chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Insomnia
Clinical narrative: Information has been received from a 32 year old female with no pertinent medical history who on approximately 03-SEP-2007 was vaccinated with a dose of PNEUMOVAX 23. There was no concomitant medication. On approximately 17-JUL-2007 the patient was "experiencing trouble sleeping". There was no laboratory or diagnostic tests performed. Unspecified medical attention was sought. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site bruising, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 52 year old female with a history of child and adult pneumonia and no drug reactions/allergies who on 03-OCT-2007 was vaccinated with PNEUMOVAX (lot# 657525/0554U) vaccine 0.5 mL subcutaneous in the mid-upper left arm.  There was no concomitant medication.  On 04-OCT-2007, the patient developed a local injection site reaction after vaccination with PNEUMOVAX.  Medical attention was sought.  On 05-OCT-2007, the patient experienced fever off 100.6 F and a 5 cm area of erythema at the injection site and was seen at the office.  The area was described as firm and tender, located at the mid-upper left arm.  Ibuprofen and BENADRYL were ordered for symptoms.  On 09-OCT-2007, the patient was seen at the office and the area was described as a "much larger area" larger area of erythema and tenderness, mostly located at the upper arm and down around the elbow.  Also at the injection site, there was a yellow, pink vesicle which was dense, not weeping, and firm to the touch.  MEDROL DOSE PAK was ordered for the patient.  On 26-OCT-2007 there is a 4 inch by 2 inch area which was "quite firm and dense feeling".  It "feels like fluid".  Around the injection site, there was bruising "quarter sized" and "reddish purple".  No further information was available.  At the time of reporting the patient had not recovered.  Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site vesicles, Local reaction, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 52 year old female with a history of child and adult pneumonia and no drug reactions/allergies who on 03-OCT-2007 was vaccinated with PNEUMOVAX (lot# 657525/0554U) vaccine 0.5 mL subcutaneous in the mid-upper left arm.  There was no concomitant medication.  On 04-OCT-2007, the patient developed a local injection site reaction after vaccination with PNEUMOVAX.  Medical attention was sought.  On 05-OCT-2007, the patient experienced fever off 100.6 F and a 5 cm area of erythema at the injection site and was seen at the office.  The area was described as firm and tender, located at the mid-upper left arm.  Ibuprofen and BENADRYL were ordered for symptoms.  On 09-OCT-2007, the patient was seen at the office and the area was described as a "much larger area" larger area of erythema and tenderness, mostly located at the upper arm and down around the elbow.  Also at the injection site, there was a yellow, pink vesicle which was dense, not weeping, and firm to the touch.  MEDROL DOSE PAK was ordered for the patient.  On 26-OCT-2007 there is a 4 inch by 2 inch area which was "quite firm and dense feeling".  It "feels like fluid".  Around the injection site, there was bruising "quarter sized" and "reddish purple".  No further information was available.  At the time of reporting the patient had not recovered.  Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant concerning a 77 year old female with no medical history and no drug allergies, who on 10-OCT-2007 was vaccinated intramuscularly with a 0.5mL dose of PNEUMOVAX 23 (Lot# 658447/1132U). There was no concomitant medication. On 11-OCT-2007 the patient developed an injection site reaction. The injection site was red and swollen. The redness has spread down the arm. The patient went to the emergency room and was seen by a physician. No laboratory diagnostics were performed. At the time of the report, the patient was not recovered. No product quality complaint was involved. 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: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Initial and follow up information has been received from a pharmacist concerning a 76 year old female patient with a history of cardiac disorder and no known allergies who on 01-OCT-2007 at 16:00, was vaccinated IM into the left deltoid with a first dose of PNEUMOVAX 23 (Lot# 65855/0964U). Concomitant therapy given into the right deltoid included a dose of FLUZONE (Lot# U2488AA). On 02-OCT-2007, twenty four hours after vaccination, the patient developed erythema and heat that spread to the elbow and up through the chest and armpit. it was also painful to move her extremity. The patient was treated with TYLENOL and ice to the left side of her arm and chest. The patient was to be seen at the pharmacy on 03-OCT-2007 for follow up. No laboratory diagnostic studies were performed. At the time of this repot, the patient recovered. No product quality complaint was involved.  Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a registered nurse concerning a 66 year old female with allergies to quinolones and BACTRIM who on 15-OCT-2007 at 11:00 am was vaccinated intramuscularly into the left deltoid with a second dose of PNEUMOVAX (Lot #657525/0554U).  Concomitant vaccination on the same day included an intramuscular injection into the left deltoid of a yearly dose of FLUZONE (influenza virus whole virion 3v vaccine inactivated) (Lot #U2465AA).  On 15-OCT-2007 at 6:00 pm the patient's left arm swelled from the shoulder to the elbow, became red and hot with no itching.  The patient's face and chest also became red and hot.  There was no laboratory or diagnostic tests performed.  On 16-OCT-2007, the patient was seen in the physician's office.  Subsequently, the patient recovered.  Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Condition aggravated, Gout, Joint warmth, Pain, Tenderness
Clinical narrative: Information has been received from a registered nurse concerning a 71 year old male with gout who on 15-OCT-2007 at 11:00 am was vaccinated intramuscularly into the left deltoid with a second dose of PNEUMOVAX 23 (Lot #657525/0554U). Concomitant vaccination on the same day included an intramuscular injection into the left deltoid of a yearly dose of FLUZONE ( Lot #U2465AA). On 15-OCT-2007 at 3:00 pm the patient experienced an increase in gout symptoms: pain, tenderness and warmth in the feet and knees. There was no laboratory or diagnostic tests performed. Subsequently, the patient recovered. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from an office manager concerning a 57 year old female patient who on 22-OCT-2007 was vaccinated with an "appropriate dose" of PNEUMOVAX.  On 24-OCT-2007 the patient developed cellulitis at the injection site.  Unspecified medical attention was sought.  The patient was administered antibiotics (unspecified medication).  The patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a medical office manager concerning a 52 year old male who on 18-OCT-2007 was vaccinated with "an appropriate dose" of PNEUMOVAX (lot #658075/0962U).  On 19-OCT-2007 the patient developed a red area at the injection site and it was reported as being hot.  The patient was diagnosed with cellulitis and on 20-OCT-2007 the patient was seen in the office and was ordered unspecified antibiotics.  No lab/diagnostic studies had been performed.  At the time of this report, the patient was recovering.  Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Feeling abnormal, Injection site cellulitis, Injection site pain, Injection site swelling
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 48 year old female receptionist (previously reported as 4 or 5 patients) with no illness at the time of being vaccinated and no history of allergies or medical conditions.  On an unspecified date, greater than 5 years ago, the patient received a first dose of PNEUMOVAX.  On 18-OCT-2007, th patient was vaccinated with a second dose of PNEUMOVAX (lot # 655500/1005F) IM in the left arm at 6:30 AM.  Also on 18-OCT-2007, the patient was vaccinated with FLUVIRIN (Novartis) (lot # 80959) IM in the left arm at 06:30 AM.  On 19-OCT-2007, the patient complained of a fever of 102 degrees Fahrenheit, swelling and pain at the injection site.  The patient described that her "bone felt detached from her skin and she felt extremely miserable" (previously reported as cellulitis at the injection site).  She continued to feel better daily and on 22-OCT-2007 she felt normal (recovered).  No additional information is expected.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 48 year old female receptionist (previously reported as 4 or 5 patients) with no illness at the time of being vaccinated and no history of allergies or medical conditions.  On an unspecified date, greater than 5 years ago, the patient received a first dose of PNEUMOVAX.  On 18-OCT-2007, th patient was vaccinated with a second dose of PNEUMOVAX (lot # 655500/1005F) IM in the left arm at 6:30 AM.  Also on 18-OCT-2007, the patient was vaccinated with FLUVIRIN (Novartis) (lot # 80959) IM in the left arm at 06:30 AM.  On 19-OCT-2007, the patient complained of a fever of 102 degrees Fahrenheit, swelling and pain at the injection site.  The patient described that her "bone felt detached from her skin and she felt extremely miserable" (previously reported as cellulitis at the injection site).  She continued to feel better daily and on 22-OCT-2007 she felt normal (recovered).  No additional information is expected.
