chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a registered pharmacist concerning a 68 year old female patient, who on 25-OCT-2010 was vaccinated IM with a dose of PNEUMOVAX 23 (Lot # not reported). On 27-OCT-2010 the patient developed a large red area about the size of a coffee cup around the injection site. The reporter did not know if there was any pain or warmth. The patient sought unspecified medical attention. At the time of the report the patient had not recovered. No further information is available.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Hyperaesthesia, Injection site pain, Injection site swelling, Sleep disorder
Clinical narrative: Information has been received from a pharmacist concerning a 53 year old female with penicillin allergy who on 21-OCT-2010 was vaccinated (IM) with 0.5 ml PNEUMOVAX 23 (lot# 667912/0933Z, expiration date 25-FEB-2012) on right deltoid. There was no concomitant medication. On 21-OCT-2010 the patient experienced swelling and pain in her right upper arm to her elbow. The pain interfered with her sleep and her arm is sensitive to touch. The patient treated her arm with an alcohol wrap. No lab/diagnostics studies were performed. The patient sought unspecified medical attention. The patient was recovering from the events. This is one of several reports received from the same source. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 77 year old female patient with no illness at the time of vaccination who on 22-DEC-2010 was vaccinated with a dose of PNEUMOVAX 23 (dose and Lot # not reported), IM, right lower deltoid, and a dose of ADACEL, IM, right deltoid. The nurse stated that on 23-DEC-2010 the patient experienced right arm pain, swelling, red and tender where ADACEL was given, patient was treated with KEFLEX 500 mg three times a day for 10 days, prednisone 20 mg daily for 5 days. There were no laboratories diagnostics performed. At the time of the report the patient had recovered from these symptoms. The patient sought medical attention emergency room / doctor visit. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse and a pharmacist concerning an approximately 67 year old female patient who on 11-OCT-2010 was vaccinated intramuscularly with a 0.5ml dose of PNEUMOVAX 23 (lot#667912/0933Z). On 14-OCT-2010 the patient returned to the practice complaining of chills, swelling and tenderness below the injection site. Nurse reported that the physician stated that the swelling appeared to be consistent with cellulitis, and that he started the patient an unspecified dose of MINOCIN. At the time of this report, the patient's outcome was not reported. The physician is concerned about this lot number and was hesitant to give other vaccinations with the same lot number. The physician requested a lot check. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information has been received from the registered nurse concerning a 67 year old male (previously reported as female) patient with no other pertinent medical history who on 11-OCT-2010 was vaccinated intramuscularly with a 0.5ml dose of PNEUMOVAX 23 (lot#667912/0933Z) into the right deltoid and a dose of FLUZONE (lot#M3654AA) into the left arm. There was no illness at time of vaccination. On 14-OCT-2010 the patient developed red, swollen and tender from injection site to elbow. He was diagnosed with cellulitis. There were no diagnostics laboratory studies performed. On 20-OCT-2010, the patient recovered. This is one of several reports from the same source. Additional information is not expected.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Swelling, Tenderness
Clinical narrative: Information has been received from a registered nurse and a pharmacist concerning an approximately 67 year old female patient who on 11-OCT-2010 was vaccinated intramuscularly with a 0.5ml dose of PNEUMOVAX 23 (lot#667912/0933Z). On 14-OCT-2010 the patient returned to the practice complaining of chills, swelling and tenderness below the injection site. Nurse reported that the physician stated that the swelling appeared to be consistent with cellulitis, and that he started the patient an unspecified dose of MINOCIN. At the time of this report, the patient's outcome was not reported. The physician is concerned about this lot number and was hesitant to give other vaccinations with the same lot number. The physician requested a lot check. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information has been received from the registered nurse concerning a 67 year old male (previously reported as female) patient with no other pertinent medical history who on 11-OCT-2010 was vaccinated intramuscularly with a 0.5ml dose of PNEUMOVAX 23 (lot#667912/0933Z) into the right deltoid and a dose of FLUZONE (lot#M3654AA) into the left arm. There was no illness at time of vaccination. On 14-OCT-2010 the patient developed red, swollen and tender from injection site to elbow. He was diagnosed with cellulitis. There were no diagnostics laboratory studies performed. On 20-OCT-2010, the patient recovered. This is one of several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a Registered Nurse concerning a female patient with drug reaction/allergy to: AUGMENTIN, VICODIN, niacin, AMBIEN, BIAXIN, WELCHOL, hydrochlorothiazide (manufacturer unknown), montelukast sodium, and unspecified statins; who on 24-JAN-2011 was vaccinated intramuscularly with the first dose of PNEUMOVAX 23 (lot # 667995/1150Z expiration date: 04-MAR-2012). Subsequently the patient experienced injection site reaction of pain, swelling and warmth. Patient was given antimicrobial (unspecified). Subsequently, the patient recovered from injection site reaction of pain, injection site swelling and injection site warmth. By nurse's request, a lot check has been initiated. 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. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a Registered Nurse concerning a male patient who on 27-JAN-2011 was vaccinated intramuscularly in the arm with the first dose of PNEUMOVAX 23 (lot #667995/1150Z expiration date: 04-MAR-2012). Subsequently the patient experienced soreness at the injected arm. No treatment needed to be given. At the time of the report patient had recovered. It was unspecified if patient sought medical attention. By nurse's request, a lot check has been initiated. 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 in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a consumer concerning her husband, who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported). The consumer stated that the patient had experienced pain and swelling at the injection site after being vaccinated with PNEUMOVAX 23. At the time of the report, the patient's outcome was unknown. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, Injection site pain, Injection site reaction, Pain in extremity
Clinical narrative: Information has been received from a medical assistant concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot# not reported) that after delivered, had sat on the counter overnight and for half the next day before it was refrigerated. Subsequently, the patient complained of muscle soreness at the injection site and painful arm. The patient mentioned it on their next office visit. It was unknown if the patient sought medical attention. On an unspecified date the patient recovered. The medical assistant contacted during telephone follow-up could not supply the following information: patient name, date of birth, date of vaccination, lot number or date of event. This is one of several reports received from the same source. No further information is available.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mass, Urticaria
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 57 year old female with no drug reactions who on 23-OCT-2010 was vaccinated IM with PNEUMOVAX 23 0.5ml (lot # 667912/0933Z) on her left arm. A pharmacist reported that a patient developed 2 red welts "under her left arm" after receiving a dose. On 24-OCT-2010 the patient developed 2 red welts "under her left arm" after receiving a dose of PNEUMOVAX 23 in that same arm. The pharmacist reported that this was not at the injection site. The patient told the pharmacist that she noticed the welts on 24-OCT-2010. On 25-OCT-2010 after the original report was filled, the patient called back to say that she got a red lump about 3 inches below the welts that she originally reported. The patient took BENADRYL and the lump and the welts resolved. The patient sought medical attention by phone call. There were no laboratories diagnostics studies performed. This one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Information has been received from a pharmacist concerning a patient who on 14-FEB-2011 was vaccinated with PNEUMOVAX 23, 0.5ml, intramuscular, lot no. 667695/1028Z, it is unknown if the patient received PNEUMOVAX 23 in the past. On approximately 15-FEB-2011 the patient experienced injection site reaction with large red welts. The patient sought medical attention via telephone call, and would office visit the next day. At the time of report, the patient's symptoms persisted. The pharmacist was requesting a lot check. This one of two 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: 0.2
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a Registered Nurse concerning a 62 day patient who on 01-MAR-2011 was vaccinated with a dose of PNEUMOVAX 23 (route and lot# unspecified) instead of a dose of PREVNAR. No adverse events were reported. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect route of drug administration, Injection site erythema, Product packaging issue
