chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Infection, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a 70 year old female "cancer survivor" consumer, with no drug reactions/allergies, who on 23-SEP-2009 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot # 663888/0627Y) into the left arm. The same day was vaccinated with a dose of FLUVIRIN (NOVARTIS) in opposite shoulders. "That evening" the patient had a reaction in her left arm where she was given PNEUMOVAX 23. By the middle of the night, her left arm was swollen from her shoulder to her elbow, and it was red, itchy and painful. The patient went to the emergency room. The doctor stated that it was an infection, possibly cellulitis. She was given antibiotics and about 5 days later it was bearable, and within another week it was gone. At the time of the report, she still got itching occasionally, but she did not know if it was related to the reaction she had or not. The patient also stated that when she was in the emergency room, the doctor told her that "it looked like needle hit the bone" when PNEUMOVAX 23 was being administered. The patient stated that she received "another pneumonia vaccine about 10 years ago, but she did not know if it was PNEUMOVAX 23 or not". No laboratory diagnostics studies were performed. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pruritus, Wrong technique in drug usage process
Clinical narrative: Information has been received from a 70 year old female "cancer survivor" consumer, with no drug reactions/allergies, who on 23-SEP-2009 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot # 663888/0627Y) into the left arm. The same day was vaccinated with a dose of FLUVIRIN (NOVARTIS) in opposite shoulders. "That evening" the patient had a reaction in her left arm where she was given PNEUMOVAX 23. By the middle of the night, her left arm was swollen from her shoulder to her elbow, and it was red, itchy and painful. The patient went to the emergency room. The doctor stated that it was an infection, possibly cellulitis. She was given antibiotics and about 5 days later it was bearable, and within another week it was gone. At the time of the report, she still got itching occasionally, but she did not know if it was related to the reaction she had or not. The patient also stated that when she was in the emergency room, the doctor told her that "it looked like needle hit the bone" when PNEUMOVAX 23 was being administered. The patient stated that she received "another pneumonia vaccine about 10 years ago, but she did not know if it was PNEUMOVAX 23 or not". No laboratory diagnostics studies were performed. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Erythema, Mobility decreased, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Information has been received from a registered nurse concerning a 48 year old female patient with allergic reaction to erythromycin who on 28-DEC-2009 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (lot # 663891/0509Y) into her right deltoid. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid which was vaccinated in the left arm on the same day. Post vaccination the patient experienced a very large, red, painful swollen area from right shoulder down to right mild arm. It was reported that the patient used ice as comfort measure. The patient sought unspecified medical attention. At the time of report, the patient was recovering. Follow-up information has been received from a licensed practitioner nurse concerning a female patient who experienced pain, swelling, redness and warmth lasting for 2 to 3 days. It was reported that the patient needed prescription drug treatment for the experience. On approximately 31-DEC-2009, the patient had recovered. It was noted that the patient was administered with PNEUMOVAX 23 "Q 10 years". This is one of several reports received from the same source. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Skin warm
Clinical narrative: Information has been received from a registered nurse concerning a 48 year old female patient with allergic reaction to erythromycin who on 28-DEC-2009 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (lot # 663891/0509Y) into her right deltoid. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid which was vaccinated in the left arm on the same day. Post vaccination the patient experienced a very large, red, painful swollen area from right shoulder down to right mild arm. It was reported that the patient used ice as comfort measure. The patient sought unspecified medical attention. At the time of report, the patient was recovering. Follow-up information has been received from a licensed practitioner nurse concerning a female patient who experienced pain, swelling, redness and warmth lasting for 2 to 3 days. It was reported that the patient needed prescription drug treatment for the experience. On approximately 31-DEC-2009, the patient had recovered. It was noted that the patient was administered with PNEUMOVAX 23 "Q 10 years". This is one of several reports received from the same source. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 38 year old female patient with allergic reaction to penicillin who on 29-DEC-2009 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (lot # 663891/0509Y) into her left deltoid. It was reported that on 30-DEC-2009 the patient called the doctor office and stated that her left arm became painful and was very hard, red, swollen from left shoulder to left arm. It was also reported that the patient used TYLENOL and ice as comfort measures and the symptoms were improving. The patient sought unspecified medical attention. At the time of reporting, the patient was recovering. Follow-up information has been received from a licensed practitioner nurse concerning a female patient who experienced pain, swelling, redness and warmth lasting for 2 to 3 days. It was reported that the patient was prescribed with clindamycin in emergency room. On approximately 31-DEC-2009, the patient had recovered. It was noted that the patient was administered with PNEUMOVAX 23 "Q 10 years". This is one of several reports received from the same source. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 38 year old female patient with allergic reaction to penicillin who on 29-DEC-2009 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (lot # 663891/0509Y) into her left deltoid. It was reported that on 30-DEC-2009 the patient called the doctor office and stated that her left arm became painful and was very hard, red, swollen from left shoulder to left arm. It was also reported that the patient used TYLENOL and ice as comfort measures and the symptoms were improving. The patient sought unspecified medical attention. At the time of reporting, the patient was recovering. Follow-up information has been received from a licensed practitioner nurse concerning a female patient who experienced pain, swelling, redness and warmth lasting for 2 to 3 days. It was reported that the patient was prescribed with clindamycin in emergency room. On approximately 31-DEC-2009, the patient had recovered. It was noted that the patient was administered with PNEUMOVAX 23 "Q 10 years". This is one of several reports received from the same source. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV, FLUX, PPV
