chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Malaise, Pain, Pyrexia, Swelling
Clinical narrative: Information has been received from a physician concerning a patient who on unspecified date was vaccinated with a dose of PNEUMOVAX. Subsequently, the patient experienced "induration on his deltoid and erythema". It is unknown if the patient sought medical attention. At the time of reporting, the patient's outcome was unknown. Follow up information has been received from a physician on 07-APR-2009. It was reported that the 50 year old male patient with bronchitis at the time of vaccination, who on 18-DEC-2008 was vaccinated in the left deltoid with one dose of PNEUMOVAX (Lot # 657526/055U) at 2:00 pm. On the same day, in the evening, the patient felt sick and had fever, Thursday night and Friday. The patient had chills and spot where shot was given was red, hard swollen. The patient started feeling better on 20-DEC-2008 and improved from there on. The patient had a greater than palm sized area of swelling. redness, pain and induration. This reaction was much more than physician usually see with immunization. There was no airway obstruction, no other rash/skin changes. This is one of two case from the same source. Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a male who in approximately October 2008 was vaccinated with a dose of PNEUMOVAX 23. In approximately October 2008, the patient's arm swelled. It was reported that the patient did go to the emergency room (ER) but it was unspecified if the patient was admitted. Additional information has been requested. This is an amended report. The date of vaccination has been added as "approximately October 2008".
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Adverse event, Oedema peripheral
Clinical narrative: Information has been received from a 57 year old male physician who on 03-FEB-2009 was vaccinated IM with a dose of PNEUMOVAX 23. On 03-FEB-2009 the patient experienced severe swelling under and down his arm after receiving a dose of PNEUMOVAX 23. He had another physician look at it and was told it "looked like blood poisoning". He took an unspecified antibiotic and the swelling diminished after 1 or 2 days. At the time of this report, the patient recovered (date unspecified). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: Information has been received from a medical assistant concerning a female who was vaccinated with a dose of PNEUMOVAX 23. Subsequently the patient experienced fever and swelling. Lot number and number of doses of PNEUMOVAX 23 received not provided. At the time of this report, the patient recovered from the adverse events. The patient sought unspecified medical attention. No further information is available.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injected limb mobility decreased, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a physician concerning an approximately 60 year old female who was vaccinated with a dose of PNEUMOVAX 23. Later in the vaccination evening, the patient had pain, swelling, redness, hot to touch and cellulites that went from below the injection site down the arm. The physician reported that the experience got progressively worse over the next couple of days, and a hot pad and anti inflammatory medication was provided. The physician reported that the patient was recovered on therapy. The physician reported that he gave this same vial to two other patients who had a similar experience (reported in 0902USA01697 and 0902USA01706). The patient saw physician for medical attention. Follow-up information was received from a certified medical assistant concerning a 66 year old female with hypertension (HTN), hypothyroidism, hypercholesterolaemia who on 05-FEB-2009, at 10:30, was vaccinated with a dose of PNEUMOVAX 23 (lot #: 661528/0867X) into her right deltoid. On 05-FEB-2009, at 17:00, the patient developed pain swelling redness at the injection site within 4-5 hours post injection. Area of swelling was from right shoulder to right wrist. The patient also experienced difficulty moving arm with 24 hours of injection and worsening cellulitis to 48 hours post injection. BENADRYL and ice packs provided little relief or change. Swelling and pain lasted for 72 hours post injection. Issues/reaction completely resolved within 96-100 hours post injection without further intervention. No further information is available.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Information has been received from a physician concerning an approximately 60 year old female who was vaccinated with a dose of PNEUMOVAX 23. Later in the vaccination evening, the patient had pain, swelling, redness, hot to touch and cellulites that went from below the injection site down the arm. The physician reported that the experience got progressively worse over the next couple of days, and a hot pad and anti inflammatory medication was provided. The physician reported that the patient was recovered on therapy. The physician reported that he gave this same vial to two other patients who had a similar experience (reported in 0902USA01697 and 0902USA01706). The patient saw physician for medical attention. Follow-up information was received from a certified medical assistant concerning a 66 year old female with hypertension (HTN), hypothyroidism, hypercholesterolaemia who on 05-FEB-2009, at 10:30, was vaccinated with a dose of PNEUMOVAX 23 (lot #: 661528/0867X) into her right deltoid. On 05-FEB-2009, at 17:00, the patient developed pain swelling redness at the injection site within 4-5 hours post injection. Area of swelling was from right shoulder to right wrist. The patient also experienced difficulty moving arm with 24 hours of injection and worsening cellulitis to 48 hours post injection. BENADRYL and ice packs provided little relief or change. Swelling and pain lasted for 72 hours post injection. Issues/reaction completely resolved within 96-100 hours post injection without further intervention. No further information is available.