal contraceptives (unspecified). On 26-MAR-2008, the patient experienced redness and pain at the injection site. Unknown medical attention was sought in the office. At the time of the report the patient was recovering. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Lymphadenitis
Clinical narrative: Information has been received from a pharmacist concerning a 51 year old female with sinus disorder and sulfonamide allergy who on 29-MAR-2008 was vaccinated SQ into the right arm with a dose of pneumococcal 23v polysaccharide vaccine (Lot# 658200/0804U). On 31-MAR-2008, the patient developed lymphadenitis. Unknown medical attention was sought via telephone. The patient's lymphadenitis persisted. No product quality complaint was involved. In follow up, the healthcare worker asked for information to identify the patient in the adverse reaction. No further information reported. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discolouration, Injection site pain, Injection site swelling
Clinical narrative: Initial and follow-up information has been received from a licensed practical nurse concerning a 74 year old female with hypothyroidism and diverticulitis, with no illness at the time of the vaccination and no drug reactions/allergies who on 27-MAR-2008 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot# 659010/1537U) 0.5 mL IM in the right deltoid. Concomitant medication included homeopathic medications (unspecified), levothyroxine sodium (SYNTHROID) and omeprazole (PRILOSEC). The nurse reported that on 28-MAR-2008 the patient developed a swollen arm at the injection site. The patient had no record of previous vaccination with pneumococcal 23v polysaccharide vaccine. The patient applied heat to the site. The onset of the adverse event was 27-MAR-2008 at 10:30AM. On Saturday 29-MAR-2008 the patient's injection site arm turned black, was swollen and painful. On 01-APR-2008 the patient sought unspecified medical attention. On 01-APR-2008 the injection site arm was better but not recovered. At the time of reporting the patient was recovered on an unspecified date. There was no other information to report. Additional information is not expected.
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Oedema peripheral, Pyrexia, X-ray
Clinical narrative: Information has been received from a consumer concerning her two and half year old daughter who on 31-MAR-2008 was vaccinated IM with 0.5 mL of pneumococcal 23v polysaccharide vaccine (lot # 655290/0959F). The reporter reported that on 31-MAR-2008 her daughter developed fever and edema in her right leg from her knee to her thigh after receiving a dose of pneumococcal 23v polysaccharide vaccine. Follow up information received from the patient's mother stated that a magnetic resonance imaging (MRI) indicated her daughter had cellulitis. She also had a X-ray but result not reported. She was admitted to the hospital on 01-APR-2008. At the time of this report the patient had not recovered. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site swelling, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Information has been received from a 51 year old female registered nurse with allergies to codeine and sulfa, who on 01-APR-2008 at 10:00 was vaccinated intradermally into the right forearm with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included estrogens (unspecified) and zolpidem tartrate (AMBIEN), and unspecified over the counter medications. On 01-APR-2008 she was inadvertently vaccinated intradermally into the right forearm with pneumococcal 23v polysaccharide vaccine, instead of PPD Tuberculin. She stated it was human error only. She stated that she had extreme swelling 4 inches above the injection site and 4 inches below the injection site. She stated that her right arm was very painful and warm to the touch. She was vaccinated at 10:00 on 01-APR-2008. By 15:00 on 01-APR-2008 she experienced arm pain and by 17:00 PM the right arm was swollen. On 01-APR-2008 "last night," she developed aches and pains in her hips, neck, shoulders and she had a headache. She was seen in the office and was being monitored by her physician and was placed on prednisone, "40 mg today, 20 mg tomorrow, etc." At the time of this report the patient had not recovered. No product quality complaint was involved. Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Wrong drug administered
Clinical narrative: Information has been received from a 51 year old female registered nurse with allergies to codeine and sulfa, who on 01-APR-2008 at 10:00 was vaccinated intradermally into the right forearm with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included estrogens (unspecified) and zolpidem tartrate (AMBIEN), and unspecified over the counter medications. On 01-APR-2008 she was inadvertently vaccinated intradermally into the right forearm with pneumococcal 23v polysaccharide vaccine, instead of PPD Tuberculin. She stated it was human error only. She stated that she had extreme swelling 4 inches above the injection site and 4 inches below the injection site. She stated that her right arm was very painful and warm to the touch. She was vaccinated at 10:00 on 01-APR-2008. By 15:00 on 01-APR-2008 she experienced arm pain and by 17:00 PM the right arm was swollen. On 01-APR-2008 "last night," she developed aches and pains in her hips, neck, shoulders and she had a headache. She was seen in the office and was being monitored by her physician and was placed on prednisone, "40 mg today, 20 mg tomorrow, etc." At the time of this report the patient had not recovered. No product quality complaint was involved. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Immunisation reaction, Oedema peripheral, Sensation of pressure
