chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cold compress therapy, Fatigue, Injection site pain, Local reaction, Malaise
Clinical narrative: Information has been received from a Licensed Visiting Nurse (LVN), concerning a 16 year old female with penicillin allergy, rhinitis allergic, gastrooesophageal reflux disease, depression, cough and recurrent upper respiratory infections who on 02-APR-2010 was vaccinated with PNEUMOVAX 23 (Lot # 664653/1337Y) 0.5 mL IM into the left deltoid. Concomitant therapy included XYZAL, PATANASE, VERAMYST, PROTONIX, JOLESSA and FLUOXETINE. It was reported that the patient experienced a swollen red large area at site of injection and tenderness after administration of PNEUMOVAX 23. She also had fever of 101F, body aches, malaise and fatigue. The patient was treated with NSAIDS, cold compresses, fluid and rest. The patient sought unspecified medical attention. It was reported that the patient recovered from the events. Follow-up information has been received from a licensed visiting nurse, concerning a 16 year old female child who after vaccination with PNEUMOVAX 23 experienced tenderness at the injection site (previously reported as tenderness). The reporter stated that the patient recovered from the events on an unknown dates. This is one of three reports concerning the same source. No additional information is expected.
Age: 16.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Information has been received from a Licensed Visiting Nurse (LVN), concerning a 16 year old female with penicillin allergy, rhinitis allergic, gastrooesophageal reflux disease, depression, cough and recurrent upper respiratory infections who on 02-APR-2010 was vaccinated with PNEUMOVAX 23 (Lot # 664653/1337Y) 0.5 mL IM into the left deltoid. Concomitant therapy included XYZAL, PATANASE, VERAMYST, PROTONIX, JOLESSA and FLUOXETINE. It was reported that the patient experienced a swollen red large area at site of injection and tenderness after administration of PNEUMOVAX 23. She also had fever of 101F, body aches, malaise and fatigue. The patient was treated with NSAIDS, cold compresses, fluid and rest. The patient sought unspecified medical attention. It was reported that the patient recovered from the events. Follow-up information has been received from a licensed visiting nurse, concerning a 16 year old female child who after vaccination with PNEUMOVAX 23 experienced tenderness at the injection site (previously reported as tenderness). The reporter stated that the patient recovered from the events on an unknown dates. This is one of three reports concerning the same source. No additional information is expected.
Age: 16.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Information has been received from a Licensed Visiting Nurse (LVN), concerning a 16 year old female with penicillin allergy, rhinitis allergic, gastrooesophageal reflux disease, depression, cough and recurrent upper respiratory infections who on 02-APR-2010 was vaccinated with PNEUMOVAX 23 (Lot # 664653/1337Y) 0.5 mL IM into the left deltoid. Concomitant therapy included XYZAL, PATANASE, VERAMYST, PROTONIX, JOLESSA and FLUOXETINE. It was reported that the patient experienced a swollen red large area at site of injection and tenderness after administration of PNEUMOVAX 23. She also had fever of 101F, body aches, malaise and fatigue. The patient was treated with NSAIDS, cold compresses, fluid and rest. The patient sought unspecified medical attention. It was reported that the patient recovered from the events. Follow-up information has been received from a licensed visiting nurse, concerning a 16 year old female child who after vaccination with PNEUMOVAX 23 experienced tenderness at the injection site (previously reported as tenderness). The reporter stated that the patient recovered from the events on an unknown dates. This is one of three reports concerning the same source. No additional information is expected.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cough, Nasopharyngitis
Clinical narrative: Information has been received from a pharmacist concerning a 71 year old female patient with diabetes and high blood pressure who on 20-SEP-2005 was vaccinated with a first dose of PNEUMOVAX 23 and on 01-APR-2010 received a second dose of PNEUMOVAX (Lot# 664516/1192Y). On 07-APR-2001 the patient began to develop a could and cough. The patient called the pharmacist for medical attention. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cough, Inappropriate schedule of drug administration, Nasopharyngitis
Clinical narrative: Information has been received from a pharmacist concerning a 71 year old female patient with diabetes and high blood pressure who on 20-SEP-2005 was vaccinated with a first dose of PNEUMOVAX 23 and on 01-APR-2010 received a second dose of PNEUMOVAX (Lot# 664516/1192Y). On 07-APR-2001 the patient began to develop a could and cough. The patient called the pharmacist for medical attention. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Body temperature increased, Erythema, Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old female patient with diabetes and blood pressure high who on 06-APR-2010, was vaccinated with the first dose of PNEUMOVAX 23 (Lot# 664516/1192Y) into her left deltoid. On 08-APR-2010, the patient developed a temperature of 101 F and experienced injection site pain with a red streaking around her left deltoid, the site of injection. On 09-APR-2010, the fever resolved. On an unspecified date the patient recovered. The patient sought medical attention by a call to the doctor's office. This is one of several reports from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Body temperature increased, Injection site pain, Injection site streaking, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old female patient with diabetes and blood pressure high who on 06-APR-2010, was vaccinated with the first dose of PNEUMOVAX 23 (Lot# 664516/1192Y) into her left deltoid. On 08-APR-2010, the patient developed a temperature of 101 F and experienced injection site pain with a red streaking around her left deltoid, the site of injection. On 09-APR-2010, the fever resolved. On an unspecified date the patient recovered. The patient sought medical attention by a call to the doctor's office. This is one of several reports from the same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning a 69 year old patient with diabetes and blood pressure high who on 24-APR-2006, was vaccinated with the first dose of PNEUMOVAX 23 and on 08-APR-2010, was vaccinated with the second dose of PNEUMOVAX 23 (Lot# 664516/1192Y) into her left deltoid. Later the same day, on 08-APR-2010, the patient called her health care provider reporting pain radiating from the injection site and local warmth. On an unspecified date the patient recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 69 year old patient with diabetes and blood pressure high who on 24-APR-2006, was vaccinated with the first dose of PNEUMOVAX 23 and on 08-APR-2010, was vaccinated with the second dose of PNEUMOVAX 23 (Lot# 664516/1192Y) into her left deltoid. Later the same day, on 08-APR-2010, the patient called her health care provider reporting pain radiating from the injection site and local warmth. On an unspecified date the patient recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pruritus, Joint range of motion decreased, Muscular weakness, Oedema peripheral, Sensory loss
Clinical narrative: Information has been received from a physician assistant concerning a 24 year old female patient with an allergy to KEFLEX and no other pertinent medical history who on 07-APR-2010 was supposed to receive a Tuberculin purified protein derivative (PPD) injection, but inadvertently was vaccinated intradermally with a 0.5 ml dose of PNEUMOVAX 23 (665402/1339Y).  Concomitant therapy included NEXIUM.  It was reported that the patient received the vaccine 3 hours ago and was currently experiencing swelling and numbness of her arm.  The patient was taking BENADRYL and NAPROSYN to treat her symptoms.  The patient sought medical attention via phone call.  No laboratory diagnosed studies were performed.  At the time of the report, the patient had not recovered from these events.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician assistant concerning a 24 year old female patient with an allergy to KEFLEX and no other pertinent medical history who on 07-APR-2010 was supposed to receive a Tuberculin purified protein derivative (PPD) injection, but inadvertently was vaccinated intradermally with a 0.5 ml dose of PNEUMOVAX 23 (665402/1339Y).  Concomitant therapy included NEXIUM.  It was reported that the patient received the vaccine 3 hours ago and was currently experiencing swelling and numbness of her arm.  The patient was taking BENADRYL and NAPROSYN to treat her symptoms.  The patient sought medical attention via phone call.  No laboratory diagnosed studies were performed.  At the time of the report, the patient had not recovered from these events.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypoaesthesia, Oedema peripheral, Wrong drug administered
Clinical narrative: Information has been received from a physician assistant concerning a 24 year old female patient with an allergy to KEFLEX and no other pertinent medical history who on 07-APR-2010 was supposed to receive a Tuberculin purified protein derivative (PPD) injection, but inadvertently was vaccinated intradermally with a 0.5 ml dose of PNEUMOVAX 23 (665402/1339Y).  Concomitant therapy included NEXIUM.  It was reported that the patient received the vaccine 3 hours ago and was currently experiencing swelling and numbness of her arm.  The patient was taking BENADRYL and NAPROSYN to treat her symptoms.  The patient sought medical attention via phone call.  No laboratory diagnosed studies were performed.  At the time of the report, the patient had not recovered from these events.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Axillary pain, Bone pain, Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a 65 year old female consumer concerning herself who on 08-APR-2010 was vaccinated with a dose of PNEUMOVAX 23 vaccine (lot# not reported). On 08-APR-2010 the patient experienced severe pain in her arm. Unspecified medical attention was sought. At the time of this report the patient had recovered after she was put on therapy. Follow up information has been received from the 65 year old female "retired cord professional" concerning herself who on 08-APR-2010, at 15:20, was vaccinated with a dose of PNEUMOVAX 23 (lot# 665270/1398Y) into her left arm. The patient did not report her experiences to her physician's office. There were no laboratory diagnostics studies performed. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a 65 year old female consumer concerning herself who on 08-APR-2010 was vaccinated with a dose of PNEUMOVAX 23 vaccine (lot# not reported). On 08-APR-2010 the patient experienced severe pain in her arm. Unspecified medical attention was sought. At the time of this report the patient had recovered after she was put on therapy. Follow up information has been received from the 65 year old female "retired cord professional" concerning herself who on 08-APR-2010, at 15:20, was vaccinated with a dose of PNEUMOVAX 23 (lot# 665270/1398Y) into her left arm. The patient did not report her experiences to her physician's office. There were no laboratory diagnostics studies performed. Additional information is not expected.