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a physician concerning an approximately 50 year old male who was vaccinated with a dose of PNEUMOVAX vaccine. Later in the vaccination evening, the patient had pain, redness, hot to the touch and cellulitis that went from the injection site down his arm. The physician reported that the experience got progressively worse over the next couple of days. The physician reported that the patient had recovered on therapy. The physician reported that he gave this sale vial to two other patients who had a similar experience (reported in 0902USA01696 and 0902USA01706). The patient called physician for medical attention. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Information has been received from a physician concerning a 4 year old female who was vaccinated with a dose of PNEUMOVAX 23 in her thigh. Later in the vaccination evening, the patient had experienced swelling of the thigh, redness, hot to touch, cellulites and pain that went from the injection site down the leg. The physician reported that the experience got progressively worse over the next couple of days, and a hot pad and anti inflammatory medication was provided. At the time of this report, the patient has seen the physician and was recovered on therapy. The physician reported that he gave this same vial to two other patients who had a similar experience (reported in 0902YUSA01696 and 0902USA01697). Additional information has been requested.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from an office manager concerning a patient who on an unknown date, was vaccinated with PNEUMOVAX 23 (lot# not reported). Concomitant therapy include influenza virus vaccine (unspecified). Subsequently the patient experienced something like an anaphylactic response. Unspecified medical attention was sought. Additional information has been requested.
Age: 0.7
Sex: F
Vaccine: PPV
Symptoms: Rhinorrhoea, Wrong drug administered
Clinical narrative: Information has been received from a registered pharmacist concerning an 8 month old female child who on 11-FEB-2009 was vaccinated with PNEUMOVAX vaccine (lot # 662017/1287X). On 12-FEB-2009 the patient had a runny nose. The mother also mentioned that the child's sister had a cold. The child also received other unknown vaccines. It was unknown why PNEUMOVAX vaccine was given when the child was supposed to get PEDIARIX. The child's mother spoke to physician and pharmacist in person for medical attention. At the time of reporting the child's runny nose persisted. As of 16-FEB-2009 follow up attempts have not provided additional information regarding product confusion. Follow-up information has been received from the Licensed Practical Nurse that the child was vaccinated with PNEUMOVAX vaccine (lot # 662017/1287X) instead of PEDIARIX on 09-FEB-2009. The child would be given PEDIARIX at her next 9 month well baby checkup. The child and the child's sister were exhibiting signs of cold symptoms but there was no concern as the family household was experiencing colds at the time. The administration of PNEUMOVAX vaccine instead of PEDIARIX was a result of human error. The nurse who administered the vaccine did not normally work in that office and she felt the cap colors were similar. The 2 vaccines were also stored in the same refrigerator. She mistakenly picked up the PEDIARIX. The office had no suggestion other than perhaps making the cap color a different color than any other vaccines. The Licensed Practical Nurse felt it was more human error than product confusion. Follow-up information has been received from the Licensed Practical Nurse that the child was born at 7 lbs and 14 ounces and had 2 siblings. The Licensed Practical Nurse reported that on 09:30 AM 09-FEB-2009 the child was vaccinated with her first dose of PNEUMOVAX vaccine (lot # 662017/1287X) IM into the right leg instead of PEDIARIX. At the time of the report, the patient's weight was reported as 18 lbs, 7 ounces and height was 26.5 inches. No further information is available.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hyperaesthesia, Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 36 year old female patient with BACTRIM and BIAXIN allergy and no known medical history who on 10-FEB2009 was vaccinated intramuscularly into the right arm with the first 0.5ml dose of PNEUMOVAX 23 (Lot #662599/1076X). Concomitant therapy included hormonal contraceptives (unspecified). On 11-FEB-2009 the patient experienced swelling, warmth, decreased mobility, and pain in her right arm after vaccination. The patient was unable to tolerate anything touching her arm. The patient was started on CIPRO on 10-FEB-2009. The patient sought medical attention by office visit. At the time of reporting the patient had not recovered. In follow-up, the medical assistant reported that the patient was a 36 year old female patient, weighing 137 pounds and 60 inches in height, who was vaccinated in the right arm with the first dose of PNEUMOVAX 23. At the time of the vaccination, the patient had recurrent sinusitis. The medical assistant reported that on 11-FEB-2009, the patient experienced red swelling and pain. The patient recovered on 20-FEB-2009. Additional information is not expected.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pain, Swelling