Clinical narrative: Information has been received from a registered nurse concerning a 68 year old female who on 01-APR-2008 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot# 659149/1383U). On approximately 03-APR-2008 the patient had a reaction from pneumococcal 23v polysaccharide vaccine. It was reported that the patient developed a "swollen arm from her shoulder elbow" and "it is very tight". The patient went to the emergency room on 03-APR-2008 and it was reported that she was "going to be admitted". At the time of the report, the patient had not recovered. The nurse requested a lot check for Lot#659149/1383U. 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 Drug Evaluation and Research and was released. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Breast pain, Breast swelling, Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a 69 year old female consumer with a penicillin allergy and a history of pneumonia (1993, 1995 and 1996), who in approximately 1999 or 2000 was vaccinated with the first dose, and on 02-APR-2008 was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine (lot # not reported). On 02-APR-2008, following the vaccination, her arm was sore, warm to touch, and slightly red. She reported the pain and swelling started about 2 to 3 inches above her elbow and extended to the middle of her left breast. She also reported she had some bruising at the site where she had blood drawn (site not specified). At the time of this report, the patient had not recovered. She sought medical attention by telephone (treatment not specified). Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Information has been received from a 69 year old female consumer with a penicillin allergy and a history of pneumonia (1993, 1995 and 1996), who in approximately 1999 or 2000 was vaccinated with the first dose, and on 02-APR-2008 was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine (lot # not reported). On 02-APR-2008, following the vaccination, her arm was sore, warm to touch, and slightly red. She reported the pain and swelling started about 2 to 3 inches above her elbow and extended to the middle of her left breast. She also reported she had some bruising at the site where she had blood drawn (site not specified). At the time of this report, the patient had not recovered. She sought medical attention by telephone (treatment not specified). Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a registered nurse, concerning a 64 year old male patient with hypertension, coronary artery disease, gout, obesity, hypercholesterolaemia, hyperthyroidism and haemorrhoids, who on 02-APR-2008 was vaccinated IM in the left arm, with a dose, 0.5 ml, of pneumococcal 23v polysaccharide vaccine (lot # 659487/1960U). Concomitant therapy included levothyroxine Na (SYNTHROID), aspirin, indomethacin (INDOCIN (indomethacin)), atorvastatin calcium (LIPITOR), metoprolol succinate (TOPROL XL TABLETS), testosterone, nitroglycerin and HCTZ/triamterene (MAXZIDE). On 03-APR-2008, about 24 hours after the vaccination, the patient developed fever (value not specified), and his left arm was hot and red. On 04-APR-2008, he presented to the office, and his arm was also swollen. At the time of this report, the patient had not recovered from the events. This is one of 2 reports from the same source. Additional information has been requested. 07/30/09 This is in follow-upto report(s) previously submitted on 7/30/2008. Initial and follow up information has been received from a registered nurse, concerning a 64 year old male patient with hypertension, coronary artery disease, gout, obesity, hypercholesterolaemia, hyperthyroidism and haemorrhoids, who on 02-APR-2008 at 10:00 AM was vaccinated IM into the left deltoid, with a dose, 0.5 ml, of PNEUMOVAX (lot # 659487/1960U). Concomitant therapy included SYNTHROID, aspirin, INDOCIN, LIPITOR, TOPROL XL tablets, testosterone, nitroglycerin and MAXIDE. On 03-APR-2008, about 24 hours after the vaccination, the patient developed fever (value not specified), and his left arm was hot and red. On 04-APR-2008, he presented to the office, and his arm was also swollen. At the time of this report the patient had not recovered from the events. In follow up information from the doctor's office it was reported that patient had heat, redness, swelling and fever and he recovered on an unknown day. This is one of 2 reports from the same source. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received via a company representative, from a pharmacist who stated that a registered nurse informed him of a 78 year old male patient, who on 19-MAR-2008 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 658200/0804U). On approximately 19-MAR-2008 or 20-MAR-2008, the patient developed an injection site reaction, with redness and swelling from the elbow to the shoulder. The patient called the nurse's office, and was instructed to treat the symptoms with ice and acetaminophen (TYLENOL). On 24-MAR-2008, the patient informed the nurse that the symptoms had subsided. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm, Ultrasound scan