Age: 33.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Oedema peripheral, Pyrexia
Clinical narrative: Initial information has been received from a pharmacy student concerning a female with postpartum depression and no known drug allergies who on 12-APR-2010 was vaccinated intramuscularly with a 0.5ml dose of PNEUMOVAX 23 (lot#664608/1312Y). Concomitant therapy included quetiapine fumarate, albuterol, ADVAIR, and montelukast sodium (MSD). On 13-APR-2010 the patient experienced fever and chills within 24 hours of administration of PNEUMOVAX 23. Unspecified medical attention was sought. There were no laboratory diagnostics studies performed. At the time of this report, the patient had recovered. Additional information has been received from a licensed practical nurse concerning the 33 year old female who on 12-APR-2010 was vaccinated intramuscularly with a 0.5ml dose of PNEUMOVAX 23(lot#664608/1312Y) into the right deltoid. On 12-APR-2010, in the evening the patient experienced "elevated body temperature (103F) and severe body shaking". The patient also had an injection site reaction. The patient visited the office and was treated with ibuprofen 800 mg and instructed to drink plenty of water. Subsequently, the patient recovered from elevated body temperature (103F) and severe body shaking. At the time of this report, the patient's outcome of injection site reaction was unknown. Follow up information has been received from a physician concerning a 33 year old female also with asthma who on 12-APR-2010, at 16:30, was vaccinated intramuscularly with the first 0.5ml dose of PNEUMOVAX 23 (lot#664608/1312Y) into the right arm. It was reported that the patient had bacterial vaginosis at time of vaccination. On 12-APR-2010, at 20:00, the patient developed red swollen arm, later she had fever to 103 F and myalgia. At the time of this report, the patient had recovered. This is one of several reports from the same source. Additional information is not expected.
Age: 33.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Erythema, Injection site reaction, Myalgia, Oedema peripheral
Clinical narrative: Initial information has been received from a pharmacy student concerning a female with postpartum depression and no known drug allergies who on 12-APR-2010 was vaccinated intramuscularly with a 0.5ml dose of PNEUMOVAX 23 (lot#664608/1312Y). Concomitant therapy included quetiapine fumarate, albuterol, ADVAIR, and montelukast sodium (MSD). On 13-APR-2010 the patient experienced fever and chills within 24 hours of administration of PNEUMOVAX 23. Unspecified medical attention was sought. There were no laboratory diagnostics studies performed. At the time of this report, the patient had recovered. Additional information has been received from a licensed practical nurse concerning the 33 year old female who on 12-APR-2010 was vaccinated intramuscularly with a 0.5ml dose of PNEUMOVAX 23(lot#664608/1312Y) into the right deltoid. On 12-APR-2010, in the evening the patient experienced "elevated body temperature (103F) and severe body shaking". The patient also had an injection site reaction. The patient visited the office and was treated with ibuprofen 800 mg and instructed to drink plenty of water. Subsequently, the patient recovered from elevated body temperature (103F) and severe body shaking. At the time of this report, the patient's outcome of injection site reaction was unknown. Follow up information has been received from a physician concerning a 33 year old female also with asthma who on 12-APR-2010, at 16:30, was vaccinated intramuscularly with the first 0.5ml dose of PNEUMOVAX 23 (lot#664608/1312Y) into the right arm. It was reported that the patient had bacterial vaginosis at time of vaccination. On 12-APR-2010, at 20:00, the patient developed red swollen arm, later she had fever to 103 F and myalgia. At the time of this report, the patient had recovered. This is one of several reports from the same source. Additional information is not expected.
