chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 68 year old female patient with polycystic kidney, hypertension, hypercholesterolaemia and drug reactions/allergy to prednisone, sulfa drugs and lisinopril (WAES 0912USA01433) who on 05-OCT-2007 was vaccinated intramuscularly with the first 0.5 ml dose of PNEUMOVAX 23 (lot number 664871/1142Y). On 26-OCT-2009 was vaccinated intramuscularly with the second dose of PNEUMOVAX 23. Concomitant therapy included DIOVAN, atenolol, CRESTOR and vitamin D (unspecified). On 26-OCT-2009 the patient experienced redness, swelling, warmth and pain on her arm at the injection site, that extended to her fingers, after receiving a dose of PNEUMOVAX 23. At the time of the report the patient had recovered. The patient sought medical attention (office visit). No laboratory diagnostic studies were performed. Follow up information has been received from the nurse who reported that on 26-OCT-2009 at 10:45 am the patient was vaccinated intramuscularly in the left deltoid with the second dose of PNEUMOVAX 23 (lot number 664871/1142Y). The nurse stated that on 26-OCT-2009 at 9:00 pm the patient experienced pain, swelling, redness in the entire upper left arm with extension to elbow and the arm was warm to touch. The patient was unable to bend arm. The patient recovered on 29-OCT-2009. The patient did not experience any adverse event following prior vaccination. No laboratory diagnostics studies were performed. No further information was available.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: No reaction on previous exposure to drug
Clinical narrative: Information has been received from a registered nurse concerning a 68 year old female patient with polycystic kidney, hypertension, hypercholesterolaemia and drug reactions/allergy to prednisone, sulfa drugs and lisinopril (WAES 0912USA01433) who on 05-OCT-2007 was vaccinated intramuscularly with the first 0.5 ml dose of PNEUMOVAX 23 (lot number 664871/1142Y). On 26-OCT-2009 was vaccinated intramuscularly with the second dose of PNEUMOVAX 23. Concomitant therapy included DIOVAN, atenolol, CRESTOR and vitamin D (unspecified). On 26-OCT-2009 the patient experienced redness, swelling, warmth and pain on her arm at the injection site, that extended to her fingers, after receiving a dose of PNEUMOVAX 23. At the time of the report the patient had recovered. The patient sought medical attention (office visit). No laboratory diagnostic studies were performed. Follow up information has been received from the nurse who reported that on 26-OCT-2009 at 10:45 am the patient was vaccinated intramuscularly in the left deltoid with the second dose of PNEUMOVAX 23 (lot number 664871/1142Y). The nurse stated that on 26-OCT-2009 at 9:00 pm the patient experienced pain, swelling, redness in the entire upper left arm with extension to elbow and the arm was warm to touch. The patient was unable to bend arm. The patient recovered on 29-OCT-2009. The patient did not experience any adverse event following prior vaccination. No laboratory diagnostics studies were performed. No further information was available.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 62 year old male patient with diabetes and heart problems who on 25-NOV-2009 was vaccinated SQ in the left arm with a 0.5 ml dose of PNEUMOVAX 23 (Lot number 664654/0823Y) for diabetes and heart problems. The patient's relevant concomitant medications and relevant past drug history were unknown. On 26-NOV-2009 the patient developed nausea and a slight elevation in temperature which lasted only for a few hours, and erythema of the left arm which continued to spread over the last few days. On 29-NOV-2009 the pharmacist assessed the erythema and described it as warm to the touch with mild swelling which extended downward from the injection site beyond his elbow and appeared to be continuing to spread. No relevant laboratory testing had been performed. On 29-NOV-2009 it was unknown if the patient would continue to receive further doses of PNEUMOVAX 23. At the time of the report the patient was no longer experiencing nausea or an elevated temperature and the erythema on his left arm was described by the pharmacist as red, warm to the touch, with mild swelling which covered 2/3 of his upper arm and continued to spread downward from the injection site to beyond the elbow. Follow up information has been received from a pharmacist concerning a 62 year old male patient with diabetes, high blood pressure and a history of heart surgery who on 25-NOV-2009 was vaccinated SQ in the left arm with a 0.5 ml dose of PNEUMOVAX 23 (Lot number 664654/0823Y). There was no illness at the time of vaccination. Subsequently the patient experienced slight temperature, erythema and mild swelling. On 04-DEC-2009 the patient recovered. No further information is available.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a pharmacist concerning a 62 year old male patient with diabetes and heart problems who on 25-NOV-2009 was vaccinated SQ in the left arm with a 0.5 ml dose of PNEUMOVAX 23 (Lot number 664654/0823Y) for diabetes and heart problems. The patient's relevant concomitant medications and relevant past drug history were unknown. On 26-NOV-2009 the patient developed nausea and a slight elevation in temperature which lasted only for a few hours, and erythema of the left arm which continued to spread over the last few days. On 29-NOV-2009 the pharmacist assessed the erythema and described it as warm to the touch with mild swelling which extended downward from the injection site beyond his elbow and appeared to be continuing to spread. No relevant laboratory testing had been performed. On 29-NOV-2009 it was unknown if the patient would continue to receive further doses of PNEUMOVAX 23. At the time of the report the patient was no longer experiencing nausea or an elevated temperature and the erythema on his left arm was described by the pharmacist as red, warm to the touch, with mild swelling which covered 2/3 of his upper arm and continued to spread downward from the injection site to beyond the elbow. Follow up information has been received from a pharmacist concerning a 62 year old male patient with diabetes, high blood pressure and a history of heart surgery who on 25-NOV-2009 was vaccinated SQ in the left arm with a 0.5 ml dose of PNEUMOVAX 23 (Lot number 664654/0823Y). There was no illness at the time of vaccination. Subsequently the patient experienced slight temperature, erythema and mild swelling. On 04-DEC-2009 the patient recovered. No further information is available.