chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 60 year old female who on 28-SEP-2010 was vaccinated with PNEUMOVAX 23 (Lot # not reported, route and injection site not reported). After administration of the vaccine, the patient experienced redness, pain and swelling at the injection site. The patient also experienced swelling of the arm. Outcome of the events were not reported. Follow-up information has been received from a medical assistant concerning the patient who had injection site reactions after vaccination with the same lot number (Lot # 667274/0883Z) of PNEUMOVAX 23. The patient had "severe" reactions consisting of red, hot, painful and swollen arms with the reaction extending from the injection site to elbow. Outcome of the events were not reported. This is one of several reports received from a same source. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 6 year old male who on 04-OCT-2010 was vaccinated with one shot of PNEUMOVAX 23 (LOT# 663998/0623Y expiration unspecified). Secondary suspected vaccination included of dose of seasonal influenza virus vaccine (unspecified) (manufacturer unknown). In October 2010, the patient experienced fever, rash and cellulitis. It started later than the female patient (had captured in WAES # 1010USA00854). Unspecified medical attention sought. The patient's fever, rash and cellulitis persisted. The physician mentioned other patients, including the brother, are beginning to experienced flu-like symptoms with the same vaccine. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Follow-up information has been received via telephone call from the physician's nurse who reported that it was just two patients. The female first (had captured in 1010USA00854) and then the brother started with the same symptoms, although not as severe. Nurse requested a call back regarding whether they sent the remainder of the doses back, or if they were required to do anything else. A PIR will be completed. This is one of the reports received from same source. Additional information is not expected.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Incorrect route of drug administration, Induration, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 45 year old female patient with asthma and many allergies (including pollen allergy, codeine allergy and KEFLEX allergy) who on 27-SEP-2010 was vaccinated subcutaneously rather than intramuscularly with a dose of PNEUMOVAX 23 (lot# not reported) in her left upper arm. Concomitant therapy included ADVAIR. On 27-SEP-2010, six hours after she received the vaccine, she began to be febrile and her arm became red, swollen and painful. She sought medical attention with the nurse practitioner on 29-SEP-2010 who prescribed steroids and antihistamines. The symptoms continued to worsen, and the patient went to the Emergency Department on 30-SEP-2010. She was prescribed BACTRIM, and after 7 days of BACTRIM the redness had gone away but her arm was still hard, swollen and painful. She was improving, but the nurse practitioner said that her recovery was slow. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 45 year old female patient with asthma and many allergies (including pollen allergy, codeine allergy and KEFLEX allergy) who on 27-SEP-2010 was vaccinated subcutaneously rather than intramuscularly with a dose of PNEUMOVAX 23 (lot# not reported) in her left upper arm. Concomitant therapy included ADVAIR. On 27-SEP-2010, six hours after she received the vaccine, she began to be febrile and her arm became red, swollen and painful. She sought medical attention with the nurse practitioner on 29-SEP-2010 who prescribed steroids and antihistamines. The symptoms continued to worsen, and the patient went to the Emergency Department on 30-SEP-2010. She was prescribed BACTRIM, and after 7 days of BACTRIM the redness had gone away but her arm was still hard, swollen and painful. She was improving, but the nurse practitioner said that her recovery was slow. Additional information has been requested.