Clinical narrative: Information has been received from a registered nurse concerning a 52 year old female patient, who on 25-OCT-2010 was vaccinated with PNEUMOVAX 23 (lot # 665400/1315Y), 0.1 ml, intradermally. On 26-OCT-2010 the patient came back to the office with a flat, red area at the injection site. The nurse stated that she thought she was giving the PPD (purified protein derivative) skin test for tuberculosis screening. She stated that the vials for these 2 products are similar as they are the "same height" and that one vial was "on top of the other one". The patient sought medical attention by an office visit. At the time of the report, the patient was not recovered from a flat, red area at the injection site. There were no laboratories diagnostics studies performed. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Seroconversion test negative
Clinical narrative: Information has been received from a physician concerning a 64 year old female with immunodeficiency who was vaccinated with two dose of PNEUMOVAX 23 without sero-converting. Physician also mentioned the patient received PREVNAR with no seroconversion. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pain, Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a young female who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23. On an unknown date, the patient experienced localized pain and swelling at the site of the injection. The outcome of the patient was unknown. It was unknown if the patient sought unspecified medical attention. Follow-up information has been received from a pharmacist concerning herself, a 26 year old female with asthma and environmental allergy and no illness at time of vaccination who at 17:00 on 30-SEP-2010 was vaccinated with the first dose of PNEUMOVAX 23 (Lot number: 665924/0930Z) into her right upper arm. On 30-SEP-2010 at 17:00 the patient experienced severe pain in right arm radiating from right shoulder to wrist. None of lab diagnostics studies performed. There was no adverse event following prior vaccination. The patient did not seek medical attention. The patient was given naproxen and heat for treatment. On 04-OCT-2010, the patient recovered. This is one of two reports received from the same source. No further information is available.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Information has been received from a registered nurse concerning an approximately 46 year old female with a history of Tetralogy of Fallot repair at age 9, bundle branch block right, mitral valve regurgitation, unspecified thyroid disorder and fibromyalgia who on 11-OCT-2010 was vaccinated intramuscularly with a 0.5ml dose PNEUMOVAX 23 (lot#667912/0933Z). On 12-OCT-2010 the patient returned to the practice complaining of swelling and tenderness below the injection site. Nurse reported that examination of the arm revealed a 4.5 cm erythematous area, slightly raised, with well defined borders. There were no laboratory diagnostics studies performed. At the time of this report, the patient's outcome was recovering. Physician's office would like a lot check. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 667912/0933Z were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information has been received from the registered nurse concerning the 46 year old female patient with no illness at time of vaccination, no preexisting allergies, birth defects or medical conditions and no adverse events following prior vaccination. The nurse reported that on 12-OCT-2010, the patient experienced local erythema. On 16-OCT-2010, the patient recovered from local erythema. There were no laboratory tests or diagnostic studies performed. This is one of several reports from the same source. No further information is available.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician's assistant (PA) student concerning a female who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (no lot number or expiration date provided). Suspect vaccine include dose of ZOSTAVAX (Merck) concomitantly (no lot number or expiration date provided). After receiving that, the patient experienced itching, swelling, redness, and heat at the injection site. It was not specified if the injections were administered in different arm or the same arm/injection site. It was reported that the patient did not received treatment for the adverse events. It was unknown if the patient sought medical attention. At time of the report, the patient's outcome was unknown. No additional information is available.