chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site swelling, Malaise
Clinical narrative: Information has been received from a physician concerning an under 65 year old female with diabetes who was vaccinated with PNEUMOVAX vaccine. Subsequently, the patient experienced swelling at the injection site which went up the arm to her neck which the physician called quite remarkable. The area was hard to the touch and the patient experienced malaise. As of 05-NOV-2008 the patient was not recovered. The patient sought medical attention. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 50 year old female who on 05-NOV-2008 was vaccinated with dose of PNEUMOVAX (lot number 661065/1021X) (injection site and route not reported).  Subsequently the patient had a red raised spot around the injection site and experienced fever.  Unspecified medical attention was sought.  The outcome of the patient's experience was unknown.  This is one of several reports from the same source.  No further information is available.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with PNEUMOVAX (lot # not provided).  Secondary suspect therapy included influenza virus vaccine (unspecified) in the same arm on the same day.  After receiving the vaccination, the patient experienced swelling and redness in the area of the injection.  The patient sought medical attention.  The physician reported that she thought the patient might have cellulitis and did not believe the adverse events were vaccine-related.  At the time of the report, the outcome of the patient was unknown.  Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pain in extremity, Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX.  The nurse reported that the patient experienced swelling at the injection site, high fever, extreme pain and rash down her arm after getting PNEUMOVAX.  Subsequently, the patient recovered.  This is one of two reports received from the same source.  Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Cellulitis, Erythema, Pain, Skin warm
Clinical narrative: Information has been received from a woman at a medical clinic concerning a 63 year old female who on 26-SEP-2008 was vaccinated with a first dose of PNEUMOVAX 23 (lot # 658074/0961U) IM in left arm. Illness at the time of vaccination included fatigue, arthritis and bursitis. Concomitant therapy included vitamins (unspecified), omega-3 marine triglycerides, trazodone HCl, MOBIC. On 26-SEP-2008 the patient experienced arm cellulitis, red, swollen, painful, warm, tem 102 f. The patient sought medical attention at physician's office. Treatment included KEFLEX, 500 mg, TID for 10 days. Subsequently, the patient recovered on an unspecified date. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a woman at a medical clinic concerning a 63 year old female who on 26-SEP-2008 was vaccinated with a first dose of PNEUMOVAX 23 (lot # 658074/0961U) IM in left arm. Illness at the time of vaccination included fatigue, arthritis and bursitis. Concomitant therapy included vitamins (unspecified), omega-3 marine triglycerides, trazodone HCl, MOBIC. On 26-SEP-2008 the patient experienced arm cellulitis, red, swollen, painful, warm, tem 102 f. The patient sought medical attention at physician's office. Treatment included KEFLEX, 500 mg, TID for 10 days. Subsequently, the patient recovered on an unspecified date. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a 76 year old female with a rapid heart beat and allergic reaction to erythromycin and tetracycline who on 04-NOV-2008 was vaccinated with a dose of PNEUMOVAX 23 (lot # was not available). Concomitant therapy included a dose of influenza virus vaccine (unspecified), SYNTHROID and TOPROL XL TABLETS. Two hours later of the post-vaccination, the patient developed swelling on the injection site. The patient sought medical attention. As of 10-NOV-2008, the patient was recovering. No further information is available.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning herself, a 59 year old female with latex, iodine, HIBICLENS and Neomycin allergies, who was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (lot # not reported) about 2 years ago, approximately in 2006. On 11/03/2008, the patient was vaccinated intramuscularly with a second dose of PNEUMOVAX 23. There was no concomitant medication. On the same day the patient experienced redness, swelling, itching and pain at injection site in upper arm (period). She also experienced some dizziness. The patient sought medical attention, via phone call to a physician. The patient is taking BENADRYL and an anti-inflammatory medication for these symptoms. At the time of reporting, the patient was not recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Injection site reaction, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from an inventory manager concerning a female nurse who on 03-NOV-2008 was vaccinated with PNEUMOVAX 23. On 03-NOV-2008, the nurse developed a reaction. The nurse was seen at her physician's office in the morning of 04-NOV-2008. Additional information was received from a pharmacist concerning the nurse who on 03-NOV-2008, at 13:00, was vaccinated with PNEUMOVAX 23 (lot# 659199/1541U). It was unknown if the patient has received PNEUMOVAX 23 in the past. It was reported that influenza virus vaccine (unspecified) was given on 21-OCT-2008, 2 weeks ago. On 03-NOV-2008, within the hour of vaccination (by 14:00), the nurse experienced an "allergic reaction" at the injection site. Her left arm was swollen, burning and painful. The patient saw a physician at a clinic for follow-up but pharmacist did not know the physician's name. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Oral pruritus, Pruritus
Clinical narrative: Information has been received from a healthcare worker concerning a 52 year old female with allergy to soy products, sulfa, BACTRIM, CIPRO and LEVAQUIN and no illness at the time of vaccination who on 31-OCT-2008 was vaccinated with the first dose of PNEUMOVAX 23 (lot#: 660717/0224X) 0.5ml IM into the left deltoid. Concomitant therapy included flu vaccine and albuterol inhaler. After receiving the vaccination the patient experienced itching on her legs and mouth. Subsequently, the patient recovered from itching on her legs and mouth. Follow-up information was received from the healthcare worker. The healthcare worker indicated that the patient called on 03-NOV-2008 and stated she felt itching and wanted to know if the vaccine contained soy. the patient took BENADRYL to treat itching. The patient's itching lasted 1 day and recovered at the time reporting. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Information has been received from a nurse concerning a 63 year old female with cholesterol high, blood pressure high, lupus, arthritis, seizures and allergy to dye who in January 1999, was vaccinated with a dose of PNEUMOVAX 23, IM, 0.5 ml. In January 1999, the patient experienced injection site reaction, including erythema, warmth and swelling of the whole upper arm. The patient was instructed to apply a corticosteroid cream and wrap a hot towel around the arm covered by a plastic, twice a day. The patient recovered within a few days. The patient sought medical attention and was seen by the physician. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain in extremity, Sensory disturbance
Clinical narrative: Information has been received from an adult female who was vaccinated with PNEUMOVAX 23 (route not reported) in her left arm 1 week after receiving a flu shot in that arm. Since receiving the PNEUMOVAX 23 the patient had been experiencing pain in the injection arm from her armpit to her breast. The patient also had a "pulsating sensation in her foot near her ankle in a very distinct pattern". The patient's symptoms persisted. No further information is available.
Age: 67.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 67 year old female who on approximately 03-NOV-2008 was vaccinated with PNEUMOVAX 23, 0.5 ml. Concomitant therapy included influenza virus vaccine (unspecified). In November 2008, the patient developed a local swelling and redness at the injection site after receiving a dose of the vaccine. As of 10-NOV-2008, the patient was recovering. The patient was seen by the pharmacist. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 65 year old female with hypertension and joint discomfort who in December 2003 was vaccinated with a first dose of PNEUMOVAX 23 (lot number, injection site and route not reported). On 29-OCT-2008 the patient was vaccinated intramuscularly with a second dose of PNEUMOVAX 23 (lot # 657525/0554U) in the right deltoid and a dose of FLUZONE (lot number U2805AA) in the left deltoid. Concomitant therapy also included TENORMIN, glaucoma drops, hydrochlorothiazide (manufacturer unknown) and LILPITOR. The physician reported that the patient's blood pressure had been checked once or twice a week and remained stable. Three or four weeks ago actually got a bit low into the 90s. Five days ago she started on 50 mg of INDOCIN a day for some joint discomfort and coincident with that her BP jumped up into the 155 range systolic with normal diastolics. On the same day, within about 4-5 hours after receiving the vaccine, the patient experienced pain, swelling and erythema which had gradually involved the upper arm on the right side. She had not other systemic symptoms. On 31-OCT-2008, the patient visited the doctor's office. Physical examination showed that BP: 154/80, pulse 70 and regular. Lungs: clear. From just distal to the shoulder to approximately the elbow of the right arm, there was mild generalized erythema, mild warmth and some mild swelling. The physician stated that this was all consistent with a reaction to the PNEUMOVAX 23. The patient had been using TYLENOL and was prescribed BENADRYL 50 mg every 4 hours as needed, along with moist warm compresses. As of the reporting time, the patient recovered from the events. This is one of several reports received from the same source. All these patients developed reactions after receiving PNEUMOVAX 23 (lot # 657525/0554U) from the same multiple dose vial. A standard lot check investigation was performed. All in-process quality checks for the lot number 657525/0554U in question were satisfactory. The lot met the requirements of the center and was released. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Musculoskeletal pain, Oedema peripheral, Skin warm, Tenderness
