chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 65 year old retired male with no illness at the time of vaccination, polyarthritis, peripheral vascular disorder, hypertension and a history of non-specific abnormal liver function studies related to hyperlipidemia who on 19-MAR-2007 was vaccinated with a first dose of Pneumovax 23 (lot # 655290/0959F) 0.75 to 0.8 ml subcutaneously in the right tricep area at 10:30 AM. Concomitant therapy included enalapril maleate (MSD), warfarin, DEMADEX, amitriptyline hydrochloride (MSD), OMACOR, meclizine and VIAGRA. The nurse withdrew 1 ml. from a multi-dose vial of Pneumovax 23. During administration, the nurse realized the recommended dose, stopped administration of the 1 ml dose and 0.75 to 0.8 ml was administered to the patient. On 20-MAR-2007 (previously reported as 19-MAR-2007), the patient experienced chills and fever. At the time of reporting, the patient had not recovered. No further information was available at the time of reporting. Follow-up information was received from the licensed practical nurse. On 20-MAR-2007, the patient experienced fever, chills, muscle aches, and erythema of the right tricep. No diagnostic tests were performed. The patient was treated with rest, fluids, and TYLENOL. On 23-MAR-2007, the patient reported feeling much better and had recovered. No additional information is expected.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Information has been received from a certified medical assistant concerning an 80 year old female with hypertension who on 13-MAR-2007 was vaccinated with a dose of Pneumovax 23 (lot #655152/0889F), 0.5 ml, IM.  Concomitant therapy included alendronate sodium (MSD) and MICARDIS.  On 14-MAR-2007, the patient experienced redness in the arm in which she was vaccinated (which arm was unspecified).  The patient was treated with topical hydrocortisone and TYLENOL.  The outcome and causality of the event was not reported.  Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant concerning a 69 year old female with hyperthyroidism, hyperlipidaemia, hypertension and no history of drug reactions/allergies who on 15-MAR-2007 was vaccinated with one dose of Pneumovax 23 (lot # 655152/0889F) 0.5 ml IM.  Concomitant therapy included aspirin, simvastatin (MSD), DIOVAN, and atenolol.  On 16-MAR-2007, the patient experienced redness and swelling from the shoulder to elbow in the arm in which she was vaccinated.  Medical attention was sought.  Treatment included topical hydrocortisone and TYLENOL.  At the time of reporting, the patient had recovered.  Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse practitioner concerning a 54 year old female with diabetes, hypothyroidism, hypercholesterolaemia, and drug allergies to aspirin and ACTOS who on 13-MAR-2007 was vaccinated subcutaneously in the left arm with a 0.5 mL dose of Pneumovax 23 (Lot# 651406/0620F).  There was no concomitant medication.  On 14-MAR-2007 the patient developed an injection site reaction.  It was reported that the development of the reaction was unclear, but on 14-MAR-2007, the patient was seen in the office and the injection site was red, swollen and hot to the touch from the shoulder to the elbow.  There was no fever.  The patient was treated with ice applied to the site and unspecified nonsteroidal anti-inflammatories and BENADRYL.  The reaction started to resolve on 18-MAR-2007 and the patient was considered to be recovering.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site nodule
Clinical narrative: Information has been received from a health professional concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with a dose of Pneumovax 23 (lot 651319/1007P).  Subsequently the patient experienced knotting at the injection site.  the patient sought unspecified medical attention.  At the time of this report, the outcome was unknown.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant concerning a 65 year old female who on 19-MAR-2007 was vaccinated, intramuscularly with a 0.5 mL dose of Pneumovax 23, (Lot #655500/1005F).  There was no concomitant medication.  On 20-MAR-2007 the patient developed injection site reaction that was red, swollen, and hot to touch, about one day after the Pneumovax 23 vaccination.  The patient sought unspecified medical attention.  The patient was treated with KEFLEX.  No other symptoms noted.  At the time of the report, the patient had recovered.  Additional information has been requested. Follow-up received 08/06/2008 reported patient is retired female. Vaccinated in left deltoid with first dose of PNEUMOVAX. At the time of the report it was unknown if the patient recovered. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Lymphadenopathy, Neck pain