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Muscle mass
Clinical narrative: Information has been received from a registered nurse concerning an 85 year old male with no allergies or drug reactions, with anemia and chronic kidney disease who on 24-FEB-2011, was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml, intramuscular in the left deltoid (lot number 667915/1111Z, exp. 02-MAR-2012). Concomitant therapy included ascorbic acid/vitamin B complex, amiodarone, darbepoetin alfa, LASIX, ferrous SO4, SYNTHROID, lidocaine, nystatin, omeprazole (MSD) and simvastatin (MSD). Two weeks after the PNEUMOVAX 23 injection (on approximately 10-MAR-2011), the patient developed "a knot" in this left biceps muscle. Also was reported than on 24-MAR-2011, the nurse saw the patient and the "knot" was smaller than a ping-pong ball, and the knot was without redness or drainage. It was noted no laboratories were performed. It was reported that the patient did not receive treatment for the event. At the time of the report the patient was recovering. Follow up information has been received from the registered nurse who reported that the retired patient on the afternoon at 14:01 of 24-FEB-2011, was vaccinated with a second dose of PNEUMOVAX 23, intramuscular in the left deltoid (lot number 667915/1111Z, exp. 02-MAR-2012). On 24-MAR-2011, the patient complained of knot on left bicep decreasing in size. The patient questioned if knot was due to PNEUMOVAX 23 administered on 24-FEB-2011. The patient did not seek medical attention. Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: Information has been received from a pharmacist concerning a male patient who on an unspecified date, was vaccinated wit a dose of 0.5 ml PNEUMOVAX 23 (Lot #, route not reported). The pharmacist reported that the patient developed pneumonia after receiving a shot of PNEUMOVAX 23. At the time of the report, the patient's outcome was recovered. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Fatigue, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a patient who on unspecified date, was vaccinated with a dose of PNEUMOVAX 23 (lot number, dose and site of administration not reported). It was reported that on unknown date, the patient experienced significant pain and swelling at the injection site and had fever and fatigue. The patient received unspecified medical attention. At the time of the report, the patient had recovered (date unspecified). Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Chills, Cough, Injection site discomfort, Injection site erythema
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N) concerning a currently 68 year old female with hypercholesterolemia, sulfa and codeine drug reactions who on 28-MAR-2011 was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml, subcutaneously, (lot #1411U is an invalid lot number). Concomitant therapy included CRESTOR. On 28-MAR-2011, the patient experienced increased swelling around the area of the injection, it was warm to touch and bothersome. Also, it was reported that the patient had chills and a fever throughout the night a temperature of 100.3. The the patient developed a persistent cough. No lab diagnostics were performed. The patient was told that if the symptoms persist to come into the office. The patient did not seek a medical attention. No treatment was given for the adverse event. At the time of the report, the patient had not recovered. Follow-up information was received from a licensed practical nurse (L.P.N) who stated that the 68 year old (currently 69 year old) female patient with no illness at time of vaccination who on 28-MAR-2011, was vaccinated IM (reported before as SQ) with the second dose of PNEUMOVAX 23 (lot# 667692/1110Z) at 11:50 am. On 28-MAR-2011 by night at 20:00 pm, the patient experienced left upper arm swollen, reddened and warm to touch. The patient also complained of extreme chills and fever. The patient was placed on BENADRYL 25 mg, half a tablet every night and continued half a tablet for 8 hours and continued for the next 24 hours. The chills resolved after several hours on 29-MAR-2011. The patient also did feel some chest tightness, some coughing and there was no shortness of breath. Relevant diagnostic tests were not performed. All symptoms abated in 3 days "on 31-MAR-2011". The patient never sought additional evaluation of treatment. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N) concerning a currently 68 year old female with hypercholesterolemia, sulfa and codeine drug reactions who on 28-MAR-2011 was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml, subcutaneously, (lot #1411U is an invalid lot number). Concomitant therapy included CRESTOR. On 28-MAR-2011, the patient experienced increased swelling around the area of the injection, it was warm to touch and bothersome. Also, it was reported that the patient had chills and a fever throughout the night a temperature of 100.3. The the patient developed a persistent cough. No lab diagnostics were performed. The patient was told that if the symptoms persist to come into the office. The patient did not seek a medical attention. No treatment was given for the adverse event. At the time of the report, the patient had not recovered. Follow-up information was received from a licensed practical nurse (L.P.N) who stated that the 68 year old (currently 69 year old) female patient with no illness at time of vaccination who on 28-MAR-2011, was vaccinated IM (reported before as SQ) with the second dose of PNEUMOVAX 23 (lot# 667692/1110Z) at 11:50 am. On 28-MAR-2011 by night at 20:00 pm, the patient experienced left upper arm swollen, reddened and warm to touch. The patient also complained of extreme chills and fever. The patient was placed on BENADRYL 25 mg, half a tablet every night and continued half a tablet for 8 hours and continued for the next 24 hours. The chills resolved after several hours on 29-MAR-2011. The patient also did feel some chest tightness, some coughing and there was no shortness of breath. Relevant diagnostic tests were not performed. All symptoms abated in 3 days "on 31-MAR-2011". The patient never sought additional evaluation of treatment. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Information has been received via telephone call from a doctor of pharmacy concerning a 25 years old female patient, who on 11-NOV-2010 was vaccinated with a dose PNEUMOVAX (Lot "not reported). The pharmacist reported that the patient experienced soreness, redness, swelling, and a "burning pain" in her upper arms, low grade fever and chills. The patient was not feeling any better on unspecified antibiotics, in fact was feeling worse. This one of three reports from the same source. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: Information has been received from an other health professional concerning a female patient who on an unspecified date, was vaccinated with a dose of PNEUMOVAX 23 (lot# not reported). It was reported that on an unspecified date, the patient experienced soreness and swelling. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. This is one of several reports received from the same resource. No further information is available.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a healthcare worker concerning a 73 year old female who on 20-DEC-2010 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (lot # 667271/0880Z). On an unspecified date the patient experienced redness, swelling and warmth at the injection site (on the arm). At the time of the report, the patient's status was unknown. The patient sought medical attention by office visit. The physician was not comfortable using the remaining doses of PNEUMOVAX 23. The reporter requested a lot check. A lot check has been initiated. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: Information has been received from an other health professional concerning a female patient who on an unspecified date, was vaccinated with a dose of PNEUMOVAX 23 (lot# not reported). It was reported that on an unspecified date, the patient experienced soreness and swelling. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. No further information is available.
Age: 0.5
Sex: U
Vaccine: PPV
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a consumer concerning his 6 month old child who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 instead of flu vaccine (date, strength, route were all unknown). On an unspecified date, the patient experienced symptoms including fever, nausea and vomiting. It was unknown if the patient sought medical attention. At the time of the report the patient's outcome was unknown. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Cardiac valve disease
Clinical narrative: Information has been received from a consumer, who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot # not provided). The consumer mentioned she received PNEUMOVAX 23 and got reactions. The consumer was told she had mild valve damage to her heart. In the past years during regular checkups was told she had no heart murmur. The consumer before she received PNEUMOVAX 23 was told she had no heart murmur. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 67 year old male patient who on 20-OCT-2010 was vaccinated in the right arm with a 0.5ml dose of PNEUMOVAX 23 (lot number 665924/0930Z). Concomitant therapy included ADACEL in the left arm. On 21-OCT-2010 the patient went to an urgent care facility at the physician's office address for redness and swelling in his right arm. While there he was advised to apply an ice pack on his right arm. On 08-NOV-2010 the patient called in to the physician's office complaining of redness and swelling in his right arm and was advised to come in the next day. On 09-NOV-2010 the patient arrived at the office complaining of redness and swelling in his right arm and he stated that he had had a fever for 3 days. The physician diagnosed it as a reaction to PNEUMOVAX 23. On 20-FEB-2011 the patient called the office back, complaining of pain in the right arm and was told to take TYLENOL and apply ice packs to the affected arm. At the time of the report, the patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Epistaxis, Injection site mass, Injection site pain
Clinical narrative: Information has been received from a female consumer, who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported) IM in her upper arm. Subsequently the consumer experienced "nose bleeds" for two weeks, felt dizzy and had a painful lump at the injection site. It was unknown if the patient sought medical attention. At the time of the report, the outcome of dizzy and painful lump at the injection site was unknown. No further information is available.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Wrong drug administered
Clinical narrative: Information has been received from a Registered Nurse concerning a 35 year old female patient with no allergies and no pertinent medical history who on 28-FEB-2010 was inadvertently vaccinated with a 0.1 ml dose of PNEUMOVAX 23 (Lot#667913/1021Z, Exp date 27-FEB-2012), Intradermally, when supposed to received the MANTOUX II test (PPD). There was no concomitant medication. The nurse reported that on 28-FEB-2010 the patient experienced local injection-site reaction, after the patient was inadvertently administered PNEUMOVAX 23. There was no treatment given for the events. There were no laboratories diagnostics performed. At the time of the report the patient had recovered from the symptom. The patient sought unspecified medical attention. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Information has been received via telephone call from doctor of pharmacy concerning an approximately 65 years old female patient, who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot # 667271/0880Z EXP 11-DEC-2011). The pharmacist reported that the patient experienced soreness, redness, swelling, and a "burning pain" in her right upper arm. She was given ciprofloxacin. At the time of the report, the outcome of the patient was unknown. This one of three reports from the same source. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Malaise, Skin discolouration
Clinical narrative: Information has been received from a caller concerning a 14 year old female patient who on 21-FEB-2011 was vaccinated with the first dose of PNEUMOVAX 23 (Lot #, expire date and route not reported). Suspect therapy administered also on 21-FEB-2011 included AFLURIA. Caller stated that on 21-FEB-2011 within minutes of receiving the first dose of PNEUMOVAX 23 and a dose of AFLURIA, the patient's face became purple and she had difficulty breathing. Caller mentioned that the patient was taken to an emergency room at an unspecified hospital. That same day the patient had been to her physician's office for evaluation of an unspecified illness. The caller reported that the patient had had a flu vaccine in the past, but she believed that this was the patient's first dose of PNEUMOVAX 23. At the time of the report, patient's outcome was unknown. No further information is available. It has been determined that WAES # 1102USA03540 was mistakenly created from WAES# 1102USA03129. Therefore, WAES # 1102USA03540 is being deleted from our files and the reports consolidated into WAES # 1102USA03129.