Age: 33.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia, Tremor
Clinical narrative: Initial information has been received from a pharmacy student concerning a female with postpartum depression and no known drug allergies who on 12-APR-2010 was vaccinated intramuscularly with a 0.5ml dose of PNEUMOVAX 23 (lot#664608/1312Y). Concomitant therapy included quetiapine fumarate, albuterol, ADVAIR, and montelukast sodium (MSD). On 13-APR-2010 the patient experienced fever and chills within 24 hours of administration of PNEUMOVAX 23. Unspecified medical attention was sought. There were no laboratory diagnostics studies performed. At the time of this report, the patient had recovered. Additional information has been received from a licensed practical nurse concerning the 33 year old female who on 12-APR-2010 was vaccinated intramuscularly with a 0.5ml dose of PNEUMOVAX 23(lot#664608/1312Y) into the right deltoid. On 12-APR-2010, in the evening the patient experienced "elevated body temperature (103F) and severe body shaking". The patient also had an injection site reaction. The patient visited the office and was treated with ibuprofen 800 mg and instructed to drink plenty of water. Subsequently, the patient recovered from elevated body temperature (103F) and severe body shaking. At the time of this report, the patient's outcome of injection site reaction was unknown. Follow up information has been received from a physician concerning a 33 year old female also with asthma who on 12-APR-2010, at 16:30, was vaccinated intramuscularly with the first 0.5ml dose of PNEUMOVAX 23 (lot#664608/1312Y) into the right arm. It was reported that the patient had bacterial vaginosis at time of vaccination. On 12-APR-2010, at 20:00, the patient developed red swollen arm, later she had fever to 103 F and myalgia. At the time of this report, the patient had recovered. This is one of several reports from the same source. Additional information is not expected.
Age: 9.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth, Local reaction
Clinical narrative: Information has been received from a Licensed Visiting Nurse (L.V.N) concerning a 9 year old male patient with asthma, rhinitis allergic, recurrent upper respiratory infection and no known drug allergies/drug reactions who on 13-APR-2010 was vaccinated with the first 0.5 mL dose of PNEUMOVAX 23 (Lot # 664653/1337Y) intramuscularly into his left thigh. Concomitant therapy included ADVAIR, XYZAL, OMNARIS, PREVACID, "PANTANASE" and PROAIR. It was reported that soon after receiving PNEUMOVAX 23, on 13-APR-2010, the patient experienced localized pain and a large area of swelling at site of injection. On 15-APR-2010, he experienced an increased in severity symptoms and a warm red rash. The patient sought unspecified medical attention. He was treated with ibuprofen and oral prednisone 30 mg daily for 3 days. At the time of the report the patient had not recovered. Follow up information has been received from the Licensed Visiting Nurse (L.V.N) who reported that on 13-APR-2010 at 11:00 a.m., the patient was vaccinated with a dose of PNEUMOVAX 23 (Lot # 664653/1337Y) intramuscularly into his left thigh. Concomitant therapy also included PATANASE. It was reported that on 13-APR-2010, the patient experienced a large local reaction, a localized pain increasing in severity over the day. On 15-APR-2010 at 15:00, the patient developed a warm red rash. The adverse events required emergency room (ER) visit. The patient would continue ibuprofen and given ORAPRED 30 mg by 3 days. This is one of several reports from the same source. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Local reaction, Pain, Rash erythematous, Skin warm
Clinical narrative: Information has been received from a Licensed Visiting Nurse (L.V.N) concerning a 9 year old male patient with asthma, rhinitis allergic, recurrent upper respiratory infection and no known drug allergies/drug reactions who on 13-APR-2010 was vaccinated with the first 0.5 mL dose of PNEUMOVAX 23 (Lot # 664653/1337Y) intramuscularly into his left thigh. Concomitant therapy included ADVAIR, XYZAL, OMNARIS, PREVACID, "PANTANASE" and PROAIR. It was reported that soon after receiving PNEUMOVAX 23, on 13-APR-2010, the patient experienced localized pain and a large area of swelling at site of injection. On 15-APR-2010, he experienced an increased in severity symptoms and a warm red rash. The patient sought unspecified medical attention. He was treated with ibuprofen and oral prednisone 30 mg daily for 3 days. At the time of the report the patient had not recovered. Follow up information has been received from the Licensed Visiting Nurse (L.V.N) who reported that on 13-APR-2010 at 11:00 a.m., the patient was vaccinated with a dose of PNEUMOVAX 23 (Lot # 664653/1337Y) intramuscularly into his left thigh. Concomitant therapy also included PATANASE. It was reported that on 13-APR-2010, the patient experienced a large local reaction, a localized pain increasing in severity over the day. On 15-APR-2010 at 15:00, the patient developed a warm red rash. The adverse events required emergency room (ER) visit. The patient would continue ibuprofen and given ORAPRED 30 mg by 3 days. This is one of several reports from the same source. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered pharmacist concerning a 67 year old male patient with no drug reactions or allergies who on 25-MAR-2010 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (Lot number 664537/1193Y) as a routine order for hospitalized patients, while he was an inpatient in the hospital.  On 28-Mar-2010 the patient developed redness and swelling of his arm at the injection site, from his shoulder to his elbow.  It was unspecified if this caused his hospital stay to be prolonged.  