chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: U
Vaccine: PNC, PPV
Symptoms: Wrong drug administered
Clinical narrative: Information and follow-up information has been received from two physicians concerning a patient (gender unknown) who at the age of 8 weeks was inadvertently vaccinated with a dose of Pneumovax 23. At the age of 16 weeks, the patient was inadvertently vaccinated with a second dose of Pneumovax 23. The physician stated that there was an error on the part of the office. Specifically, 70 doses of Pneumovax 23 was ordered instead of Prevnar because both products were next to each other on the order form and then 40 doses were administered by accident. It was reported that there was no confusion in regards to product packaging. The physician stated that the problem had been corrected at the office and he did not foresee any future problems. Follow-up reported that unspecified medical attention was sought and on an unspecified date, the patient was vaccinated with a dose of Prevnar. At the time of the report, there were no adverse experiences reported. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: PNC, PPV
Symptoms: Medication error, No adverse reaction, Wrong drug administered
Clinical narrative: Initial and follow-up information has been received from two physicians concerning a patient (gender unknown) who at the age of 16 weeks was inadvertently vaccinated with a dose of Pneumovax 23.  At the age of 6 months, the patient was inadvertently vaccinated with a second dose of Pneumovax 23.  The physician stated that there was an error on the part of the office.  Specifically, 70 doses of Pneumovax 23 (MSD) was ordered instead of PREVNAR because both products were next to each other on their order form and then 40 doses were administered by accident.  It was reported that there was no confusion in regards to product packaging.  The physician stated that that problem had been corrected at the office and he did not foresee any future problems.  Follow-up reported that on an unspecified date, the patient was vaccinated with a dose of PREVNAR.  At the time of the report, there were no adverse experiences reported.  Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 79 year old female with no past medical history and no drug allergies who on 18-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot # 651400/0618F) (0.5 ml), intramuscularly. On 18-OCT-2006, "a few hours after receiving the vaccination" the patient called the office complaining of pain. The patient stated she was unable to move her arm where the injection was given. At the time of the report, the patient was recovering. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a pharmacist concerning a patient (age and sex not reported) who in the 1980's was vaccinated with Pneumovax 23. Sometime in the 1980's, the patient experienced an allergic reaction (details not provided) to Pneumovax 23. The outcome of the events was not reported. No further information is available.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old female with no pertinent medical history or drug reactions/allergies who on 17-OCT-2006 was vaccinated with Pneumovax 23 (lot # 651400/0618f) 0.5 ml IM in left deltoid. No concomitant therapy. On 17-OCT-2006, in the afternoon, the patient experienced pain in her arm after being given Pneumovax 23. The patient sought medical attention. The patient reported she "cannot move her arm and it feels as though her arm was broken". No lab diagnostic studies were performed. At the time of reporting the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a medical assistant concerning an adult female (age unknown) who was vaccinated on an unspecified date with Pneumovax 23 (Lot # 651401/0619F).  Subsequently the patient experienced swelling of the arm which was vaccinated.  At the time of this report, the patient was recovering.  The physician requested a lot check of Pneumovax 23 (Lot # 651401/0619F).  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Body temperature increased, Breast pain, Breast swelling, Injection site erythema
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a 59 year old female with a history of pneumonia and no history of drug reactions/allergies who on 02-OCT-2006 was vaccinated with Pneumovax 23 (lot # 650457/0937P) 0.5 ml IM in left deltoid. Concomitant therapy included Atenolol and DIOVAN. On 02-OCT-2006, a couple of hours after the vaccination, the patient developed pain, redness, and swelling around the injection site. The swelling and pain spread to underneath her underarm and over the patient's breast. Also, the patient fever up to 101-102 degrees Fahrenheit. Medical attention was sought. No lab diagnostic studies were performed. The patient was treated with TYLENOL. The symptom improved on therapy. On 07-OCT-2006, the patient recovered. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a 59 year old female with a history of pneumonia and no history of drug reactions/allergies who on 02-OCT-2006 was vaccinated with Pneumovax 23 (lot # 650457/0937P) 0.5 ml IM in left deltoid. Concomitant therapy included Atenolol and DIOVAN. On 02-OCT-2006, a couple of hours after the vaccination, the patient developed pain, redness, and swelling around the injection site. The swelling and pain spread to underneath her underarm and over the patient's breast. Also, the patient fever up to 101-102 degrees Fahrenheit. Medical attention was sought. No lab diagnostic studies were performed. The patient was treated with TYLENOL. The symptom improved on therapy. On 07-OCT-2006, the patient recovered. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Information has been received from a healthcare student concerning an "over" 60 year old male who was vaccinated with a dose of Pneumovax 23.  Subsequently the patient experienced rash.  The patient is "on therapy", recovering from the rash.  Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 9 year old female patient with a history of yearly pneumonia who on 21-OCT-2006 was vaccinated IM into the right arm deltoid with "one time" 0.5 ml dose of Pneumovax 23 (lot # 650457/0973P).  Concomitant therapy included SYNTHROID.  On 21-OCT-2006 the patient experienced swelling of the right arm, pain and redness at site of injection.  The symptoms started within one hour of injection.  The patient also developed a fever up to 103.  The patient has been treated with alternating doses of ibuprofen and TYLENOL.  The symptoms had not yet resolved.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Information has been received from a pharmacist and a registered nurse concerning a 23 year old female with sickle cell anaemia who was vaccinated with Pneumovax 23 (Lot # 654982/0675F). Subsequently the patient experienced excessive swelling in the mid upper arm injection site, that was all the way down to the elbow, that was 1 and 1/2 times the size of the normal circumference of the arm. The arm was warm to the touch, tender and there was pain with the swelling. The patient was examined in the emergency room (ER) and released. The patient was instructed to put a hot pack on the affected area and take basic analgesic or nonsteroidal anti-inflammatory drug (unspecified) NSAID. There was no fever and no induration at the site of injection. The patient was instructed to take acetaminophen or NSAIDS to manage the discomfort. At the time of the report, it was unknown if the patient recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site rash, Injection site reaction, Local reaction, Urticaria
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with a 0.5 ml dose of Pneumovax 23 (lot # 654982/0675F).  Subsequently on 17-OCT-2006 the patient experienced severe localized reactions which included welts and a rash on the extremity that was vaccinated, but not necessarily at the injection site.  The reaction was reported "from the shoulder to the elbow."  The patient sought unspecified medical attention.  It was reported that the lot # would not be used and there was concern expressed regarding the lot number.  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: Induration, Local reaction, Rash, Urticaria
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with a 0.5 ml dose of Pneumovax 23 (lot # 654982/0675F). Subsequently the patient experienced severe localized reactions which included welts and a rash on the extremity that was vaccinated, but not necessarily at the injection site. The reaction was reported "from the shoulder to the elbow." It was reported that there was "firm tissue" that extended from the elbow to the wrist. The patient was treated with antibiotics and antihistamines. It was reported that the lot # would not be used and there was concern expressed regarding the lot number. 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 government agency and was released by the regulatory agency. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Induration, Local reaction, Urticaria
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with a 0.5 ml dose of Pneumovax 23 (lot # 654982/0675F). Subsequently the patient experienced severe localized reactions which included welts and a rash on the extremity that was vaccinated, but not necessarily at the injection site. The reaction was reported "from the shoulder to the elbow." It was reported that there was "firm tissue" that extended from the was reported that there was "firm tissue" that extended from the elbow to the wrist. The patient sought unspecified medical attention. It was reported that the lot # would not be used and there was concern expressed regarding the lot number. 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 government agency and was released by the regulatory agency. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Local reaction, Rash, Urticaria