Clinical narrative: Information has been received from a medical assistant concerning a 36 year old female patient with BACTRIM and BIAXIN allergy and no known medical history who on 10-FEB2009 was vaccinated intramuscularly into the right arm with the first 0.5ml dose of PNEUMOVAX 23 (Lot #662599/1076X). Concomitant therapy included hormonal contraceptives (unspecified). On 11-FEB-2009 the patient experienced swelling, warmth, decreased mobility, and pain in her right arm after vaccination. The patient was unable to tolerate anything touching her arm. The patient was started on CIPRO on 10-FEB-2009. The patient sought medical attention by office visit. At the time of reporting the patient had not recovered. In follow-up, the medical assistant reported that the patient was a 36 year old female patient, weighing 137 pounds and 60 inches in height, who was vaccinated in the right arm with the first dose of PNEUMOVAX 23. At the time of the vaccination, the patient had recurrent sinusitis. The medical assistant reported that on 11-FEB-2009, the patient experienced red swelling and pain. The patient recovered on 20-FEB-2009. Additional information is not expected.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Information has been received from a retired registered nurse concerning her 43 year old daughter with "MELOXOCAM" allergy and arthritis and scoliosis who on 09-FEB-2009 was vaccinated with her first dose of PNEUMOVAX.  On 10-FEB-2009 the patient experienced widespread muscle aching and "flu-like symptoms".  The patient also developed soreness and swelling at the injection site of the right upper arm.  The nurse reported that her daughter had not sought medical attention for the adverse reaction.  At the time of reporting the patient's adverse reaction persisted.  No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning unspecified number of patients who "about a year ago" were vaccinated with PNEUMOVAX (lot number 655289/0958F).  Subsequently the patients experienced painful swelling on the injection site.  The patients had sought medical attention from the physician. The outcome of the unspecified number of patient's adverse effect was not reported.  Attempts are being made to obtain number of patients and additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.
Sex: M
Vaccine: PPV
Symptoms: Gait disturbance, Lymphadenopathy
Clinical narrative: Information has been received concerning a male physician who on 13-FEB-2009 was vaccinated with PNEUMOVAX vaccine 0.5ML (lot# 659922/1667U). Subsequently the physician experienced swollen lymph nodes and could hardly walk. Unspecified medical attention was sought. No further information is available.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 67 year old female with mitral valve prolapse, elevated lipids, diverticulitis, irritable bowel syndrome, reflux, osteoporosis, penicillin allergy, sulfonamide allergy and allergies to erythromycin, fluoroquinolones, dicyclomine, "statins" and ACIPHEX who in 1999 was vaccinated with the first dose of PNEUMOVAX vaccine (lot# not reported). On 16-FEB-2009 the patient received the second dose of PNEUMOVAX vaccine (lot# 663012/1163X). Concomitant therapy included NIASPAN, estrogens, PREMARIN, aspirin (manufacturer unknown), ezetimibe, DITROPAN, PREVACID and NASONEX. On 16-FEB-2009 the patient developed injection site reaction on her left arm. She had warmth and swelling that was 6 inches long and 5 inches wide. There was redness inferior to the injection site and it looked like cellulitis. There was no itching. The patient was given an injection of DEPO-MEDROL 60mg on 17-FEB-2009. The patient's symptoms persisted. The patient sought medical attention in the office. In follow-up, the registered nurse reported that the patient with fatigue, osteopenia, hypolipidaemia and allergies to LEVAQUIN, BENADRYL and CIPRO received her first dose (previously reported by the same nurse as the second dose) of PNEUMOVAX vaccine (lot# 663012/1163X) into left deltoid on 16-FEB-2009. On 16-FEB-2009 the patient developed redness at injection site with no itching. On 17-FEB-2009 the redness had spread inferior to the majority of the dorsum of the lower upper arm. The patient also had a swollen and warm left deltoid. On 17-FEB-2009, the patient was given OMNICEF 300mg BID #20 and DEPO-MEDROL 60mg IM for treatment. Subsequently, the patient recovered. The reporter considered the events to be non-serious. Additional information is not expected.
Age: 81.0
Sex: M
Vaccine: PPV, TD
Symptoms: Cellulitis
Clinical narrative: Information has been received from a nurse concerning an 81 year old male who on 13-FEB-2009 was vaccinated SQ with a dose of PNEUMOVAX vaccine into the right arm and tetanus diphtheria into the left arm. On 13-FEB-2009 evening, the patient developed cellulitis on the right arm. It was reported that the patient was followed-up on 16-FEB-2009. The patient was given an unspecified antibiotic. The patient was seen for medical attention. Follow-up information was received from a physician office staff member concerning 81 year old male sulfonamide and terazosin allergy, hyperlipidaemia, hypertension, abdominal aortic aneurysm, angina and carotid bruit and a history of stent placement who on 13-FEB-2009, at 13:00, was vaccinated SQ with a 0.5ml dose of PNEUMOVAX vaccine into the right arm. Later that evening from injection site down past the elbow to just above the wrist, the patient exhibited an onset of redness, swelling, pain and flesh which was warm to hot the touch. The physician's diagnosis was cellulitis and prescribed doxycycline 100mg twice daily for 10 days. At the time of this report, the patient was recovered. Cellulitis was considered to be an other important medical event. No further information is available.
