chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Activities of daily living impaired, Fatigue, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a pharmacist concerning a 34 year old female with asthma and no known drug reaction who on 21-MAR-2011 was subcutaneously vaccinated with PNEUMOVAX 23 (dose and lot# not reported) into her left arm. Concomitant therapy included Tdap(dose, route and lot# not reported) into the same arm different site. On approximately 21-MAR-2011 the patient developed an injection site reaction following vaccination with PNEUMOVAX 23. The patient contacted the office and was seen in the office on 23-MAR-2011and the patient's arm had a 3 by 5cm round, swollen, red, warm and painful to the touch reaction at the injection site of PNEUMOVAX 23. The patient was also complaining of fatigue and had a mild fever during the office visit on 23-MAR-2011. The patient called the office next day (24-MAR-2011) reporting a doubling of the injection site reaction and continued redness and warmth. The patient was sent to another physician (unspecified) where the patient was treated with a 7 day course of the antibiotic KEFLEX and pain medication (unspecified). No lab diagnostics study was performed. The reporter was unsure if the patient experienced significant disability; patient had significant pain and might have missed work. At the time of reporting, the patient recovered. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 34 year old female with asthma and no known drug reaction who on 21-MAR-2011 was subcutaneously vaccinated with PNEUMOVAX 23 (dose and lot# not reported) into her left arm. Concomitant therapy included Tdap(dose, route and lot# not reported) into the same arm different site. On approximately 21-MAR-2011 the patient developed an injection site reaction following vaccination with PNEUMOVAX 23. The patient contacted the office and was seen in the office on 23-MAR-2011and the patient's arm had a 3 by 5cm round, swollen, red, warm and painful to the touch reaction at the injection site of PNEUMOVAX 23. The patient was also complaining of fatigue and had a mild fever during the office visit on 23-MAR-2011. The patient called the office next day (24-MAR-2011) reporting a doubling of the injection site reaction and continued redness and warmth. The patient was sent to another physician (unspecified) where the patient was treated with a 7 day course of the antibiotic KEFLEX and pain medication (unspecified). No lab diagnostics study was performed. The reporter was unsure if the patient experienced significant disability; patient had significant pain and might have missed work. At the time of reporting, the patient recovered. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Myalgia, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 54 year old male patient who on 09-MAR-2011 was vaccinated with a dose of PNEUMOVAX 23 (lot # 669372/1822Z, Exp. 05-AUG-2012). Four hours after vaccination the patient had a fever (100.5 F) along with myalgia and arthralgias. On 10-MAR-2011, the patient was at the emergency room but the physician stated that the patient would not be admitted to the hospital. At the time of the reporting,  the patient had not recovered from fever (100.5 F), myalgias and arthralgias. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Pain
Clinical narrative: Information has been received from a female pharmacist concerning herself who in approximately November 2010, reported as "within the past 3 months" was vaccinated with PNEUMOVAX 23, (route, doe and lot number was unspecified). In approximately November 2010, also reported as "within the past 3 months", the pharmacist experienced localized pain and swelling at the sight of the injection. On an unknown date, the she recovered from the symptoms. It was unknown if the pharmacist sought unspecified medical attention. This is one of two reports received from the same source. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Headache, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 31 year old female patient, with allergy to ADVAIR, who on 05-MAY-2011 was vaccinated intramuscularly in the left deltoid, with a 0.5 ml dose of PNEUMOVAX 23 (Lot # not reported). Concomitant therapy included ZOLOFT, FLOVENT, VENTOLIN HFA, metformin, PREVACID, FLONASE and aspirin. Nurse practitioner reported that on 06-MAY-2011, the patient developed pain and swelling at the injection site down to her elbow. Nurse practitioner also reported that patient had chills, a 100 f temperature, body aches, throat pain and headache. No treatment was given for the events. The patient sought medical attention by calling the office. The patient had not returned to office since administration of PNEUMOVAX 23, for evaluation. At the time of the report, the patient's outcome was not recovered. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Oropharyngeal pain, Pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 31 year old female patient, with allergy to ADVAIR, who on 05-MAY-2011 was vaccinated intramuscularly in the left deltoid, with a 0.5 ml dose of PNEUMOVAX 23 (Lot # not reported). Concomitant therapy included ZOLOFT, FLOVENT, VENTOLIN HFA, metformin, PREVACID, FLONASE and aspirin. Nurse practitioner reported that on 06-MAY-2011, the patient developed pain and swelling at the injection site down to her elbow. Nurse practitioner also reported that patient had chills, a 100 f temperature, body aches, throat pain and headache. No treatment was given for the events. The patient sought medical attention by calling the office. The patient had not returned to office since administration of PNEUMOVAX 23, for evaluation. At the time of the report, the patient's outcome was not recovered. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: Information has been received from a medical assistant concerning a 57 year old female patient with osteopenia, gastro esophageal reflux disease, chronic obstructive pulmonary disease, depression, chronic pain syndrome and hyperlipidemia who on 20-APR-2011 was vaccinated with a dose of PNEUMOVAX 23 (dose and route not reported) (Lot number 669382/1490z). Concomitant therapy included ezetimibe (MSD), pravastatin Na, SPIRIVA, NEXIUM, CYMBALTA, ATIVAN, TOPAMAX, oxycodone and OXYCONTIN. The medical assistant reported that on 20-APR-2011 the patient experienced a fever of 100.7 and complained of chills, pain in the arm where she received the injection and reduced mobility in that arm. The patient had difficult sleeping the previous night and she said that he normal pain medications did not give her relief. Laboratory diagnostics studies were not performed. The patient presented at the office on 21-APR-2011. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 57 year old female patient with osteopenia, gastro esophageal reflux disease, chronic obstructive pulmonary disease, depression, chronic pain syndrome and hyperlipidemia who on 20-APR-2011 was vaccinated with a dose of PNEUMOVAX 23 (dose and route not reported) (Lot number 669382/1490z). Concomitant therapy included ezetimibe (MSD), pravastatin Na, SPIRIVA, NEXIUM, CYMBALTA, ATIVAN, TOPAMAX, oxycodone and OXYCONTIN. The medical assistant reported that on 20-APR-2011 the patient experienced a fever of 100.7 and complained of chills, pain in the arm where she received the injection and reduced mobility in that arm. The patient had difficult sleeping the previous night and she said that he normal pain medications did not give her relief. Laboratory diagnostics studies were not performed. The patient presented at the office on 21-APR-2011. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse (R.N) concerning a female patient who on 20-APR-2011, was vaccinated in error with a dose of PNEUMOVAX 23, intradermal (lot number not reported) instead of a tuberculin skin test. On 20-APR-2011, the patient developed itching at the site and the area was "raised about the size of a nickle". Mistake caught when she returned for the reading. The patient sought called office. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a male patient who on 28-FEB-2011 or 06-MAR-2011 was vaccinated with a dose of PNEUMOVAX 23 ("intramuscular or subcutaneous injection", 0.5 ML, Lot # 667995/1150Z and expiration date: 04-Mar-2012). The physician reported that the patient experienced swollenness and redness at the injection-site in the arm and also the patient experienced cellulitis. The physician had not seen this type of reaction in this type of consistency. Patient sought unspecified medical attention. At the time of reporting the patient was recovering. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: PPV
Symptoms: Product name confusion, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning an infant patient, who on an unspecified date was accidentally vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported) which was not indicated for patients under two years of age when they were supposed to give PREVNAR 13. The physician said they got the numbers confused with the 23 and 13. This is one of several reports received from the same source. Follow up information has been received from the physician concerning a 21 (no 22) month old (gender unknown) patient, who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported). There were no adverse reactions. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Dysstasia, Influenza, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a 66 year old female nurse practitioner concerning herself with penicillin allergy, sulfonamide allergy, and COMPAZINE allergy and chronic obstructive pulmonary disease and a history of breast cancer, who in September 2004, "6 years ago" was vaccinated with the first 0.5 ml dose of PNEUMOVAX 23 (Lot # unknown) and on 24-SEP-2010 was vaccinated SC with a second 0.5ml dose of PNEUMOVAX 23 (Lot No. 664864/1365Y). Concomitant therapy included ARIMIDEX, montelukast sodium (MSD), CLARITIN, multivitamins and fish oil. On 25-SEP-2010, the day after administration of her second dose, she experienced erythema and soreness at the injection site. On 26-SEP-2010 she felt like she had the flu. She had a fever of 102F, could barely stand up, felt "like she was going to die", coughing, pain in her arm, and the erythema was about the size of an orange. She was not able to get out of bed. On 27-SEP-2010 she felt much better, she did not have fever and was not hurting as much. The area on her arm was still very red. She was able to return to work. The patient sought unspecified medical attention. There were no Lab diagnostics/studies performed. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a 66 year old female nurse practitioner concerning herself with penicillin allergy, sulfonamide allergy, and COMPAZINE allergy and chronic obstructive pulmonary disease and a history of breast cancer, who in September 2004, "6 years ago" was vaccinated with the first 0.5 ml dose of PNEUMOVAX 23 (Lot # unknown) and on 24-SEP-2010 was vaccinated SC with a second 0.5ml dose of PNEUMOVAX 23 (Lot No. 664864/1365Y). Concomitant therapy included ARIMIDEX, montelukast sodium (MSD), CLARITIN, multivitamins and fish oil. On 25-SEP-2010, the day after administration of her second dose, she experienced erythema and soreness at the injection site. On 26-SEP-2010 she felt like she had the flu. She had a fever of 102F, could barely stand up, felt "like she was going to die", coughing, pain in her arm, and the erythema was about the size of an orange. She was not able to get out of bed. On 27-SEP-2010 she felt much better, she did not have fever and was not hurting as much. The area on her arm was still very red. She was able to return to work. The patient sought unspecified medical attention. There were no Lab diagnostics/studies performed. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product name confusion, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning an infant patient, who on an unspecified date was accidentally vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported) which was not indicated for patients under two years of age when they were supposed to give PREVNAR 13. The physician said they got the numbers confused with the 23 and 13. Follow up information has been received from the physician concerning a 20 month old (gender unknown) patient, who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported). There were no adverse reactions. This is one of several reports received from the same source. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, HIV antibody positive, Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: Information has been received from a healthcare worker (also reported as medical assistant) concerning a 35 year old male patient recently diagnosed as Human immunodeficiency virus (HIV) positive with no drug allergies who on 26-JAN-2011 was vaccinated IM with the first dose of PNEUMOVAX 23 (lot # 667916/1066Z, expiration date 03-MAR-2012) into the left deltoid. Concomitant therapy included ADDERALL (tablets). On approximately 26-JAN-2011 within 6 hours of receiving the vaccine the patient developed a fever (102 degrees F), redness, warmth and induration of 3-4 inches at the injection site and rash at the injection site. The patient had sought medical attention by office visit. Lab diagnostics studies were not performed. The symptoms subsided by 31-JAN-2011. Follow up information has been received from the healthcare worker who reported that the patient with HIV positive at time of vaccination on 26-JAN-2011 at approximately 2:00 PM was vaccinated with PNEUMOVAX 23. On 26-JAN-2011 approximately 4:00 PM approximately 2 hours after the vaccination the patient developed of pain, swelling, redness, warm to touch, fever persisted over the weekend. The patient's red area grew to approximately 4-5 inches diameter. The healthcare worker mentioned the patient's mother reported the patient's sister also has a similar reaction to PNEUMOVAX 23, which was reported in WAES # 1103USA01857. Additional information is not expected.
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: Injection site warmth, Pain, Pyrexia, Skin warm, Swelling
Clinical narrative: Information has been received from a healthcare worker (also reported as medical assistant) concerning a 35 year old male patient recently diagnosed as Human immunodeficiency virus (HIV) positive with no drug allergies who on 26-JAN-2011 was vaccinated IM with the first dose of PNEUMOVAX 23 (lot # 667916/1066Z, expiration date 03-MAR-2012) into the left deltoid. Concomitant therapy included ADDERALL (tablets). On approximately 26-JAN-2011 within 6 hours of receiving the vaccine the patient developed a fever (102 degrees F), redness, warmth and induration of 3-4 inches at the injection site and rash at the injection site. The patient had sought medical attention by office visit. Lab diagnostics studies were not performed. The symptoms subsided by 31-JAN-2011. Follow up information has been received from the healthcare worker who reported that the patient with HIV positive at time of vaccination on 26-JAN-2011 at approximately 2:00 PM was vaccinated with PNEUMOVAX 23. On 26-JAN-2011 approximately 4:00 PM approximately 2 hours after the vaccination the patient developed of pain, swelling, redness, warm to touch, fever persisted over the weekend. The patient's red area grew to approximately 4-5 inches diameter. The healthcare worker mentioned the patient's mother reported the patient's sister also has a similar reaction to PNEUMOVAX 23, which was reported in WAES # 1103USA01857. Additional information is not expected.