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 70 year old female patient with reflux and hypertension who on 17-OCT-2008 was vaccinated intramuscularly with a dose of FLUZONE (U2805AA) in the right deltoid. On 23-OCT-2008, the patient was vaccinated intramuscularly with a first dose of PNEUMOVAX 23 (lot # 657525/0554U) in the left deltoid. Concomitant therapy included omeprazole (MSD), TOPROL XL TABLETS, hydrochlorothiazide (manufacturer unknown), calcium (unspecified) and vitamin D (unspecified). On 24-OCT-2008, the patient had a hot, red shoulder and upper arm. The patient said it was swollen from elbow to shoulder with sore and tender. The patient went to see the physician. The physician examined the patient and regarded the events as local reaction to injection. The physician advised the patient to have cool compress every 2 hours and was prescribed BENADRYL 50 mg every 4 hours. The physician also advised the patient to elevate and rest the arm. As of the reporting time, the patient recovered from the events. This is one of several reports received from the same source. All three patients developed reactions after receiving PNEUMOVAX 23 (lot # 657525/0554U) from the same multiple dose vial. A standard lot check investigation was performed. All in-process quality checks for the lot number 657525/0554U in question were satisfactory. The lot met the requirements of the center and was released. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a physician concerning a female who on an unknown date was vaccinated with PNEUMOVAX 23 (Lot # 660685/0619X) in the arm (dose, route not reported). Subsequently the patient developed cellulitis. It is unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a nurse practitioner concerning a 65 year old female who in 2000 was vaccinated with the first dose of PNEUMOVAX 23 with no problems. In 2005, the patient received a second dose of PNEUMOVAX 23 and developed what was described as an "allergic reaction". No specific details about the reaction was known. Subsequently, the patient recovered from allergic reaction. The adverse event was not reported to the physician at the time of the reaction. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a patient who was vaccinated with a dose of PNEUMOVAX 23 in the past. Subsequently the patient experienced a "reaction" from PNEUMOVAX 23. The nurse did not have much information and did not wish to participate in the AE reporting at this time. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered nurse concerning a 53 year old female patient with a medical history of cancer and no known drug reactions/allergies, who on 30-OCT-2008 was vaccinated with PNEUMOVAX 23 (Lot. 660717/0224X), 0.5ml, intramuscularly and experienced cellulitis in the arm of administration. At the time this report, the patient was recovering. The patient sought medical attention and was seen at the practice office. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Jaundice
Clinical narrative: Information has been received from a pharmacist, an adult female with a history of splenectomy at 28 years of age resulted from a car accident, who approximately in 1998 ("about 10 years ago") received the second dose of PNEUMOVAX 23 (lot number, route and injection site unknown). Subsequently the arm where she receiving the vaccine turned yellow, which looked like "jaundice of the arm". In an unspecified time period, her symptom resolved spontaneously. On 07-NOV-2008, she received her fourth dose of PNEUMOVAX 23 (lot number, route and injection site unknown), and subsequently experienced some redness and pain at the injection site which she still had at the time of reporting. The patient also reported that she had a total of 4 doses of PNEUMOVAX 23 administered every 5 years because she did not have a spleen. There were no problems with the first and third dose. She had sought medical attention in physician's office. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a patient who was vaccinated with a dose of PNEUMOVAX 23 (lot#662100/0742X with expiration date of 06-MAR-2010) on an unspecified date. There was no concomitant medication. Subsequently the patient experienced local injection site reactions on an unspecified date. At time of reporting, the outcome of the event was unknown. The patients sought unspecified medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure abnormal, Cellulitis, Heart rate normal, Oedema peripheral, Pain