Symptoms: Amnesia, Ataxia, CSF protein normal, CSF test, CSF white blood cell count negative
Clinical narrative: Information has been received from a registered nurse concerning a male patient who on 27-OCT-2008 was vaccinated with a dose of PNEUMOVAX 23 (Lot#661529/0868X) and a dose of influenza virus vaccine (manufacturer unspecified). Subsequently the patient experienced an adverse event (not specified). It was also reported that the patient did not receive any vaccination on 27-OCT-2007. It is unknown if the patient sought medical attention. At the time of the report, the outcome of the patient was unknown. Follow-up information has been received from from a registered nurse who indicated that on 27-OCT-2008 at 12:25 p.m. the patient was vaccinated with an IM dose of PNEUMOVAX 23. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: PPV, FLUX, PPV
Symptoms: Chills, Computerised tomogram normal, Full blood count normal, Headache, Hyperhidrosis
Clinical narrative: Information has been received from a registered nurse concerning a male patient who on 27-OCT-2008 was vaccinated with a dose of PNEUMOVAX 23 (Lot#661529/0868X) and a dose of influenza virus vaccine (manufacturer unspecified). Subsequently the patient experienced an adverse event (not specified). It was also reported that the patient did not receive any vaccination on 27-OCT-2007. It is unknown if the patient sought medical attention. At the time of the report, the outcome of the patient was unknown. Follow-up information has been received from from a registered nurse who indicated that on 27-OCT-2008 at 12:25 p.m. the patient was vaccinated with an IM dose of PNEUMOVAX 23. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: PPV, FLUX, PPV
Symptoms: Laboratory test normal, Lethargy, Lumbar puncture normal, Malaise, Memory impairment
Clinical narrative: Information has been received from a registered nurse concerning a male patient who on 27-OCT-2008 was vaccinated with a dose of PNEUMOVAX 23 (Lot#661529/0868X) and a dose of influenza virus vaccine (manufacturer unspecified). Subsequently the patient experienced an adverse event (not specified). It was also reported that the patient did not receive any vaccination on 27-OCT-2007. It is unknown if the patient sought medical attention. At the time of the report, the outcome of the patient was unknown. Follow-up information has been received from from a registered nurse who indicated that on 27-OCT-2008 at 12:25 p.m. the patient was vaccinated with an IM dose of PNEUMOVAX 23. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: PPV, FLUX, PPV
Symptoms: Pyrexia, Sopor, Starvation, West Nile virus test negative
Clinical narrative: Information has been received from a registered nurse concerning a male patient who on 27-OCT-2008 was vaccinated with a dose of PNEUMOVAX 23 (Lot#661529/0868X) and a dose of influenza virus vaccine (manufacturer unspecified). Subsequently the patient experienced an adverse event (not specified). It was also reported that the patient did not receive any vaccination on 27-OCT-2007. It is unknown if the patient sought medical attention. At the time of the report, the outcome of the patient was unknown. Follow-up information has been received from from a registered nurse who indicated that on 27-OCT-2008 at 12:25 p.m. the patient was vaccinated with an IM dose of PNEUMOVAX 23. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: PPV, FLUX, PPV
Symptoms: Adverse event
Clinical narrative: Information has been received from a registered nurse concerning a male patient who on 27-OCT-2008 was vaccinated with a dose of PNEUMOVAX 23 (Lot#661529/0868X) and a dose of influenza virus vaccine (manufacturer unspecified). Subsequently the patient experienced an adverse event (not specified). It was also reported that the patient did not receive any vaccination on 27-OCT-2007. It is unknown if the patient sought medical attention. At the time of the report, the outcome of the patient was unknown. Follow-up information has been received from from a registered nurse who indicated that on 27-OCT-2008 at 12:25 p.m. the patient was vaccinated with an IM dose of PNEUMOVAX 23. Additional information is not expected.
Age: 42.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Information has been received from a registered pharmacist concerning a 42 year old female inpatient with diagnosis of pneumonia who on 16-JAN-2010 was intramuscularly vaccinated in the left deltoid with a 0.5 mL dose of PNEUMOVAX 23 (Lot#664516/1192Y). Concomitant therapy included Antibiotics "UNISION IV" (unspecified) and VICODIN for pain. The registered pharmacist reported that 24 hour post vaccination with PNEUMOVAX 23, on 17-JAN-2010, the patient developed a red raised rash that started under the injection site of the left deltoid and extended downward for 6 to 8 inches. The patient sought unspecified medical attention. The patient was treated with comfort measures and did not require other intervention. On an unspecified date the patient had recovered. The registered pharmacist stated that the hospital stay was not prolonged due to the injection site reactions. The pharmacist was requesting a lot check. A standard lot check was performed. All in process quality checks for the lot number 664516/1192Y was 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 number 664516/1192Y met the requirements of the Center for Drug Evaluation and Research and was released. Additional information has been requested. This is of several cases reported by the same source.