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with a 0.5 ml dose of Pneumovax 23 (lot # 654982/0675F).  Subsequently the patient experienced severe localized reactions which included welts and a rash on the extremity that was vaccinated, but not necessarily at the injection site.  The reaction was reported "from the shoulder to the elbow."  The patient sought unspecified medical attention.  It was reported that the lot # would not be used and there was concern expressed regarding the lot number.  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: Local reaction, Rash, Urticaria
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with a 0.5 ml dose of Pneumovax 23 (lot # 654982/0675F). Subsequently the patient experienced severe localized reactions which included welts and a rash on the extremity that was vaccinated, but not necessarily at the injection site. The reaction was reported "from the shoulder to the elbow." The patient sought unspecified medical attention. It was reported that the lot # would not used and there was concern expressed regarding the lot number. 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 government agency and was released by the regulatory agency. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Local reaction, Rash, Urticaria
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with a 0.5 ml dose of Pneumovax 23 (lot # 654982/0675F). Subsequently the patient experienced severe localized reactions which included welts and a rash on the extremity that was vaccinated, but not necessarily at the injection site. The reaction was reported "from the shoulder to the elbow." The patient sought unspecified medical attention. It was reported that the lot # would not be used and there was concern expressed regarding the lot number. 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 Office of Biologics Research and Review and was released by the regulatory agency. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Local reaction, Rash, Urticaria
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with a 0.5 ml dose of Pneumovax 23 (lot # 654982/0675F). Subsequently the patient experienced severe localized reactions which included welts and a rash on the extremity that was vaccinated, but not necessarily at the injection site. The reaction was reported "from the shoulder to the elbow." The patient sought unspecified medical attention. It was reported that the lot # would not be used and there was concern expressed regarding the lot number. 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 authority and was released by the regulatory agency. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist and a registered nurse concerning a 42 year old male with sickle cell anaemia who was vaccinated with Pneumovax 23 (Lot # 654982/0675F).  Subsequently the patient developed excessive swelling in the mid upper arm injection site, that was all the way down to the elbow that was 1 and 1/2 times the size of the normal circumference of the arm.  The area was warm to the touch, tender and there was pain with the swelling.  There was no fever and no induration at the site of injection.  The patient was instructed to take acetaminophen or nonsteroidal anti-inflammatory drug (unspecified) (NSAIDs) to manage the discomfort.  The patient sought unspecified medical attention.  At the time of the report, it was unknown if the patient recovered.  Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist and a registered nurse concerning a 50 year old female with sickle cell anaemia who was vaccinated with Pneumovax 23 (Lot # 654982/0675F). Subsequently the patient developed excessive swelling in the mid upper arm injection site, that was all the way down to the elbow that was 1 and 1/2 times the size of the normal circumference of the arm. The arm was warm to the touch, tender and there was pain with the swelling. There was no fever and no induration at the site of injection. The patient was instructed to take acetaminophen or nonsteroidal anti-inflammatory drug (unspecified) (NSAIDs) to manage the discomfort. The patient sought unspecified medical attention. At the time of the report, it was unknown if the patient recovered. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Erythema, Induration, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from an office manager concerning a 67 year old female with type II diabetes mellitus, neuropathy peripheral, allergies to penicillin, LEVAQUIN, "adhesives from tape" and history of right hip fracture and past breast cancer who on 23-OCT-2006 was vaccinated with a first dose of Pneumovax 23 (lot # 651357/0391F) (0.5 ml), intramuscularly in the left deltoid.  Concomitant therapy included a dose of influenza virus vaccine (unspecified), in the same arm but different area.  On 25-OCT-2006 the patient experienced cellulitis.  It started below the Pneumovax 23 injection site and spread to her elbow.  The reaction consisted of a red, hot, swollen area.  Redness and induration down left arm were also reported at 8:00 AM.  The patient was given KEFLEX, BENADRYL and KENALOG for the treatment.  On 08-NOV-2006 the patient recovered.  Additional information is not expected.