At the time of the report the status of the patient was unspecified.  The pharmacist was requesting a lot check for PNEUMOVAX 23 Lot number 664537/1193Y.  The patient sought medical attention since the patient was an in-patient in the hospital when the adverse event occurred.  Follow up information has been received from a registered pharmacist who reported that on 24-MAR-2010 the patient was admitted to the hospital for rehabilitation secondary to decreased mobility.  On 25-MAR-2010, the patient was administered a dose of PNEUMOVAX 23 (Lot number 664537/1193Y) with no concomitant vaccinations administered at the time.  The patient was diagnosed with cellulitis and was treated with antibiotics (unspecified).  The pharmacist did not know if the patient's cellulitis prolonged the patient's hospitalization.  The patient was discharged from the hospital on 08-APR-2010.  The pharmacist did not know if the patient recovered.  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.  Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered pharmacist concerning a 67 year old male patient with no drug reactions or allergies who on 25-MAR-2010 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (Lot number 664537/1193Y) as a routine order for hospitalized patients, while he was an inpatient in the hospital.  On 28-Mar-2010 the patient developed redness and swelling of his arm at the injection site, from his shoulder to his elbow.  It was unspecified if this caused his hospital stay to be prolonged.  At the time of the report the status of the patient was unspecified.  The pharmacist was requesting a lot check for PNEUMOVAX 23 Lot number 664537/1193Y.  The patient sought medical attention since the patient was an in-patient in the hospital when the adverse event occurred.  Follow up information has been received from a registered pharmacist who reported that on 24-MAR-2010 the patient was admitted to the hospital for rehabilitation secondary to decreased mobility.  On 25-MAR-2010, the patient was administered a dose of PNEUMOVAX 23 (Lot number 664537/1193Y) with no concomitant vaccinations administered at the time.  The patient was diagnosed with cellulitis and was treated with antibiotics (unspecified).  The pharmacist did not know if the patient's cellulitis prolonged the patient's hospitalization.  The patient was discharged from the hospital on 08-APR-2010.  The pharmacist did not know if the patient recovered.  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.  Additional information has been requested.
Age: 48.0
Sex: U
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a pharmacist concerning a 48 year old patient who on 26-MAR-2010 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX (Lot# 664608/1312Y, exp 24-FEB-2011) in right arm. On 28-MAR-2010 the patient had redness, pain and swelling at the injection site. Patient was treated with cool compress, TYLENOL and Ibuprofen (manufacturer unknown). Patient sought unknown medical attention. At the time of report the patient's status was recovered. The patient was hospitalized at the hospital for unrelated issue and PNEUMOVAX vaccine was given as routine vaccination and did not prolong the hospitalization. This is one of several reports from the same source. No further information is available.
Age: 48.0
Sex: U
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 48 year old patient who on 26-MAR-2010 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX (Lot# 664608/1312Y, exp 24-FEB-2011) in right arm. On 28-MAR-2010 the patient had redness, pain and swelling at the injection site. Patient was treated with cool compress, TYLENOL and Ibuprofen (manufacturer unknown). Patient sought unknown medical attention. At the time of report the patient's status was recovered. The patient was hospitalized at the hospital for unrelated issue and PNEUMOVAX vaccine was given as routine vaccination and did not prolong the hospitalization. This is one of several reports from the same source. No further information is available.
Age: 45.0
Sex: M
Vaccine: PPV, TDAP, PPV
Symptoms: Chills, Dyspnoea, Headache, Pyrexia, Tremor
Clinical narrative: Information has been received from a pharmacy student and a licensed practical nurse concerning a 45 year old male with asthma and degenerative joint disease of the lower back and a history of depression who on 19-APR-2010 was intramuscularly vaccinated in the left arm with a 0.5 mL dose of PNEUMOVAX 23 vaccine (LOT# 664608/1312Y). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown) (also reported as Tetanus vaccine), CELEXA, ALBUTEROL, FLEXERIL, MOTRIN and AMBIEN. The licensed practical nurse reported that on 19-APR-2010, the patient experienced fever 101.8 F, severe chills, headache, sensation of burning, aches, cough with wheezing. The pharmacist reported that the patient experience the fever and chills within 24 hours of administration of PNEUMOVAX 23 vaccine. The nurse reported that the next day, on 20-APR-2010, the patient was "drained and had aches". No lab tests were performed. The patient sought medical attention by a call to the office. The patient used ALBUTEROL for the wheezing and was treated with MOTRIN. On an unspecified date, the patient had recovered. This is one of several cases reported by the same source. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: PPV, TDAP, PPV
Symptoms: Burning sensation, Chills, Cough, Headache, Malaise