Age: 0.2
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning an 8 weeks old patient who on 18-FEB-2011 was vaccinated intramuscularly with a 0.5ml dose of PNEUMOVAX 23 (lot number not provided) instead of a dose of PREVNAR. The patient was not experiencing any known symptoms. Follow up information was received via telephone call from the medical assistant who stated that there had not been any side effects from administering PNEUMOVAX 23 to the female baby patient. The medical assistant also stated that she was not used to working with infants and vaccinated the baby with PNEUMOVAX 23 in stead of PREVNAR. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Blood test, Erythema, Gait disturbance, Pneumonia
Clinical narrative: Information has been received from a consumer concerning her 82 year old husband with high blood pressure and no drug reactions. On 13-OCT-2010, the patient was vaccinated with 0.5ml dose of PNEUMOVAX 23. Concomitant therapy included AVELOX "and many other medications". "A week ago" on approximately 31-DEC-2010 the patient "came down with pneumonia". The patent's arms became bright red from the elbow to the shoulder and hot to touch. "One day he could hardly walk." The patient sought unspecified medical attention and was treated with oxygen for his lung. Blood work was performed (result not reported). When the information was reporting, the patient had not recovered (It was also reported as recovering). Follow-up information has been received which reported that the patient was administered at a pharmacy, not the physician's office. No further information is available.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Chills, Erythema, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a consumer concerning her 50 year old husband with drug reactions/allergies to penicillin, sulfa and MINOCIN who on 23-FEB-2011 was vaccinated with a dose of PNEUMOVAX 23 (lot number not provided). The patient's wife reported that on 23-FEB-2011 evening, her husband experienced his right arm swelled at the injection site and on his entire arm and turned bright red, was hot to the touch, and was diagnosed as cellulitis. He developed fever and chills and felt like had pneumonia in his lungs as he had pneumonia previously. His physician prescribed BIAXIN. No lab diagnostic studies were performed. At the time of the report the patient had not recovered. Follow up information was received from the familiar nurse practitioner, indicated that the printer patient, with no birth defects and no other medical condition and no illness at the time of vaccination or adverse events following prior vaccination, received PNEUMOVAX 23on 23-FEB-2011, approximately late pm, into the right deltoid and on 24-FEB-2011. The patient called complained of high redness and swelling at site. The physician said that the patient was told apply cool soaks and appointment to 25-FEB-2011. The physician diagnosed adverse reaction to injection and cellulitis. It was also reported that the patient felt like had pneumonia and was placed on BIAXIN 500mg BID for 7 days and cool soaks and ALEVE pm. The physician stated that the next appointment was on 01-MAR-2011. On an unspecified date the patient recovered. Additional information is not expected.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Lung disorder, Pyrexia, Skin warm
Clinical narrative: Information has been received from a consumer concerning her 50 year old husband with drug reactions/allergies to penicillin, sulfa and MINOCIN who on 23-FEB-2011 was vaccinated with a dose of PNEUMOVAX 23 (lot number not provided). The patient's wife reported that on 23-FEB-2011 evening, her husband experienced his right arm swelled at the injection site and on his entire arm and turned bright red, was hot to the touch, and was diagnosed as cellulitis. He developed fever and chills and felt like had pneumonia in his lungs as he had pneumonia previously. His physician prescribed BIAXIN. No lab diagnostic studies were performed. At the time of the report the patient had not recovered. Follow up information was received from the familiar nurse practitioner, indicated that the printer patient, with no birth defects and no other medical condition and no illness at the time of vaccination or adverse events following prior vaccination, received PNEUMOVAX 23on 23-FEB-2011, approximately late pm, into the right deltoid and on 24-FEB-2011. The patient called complained of high redness and swelling at site. The physician said that the patient was told apply cool soaks and appointment to 25-FEB-2011. The physician diagnosed adverse reaction to injection and cellulitis. It was also reported that the patient felt like had pneumonia and was placed on BIAXIN 500mg BID for 7 days and cool soaks and ALEVE pm. The physician stated that the next appointment was on 01-MAR-2011. On an unspecified date the patient recovered. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a Registered Pharmacist concerning an approximately 68 year old female patient with no pertinent medical history and with allergies to penicillin, iodines and latex who "in the past" (date unspecified) was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot # unspecified) and a dose of AFLURIA (manufacturer unknown) (dose, route and lot # unspecified). Subsequently the patient "had a reaction". On an unspecified date, the patient recovered. It was unspecified if patient sought medical attention. Follow up information has been received from a Registered Pharmacist, concerning about the 68 year old female patient. The pharmacist reported not having more knowledge of this event. No further information is available.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nervous system disorder, Nuclear magnetic resonance imaging, Pain in extremity, Ultrasound scan, X-ray limb
Clinical narrative: Information has been received from a nurse concerning an 82 year old female patient who on 14-OCT-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 667914/1067Z, expire date February 2012, route not reported), 0.5 ml, in her right arm. Concomitant therapy included FLUZONE, in her left arm, administered on the same day, aspiring, PREVACID, metoprolol and CARDIZEM. Nurse stated that on 27-OCT-2010, the patient notified the doctor that she was having pain in her right arm. The doctor recommended that she took ALEVE and VICODIN. On 05-NOV-2010, the patient had a sonogram and a magnetic resonance imaging (MRI) on her right shoulder and an X-ray of her right arm on 08-DEC-2010 (results not provided). The patient was prescribed gabapentin for the pain. The patient came to the doctor's office in February 2011 for a neurological disorder. At the time of the report, patient's outcome was unknown. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a consumer who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot #, expire date and route not reported). Consumer stated that on an unspecified date, had a terrible reaction to PNEUMOVAX 23. At the time of the report, consumer's outcome was unknown. It is unknown if the patient sought medical attention. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse, who heard this from another nurse, concerning a patient who on an unspecified date, several years ago, was vaccinated with the second dose of PNEUMOVAX 23 (lot number not provided). The nurse reported that on an unspecified date the patient complained of swollen and soreness at the injection site after receiving the second dose of of vaccination 2 years apart. It was unknown if lab diagnostic studies were performed. The patient recovered from the symptoms with TYLENOL and compress treatment. Attempts are being made to verify the existence of an identifiable patient. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Rash
Clinical narrative: Information has been received from a pharmacist concerning an approximately 70 year old female patient who "a few years ago" was vaccinated with a dose of PNEUMOVAX 23 (Dose, route and Lot# not reported). Pharmacist stated that on an unspecified date the patient experienced an allergic reaction to PNEUMOVAX 23 and developed rash. Pharmacist also stated that the patient on unspecified date took BENADRYL for the rash and it went away. The patient sought unspecified medical attention. No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a female who on an unspecified date was vaccinated with PNEUMOVAX 23 (Lot# 667095/1150Z, expiration date on 4-MAR-2012). Subsequently the patient experienced cellulitis and fever after administration of PNEUMOVAX 23. The patient was treated with antibiotics. She did not have the patient's chart so she could not provide patient specific information. She was requesting a lot check. A lot check has been initiated. The health care professional contacted during telephone follow up could not supply the following information: patient name, date of birth, date of vaccination, date of event, recovery status. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Skin lesion, Urticaria