Age: 70.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Blood pressure increased, Injection site bruising, Injection site pain, Injection site reaction, Injection site urticaria
Clinical narrative: Information has been received from a 70 year old female who in approximately 2002 (at age 65, 5 years ago) was vaccinated with a first dose of PNEUMOVAX 23 without any adverse events. On 25-OCT-2007, the patient was vaccinated with a second dose of PNEUMOVAX 23 (lot # 655766/0038U) 0.5 ml injection in the right arm. Also given on the same date on 25-OCT-2007 included influenza virus vaccine (unspecified) in the left arm. Concomitant therapy included PREMARIN CREAM. On 25-OCT-2007, the patient experienced bruising, pain, and welts in the area where she received the PNEUMOVAX 23. She sought the medical attention of her physician who prescribed prednisone and the events dissappated. The patient did not have any adverse events in the arm where the influenza virus vaccine vaccine was given. In October 2007, the patient recovered. Follow-up information was received from the physician. Since being vaccinated on 25-OCT-2007, the patient developed a very warm erythematous rash with mild itching. On 27-OCT-2007, the patient was evaluated by the physician. Her temperature was 98.2 and blood pressure was 186/58. The patient was in no distress. The left arm injection site was clean and intact. The right arm had an injection site with a small ecchymosis surrounding it of less than 1 cm in size. Beyond that, there was some urticaria-appearing rash of about 10 x 6 cm in size. It did not have a cellulitic appearance. Impression was a reaction to PNEUMOVAX 23. Flan was to treat her with prednisone for 3 days to calm down the inflammation. She may use BENADRYL for any itching. The patient desired an allergy consultation to determine what causative agent was present in the vaccination and this was provided. The patient, later in the day, called the physician questioning the need for prednisone: it was agreed that she try the diphenhydramine and then start prednisone if no improvement or any worsening. The outcome of the urticaria appearing erythematous rash was not reported. No additional information is expected.
Age: 70.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Rash erythematous, Rash pruritic, Skin warm, Urticaria
Clinical narrative: Information has been received from a 70 year old female who in approximately 2002 (at age 65, 5 years ago) was vaccinated with a first dose of PNEUMOVAX 23 without any adverse events. On 25-OCT-2007, the patient was vaccinated with a second dose of PNEUMOVAX 23 (lot # 655766/0038U) 0.5 ml injection in the right arm. Also given on the same date on 25-OCT-2007 included influenza virus vaccine (unspecified) in the left arm. Concomitant therapy included PREMARIN CREAM. On 25-OCT-2007, the patient experienced bruising, pain, and welts in the area where she received the PNEUMOVAX 23. She sought the medical attention of her physician who prescribed prednisone and the events dissappated. The patient did not have any adverse events in the arm where the influenza virus vaccine vaccine was given. In October 2007, the patient recovered. Follow-up information was received from the physician. Since being vaccinated on 25-OCT-2007, the patient developed a very warm erythematous rash with mild itching. On 27-OCT-2007, the patient was evaluated by the physician. Her temperature was 98.2 and blood pressure was 186/58. The patient was in no distress. The left arm injection site was clean and intact. The right arm had an injection site with a small ecchymosis surrounding it of less than 1 cm in size. Beyond that, there was some urticaria-appearing rash of about 10 x 6 cm in size. It did not have a cellulitic appearance. Impression was a reaction to PNEUMOVAX 23. Flan was to treat her with prednisone for 3 days to calm down the inflammation. She may use BENADRYL for any itching. The patient desired an allergy consultation to determine what causative agent was present in the vaccination and this was provided. The patient, later in the day, called the physician questioning the need for prednisone: it was agreed that she try the diphenhydramine and then start prednisone if no improvement or any worsening. The outcome of the urticaria appearing erythematous rash was not reported. No additional information is expected.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Information has been received from an RN concerning a 74 year old female patient with irritable bowel syndrome, hypothyroidism, gastrooesophageal reflux disease, osteoarthritis, migraines, depression, and allergies to sulfa, tape, and amoxicillin who on 16-JUL-2007 at 11:15 a.m. was vaccinated in left deltoid with her first dose of PNEUMOVAX 23, lot #655592/0692F. Concomitant therapy included LEVOXYL, PROVIGIL, FLORICET TABLETS, TIGAN, montelukast sodium, AMBIEN CR, lorazepam, PREVACID, BENEFIBER, ROBITUSSIN, ZANTAC, ALLEGRA, LUNESTA, SEROQUEL, LYRICA, Tramadol HCl and "methscopalom". On 18-JUL-2007 the patient developed redness beginning 2-3 inches below the injection site that was 7 cm X 14 cm in size. It was erythematous, swollen moderately, site very hot to touch and tender. The patient applied ice without resolution. On 19-JUL-2007 she was prescribed prednisone 40 mg daily for 3 days, then 20 mg daily for 3 days, then 10 mg daily for 3 days. She was also given 60 mg IM. The patient was currently taking montelukast sodium and ALLEGRA. On 23-JUL-2007 the patient recovered. The reporter felt that the events were related to PNEUMOVAX 23 (that the patient was allergic). The reporter felt the events were other important medical events that required medical intervention in order to prevent serious outcome. No further information is available.