Age: 42.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site rash, Rash erythematous
Clinical narrative: Information has been received from a registered pharmacist concerning a 42 year old female inpatient with diagnosis of pneumonia who on 16-JAN-2010 was intramuscularly vaccinated in the left deltoid with a 0.5 mL dose of PNEUMOVAX 23 (Lot#664516/1192Y). Concomitant therapy included Antibiotics "UNISION IV" (unspecified) and VICODIN for pain. The registered pharmacist reported that 24 hour post vaccination with PNEUMOVAX 23, on 17-JAN-2010, the patient developed a red raised rash that started under the injection site of the left deltoid and extended downward for 6 to 8 inches. The patient sought unspecified medical attention. The patient was treated with comfort measures and did not require other intervention. On an unspecified date the patient had recovered. The registered pharmacist stated that the hospital stay was not prolonged due to the injection site reactions. The pharmacist was requesting a lot check. A standard lot check was performed. All in process quality checks for the lot number 664516/1192Y was 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 number 664516/1192Y met the requirements of the Center for Drug Evaluation and Research and was released. Additional information has been requested. This is of several cases reported by the same source.
Age: 72.0
Sex: M
Vaccine: FLU(H1N1), PPV, FLU(H1N1), PPV
Symptoms: Injection site rash, Rash papular
Clinical narrative: information has been received from a registered pharmacist concerning a 72 year old male inpatient with diagnosis of pneumonia who on 15-JAN-2010 was intramuscularly vaccinated in the right deltoid with a 0.5 mL dose of PNEUMOVAX 23 (lot#664516/1192Y). In that same day the patient was vaccinated in the left deltoid with H1N1. Concomitant therapy included PLAVIX, famotidine, meclizine, carvedilol, levofloxacin and metronidazole. The registered pharmacist reported that 24 hour post vaccination with PNEUMOVAX 23, on 16-JAN-2010, the patient developed a red raised rash that started under the injection site of the right deltoid and extended downward for 6 to 8 inches. The patient sought unspecified medical attention. The patient was treated with comfort measures and did not require other intervention. On an unspecified date the patient had recovered. The registered pharmacist stated that the hospital stay was not prolonged due to the injection site reactions. The pharmacist was requesting a lot check. Follow up information has been received from the registered pharmacist concerning the 72 year old male patient with penicillin allergy, pneumonia and hospitalization who on 15-JAN-2010 at 14:40 was vaccinated IM with a first dose of PNEUMOVAX 23 (664516/0092Y). On the same day at 14:00 the patient was vaccinated IM with a first dose of H1N1 (Sanofi Pasteur) (lot# UT041AA). It was noted that the patient was admitted to the hospital for pneumonia 6 days prior to vaccination with PNEUMOVAX 23. The patient was afebrile for 48 hours before vaccination. On 17-JAN-2010 (previously reported 16-JAN-2010) in the AM, the patient developed a red, raised rash 24-36 hours following PNEUMOVAX 23 just below the injection site on the right deltoid. No treatment was required. On 18-JAN-2010, the patient recovered. No further information is expected. This is one of several cases reported by 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. This is an amended report the CSD for version 2 was corrected to 21-JAN-2010.
