chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Drug administered at inappropriate site, Pruritus, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a 64 year old male patient with coronary artery disease and dyslipidaemia and a history of cardiac pacemaker, stent and catheterisation cardiac, and no known drug allergies who on 26-APR-2010 was vaccinated with a dose of PNEUMOVAX 23 in his abdomen. Concomitant therapy included CRESTOR, aspirin, nitroglycerin, PLAVIX and BYSTOLIC. On 26-APR-2010 the patient experienced swelling from his nipple line to his scrotum, the area was red and itchy. The patient went to the emergency room at 3 am. He was not admitted but was administered BENADRYL injection and released. The patient was also examined by his physician on 27-APR-2010 (no comments were reported). The patient's swelling from his nipple line to his scrotum and the area was red and the area was itchy persisted. Follow-up information had been received from the registered nurse via phone call who reported that while the patient was in the hospital for a heart catherization, the patient was vaccinated with the PNEUMOVAX 23 (lot number unknown). The reporter did not know by what route the BENADRYL was given. The health care professional contacted during telephone follow-up could not supply the following information: lot number. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a health professional concerning a patient who on 10-MAR-2010 was vaccinated intramuscularly with a first dose of PNEUMOVAX 23 (lot# 664871/1142Y). On an unspecified date the patient experienced swelling under arm pit for 48 hours. Subsequently, the patient recovered from swelling under arm on an unspecified date. The patient did not require an emergency room or doctor visit. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from the reporter who stated that she was told by a doctor. An 80 year old female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot number 665402/1339Y). On 16-MAR-2010 the patient's arm where she was given the dose in was extremely swollen and very red. The doctor prescribed an antihistamine and told the patient to use ice packs. The adverse event lasted for about a week and it was finished (on approximately 23-MAR-2010). The doctor told the reporter that he had 3 patients who all had the same reaction to injections given from the same 5 dose vial. Follow-up information was received which reported that the adult patient was vaccinated and had severe local reaction which appeared to be allergic. The patient was treated with ice packs and CLARITIN and the patient did well. The final outcome of the patient was not reported. Follow-up information received from a physician concerning the 80 year old female who on 16-MAR-2010 had a reaction to PNEUMOVAX 23. The injection site on the patient's arm became extremely swollen and very red. The physician described the look of reaction as "awful". The physician stated "never saw reactions so severe in all the time he has been administering this product". The physician prescribed an antihistamine and had the patient put cold packs on the arm. The swelling and redness lasted about a week and the patient was fine as of 30-APR-2010. This is one of several reports from the same source. Additional information is not expected.
Age: 24.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a physician concerning a currently 24 year old male patient with rhinitis allergic and not known drug reactions or allergies who on 19-MAR-2010, was vaccinated IM with a dose of PNEUMOVAX 23 (Lot # 665402/1339Y). There was no concomitant medication. According to the physician, the patient developed an urticarial reaction at the injection site that lasted for 4 days. At the time of the report the patient had recovered. The patient sought medical attention by an office visit. No diagnostic tests were performed. Follow up information has been received from a physician who indicated that the patient was a male student with pollen, cat, dust mite allergies and rhinitis allergic who on 19-MAR-2010, was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665402/1339Y) into his left deltoid. Concomitant vaccinations included a dose of ADACEL given into his right deltoid. There were no illnesses reported at the time of vaccination. On 19-MAR-2010 the patient experienced hives at the injection site (Left deltoid) that lasted 4 days. On 23-MAR-2010 the patient recovered from hives at the injection site without intervention. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Burning sensation, Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician's office and an office manager concerning a 66 year old male patient with no known drug allergies and no adverse events following prior vaccination who on 13-NOV-2000 was vaccinated with a first dose of PNEUMOVAX 23 and on 13-APR-2010 was vaccinated IM in the left deltoid with a second 0.5 ml dose of PNEUMOVAX 23 (Lot# 664864/1365Y) at 08:30. On 13-APR-2010 at 20:00, the patient experienced redness and swelling (cellulitis) of the left arm from shoulder to elbow/forearm. On 14-APR-2010 the patient called the office stating that the arm was red and swollen. The patient then came into the office later in the day on 14-APR-2010 and was given an oral prescription (name and manufacturer unspecified). By 15-APR-2010 the patient called the office again stating that now the arm was burning. The patient came into the office and was sent to the emergency room (name, address and phone number unspecified) because the patient developed cellulitis and at the emergency room the patient was given an IV antibiotic (name and manufacturer unspecified). The office manager stated that the patient was back in the office yesterday on 20-APR-2010 but she did not know the patient's status. On 21-APR-2010, the patient had recovered. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a patient who on an unspecified date was vaccinated with the second dose of PNEUMOVAX 23. Subsequently the patient experienced redness to the area, fever and other injection site reactions. The patient sought unknown medical attention. At the time of the report, the patient's outcome was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Arthralgia, Arthritis
Clinical narrative: Information has been received from a physician concerning a patient who on an unknown date, was vaccinated with a dose of PNEUMOVAX 23 (route and lot number not provided). On an unknown date, the patient experienced arthritis or arthralgia after receiving PNEUMOVAX 23. The patient's outcome was unknown at the time of reporting. It was unknown if the patient sought medical attention. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 65 year old female consumer with a sinus infection, who on 14-SEP-2009 was vaccinated with a dose of INFLUENZA virus vaccine (manufacturer unspecified), on 01-OCT-2009 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (manufacturer unspecified) and on 01-DEC-2009 was vaccinated with a dose of H1N1 (manufacturer unspecified). The patient was also taking antibiotics (name and manufacturer unspecified) for a sinus infection and prednisone. On 22-DEC-2009 the patient developed shingles. On an unspecified date the patient recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 25 year old female inpatient with Crohn's disease and allergic reaction to tetracycline who on 23-APR-2010 was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number unspecified). The pharmacist reported that the patient who was hospitalized with Crohn's disease was vaccinated with PNEUMOVAX 23 and the patient had injection site swelling. At the time of the report the outcome of the patient was not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Malaise, Pain, Rash generalised
Clinical narrative: Information has been received from a family nurse practitioner concerning a 72 year old female patient with no known drug reactions or allergies who two years ago, in approximately 2008, was vaccinated with a dose of PNEUMOVAX 23. On the same date, the patient received concomitantly a dose of tetanus injection. It was reported that within the same day or so, the patient experienced a generalized rash, aches and felt "really sick". At the time of the report, the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 94.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a Medical Assistant (M.A.) concerning a 94 year old female patient with hypertension, hypercholesterolaemia, osteoarthritis, sulfonamide allergy, allergic reaction to antibiotics (CIPRO) and history of diverticulitis, cataract and eye operation in March 2010 who in "1998" was vaccinated with the first 0.5 mL dose of PNEUMOVAX 23 intramuscularly (unspecified if the patient had any problems with the first dose). It was reported that on 26-APR-2010, the patient received the second 0.5 mL dose of PNEUMOVAX 23 (Lot # 665300/1314Y) intramuscularly. Concomitant medications included "6 medications" (unspecified). It was reported that on the same day, on 26-APR-2010, in the evening the patient experienced pain in the neck and both shoulders down her arms and in both hands. The left deltoid injection site was swollen, red, painful, warmth to the touch and 8 inches in diameter. The patient was instructed by the physician to ice the area for 10-15 minutes every few hours and take BENADRYL as directed, TYLENOL or ADVIL for the pain. It was reported that the patient "felt like run over by a truck and very painful". The patient sought medical attention via phone call on 28-APR-2010. There were no laboratory diagnostic tests performed. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 94.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Neck pain, Pain, Pain in extremity