Age: 1.0
Sex: M
Vaccine: IPV, MMR, PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse and a certified medical assistant concerning a 12 month old male, who on an unknown date was vaccinated with PNEUMOVAX (Lot number 663012/1163X). The reporters stated that the patient was inadvertently given PNEUMOVAX instead of the third dose of PREVENAR. The medical assistant reported that this was an office error. The patient sought medical attention. Additional information has been requested. Follow up information has been received from a certified medical assistant concerning a 12 month old male who on 23-FEB-2009 was vaccinated intramuscularly with 0.5mL dose of PNEUMOVAX. Concomitant therapy included MMR II (lot number 661679/1247X), VARICELLA vaccine (lot number 658964/1466U) and POLIO (lot number A11092) (unknown manufacturer). The reporter stated that the reason for the confusion was name error and that vaccines were stored in the same refrigerator. The patient did not experience any adverse events. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Information has been received from a healthcare worker concerning a 46 year old female patient, with no known drug reactions/allergies and with a history of therapeutic phlebotomy for polycythaemia, who on 19-FEB-2009 was vaccinated with the first dose of PNEUMOVAX (lot number was unknown). The reporter stated that on 20-FEB-2009, the patient "felt ill". She also experienced soreness, redness and swelling at the injection. The patient sought medical attention via telephone. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 75.0
Sex: U
Vaccine: PPV
Symptoms: Rash macular, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 75 year old patient with hypothyroidism, no known drug allergies and a history of depression and breast cancer who in August 2006, was vaccinated with the first dose of PNEUMOVAX (lot # not provided) 0.5 ml intramuscularly on the left deltoid. On October 2008 patient received a second dose of PNEUMOVAX (lot # not provided) 0.5 ml intramuscularly on the left deltoid. Concomitant therapy included CYMBALTA. On approximately 16-FEB-2009, "last week", the patient developed a pruritic, macular rash of the left deltoid area. The patient was examined in the office but no treatment was prescribed. No lab diagnostics studies performed. Patient is scheduled for an evaluation with an unspecified dermatologist. At the time of this report the patient had not yet recovered. Additional information has been requested.
Sex: F
Vaccine: PNC
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a female who on 25-FEB-2009 was inadvertently vaccinated with one dose of (PREVENAR) (lot number, route and site not reported) instead of PNEUMOVAX. No adverse effects were reported. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia, Influenza like illness, Injected limb mobility decreased, Injection site erythema, Injection site inflammation
Clinical narrative: Information has been received from a nurse concerning a male physician with hypercholesterolemia who in approximately 2002, "about 7 years ago" was vaccinated with the first 0.5 ml dose of PNEUMOVAX 23 intramuscularly. On 24-FEB-2009 the patient was vaccinated with the second 0.5 ml dose of PNEUMOVAX 23 (Lot # 661529/0868X) intramuscularly. Concomitant therapy included TRICOR and MICRO K. It was reported that on 24-FEB-2009, the patient developed high fever, swelling of the entire left arm and left axillary nodes, and "flu-like symptoms" a few hours after receiving his second dose of PNEUMOVAX 23 on 24-FEB-2009. It was reported that the patient was taking ADVIL and BENADRYL and was recovering. The patient sought unspecified medical attention. Follow up information was received from a registered nurse (R.N.) concerning a patient with no pertinent medical history and no known drug allergies/drug reactions who on 24-FEB-2009 was vaccinated with a fourth dose of PNEUMOVAX 23 (Lot # 661529/0868X) at 14:00. It was reported that on 24-FEB-2009 at 16:00 the patient experienced swelling redness and inflammation at the injection site and down arm; he also experienced decreased function, as well as numbness and tingling down arm. It was reported that the reaction lasted three days before improvement. This is one case of three from the same source. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Lymphadenopathy, Oedema peripheral, Paraesthesia, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a male physician with hypercholesterolemia who in approximately 2002, "about 7 years ago" was vaccinated with the first 0.5 ml dose of PNEUMOVAX 23 intramuscularly. On 24-FEB-2009 the patient was vaccinated with the second 0.5 ml dose of PNEUMOVAX 23 (Lot # 661529/0868X) intramuscularly. Concomitant therapy included TRICOR and MICRO K. It was reported that on 24-FEB-2009, the patient developed high fever, swelling of the entire left arm and left axillary nodes, and "flu-like symptoms" a few hours after receiving his second dose of PNEUMOVAX 23 on 24-FEB-2009. It was reported that the patient was taking ADVIL and BENADRYL and was recovering. The patient sought unspecified medical attention. Follow up information was received from a registered nurse (R.N.) concerning a patient with no pertinent medical history and no known drug allergies/drug reactions who on 24-FEB-2009 was vaccinated with a fourth dose of PNEUMOVAX 23 (Lot # 661529/0868X) at 14:00. It was reported that on 24-FEB-2009 at 16:00 the patient experienced swelling redness and inflammation at the injection site and down arm; he also experienced decreased function, as well as numbness and tingling down arm. It was reported that the reaction lasted three days before improvement. This is one case of three from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Lymphadenopathy, Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a female office receptionist who on 24-FEB-2009 was vaccinated IM with the second 0.5 mL dose of PNEUMOVAX (661529/0868X). Concomitant therapy included PROTONIX and BENICAR. Later that night the patient developed high fever, swelling of the entire left arm, and left axilliary nodes and flu-like symptoms. the patient was advised to take ADVIL and BENADRYL. At the time of reporting the patient was recovering. It was reported that two other patients experienced the similar adverse events after being vaccinated with the same lot number of PNEUMOVAX. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a female office medical assistant who on 24-FEB-2009 was vaccinated IM with the first 0.5 mL dose PNEUMOVAX (661529/0868X). Concomitant therapy included birth control pills (unspecified), antidepressant (unspecified) and diuretic (unspecified). A few hours after receiving the vaccine, the patient developed high fever, swelling at the injection site on the left upper arm, left axillary nodes and body aches. The patient was advised to take ADVIL and BENADRYL. At the time of reporting the patient was recovering. It was reported that two other patients experienced the similar adverse events after being vaccinated with the same lot number of PNEUMOVAX. The physician returned the PNEUMOVAX. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Ecchymosis, Haematoma, Injected limb mobility decreased, Joint range of motion decreased
Clinical narrative: Information has been received from a physician concerning a 69 year old female who on 21-JAN-2009 was vaccinated with a 0.5mL dose of PNEUMOVAX (lot number 659150/1384U).  On 22-JAN-2009, the as next day after vaccination the patient experienced stiffness on her arm, blood clot and bruises on her arm.  Physician noted that the arm where the patient had the reaction is not the injection site where she received PNEUMOVAX.  The patient recovered from the events on an unknown date.  The patient sought medical attention by calling the office.  Follow-up information was received from a physician concerning the 69 year old female patient with no pertinent medical history and no known allergies/drug reactions who on 21JAN-2009 received the dose of PNEUMOVAX (lot number 659150/1384U) intramuscularly into her left deltoid.  The physician reported that on 22-JAN-2009, the patient described feeling tightness, heaviness in arm and subsequently went on to difficulty moving the arm and had decreased range of motion for 1-2 weeks.  On 23-JAN-2009, two days after vaccination, the patient also developed ecchymosis and hematoma in antecubical fossa.  The physician described all the adverse events as self limiting.  At the time of the report, the patient had recovered.  No relevant diagnostic tests and laboratory data were performed.  There was no illness at time of vaccination.  No further information is available.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Sensation of heaviness, Thrombosis
Clinical narrative: Information has been received from a physician concerning a 69 year old female who on 21-JAN-2009 was vaccinated with a 0.5mL dose of PNEUMOVAX (lot number 659150/1384U).  On 22-JAN-2009, the as next day after vaccination the patient experienced stiffness on her arm, blood clot and bruises on her arm.  Physician noted that the arm where the patient had the reaction is not the injection site where she received PNEUMOVAX.  The patient recovered from the events on an unknown date.  The patient sought medical attention by calling the office.  Follow-up information was received from a physician concerning the 69 year old female patient with no pertinent medical history and no known allergies/drug reactions who on 21JAN-2009 received the dose of PNEUMOVAX (lot number 659150/1384U) intramuscularly into her left deltoid.  The physician reported that on 22-JAN-2009, the patient described feeling tightness, heaviness in arm and subsequently went on to difficulty moving the arm and had decreased range of motion for 1-2 weeks.  On 23-JAN-2009, two days after vaccination, the patient also developed ecchymosis and hematoma in antecubical fossa.  The physician described all the adverse events as self limiting.  At the time of the report, the patient had recovered.  No relevant diagnostic tests and laboratory data were performed.  There was no illness at time of vaccination.  No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received via Novartis (manufacturer control # S2009US02845), from a female that received a dose of PNEUMOVAX (manufacturer unknown) in 2004, that caused pain in her arms for years. No further information is available.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 77 year old female patient with ULTRAM and PENICILLIN allergy, who in 1998 was vaccinated with the first dose of PNEUMOVAX, 0.5ml, intramuscularly;  in October 2008, was vaccinated with the second dose of PNEUMOVAX, 0.5ml, intramuscularly and on 24-FEB-2009, was inadvertently vaccinated with a third dose of PNEUMOVAX, 0.5ml, intramuscularly (Lot # /0982X).  Concomitant therapy included SIMVASTATIN (manufacturer unknown), levothyroxine Na, DIAZIDE and baby ASPIRIN.  The nurse reported  that on 24-FEB-2009, the patient experienced redness and pain at the injection site.  It was noted that the redness and pain began at the injection site and extended towards the elbow.  The patient sought medical attention and was seen at the physician's office.  At the time of the report, the patient had not recovered.  Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Injection site swelling, Joint range of motion decreased, Oedema peripheral