Clinical narrative: Information has been received from a 59 year old nurse via a company representative concerning herself.  The nurse reported that on 14-DEC-2006, she was vaccinated with a dose of Pneumovax 23 (Lot# 651357/0391F) and subsequently had an adverse reaction to the vaccine.  The nurse reported that within 24 hours of getting the vaccine, on 15-DEC-2006, she developed a rash around the injection site and pain that radiated from the injection site to her neck.  She also reported having swollen lymph nodes in her neck.  The nurse felt that her experience was related to therapy with Pneumovax 23.  The nurse sought unspecified medical attention.  On an unknown date, she recovered.  Additional information has been requested. 02/19/2010 The nurse felt that her experience was related to therapy with PNEUMOVAX. 23 The nurse originally indicated she sought medical attention, but on follow up confirmed no treatment or visist was required. On an unknown date, she recovered. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: Information has been received from a registered nurse concerning a female patient (age unknown) who, on an unspecified date, was vaccinated with a dose of Pneumovax 23.  Subsequently, on an unknown date, the patient developed a "sizable rash which extended from the injection site to the patient's elbow after being vaccinated."  Unspecified medical attention was sought.  At the time of this report, the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Oedema peripheral
Clinical narrative: Information has been received from a nurse practitioner concerning a 27 year old female who, on an unspecified date, was vaccinated with a dose of Pneumovax 23.  Immediately following vaccination, the patient's arm swelled up to 3 times the normal size and the patient developed a temperature of 105 degrees.  The patient sought unspecified medical attention.  The patient was not a patient of the reporter at the time the Pneumovax 23 was administered.  At the time of this report, the outcome was unknown.  No product quality complaint was involved.  Additional information is not expected.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a pharmacist concerning a 53 year old female who on 12-DEC-2005 had a pre-vaccination titer performed. On 10-JAN-2006, the patient was vaccinated with Pneumovax 23 (lot # not reported). On 19-MAR-2007, the patient had a post vaccination titer performed that revealed low titer. Medical attention was sought. No symptoms have been reported. No further information was available at the time of reporting. Additional information has been requested. Follow-up information was received froma pharmacist. The patient was reported as immune deficient. No other information was provided. No additional information is expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a female (demographics not provided) who on 29-MAR-2007 was vaccinated intramuscularly with Pneumovax 23 (Lot#655290/0959F).  On 31-MAR-2007 the patient experienced an injection site reaction (NOS).  The patient sought unspecified medical advice.  At the time of this report the patient was recovering from the events.  Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: PPV
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Information has been received from a physician and a "nurse" concerning a 12 week old male who on 04-APR-2007 was vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23 (Lot # not reported).  The nurse reported that the patient was supposed to receive PREVENAR.  She was in a rush that day and the names of the two vaccines are so similar that she mistakenly used the adult vaccine.  The patient was reported to have no symptoms.  The nurse also reported that they separated the adult and children vaccines so that this does not happen again.  Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Cellulitis, Immune system disorder, Injection site erythema, Injection site pain
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 30 year old, male, system analyst with no drug reactions or allergies, with no illness at the time of vaccination, whose reported weight was 285 pounds and whose reported height was 72 inches who on 11-APR-2007, at 7:30 a.m., was vaccinated subcutaneously, into the left arm with the first 0.5 mL dose of Pneumovax 23 vaccine, reportedly for recurrent sinusitis, "low titers and to assess immune infection" and decreased "pneumoniae AB titers", (Lot # 655290/0959F). Concomitant therapy included omeprazole (MSD), lisinopril (manufacturer unknown) and Sudafed. The physician was seen in the emergency room (ER) about 24 hours after vaccination. The patient's symptoms included a fever of 102 degrees, Fahrenheit and a small amount of redness at the injection site. The patient was ordered antibiotics (unspecified brand). The next day, the patient complained of more pain and redness. He was admitted to the hospital on intravenous (IV) antibiotics (unspecified brand) for cellulitis. The physician mentioned that the hospital will keep the patient for one week. At the time of the report, the patient had not recovered. In follow-up it was reported by the physician that the patient was put on clindamycin and had a negative test for the cellulitis. The patient recovered and had been sent home from the hospital. The physician considered the patient's fever of 102 degrees, Fahrenheit, pain and redness at the injection site to be disabling and other important medical events. In follow-up it was reported by the physician that on 13-APR-2007 the patient developed a fever of 102 degrees. On 14-APR-2007 the patient developed cellulitis of the left arm and was hospitalized. A surgeon was "consulted". At the time of the report, it was unknown if the patient recovered. Follow-up information via Medical Records included laboratory evaluation of streptococcus pneumoniae IGG AB (12 serotypes) which revealed serotype 3 (3) 0.6 ug/mL, serotypes 12 (12F) 1.0 ug/mL, serotype 23 (23F), 1.5 ug/mL and serotype 51 (7F) 0.6 ug/mL. Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Laboratory test normal, Pain, Pneumonia pneumococcal, Pyrexia