Clinical narrative: Information has been received from a Medical Assistant (M.A.) concerning a 94 year old female patient with hypertension, hypercholesterolaemia, osteoarthritis, sulfonamide allergy, allergic reaction to antibiotics (CIPRO) and history of diverticulitis, cataract and eye operation in March 2010 who in "1998" was vaccinated with the first 0.5 mL dose of PNEUMOVAX 23 intramuscularly (unspecified if the patient had any problems with the first dose). It was reported that on 26-APR-2010, the patient received the second 0.5 mL dose of PNEUMOVAX 23 (Lot # 665300/1314Y) intramuscularly. Concomitant medications included "6 medications" (unspecified). It was reported that on the same day, on 26-APR-2010, in the evening the patient experienced pain in the neck and both shoulders down her arms and in both hands. The left deltoid injection site was swollen, red, painful, warmth to the touch and 8 inches in diameter. The patient was instructed by the physician to ice the area for 10-15 minutes every few hours and take BENADRYL as directed, TYLENOL or ADVIL for the pain. It was reported that the patient "felt like run over by a truck and very painful". The patient sought medical attention via phone call on 28-APR-2010. There were no laboratory diagnostic tests performed. At the time of the report the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23. Subsequently the patient experienced redness to the area, fever and other injection site reactions. The patient sought unknown medical attention. At the time of the report, the patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a 4 year old patient who on 29-APR-2010 was inadvertently vaccinated with PNEUMOVAX 23 instead of PREVNAR. There was no adverse effect reported. It was unknown if medical attention was sought. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, Injection site pain
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning a patient with no medical history or drug reactions/allergies, who on 28-APR-2010 was vaccinated intramuscularly with the first 0.5 ml dose of PNEUMOVAX 23 (lot # not available). There was no concomitant medication. On 28-APR-2010, the patient experienced pain at the injection site after vaccine administration. The pharmacist added that the PNEUMOVAX 23 administered had expired on 18-APR-2010. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. No laboratory diagnostics studies were performed. No further information is available.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Breast pain, Injection site pain, Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning a 42 year old female patient who was vaccinated with a dose of PNEUMOVAX 23 about a month ago (approximately March 2010). On an unspecified date, the patient saw the pharmacist and mentioned that she had pain at the injection site which spread to her underarm and breast area. The pharmacist noticed that the patient had a heat rash around the injection site. At the time of this report, the patient's status was unknown. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a licensed practical nurse concerning a 76 year old female with an allergy to "Sulfa" who on 30-APR-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot # 665401/1320Y). On 01-MAY-2010 the patient experienced cellulitis. The patient went to the emergency room (name of hospital was unspecified) but was not admitted. The patient was treated with ROCEPHIN IV and discharged on clindamycin, 300mg, 4 times a day. The nurse was requesting a lot check. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a Registered Nurse concerning a 53 year old female with a history of asthma and no drug allergies who was vaccinated SC with a 0.5 mL dose of PNEUMOVAX 23 (lot # 665400/1315Y) on 27-APR-2010 developed an injection site reaction including itching, swelling and pain. The patient called the office on 28-APR-2010 regarding her symptoms and she was told to treat the area with ice and over-the-counter anti-inflammatories. On unspecified date, the patient recovered. The patient had been vaccinated with a dose of PNEUMOVAX "10 years ago". Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a Registered Nurse concerning a 66 year old male patient with asthma, chronic obstructive pulmonary disease and no drug reactions/ allergies, who in 2005 was vaccinated subcutaneously with one 0.5 ml dose of PNEUMOVAX 23. On 27-APR-2010, the patient was vaccinated with a second dose of PNEUMOVAX 23 (lot # 665400/1315Y). On 29-APR-2010, the patient called the office because she was experiencing an injection site reaction involving itching, swelling and pain. The patient was told to treat the area with ice and over-the-counter anti inflammatories. On an unspecified date, the patient recovered. No laboratory diagnostics studies were performed. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Gait disturbance, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Information has been received from a pharmacist concerning a 42 year old female patient with no known drug allergies who in April 2010, was vaccinated with a dose of PNEUMOVAX 23. Within 24 hours of receiving vaccine, the patient experienced redness, swelling and pain at site of injection for a week. The patient also had problems walking because of pain and was examined in an emergency room. The patient was not admitted and was released the same day. Lot number and expiration dates unknown because the hospital did not record lot numbers. At the time of the report, the patient had not recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner, concerning a female patient with allergy to ibuprofen, who on 03-MAY-2010, "yesterday", was vaccinated in the left deltoid with a dose of PNEUMOVAX 23 (route and dose not reported) (lot number not reported) (expiration date "10-NOV-2019"). On 04-MAY-2010, the patient presented to office with "severe pain and limited range of motion" of the left arm. It was also reported that on approximately 27-APR-2010, "a week ago", the patient received in the left arm a shot of tetanus toxoid and a shot of influenza virus A (antigen type unspecified) vaccine (H1N1). At the time of reporting, the patient had not recovered. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Chest discomfort, Electrocardiogram normal, Erythema, Injection site inflammation, Myalgia