Age: 72.0
Sex: M
Vaccine: FLU(H1N1), PPV, FLU(H1N1), PPV
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: information has been received from a registered pharmacist concerning a 72 year old male inpatient with diagnosis of pneumonia who on 15-JAN-2010 was intramuscularly vaccinated in the right deltoid with a 0.5 mL dose of PNEUMOVAX 23 (lot#664516/1192Y). In that same day the patient was vaccinated in the left deltoid with H1N1. Concomitant therapy included PLAVIX, famotidine, meclizine, carvedilol, levofloxacin and metronidazole. The registered pharmacist reported that 24 hour post vaccination with PNEUMOVAX 23, on 16-JAN-2010, the patient developed a red raised rash that started under the injection site of the right deltoid and extended downward for 6 to 8 inches. The patient sought unspecified medical attention. The patient was treated with comfort measures and did not require other intervention. On an unspecified date the patient had recovered. The registered pharmacist stated that the hospital stay was not prolonged due to the injection site reactions. The pharmacist was requesting a lot check. Follow up information has been received from the registered pharmacist concerning the 72 year old male patient with penicillin allergy, pneumonia and hospitalization who on 15-JAN-2010 at 14:40 was vaccinated IM with a first dose of PNEUMOVAX 23 (664516/0092Y). On the same day at 14:00 the patient was vaccinated IM with a first dose of H1N1 (Sanofi Pasteur) (lot# UT041AA). It was noted that the patient was admitted to the hospital for pneumonia 6 days prior to vaccination with PNEUMOVAX 23. The patient was afebrile for 48 hours before vaccination. On 17-JAN-2010 (previously reported 16-JAN-2010) in the AM, the patient developed a red, raised rash 24-36 hours following PNEUMOVAX 23 just below the injection site on the right deltoid. No treatment was required. On 18-JAN-2010, the patient recovered. No further information is expected. This is one of several cases reported by 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. This is an amended report the CSD for version 2 was corrected to 21-JAN-2010.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Allergy test negative, Erythema, Nausea, Pyrexia, Skin tightness
Clinical narrative: Information has been received from a physician concerning a 71 year old female patient with no medical history and no known drug reactions/allergies who in 2003 was vaccinated with the first 0.5ml dose of PNEUMOVAX 23 (lot# 664864/1365Y) IM in the left arm. On 27-JAN-2010 the patient was vaccinated with the second 0.5ml dose of PNEUMOVAX 23 (lot# 664864/1365Y) IM in the left arm. There was no concomitant medication. On 28-JAN-2010 the patient developed redness, pain, swelling of the left arm. She also experienced nausea and a fever. Her temperature in the office was 99.8 degrees F. The patient was seen in the office for follow up on 28-JAN-2010, 29-JAN-2010 and 04-FEB-2010. Allergy tests were done with negative result. From the office notes from 04-FEB-2010 there is a 75% improvement noticed. The nurse mentioned the patient did not have an issue following her first dose. At the time of the report, the patient was recovering. Follow-up information has been received from a physician concerning a 71 year old female patient with allergic reactions to cyclines, penicillin, FLAGYL and OTC vaginal creams who on 27-JAN-2010 was vaccinated with the second dose of PNEUMOVAX 23 (lot# 664864/1365Y) in her left deltoid. On 28-JAN-2010, the patient experienced 4cm induration at the injection site, with erythema and pain. She also experienced nausea and fever. The patient was advised to use BENADRYL and ice at the injection site. On 29-JAN-2010, fever had gone but there were still other symptoms. On 04-FEB-2010, there was 75% decrease in swelling. At the time of the report, the patient had not completely recovered. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a physician concerning a 71 year old female patient with no medical history and no known drug reactions/allergies who in 2003 was vaccinated with the first 0.5ml dose of PNEUMOVAX 23 (lot# 664864/1365Y) IM in the left arm. On 27-JAN-2010 the patient was vaccinated with the second 0.5ml dose of PNEUMOVAX 23 (lot# 664864/1365Y) IM in the left arm. There was no concomitant medication. On 28-JAN-2010 the patient developed redness, pain, swelling of the left arm. She also experienced nausea and a fever. Her temperature in the office was 99.8 degrees F. The patient was seen in the office for follow up on 28-JAN-2010, 29-JAN-2010 and 04-FEB-2010. Allergy tests were done with negative result. From the office notes from 04-FEB-2010 there is a 75% improvement noticed. The nurse mentioned the patient did not have an issue following her first dose. At the time of the report, the patient was recovering. Follow-up information has been received from a physician concerning a 71 year old female patient with allergic reactions to cyclines, penicillin, FLAGYL and OTC vaginal creams who on 27-JAN-2010 was vaccinated with the second dose of PNEUMOVAX 23 (lot# 664864/1365Y) in her left deltoid. On 28-JAN-2010, the patient experienced 4cm induration at the injection site, with erythema and pain. She also experienced nausea and fever. The patient was advised to use BENADRYL and ice at the injection site. On 29-JAN-2010, fever had gone but there were still other symptoms. On 04-FEB-2010, there was 75% decrease in swelling. At the time of the report, the patient had not completely recovered. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Allergy test negative, Body temperature increased, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 71 year old female patient with no medical history and no known drug reactions/allergies who in 2003 was vaccinated with the first 0.5ml dose of PNEUMOVAX 23 (lot# 664864/1365Y) IM in the left arm. On 27-JAN-2010 the patient was vaccinated with the second 0.5ml dose of PNEUMOVAX 23 (lot# 664864/1365Y) IM in the left arm. There was no concomitant medication. On 28-JAN-2010 the patient developed redness, pain, swelling of the left arm. She also experienced nausea and a fever. Her temperature in the office was 99.8 degrees F. The patient was seen in the office for follow up on 28-JAN-2010, 29-JAN-2010 and 04-FEB-2010. Allergy tests were done with negative result. From the office notes from 04-FEB-2010 there is a 75% improvement noticed. The nurse mentioned the patient did not have an issue following her first dose. At the time of the report, the patient was recovering. Follow-up information has been received from a physician concerning a 71 year old female patient with allergic reactions to cyclines, penicillin, FLAGYL and OTC vaginal creams who on 27-JAN-2010 was vaccinated with the second dose of PNEUMOVAX 23 (lot# 664864/1365Y) in her left deltoid. On 28-JAN-2010, the patient experienced 4cm induration at the injection site, with erythema and pain. She also experienced nausea and fever. The patient was advised to use BENADRYL and ice at the injection site. On 29-JAN-2010, fever had gone but there were still other symptoms. On 04-FEB-2010, there was 75% decrease in swelling. At the time of the report, the patient had not completely recovered. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Nausea, No reaction on previous exposure to drug, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 71 year old female patient with no medical history and no known drug reactions/allergies who in 2003 was vaccinated with the first 0.5ml dose of PNEUMOVAX 23 (lot# 664864/1365Y) IM in the left arm. On 27-JAN-2010 the patient was vaccinated with the second 0.5ml dose of PNEUMOVAX 23 (lot# 664864/1365Y) IM in the left arm. There was no concomitant medication. On 28-JAN-2010 the patient developed redness, pain, swelling of the left arm. She also experienced nausea and a fever. Her temperature in the office was 99.8 degrees F. The patient was seen in the office for follow up on 28-JAN-2010, 29-JAN-2010 and 04-FEB-2010. Allergy tests were done with negative result. From the office notes from 04-FEB-2010 there is a 75% improvement noticed. The nurse mentioned the patient did not have an issue following her first dose. At the time of the report, the patient was recovering. Follow-up information has been received from a physician concerning a 71 year old female patient with allergic reactions to cyclines, penicillin, FLAGYL and OTC vaginal creams who on 27-JAN-2010 was vaccinated with the second dose of PNEUMOVAX 23 (lot# 664864/1365Y) in her left deltoid. On 28-JAN-2010, the patient experienced 4cm induration at the injection site, with erythema and pain. She also experienced nausea and fever. The patient was advised to use BENADRYL and ice at the injection site. On 29-JAN-2010, fever had gone but there were still other symptoms. On 04-FEB-2010, there was 75% decrease in swelling. At the time of the report, the patient had not completely recovered. Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Blood culture negative, Body temperature increased, Chills, Culture urine positive, Injection site erythema
Clinical narrative: Information has been received from a physician concerning two patients who on unspecified dates were vaccinated with PNEUMOVAX 23. The physician reported that after received the PNEUMOVAX 23 the two patients experienced injection site reactions. At the time of the report, the patient's outcomes were unspecified. The physician contacted during telephone follow-up could not supply the following information: patients name, dates of birth, and dates of vaccination. Follow up information has been received from a health professional concerning a 27 year old female patient who recently had a baby and on 03-NOV-2009 was hospitalized with a breast abscess. On 13-NOV-2009 while she was hospitalized the patient was vaccinated in the left deltoid with a dose of PNEUMOVAX 23 (Lot#663998/0623Y) and also received influenza virus vaccine (unspecified) (manufacturer unknown). It was reported that the patient complained of left shoulder soreness. On 14-NOV-2009 the soreness was improving. The patient was discharged from the hospital on 14-NOV-2009. Additional information has been requested. This is one of several cases reported by the same source.
Age: 27.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injection site haemorrhage, Injection site pain, Injection site pruritus, Myalgia, Pyrexia
Clinical narrative: Information has been received from a physician concerning two patients who on unspecified dates were vaccinated with PNEUMOVAX 23. The physician reported that after received the PNEUMOVAX 23 the two patients experienced injection site reactions. At the time of the report, the patient's outcomes were unspecified. The physician contacted during telephone follow-up could not supply the following information: patients name, dates of birth, and dates of vaccination. Follow up information has been received from a health professional concerning a 27 year old female patient who recently had a baby and on 03-NOV-2009 was hospitalized with a breast abscess. On 13-NOV-2009 while she was hospitalized the patient was vaccinated in the left deltoid with a dose of PNEUMOVAX 23 (Lot#663998/0623Y) and also received influenza virus vaccine (unspecified) (manufacturer unknown). It was reported that the patient complained of left shoulder soreness. On 14-NOV-2009 the soreness was improving. The patient was discharged from the hospital on 14-NOV-2009. Additional information has been requested. This is one of several cases reported by the same source.
Age: 27.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Urine analysis normal
Clinical narrative: Information has been received from a physician concerning two patients who on unspecified dates were vaccinated with PNEUMOVAX 23. The physician reported that after received the PNEUMOVAX 23 the two patients experienced injection site reactions. At the time of the report, the patient's outcomes were unspecified. The physician contacted during telephone follow-up could not supply the following information: patients name, dates of birth, and dates of vaccination. Follow up information has been received from a health professional concerning a 27 year old female patient who recently had a baby and on 03-NOV-2009 was hospitalized with a breast abscess. On 13-NOV-2009 while she was hospitalized the patient was vaccinated in the left deltoid with a dose of PNEUMOVAX 23 (Lot#663998/0623Y) and also received influenza virus vaccine (unspecified) (manufacturer unknown). It was reported that the patient complained of left shoulder soreness. On 14-NOV-2009 the soreness was improving. The patient was discharged from the hospital on 14-NOV-2009. Additional information has been requested. This is one of several cases reported by the same source.