Clinical narrative: Information has been received from a 66 year old female patient who on 09-FEB-2011 was vaccinated with a dose of PNEUMOVAX 23 (lot number 667915/1111Z). On 09-FEB-2011 the patient experienced swelling, sores and welts on her arm after receiving a PNEUMOVAX 23 injection. The patient sought unspecified medical attention. It was unspecified if any treatment was given for the adverse events or if any lab diagnostic studies were performed. At the time of the report, the patient's outcome was unknown. Follow up information was received which indicated that the patient was not hospitalized but was treated just back and forth to the doctor 2 or 3 times. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Cellulitis, Injection site cellulitis, Malaise, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 76 year old male patient who "5 years ago", in approximately October 2010, was vaccinated with the first dose of PNEUMOVAX 23 without reaction. On 05-OCT-2010, the patient was vaccinated intramuscularly with a second 0.5 ml dose of PNEUMOVAX 23 (lot # 665904/0866Z). Several days later, (onset also reported as 05-OCT-2010) the patient returned to the office with a very severe cellulitis from the injection site to below his elbow. The patient also experienced asthenia, malaise and fever. At the time of the report, the patient was recovering. This is one of several reports received from the same source. The office concerned for the lot. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question, 665904/0866Z, were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a male patient who on 28-FEB-2011 or 06-MAR-2011 was vaccinated with a dose of PNEUMOVAX 23 ("intramuscular or subcutaneous injection", 0.5 ML, Lot # 667995/1150Z and expiration date: 04-Mar-2012). The physician reported that the patient experienced swollenness and redness at the injection-site in the arm. The physician had not seen this type of reaction in this type of consistency. Patient sought unspecified medical attention. At the time of reporting the patient was recovering. This is one of several reports received from the same source. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a physician concerning an approximately 76 year old male patient with Chronic obstructive pulmonary disease (COPD), asthma, hypertension and rheumatoid arthritis who in 2002 was vaccinated with a dose of PNEUMOVAX 23 (Dose, route and Lot# Not reported) and on 12-08-2010 the patient received a booster of PNEUMOVAX 23 (Dose, route and Lot# Not reported). The physician stated that "around 11-DEC-2010" a few days after of PNEUMOVAX 23 booster administered, the patient experienced cellulitis. The area this presented on the patient's skin was traced with a marker. The physician also stated that on 13-DEC-2010 the patient was seen and the cellulitis had started to recede, KEFLEX was given as treatment for the event. At the time of the report the patient improved the cellulitis on therapy. The patient sought unspecified medical attention. This is one of two reports received from the same source. Additional information has been requested.
Age: 89.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site oedema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning an 89 year old male patient who on 25-FEB-2011 was vaccinated with a dose (nurse believes that this was his second dose) of PNEUMOVAX 23 (route and lot # unspecified). The nurse reported that on 26-FEB-2011, the patient developed an injection site reaction of swelling and redness and he developed a fever. As treatment, the patient received TYLENOL suppositories, BACTRIM and MEDROL. The nurse reported that his fever "this morning" (on 01-MAR-2011) was 99.8, which she said was "better than it was". The patient being screened for influenza and results were still pending. At the time of the report the patient was recovering. Patient sought unspecified medical attention. Follow up information has been received from a licensed practical nurse concerning a male elective engineer with no pertinent medical history and no drug reactions or allergies who on 25-FEB-2011 was vaccinated in his left arm (deltoid) with a dose of PNEUMOVAX 23 (route not reported). Lot number (9874408) is an invalid lot number for PNEUMOVAX 23. The nurse reported that the patient had the vaccine before but his wife did not remember the date. On 27-FEB-2011 at 10:00 the patient developed a fever of 99.9 axillary, APAP 650mg orally was given. At 14:15 the patient developed a fever of 100.8 axillary. APAP 650 mg orally was given. At 20:00 the patient developed a fever of 101.4 axillary, the site was red and mild edema. Ice pack was applied. On 28-FEB-2011 at 24:00 the patient developed a fever of 100.1, APAP 650 mg orally was given. At 5 the patient developed a fever of 101.3, APAP suppository 650 mg was administered. Treatment for the adverse events included BACTRIM DS for seven days, TAMIFLU 75 mg twice a day for two days and medicine dose as during effects. Conflicting information has been received from Licensed Practical Nurse who reported that fever and cellulitis spreading from the injection site to near shoulder down to the elbow area as illness at time of vaccination and previously reported as adverse events. Influenza testing became positive shortly after fever onset. At the time of the report, the patient recovered from cellulitis and pyrexia on 03-MAR-2011. Additional information has been requested.