Clinical narrative: Information has been received from a pharmacy student and a licensed practical nurse concerning a 45 year old male with asthma and degenerative joint disease of the lower back and a history of depression who on 19-APR-2010 was intramuscularly vaccinated in the left arm with a 0.5 mL dose of PNEUMOVAX 23 vaccine (LOT# 664608/1312Y). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown) (also reported as Tetanus vaccine), CELEXA, ALBUTEROL, FLEXERIL, MOTRIN and AMBIEN. The licensed practical nurse reported that on 19-APR-2010, the patient experienced fever 101.8 F, severe chills, headache, sensation of burning, aches, cough with wheezing. The pharmacist reported that the patient experience the fever and chills within 24 hours of administration of PNEUMOVAX 23 vaccine. The nurse reported that the next day, on 20-APR-2010, the patient was "drained and had aches". No lab tests were performed. The patient sought medical attention by a call to the office. The patient used ALBUTEROL for the wheezing and was treated with MOTRIN. On an unspecified date, the patient had recovered. This is one of several cases reported by the same source. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: PPV, TDAP, PPV
Symptoms: Pain, Pyrexia, Wheezing
Clinical narrative: Information has been received from a pharmacy student and a licensed practical nurse concerning a 45 year old male with asthma and degenerative joint disease of the lower back and a history of depression who on 19-APR-2010 was intramuscularly vaccinated in the left arm with a 0.5 mL dose of PNEUMOVAX 23 vaccine (LOT# 664608/1312Y). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown) (also reported as Tetanus vaccine), CELEXA, ALBUTEROL, FLEXERIL, MOTRIN and AMBIEN. The licensed practical nurse reported that on 19-APR-2010, the patient experienced fever 101.8 F, severe chills, headache, sensation of burning, aches, cough with wheezing. The pharmacist reported that the patient experience the fever and chills within 24 hours of administration of PNEUMOVAX 23 vaccine. The nurse reported that the next day, on 20-APR-2010, the patient was "drained and had aches". No lab tests were performed. The patient sought medical attention by a call to the office. The patient used ALBUTEROL for the wheezing and was treated with MOTRIN. On an unspecified date, the patient had recovered. This is one of several cases reported by the same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Back pain, Chest pain, Computerised tomogram abnormal, Dyspnoea, Pain in extremity
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 year old female on 20-MAY-2010, was vaccinated with a second dose of GARDASIL (Lot number 661952/1129X). Concomitant therapy included DEPO-PROVERA. On 28-SEP-2009, the patient experienced pain in legs and back pain after 15 days/30 days. Shortness of breath 45 days. Pulmonary embolisms 45 days. Chest pains 45 days. A CT scan showed bilateral embolisms. The patient received 9 months of treatment with DOVE and warfarin. The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. No further information is available. This was originally reported by a consumer. 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 Evaluation and Research and was released. The VAERS ID # is 390696-1.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pulmonary embolism
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 year old female on 20-MAY-2010, was vaccinated with a second dose of GARDASIL (Lot number 661952/1129X). Concomitant therapy included DEPO-PROVERA. On 28-SEP-2009, the patient experienced pain in legs and back pain after 15 days/30 days. Shortness of breath 45 days. Pulmonary embolisms 45 days. Chest pains 45 days. A CT scan showed bilateral embolisms. The patient received 9 months of treatment with DOVE and warfarin. The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. No further information is available. This was originally reported by a consumer. 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 Evaluation and Research and was released. The VAERS ID # is 390696-1.
Age: 13.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Dizziness, Pallor
Clinical narrative: Initial report was received 02 June 2010 from a health care professional. A 13-year-old female patient had received MENACTRA, lot number U3358BA (dose number, route and site not reported) on 27 May 2010 and within a few minutes, the patient "turned white", and complained of blurry vision and that she was unable to hear. The events lasted approximately 1 to 2 minutes and then completely resolved. The patient had a history of depression and had been taking LEXAPRO at the time of vaccination. Medical history also noted she was allergic to Amoxicillin and Codeine. It was unknown if the patient had adverse events following prior vaccinations. She had no concurrent illness at the time of vaccination. Follow-up information received on 28 June 2010 from a health care professional. The patient had not received any other vaccinations within 4 weeks of 27 May 2010. Section 21 of the VAERS form requesting information for adverse events following prior vaccination was completed by the reporter as "N/A." MENACTRA administration on 27 May 2010 was the first dose the patient had received and was administered in the right deltoid. Follow-up information received on 30 July 2010 from a health care professional who reported that the event diagnosis was syncope. Based upon this new information received, it was determined this case now meets seriousness criteria and it has been upgrade from non-serious to serious. No other information was provided at the time of this report. Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Hearing impaired, Skin discolouration, Syncope, Vision blurred