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 30 year old, male, system analyst with no drug reactions or allergies, with no illness at the time of vaccination, whose reported weight was 285 pounds and whose reported height was 72 inches who on 11-APR-2007, at 7:30 a.m., was vaccinated subcutaneously, into the left arm with the first 0.5 mL dose of Pneumovax 23 vaccine, reportedly for recurrent sinusitis, "low titers and to assess immune infection" and decreased "pneumoniae AB titers", (Lot # 655290/0959F). Concomitant therapy included omeprazole (MSD), lisinopril (manufacturer unknown) and Sudafed. The physician was seen in the emergency room (ER) about 24 hours after vaccination. The patient's symptoms included a fever of 102 degrees, Fahrenheit and a small amount of redness at the injection site. The patient was ordered antibiotics (unspecified brand). The next day, the patient complained of more pain and redness. He was admitted to the hospital on intravenous (IV) antibiotics (unspecified brand) for cellulitis. The physician mentioned that the hospital will keep the patient for one week. At the time of the report, the patient had not recovered. In follow-up it was reported by the physician that the patient was put on clindamycin and had a negative test for the cellulitis. The patient recovered and had been sent home from the hospital. The physician considered the patient's fever of 102 degrees, Fahrenheit, pain and redness at the injection site to be disabling and other important medical events. In follow-up it was reported by the physician that on 13-APR-2007 the patient developed a fever of 102 degrees. On 14-APR-2007 the patient developed cellulitis of the left arm and was hospitalized. A surgeon was "consulted". At the time of the report, it was unknown if the patient recovered. Follow-up information via Medical Records included laboratory evaluation of streptococcus pneumoniae IGG AB (12 serotypes) which revealed serotype 3 (3) 0.6 ug/mL, serotypes 12 (12F) 1.0 ug/mL, serotype 23 (23F), 1.5 ug/mL and serotype 51 (7F) 0.6 ug/mL. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a pharmacist via a nurse concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with Pneumovax 23.  Concomitant medication was not reported.  Subsequently on an unspecified date, the patient experienced an anaphylactic reaction.  The patient sought unspecified medical attention.  The outcome and causality were not reported.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Hypotension
Clinical narrative: Information has been received from a female physician consumer (age not reported) with environmental allergies, penicillin allergy and allergy to lidocaine and clindamycin who a long time ago was vaccinated with first and only dose of Pneumovax 23 (lot # not reported).  One half hour post-vaccination, the patient developed hypotension and felt like she was going to pass out.  The outcome was not reported.  No further information is available.
Age: 37.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect dose administered, Local reaction, Overdose, Rash
Clinical narrative: Information has been received from a pharmacist concerning a 37 year old male with a history of a splenectomy who on 28-MAR-2007 was vaccinated with an entire 5 dose vial of Pneumovax 23.  The vaccine was administered by a nurse who injected all 5 doses thinking it was a unit dose vial.  On 28-MAR-2007 the patient developed a large local reaction (rash) in the deltoid region which has since subsided.  Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Local reaction, Mass, Swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 42 year old male with no known allergies who on 19-APR-2007 was vaccinated in the right deltoid with a dose of Pneumovax 23 (lot #654977/0888F).  Concomitant therapy included vaccination into the left deltoid with a dose of MENACTRA (lot#U2234AA).  On 11-APR-2007, at 11:00, the patient developed localized swelling in the right arm and a lump which measured 3 cm.  After 24 hours, symptoms were resolving.  No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Dizziness, Ear pain, Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a health professional concerning a female consumer (age not reported) with allergic reaction to antibiotics (therapy not specified) who on approximately 29-MAR-2007 about three weeks ago, was vaccinated with a second dose of Pneumovax 23 (lot #651330/1048P), 0.5 ml, SC.  Concomitant medication was not reported.  On approximately 29-MAR-2007 about three weeks ago, the patient developed an injection site reaction.  The patient's arm became red, hot to touch and painful.  The patient developed edema from the injection site in the upper arm to the level of the elbow.  