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 61 year old female patient who "5 years ago", in October 2005, was vaccinated with the first dose of PNEUMOVAX 23 without reaction. On 20-OCT-2010, the patient was vaccinated with a second dose of PNEUMOVAX 23 (lot # reported as 667913/1021Z). The patient called the next day to say that she had a severe reaction. The patient was seen and the caller the patient as looking "like she had pancake under the flesh of her arm all around injection site". The patient was treated and was recovering at the time of the report. 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 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: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse (R.N) concerning a 60 year old female patient who on 15-OCT-2010 was vaccinated into her right deltoid with a 0.5mL dose of PNEUMOVAX 23 (lot number 664653/1337Y; expiration date: 03-MAR-2011). The nurse stated that the patient experienced pain and swelling at the injection site. On 19-OCT-2010 patient was seen at the doctor's office and on 20-OCT-2010 she went to the emergency room. The patient was treated with antibiotic and released (she was not hospitalized). At the time of report, the patient's outcome was unknown. This is one of several reports from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Headache, Nausea, Pyrexia, Rash, Vomiting
Clinical narrative: Information has been received from a pharmacist concerning a patient with asthma who on 26-OCT-2010 was vaccinated with a single injection of PNEUMOVAX 23 (lot# 667418/0978Z). Subsequently the patient experienced fever, rash, headache, nausea and vomiting. The patient experienced these side effects for 3 to 4 days after the initial injection. This is one of several reports received from the same source. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local reaction, Skin warm, Swelling, Urticaria
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 23 (lot # and expire date not reported) (dose and route not reported). On an unspecified date, the patient experienced a localized reaction, which included redness, warmth and swelling. This reaction was considered severe by the nurse. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. Follow up information has been received from the registered nurse who indicated that the patient was a 75 year old female retired (registered nurse) allergic to penicillin who on 27-OCT-2009, was vaccinated IM with the first dose of PNEUMOVAX 23 (Lot # 664654/0823Y). Concomitant vaccinations included a dose of Flu (manufacturer unspecified) "received after work". According to the reporting registered nurse, the patient was seen on 30-OCT-2009, she had a right deltoid area of 6cmx11cm approximately which was pink, blanched easily and had some urticaria. It was not raised. The patient called on 31-OCT-2009, she had improved on her own. Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Local swelling
Clinical narrative: Information has been received from a doctor of pharmacy concerning a male patient, who on 08-FEB-2011 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 667690/1158Z). The pharmacist reported that on 08-FEB-2011 the patient developed local swelling after receiving PNEUMOVAX 23. At the time of the report, the patient's outcome was unknown. This is one of several reports received from the same source. No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a Registered Nurse concerning a female patient with allergy to penicillin and sulfa, who on 24-JAN-2011 was vaccinated subcutaneously with the first dose of PNEUMOVAX 23 (lot #665903/1427Y expiration date: 07-MAR-2012). Subsequently the patient experienced injection site reaction of pain, swelling and warmth. Patient was given antimicrobials (unspecified). At the time of the report patient had recovered. 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 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: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Information has been received from a pharmacist concerning a 68 year old male with hypertension, hypercholesterolaemia and asthma who was in patient at the hospital for 24 hour observation, due to other health care related problems (chest pains, cardiac workup). Before being discharged on 29-DEC-2010 the patient was vaccinated with a subcutaneous PNEUMOVAX 23 in the abdomen. Concomitant therapy included MIRAPEX, PLAVIX, NORVASC, montelukast sodium (MSD), LOPRESSOR and corticosteroids (unspecified). In approximately December 2010, the patient's abdomen was red, hot and firm. the erythema went from navel to groin and around to the backside. Patient's primary care physician was contacted and the patient was treated with BENADRYL and ibuprofen as needed. On 03-Jan-2011, patient was better, recovering, but some redness persisted. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Information has been received from a pharmacist (Pharm.D.) concerning a patient who on an unknown date, was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot# not reported). Subsequently the patient experienced urticaria. It was unknown if the patient sought medical attention. At the time of reporting, the outcome was unknown. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Injection site pain, Lymphadenopathy, Pain