Age: 27.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a physician concerning two patients who on unspecified dates were vaccinated with PNEUMOVAX 23. The physician reported that after received the PNEUMOVAX 23 the two patients experienced injection site reactions. At the time of the report, the patient's outcomes were unspecified. The physician contacted during telephone follow-up could not supply the following information: patients name, dates of birth, and dates of vaccination. Follow up information has been received from a health professional concerning a 27 year old female patient who recently had a baby and on 03-NOV-2009 was hospitalized with a breast abscess. On 13-NOV-2009 while she was hospitalized the patient was vaccinated in the left deltoid with a dose of PNEUMOVAX 23 (Lot#663998/0623Y) and also received influenza virus vaccine (unspecified) (manufacturer unknown). It was reported that the patient complained of left shoulder soreness. On 14-NOV-2009 the soreness was improving. The patient was discharged from the hospital on 14-NOV-2009. Additional information has been requested. This is one of several cases reported by the same source.
Age: 8.0
Sex: F
Vaccine: DTAP, PPV, PPV
Symptoms: Aspartate aminotransferase increased, Blood urea nitrogen/creatinine ratio, Blood urine present, Chest X-ray normal, Condition aggravated
Clinical narrative: Information has been received from a licensed practical nurse concerning an 8 year old female patient with asthma, upper respiratory tract infection and allergy to ZITHROMAX and BIAXIN who on 20-JUL-2007 was vaccinated with her first IM dose of PNEUMOVAX 23. On 11-MAR-2010 the patient was vaccinated with a second IM dose of PNEUMOVAX 23 (lot# 665402/1339Y). Concomitant therapy included montelukast sodium (MSD), SYMBICORT and albuterol. On 12-MAR-2010 the patient experienced a high fever of 103F and cellulitis of her left arm. The patient went to the Emergency Room where she was told it was just a normal reaction and the patient was discharged from the emergency room. The symptoms persisted and on 14-MAR-2010 the patient went to the Emergency Room and was admitted to the hospital. At the time of the report the patient was still hospitalized. At the time of the report, the outcome of the patient was unknown. The licensed practical nurse also reported that the patient had a low pneumococcal titer. Additional information is not expected.
Age: 8.0
Sex: F
Vaccine: DTAP, PPV, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Lymphocyte percentage decreased, Platelet count decreased, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning an 8 year old female patient with asthma, upper respiratory tract infection and allergy to ZITHROMAX and BIAXIN who on 20-JUL-2007 was vaccinated with her first IM dose of PNEUMOVAX 23. On 11-MAR-2010 the patient was vaccinated with a second IM dose of PNEUMOVAX 23 (lot# 665402/1339Y). Concomitant therapy included montelukast sodium (MSD), SYMBICORT and albuterol. On 12-MAR-2010 the patient experienced a high fever of 103F and cellulitis of her left arm. The patient went to the Emergency Room where she was told it was just a normal reaction and the patient was discharged from the emergency room. The symptoms persisted and on 14-MAR-2010 the patient went to the Emergency Room and was admitted to the hospital. At the time of the report the patient was still hospitalized. At the time of the report, the outcome of the patient was unknown. The licensed practical nurse also reported that the patient had a low pneumococcal titer. Additional information is not expected.
Age: 8.0
Sex: F
Vaccine: DTAP, PPV, PPV
Symptoms: Urine analysis abnormal, Urine ketone body present, Vaccination site reaction, Viral infection, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning an 8 year old female patient with asthma, upper respiratory tract infection and allergy to ZITHROMAX and BIAXIN who on 20-JUL-2007 was vaccinated with her first IM dose of PNEUMOVAX 23. On 11-MAR-2010 the patient was vaccinated with a second IM dose of PNEUMOVAX 23 (lot# 665402/1339Y). Concomitant therapy included montelukast sodium (MSD), SYMBICORT and albuterol. On 12-MAR-2010 the patient experienced a high fever of 103F and cellulitis of her left arm. The patient went to the Emergency Room where she was told it was just a normal reaction and the patient was discharged from the emergency room. The symptoms persisted and on 14-MAR-2010 the patient went to the Emergency Room and was admitted to the hospital. At the time of the report the patient was still hospitalized. At the time of the report, the outcome of the patient was unknown. The licensed practical nurse also reported that the patient had a low pneumococcal titer. Additional information is not expected.