Clinical narrative: Information has been received from a registered nurse, concerning a 71 year old female patient with osteoporosis, hypercholesterolaemia and goiter, who on 01-APR-2008 was vaccinated IM in the left arm, with a dose, 0.5 mL, of pneumococcal 23v polysaccharide vaccine (Lot # 659487/1960U). Concomitant therapy included LIPITOR, oxybutynin and aspirin. On 02-APR-2008, about 24 hours after the vaccination, the patient "developed symptoms" below the injection site and spreading to her hand. The area was described as "indiscreet, warm, painful to the touch, plus erythema." The site was not swollen. The patient was seen in the office, and a BENADRYL injection (1cc) was administered, and ADVIL was prescribed. At the time of this report, the patient had not recovered. This is 1 of 2 reports from the same source. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 7/30/2008.  Initial and follow up information has been received from a registered nurse, concerning a 71 year old female patient with osteoporosis, hypercholesterolaemia and goiter, who on 01-APR-2008 was vaccinated IM in the left arm deltoid, with a first dose, 0.5 ml, of pneumocuccal 23v polysaccharide vaccine (lot # 659487/19600).  Concomitant therapy included LIPITOR, oxybutynin and aspirin.  Patient had a venous dopper study done on an unspecified day.  On 02-APR-2008, about 24 hours after the vaccination, the patient "developed symptoms" below the injection site and spreading to her hand.  The area was described a "indiscreet, warm, painful to the touch, plus erythema."  The site was not swollen.  The patient was seen in the office, and a BENADRYL injection (1cc) was administered, and ADVIL and prescribed.  In follow up it was reported that patient recovered.  This is 1 of 3 reports from the same source.  Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site bruising, Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant concerning an 81 year old female with drug hypersensitivities to PERCOCET, PERCODAN, DARVOCT, benazepril, and codeine and a history of high blood pressure, anaemia and osteoporosis who on 20-MAR-2008 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine, 0.5 mL IM, (lot# 6562331/0200U). A first dose of pneumococcal 23v polysaccharide vaccine had been given on a unspecified date in 2000 and no adverse symptoms were note. Concomitant therapy included PREMARIN, (therapy unspecified) "CYCLODENZ", alendronate sodium (MSD), zolpidem tartrate, tramadol HCl, candesartan and hydrochlorothiazide (manufacturer unknown). On 20-MAR-2008, the patient called that afternoon to report that she developed swelling, redness and bruising of her upper arm at the injection site. She was treated with ice, and ibuprofen or aspirin. On 21-MAR-2008, the patient went to the emergency room when the symptoms worsened, she was diagnosed with cellulitis at the injection site and treated with KEFLEX. On 25-MAR-2008, she was seen in the office and the condition was reported to be improving. On an unspecified date, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant concerning an 81 year old female with drug hypersensitivities to PERCOCET, PERCODAN, DARVOCT, benazepril, and codeine and a history of high blood pressure, anaemia and osteoporosis who on 20-MAR-2008 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine, 0.5 mL IM, (lot# 6562331/0200U). A first dose of pneumococcal 23v polysaccharide vaccine had been given on a unspecified date in 2000 and no adverse symptoms were note. Concomitant therapy included PREMARIN, (therapy unspecified) "CYCLODENZ", alendronate sodium (MSD), zolpidem tartrate, tramadol HCl, candesartan and hydrochlorothiazide (manufacturer unknown). On 20-MAR-2008, the patient called that afternoon to report that she developed swelling, redness and bruising of her upper arm at the injection site. She was treated with ice, and ibuprofen or aspirin. On 21-MAR-2008, the patient went to the emergency room when the symptoms worsened, she was diagnosed with cellulitis at the injection site and treated with KEFLEX. On 25-MAR-2008, she was seen in the office and the condition was reported to be improving. On an unspecified date, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site bruising, Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant concerning a patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient experienced bruising, redness and swelling of the left upper arm injection site. At the time of this report, the patient's outcome was unknown. Follow up information stated that the patient was seen in hte emergency room and was not admitted to the hospital. On a pproximately 04-APR-2008, the reporter spoke with the patient who stated that she had recovered.  No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant concerning a patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient experienced bruising, redness and swelling of the left upper arm injection site. At the time of this report, the patient's outcome was unknown. Follow up information stated that the patient was seen in hte emergency room and was not admitted to the hospital. On a pproximately 04-APR-2008, the reporter spoke with the patient who stated that she had recovered.  No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Immunisation reaction, Oedema peripheral, Sensation of pressure