The patient was placed on antibiotics for 7 days and the swelling, redness and pain resolved after completing the antibiotics.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/30/2007. Information has been received from a certified medical assistant concerning a 60 year old female Estate Trustee with allergic reaction to antibiotics (therapy not specified) and a history of heart disease who on 26-MAR-2007 was vaccinated with a first dose of PNEUMOVAX 23 (lot #651330/1048P), 0.5 ml, SC in the left upper extremity. Concomitant medication included LANOXIN and EVISTA. Illness at time of vaccination was reported as none. On 27-MAR-2007, the patient presented to the emergency department, the area where vaccination occurred was becoming red, swollenand very tender. The patient also reported that she was lightheaded, dizzy and she developed a fever. The patient had no nausea, vomiting or diarrhea. She just felt lightheaded and dizzy. She developed a little bit of a sore throat this evening and she was not experiencing and earache. The patient's temperature was 100.9 degrees, pulse was 90, respirations was 18 and blood pressure was 146/80. The patient was hydrated with saline and given a gram of VANCOMYCIN. The patient was prescribed KEFLEX and SEPTRA and was instructed touse warm compresses on the area, 15 minutes 3 times a day. The patient was diagnosed with cellulitis left arm versus inflammatory reaction from PNEUMOVAX 23. The patient recovered from the events on 06-APR-2007. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site pain, Injection site reaction, Injection site warmth, Oropharyngeal pain
Clinical narrative: Information has been received from a health professional concerning a female consumer (age not reported) with allergic reaction to antibiotics (therapy not specified) who on approximately 29-MAR-2007 about three weeks ago, was vaccinated with a second dose of Pneumovax 23 (lot #651330/1048P), 0.5 ml, SC.  Concomitant medication was not reported.  On approximately 29-MAR-2007 about three weeks ago, the patient developed an injection site reaction.  The patient's arm became red, hot to touch and painful.  The patient developed edema from the injection site in the upper arm to the level of the elbow.  The patient was placed on antibiotics for 7 days and the swelling, redness and pain resolved after completing the antibiotics.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/30/2007. Information has been received from a certified medical assistant concerning a 60 year old female Estate Trustee with allergic reaction to antibiotics (therapy not specified) and a history of heart disease who on 26-MAR-2007 was vaccinated with a first dose of PNEUMOVAX 23 (lot #651330/1048P), 0.5 ml, SC in the left upper extremity. Concomitant medication included LANOXIN and EVISTA. Illness at time of vaccination was reported as none. On 27-MAR-2007, the patient presented to the emergency department, the area where vaccination occurred was becoming red, swollenand very tender. The patient also reported that she was lightheaded, dizzy and she developed a fever. The patient had no nausea, vomiting or diarrhea. She just felt lightheaded and dizzy. She developed a little bit of a sore throat this evening and she was not experiencing and earache. The patient's temperature was 100.9 degrees, pulse was 90, respirations was 18 and blood pressure was 146/80. The patient was hydrated with saline and given a gram of VANCOMYCIN. The patient was prescribed KEFLEX and SEPTRA and was instructed touse warm compresses on the area, 15 minutes 3 times a day. The patient was diagnosed with cellulitis left arm versus inflammatory reaction from PNEUMOVAX 23. The patient recovered from the events on 06-APR-2007. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a health professional concerning a female consumer (age not reported) with allergic reaction to antibiotics (therapy not specified) who on approximately 29-MAR-2007 about three weeks ago, was vaccinated with a second dose of Pneumovax 23 (lot #651330/1048P), 0.5 ml, SC.  Concomitant medication was not reported.  On approximately 29-MAR-2007 about three weeks ago, the patient developed an injection site reaction.  The patient's arm became red, hot to touch and painful.  The patient developed edema from the injection site in the upper arm to the level of the elbow.  The patient was placed on antibiotics for 7 days and the swelling, redness and pain resolved after completing the antibiotics.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/30/2007. Information has been received from a certified medical assistant concerning a 60 year old female Estate Trustee with allergic reaction to antibiotics (therapy not specified) and a history of heart disease who on 26-MAR-2007 was vaccinated with a first dose of PNEUMOVAX 23 (lot #651330/1048P), 0.5 ml, SC in the left upper extremity. Concomitant medication included LANOXIN and EVISTA. Illness at time of vaccination was reported as none. On 27-MAR-2007, the patient presented to the emergency department, the area where vaccination occurred was becoming red, swollenand very tender. The patient also reported that she was lightheaded, dizzy and she developed a fever. The patient had no nausea, vomiting or diarrhea. She just felt lightheaded and dizzy. She developed a little bit of a sore throat this evening and she was not experiencing and earache. The patient's temperature was 100.9 degrees, pulse was 90, respirations was 18 and blood pressure was 146/80. The patient was hydrated with saline and given a gram of VANCOMYCIN. The patient was prescribed KEFLEX and SEPTRA and was instructed touse warm compresses on the area, 15 minutes 3 times a day. The patient was diagnosed with cellulitis left arm versus inflammatory reaction from PNEUMOVAX 23. The patient recovered from the events on 06-APR-2007. Additional information is not expected.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Induration, Rash, Skin warm