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Follow up information has been received from a physician concerning a 63 year old female patient who on 31-OCT-2007 at 10:30 AM was vaccinated IM in the right deltoid, with PNEUMOVAX 23 (lot # 658447/1132U).  About 5 hours after the vaccine administration the patient contacted the office with pain at the injection site.  Seen in the office at 4:15 PM with 5X8 cm erythema, induration, warmth and tenderness around injection site with decreased ability to abduct the right arm.  Although cellulitis felt unlikely patient was started on KEFLEX 500 mg 3X/day X 5 days.  Unknown medical attention was sought.  The patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 75 year old female patient with no known drug allergies and no pertinent medical history, who on 14-NOV-2007 was vaccinated IM with a dose, 0.5ml, of PNEUMOVAX (lot #658449/0989U).  There was no concomitant medication.  Immediately after the vaccination, the patient developed swelling at the injection site.  At the time of this report, the patient had not recovered.  The patient sought medical attention at the pharmacy (details not specified).  Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Axillary pain, Chest discomfort, Chills, Lymphadenopathy, Pain
Clinical narrative: Initial and follow-up information has been received from a physician's office manager, pharmacist, and registered nurse concerning a 51 year old male teacher with seasonal allergies and asthma, who on 01-NOV-2007 at 08:00 was vaccinated IM in the right deltoid with a first dose of PNEUMOVAX 23 (lot #657149/1226U).  Concomitant vaccination included influenza virus vaccine (unspecified) administered in the left deltoid.  Other concomitant medications included PULMICORT, and albuterol.  There were no illnesses at the time of the vaccinations.  On 01-NOV-2007 within 15 minutes post injection the patient experienced chest tightness that lasted a few minutes.  The patient did not return to the clinic.  On 01-NOV-2007 at 19:00 the patient felt feverish, aching, and had chills until the fever broke in the night.  The patient experienced enlarged lymph nodes under the right arm that were swollen and tender, and arm pain.  The symptoms lasted 48 to 60 hours.  It was reported that no treatment was sought.  The patient visited the school district nurse.  The patient recovered on 04-NOV-2007.  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 and was released.  Additional information is not expected.
Age: 51.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Initial and follow-up information has been received from a physician's office manager, pharmacist, and registered nurse concerning a 51 year old male teacher with seasonal allergies and asthma, who on 01-NOV-2007 at 08:00 was vaccinated IM in the right deltoid with a first dose of PNEUMOVAX 23 (lot #657149/1226U).  Concomitant vaccination included influenza virus vaccine (unspecified) administered in the left deltoid.  Other concomitant medications included PULMICORT, and albuterol.  There were no illnesses at the time of the vaccinations.  On 01-NOV-2007 within 15 minutes post injection the patient experienced chest tightness that lasted a few minutes.  The patient did not return to the clinic.  On 01-NOV-2007 at 19:00 the patient felt feverish, aching, and had chills until the fever broke in the night.  The patient experienced enlarged lymph nodes under the right arm that were swollen and tender, and arm pain.  The symptoms lasted 48 to 60 hours.  It was reported that no treatment was sought.  The patient visited the school district nurse.  The patient recovered on 04-NOV-2007.  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 and was released.  Additional information is not expected.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Axillary pain, Erythema, Injection site erythema, Lymphadenopathy
Clinical narrative: Initial and follow-up information has been received from a physician's office manager, pharmacist, and a registered nurse concerning a 56 year old female teacher with frequent upper respiratory infections and nasal allergies, who on 01-NOV-2007 at 08:00 was vaccinated IM in the right deltoid with a first dose of PNEUMOVAX 23 (lot # 657145/1226U). Concomitant vaccination included influenza virus vaccine (unspecified) (Lot# U2466AA) administered in the left deltoid. There were no illness at the time of the vaccination. Within nine hours post injection on 01-NOV-2007 at 17:30 the patient experienced redness at the injection site, fever, aches, and joint pain. the patient's fever broke in the night. The patient developed swollen, palpable, and tender lymph nodes under her right arm for three days. Thirty six hours post vaccination it was noted that the patient developed a 2" reddened circular area near the armpit.  All the patient's symptoms resolved after four days. There was no treatment. The patient visited the school district nurse. The patient recovered on 05-NOV-2007. 