Clinical narrative: Initial report was received 02 June 2010 from a health care professional. A 13-year-old female patient had received MENACTRA, lot number U3358BA (dose number, route and site not reported) on 27 May 2010 and within a few minutes, the patient "turned white", and complained of blurry vision and that she was unable to hear. The events lasted approximately 1 to 2 minutes and then completely resolved. The patient had a history of depression and had been taking LEXAPRO at the time of vaccination. Medical history also noted she was allergic to Amoxicillin and Codeine. It was unknown if the patient had adverse events following prior vaccinations. She had no concurrent illness at the time of vaccination. Follow-up information received on 28 June 2010 from a health care professional. The patient had not received any other vaccinations within 4 weeks of 27 May 2010. Section 21 of the VAERS form requesting information for adverse events following prior vaccination was completed by the reporter as "N/A." MENACTRA administration on 27 May 2010 was the first dose the patient had received and was administered in the right deltoid. Follow-up information received on 30 July 2010 from a health care professional who reported that the event diagnosis was syncope. Based upon this new information received, it was determined this case now meets seriousness criteria and it has been upgrade from non-serious to serious. No other information was provided at the time of this report. Documents held by sender: None.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Abdominal discomfort, Headache, Hypoaesthesia, Injection site reaction, Neck pain
Clinical narrative: Information has been received from a nurse concerning a 51 year old female with house dust allergy, drug hypersensitivity, paint-stripper's asthma, allergy to chemicals, food allergy, ham allergy, egg allergy, smoked food allergy and cats allergy who on 29-JUL-2009 was vaccinated with a dose of PNEUMOVAX 23 in the left arm and ADACEL in the right arm. On 30-JUL-2009 the patient received complaining of headache, neck and jaw pain. The patient attributed the symptoms to be because of the vaccines given. Patient was advised to use comfort measure such as MOTRIN and cold compress to injection site. On 31-JUL-2009 the patient stated she felt better but her jaw pain continues.  The patient was asked to come into the office for follow up but she declined. On 02-AUG-2009 the patient called the doctor and stated she was achy, had abdominal upset and stated she believed it was the tetanus shot that caused the events. The patient was not taking any other medications, MOTRIN was suggested as therapy. On 03-AUG-2009 the patient was feeling better, but her ankle, leg and foot was still numb. The patient was advised not to get anymore tetanus shots. This morning the patient left a note stating that she would be following up with an allergy specialist at a hospital. At the report time the patient's ankle, leg and foot were still numb. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Pain in jaw
Clinical narrative: Information has been received from a nurse concerning a 51 year old female with house dust allergy, drug hypersensitivity, paint-stripper's asthma, allergy to chemicals, food allergy, ham allergy, egg allergy, smoked food allergy and cats allergy who on 29-JUL-2009 was vaccinated with a dose of PNEUMOVAX 23 in the left arm and ADACEL in the right arm. On 30-JUL-2009 the patient received complaining of headache, neck and jaw pain. The patient attributed the symptoms to be because of the vaccines given. Patient was advised to use comfort measure such as MOTRIN and cold compress to injection site. On 31-JUL-2009 the patient stated she felt better but her jaw pain continues.  The patient was asked to come into the office for follow up but she declined. On 02-AUG-2009 the patient called the doctor and stated she was achy, had abdominal upset and stated she believed it was the tetanus shot that caused the events. The patient was not taking any other medications, MOTRIN was suggested as therapy. On 03-AUG-2009 the patient was feeling better, but her ankle, leg and foot was still numb. The patient was advised not to get anymore tetanus shots. This morning the patient left a note stating that she would be following up with an allergy specialist at a hospital. At the report time the patient's ankle, leg and foot were still numb. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Abdominal discomfort, Headache, Hypoaesthesia, Neck pain, Pain
Clinical narrative: Information has been received from a nurse concerning a 51 year old female with house dust allergy, drug hypersensitivity, paint-stripper's asthma, allergy to chemicals, food allergy, ham allergy, egg allergy, smoked food allergy and cats allergy who on 29-JUL-2009 was vaccinated with a dose of PNEUMOVAX 23 in the left arm and ADACEL in the right arm. On 30-JUL-2009 the patient received complaining of headache, neck and jaw pain. The patient attributed the symptoms to be because of the vaccines given. Patient was advised to use comfort measure such as MOTRIN and cold compress to injection site. On 31-JUL-2009 the patient stated she felt better but her jaw pain continues.  The patient was asked to come into the office for follow up but she declined. On 02-AUG-2009 the patient called the doctor and stated she was achy, had abdominal upset and stated she believed it was the tetanus shot that caused the events. The patient was not taking any other medications, MOTRIN was suggested as therapy. On 03-AUG-2009 the patient was feeling better, but her ankle, leg and foot was still numb. The patient was advised not to get anymore tetanus shots. This morning the patient left a note stating that she would be following up with an allergy specialist at a hospital. At the report time the patient's ankle, leg and foot were still numb. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Fall, Head injury, Heart rate irregular, Pallor, Syncope