Age: 8.0
Sex: F
Vaccine: DTAP, PPV, PPV
Symptoms: White blood cell count increased, White blood cells urine positive
Clinical narrative: Information has been received from a licensed practical nurse concerning an 8 year old female patient with asthma, upper respiratory tract infection and allergy to ZITHROMAX and BIAXIN who on 20-JUL-2007 was vaccinated with her first IM dose of PNEUMOVAX 23. On 11-MAR-2010 the patient was vaccinated with a second IM dose of PNEUMOVAX 23 (lot# 665402/1339Y). Concomitant therapy included montelukast sodium (MSD), SYMBICORT and albuterol. On 12-MAR-2010 the patient experienced a high fever of 103F and cellulitis of her left arm. The patient went to the Emergency Room where she was told it was just a normal reaction and the patient was discharged from the emergency room. The symptoms persisted and on 14-MAR-2010 the patient went to the Emergency Room and was admitted to the hospital. At the time of the report the patient was still hospitalized. At the time of the report, the outcome of the patient was unknown. The licensed practical nurse also reported that the patient had a low pneumococcal titer. Additional information is not expected.
Age: 8.0
Sex: F
Vaccine: DTAP, PPV, PPV
Symptoms: Antibody test abnormal, Cellulitis, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning an 8 year old female patient with asthma, upper respiratory tract infection and allergy to ZITHROMAX and BIAXIN who on 20-JUL-2007 was vaccinated with her first IM dose of PNEUMOVAX 23. On 11-MAR-2010 the patient was vaccinated with a second IM dose of PNEUMOVAX 23 (lot# 665402/1339Y). Concomitant therapy included montelukast sodium (MSD), SYMBICORT and albuterol. On 12-MAR-2010 the patient experienced a high fever of 103F and cellulitis of her left arm. The patient went to the Emergency Room where she was told it was just a normal reaction and the patient was discharged from the emergency room. The symptoms persisted and on 14-MAR-2010 the patient went to the Emergency Room and was admitted to the hospital. At the time of the report the patient was still hospitalized. At the time of the report, the outcome of the patient was unknown. The licensed practical nurse also reported that the patient had a low pneumococcal titer. Additional information is not expected.
Age: 70.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 70 year old male with hypersensitivity to "statins", hyperlipidaemia and colonic polyp who on 01-APR-2010 was vaccinated intramuscularly with a 0.5 mL dose of PNEUMOVAX 23 (LOT# 664553/1242Y). Concomitant therapy included TRICOR and aspirin. On 01-APR-2010 the patient experienced redness and swelling at the injection site (no fever) after receiving PNEUMOVAX 23. No laboratory or diagnostic studies were performed. The patient called the office. At this time of reporting, the patient's outcome was unknown. This is one of the three reports from the same source. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Pain, Pruritus
Clinical narrative: Information has been received from a nurse concerning a 21 year old male with bipolar disorder, schizophrenia, dyslipidaemia, convulsion disorder, gastrooesophageal reflux disease and penicillin allergy who on 30-MAR-2010 was vaccinated intramuscularly in left arm with a 0.5 mL dose of PNEUMOVAX 23 (LOT# 664553/1242Y). Secondary suspected vaccination included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid was received on the same day same arm. Concomitant therapy included ABILIFY, TRILEPTAL, FLONASE and omeprazole (manufacturer unknown). The patient experienced "itchy" painful rash at the injection site, that is spreading to his chest after receiving PNEUMOVAX 23. No laboratory or diagnostic studies were performed. The patient was called the office. At this time of reporting, the patient's "itchy" painful rash at the injection site, that is spreading to chest persisted. This is one of the three reports from the same source. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Rash
Clinical narrative: Information has been received from a nurse concerning a 21 year old male with bipolar disorder, schizophrenia, dyslipidaemia, convulsion disorder, gastrooesophageal reflux disease and penicillin allergy who on 30-MAR-2010 was vaccinated intramuscularly in left arm with a 0.5 mL dose of PNEUMOVAX 23 (LOT# 664553/1242Y). Secondary suspected vaccination included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid was received on the same day same arm. Concomitant therapy included ABILIFY, TRILEPTAL, FLONASE and omeprazole (manufacturer unknown). The patient experienced "itchy" painful rash at the injection site, that is spreading to his chest after receiving PNEUMOVAX 23. No laboratory or diagnostic studies were performed. The patient was called the office. At this time of reporting, the patient's "itchy" painful rash at the injection site, that is spreading to chest persisted. This is one of the three reports from the same source. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Rash