Clinical narrative: Information has been received from a 78 year old female patient with no pertinent medical history and allergy to sulfonamides and meperidine hydrochloride who "2 months ago" on approximately 06-NOV-2010 was vaccinated with the first 0.5 ml dose, subcutaneously into the right upper arm of PNEUMOVAX 23 (Lot # not reported). There was no concomitant medication. The consumer reported that she developed soreness at the injection site of the right upper arm a few days after administration. The patient then developed throbbing at the injection site and a "burning feeling" at the right shoulder. On approximately 06-DEC-2010, one month after vaccination, the patient was evaluated by her physician. A "lump" on the top of the patient's right forearm was diagnosed as an enlarged lymph node. No therapy was prescribed but the physician was considering to referral to an unspecified orthopedic specialist. At the time of the report, the patient had not recovered. No laboratory tests were performed. The patient sought medical attention by visiting the physician's office. Follow up information received from patient's daughter who indicated that patient was still experiencing severe pain in her right arm at the PNEUMOVAX 23 injection site. No further information is available.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a healthcare worker concerning a 72 year old female who on 23-DEC-2010 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (667695/1028Z). On an unspecified date the patient experienced redness, swelling and warmth at the injection site (on the arm). At the time of the report, the patient's status was unknown. The patient sought medical attention by office visit. The physician was not comfortable using the remaining doses of PNEUMOVAX 23. The reporter requested a lot check. A lot check has been initiated. 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 in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a medical assistant concerning an old male patient in his 50s who was vaccinated with PNEUMOVAX 23. The patient experienced a cellulitis reaction after being administered PNEUMOVAX 23. The patient was on methotrexate. Therapy was discontinued. The patient was recovered a week later from the cellulitis reaction. The patient did not seek medical attention. Follow up information was received concerning the patient with no illness at time of vaccination and pre-existing allergies, birth defects, medical conditions unknown who vaccinated with PNEUMOVAX 23 (exp. 03-JAN-2012) IM on deltoid. The patient experienced edema and redness to the arm below the injection site which cleaned within 1 week. No further information is available. This is one of several reports received from the same source.
Sex: U
Vaccine: PPV
Symptoms: Axillary pain, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who on 11-OCT-2010 was vaccinated with PNEUMOVAX 23 0.5 ml IM (LOT # 664556/1307Y, EXP 21-JAN-2011). The patient experienced injection site swelling and pain. Follow up information from the nurse practitioner who reported that apparently the patient encountered severe injection-site reactions (redness, swelling pain radiating to the armpit and difficulty moving the arm on the patient) after vaccination which eventually improved. The clinic would like Merck to initiate an investigation of this lot but they would not use the lot unless Merck checked it again. This is one of several reports received from the same source. At the time of the report, the patient was recovering. The nurse requested a lot check. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question (lot # 664556/1307Y) were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a female patient (now 68 years old) with osteoporosis, asthma, environmental allergies, drug allergy to erythromycin and ketamine, dust allergy and mold allergy and a history of stroke two and a half years ago who in the 1970's was vaccinated with PPV 23 vaccine (manufacturer unknown, reported as a "pneumonia vaccine", lot # not reported). Concomitant therapy included PREVACID, famotidine (MSD), baby aspirin, CELEXA, EVISTA and montelukast sodium (MSD). Subsequently the patient experienced redness and swelling of her arm at the injection site. No treatment was given to the patient. Lab diagnostics studies were not performed. Subsequently, the patient recovered from the adverse events. The patient had sought unspecified medical attention. The patient also reported that she experienced redness and swelling of her arm at the injection site after receiving the "flu vaccine" (on multiple occasions). The last time she received a flu vaccine (in the 1970's) she developed bronchitis and was hospitalized. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV, TTOX