Age: 9.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Injection site cellulitis, Local reaction, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 9 year old female who on 04-OCT-2010 was vaccinated with one shot of PNEUMOVAX 23 (LOT# 663998/0623Y expiration 01-DEC-2010). Secondary suspected vaccination included a dose of seasonal influenza virus vaccine (unspecified) (manufacturer unknown). The patient's medical history included "not that she knows of". In October 2010 (unreported by physician), the patient experienced local reaction, severe cellulites at injection site, a fever of 103 degree and flu like symptoms. To treat these symptoms, the patient was put on DURICEF and BACTRIM. It had not had other lab diagnose study performed. At this time of reporting, the patient's local reaction and severe cellulites at injection site and a fever of 103 degree and flu like symptoms persisted. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site rash, Injection site warmth
Clinical narrative: Information has been received from a healthcare worker (also reported as medical assistant) who reported that a female consumer reported her daughter on an unspecified date (prior to 26-JAN-2011) was vaccinated with PNEUMOVAX 23 (lot # not reported). On an unknown date the patient developed a fever, redness, warmth and induration of 3-4 inches at the injection site and rash at the injection site. It was unspecified if the patient sought medical attention. At the time of reporting, the patient's outcome was unknown. Follow up information has been received from the healthcare worker who reported that the patient experienced pain, swelling, redness, warm to touch, fever after receiving the vaccine. At the time of reporting, the patient's outcome was unknown. The healthcare worker mentioned the patient's brother also had a similar reaction to PNEUMOVAX 23, which was reported in WAES # 1103USA01404. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia, Skin warm, Swelling
Clinical narrative: Information has been received from a healthcare worker (also reported as medical assistant) who reported that a female consumer reported her daughter on an unspecified date (prior to 26-JAN-2011) was vaccinated with PNEUMOVAX 23 (lot # not reported). On an unknown date the patient developed a fever, redness, warmth and induration of 3-4 inches at the injection site and rash at the injection site. It was unspecified if the patient sought medical attention. At the time of reporting, the patient's outcome was unknown. Follow up information has been received from the healthcare worker who reported that the patient experienced pain, swelling, redness, warm to touch, fever after receiving the vaccine. At the time of reporting, the patient's outcome was unknown. The healthcare worker mentioned the patient's brother also had a similar reaction to PNEUMOVAX 23, which was reported in WAES # 1103USA01404. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning an approximately 73 year old female who on 23-SEP-2010 was vaccinated with PNEUMOVAX 23 (lot # 667134/0738Z, route not reported). After administration of the vaccine, the patient experienced redness, pain and swelling at the injection site. The patient also experienced swelling of the arm. Outcome of the events were not reported. This is one of several reports received from a same source. Additional information has been requested.
Age: 52.0
Sex: U
Vaccine: PPV
Symptoms: Insomnia, Local reaction, Oedema peripheral, Pain
Clinical narrative: Information has been received from a physician's assistant concerning a 52 year old patient with chronic obstructive pulmonary disease and allergy to VIOXX, who on 17-MAR-2011 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot # 667271/0880Z EXP 11-DEC-2011) IM. Concomitant therapy included bupropion HCl, hydrochlorothiazide, cyclobenzaprine HCl, acetaminophen/hydrocodone bitartrate, lisinopril (manufacturer unknown), omeprazole, PROAIR and promethazine. The physician's assistant reported that the patient experienced severe local reactions, after receiving PNEUMOVAX 23. Patient's whole arm was swollen and she felt so much pain that she took VICODIN she had at home but did not get any pain relief. The patient could not sleep at all due to severe pain. There were not Lab diagnosis/studies performed. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect route of drug administration, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a doctor of pharmacy concerning an adult patient who on unknown date, was vaccinated with a dose of PNEUMOVAX 23. The pharmacist stated that a patient at a long term facility may had received PNEUMOVAX 23 intradermally. Also, the pharmacist said that "he did not know who the patient was or who the physician was" and" the nursing staff may have mistakenly thought they were giving the patient a Purified Protein Derivate (PPD)". No adverse effect reported. At the time of the report, the patient's outcome was unknown. Additional information has been requested. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Head injury, Injection site erythema, Injection site reaction, Injection site swelling, Loss of consciousness
Clinical narrative: Information has been received from a wife concerning her 51 year old husband with "diabetic type 1", who in the Friday afternoon on 25-MAR-2011 was vaccinated with PNEUMOVAX 23 (lot# 667914/1067Z). Concomitant therapy included insulin (unspecified type and manufacturer) and LIPITOR. The patient's wife reported that the patient experienced an injection site reaction, fever (100 degrees F) and fainting following vaccination with PNEUMOVAX 23. The patient experienced swelling, stiffness and redness down to the elbow in the injection site arm and fever that started 2 hours after vaccination on 25-MAR-2011. The next morning on 26-MAR-2011 about 3 minutes after walking up, the patient stated that he was not feeling well, fainted and hit his head. The patient lost consciousness for about one minute and then recovered from the fainting. The patient's injection site reaction and fever were fully recovered by Sunday night on 27-MAR-2011. The patient sought unspecified medical attention and was not given treatment for the events. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Malaise, Musculoskeletal stiffness, Pyrexia, Syncope
Clinical narrative: Information has been received from a wife concerning her 51 year old husband with "diabetic type 1", who in the Friday afternoon on 25-MAR-2011 was vaccinated with PNEUMOVAX 23 (lot# 667914/1067Z). Concomitant therapy included insulin (unspecified type and manufacturer) and LIPITOR. The patient's wife reported that the patient experienced an injection site reaction, fever (100 degrees F) and fainting following vaccination with PNEUMOVAX 23. The patient experienced swelling, stiffness and redness down to the elbow in the injection site arm and fever that started 2 hours after vaccination on 25-MAR-2011. The next morning on 26-MAR-2011 about 3 minutes after walking up, the patient stated that he was not feeling well, fainted and hit his head. The patient lost consciousness for about one minute and then recovered from the fainting. The patient's injection site reaction and fever were fully recovered by Sunday night on 27-MAR-2011. The patient sought unspecified medical attention and was not given treatment for the events. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from an office administrator female consumer reporting on herself, with multiple sclerosis who on 14-MAR-2011 was vaccinated with a dose of PNEUMOVAX 23 (Lot number not reported), intramuscularly. Concomitant therapy included unspecified medication for multiple sclerosis. The consumer reported that on 14-MAR-2011 she experienced warmth and swelling at the injection site two hours after the administration of the vaccine. She contacted her physician by phone and she was advised to apply ice packs. Subsequently, on 17-MAR-2011 the patient recovered from the experience. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site inflammation, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a 70 year old female consumer reporting herself with seasonal allergy that many years ago a nurse gave her the wrong type of "syrum", and put a (DPT) "under the skin" who on an unknown date, was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported). Concomitant therapy included levothyroxine Na, ZYRTEC, PREVACID and losartan potassium (MSD). The patient mentioned that after she received PNEUMOVAX 23, she got sore at the injection site. Then the next evening, when she looked at the size of it, it was about three inches and very red and inflamed. Late that evening, the patient ran a fever of 101.4 and the patch grew to about inches. This is one of two reports received form the same patient. At the time of the report the patient's outcome was unknown. Additional information is not expected.