Age: 56.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning a 56 year old male with a history of alcohol abuse and no history of drug reactions/allergies who on 24-OCT-2006 was vaccinated with Pneumovax (lot # 651437/0899F0 intramuscularly. Concomitant therapy included influenza virus vaccine (unspecified) given at the same visit. On 24-OCT-2006, the patient experienced pain and warmth at the injection site after vaccination with Pneumovax 23. The patient sought medical attention. No laboratory diagnostic tests were performed. Treatment included warm compresses, AUGMENTIN, and ADVIL. The patient improved while on therapy. At the time of reporting, the patient was recovering. 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 Center for Biologics Evaluation and Research and was released by the regulatory agency. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Full blood count normal, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 73 year old retired male with hyperlipidaemia, no known drug allergies, and no illness at the time of being vaccinated who on 23-OCT-2006 was vaccinated with Pneumovax 23 (lot # 651404/0325F exp. 11-MAY-2007) 0.5 ml IM into the left deltoid. Concomitant therapy included LIPITOR and ezetimibe (MSD). On 24-OCT-2006, the patient experienced fever of 100 degrees Fahrenheit, chills, and redness, tenderness, and warmth at the injection site of the left deltoid. On 24-OCT-2006, the patient sought medical attention and was examined. The physician prescribed KEFLEX, and MEDROL. The patient self-medicated with BENADRYL previous to seeking medical attention. The outcome of the events was unspecified. No further information was available at the time of reporting. Information was received from the registered nurse who requested a lot number check because several patients had a reaction to this Pneumovax 23 vaccine lot number. Additional information was received from a physician. The onset date of the events was reported as 23-OCT-2006 (previously reported as 24-OCT-2006). Laboratory diagnostic tests performed included liver function tests and cell blood count (CBC) which were within normal limits (WNL). The patient recovered after 27-OCT-2006. 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 agency and was released by the regulatory agency. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Injection site warmth, Liver function test normal, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 73 year old retired male with hyperlipidaemia, no known drug allergies, and no illness at the time of being vaccinated who on 23-OCT-2006 was vaccinated with Pneumovax 23 (lot # 651404/0325F exp. 11-MAY-2007) 0.5 ml IM into the left deltoid. Concomitant therapy included LIPITOR and ezetimibe (MSD). On 24-OCT-2006, the patient experienced fever of 100 degrees Fahrenheit, chills, and redness, tenderness, and warmth at the injection site of the left deltoid. On 24-OCT-2006, the patient sought medical attention and was examined. The physician prescribed KEFLEX, and MEDROL. The patient self-medicated with BENADRYL previous to seeking medical attention. The outcome of the events was unspecified. No further information was available at the time of reporting. Information was received from the registered nurse who requested a lot number check because several patients had a reaction to this Pneumovax 23 vaccine lot number. Additional information was received from a physician. The onset date of the events was reported as 23-OCT-2006 (previously reported as 24-OCT-2006). Laboratory diagnostic tests performed included liver function tests and cell blood count (CBC) which were within normal limits (WNL). The patient recovered after 27-OCT-2006. 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 agency and was released by the regulatory agency. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Cellulitis, Erythema, Pyrexia, Skin warm
Clinical narrative: Information has been received from a registered nurse concerning a 69 year old female with the following drug allergies PAMELOR, PAXIL, "BENZINATE", CECLOR and ZITHROMAX and a history of osteoporosis, irritable bowel syndrome, anxiety, diverticulosis, and mitral valve prolapse who on 16-OCT-2006 was vaccinated in the left deltoid with Pneumovax 23 (lot #651404/0352F), 0.5 ml, IM.  Concomitant therapy included CITRUCEL, ATIVAN, ZOLOFT, CLARINEX, FORTEO, REQUIP and vitamins (unspecified).  On 18-OCT-2006, the patient was examined and complained of fever, pain and warmth left axilla and under arm area.  The physician diagnosed cellulitis (also reported as pain and erythema) and prescribed ice compresses and KEFLEX.  A verbal report from the patient stated that the symptoms were improving.  Further information has been received from the registered nurse who requested a lot number check be performed because several patients had a reaction to this Pneumovax 23 lot number.  Follow up information has been received from the physician.  The patient had laboratory test performed and white blood cell count was within normal limit.  The patient recovered from the cellulitis left arm after 18-OCT-2006.  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.  Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: White blood cell count normal