Clinical narrative: Information has been received from a medical assistant concerning a 73 year old female patient who on 03-NOV-2008 was vaccinated with PNEUMOVAX 23 (Lot #662100/0742X), 0.5ml, intramuscularly and developed cellulitis of the whole arm, warm, sore to touch, and pink. The nurse reported this patient was seen in the office on 05-NOV-2008 and was given CLARITIN and ALEVE for pain, as needed. The nurse stated that they haven't heard back from the patient so they are assuming she recovered. A lot check has been requested by the medical assistant's office. A standard lot check investigation was performed. All in-process quality checks for the lot number 662100/0745X 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 and was released. Follow-up information has been received in the form of medical records on 15-Dec-2008, which indicated that the 73 year old female patient had a CODEINE allergy. On 03-NOV-2008, the patient was vaccinated with PNEUMOVAX 23 (Lot #662100/0742X), 0.5ml, on the right arm intramuscularly. On 05-NOV-2008 the patient developed a local allergic reaction including pain and swelling on the arm through the elbow. She also experience warm and sore to touch, pink, skin firmness, distal N/V/M intact. CLARITIN twice a day and ALEVE as needed were indicated. On an unknown date in 2008 the patient had recovered. Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Respiratory rate decreased, Skin discolouration, Skin warm
Clinical narrative: Information has been received from a medical assistant concerning a 73 year old female patient who on 03-NOV-2008 was vaccinated with PNEUMOVAX 23 (Lot #662100/0742X), 0.5ml, intramuscularly and developed cellulitis of the whole arm, warm, sore to touch, and pink. The nurse reported this patient was seen in the office on 05-NOV-2008 and was given CLARITIN and ALEVE for pain, as needed. The nurse stated that they haven't heard back from the patient so they are assuming she recovered. A lot check has been requested by the medical assistant's office. A standard lot check investigation was performed. All in-process quality checks for the lot number 662100/0745X 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 and was released. Follow-up information has been received in the form of medical records on 15-Dec-2008, which indicated that the 73 year old female patient had a CODEINE allergy. On 03-NOV-2008, the patient was vaccinated with PNEUMOVAX 23 (Lot #662100/0742X), 0.5ml, on the right arm intramuscularly. On 05-NOV-2008 the patient developed a local allergic reaction including pain and swelling on the arm through the elbow. She also experience warm and sore to touch, pink, skin firmness, distal N/V/M intact. CLARITIN twice a day and ALEVE as needed were indicated. On an unknown date in 2008 the patient had recovered. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local reaction, Oedema peripheral
Clinical narrative: Information has been received from a licensed practitioner nurse concerning a 72 year old female patient with diabetes, allergies to prednisone, cortisone, NEOSYNEPHRINE and BENTYL, who in 2003 was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included influenza virus vaccine (unspecified). On 10-NOV-2008 the patient experienced a localized reaction after receiving a second dose of PNEUMOVAX 23 (lot # 657143/0380U). The patient symptoms included redness and swelling of her arm, the patient called the doctor's office. The localized reaction, redness and swelling persisted. This is one of two reports received from the same source.. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: PPV, VARCEL
Symptoms: Expired drug administered, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old male with asthma and allergies to amoxicillin and CEFZIL who on 23-OCT-2008 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 intramuscularly, which had expired on 04-OCT-2008, and a dose of VARIVAX (MSD) subcutaneously, both in the left arm. Concomitant therapy included albuterol and montelukast sodium (MSD). On 24-OCT-2008, one day after vaccination, the patient developed a fever of 102 F and "a sore left arm". On 26-OCT-2008 the patient recovered from the fever and soreness without requiring treatment. No lab tests were performed. Unspecified medical attention was sought. Follow-up information was received from the registered nurse which reported that patient also had allergy to dust mites and no illness at time of vaccination. It was reported that on 23-OCT-2008 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # 655054/0749F) in the deltoid. The vaccine was expired on 04-OCT-2008. Because of only 10 days expiration, the Doctor of Medicine (MD) decided not to revaccinate. The patient was seen by the physician and mentioned that the arm was sore and had 102 fever for days. Additional information is not expected.