Age: 61.0
Sex: U
Vaccine: PPV
Symptoms: No therapeutic response
Clinical narrative: This report was received from Pfizer and was assigned manufacturer report number 2010122964 concerning a 61 year old elderly patient with IgG and IgA deficiency who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot# unknown). The physician reported that the patient was given PNEUMOVAX 23 and had no immune response. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. This was originally reported by a physician. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pain, Pyrexia, Swelling
Clinical narrative: Information has been received from a physician concerning a 56 year old female patient who on 10-SEP-2009, was vaccinated with a dose of PNEUMOVAX 23 (Lot# 663888/0627Y). Concomitant therapy included steroids. On 14-SEP-2009, the patient developed swelling at the injection site, fever and body aches. At the time of the report, the patient's outcome was unknown. The patient sought medical attention. Follow up information has been received from a health care professional concerning a 56 year old female patient who on 10-SEP-2009, was vaccinated with a dose of PNEUMOVAX 23 (Lot# 663888/0627Y). On an unspecified date, the patient developed swelling, fever and body aches. The patient went to the office on 14-OCT-2010 and she received her steroids (unspecified). At the time of the report the patient present status was unknown. This is one of the cases received from same source. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Mobility decreased, Myalgia, Pain, Pain in extremity
Clinical narrative: Information has been received from a distributor who was informed by a physician concerning a 57 year old female who on 24-SEP-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot # 663888/0627Y, expiration in November 2010). On 24-SEP-2010 the patient developed numbness in the arm she received the PNEUMOVAX 23. It was reported that the patient received care from an emergency room and followed up with her doctor after that. At the time of reporting, the outcome of the event was unknown. Follow-up information has been received from a healthcare professional who reported that the 57 year old female on 24-SEP-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot # 663888/0627Y, expiration in November 2010). She went to the emergency room complaining of her whole arm was in pain and she could not left her arm. The administered a steroid injection and gave her naproxen. "Today" she went to a walk in clinic complaining of soreness and muscle ache all over. They did not give her anything so she came back to their office where they administered a steroid dose pack. This is one of the cases received from same source (a distributor). Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 66 year old female consumer reporting herself with breast cancer and morphine allergy who on 21-MAR-2011 was vaccinated in her buttocks with a dose of PNEUMOVAX 23 (dose, route and lot number not provided) and with a dose of ZOSTAVAX (Merck) (MSD, dose, route and lot number not provided), in the left arm during the same office visit. Concomitant therapy also included letrozole. On 21-MAR-2011 the patient reported she experienced swelling, redness, warmth and tenderness at the site of injection 4 hours after administered PNEUMOVAX 23 in her buttocks. The area was about the size of a tennis ball. Patient sought unspecified medical attention. No laboratory diagnostics studies were performed. No treatment for the adverse event was given. At the time of the report, the patient was recovering. No further information is available.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Information has been received from a 28 year old female with latex allergy who on 01-OCT-2010 was vaccinated with a dose of PNEUMOVAX 23. On 01-OCT-2010 ("within a few hours" of the vaccination), the patient noticed redness, swelling, pain within 2 inches from injection point. She also had soreness in her muscle and headache. There was no lab diagnostics studies performed. At the time of the report, the patient had not recovered from these adverse events. The patient sought an unknown medical attention. No further information is available.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 76 year old male patient with hypertension, benign prostatic hypertrophy and with no drug reactions or allergies who on 22-SEP-2010, was vaccinated with the first dose of PNEUMOVAX 23 (Lot# 665708/0651Z). Concomitant therapy included lisinopril-HCTZ. It was reported that on the evening of 24-SEP-2010, the patient saw the doctor for an injection site reaction of the left arm with inflammation, redness and tenderness to touch. The patient was treated with cephalexin for diagnosis of Cellulitis. Lab diagnostics studies were not performed. The patient was seen on 01-OCT-2010, and the area was clear. The licensed practical nurse stated that it was the first time he had received PNEUMOVAX 23 and he did not receive other injections on 22-SEP-2010. The doctor was requesting a lot check because of the above symptoms. On 01-OCT-2010, the patient recovered. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center of Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Discomfort, Erythema, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 69 year old female patient with no known medical history and no known drug reactions/allergies who on 29-SEP-2010 was vaccinated in the left deltoid with a 0.5 ml of PNEUMOVAX 23 (lot # 665904/0966z, exp 04-JUL-2011). There was no concomitant medication. In the evening of 29-SEP-2010 the patient experienced "discomfort", fever, whole left arm was red and a burning sensation in the left arm. On an unspecified date, the patient recovered from discomfort, fever, whole left arm was red and a burning sensation in the left arm. There was no lab diagnostics studies performed. The patient sought unknown medical attention. "Pharmacist would like lot check." 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 of Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Influenza like illness, Mobility decreased