Clinical narrative: Information has been received from a nurse concerning a 21 year old male with bipolar disorder, schizophrenia, dyslipidaemia, convulsion disorder, gastrooesophageal reflux disease and penicillin allergy who on 30-MAR-2010 was vaccinated intramuscularly in left arm with a 0.5 mL dose of PNEUMOVAX 23 (LOT# 664553/1242Y). Secondary suspected vaccination included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid was received on the same day same arm. Concomitant therapy included ABILIFY, TRILEPTAL, FLONASE and omeprazole (manufacturer unknown). The patient experienced "itchy" painful rash at the injection site, that is spreading to his chest after receiving PNEUMOVAX 23. No laboratory or diagnostic studies were performed. The patient was called the office. At this time of reporting, the patient's "itchy" painful rash at the injection site, that is spreading to chest persisted. This is one of the three reports from the same source. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV, TDAP, DTAP, PPV
Symptoms: Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Information has been received from a registered nurse concerning a 57 year old female patient with hypothyroidism, mitral regurgitation (MR), coronary artery disease (CAD), hypercholesterolaemia, hypertension, migraine headaches, rheumatoid arthritis (RA), possible osteoarthritis and allergy to penicillin, WYGESIC and codeine. On 24-MAR-2010 the patient was vaccinated with a 0.5 ml IM dose of PNEUMOVAX 23 (Lot# 663999/0624Y) into her left arm and a dose of DTAP (manufacturer unknown) in her left arm. Concomitant therapy included albuterol inhaler, aspirin, CRESTOR, folic acid, hydrochlorothiazide, SYNTHROID, TOPAMAX, TOPROL and fluoxetine.  In approximately April 2010, "several days after receiving PNEUMOVAX 23", the patient experienced injection site reaction. She developed swelling, pain and warmth to her arm at the injection site. There was no fever. The patient was being treated for cellulitis with LEVAQUIN. The patient sought medical attention by an office visit. At the time of the report, the outcome of the patient was unknown. No laboratory or diagnostic studies were performed. This is one of several reports received from the same source. Follow up information was received from a registered nurse via medical records concerning a 57 year old female with no illness at the time of vaccination, hypothyroidism (since 24-MAR-2010), mitral regurgitation (09-JUL-2008), coronary artery disease (09-JUL-2008), hypercholesterolaemia (09-JUL-2008), hypertension (09-JUL-2008), migraine headache (09-JUL-2008), rheumatoid arthritis (09-JUL-2008), osteoarthritis (09-JUL-2008), penicillin allergy (09-JUL-2008) (rash) and drug hypersensitivity (09-JUL-2008) (allergy to WYGESIC): vertigo, vomiting and codeine: disorientation) who on 24-MAR-2010 at 09:00 a.m. was vaccinated IM into the left deltoid with first dose of PNEUMOVAX 23 (lot number 663999/0624Y) and a dose of DAPTACEL (dose not reported, route IM into left deltoid, lot number C3250BA). Concomitant therapy included albuterol, aspirin, CRESTOR, folic acid, hydrochlorothiazide (manufacturer unknown), SYNTHROID, TOPAMAX, TOPROL XL tablets, fluoxetine and nitroglycerin. On 30-MAR-2010, the patient was seen and reported that "several days after" injections she started with swollen, painful and warm upper arm. The patient was started on LEVAQUIN 500mg daily, PO. The final outcome was unknown at this time. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV, TDAP, DTAP, PPV
Symptoms: Cellulitis, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 57 year old female patient with hypothyroidism, mitral regurgitation (MR), coronary artery disease (CAD), hypercholesterolaemia, hypertension, migraine headaches, rheumatoid arthritis (RA), possible osteoarthritis and allergy to penicillin, WYGESIC and codeine. On 24-MAR-2010 the patient was vaccinated with a 0.5 ml IM dose of PNEUMOVAX 23 (Lot# 663999/0624Y) into her left arm and a dose of DTAP (manufacturer unknown) in her left arm. Concomitant therapy included albuterol inhaler, aspirin, CRESTOR, folic acid, hydrochlorothiazide, SYNTHROID, TOPAMAX, TOPROL and fluoxetine.  In approximately April 2010, "several days after receiving PNEUMOVAX 23", the patient experienced injection site reaction. She developed swelling, pain and warmth to her arm at the injection site. There was no fever. The patient was being treated for cellulitis with LEVAQUIN. The patient sought medical attention by an office visit. At the time of the report, the outcome of the patient was unknown. No laboratory or diagnostic studies were performed. This is one of several reports received from the same source. Follow up information was received from a registered nurse via medical records concerning a 57 year old female with no illness at the time of vaccination, hypothyroidism (since 24-MAR-2010), mitral regurgitation (09-JUL-2008), coronary artery disease (09-JUL-2008), hypercholesterolaemia (09-JUL-2008), hypertension (09-JUL-2008), migraine headache (09-JUL-2008), rheumatoid arthritis (09-JUL-2008), osteoarthritis (09-JUL-2008), penicillin allergy (09-JUL-2008) (rash) and drug hypersensitivity (09-JUL-2008) (allergy to WYGESIC): vertigo, vomiting and codeine: disorientation) who on 24-MAR-2010 at 09:00 a.m. was vaccinated IM into the left deltoid with first dose of PNEUMOVAX 23 (lot number 663999/0624Y) and a dose of DAPTACEL (dose not reported, route IM into left deltoid, lot number C3250BA). Concomitant therapy included albuterol, aspirin, CRESTOR, folic acid, hydrochlorothiazide (manufacturer unknown), SYNTHROID, TOPAMAX, TOPROL XL tablets, fluoxetine and nitroglycerin. On 30-MAR-2010, the patient was seen and reported that "several days after" injections she started with swollen, painful and warm upper arm. The patient was started on LEVAQUIN 500mg daily, PO. The final outcome was unknown at this time. Additional information has been requested.