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old male who on 26-FEB-2009 was vaccinated with the first dose of PNEUMOVAX (lot n. 661528/0867X).  Concomitant therapy included influenza virus vaccine (unspecified).  The pharmacist reported that the patient experienced soreness and swelling at the injection site 4 hours after administration of his first dose of PNEUMOVAX.  The patient eventually was not able to raise his arm above his head because of pain.  His arm swelled to twice its normal size and became red and warm to touch from injection site area to his elbow.  The patient sought medical attention via telephone.  He had been taking IBUPROFEN and TYLENOL.  The pharmacist stated that the patient receives influenza virus vaccine (unspecified) once a year occasionally has experienced mild swelling at the size of injection.  No labs were performed.  At time of reporting the patient had experienced some improvement with pain and swelling.  Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old male who on 26-FEB-2009 was vaccinated with the first dose of PNEUMOVAX (lot n. 661528/0867X).  Concomitant therapy included influenza virus vaccine (unspecified).  The pharmacist reported that the patient experienced soreness and swelling at the injection site 4 hours after administration of his first dose of PNEUMOVAX.  The patient eventually was not able to raise his arm above his head because of pain.  His arm swelled to twice its normal size and became red and warm to touch from injection site area to his elbow.  The patient sought medical attention via telephone.  He had been taking IBUPROFEN and TYLENOL.  The pharmacist stated that the patient receives influenza virus vaccine (unspecified) once a year occasionally has experienced mild swelling at the size of injection.  No labs were performed.  At time of reporting the patient had experienced some improvement with pain and swelling.  Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician assistant concerning a male over 60 year old who on an unknown date was vaccinate with an unspecified dose of PNEUMOVAX vaccine. Physician assistant reported that the patient developed hives after receiving PNEUMOVAX vaccine. It is unknown if this was the only PNEUMOVAX vaccine for this patient. The hives have appeared intermittently since PNEUMOVAX vaccine and respond to BENADRYL. The patient has had several episodes of hives separated by varying periods of time (no pattern). Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature decreased, Injection site cellulitis, Injection site erythema, Injection site pain, Skin striae
Clinical narrative: Information has been received from a physician and via medical records. A 45 year old male with gastroesophageal reflux disease, irritable bowel syndrome, allergy to SKELAXIN and IMITREX, migraine and a history of hernia repair, was vaccinated with a dose of PNEUMOVAX vaccine  (lot # 662599/1076X) 0.5ml, IM into his right deltoid on 05-FEB-2009 at 8:45 am. At time of vaccination, the patient had polycythemia. On 06-FEB-2009 the patient complained of streaking of the skin and pain with movement of the right shoulder. On 07-FEB-2009, the patient went to the emergency room and presented with redness and pain on the right biceps and was given KEFLEX. On 10-FEB-2009, the patient denied fever, chills and sweats, nausea, vomiting and diarrhea, shortness of breath and chest pain. On the same day, physical examination resulted normal. Heart rate was 80 and blood pressure measurement was 130/80 and 110/70. Total heartbeat count was 80. The patient's body temperature was 88.2. The  patient was diagnosed with right shoulder cellulitis. The patient was recovering from cellulitis and was asked to continue with antibiotics until finished. The patient was advised to use warm compress and to return to office if symptoms return. The patient's GERD and IBS were stable. It was reported that the patient was not in medication for GERD and IBS. No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Mental status changes, Pyrexia
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a female who was vaccinated with a dose of PNEUMOVAX (lot # not reported) several years ago.  Subsequently the patient developed a "very high fever" for one week and as the patient stated it was "out of my head".  The patient sought unspecified medical attention.  On an unspecified date the patient recovered.  Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a medical assistant concerning a 6 year old male with no pertinent medical history and no reported allergies, who on 04-Mar-2009was vaccinated SC in his left arm with a 0.5ml dose of PNEUMOVAX 23 (lot number 1085X). Concomitant therapy included glucosamine, saw palmetto, vitamins (unspecified) and Naprosyn. The medical assistant reported that on 07-Mar-2009, the patient's left arm was swelled as if had cellulitis. The patient went to the emergency room over the weekend. The patient recovered from the event on an unspecified date. No labs studies were performed. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with PNEUMOVAX (lot # not provided).  It was reported that on an unspecified date the patient developed severe fever after getting PNEUMOVAX.  The patient sought unspecified medical attention.  Patient's outcome is unknown.  Additional information is not expected.