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 is not expected.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Initial and follow-up information has been received from a physician's office manager, pharmacist, and a registered nurse concerning a 56 year old female teacher with frequent upper respiratory infections and nasal allergies, who on 01-NOV-2007 at 08:00 was vaccinated IM in the right deltoid with a first dose of PNEUMOVAX 23 (lot # 657145/1226U). Concomitant vaccination included influenza virus vaccine (unspecified) (Lot# U2466AA) administered in the left deltoid. There were no illness at the time of the vaccination. Within nine hours post injection on 01-NOV-2007 at 17:30 the patient experienced redness at the injection site, fever, aches, and joint pain. the patient's fever broke in the night. The patient developed swollen, palpable, and tender lymph nodes under her right arm for three days. Thirty six hours post vaccination it was noted that the patient developed a 2" reddened circular area near the armpit.  All the patient's symptoms resolved after four days. There was no treatment. The patient visited the school district nurse. The patient recovered on 05-NOV-2007. 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 is not expected.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Anxiety, Arthralgia, Chest discomfort, Injected limb mobility decreased, Injection site pain
Clinical narrative: Initial and follow-up information has been received from a physician's office manager, pharmacist, and registered nurse concerning a 54 year old female information officer with a pacemaker, and a history of transposition of great vessels, and a heart blockage 26 years ago, who on 01-NOV-2007 at 08:00 was vaccinated IM in the right deltoid with a first dose of PNEUMOVAX (lot #657145/1226U).  Concomitant vaccination included FLUZONE (unspecified) (Lot# U2466A) administered IM in the left deltoid.  Other concomitant medications included LIPITOR, PREMARIN, SYNTHROID, and blood pressure medicine "possible terazosin hydrochloride" (therapy unspecified).  There were no illnesses at the time of the vaccinations.  On 01-NOV-2007 at 12:00 the patient experienced soreness at the injection site, decreased arm mobility, anxiety, chest tightness, black knuckles and black nails ("like dirt or oil").  The patient visited the school district nurse.  The patient's black knuckles and nails lasted 96 hours (previously reported as resolved by 06-NOV-2007).  Five to six days post injection the patient experienced joint pain and fever.  The patient recovered on 09-NOV-2007.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the research center and was released.  Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nail discolouration, Pyrexia, Skin discolouration
Clinical narrative: Initial and follow-up information has been received from a physician's office manager, pharmacist, and registered nurse concerning a 54 year old female information officer with a pacemaker, and a history of transposition of great vessels, and a heart blockage 26 years ago, who on 01-NOV-2007 at 08:00 was vaccinated IM in the right deltoid with a first dose of PNEUMOVAX (lot #657145/1226U).  Concomitant vaccination included FLUZONE (unspecified) (Lot# U2466A) administered IM in the left deltoid.  Other concomitant medications included LIPITOR, PREMARIN, SYNTHROID, and blood pressure medicine "possible terazosin hydrochloride" (therapy unspecified).  There were no illnesses at the time of the vaccinations.  On 01-NOV-2007 at 12:00 the patient experienced soreness at the injection site, decreased arm mobility, anxiety, chest tightness, black knuckles and black nails ("like dirt or oil").  The patient visited the school district nurse.  The patient's black knuckles and nails lasted 96 hours (previously reported as resolved by 06-NOV-2007).  Five to six days post injection the patient experienced joint pain and fever.  The patient recovered on 09-NOV-2007.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the research center and was released.  Additional information is not expected.
Age: 36.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site streaking, Injection site swelling, Pain in extremity
Clinical narrative: Information has been received from a physician's office manager pharmacist, and a registered nurse concerning a 36 year old white male bartender with nasal allergies, frequent upper respiratory infections, and a history of pneumonia two times in 2006, who on 25-OCT-2007 at 15:00 was vaccinated IM in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot #657145/1226U). Concomitant vaccination included influenza virus vaccine (unspecified). Other concomitant medication included "OTC Allergy medications" (therapy unspecified). There were no illnesses at the time of the vaccination. On 25-OCT-2007 at 19:00, the patient experienced pain and decreased mobility of the left arm and shoulder. By the next morning a "raised red line" developed from the injection site into the left armpit and was very tender. It was reported that all symptoms were gone by the fourth day post injection. There was no treatment. The patient visited the school district nurse. The patient recovered on 29-OCT-2007. 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. No additional information is expected.