Age: 0.2
Sex: U
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a 2 month old infant who on 11-NOV-2008 was vaccinated with PNEUMOVAX 23, polyval, 0.5 ml via subcutaneous (lot # 9733401). The medical assistant stated that the office person that ordered the PREVNAR ordered PNEUMOVAX 23, polyval in error. The vaccine that was delivered to the office was PNEUMOVAX 23, polyval. The medical assistant stated that the PNEUMOVAX 23, polyval was originally placed where the office stored the PREVNAR. The medical assistant stated that the PNEUMOVAX 23, polyval was no longer stored where the PREVNAR was stored. The medical assistant stated that there was a sign to the PNEUMOVAX 23, polyval which stated that the vaccine was not to be used. No adverse effect was reported. No additional information was provided. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Musculoskeletal stiffness, Neck pain, Pyrexia, Rash, Somnolence
Clinical narrative: Information has been received from a registered pharmacist concerning a 60 to 65 year old male patient, with no known allergies, who on 07-NOV-2008 was vaccinated with a dose of PNEUMOVAX. Concomitant therapy included Influenza virus vaccine (unspecified). On 10-NOV-2008 the patient experienced painful stiff neck, fever and rash under his arm. The pharmacist said the patient's wife described these as "meningitis like symptoms". The patient was placed on OXYCONTIN for the pain with his stiff neck and BENADRYL for the rash. The physician did not diagnose meningitis. At the time of this report the patients fever was improved but the stiff neck and rash under his arm persisted. On 11-NOV-2008 the patient was sleepy but able to go to work. The patient sought medical attention through an office visit. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Initial information has been received from a healthcare worker and follow-up information was received from a physician concerning a 46 year old female who on 31-OCT-2008 was vaccinated with a dose of PNEUMOVAX (lot # 657143/0380U) intramuscularly. The patient had skin reactions after administration of PNEUMOVAX. The patient developed redness and pain in the injection arm. She had sore area a few inches across. On 17-NOV-2008, the patient was in the office and had recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 86.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Ultrasound Doppler
Clinical narrative: Information has been received from a registered nurse concerning an approximately 81 year old male with sulfonamide allergy and history of cardiovascular disorder who on 10-NOV-2008, was vaccinated with a 0.5 ml dose of PNEUMOVAX (LOT# 661577/1161X). Concomitant therapy included COUMADIN. On 10-NOV-2008 the patient experienced redness and swelling at the injection site. The registered nurse reported that 5 years ago the patient received PNEUMOVAX vaccine and experienced an unspecified adverse event. Also on an unspecified date a Doppler Reading Diagnostic test was performed with unknown result. The patient sought unspecified medical attention. At the time of the report the patient has not recovered. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 64 year old female patient who on 04-NOV-2008 at 10:00, was vaccinated with a dose of PNEUMOVAX (lot# 661529/0868X) into the left arm. The physician reported that after receiving pneumococcal vaccine, the patient experienced severe pain in her arm and redness (approximately 5 inches below injection site). The patient was treated with ZYRTEC 10mg every 12 hours, PRN and MEDROL 4 mg dose pack. The patient sought medical attention in doctor visit. This is one of two reports received from the same source. Additional information is not available.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a patient who was vaccinated with a dose of PNEUMOVAX (lot # 662100/0742X with expiration date of 06-MAR-2010) on an unspecified date. There was no concomitant medication. Subsequently the patient developed cellulitis on an unspecified date. At the time of reporting, the outcome of the event was unknown. The patient sought unspecified medical attention. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Arthralgia, Immobile, Injection site reaction
Clinical narrative: Information has been received from a pharmacist and a registered nurse concerning a patient who on an unspecified date was vaccinated with PNEUMOVAX (Lot# 660717/0224X) and developed injection site reaction. The pharmacist   stated that the reactions included joint pain and immobility and were "over and beyond soreness". The pharmacist reported that he was not sure if it was the first or the second dose for the patient. A lot check has been requested by the registered nurse. Follow up information was received via a telephone call from the registered nurse (R.N.) who reported that the patient did not go the the emergency room and was recovering (95% recovered)/ A standard lot check for the lot number in question were satisfactory. The lot met the requirements of the Center and was released. Additional information ahs been requested.