Clinical narrative: Information has been received from a pharmacist concerning a 74 year old male patient with no pertinent medical history who on 29-SEP-2010 was vaccinated in right deltoid with a 0.5ml dose of PNEUMOVAX 23 (lot # 665904/0866Z). There was no concomitant medication. On 29-SEP-2010, the patient experienced redness in his right arm, flu-like symptoms and difficulty raisin his arm. On an unspecified date, the patient recovered. The pharmacist would like a lot check. The patient sought unspecified medical attention. 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 (lot # 665904/0866Z) 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 of Biologics Evaluation and Research and was released. No further information is available.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Injection site erythema, Pyrexia, Swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning an 82 year old female patient with allergy to lorazepam and a history of mastectomy who on 20-SEP-2010, was vaccinated in the arm with a dose of PNEUMOVAX 23 (Lot# 665924/0930Z). On the same day, the patient was vaccinated inn the same arm with a dose of FLUZONE. On 21-SEP-2010, the patient developed redness, swelling, fever and chills. On 22-SEP-2010, was started on KEFLEX and the symptoms resolved. Lab diagnostics studies were not performed. The patient sought medical attention. At the time of the report, the patient had recovered. Follow-up information has been received from a physician, who reported that female patient with rash at the time of vaccination on 20-SEP-2010 was vaccinated in the right arm with a dose of PNEUMOVAX 23 and flu vaccine, but the patient refused to have the vaccine in the right arm. She developed redness at the injection sites. At the time of the report the patient had recovered. The patient did not seek medical attention. Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Local reaction
Clinical narrative: Information has been received from a registered pharmacist concerning a 74 year old female patient with allergy to penicillin and salicylates and no pertinent medical history who in 2002 was vaccinated with a dose of PNEUMOVAX 23 and had no reaction. On 29-SEP-2010 the patient received a second 0.5ml SQ dose of PNEUMOVAX 23 (Lot #665708/0651Z). Concomitant therapy included "thyroid pills and an inhaler". On 29-SEP-2010 the patient developed local injection site reaction after receiving second dose of PNEUMOVAX 23. The site of injection became painful and swollen. At the time of the report the patient had not recovered. The patient sought unspecified medical attention. No laboratories or diagnostics studies were performed. Follow up information has been received from a registered pharmacist who indicated that on 29-SEP-2009 the patient received an injection of PNEUMOVAX 23. It was reported that the patient had had PNEUMOVAX 23 at least 3-4 times in his life; she had had PNEUMOVAX 23 before with no problem. Concomitant therapy included levothyroxine Na. Called the next day and was swollen and sore. The pharmacist called the next day and the patient was better. Swelling of the injected arm lasted 2 days. The pharmacist stated that the patient had since made a full recovery (also reported as not recovered). Additional information is not expected.
Age: 40.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pruritus, Pyrexia, Swelling
Clinical narrative: Information has been received concerning an "around 40 year old" female with no drug allergy and immunocompromission and a tumor in her brain who "a month ago", on approximately 30-AUG-2010 was vaccinated intramuscularly into the left arm with a first dose of PNEUMOVAX 23 (lot # not reported). At the same time the patient also vaccinated into the left arm with a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown). The "day after receiving the injection", on approximately 31-AUG-2010, the patient had a lot of swelling, itching and fever that lasted 2 to 3 weeks. The patient sought unspecified medical attention. "Sometime this week", in September 2010, the patient recovered. No further information is available.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a "66 year old" female who on 28-SEP-2010 was vaccinated intramuscularly with a dose of PNEUMOVAX 23. On 29-SEP-2010 the patient's injection site got swollen and tender to touch. The patient had a hard time lifting her left arm. The patient sought unspecified medical attention. As of 30-SEP-2010 the patient was recovering. Follow-up information was received from a physician concerning a 66 year old female with allergic reaction to alendronate sodium (MSD) and NAPROSYN, who at 11:04 on 28-SEP-2010 was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (lot # 665925/0932Z) in the left arm. In the evening of 28-SEP-2010 the patient experienced redness, swelling and difficulty moving arm. She was given prednisone and KEFLEX. The patient was improved on exam on 30-SEP-2010. No further information is available. The patient has a history of drug hypersensitivity while on prior therapy with alendronate sodium (MSD) (WAES 1010USA03131).