Age: 36.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Tenderness
Clinical narrative: Information has been received from a physician's office manager pharmacist, and a registered nurse concerning a 36 year old white male bartender with nasal allergies, frequent upper respiratory infections, and a history of pneumonia two times in 2006, who on 25-OCT-2007 at 15:00 was vaccinated IM in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot #657145/1226U). Concomitant vaccination included influenza virus vaccine (unspecified). Other concomitant medication included "OTC Allergy medications" (therapy unspecified). There were no illnesses at the time of the vaccination. On 25-OCT-2007 at 19:00, the patient experienced pain and decreased mobility of the left arm and shoulder. By the next morning a "raised red line" developed from the injection site into the left armpit and was very tender. It was reported that all symptoms were gone by the fourth day post injection. There was no treatment. The patient visited the school district nurse. The patient recovered on 29-OCT-2007. 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. No additional information is expected.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Information has been received from a nurse concerning a 76 year old female with no pre-existing medical conditions or allergies who on 18-Nov-2007 at 9:30 am was vaccinated intramuscularly in left deltoid muscle with the first dose of the pneumococcal 23v polysaccharide vaccine (lot# 654977/0888F). On 19-NOV-2007 at 10:00am, the patient upper arm swelled, was sore and warm the day after the injection. The arm stayed swollen and sore for 4 days. The patient was unable to lift her arm. The patient had to use her other arm to lift the arm which had the injection. The patient did receive unspecified medical attention and improved. No additional information is expected.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a registered nurse concerning a 61 year old male patient with no medical history who on 20-NOV-2007 at 09:00, was vaccinated into the right arm with a first dose of PNEUMOVAX (Lot# 657525/0554U).  On 20-NOV-2007 at 13:00, the patient's right arm swelled from the injection site to his fingertips.  The area was red and hot and it was reported to have lasted for 5 days.  Subsequently, the patient recovered.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Erythema, Induration, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 64 year old female with penicillin, erythromycin, and KEFLEX allergies and no illness at the time of vaccination, who on 03-DEC-2007 was vaccinated with PNEUMOVAX 23 (lot # 658200/0804U) intramuscularly in the right deltoid. Concomitant therapy included influenza virus vaccine (unspecified) (Lot #AFLLA061AA) intramuscularly in the left deltoid on the same day. On 03-DEC-2007, the patient developed a silver dollar size induration, right arm was erythematous and painful the same day. The patient had a fever of 102 degrees Fahrenheit. The patient sought medical attention (date not reported) and was treated with SEPTRA DS twice a day for ten days. The patient recovered on an unspecified date. No additional information is expected.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Full blood count normal, Haemoglobin increased
Clinical narrative: Information has been received from a physician concerning a 68 year old female patient with a sulfonamide allergy, who on 29-OCT-2007 at 08:45 was vaccinated intramuscularly with a first 0.5 mL dose of PNEUMOVAX (Lot # 658673/0990U).  On 30-OCT-2007 the patent experienced redness, swelling and tenderness at the injection site.  The physician stated that the patient's arm "looked horrible."  Unspecified medical attention was sought.  The patient was advised to use cool compresses to the arm.  Diagnostic laboratory studies performed included a complete blood count on 31-OCT-2007 within normal limits except for mean corpuscular hemoglobin 34.5 pg (27-31 pg) and mean corpuscular hemoglobin concentration 36.3 g/dl (32-36 g/dl) and on 01-NOV-2007 a complete blood count within normal limits except for hemoglobin 15.2 g/dL (11.5-15.0 g/dl), and mean corpuscular hemoglobin 34.3 pg (27-34 pg); total bilirubin 1.8 mg/dL (0.1-1.2 mg/dl), serum aspartate aminotransferase test 60 IU/L (0-40 IU/L) and serum alanine aminotransferase test 110 IU/L (0-40 IU/L).  On 01-NOV-2007 the swelling decreased slightly.  On 01-NOV-2007 the patient recovered.  No product quality complaint was involved.  Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Mean cell haemoglobin, Mean cell volume decreased
Clinical narrative: Information has been received from a physician concerning a 68 year old female patient with a sulfonamide allergy, who on 29-OCT-2007 at 08:45 was vaccinated intramuscularly with a first 0.5 mL dose of PNEUMOVAX (Lot # 658673/0990U).  On 30-OCT-2007 the patent experienced redness, swelling and tenderness at the injection site.  The physician stated that the patient's arm "looked horrible."  Unspecified medical attention was sought.  The patient was advised to use cool compresses to the arm.  Diagnostic laboratory studies performed included a complete blood count on 31-OCT-2007 within normal limits except for mean corpuscular hemoglobin 34.5 pg (27-31 pg) and mean corpuscular hemoglobin concentration 36.3 g/dl (32-36 g/dl) and on 01-NOV-2007 a complete blood count within normal limits except for hemoglobin 15.2 g/dL (11.5-15.0 g/dl), and mean corpuscular hemoglobin 34.3 pg (27-34 pg); total bilirubin 1.8 mg/dL (0.1-1.2 mg/dl), serum aspartate aminotransferase test 60 IU/L (0-40 IU/L) and serum alanine aminotransferase test 110 IU/L (0-40 IU/L).  On 01-NOV-2007 the swelling decreased slightly.  On 01-NOV-2007 the patient recovered.  No product quality complaint was involved.  Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Contusion, Erythema, Joint swelling, Nuclear magnetic resonance imaging, Oedema peripheral