Clinical narrative: Information has been received from a registered nurse concerning a 69 year old female with the following drug allergies PAMELOR, PAXIL, "BENZINATE", CECLOR and ZITHROMAX and a history of osteoporosis, irritable bowel syndrome, anxiety, diverticulosis, and mitral valve prolapse who on 16-OCT-2006 was vaccinated in the left deltoid with Pneumovax 23 (lot #651404/0352F), 0.5 ml, IM.  Concomitant therapy included CITRUCEL, ATIVAN, ZOLOFT, CLARINEX, FORTEO, REQUIP and vitamins (unspecified).  On 18-OCT-2006, the patient was examined and complained of fever, pain and warmth left axilla and under arm area.  The physician diagnosed cellulitis (also reported as pain and erythema) and prescribed ice compresses and KEFLEX.  A verbal report from the patient stated that the symptoms were improving.  Further information has been received from the registered nurse who requested a lot number check be performed because several patients had a reaction to this Pneumovax 23 lot number.  Follow up information has been received from the physician.  The patient had laboratory test performed and white blood cell count was within normal limit.  The patient recovered from the cellulitis left arm after 18-OCT-2006.  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.  Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Erythema, Injection site induration, Injection site pruritus, Oedema peripheral
Clinical narrative: Initial and follow-up information has been received from a healthcare worker (also reported as office manager) concerning a 69 year old female with chronic obstructive pulmonary disease and no history of drug reactions/allergies who on 23-OCT-2006 was vaccinated in the left deltoid with a second dose of Pneumovax 23 (lot # 651357/0391F) 0.5 ml intramuscularly. Concomitant vaccination on 23-OCT-2006 included a dose of influenza virus vaccine (unspecified) given in the same arm but in a different area. ON 25-OCT-2006, the patient sought medical attention by returning to the physician's office 2 days after receiving Pneumovax 23 with cellulitis. It started at the Pneumovax 23 vaccine site and spread down to her wrist. The reactions consisted of red hot swollen areas. Follow-up information from the reporter confirmed redness of upper arm, itching and induration. The patient was given KEFLEX, BENADYRL, and KENALOG for the treatment. Follow-up from the reporter noted that the patient was given KEFLEX "one more course" and BENADRYL cream for itching." At time time of reporting, the patient was recovering. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Skin warm
Clinical narrative: Initial and follow-up information has been received from a healthcare worker (also reported as office manager) concerning a 69 year old female with chronic obstructive pulmonary disease and no history of drug reactions/allergies who on 23-OCT-2006 was vaccinated in the left deltoid with a second dose of Pneumovax 23 (lot # 651357/0391F) 0.5 ml intramuscularly. Concomitant vaccination on 23-OCT-2006 included a dose of influenza virus vaccine (unspecified) given in the same arm but in a different area. ON 25-OCT-2006, the patient sought medical attention by returning to the physician's office 2 days after receiving Pneumovax 23 with cellulitis. It started at the Pneumovax 23 vaccine site and spread down to her wrist. The reactions consisted of red hot swollen areas. Follow-up information from the reporter confirmed redness of upper arm, itching and induration. The patient was given KEFLEX, BENADYRL, and KENALOG for the treatment. Follow-up from the reporter noted that the patient was given KEFLEX "one more course" and BENADRYL cream for itching." At time time of reporting, the patient was recovering. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Induration, Oedema peripheral
Clinical narrative: Information has been received from an approximately 66 year old female nurse with a sulfonamide allergy and a history of pneumonia who on an unspecified date in 2005 was vaccinated with a first dose of Pneumovax 23 vaccine. The nurse mentioned she "was alright other than a sore arm". On 23-OCT-2006, the nurse was vaccinated intramuscularly in the deltoid with a 0.5 mL second dose Pneumovax 23 (lot 651332/1049P). Concomitant therapy included PROCARDIA, baby aspirin, omega-3 marine triglycerides, and unspecified cholesterol medication. During the evening of 24-OCT-2006, the patient's arm got red, increased in size and started to swell up. There was indurated of the whole left arm that developed into cellulitis. On 25-OCT-2006, the induration area enlarged to 17 and 1/2 inches of the arm measurement that went around the mid part of the under aspect of the arm. The nurse applied ice and then warm compresses on the area every 2 to 3 hours and started therapy with doxycycline to help the reaction. At the time of this report, the induration had gone down in size, but the area had not decreased back to normal. The nurse felt the cellulitis was disabling and an other medical event. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Bacterial infection, Cellulitis, Erythema, Oedema peripheral