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Immobile, Injection site reaction
Clinical narrative: Information has been received from a pharmacist and a registered nurse concerning a patient who on an unspecified date was vaccinated with PNEUMOVAX (Lot # 660717/0224X) and developed injections site reactions. The pharmacist stated that the reactions included joint pain and immobility and were "over and beyond soreness". The pharmacist reported that he was not sure if it was the first or the second dose for the patient. A lot check has been requested by the registered nurse. Follow up information was received via a telephone call from the registered nurse (R.N.) who reported that the patient was a male and he fully recovered. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center and were released. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Swelling
Clinical narrative: Information has been received from a health professional concerning a patient who on unknown dates was vaccinated with PNEUMOVAX (lot #660685/0619X). The patient experienced pain, swelling and unable to lift arm after getting the vaccine. Unspecified medical attention was sought. The outcomes of the events were not reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Swelling
Clinical narrative: Information has been received from a health professional concerning a patient who on unknown dates was vaccinated with PNEUMOVAX (lot # 660685/0619X). The patient experienced pain, swelling and unable to lift arm after getting the vaccine. Unspecified medical attention was sought. The outcomes of the evnts were not reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Swelling
Clinical narrative: Information has been received from a health professional concerning a patient who on unknown dates was vaccinated with PNEUMOVAX. Lot number was not provided. The patient experienced pain, swelling and unable to lift the arm after getting the vaccine. Unspecified medical attention was sought. The outcomes of the events were not reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a pharm D. concerning a 59 year old female who in approximately 2006 "about 2 years ago" was vaccinated with PNEUMOVAX vaccine. After receiving the vaccine the patient experienced swelling of entire arm. On unknown date the patient recovered. No further information is available.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 71 year old female with no medical history or allergies who on 13-NOV-2008 was intramuscularly vaccinated with 0.5 ml dose of PNEUMOVAX (lot #661577/1161X). There was no concomitant medication. On 13-NOV-2008 the patient developed cellulitis below the injection site near the forearm after receiving PNEUMOVAX. At the time of reporting the patient did not recover. The patient was seen by the nurse for medical attention. This is one of several reports from the same source. A lot check was requested. A standard lot check investigation was performed. 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: 0.5
Sex: F
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a medical assistant /office manager concerning a 6 month old female who on 14-NOV-2008 was inadvertently vaccinated with 0.5 ml dose of PNEUMOVAX. IM in the thigh. This was a human error. No adverse effects reported. The patient sought medical attention at the office. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site haematoma, Injection site induration, Injection site swelling, Musculoskeletal pain
Clinical narrative: Information has been received from a nurse concerning a 53 year old female with DARVOCET allergy history and no medical history who on 13-NOV-2008 was subcutaneously vaccinated with 0.5 ml dose of PNEUMOVAX (lot number #661065/1021X). Concomitant therapy included influenza virus vaccine (unspecified). On 13-NOV-2008, after receiving PNEUMOVAX, the patient developed red and swelling area approximately two inch in diameter at the injection site. The area was also hard and bruised. The patient was radiated from her arm onto her shoulder. The outcome was recovering. The patient sought medical attention by calling the office. This is one of 3 cases from the same source. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 35 year old female with allergy to nortriptyline and no pertinent medical history who on 03-NOV-2008 was vaccinated SC with a 0.5 ml dose of PNEUMOVAX (lot # 662662/0979X). Concomitant therapy included influenza virus vaccine (unspecified). On the same day, the patient developed swelling, redness and tenderness at the injection site. The patient was recovering from swelling, redness and tenderness at the injection site. No lab tests were performed. The patient called the office and sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site anaesthesia, Injection site erythema, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 62 year old female with sulfonamide allergy, allergy to tetanus toxoid and no pertinent medical history who on 04-NOV-2008 was vaccinated SC with a 0.5 ml dose of PNEUMOVAX *lot # 661065/1021X). Concomitant therapy included influenza virus vaccine (unspecified). On the same day, the patient developed numbness and redness at the injection site. She had to go to an emergency room because she also had 102 degrees F fever. At the time of this report, the patient was recovering. No lab tests were performed. This is one of several reports received from the same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Initial and follow-up information has been received from a pharmacist concerning a 70 year old female who on 20-OCT-2008 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX (Lot# 660717/0224X), which was the recalled lot from a health care supplier. On 21-OCT-2008 the patient experienced redness and pain at the injection site. The arm was hot to touch and sore. Subsequently, the patient recovered from redness and pain at the injection site. No lab tests were performed. The patient consulted with the pharmacist and sought unspecified medical attention. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with PNEUMOVAX.  A nurse told the pharmacist that the patient had to go to an emergency room because the axillary lymph nodes were swollen.  At the time of this report, the outcome was unknown.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Lethargy
Clinical narrative: Information has been received from a consumer concerning his 30 year old wife with asthma and seasonal allergies who on 14-NOV-2008 was vaccinated with PNEUMOVAX (lot# not provided).  Concomitant therapy included montelukast sodium (MSD), rizatriptan benzoate (MSD), influenza virus vaccine (unspecified) at the same time, PULMICORT.  On 17-NOV-2008 the patient became lethargic and experienced malaise.  The injection site was red, warm to touch, extremely sore, raised, and swollen.  The patient's symptoms persisted.  The patient did not seek medical attention.  Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Malaise
Clinical narrative: Information has been received from a consumer concerning his 30 year old wife with asthma and seasonal allergies who on 14-NOV-2008 was vaccinated with PNEUMOVAX (lot# not provided).  Concomitant therapy included montelukast sodium (MSD), rizatriptan benzoate (MSD), influenza virus vaccine (unspecified) at the same time, PULMICORT.  On 17-NOV-2008 the patient became lethargic and experienced malaise.  The injection site was red, warm to touch, extremely sore, raised, and swollen.  The patient's symptoms persisted.  The patient did not seek medical attention.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Tenderness
Clinical narrative: Information has been received from a physician concerning a 65 year old female with hypertension, lipids increased, osteoporosis and penicillin allergy who on 10-NOV-2008 was vaccinated with PNEUMOVAX. Concomitant therapy included lisinopril (manufacturer unknown), lovastatin (manufacturer unknown), potassium (unspecified) and alendronate sodium. Within a few hours after the vaccination the patient began to develop pain at injection site. The pain has persisted and the patient was seen by the physician on17-NOV-2008. No redness or swelling was noted. The physician mentioned that the patient had tenderness upon palpation and had difficulty moving her arm to remove her jacket. At the time of this report, the patient was recovering from the adverse events. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: Initial information has been received from a healthcare worker and follow-up information was received from a physician concerning a 84 year old female who on 31-OCT-2008 was vaccinated with a dose of PNEUMOVAX (lot # 657143/0380U) intramuscularly.  The patient had skin reactions after administration of PNEUMOVAX.  The patient developed redness and pain in the injection arm.  She had a sore area a few inches across.  On 17-NOV-2008, the patient was in the office and had recovered.  This is one of several reports received from the same source.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a mid thirties old female patient with no pertinent medical history and no known allergies who on 12-NOV-2008 was vaccinated intradermally (lot # 659199/1541U). There was no concomitant medication. On 14-NOV-2008 the patient experienced soreness, swelling and erythema at the injection site. No lab diagnostics studies were performed. The patient's sought unspecified medical attention. No further information is available.