Symptoms: Arthralgia, Erythema, Injected limb mobility decreased, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a medical assistant concerning a 65 year old male with no drug reaction/allergies and no pertinent medical history, who on 04-JAN-2011 was intramuscularly vaccinated in his left arm with a first dose of PNEUMOVAX 23 (dose not reported, lot # 667690/1158Z). Concomitant therapy included tetanus injection in the right arm. On 04-JAN-2011 the patient had a severe injection site reaction after vaccination with PNEUMOVAX 23. The patient had severe swelling and soreness of his left arm and could not lift his arm. He also had a fever of 102.1F and joint pain. The patient was applied ice to the arm and was taken TYLENOL. No diagnostic laboratory tests were performed. At the time of this report, the patient's status was not recovered. The patient sought medical attention by office visit. Follow-up information was received from a medical assistant concerning the patient who with no known drug allergy on 04-JAN-2011 was vaccinated in his left deltoid with the first dose of PNEUMOVAX 23. The patient had no illness at time of vaccination. After 10 minutes injection given, the patient experienced pain in deltoid area, redness, fever, swelling and unable to lift arm. The patient was seen for systems on 05-JAN-2011 and resolved on 07-JAN-2011 "3 days later". Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: PPV, TTOX
Symptoms: Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 65 year old male with no drug reaction/allergies and no pertinent medical history, who on 04-JAN-2011 was intramuscularly vaccinated in his left arm with a first dose of PNEUMOVAX 23 (dose not reported, lot # 667690/1158Z). Concomitant therapy included tetanus injection in the right arm. On 04-JAN-2011 the patient had a severe injection site reaction after vaccination with PNEUMOVAX 23. The patient had severe swelling and soreness of his left arm and could not lift his arm. He also had a fever of 102.1F and joint pain. The patient was applied ice to the arm and was taken TYLENOL. No diagnostic laboratory tests were performed. At the time of this report, the patient's status was not recovered. The patient sought medical attention by office visit. Follow-up information was received from a medical assistant concerning the patient who with no known drug allergy on 04-JAN-2011 was vaccinated in his left deltoid with the first dose of PNEUMOVAX 23. The patient had no illness at time of vaccination. After 10 minutes injection given, the patient experienced pain in deltoid area, redness, fever, swelling and unable to lift arm. The patient was seen for systems on 05-JAN-2011 and resolved on 07-JAN-2011 "3 days later". Additional information is not expected.
Age: 51.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a 51 year old male with a cardiac history with surgery and no drug reaction or allergies who on 06-OCT-2010 was vaccinated with PNEUMOVAX 23 (lot # 667418/0978Z, expiration date 21-DEC-2011). This was the first time the patient received PNEUMOVAX 23. Concomitant therapy included atenolol, lisinopril (manufacturer unknown), ezetimibe (+) simvastatin and CLARINEX. On 07-OCT-2010 the patient experienced arm pain and swelling with 2 raised red areas. One area was 1 cm x 1.5 cm at the injection site. One inch to the left was the second area which was 8 cm x 9 cm raised, warm and red. He was seen in the office on 07-OCT-2010, 08-OCT-2010 and on 11-OCT-2010. The patient was treated with TYLENOL and ice. No lab/diagnostics studies were performed. On 10-OCT-2010 the patient recovered from the events. Follow up information was received from the Registered Nurse (R.N.) who reported that on 05-OCT-2010 (previously reported as 06-OCT-2010), at 13:50 pm, the 51 year old male patient was vaccinated with the first dose of PNEUMOVAX 23 (lot # 667418/0978Z) intramuscularly into the right deltoid. The patient also received on the same day, at 13:50pm, concomitantly the first dose of AFLURIA (Lot # reported as 11049121A) intramuscularly into the left deltoid. It was reported that on 06-OCT-2010, previously reported as 07-OCT-2010, the patient experienced 1cm x 1.5 cm redness at injection site to left of injection site 8cm x 9 cm redness and heat raised. The patient also complained of pain at site. It was reported that the patient recovered on 10-OCT-2010. It was reported that the patient did not seek medical attention. No further information is available.