Clinical narrative: Information has been received from a nurse concerning a female (age not reported) who on 23-OCT-2006 was vaccinated intramuscularly with a 0.5mL dose of Pneumovax 23 (lot 651374/0485F). Later the same day, the patient's arm in which the vaccine was administered swelled and became red and swollen from elbow to shoulder. She was seen in an urgent care clinic and was diagnosed with cellulitis and released. The next day, the patient was re-evaluated and diagnosed with bacterial cellulitis. At the time of this report, the outcome was unknown. The nurse reported that he was unaware if the patient missed work because of the reaction. The reporter requested a lot check to be performed on lot 651374/0485F. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
Age: 88.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from an LPN concerning an 88 year old male patient with hypertension and hardening of arteries who on 18-OCT-2006 was vaccinated IM with a 2nd dose of Pneumovax 23 (lot #651437/0899F).  Concomitant therapy included influenza virus vaccine (unspecified), given at the same visit.  On 19-OCT-2006 the patient experienced local pain, tenderness, redness and warmth at the injection site after vaccination with Pneumovax 23.  Medial treatment was sought, and the patient was treated with cool compresses and TYLENOL.  Subsequently, the patient recovered.  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.  There was no product quality complaint involved.  Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 58 year old female with breast cancer, diabetes, hypertension, hernia, stomach polyps and AUGMENTIN allergy who on 24-OCT-2006 was vaccinated with Pneumovax 23 (lot # 651404/0352F) (0.5 ml), intramuscularly.  Concomitant therapy included losartan potassium (MSD), LYRICA, ZELNORM, ACTOS, ARIMIDEX, and "ZELGRID".  On 25-OCT-2006 the patient experienced fever of 101.3 F, swelling and pain at the injection site.  The physician recommended TYLENOL and ice compresses.  A lot check was requested.  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.  Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Body temperature increased, Erythema, Lymphadenopathy, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 44 year old female with seasonal allergies and no known allergies who on 23-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot # 651404/0352F), intramuscularly. Concomitant therapy included ALLEGRA and NASOCORT. There was no illness at the time of vaccination. On 24-OCT-2006 the patient was seen by a physician complaining of swelling, redness and severe tenderness of left axillary area. The patient had a fever to 102. The physician prescribed OMNICEF and DILAUDID. The patient was re-examined on 25-OCT-2006 and on 26-OCT-2006. On 26-OCT-2006 the physician prescribed MEDROL dose pack and CLARINEX in addition to staying course of OMNICEF. A lot check was requested. 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 Center for Biologics Evaluation and Research and was released. No further information is available.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a male patient who on 24-OCT-2006 was vaccinated with a dose of Pneumovax 23 (Lot #651399/0486F) and a dose of influenza virus vaccine (unspecified) in the other arm.  Subsequently the patient experienced redness, swelling and warm to touch at the injection site.  The patient sought unspecified medical attention.  The patient took ibuprofen for the symptoms and recovered in less than 24 hours.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Oedema peripheral
Clinical narrative: Information has been received from a nurse concerning a female patient (age not reported) who on 23-OCT-2006 was vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23 (Lot # 651356/0089F).  Later the same day the patient's arm in which the vaccine was administered swelled and became red and was swollen from the elbow to the shoulder.  The patient was seen in an urgent care clinic and diagnosed with cellulitis and released.  On 24-OCT-2006, "the next day", the patient was re-evaluated and diagnosed with cellulitis.  The nurse stated that he was unaware that the patient missed any work because of the reaction.  At the time of this report, the current status of the patient was unknown.  A lot check was requested by the reporter.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning a patient (age and gender not reported) who on 24-OCT-2006 was vaccinated with Pneumovax 23 (lot # 651356/0089F). Concomitant medication was not reported. On 24-OCT-2006 (later the same day), the patient experienced a cellulitis-like reactions in which the arm where the vaccine was administered swelled and became red and swollen from the elbow to the shoulder. The current status of the patient was reported as unknown. The nurse stated that he was unaware of the patient missing any work because of the reaction. Follow-up information has been received. 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 Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Injection site swelling, Medication error, Oedema peripheral