Clinical narrative: Information has been received from a physician concerning a male patient, who on 03-MAY-2010, was vaccinated in the right upper arm with a dose of PNEUMOVAX 23 (dose, route and lot number not provided). On 04-MAY-2010, "1 day after receiving PNEUMOVAX 23, the patient developed "mild inflammation" at the injection site. Additionally, there was a 3 cms X 1 cm red, raised area, 2 cm distal to the injection site. The patient also noticed discomfort in the right chest area, which the physician had diagnosed as myalgia. A electrocardiogram (EKG) and an X-ray was performed and the results were normal. At the time of reporting, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: X-ray normal
Clinical narrative: Information has been received from a physician concerning a male patient, who on 03-MAY-2010, was vaccinated in the right upper arm with a dose of PNEUMOVAX 23 (dose, route and lot number not provided). On 04-MAY-2010, "1 day after receiving PNEUMOVAX 23, the patient developed "mild inflammation" at the injection site. Additionally, there was a 3 cms X 1 cm red, raised area, 2 cm distal to the injection site. The patient also noticed discomfort in the right chest area, which the physician had diagnosed as myalgia. A electrocardiogram (EKG) and an X-ray was performed and the results were normal. At the time of reporting, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Local reaction, Oedema peripheral
Clinical narrative: Information has been received from the reporter who stated that she was told by a doctor. An 80 year old female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot number 665402/1339Y). On 16-MAR-2010 the patient's arm she was given the dose in was extremely swollen and very red. The doctor prescribed an antihistamine and told the patient to use ice packs. The adverse event lasted for about a week and it was finished (on approximately 23-MAR-2010). The doctor told the reporter that he had 3 patients who all had the same reaction to injections given from the same 5 dose vial. Follow-up information was received which reported that the adult patient was vaccinated and had severe local reaction which appeared to be an allergic. The patient was treated with ice packs and CLARITIN and the patient did well. The final outcome of the patient was not reported. Follow-up information received from a physician concerning the 60 year old (previously reported as 80 year old) female patient who on 16-MAR-2010 had a reaction to PNEUMOVAX 23. The injection site on the patient's arm became extremely swollen and very red. The physician described the look of reaction as "awful". The physician stated "never saw reactions so severe in all the time he has been administering this product". The physician prescribed an antihistamine and had the patient put cold packs on the arm. The swelling and redness lasted about a week and the patient was fine as of 30-APR-2010. This is one of several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist concerning a female patient with latex allergy who on 26-MAY-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # not provided). The next day, on 27-MAY-2010 the patient experienced a rash around her eyes. The patient talked to the pharmacist. At the time of this report, the patient had not recovered. No further information is available.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: Information has been received from a healthcare student concerning a 50 year old female patient with Crohn's disease and no drug reactions/allergies, who in late January 2010 and on 27-MAY-2010 was vaccinated with a first and a second dose of PNEUMOVAX 23 (Lot # not provided) respectively. Concomitant therapy included LEXAPRO, LIPITOR, omeprazole (MSD), cyanocobalamin, TRICOR, nitroglycerin, albuterol and QUESTRAN. The healthcare student also reported that on 28-MAY-2010 the patient experienced mild soreness at the injection site. At the time of this report, the patient was in the process of recovery. The patient sought unspecified medical attention. There were no labs/diagnostic studies performed. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered nurse concerning a patient who between 09-MAR-2010 and 18-MAR-2010 received a 0.5 ml IM dose of PNEUMOVAX 23 (lot# 664476/1190Y). Between 09-MAR-2010 and 18-MAR-2010, 24 hours after vaccination with PNEUMOVAX 23, the patient developed cellulitis reaction on their arms. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 664476/1190Y were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The nurse contacted during telephone follow-up could not supply the following information: patient names, dates of birth, dates of vaccination, dates of events and recovery status. Additional information has been requested.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Culture negative, Erythema, Full blood count abnormal, Induration, Malaise