Age: 1.5
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation, Wrong drug administered
Clinical narrative: Information has been received from an office manager concerning an 18 month old female who was vaccinated with PNEUMOVAX vaccine, instead of PREVNAR vaccine on the leg. Secondary suspect therapy included poliovirus vaccine inactivated (manufacturer unknown) on the same leg. On an unspecified date the patient developed inflammation on her leg. The patient was brought to the emergency room but was not admitted to the hospital (hospital demographics unspecified). Subsequently, the patient recovered from inflammation on her leg. Follow up information was received from the office manager who reported that a medical assistant was filling in for a nurse on maternity leave. The medical assistant was not very familiar with pediatric vaccines and misread the order for the patient. When the problem was realized, the mother was contacted. At the time of reporting, the patient was fine. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from an office manager concerning a 71 year old female with drug hypersensitivity of lisinopril and AUGMENTIN, oesophageal reflux, hypertension, venous insufficiency and arthritis who at 13:30 on 27 Feb 2009 was vaccinated in the deltoid with a third dose of PNEUMOVAX 23 vaccine (lot number 663012/1163X). On the same day the patient experienced "very severe" injection site reaction consisting of 4x8 erythema; painful and hot on injected arm. The patient sought medical attention by office visit. The patient was treated with "medrose pack" and KEFLEX 500MG. Two weeks later the patient recovered. 4x8 erythema; painful and hot on injected arm was reported as other important medical events. This is one of several reports from the same source. No further information was available.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a healthcare worker concerning a 67 year old female patient with diabetes; hypertension; hypercholesterolaemia and hypothyroidism and no known drug allergies who in November 2003, was vaccinated with the first 0.5 ml IM dose of PNEUMOUVAX 23. On 10-Mar-2009 the patient received the second 0.5 ml dose of PNEUMOUVAX 23 IM into her left deltoid (lot number 1161X. Concomitant therapy included QUINAPRIL HC1; SYNTHROID; ASPRIN and RANITIDINE. After receiving vaccine the patient developed redness; pain swelling and warmth in her left arm at the injection site. No lab diagnostics studies were performed. At the time of reporting the outcome was unknown. The patient sought medical attention via phone call. This is one of several reports from the same source. Follow up information was received from a physician concerning the female patient who on 10-Mar-2009 at 8:30 was vaccinated with the second 0.5 ml dose of PNEUMOVAX 23 IM into her left deltoid ( lot number 1161X). There was no illness at the time of vaccination on 11-Mar-2009 the patient developed redness; pain and swelling. At the time of reporting the patient recovered. The patient did not seek medical attention. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Information has been received from a manager and physician concerning a 65 year old Caucasian female worker with diabetes; hyperlipidaemia and hypertension and no known allergies who at 15:00 on 12-FEB-2009 was vaccinated with a dose of PNEUMOVAX 23 into her deltoid (lot # 662599/1076X. There was no illness and the patient had a routine office visit at the time of vaccination. On 12-FEB-2009 the patient developed 6x8 erythema, hot and pain at injected arm. The patient was treated with KEFLEX and BENADRYL in the office. Subsequently, the patient recovered. The patient sought medical attention via office visit. 6x8 erythema at injected arm, hot at injected arm and pain at injected arm wre determined to be other important medical events. This is one of several reports from the same source. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 2 month old female who on 16-MAR-2009 was vaccinated with a 0.5 mL dose of PNEUMOVAX 23 intramuscularly. The patient had not experienced any known symptoms. Follow up information was received from a RN who stated that a new nurse was confused and gave the infant PNEUMOVAX 23 instead of PREVNAR. It was reported that the patient was doing fine. This was a case of product confusion. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician concerning a male who on 23-JAN-2009 was vaccinated with "one dose" on PNEUMOVAX 23 (lot number was not available). On 27-JAN-2009 the patient developed swelling at the injection site. The patient had "unspecified test". At time of the report the patient was not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Inappropriate schedule of drug administration, Oedema peripheral