Clinical narrative: Information has been received from a licensed practical nurse concerning a 50 year old female patient with asthma, hyperlipidemia, hypertension, and mitral regurgitation who on 26-OCT-2006 at 2:45 PM was vaccinated with a second dose of Pneumovax 23 (lot # 651331/0003F).  There was no illness at the time of vaccination.  Subsequently, the reporter "heard" that the patient experienced a large, six inch swelling at the injection site. It was also reported that the patient had "large swollen arm next day."  It was noted that the patient's first and second dose of the vaccine were given to this patient within one month's time because the first dose of the vaccine was improperly stored below the recommended temperature.  Unspecified medical attention was sought.  The patient recovered.  No product quality complaint was involved.  There were no relevant diagnostic tests or laboratory data.  Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 62 year old female who on 25-OCT-2006 was vaccinated with Pneumovax 23 (Lot #654981/0674F). The patient called in to the clinic on 27-OCT-2006, with complications. On 27-OCT-2006, the symptoms were fever of 102, warm, red area 4 centimeters (cm) in diameter at injection site and headache. The headache did not respond to ibuprofen or TYLENOL. The patient was referred to the emergency room but never followed through. It was unknown how soon after vaccination the symptoms of fever, injection site warmth, redness and headache occurred. The patient sought unspecified medical attention. At the time of the report the patient's current state was unknown. A lot check was requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards of the government and was released. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a female patient (age unknown) who on 24-OCT-2006 was vaccinated with a dose of Pneumovax 23 (Lot# 651399/0486F) and a dose of influenza virus vaccine (unspecified) in the other arm.  Subsequently the patient experienced redness, swelling and warm to touch at the injection site.  The patient sought unspecified medical attention.  The patient was treated with TYLENOL and BENADRYL.  The patient's injection site redness, swelling and warmth resolved approximately 24 hours later.  Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: Information has been received from a medical assistant concerning a female patient age 70 years or older who "about two weeks ago" was vaccinated with a dose of Pneumovax 23 (lot # 651319/1007P). Subsequently the patient experienced injection site rash. Unspecified medical attention was sought. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a female patient age 70 years or older who "about two weeks ago" was vaccinated with a dose of Pneumovax 23 (lot # 651319/1007P).  Subsequently the patient experienced injection site rash and fever.  Unspecified medical attention was sought.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a pharmacist concerning a patient who on approximately 20-OCT-2006 (within the last 7 to 10 days) was vaccinated with a dose of Pneumovax 23 (lot #651981/0674F).  Subsequently, the patient experienced "cellulitis symptoms".  Unspecified medical attention was sought.  The patient's outcome was unknown.  No product quality complaint was noted.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Nausea, Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a 69 year old male who on 23-OCT-2006 was vaccinated with Pneumovax 23 (lot #654981/0674F). On an unspecified date, the patient sought medical attention. The symptoms on 24-OCT-2006 were a sore arm from elbow to shoulder in the injection site arm. The patient could not move the arm without pain. The patient was also nauseous. The pharmacist reported that it was unknown how soon after the vaccination the symptoms occurred. The patient's current state was unknown. 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 government and Research and was released by the agency. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Information has been received from a pharmacist concerning a 70 year old female who on 24-OCT-2006 was vaccinated with Pneumovax 23 (Lot # 654981/0674F).  The patient was seen in the emergency room (ER) a couple of hours after receiving the vaccination.  The patient had upper arm swelling and an area 3 inches in diameter at the injection site with redness, swelling and warmth.  