Clinical narrative: This is 1 of a cluster of 2 patients' who experienced similar adverse events following vaccination with MENACTRA. The event for the second patient was captured in case number 2010-04099. Initial report received from a health care professional via a company representative on 30 July 2010. An 18-year-old female patient received on 26 July 2010 an injection (site and route not reported) of MENACTRA, lot number U3356BA. After the administration the patient was sitting up and fainted. The outcome for the event was not reported. Documents held by sender: None.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Syncope
Clinical narrative: This is 1 of a cluster of 2 patients' who experienced similar adverse events following vaccination with MENACTRA. The event for the second patient was captured in case number 2010-04099. Initial report received from a health care professional via a company representative on 30 July 2010. An 18-year-old female patient received on 26 July 2010 an injection (site and route not reported) of MENACTRA, lot number U3356BA. After the administration the patient was sitting up and fainted. The outcome for the event was not reported. Documents held by sender: None.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPVX, MNQ, TDAP
Symptoms: Asthenia, Dizziness, Loss of consciousness, Sensation of heaviness
Clinical narrative: This is 1 of a cluster of 2 patients' who experienced similar adverse events following vaccination with MENACTRA. The event for the second patient was captured in case number 2010-04098. Initial report received from a health care professional via a company representative on 30 July 2010. An 11-year-old female patient received on 26 July 2010 the following vaccinations: a left arm injection of MENACTRA, lot number U3356BA, a left arm injection of human papillomavirus (HPV) vaccine (manufacturer and lot not reported), a right arm injections of Hepatitis A vaccine (manufacturer and lot not reported) and a right arm injections of Tdap (manufacturer and lot not reported). The patient started that she felt dizzy after the vaccinations were given. The patient was reclined and lost consciousness for approximately 45 seconds. She was weak and dizzy upon awakening. The outcome for the event was not reported. Documents held by sender: None.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPVX, MNQ, TDAP
Symptoms: Asthenia, Dizziness, Loss of consciousness
Clinical narrative: This is 1 of a cluster of 2 patients' who experienced similar adverse events following vaccination with MENACTRA. The event for the second patient was captured in case number 2010-04098. Initial report received from a health care professional via a company representative on 30 July 2010. An 11-year-old female patient received on 26 July 2010 the following vaccinations: a left arm injection of MENACTRA, lot number U3356BA, a left arm injection of human papillomavirus (HPV) vaccine (manufacturer and lot not reported), a right arm injections of Hepatitis A vaccine (manufacturer and lot not reported) and a right arm injections of Tdap (manufacturer and lot not reported). The patient started that she felt dizzy after the vaccinations were given. The patient was reclined and lost consciousness for approximately 45 seconds. She was weak and dizzy upon awakening. The outcome for the event was not reported. Documents held by sender: None.
Age: 5.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PAIN, SWELLING, TENDERNESS, WARMTH, AND ERYTHEMA AT INJECTION SITE.  STEADILY ENLARGING AREA OVER PAST TWO DAYS.  7 CM X 13 CM ON 8/4/2010, 9 CM X 18 CM ON 8/5/2010.  PATIENT WAS STARTED ON AB RX FOR POSSIBLE CELLULITIS AT INJECTION SITE
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, tender area appx. 2 inch diameter around site of vaccine. Gave BENADRYL 1 1/2 tsp. still under observation.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 2 inch raised red area surrounding injection site. Ice and BENADRYL have been utilized. Child able to use (L) arm well no restriction.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Received injection 6/29/10 arm became red, swollen.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Broke out with a rash on my face starting the 20th mainly with bites under my chin. By Sunday a rash was under my chin and on left side of my face and chest. Intense itching, no pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Arm swelling down to hand red raised area.
Age: 28.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Pt received both TDAP and Meningococcal vaccine in R deltoid on 23 Jul 2010. Within 24 hrs, notice local swelling and tenderness over injection site. As per pt. swelling extended from proximal area to mid area. Pt eval in clinic ? had 6 x 4 cm roughly 1.5 cm thick induration over injection site no rash, warmth, or erythema.
Age: 19.0
Sex: F
Vaccine: TTOX
Symptoms: Feeling of body temperature change, Flushing, Nausea, Retching, Vomiting
Clinical narrative: Nausea, vomiting, dry heaves, hot and cold flushing feelings.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling abnormal, Hyperaesthesia, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: 07/30/10 Awoke @ 3am extreme (L) arm pain. At 10am fever & feeling miserable; and bilat. arms extremely sensitive and tingling.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: Tiny red splotches on chest and back. Does not itch or hurt. Dr. says never seen anything like it and left untreated.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Patient c/o (L) arm being very swollen, red, painful and itchy 24 hours after varicella immunization given. During exam on 7-29-10, patient's (L) arm very tender and warm to the touch. See #12 for treatment.