Clinical narrative: Information has been received from a physician concerning nine patients in their late fifties, early sixties and their twenties who on unspecified dates were vaccinated with a dose of PNEUMOVAX 23 (lot # 662905/1162X or 665300/1314Y). Concomitant therapy administered on the same patient visit included a dose of influenza virus vaccine (manufacturer unspecified). After administration of PNEUMOVAX 23, the patients had severe adverse effects including malaise, pain, fever, induration, severe tenderness upon touch and erythema. Symptoms lasted for more than one week. All but two patient's had a normal CBC count. It was also reported that one of the patient was being treated for a "staph infection" at home with IV antibiotics. The physician cultured nasal area in all of the patients and did not find anything remarkable. The physician requested a lot check. The patient sought unspecified medical attention. This is one of several reports received from the same source. Follow-up telephone call information was received from a health care professional who could not supply the following information: patient name, date of birth, date of vaccination, dose number, dates of events and recovery status. A standard lot check investigation for lot 662905/1162X 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. A standard lot check investigation for lot 665300/1314Y has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Pain, Pyrexia, Staphylococcal infection, Tenderness
Clinical narrative: Information has been received from a physician concerning nine patients in their late fifties, early sixties and their twenties who on unspecified dates were vaccinated with a dose of PNEUMOVAX 23 (lot # 662905/1162X or 665300/1314Y). Concomitant therapy administered on the same patient visit included a dose of influenza virus vaccine (manufacturer unspecified). After administration of PNEUMOVAX 23, the patients had severe adverse effects including malaise, pain, fever, induration, severe tenderness upon touch and erythema. Symptoms lasted for more than one week. All but two patient's had a normal CBC count. It was also reported that one of the patient was being treated for a "staph infection" at home with IV antibiotics. The physician cultured nasal area in all of the patients and did not find anything remarkable. The physician requested a lot check. The patient sought unspecified medical attention. This is one of several reports received from the same source. Follow-up telephone call information was received from a health care professional who could not supply the following information: patient name, date of birth, date of vaccination, dose number, dates of events and recovery status. A standard lot check investigation for lot 662905/1162X 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. A standard lot check investigation for lot 665300/1314Y has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Culture negative, Erythema, Full blood count abnormal, Induration, Malaise
Clinical narrative: Information has been received from a physician concerning nine patients in their late fifties, early sixties and their twenties who on unspecified dates were vaccinated with a dose of PNEUMOVAX 23 (lot # 662905/1162X or 665300/1314Y). Concomitant therapy administered on the same patient visit included a dose of influenza virus vaccine (manufacturer unspecified). After administration of PNEUMOVAX 23, the patients had severe adverse effects including malaise, pain, fever, induration, severe tenderness upon touch and erythema. Symptoms lasted for more than one week. All but two patient's had a normal CBC count. It was also reported that one patient had a blood cell count of 18,700. The physician cultured nasal area in all of the patients and did not find anything remarkable. The physician requested a lot check. The patient sought unspecified medical attention. This is one of several reports received from the same source. Follow-up telephone information was received from a health care professional who could not supply the following information: patient name, date of birth, date of vaccination, dose number, dates of events and recovery status. A standard lot check investigation for lot# 662905/1162X 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. A standard lot check investigation for lot# 665300/1314Y has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Pain, Pyrexia, Tenderness, White blood cell count increased