Clinical narrative: Information has been received from a physician concerning a 64 year old male with diabetes mellitus who on 11-APR-2007 was vaccinated subcutaneously with a 0.5 mL dose of Pneumovax 23 (lot 654977/0888F).  Concomitant therapy included AVANDIA.  Within 24 hours of vaccination, the patient developed a rash in the arm in which he was vaccinated.  He also developed redness, induration, and warmth of the arm.  Unspecified medical attention was sought.  The patient recovered 4 days later.  The physician requested that a lot check be performed on lot 654977/0888F.  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 agency and was released.  This is one of two reports from the same source.  Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant concerning a 72 year old female with osteoporosis and drug hypersensitivity to amoxicillin and a history of migraine and fibromyalgia who on 16-APR-2007 was vaccinated with Pneumovax 23 (lot # 655501/1035F) 0.5 ml IM in the left upper arm.  Concomitant therapy included AMBIEN, amitriptyline hydrochloride (MSD), CAFERGOT, fluoxetine and alendronate sodium (MSD).  On 18-APR-2007, the patient developed cellulitis that was a couple of inches below the injection site (injection site not involved).  The area was warm to the touch and "very slightly" raised.  The affected area was from mid bicep to just below the elbow.  Medical attention was sought.  The patient was told to take TYLENOL and BENADRYL.  The patient was concerned about infection and was referred to urgent care where the physician gave the patient cephalexin 500 mg four times daily for 7 days.  The physician felt that the cellulitis did not require an antibiotic but gave it as a precaution.  At the time of reporting, the patient was recovering.  No further information was available at the time of reporting.  The reporter felt that the cellulitis was serious (Other Important Medical Event).  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Induration, Pain in extremity, Rash
Clinical narrative: Information has been received from a physician concerning a 65 female with asthma who on 13-APR-2007 was vaccinated subcutaneously with a 0.5 ml dose of Pneumovax 23 (lot #654977/0888F).  Concomitant therapy included an unspecified therapy and hydrochlorothiazide (manufacturer unknown).  On approximately 14-APR-2007 the patient developed a rash with redness, warmth, induration and pain in the arm in which she was vaccinated.  The rash was approximately 8 cm in diameter.  On 20-APR-2007, the patient called the physician's office and reported that she still had pain and developed chills and vomiting.  Medical attention was sought and the physician prescribed prednisone and a cortisone cream.  There were no laboratory or diagnostic tests performed.  At the time of the report, the patient had not recovered.  The reporting physician requested a lot check  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released by the regulatory agency.  Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Vomiting
Clinical narrative: Information has been received from a physician concerning a 65 female with asthma who on 13-APR-2007 was vaccinated subcutaneously with a 0.5 ml dose of Pneumovax 23 (lot #654977/0888F).  Concomitant therapy included an unspecified therapy and hydrochlorothiazide (manufacturer unknown).  On approximately 14-APR-2007 the patient developed a rash with redness, warmth, induration and pain in the arm in which she was vaccinated.  The rash was approximately 8 cm in diameter.  On 20-APR-2007, the patient called the physician's office and reported that she still had pain and developed chills and vomiting.  Medical attention was sought and the physician prescribed prednisone and a cortisone cream.  There were no laboratory or diagnostic tests performed.  At the time of the report, the patient had not recovered.  The reporting physician requested a lot check  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released by the regulatory agency.  Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant concerning a 73 year old female with a history of colonic polyp, hyperlipidaemia, and hypertension who on 26-MAR-2007 was vaccinated with Pneumovax 23 (lot # 655501/1035F) 0.5 ml IM in the left upper arm.  Concomitant therapy included BENICAR, hydrochlorothiazide (MSD), CLIMARA, furosemide, and trazodone HCl.  On approximately 27-MAR-2007, one to one and a half days after the vaccination, the patient experienced cellulitis that was not at the injection site but a couple of inches below the injection site.  