Age: 89.0
Sex: M
Vaccine: PPV
Symptoms: Viral test positive
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning an 89 year old male patient who on 25-FEB-2011 was vaccinated with a dose (nurse believes that this was his second dose) of PNEUMOVAX 23 (route and lot # unspecified). The nurse reported that on 26-FEB-2011, the patient developed an injection site reaction of swelling and redness and he developed a fever. As treatment, the patient received TYLENOL suppositories, BACTRIM and MEDROL. The nurse reported that his fever "this morning" (on 01-MAR-2011) was 99.8, which she said was "better than it was". The patient being screened for influenza and results were still pending. At the time of the report the patient was recovering. Patient sought unspecified medical attention. Follow up information has been received from a licensed practical nurse concerning a male elective engineer with no pertinent medical history and no drug reactions or allergies who on 25-FEB-2011 was vaccinated in his left arm (deltoid) with a dose of PNEUMOVAX 23 (route not reported). Lot number (9874408) is an invalid lot number for PNEUMOVAX 23. The nurse reported that the patient had the vaccine before but his wife did not remember the date. On 27-FEB-2011 at 10:00 the patient developed a fever of 99.9 axillary, APAP 650mg orally was given. At 14:15 the patient developed a fever of 100.8 axillary. APAP 650 mg orally was given. At 20:00 the patient developed a fever of 101.4 axillary, the site was red and mild edema. Ice pack was applied. On 28-FEB-2011 at 24:00 the patient developed a fever of 100.1, APAP 650 mg orally was given. At 5 the patient developed a fever of 101.3, APAP suppository 650 mg was administered. Treatment for the adverse events included BACTRIM DS for seven days, TAMIFLU 75 mg twice a day for two days and medicine dose as during effects. Conflicting information has been received from Licensed Practical Nurse who reported that fever and cellulitis spreading from the injection site to near shoulder down to the elbow area as illness at time of vaccination and previously reported as adverse events. Influenza testing became positive shortly after fever onset. At the time of the report, the patient recovered from cellulitis and pyrexia on 03-MAR-2011. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot # not reported). Subsequently the patient experienced significant arm swelling after administration of vaccine. The patient sought a medical attention by phone or office visit. The outcome was unknown at the time of this report. No further information is available.
Age: 21.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Skin warm, Tenderness
Clinical narrative: Information has been received from a registered nurse and a pharmacist concerning a currently 21 year old male patient who on 15-OCT-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot#667912/0933Z). It was reported that the patient developed reaction to PNEUMOVAX 23. At the time of this report, the patient's outcome was not reported. The physician is concerned about this lot number and was hesitant to give other vaccinations with the same lot number. The physician requested a lot check. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 667912/0933Z were satisfactory. The lot met the requirements of the Center of Biologics Evaluation and Research and was released. Follow up information has been received from the registered nurse who stated that the 21 year old patient with sulfa allergy on 16-OCT-2010 called the pharmacy to report arm swollen, hot, red, tender shoulder to elbow. At the time of the report, it was unknown if the patient had recovered. The patient did not seek medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Inflammation, Rash
Clinical narrative: Information has been received from a medical assistant concerning a 66 year old female patient with breast cancer, osteoarthritis and no drug reactions or allergies, who on 20-OCT-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot # 667445/0993Z, expire date not reported), 0.5 ml, intramuscularly. Concomitant medication included "cholesterol, blood pressure and thyroid medications". On 20-OCT-2010, when patient received PNEUMOVAX 23, that same day developed a rash over her left breast that traveled up to her shoulder and down her left arm to the elbow. The medical assistant stated that "it was an inflammation of the tissue, it was red and the patient had some pain in her elbow". The medical assistant also stated that believed if she did not come into the office it could have been pretty bad. There were no laboratory diagnostic studies performed. The patient sought unspecified medical attention. At the time of the report, the patient was recovering "after initiating antibiotic therapy". Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning an infant patient, who on an unspecified date was accidentally vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported) which was not indicated for patients under two years of age when they were supposed to give PREVNAR 13. Follow up information has been received from the physician concerning a 24 week old (gender unknown) patient, who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported). There were no adverse reactions. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a patient who on 14-FEB-2011 was vaccinated with PNEUMOVAX 23, 0.5ml, intramuscular, lot no. 667695/1028Z. It is unknown if the patient received PNEUMOVAX 23 in the past. On approximately 15-FEB-2011 the patient experienced slightly raised reddish pink colored welts covering the shoulder around the injection site. The patient sought medical attention via office visit, and was given BENADRYL and MOTRIN to treat the symptom. At the time of report, the patient's symptoms persisted. The pharmacist was requesting a lot check. This is one of two reports received from the same source. Additional information has been requested. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center of Biologics Evaluation and Research and was released.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a 52 year old female patient who in October 1999, was vaccinated with one dose of 0.5 ml PNEUMOVAX 23 (lot # not reported, one dose only). In October 1999 after receiving the vaccine, the patient experienced soreness in the arm of the injection site. Unspecified therapy was given to the patient and the pain went away after a couple days (in October 1999). It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect route of drug administration, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a 49 year old female patient with diabetes, obesity, rectal cancer, currently undergoing chemo and radiation therapy who on an unspecified date was vaccinated with a 0.5ml dose of PNEUMOVAX 23 intravenously via a port line. The vaccine was mixed with 2.2ml of sterile H2O prior to administration. The patient did not report any side effects following the IV administration of the vaccine. It was unspecified if the patient sought medical attention. Follow-up information received from the registered nurse. On 08-FEB-2011, another nurse accidentally grabbed the PNEUMOVAX 23 (lot number 667418/0978Z) instead of another medication that the patient was to receive. When the reporter discovered what had happened one hour later, she withdrew 2ml of fluid from the port so it was unknown how much of the PNUEMOVAX 23 the patient actually received. The patient's relevant concomitant medication included fluorouracil. It was unknown if the patient had any laboratory testing performed. As of the time of this report, the patient was feeling okay. Additional has been requested. This is a consolidation of two reports concerning the same patient.
Age: 94.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a nurse practitioner concerning a 94 year old male who on 08-FEB-2011 was vaccinated with PNEUMOVAX 23, 0.5ml, im, (lot no. 667712/1211Z). On 10-FEB-2011 the patient experienced redness, soreness in the left arm injection site after receiving PNEUMOVAX 23, and resulted in a diagnosis of cellulitis. The patient sought unspecified medical attention and treated with KEFLEX. At the time of report, the patient's cellulitis persisted. Follow up information from a health professional reported that the patient was vaccinated a 0.5 ml dose of PNEUMOVAX IM, into left deltoid. On an unspecified date, the patient experienced erythema, edema and warmth at left deltoid, extending to medial forearm which were required oral antibiotics. At the time of report, the patient present status was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist concerning a patient who on 10-FEB-2011 was vaccinated with 0.5 ml PNEUMOVAX 23 (lot # 667712/1211Z, expiration date 01-FEB-2012). On 10-FEB-2011 the patient experienced a rash on the arm of the injection. The outcome of rash on the arm of the injection was unknown. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: Information has been received from an other health professional concerning a male patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot# 667690/1158Z). It was reported that on an unspecified date, the patient experienced soreness and swelling. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. The is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with PNEUMOVAX 23 (lot # not reported) on an unknown day. The patient experienced a rash. It was not reported if the patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Full blood count, Injection site swelling, Oedema peripheral
Clinical narrative: Information has been received from a Registered Nurse concerning an 84 year old female patient with a history of breast cancer remission and no drug reactions or allergies who on 21-JAN-2011 was vaccinated with PNEUMOVAX 23 0.5 mL intramuscularly. There was no concomitant therapy. On 21-JAN-2011 the patient experienced swelling at the injection site, and her arm was red and swollen. The patient went to the emergency room and was given ADVIL and BENADRYL. Lab diagnostics included complete blood cell count "CBC test" with no result provided. The patient was recovering from the adverse events. Additional information has been requested.