Clinical narrative: Information has been received from a physician concerning nine patients in their late fifties, early sixties and their twenties who on unspecified dates were vaccinated with a dose of PNEUMOVAX 23 (lot # 662905/1162X or 665300/1314Y). Concomitant therapy administered on the same patient visit included a dose of influenza virus vaccine (manufacturer unspecified). After administration of PNEUMOVAX 23, the patients had severe adverse effects including malaise, pain, fever, induration, severe tenderness upon touch and erythema. Symptoms lasted for more than one week. All but two patient's had a normal CBC count. It was also reported that one patient had a blood cell count of 18,700. The physician cultured nasal area in all of the patients and did not find anything remarkable. The physician requested a lot check. The patient sought unspecified medical attention. This is one of several reports received from the same source. Follow-up telephone information was received from a health care professional who could not supply the following information: patient name, date of birth, date of vaccination, dose number, dates of events and recovery status. A standard lot check investigation for lot# 662905/1162X 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. A standard lot check investigation for lot# 665300/1314Y has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Hypoaesthesia
Clinical narrative: Initial case was received on 28 July 2010 from a healthcare professional. An 11 year old female received on 13 August 2009, a left deltoid intramuscular injection of ADACEL (reported lot number U29133 AA not valid for ADACEL, but is valid for MENACTRA), a right deltoid intramuscular injection of MENACTRA (lot number U2919AA) and a right deltoid intramuscular injection of GARDASIL (Merck lot number 1130X). The patient experienced numbness in both arms and legs since the vaccinations (onset date and time not specified). The patient had no pre-existing medical conditions, no concomitant medications and no known allergies. On 28 July 2010, the patient returned to the physician's office for an annual exam, reported the numbness and stated the symptoms continued. Document's held by sender: None.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Pain in extremity, Skin warm, Swelling
Clinical narrative: Initial report received from the parent of consumer who is a nurse on 30 July 2010. A 15-year-old female patient who had no concurrent illnesses, had received a first left arm injection of MENACTRA (lot number U3464AA) on 22 July 2010. That night after vaccination, the patient's left arm was sore, swollen and warm to touch. The patient also had a headache that lasted 24 hours. No diagnostic test or laboratory data were reported. Per the reporter, the patient had a reaction (description not reported) to BOOSTRIX at age 12 years. The patient has no known allergies or medical conditions. Concomitant medication included vitamin supplement. Recovery status was not reported. Documents held by sender: None.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Back pain, Hemiparesis, Injection site swelling, Pain, Swelling
Clinical narrative: Initial case received from a physician on 14 July 2010. A 16-year-old female patient received a right arm injection of MENACTRA (lot number U34400AA) and a left arm injection of GARDASIL (Merck, lot not reported) on 13 July 2010. The patient had a history of ADHD (attention deficit/hyperactivity disorder) and depression, and 8 months prior to vaccination had suffered a head trauma with symptoms involving the right side. Concomitant medications included PRISTIQ, VYVANSE, and PAMELOR. On 14 July 2010, the morning after vaccination, the patient woke up with swelling of the right side including right-sided facial swelling and right arm swelling; right-sided weakness; and lower back pain. The patient noted that she had pain when trying to get up to walk, and that she "hurt all over". She was seen by her physician on 14 July 2010. Outcome was unknown at the time of the report.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Swelling face
Clinical narrative: Initial case received from a physician on 14 July 2010. A 16-year-old female patient received a right arm injection of MENACTRA (lot number U34400AA) and a left arm injection of GARDASIL (Merck, lot not reported) on 13 July 2010. The patient had a history of ADHD (attention deficit/hyperactivity disorder) and depression, and 8 months prior to vaccination had suffered a head trauma with symptoms involving the right side. Concomitant medications included PRISTIQ, VYVANSE, and PAMELOR. On 14 July 2010, the morning after vaccination, the patient woke up with swelling of the right side including right-sided facial swelling and right arm swelling; right-sided weakness; and lower back pain. The patient noted that she had pain when trying to get up to walk, and that she "hurt all over". She was seen by her physician on 14 July 2010. Outcome was unknown at the time of the report.