The area was warm to touch and very slightly raised.  The affected area was round (baseball size) that extended around the left arm.  The patient sought medical attention and was told to take TYLENOL and BENADRYL.  On 31-MAR-2007, the patient recovered.  Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a health professional concerning a 64 year old male physician who on 11-APR-2007 was vaccinated intramuscularly, into the right deltoid, with 0.5 ml dose of Pneumovax 23 (lot #655592/1175F).  On 11-APR-2007 the patient developed an injection site reaction described as cellulitis.  Medical attention was sought and the patient was treated with KEFLEX.  On 19-APR-2007 the patient recovered.  The healthcare worker requested a lot check.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released by the regulatory agency.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a healthcare worker concerning a patient (gender and age not reported) who in April 2007 ("with in the last two weeks"), was vaccinated with a dose of Pneumovax 23 (Lot# 655592/1175F).  Subsequently, the patient reported to the office that the injection site was red and swollen within two days after receiving vaccination.  The patient was told to take ADVIL for the reaction.  It was also reported that the patient was scheduled for examination in the office but never kept the appointment.  At the time of the report, the patient's recovery status was unknown.  The reporter felt that the patient's experiences were related to therapy with Pneumovax 23.  The reporter has requested a lot check.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the agency and was released.  Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Activities of daily living impaired, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a healthcare worker concerning a 61 year old male patient who on 16-FEB-2007, was vaccinated with a dose of Pneumovax 23 (Lot# 655592/1175F).  Concomitant therapy included ADVAIR, AVELOX, XOPENEX, prednisone and LIPITOR.  The healthcare worker reported that the patient had an injection site reaction with Pneumovax 23.  On approximately 16-FEB-2007 the patient developed redness, swelling and pain at the injection site.  The patient called the office on 19-FEB-2007 and reported that the injection site arm was painful, swollen and red.  He also reported that he had been "in bed all weekend", but the onset date was unspecified.  On 22-FEB-2007, the patient called the office and reported that his arm was still hurting with movement, swollen and red.  The patient took ADVIL, for the symptoms, as directed by the office.  The patient had reported pain through the next week that improved and resolved on 27-FEB-2007.  It was reported that the patient never had a previous reaction to Pneumovax 23 and his previous dose was given on 29-MAR-2000.  The reporter has requested a lot check.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the agency and was released.  Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a healthcare worker concerning a 61 year old male patient who on 16-FEB-2007, was vaccinated with a dose of Pneumovax 23 (Lot# 655592/1175F).  Concomitant therapy included ADVAIR, AVELOX, XOPENEX, prednisone and LIPITOR.  The healthcare worker reported that the patient had an injection site reaction with Pneumovax 23.  On approximately 16-FEB-2007 the patient developed redness, swelling and pain at the injection site.  The patient called the office on 19-FEB-2007 and reported that the injection site arm was painful, swollen and red.  He also reported that he had been "in bed all weekend", but the onset date was unspecified.  On 22-FEB-2007, the patient called the office and reported that his arm was still hurting with movement, swollen and red.  The patient took ADVIL, for the symptoms, as directed by the office.  The patient had reported pain through the next week that improved and resolved on 27-FEB-2007.  It was reported that the patient never had a previous reaction to Pneumovax 23 and his previous dose was given on 29-MAR-2000.  The reporter has requested a lot check.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the agency and was released.  Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered nurse via a company representative concerning a male patient (age not reported) who on 18-APR-2007, was vaccinated with a dose of Pneumovax 23 (Lot# 656222/0381U).   On 18-APR-2007 the patient developed cellulitis after receiving Pneumovax 23.  It was reported that the patient was treated with antibiotics and hydrocortisone.  At the time of the report, it was unknown if the patient recovered.  Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Pyrexia, Swelling, Tenderness
Clinical narrative: Information has been received from a representative from a distributor ("healthcare worker") concerning a 62 year old male who, on an unspecified date, was vaccinated with a dose of Pneumovax 23 (Lot# 654977/0888F).  Subsequently, on an unspecified date, the patient developed a severe reaction involving redness, swelling, tenderness, chills and fever.  It was unknown if the patient recovered.  At the time of the report, it was noted that the patient's symptoms lasted for three days.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Pyrexia, Swelling, Tenderness