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a 71 year old female patient with low back pain, depression, restless legs syndrome, colonic polyp and gastrooesophageal reflux disease who in 2001 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. On 03-DEC-2007, she was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine IM 0.5 mL lot #659150/1384U. Concomitant therapy included NEXIUM, EVISTA, NEURONTIN, CYMBALTA, aspirin, TRAMADOLOR and RELAFEN. The reporter reported that the patient returned to the doctor's office on 05-DEC-2007, 06-DEC-2007 and 07-DEC-2007 since she developed redness and swelling in the left arm. An ultrasound of the left arm was completed and the result was negative. The nurse reported that the patient returned to the office for another issue on 26-DEC-2007 and that time the swelling and redness to the left arm had recovered. No additional information was available. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Pain in extremity, Pruritus, X-ray
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a 71 year old female patient with low back pain, depression, restless legs syndrome, colonic polyp and gastrooesophageal reflux disease who in 2001 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. On 03-DEC-2007, she was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine IM 0.5 mL lot #659150/1384U. Concomitant therapy included NEXIUM, EVISTA, NEURONTIN, CYMBALTA, aspirin, TRAMADOLOR and RELAFEN. The reporter reported that the patient returned to the doctor's office on 05-DEC-2007, 06-DEC-2007 and 07-DEC-2007 since she developed redness and swelling in the left arm. An ultrasound of the left arm was completed and the result was negative. The nurse reported that the patient returned to the office for another issue on 26-DEC-2007 and that time the swelling and redness to the left arm had recovered. No additional information was available. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Erythema, Oedema peripheral, Ultrasound scan normal
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a 71 year old female patient with low back pain, depression, restless legs syndrome, colonic polyp and gastrooesophageal reflux disease who in 2001 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. On 03-DEC-2007, she was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine IM 0.5 mL lot #659150/1384U. Concomitant therapy included NEXIUM, EVISTA, NEURONTIN, CYMBALTA, aspirin, TRAMADOLOR and RELAFEN. The reporter reported that the patient returned to the doctor's office on 05-DEC-2007, 06-DEC-2007 and 07-DEC-2007 since she developed redness and swelling in the left arm. An ultrasound of the left arm was completed and the result was negative. The nurse reported that the patient returned to the office for another issue on 26-DEC-2007 and that time the swelling and redness to the left arm had recovered. No additional information was available. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 55 year old white male letter carrier with an allergy to oxycodone HCl (OXYCONTIN), who on 21-JAN-2008 at 11:45 was vaccinated in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (Lot# 657525/0554U). Concomitant therapy included oxycodone HCl (OXYCONTIN). There were no illnesses at the time of the vaccination. On 22-JAN-2008 at 12:15 the patient experienced a severe headache, body aches, flu like symptoms, chills, redness and swelling in the area of the shot, and a serpigious redline originating from the vaccine site. The patient sought medical attention from the physician. It was reported by the physician that the patient still had the red line originating from the vaccine site. No laboratory diagnostics were performed. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information is not expected.
Age: 55.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pain
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 55 year old white male letter carrier with an allergy to oxycodone HCl (OXYCONTIN), who on 21-JAN-2008 at 11:45 was vaccinated in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (Lot# 657525/0554U). Concomitant therapy included oxycodone HCl (OXYCONTIN). There were no illnesses at the time of the vaccination. On 22-JAN-2008 at 12:15 the patient experienced a severe headache, body aches, flu like symptoms, chills, redness and swelling in the area of the shot, and a serpigious redline originating from the vaccine site. The patient sought medical attention from the physician. It was reported by the physician that the patient still had the red line originating from the vaccine site. No laboratory diagnostics were performed. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information is not expected.