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Information has been received from the reporter who stated that she was told by a doctor. A 70 year old male patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot number 665402/1339Y). On 16-MAR-2010 the patient's arm she was given the dose in was extremely swollen and very red. The doctor prescribed an antihistamine and told the patient to use ice packs. The adverse event lasted for about a week and it was finished (on approximately 23-MAR-2010). The doctor told the reporter that he had 3 patients who all had the same reactions to injections given from the same 5 dose vial. Follow-up information was received which reported that the adult was vaccinated and had severe local reaction which appeared to be allergic. The patient was treated with ice packs and CLARITIN and the patient did well. The final outcome of the patient was not reported. Follow-up information received from a physician concerning the 70 year old (also reported as 80 year old) male patient who on 16-MAR-2010 had a reaction to PNEUMOVAX 23. The injection site on the patient's arm became extremely swollen and very red. The physician described the look of reaction as "awful". The physician stated "never saw reactions so severe in all the time he has been administering this product". The physician prescribed an antihistamine and had the patient put cold packs on the arm. The swelling and redness lasted about a week and the patient was fine as of 30-APR-2010. This is one of several reports from the same source. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse manager concerning a 63 year old female who on 02-MAY-2010 was vaccinated with a first dose of PNEUMOVAX 23 (IM) (lot # 664964/1338Y). "2 days after injection", on 04-MAY-2010 the patient called and stated that the injection site area in the left deltoid was raised and red. The patient was advised to put a cool compress on it and recovered on unspecified date. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with PNEUMOVAX 23 (lot # 665300/1314Y) within the month of April 2010. The patient experienced very large redness wrapping around the arm and warmth/feverish at the injection site recently. The patient was treated with oral BENADRYL and ice. At the time of the reporting, the patient's status was unknown. This is one of several reports received from the same source. The nurse is requesting a lot check. A lot check had been initiated. Additional information has been requested.
Age: 0.58
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a 7 month old patient who on 13-MAY-2010 was inadvertently vaccinated with a dose of PNEUMOVAX 23 instead of PREVNAR due to a human error. No adverse effect reported. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 79 year old female patient who on 05-MAY-2010 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 (Lot# 664535/0060Z, exp 03-FEB-2011) in left arm. On 06-MAY-2010 the patient had redness, pain and swelling at the injection site. Patient was treated with warm compress, TYLENOL. Patient sought unknown medical attention. At the time of report the patient's status was recovering. The patient was hospitalized at the hospital for unrelated issue and PNEUMOVAX 23 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: 50.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 50 year old male patient who on 15-MAY-2010 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 664535/0060Z, exp 03-FEB-2011) in right shoulder. On 16-MAY-2010 the patient had redness, pain and swelling at the injection site. Patient was treated with unspecified treatment. Patient sought unknown medical attention. At the time of report the patient's status was recovering. The patient was hospitalized at the hospital for unrelated issue and PNEUMOVAX 23 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: 64.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse practitioner concerning a 64 year old female patient with hyperlipidaemia, coronary artery disease and had a Dual chamber pacemaker and a history of Graves' disease and Cardiac arrhythmia and no drug reactions or allergies who on 17-MAY-2010 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot # 663888/0627Y) IM. Concomitant therapy included trazodone HCl, CRESTOR, COREG, baby aspirin and influenza immunization. On 18-MAY-2010 the patient developed redness, pain swelling and warmth of the arm, starting about one inch below the injection site after receiving PNEUMOVAX 23. The patient also experienced fever, chills and myalgia. The patient sought medical attention via office visit and was treated with BENADRYL. At the time of this report, the patient had not recovered. The nurse practitioner requested a lot check. A lot check has been initiated. This is one of several reports form the same source. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 64 year old female patient with hyperlipidaemia, coronary artery disease and had a Dual chamber pacemaker and a history of Graves' disease and Cardiac arrhythmia and no drug reactions or allergies who on 17-MAY-2010 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot # 663888/0627Y) IM. Concomitant therapy included trazodone HCl, CRESTOR, COREG, baby aspirin and influenza immunization. On 18-MAY-2010 the patient developed redness, pain swelling and warmth of the arm, starting about one inch below the injection site after receiving PNEUMOVAX 23. The patient also experienced fever, chills and myalgia. The patient sought medical attention via office visit and was treated with BENADRYL. At the time of this report, the patient had not recovered. The nurse practitioner requested a lot check. A lot check has been initiated. This is one of several reports form the same source. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning 4 patients who between 09-MAR-2010 and 18-MAR-2010 received a 0.5 ml IM dose of PNEUMOVAX 23 (lot # 664476/1190Y). Between 09-MAR-2010 and 18-MAR-2010, 24 hours after vaccination with PNEUMOVAX 23, the patients developed cellulitis reaction on their arms. The patients sought unspecified medical attention. At the time of the report, the outcome of the patients was unknown. The nurse contacted during telephone follow-up could not supply the following information: patient names, dates of birth, dates of vaccination, dates of events and recovery status. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 664476/1190Y were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow-up information has been received from the registered nurse concerning a 32 year old female patient under medication follow-up and no pertinent medical history who on 16-MAR-2010 was vaccinated with the first dose of PNEUMOVAX 23 (lot # 664476/1190Y) into her left arm at 1:00 PM. On 17-MAR-2010 the patient experienced swelling and redness of her left arm. The patient did not go to emergency room or doctor office for medical attention. She was treated with ice and ibuprofen. On 17-MAR-2010, the patient recovered from these events. This is one of several reports received from the same source. No further information is available.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning 6 patients who between 09-MAR-2010 and 18-MAR-2010 received a 0.5 ml IM dose of PNEUMOVAX 23 (lot# 664476/1190Y).  Between 09-MAR-2010 and 18-MAR-2010, 24 hours after vaccination with PNEUMOVAX 23, the patients developed cellulitis reaction on their arms.  The patients sought unspecified medical attention.  At the time of the report, the outcome of the patient was unknown.  A standard lot check investigation has been finalized.  All in-process quality checks for the lot number 664476/1190Y were satisfactory.  The lot met the requirements of the Research Center and was released.  The nurse contacted during telephone follow-up could not supply the following information:  patient names, dates of birth, dates of vaccination, dates of events and recovery status.  Follow-up information has been received from a registered nurse concerning a 52 year old male with hypertension and no pre-existing allergies, birth defect, medical conditions who on 15-MAR-2010 at 11:00 AM was vaccinated in left arm with a dose of PNEUMOVAX 23 (LOT # 664476/1190Y).  On 16-MAR-2010 at 14:10 the patient experienced left arm swelling and was diagnosed with cellulitis.  The patient was given clindamycin for 7 days.  Subsequently, on 19-MAR-2010 the patient recovered.  No further information is available at this time of reporting.  This is one of several reports received from the same source.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot # not provided), 0.5 mL, IM.  The physician reported that the patient had deep whelps down her arm as a result of PNEUMOVAX 23 vaccine.  At the time of this report, the patient's outcome was unknown.  It was unknown if the patient sought medical attention.  No laboratory tests were performed.  Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Blood creatinine, Cardiac function test, Myalgia, Pain in extremity, Urine analysis
Clinical narrative: Information has been received from a registered nurse concerning a 63 year old female patient with no pertinent medical history or drug reactions/allergies who on 20-MAY-2010 was vaccinated with a single dose of PNEUMOVAX 23 (Lot # 661739/1407X, expiration date 12-JUN-2011) 0.5 mL, IM. Concomitant therapy included ALEVE and amlodipine. On 20-MAY-2010 the patient developed leg and muscle pain after receiving PNEUMOVAX 23. The patient went to an emergency room but was later released. A cardiac panel, urinalysis and creatinine levels were performed without any results available. At the time of this report, the patient was recovering. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site streaking, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 61 year old female patient with hyperlipidaemia, osteopenia and rosacea, with no drug reactions or allergies who on 18-MAY-2010 received for the first time a 0.5 ml dose of PNEUMOVAX 23 IM ( lot number 665270/1398Y).  Concomitant medication included "many unnamed medications".  Nurse reported that the patient experienced redness, swelling and tenderness of the left arm with streaking to the breast.  On 20-MAY-2010, she was sent to the emergency room with diagnosis of cellulitis.  Patient started on oral AUGMENTIN.  The next day, she called the office stating the area was warm to touch and the redness was wider.  She was advised to return to the emergency room if symptoms became worse.  At the time of reporting, the patient had not recovered from cellulitis.  Additional information has been requested.