Age: 51.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a nurse concerning a 51 year old male with a cardiac history with surgery and no drug reaction or allergies who on 06-OCT-2010 was vaccinated with PNEUMOVAX 23 (lot # 667418/0978Z, expiration date 21-DEC-2011). This was the first time the patient received PNEUMOVAX 23. Concomitant therapy included atenolol, lisinopril (manufacturer unknown), ezetimibe (+) simvastatin and CLARINEX. On 07-OCT-2010 the patient experienced arm pain and swelling with 2 raised red areas. One area was 1 cm x 1.5 cm at the injection site. One inch to the left was the second area which was 8 cm x 9 cm raised, warm and red. He was seen in the office on 07-OCT-2010, 08-OCT-2010 and on 11-OCT-2010. The patient was treated with TYLENOL and ice. No lab/diagnostics studies were performed. On 10-OCT-2010 the patient recovered from the events. Follow up information was received from the Registered Nurse (R.N.) who reported that on 05-OCT-2010 (previously reported as 06-OCT-2010), at 13:50 pm, the 51 year old male patient was vaccinated with the first dose of PNEUMOVAX 23 (lot # 667418/0978Z) intramuscularly into the right deltoid. The patient also received on the same day, at 13:50pm, concomitantly the first dose of AFLURIA (Lot # reported as 11049121A) intramuscularly into the left deltoid. It was reported that on 06-OCT-2010, previously reported as 07-OCT-2010, the patient experienced 1cm x 1.5 cm redness at injection site to left of injection site 8cm x 9 cm redness and heat raised. The patient also complained of pain at site. It was reported that the patient recovered on 10-OCT-2010. It was reported that the patient did not seek medical attention. No further information is available.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a healthcare worker concerning a 37 year old female who on 20-DEC-2010 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (lot # 667271/0680Z). On an unspecified date the patient experienced redness, swelling, warmth at the injection site (on the arm) and "rash" at the injection site. At the time of the report, the patient's status was unknown. The patient sought medical attention by office visit. The physician was not comfortable using the remaining doses of PNEUMOVAX 23. The reporter requested a lot check. A lot check has been initiated. 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 in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information has been received from a health worker concerning a 37 year old female patient with diabetes and of hepatitis C who on 20-DEC-2010 was vaccinated intramuscularly in the right deltoid with a 0.5 mL with PNEUMOVAX 23 (lot # 667271/0680Z). On 20-DEC-2010, on the evening of PNEUMOVAX 23 the patient experienced swelling at the injection site with associated redness, increased warmth and tenderness. No acute illness was reported at the time of vaccination. The patient sought medical attention by office visit. On December of 2010 the patient had recovered. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a patient who on an unspecified date was vaccinated with 0.5 ml dose of PNEUMOVAX 23 (Lot# not reported). Subsequently, in approximately 10-SEP-2010 "about three weeks ago", the patient experienced cellulitis or injection site reaction. At the time of the report, the patient's outcome was unknown. The patient did not seek medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Influenza, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning an approximately 89 year old female who 5 or 6 years ago in approximately 2005 was vaccinated with a dose of PNEUMOVAX 23, (Lot number not provided). Suspect secondary therapy included Flu vaccine (manufacturer unknown) administered at the same time. On an unknown date, the patient developed flu and hives over her whole body, the nurse did not have any other information about the flu or hives. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was recovered. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered pharmacist concerning a patient who on approximately 20-OCT-2010, with last 24-48 hours was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot# not reported). The patient developed a red swollen arm from shoulder to elbow after administration of PNEUMOVAX 23. The patient sought unspecified medical attention. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a Nurse Practitioner (N.P.) concerning a 43 year old female with asthma and no drug reactions/allergies who on 06-OCT-2010 was vaccinated in her left deltoid with a dose of PNEUMOVAX 23 (lot#667418/0978Z). There was no concomitant medication. On 07-OCT-2010 (adverse event onset date was reported as "06-OCT-2010"), the patient at an appointment with another nurse practitioner, disclosed that she developed a reaction at the injection site that included swelling, redness, itching and soreness. The patient then followed up with the reporting nurse practitioner, who was the vaccinating provider, later on 07-OCT-2010, a site examination revealed a 4 diameter, irregular reddened area at the site of the injection. The patient had been treated earlier on 07-OCT-2010 with an antihistamine as well as ZANTAC. The patient was not seen since 07-OCT-2010. There was no lab diagnostics studies performed. At the time of the report, the outcomes were unknown. No further information is available.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a 69 year old female with severe stomach acid and allergy to wheat, soy and dairy who on 22-DEC-2010 was intramuscularly vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot # not reported). Concomitant therapy included SYNTHROID, PRILOSEC and loratadine. The reporter stated that after receiving the PNEUMOVAX 23, on approximately 27-DEC-2010 ("last week") the patient experienced right above the injection site, a lemon size red area with a white streak. Then from the top of her shoulder to her elbow was swollen and painful, about 3 times the normal size. At the time of reporting, the patient was recovering. No lab diagnostics studies were performed. The patient was treated with pain medication and ice packs. The patient sought unspecified medical attention. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Skin warm