Age: 55.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chills, Erythema, Headache, Influenza like illness, Injection site streaking
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 55 year old white male letter carrier with an allergy to oxycodone HCl (OXYCONTIN), who on 21-JAN-2008 at 11:45 was vaccinated in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (Lot# 657525/0554U). Concomitant therapy included oxycodone HCl (OXYCONTIN). There were no illnesses at the time of the vaccination. On 22-JAN-2008 at 12:15 the patient experienced a severe headache, body aches, flu like symptoms, chills, redness and swelling in the area of the shot, and a serpigious redline originating from the vaccine site. The patient sought medical attention from the physician. It was reported by the physician that the patient still had the red line originating from the vaccine site. No laboratory diagnostics were performed. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information is not expected.
Age: 55.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Pain
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 55 year old white male letter carrier with an allergy to oxycodone HCl (OXYCONTIN), who on 21-JAN-2008 at 11:45 was vaccinated in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (Lot# 657525/0554U). Concomitant therapy included oxycodone HCl (OXYCONTIN). There were no illnesses at the time of the vaccination. On 22-JAN-2008 at 12:15 the patient experienced a severe headache, body aches, flu like symptoms, chills, redness and swelling in the area of the shot, and a serpigious redline originating from the vaccine site. The patient sought medical attention from the physician. It was reported by the physician that the patient still had the red line originating from the vaccine site. No laboratory diagnostics were performed. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information is not expected.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Intussusception, Surgery
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 0.6 year old (approximately 6 month old) female child was vaccinated with her third dose of ROTATEQ (lot # 659687/1598U) by mouth. Concomitant vaccinations included PEDIARIX (lot # AC21B133DA) IM into the left leg, her third dose of ACTHIB (lot # UF216AA) IM into the left leg and her third dose of PREVNAR (lot # C45891) IM into the left leg. She developed intussusception on 18-FEB-2008, for which she underwent surgery. On 14-MAR-2008 medical record was received for date of surgery, 17-FEB-2008 through 20-FEB-2008, with diagnosis: intussusception. The infant was presented to emergency room with irritability and crying. Barium enema (+) confirmed IS but unable to fully reduce. She had an exploratory laparotomy with manual reduction of intussusception and appendectomy. she was taking po (oral) well and was discharged on the third day post operation. It was reported that an ER visit was required. Intussusception was considered to be immediately life threatening. The original reporting source was not provided. The VAERS ID # is 306368. No further information is available. 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 and was released.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Appendicectomy, Barium enema abnormal, Crying, Explorative laparotomy
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 0.6 year old (approximately 6 month old) female child was vaccinated with her third dose of ROTATEQ (lot # 659687/1598U) by mouth. Concomitant vaccinations included PEDIARIX (lot # AC21B133DA) IM into the left leg, her third dose of ACTHIB (lot # UF216AA) IM into the left leg and her third dose of PREVNAR (lot # C45891) IM into the left leg. She developed intussusception on 18-FEB-2008, for which she underwent surgery. On 14-MAR-2008 medical record was received for date of surgery, 17-FEB-2008 through 20-FEB-2008, with diagnosis: intussusception. The infant was presented to emergency room with irritability and crying. Barium enema (+) confirmed IS but unable to fully reduce. She had an exploratory laparotomy with manual reduction of intussusception and appendectomy. she was taking po (oral) well and was discharged on the third day post operation. It was reported that an ER visit was required. Intussusception was considered to be immediately life threatening. The original reporting source was not provided. The VAERS ID # is 306368. No further information is available. 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 and was released.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Irritability, Surgery, X-ray abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 0.6 year old (approximately 6 month old) female child was vaccinated with her third dose of ROTATEQ (lot # 659687/1598U) by mouth. Concomitant vaccinations included PEDIARIX (lot # AC21B133DA) IM into the left leg, her third dose of ACTHIB (lot # UF216AA) IM into the left leg and her third dose of PREVNAR (lot # C45891) IM into the left leg. She developed intussusception on 18-FEB-2008, for which she underwent surgery. On 14-MAR-2008 medical record was received for date of surgery, 17-FEB-2008 through 20-FEB-2008, with diagnosis: intussusception. The infant was presented to emergency room with irritability and crying. Barium enema (+) confirmed IS but unable to fully reduce. She had an exploratory laparotomy with manual reduction of intussusception and appendectomy. she was taking po (oral) well and was discharged on the third day post operation. It was reported that an ER visit was required. Intussusception was considered to be immediately life threatening. The original reporting source was not provided. The VAERS ID # is 306368. No further information is available. 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 and was released.