Clinical narrative: Information has been received from a nurse practitioner concerning an 81 year old male patient with arthritis who in 1998 was vaccinated with a dose of PNEUMOVAX 23, in October 2007 was re-vaccinated with PNEUMOVAX 23 and on 10-MAR-2009 received a third dose of PNEUMOVAX 23. Concomitant therapy included sulindac (MSD). It was reported that the patient experienced a very bad reaction of redness and swelling that started in his upper arm and moved to the forearm. The patient outcome was not reported. It was reported that there was no death, hospitalization or life threatening effects. Follow-up information has been received from a nurse practitioner concerning the patient. It was reported that the patient had redness and excessive swelling in arm given in. Afterwards, the patient checked his records and he realized he had PNEUMOVAX 23, 2 years prior. At the time of reporting the patient had recovered. No further information is available.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Information has been received from a licensed practical nurse, concerning a 72 year old female with hypertension, chronic obstructive pulmonary disease, hypothyroidism, ATIVAN and penicillin allergy and with a history of lung cancer, who on 03-MAR-2009 was vaccinated with PNEUMOVAX 23 (659922/1667U), 0.5 ml, intramuscularly. Concomitant therapy included unspecified blood pressure medication, BENADRYL, montelukast sodium (MSD), and SYNTHROID. The licensed practical nurse reported that on 04-MAR-2009, the patient experienced pain, redness and swelling in her arm the day after receiving the vaccination. It was noted that the reaction occurred in the general area of the injection site. The patient was treated with antibiotic. The patient had previously received an unspecified number of PNEUMOVAX 23. The patient recovered on an unspecified date. The patient sought medical attention and was seen at the nurse's practice. Follow-up information was received from the licensed practical nurse indicating that the patient was a 72 year old female patient weighing 117 pounds and 61.5 inches in height, with penicillin allergy, who on 03-Mar-2009 at 11:30 AM was vaccinated with the fourth dose of PNEUMOVAX 23 (659922/1667U), intramuscularly in the left deltoid. It was reported that the patient was not acutely ill at the vaccination visit. The reporter stated that on 04-MAR-2009 at 11:00 AM, the patient was given cephalexin 500mg. It was reported that the patient was offered an ultrasound of area but she declined. At the time of report, the patient was still complaining of pain in arm. Pain around injection site, injection site red and swollen were considered to be another important medical event by the licensed practical nurse. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Information has been received from a pharmacist concerning a female nurse who was vaccinated with PNEUMOVAX 23 (Lot number 0980X). The pharmacist reported that the patient developed itching; redness and soreness at the injections site. It is not known if this was the first dose of PNEUMOVAX 23 or not. The patient recovered on an unspecified date. The patient sought medical attention contacting the pharmacist. Follow-up information was received from the pharmacist indicating that the patient was a 71 year old caucasian patient, weighing 169 pounds and 68 inches in height, who on 18-Mar-2009 at 8:23 AM was vaccinated intramuscularly with the first dose of PNEUMOVAX 23. There were no illnesses at the time of the vaccination. There was no concomitant medication. The pharmacist reported that on 18-Mar-2009 at 8:23 AM the patient developed an area very red itchy; sore and warm to touch; and small blister. It was reported that the patient took BENADRYL, Over the counter and was told to elevate and rest arm per doctor. At the time of the report, the patients status was unknown. This is one of several reports from the same source. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated IM with the second 0.5ml dose of PNEUMOVAX. After getting the second dose, the patient arm swelled up like a balloon. At the time of this report, the patient was recovered (date unspecified). This happened some time ago. The patient was seen for medical attention. No further information is available.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning a male physician who was vaccinated with a dose of PNEUMOVAX (662663/0980X). It was not known if this was the first dose or not. Subsequently the patient experienced soreness at the injection site. At the time of reporting, the patient recovered. The patient sought medical attention via contacting the pharmacist. This is one of several reports from the same source. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning a male physician who was vaccinated with a dose of PNEUMOVAX (lot # 662041/0612X). It was unknown if this was the first dose for the physician or not. Subsequently the patient experienced soreness and redness at the injection site. At the time of reporting, the patient recovered. The patient sought medical attention via contacting the pharmacist. This is one of several reports from the same source. Additional information has been requested.