Age: 7.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from an office manager concerning a 7-year-old female patient with no relevant medical history nor drug allergies, who on 05-NOV-2008 was vaccinated IM with a dose of 0.5 ml PNEUMOVAX (lot number unknown) in the right deltoid. There was no concomitant therapy. Subsequently (date not specified) she experienced swelling and tenderness at the injection site. The patient was seen in the office on 08-NOV-208 and was prescribed (AUGMENTIN). No laboratory test were performed. The patient has recovered on an unspecified date. This is one of several reports received from the same source. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from an office manager concerning a 6 year old female patient with asthma, no drug reactions/allergies, not immunocompromised, who on 13-OCT-2008 was vaccinated with intramuscularly with a 0.5 mL dose of PNEUMOVAX vaccine because according to the physician had risk of developing pneumonia. There was no concomitant medication. On 15-OCT-2008 the patient developed swelling, warmth and tenderness at the injection site of the left deltoid. The patient was seen in the office on 15-OCT-2008 and was prescribed OMNICEF. The patient had recovered. This is one case of several cases from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered nurse concerning two patients who on an unspecified date were vaccinated with a dose of PNEUMOVAX (lot #661577/1161X). Subsequently the patients developed cellulitis below the injection site near the forearm after receiving PNEUMOVAX on unspecified dates. The Outcomes were unknown. This is one of several reports from the same source. A lot check was requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Agency and was released. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a certified medical assistant concerning a 67 year old male patient with hypertension, Raynaud's syndrome, arthritis and hypercholesterolaemia.  Who on 1998 was vaccinated with 0.5 ml of a dose of PNEUMOVAX (I.M.) (Lot#:  661528/0867X).  Subsequently, the patient developed redness, swelling, and pain of his arm at the injection site.  The patient also experience a fever with a temperature of 100 degrees F.  The patient sought medical attention by phone and was treated with TYLENOL (manufacturer unknown).  At the time of reporting, the outcome of the patient experiences was unknown.  Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a male patient in his late 40's to late 50's with asthma and chronic obstructive pulmonary disease who was vaccinated with PNEUMOVAX (lot# 658449/0989U). Subsequently the patient experienced injection site reactions which included redness, induration and swelling. Physician states "It was almost like it was a cellulitis reaction". It is unspecified if the patient received PNEUMOVAX in the past because the patient could not recall their vaccination history. The patient was sent to the emergency room. No hospitalization required. Subsequently the patient recovered. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: This report was received from Sanofi Aventis concerning a patient who on an unknown date was vaccinated with PNEUMOVAX (site and route of administration was not reported). On an unknown date the patient experienced allergy to PNEUMOVAX. The outcome was not reported. Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a male patient in his late 40's to late 50's who was vaccinated with PNEUMOVAX (lot # 658449/0989U). Subsequently the patient experienced injection site reaction which included redness, induration and swelling. Physician states "It was almost like it was a cellulitis reaction". It is unspecified if the patient received PNEUMOVAX in the past because the patient could not recall their vaccination history. The patient was told to take BENADRYL, CLARITIN, PEPCID, MOTRIN or TYLENOL and to elevate his arm. No hospitalization required. Subsequently the patient recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site mass, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a female patient with asthma and graves' disease and no known drug allergies.  who in September 2008 was vaccinated intramuscularly with a 0.5mL dose of PNEUMOVAX.  Concomitant therapy included LEVOXYL, ADVAIR and NASONEX.  "24 hours after vaccination", the patient developed redness and swelling at the injection site.  It was reported that the patient had a bump at the injection site the size of a golf ball.  She had a fever of 101F.  The symptoms resolved within a couple of days.  The patient reported these adverse events during a different visit. This is one of two cases from the same source.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: Information has been received from a physician assistant concerning a 67 year old female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX (no lot # was provided). It was reported that the patient developed "pneumonia" after getting the PNEUMOVAX. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Ecchymosis, Nausea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Information has been received from a nurse concerning a 49 year old female patient with immunosupression who on 11-NOV-2008 was vaccinated with a dose of PNEUMOVAX (lot # not provided) and was vaccinated on the same day and on the same arm with a dose of (FLUVIRIN). On 11-NOV-2008, six hour post vaccination, the patient experienced nausea, fever, vomiting, soreness of arm and a developed a 4 by 3 cm ecchymosis with no erythema in upper right arm. It was reported that the patient sought medical attention at a different clinic due to the reaction she was experiencing with the vaccination, and was told in the urgent care clinic that the PNEUMOVAX vaccine and the FLUVIRIN should have been given in different arms. Nurse reported that the patient might seek legal action against the physician's office who gave the vaccinations. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Asthma, Condition aggravated, Nonspecific reaction
Clinical narrative: Information has been received from a licensed practical nurse concerning an unidentified patient with asthma who was vaccinated with a dose of PNEUMOVAX. It was reported that the patient had a reaction after getting PNEUMOVAX. The patient had an asthma attack after getting PNEUMOVAX. No details were available on this patient. This is one of two cases from the same source. Additional information has been requested.