Clinical narrative: Information has been received from a health professional concerning a 66 year old female who was vaccinated with a dose of Pneumovax 23 (lot #654977/0888F).  Subsequently the patient experienced redness, swelling, tenderness, chills and fever.  The patient was treated with prednisone.  At the time of the report, the patient was recovering.  Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Electrocardiogram, Erythema, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a 70 year old female nurse practitioner with coeliac disease, latex allergy and allergy to "INASPINE" who on 10-APR-2007 at approximately 14:00 was vaccinated intramuscularly, into the deltoid, with a 0.5 ml second dose of Pneumovax 23 (lot #"0577B").  Concomitant therapy included PAMELOR, ATIVAN and ZANTAC.  On 10-APR-2007 the patient developed fever with a painful, swollen and reddened arm from the injection site at the deltoid, to her neck and down her arm.  She also experienced a painful wrist, elbow and shoulder.  She reported the reaction to her physician by phone.  She underwent electrocardiogram and "routine annual physical labwork" (results not reported).  She treated the swollen arm with elevation and immobility.  At the time of the report, the patient was recovering from painful arm from the injection site at the deltoid, to her neck and down her arm and painful shoulder, wrist and elbow.  She reported that her arm continued to ache although the swelling, fever and redness had resolved.  The nurse practitioner received previous vaccination in approximately 1997 without any reactions.  Additional information has been requested. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Local swelling, Neck pain, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a 70 year old female nurse practitioner with coeliac disease, latex allergy and allergy to "INASPINE" who on 10-APR-2007 at approximately 14:00 was vaccinated intramuscularly, into the deltoid, with a 0.5 ml second dose of Pneumovax 23 (lot #"0577B").  Concomitant therapy included PAMELOR, ATIVAN and ZANTAC.  On 10-APR-2007 the patient developed fever with a painful, swollen and reddened arm from the injection site at the deltoid, to her neck and down her arm.  She also experienced a painful wrist, elbow and shoulder.  She reported the reaction to her physician by phone.  She underwent electrocardiogram and "routine annual physical labwork" (results not reported).  She treated the swollen arm with elevation and immobility.  At the time of the report, the patient was recovering from painful arm from the injection site at the deltoid, to her neck and down her arm and painful shoulder, wrist and elbow.  She reported that her arm continued to ache although the swelling, fever and redness had resolved.  The nurse practitioner received previous vaccination in approximately 1997 without any reactions.  Additional information has been requested. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a 70 year old female nurse practitioner with coeliac disease, latex allergy and allergy to "INASPINE" who on 10-APR-2007 at approximately 14:00 was vaccinated intramuscularly, into the deltoid, with a 0.5 ml second dose of Pneumovax 23 (lot #"0577B").  Concomitant therapy included PAMELOR, ATIVAN and ZANTAC.  On 10-APR-2007 the patient developed fever with a painful, swollen and reddened arm from the injection site at the deltoid, to her neck and down her arm.  She also experienced a painful wrist, elbow and shoulder.  She reported the reaction to her physician by phone.  She underwent electrocardiogram and "routine annual physical labwork" (results not reported).  She treated the swollen arm with elevation and immobility.  At the time of the report, the patient was recovering from painful arm from the injection site at the deltoid, to her neck and down her arm and painful shoulder, wrist and elbow.  She reported that her arm continued to ache although the swelling, fever and redness had resolved.  The nurse practitioner received previous vaccination in approximately 1997 without any reactions.  Additional information has been requested. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Fluid retention, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a nurse concerning a 66 year old male patient who in at age 65 was vaccinated with his first dose of Pneumovax 23.  In 2006, at age 66, the patient received a second dose of Pneumovax 23 because he forgot he received a previous dose.  He developed fluid retention in his hands and ankles.  Medical attention was sought. Subsequently, the patient recovered.  Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Condition aggravated, Dyspnoea, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a female (age unknown) who, on an unspecified date, was vaccinated with a dose of Pneumovax 23.  Concomitant therapy included influenza virus vaccine (unspecified).  Subsequently, on an unspecified date, the patient developed difficulty breathing after receiving both the influenza virus vaccine (unspecified) and Pneumovax 23.  It was noted by the reporter that when the patient received the flu vaccine alone (on two separate occasions in two different years), she developed difficulty breathing.  At the time of this report, the patient had recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Pyrexia, Urticaria