The patient was sent home from the ER on 24-OCT-2006 with BENADRYL.  The patient called the next morning 25-OCT-2006 to report that the red area had extended from the marked area from the previous day.  The patient was seen and prednisone was added on 26-OCT-2006.  The patient's current state is unknown.  A lot check was requested.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female patient between the age of 19 and 39 years who between 23-OCT-2006 and 27-OCT-2006 was vaccinated subcutaneously with a dose of Pneumovax 23 (lot #654981/0674F). Within five minutes of receiving the vaccine the patient fainted. Unspecified medical attention was sought. Subsequently, the patient recovered from fainting. The nurse requested a lot check for lot Number 0674F. No product quality complaint was involved. 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 government and was released by the agency. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Antibody test negative, Immunodeficiency
Clinical narrative: Information has been received from a pharmacist concerning an immunocompromised male patient who in 2004 was vaccinated with a dose of Pneumovax 23.  In September 2006, a titer did not show that he responded to the vaccine.  No product quality complaint is involved.  Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 44 year old male with no past medical history who on 29-OCT-2006 was vaccinated IM with a first dose of Pneumovax 23 as part of a church immunization program.  There was no concomitant medications.  On 29-OCT-2006 the patient developed local injection site reactions that progressed over the next 48 hours.  On approximately 29-OCT-2006 the patient developed a 4 and a half inch, round rash at the injection site and the are was swollen and painful.  The patient was going to see his physician on 31-OCT-2006.  At the time of the report, the patient had not recovered.  Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 61 year old female with a history of sneezing (week before) who on 21-OCT-2006 at 10:00 was vaccinated SC with a third dose of Pneumovax 23 (lot# 651400/0618F).  Two days later, the patient experienced a painful, swelling, erythematous left arm the size of a quarter in her arm.  Ten days later, the patient recovered.  No product quality complaint was involved.  Additional information is not expected.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Information has been received from a physician concerning a 57 year old female with penicillin allergy, allergic reaction to antibiotics ("e-mycin", azithromycin, clindomycin), drug allergy to indomethacin and drug allergy to codeine who on 30-OCT-2006 was vaccinated subcutaneously with a 0.5 mL dose of Pneumovax 23 (Lot# 651319/1007P). Concomitant therapy included ATROVENT, ACCOLATE, CLARITIN, ACIPHEX, ESTRING, vitamins (unspecified), ASPIRINE, AMBIEN and FLOVENT. The physician reported that on 30-OCT-2006 the patient had fever, chills, muscle aches, localized swelling, redness and tenderness at injection site (right upper arm) approximately 4-5 hours post-injection. The patient was treated with BENADRYL and TYLENOL. At the time of the report, the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 57 year old female with penicillin allergy, allergic reaction to antibiotics ("e-mycin", azithromycin, clindomycin), drug allergy to indomethacin and drug allergy to codeine who on 30-OCT-2006 was vaccinated subcutaneously with a 0.5 mL dose of Pneumovax 23 (Lot# 651319/1007P). Concomitant therapy included ATROVENT, ACCOLATE, CLARITIN, ACIPHEX, ESTRING, vitamins (unspecified), ASPIRINE, AMBIEN and FLOVENT. The physician reported that on 30-OCT-2006 the patient had fever, chills, muscle aches, localized swelling, redness and tenderness at injection site (right upper arm) approximately 4-5 hours post-injection. The patient was treated with BENADRYL and TYLENOL. At the time of the report, the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: PNC, PPV
Symptoms: Medication error, No adverse reaction, Wrong drug administered
Clinical narrative: Initial and follow-up information has been received from a physician concerning a patient who was inadvertently vaccinated with a dose of Pneumovax 23 instead of a fourth dose of PREVNAR.  The physician stated that there was an error on the part of the office.  Specifically, 70 doses of Pneumovax 23 (MSD) were ordered instead of PREVNAR because both products were next to each other on the order form.  It was reported that 40 doses were administered with the belief that they were PREVNAR.  It was reported that there was no confusion in regards to product packaging.  The physician stated that the problem had been corrected at the office and did not foresee any future problems.  On an unspecified date, the patient was vaccinated with a fourth dose of PREVNAR.  There were no adverse experiences reported.  Follow-up reported that the patient had "done well" and no pneumococcal infection had been noted.  Additional information is not expected.