Clinical narrative: Information has been received from a registered nurse concerning a male patient who on 01-APR-2008 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot# 659149/1383U). On approximately 01-APR-2008, the patient "had a similar reaction and he was given (pneumococcal 23v polysaccharide vaccine)". Reaction reported was swollen arm and "it is very tight". At the time of the report, the patient was not recovered. The nurse requested a lot check for Lot#659149/1383U. 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 Drug Evaluation and Research and was released. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Information has been received from a certified medical assistant concerning a 66 year old female with blood pressure high, hyperlipidaemia, rhinitis allergic, penicillin allergy and drug hypersensitivities to morphine sulfate, hydrochlorothiazide (HCTZ), atorvastatin calcium (ATORVASTATIN), ibuprofen, benazepril hydrochloride and gemfibrozil who on 03-APR-2008, was vaccinated IM with a first 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot# 656233/0200U). Concomitant therapy included valsartan (PROVAS (valsartan)). Later that same day, the patient experienced bruising, redness and swelling of the left upper arm injection site. She was treated with aspirin and ice. The area worsened overnight and she went to the emergency room on 04-APR-2008. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/30/2008.  Information has been received from a certified medical assistant and medical records concerning a 66 year old female with blood pressure high, hyperlipidaemia, rhinitis allergic, penicillin allergy, gastroesophageal reflux disease (GERD), irritable bowel syndrome (IRS) and drug hypersensitivities to morphine sulfate, hydrochlorothiazide (HCTZ), ATORVASTATIN, ibuprofen, benazepril hydrochloride and gemfibrozil, past surgical history of tonaillectomy, hysterectomy, previous knee surgery and a breast biopsy and a history of endometriosis who on 03-APR-2008 AT 10:30, was vaccinated IM into the deltoid with a first 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot # 656233/0200U).  Concomitant therapy included PROVAS (valsartan).  Later that same day, the patient experienced bruising, redness and swelling of the left upper arm injection site.  She was treated with aspirin and ice.  The area worsened overnight and she went to the emergency room on 04-APR-2008.  On 04-APR-2008 at 12:30, the patient experienced a local reaction including pain and an urticaria type appearance.  A physical examination done in the ER was reported as left tingling to the distal extremity.  Pulse and perfusion were intact.  There was some splotchy erythema around the area of the upper left arm.  A diagnosis of local allergic reaction was made.  The patient began taking BENADRYL and a prescription for PREDNISONE was given to the patient.  The patient will recheck her arm in 24 hours and if symptoms persist or increase she will return to the ER.  At the time of this report, the patient had not recovered.  No product quality complaint was involved.  This is one of two reports from the same source.  Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning her 52 year old husband who was vaccinated into the abdomen with a dose pneumococcal 23v polysaccharide vaccine. She was not sure if the vaccine was given subcutaneously or intramuscularly. Subsequently, the patient developed injection site redness and the injection site was swollen and painful. The patient sought unspecified medical attention. At the time of this report the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Hyperaesthesia, Injection site erythema, Injection site induration, Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a health professional concerning a 60 year old white male with no drug reactions/allergies and no illness at the time of vaccination who on 16-JAN-2008 at 10:30 AM was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot# 658493/0991U) subcutaneous in the left arm. On 17-JAN-2008 at 8 AM, the patient experienced swelling at the vaccine site, redness, tenderness, was hard to the touch, had pain shooting down to the forearm, was sensitive and had a warm feeling. On 28-JAN-2008, the patient recovered from all the events. Additional information is not expected.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Information has been received from a health professional concerning a 60 year old white male with no drug reactions/allergies and no illness at the time of vaccination who on 16-JAN-2008 at 10:30 AM was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot# 658493/0991U) subcutaneous in the left arm. On 17-JAN-2008 at 8 AM, the patient experienced swelling at the vaccine site, redness, tenderness, was hard to the touch, had pain shooting down to the forearm, was sensitive and had a warm feeling. On 28-JAN-2008, the patient recovered from all the events. Additional information is not expected.