Clinical narrative: Information has been received from a physician concerning a 72 year old female who was vaccinated with the first dose of Pneumovax 23.  Subsequently the patient developed cellulitis and fever.  Seven days after vaccination the patient developed hives and was treated with steroids.  The patient sought unspecified medical attention.  On an unreported date, the patient recovered.  Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: DTAP, IPV, PPV
Symptoms: Oedema peripheral, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 24 month old female with no known drug allergies, who on 30-APR-2007 was vaccinated into the right thigh with a first dose of Pneumovax 23 (lot# 651437/0899F) instead of PREVNAR.  Concomitant therapy included an IM dose of poliovirus vaccine (batch# Y0576) into the left thigh and Daptacel into the left thigh (batch# C2431AA).  It was noted that product confusion occurred since both vaccines read pneumococcal vaccine.  The physician suggested the print to be larger on the vials.  On 30-APR-2007, the patient developed swelling in her thigh.  Unspecified medical attention was sought.  In a follow-up evaluation the patient was doing fine and no issues were reported by the patient's mother.  No product quality complaint was involved.  Additional information is not expected.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Rash macular, Skin warm
Clinical narrative: Information has been received from a licensed practical nurse concerning a 49 year old male with aspirin allergy and bronchitis at the time of vaccination who on 24-APR-2007 was vaccinated with the first dose of Pneumovax 23 (lot #655152/0889F), IM in the left deltoid. Concomitant therapy included Allegra and Flonase. On 26-APR-2007, the patient experienced red blotchy areas, slight warm and sore to touch. Treatment with cool compresses was recommend. Subsequently on an unspecified date, the patient recovered from red blotchy areas, slight warm and sore to touch. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Information has been received from a registered nurse via a company representative concerning a female patient who on 17-APR-2007, was vaccinated with a dose of Pneumovax 23 (Lot #656222/0381U). On approximately 17-APR-2007 the patient developed erythema. It was reported that the pateint was treated with hydrocortisone. At the time of the report, it was unknown if the patient recovered from erythema. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Accidental exposure, Eye irritation
Clinical narrative: Information has been received from a medical assistant who reported that on 03-MAY-2007 another medical assistant at the office had part of the Pneumovax 23 splash in her eye while withdrawing the vaccine into a syringe. The medical assistant complained of burning. Her eyes were rinsed with an eye wash. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a physician concerning an 82 year old female who on 09-MAR-2007 was vaccinated with a dose of Pneumovax 23. On 09-MAR-2007 the patient developed right arm swelling post vaccination. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 89.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Immune system disorder, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a Doctor of Pharmacy and a Pharm D. student concerning an 89 year old male with no known drug allergies who on 24-APR-2007 was hospitalized for a cerebrovascular accident. On the morning he was admitted to the hospital, the patient was given intravenous immune globulin. During the evening of 24-APR-2007, the patient was vaccinated intramuscularly in the left arm with a dose of Pneumovax 23. The patient's left arm became very hot, red, and very swollen. By the next day, the swelling traveled down the arm. The Pharm D. stated that the physician thought the patient may have had a "hyper immune response". The patient was discharged from the hospital on 29-APR-2007 and was considered recovered. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Information has been received via a 34 year old female who on an unspecified date was vaccinated with a dose of Pneumovax 23 (manufacturer not specified). Concomitant medication was not reported. Subsequently on an unspecified date, the patient experienced redness at vaccine site, swollen at vaccine site, hot reaction at vaccine site, achy and fever during administration. The outcome and causality of the event were not reported. No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a certified medical assistant concerning a female (age not reported) who on an unspecified date was vaccinated with a dose of Pneumovax 23. Subsequently the pateint developed cellulitis. The pateint sought unspecified medical attention. It was unknown of the patient recovered. This is one of two reports from the same source. Additional information has been requested.