Clinical narrative: Information has been received from an 82 year old female with thrombocytopenia, cold induced asthma, peripheral neuropathy and penicillin allergy who on approximately 05-OCT-2010 (reported as "about 2 weeks") was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included ATENOL, LEVOXIN and vitamins (unspecified). On approximately 05-OCT-2010 (reported as "about 2 weeks") the patient had a "horrible reaction". Patient stated that her arm swelled to "about the size of a lemon" and her arm became "burning hot". This condition lasted for 4 days. There was no lab diagnostics studies performed. At the time of the report, the patient was recovering from her adverse events. The patient did not seek medical attention. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Information has been received from a medical assistant (C.M.A.) concerning a female in her 60's who in about the week of 04-OCT-2010 was vaccinated IM with 0.5 ml dose of PNEUMOVAX 23 (lot # 665925/0932Z, expiration date 18-JUL-2011). On approximately 04-OCT-2010 the patient experienced warmth at the injection site that night and next day (approximately 05-OCT-2010) "her arm was blown up all the way down her arm" from her shoulder to her wrist. The patient was treated with ice and BENADRYL. Subsequently, the symptoms had completely resolved. The patient received PNEUMOVAX 23 (lot # and date not reported) in the past with no reaction noted. If was unspecified if the patient sought medical attention. This is one of several reports received from the same source. The doctor was requesting a lot check since each patient received the same lot number. The doses were administered by different staff members. The doctor had four more vials of the vaccine and was concerned about using them because of the above reactions. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a medical assistant (C.M.A.) concerning a female in her 60's or more, who in about the week of 04-OCT-2010 was vaccinated IM with 0.5 ml dose of PNEUMOVAX 23 (lot # 665925/0932Z, expiration date 18-JUL-2011). The next day (approximately 05-OCT-2010) the patient's arm was "blown up from the shoulder to the wrist". The patient was treated with ice and BENADRYL. Subsequently, the symptoms had completely resolved. It was unknown at that time if the patient received PNEUMOVAX 23 in the past. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. The doctor was requesting a lot check since each patient received the same lot number. The doses were administered by different staff members. The doctor had four more vials of the vaccine and was concerning about using them because of the above reactions. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a female consumer who on 18NOV2010 received a dose of PNEUMOVAX 23 (dose unknown) (lot#667912/0933Z). On 19NOV2010 the patient experienced an "acute allergic reaction" after receiving the vaccine. The outcome was unknown. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 62 day old male patient who on 24-NOV-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 667445/0993Z, expire date 05-JAN-2012), 0.5 ml, intramuscularly instead of PREVNAR. No adverse effect was reported. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Joint effusion, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Osteoarthritis
Clinical narrative: Information has been received from a licensed practical nurse concerning a 45 year old male patient who on 11-SEP-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot number: 665270/1398Y) intramuscularly in the left deltoid. The patient woke up on 12-SEP-2010 with severe pain in left shoulder with no relief from ADVIL. There was no redness, pain, swelling at the injection site. The patient sent for MRI, on 01-OCT-2010, which showed no evidence of full or partial thickness rotator cuff tear, mild subacronial / subdeltoid bursitis. Moderate degenerative change, capsular thickening left acromioclavicular joint, type II curved acromion. Edema left acromioclavicular joint, capsular edema, different above. At the time of the report the patient's present status was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a Registered Pharmacist concerning a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot# unknown). The pharmacist reported that the patient mentioned on a pharmacy medical history questionnaire that she had an unspecified allergic reaction to PNEUMOVAX 23. At the time of the report, the patient had recovered. It was unknown if the patient sought medical attention. No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on 13-DEC-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot number and expiration date not provided). After receiving a dose of PNEUMOVAX 23, prior to 21-DEC-2010, the patient developed a rash along her chest, right arm and back. The patient sought unspecified medical attention. Treatment was given for the rash but the medication was unspecified. At time of the report, the patient's outcome was unknown. Additional information has been requested.