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 53 year old female patient with a history of bone marrow transplant who on 24-MAR-2010 was vaccinated with a dose of PNEUMOVAX 23 instead of PREVNAR. It was recommended by the patient's oncologist that the patient received "PNEUMOVAX 7". It was believed the oncologist meant PREVNAR. The patient had not experienced any known symptoms. It was unknown if patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Oedema, Rash
Clinical narrative: Information has been received from a nurse concerning a female who on 06-OCT-2010 was vaccinated with the first dose of PNEUMOVAX 23 (lot # 665924/0930Z, expiration date 17-JUL-2011). Subsequently the patient developed adverse events of 3 to 4 inch swelling at injection site, rash and edema. The patient's 3 to 4 inch swelling at injection site, rash and edema persisted. The patient sought unspecified medical attention. The nurse reported that for two patients that vaccination was their first vaccination of PNEUMOVAX 23. It was also reported that the route of vaccination was IM for one patient and SC for two patients. The nurse requested a lot check. A lot check was initiated. This is one of several reports received from the same source. Additional information has been requested. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center of Biologics Evaluation and Research and was released.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 79 year old female with hypertension, diabetes and no drug reactions or allergies who "five years ago" (in approximately 2005), was vaccinated with a 0.5 mL first dose of PNEUMOVAX 23 (Lot # unknown), intramuscularly. On 05-OCT-2010, the patient was vaccinated with a 0.5 mL second dose of PNEUMOVAX 23 (Lot # 665708/0651Z, expire date 15-JUN-2011) intramuscularly in the right deltoid. Concomitant therapy included GLUCOPHAGE, alendronate sodium (MSD), lisinopril (manufacturer unknown), amlodipine, SYNTHROID and TRILIPIX, also reported as "TRILIPIDS". On 05-OCT-2010, 4 hours after receiving her second dose of PNEUMOVAX 23, the patient developed redness and hives at the injection site of the right upper arm. The patient sought medical attention; she was evaluated in the office on 08-OCT-2010. The right upper arm was red, painful, swollen and warm extending from the injection site distal to the elbow. The patient was afebrile. There were no laboratory diagnostics performed. At the time of the report; the patient's outcome was not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician concerning an over 65 year old female patient who on approximately 23-SEP-2010, "within last two weeks", was vaccinated with her first dose of PNEUMOVAX 23 (Lot # not reported). On an unspecified date the patient had "swelling of arm at injection site from PNEUMOVAX 23 therapy." No lab diagnostics studies performed. At the time of reporting, the patient's swelling of arm at the injection site was recovering. The patient did not seek medical attention. No further information is available.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a physician and a certified medical assistant concerning a 68 year old female patient with high cholesterol who on 06-OCT-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot# 665925/0932Z) and a dose of FLUARIX in the other arm. Another concomitant therapy included LIPITOR. The physician reported that on 07-OCT-2010, the patient experienced swelling and warmth on the arm the dose of PNEUMOVAX 23 was administered in. The certified medical assistant reported that the patient experienced no injection site reaction on the arm that was vaccinated with FLUARIX. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. The physician's office requested a lot check. This is one of two reports from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 665925/0932Z were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning an approximately 63 year old female who on 28-SEP-2010 was vaccinated with PNEUMOVAX 23 (Lot # not provided, route and injection site not reported). After administered of the vaccine, the patient experienced redness, pain and swelling at the injection site. The patient also experienced swelling of the arm. Outcome of the events were not reported. Follow-up information has been received from a medical assistant concerning the patient who had injection site reactions after vaccination with the same lot number (Lot # 667274/0883Z) of PNEUMOVAX 23. The patient had "severe" reactions consisting of red, hot, painful and swollen arms with the reaction extending from the injection site to elbow. Outcome of the events were not reported. This is one of several reports received from a same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning an approximately 67 year old female who on 30-SEP-2010 was vaccinated with PNEUMOVAX 23 (Lot # 667274/0883Z, route and injection site not reported). After administration of the vaccine, the patient experienced redness, pain and swelling at the injection site. The patient also experienced swelling of the arm. Outcome of the events were not reported. Follow-up information has been received from a medical assistant concerning the patient who had injection site reactions after vaccination with the same lot number (Lot # 667274/0883Z) of PNEUMOVAX 23. The patient had "severe" reactions consisting of red, hot, painful and swollen arms with the reaction extending from the injection site to elbow. Outcome of the events were not reported. This is one of several reports received from a same source. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 63 year old female who on 28-SEP-2010 was vaccinated with PNEUMOVAX 23 (Lot # 667274/0883Z, route and injection site not reported). After administration of the vaccine, the patient experienced redness, pain and swelling at the injection site. The patient also experienced swelling of the arm. Outcome of the events were not reported. Follow-up information has been received from a medical assistant concerning the patient who had injection site reactions after vaccination with the same lot number (Lot # 667274/0883Z) of PNEUMOVAX 23. The patient had "severe" reactions consisting of red, hot, painful and swollen arms with the reaction extending from the injection site to elbow. Outcome of the events were not reported. This is one of several reports received from a same source. Additional information has been requested.