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 51 year old female with history of renal transplant, depression, osteoporosis, hypertension, occipital neuralgia, past history of skin cancer, KEFLEX and Codeine allergies, who on 03-DEC-2009 was vaccinated with a 0.5ml dose of PNEUMOVAX 23 (lot # 664871/1142Y) IM. Concomitant therapy included CRESTOR, DARVOCET-N, CELLCEPT, RAPAMUNE, ZOMIG, ACTONEL, ECOTRIN, omega-3 marine triglycerides, NEXIUM, vitamin D (unspecified), ALLEGRA, TAMADOLOR, estrogens, conjugate PREMARIN and progesterone. On 03-DEC-2009 the patient experienced redness, swelling, warmth and pain on her arm at the injection site. It was also reported that the patient was having difficulty moving her arm on the side where the vaccine was given. There were no labs and diagnostic tests performed. The patient had made a phone call for medical attention. At the time of the report, the patient's status was unknown. Follow up information has been received from a registered nurse concerning a 51 year old female with history of renal transplant, osteoporosis, hypertension, skin cancer, KEFLEX and Codeine allergies, who on 03-DEC-2009 at 2:45 PM was vaccinated with a first dose of PNEUMOVAX 23 (lot # 664871/1142Y) IM in the left arm. On 03-DEC-2009 at 10:00 PM the patient experienced redness, swelling, tenderness in the upper left arm. The patient also had fever. There were no labs and diagnostic tests performed. The patient did not receive medical attention. On 06-DEC-2009 the patient recovered from redness, swelling, tenderness and fever. No further information is available.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Tenderness
Clinical narrative: Information has been received from a registered nurse concerning a 51 year old female with history of renal transplant, depression, osteoporosis, hypertension, occipital neuralgia, past history of skin cancer, KEFLEX and Codeine allergies, who on 03-DEC-2009 was vaccinated with a 0.5ml dose of PNEUMOVAX 23 (lot # 664871/1142Y) IM. Concomitant therapy included CRESTOR, DARVOCET-N, CELLCEPT, RAPAMUNE, ZOMIG, ACTONEL, ECOTRIN, omega-3 marine triglycerides, NEXIUM, vitamin D (unspecified), ALLEGRA, TAMADOLOR, estrogens, conjugate PREMARIN and progesterone. On 03-DEC-2009 the patient experienced redness, swelling, warmth and pain on her arm at the injection site. It was also reported that the patient was having difficulty moving her arm on the side where the vaccine was given. There were no labs and diagnostic tests performed. The patient had made a phone call for medical attention. At the time of the report, the patient's status was unknown. Follow up information has been received from a registered nurse concerning a 51 year old female with history of renal transplant, osteoporosis, hypertension, skin cancer, KEFLEX and Codeine allergies, who on 03-DEC-2009 at 2:45 PM was vaccinated with a first dose of PNEUMOVAX 23 (lot # 664871/1142Y) IM in the left arm. On 03-DEC-2009 at 10:00 PM the patient experienced redness, swelling, tenderness in the upper left arm. The patient also had fever. There were no labs and diagnostic tests performed. The patient did not receive medical attention. On 06-DEC-2009 the patient recovered from redness, swelling, tenderness and fever. No further information is available.
Age: 3.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a Registered Pharmacist concerning a 3 year old child who on unspecified date was vaccinated with a dose of PNEUMOVAX 23 accidently instead of the flu vaccine. The wrong vial was grabbed, medical error. The patient was not experiencing any known symptoms. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Headache, Influenza, Influenza A virus test positive, Pyrexia
Clinical narrative: A non-serious spontaneous report of Influenza A has been received from the patient's parent/registered nurse concerning a five-year-old female patient, subsequent to receiving FLUMIST. The patient's medical history and concomitant medications were not reported. On 09-Oct-2009, patient received FLUMIST. On 19-Oct-2009, the patient experienced a fever of 101.8 F, terrible cough, and headache. She tested positive for Influenza A. The outcome for the reported adverse event was not reported.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received form a consumer concerning a female patient in her 60's who on an unspecified date was vaccinated with a first dose of PNEUMOVAX 23 (lot number and route not reported) in the left arm. The consumer reported that later the same evening she had the onset of swelling redness and tenderness over site of injection in the left arm. Also she had chills and arthralgias. It was reported that all symptoms resolved within three days except for some remaining redness and swelling at the injection site at the time of this report. The patient sought medical attention by seeing her physician but no specific therapy was prescribed. No further information is available.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Information has been received from a medical assistant concerning a 38 year old male patient with cardiac disease (right sided), mild intermittent asthma, drug reaction to hydrocodone and morphine (caused nausea and vomiting) and a history of hernia surgery who on 24-NOV-2009 was vaccinated SQ in the left deltoid with a 0.5 ml first dose of PNEUMOVAX 23 (Lot number 664653/1337Y). Concomitant therapy included VALTREX and PROVENTIL HFA. On 25-NOV-2009 the patient experienced pain at the site of the shot radiating elbow to neck and had difficulty turning his neck. The patient had no rash and no shortness of breath. Subsequently on 30-NOV-2009 the patient recovered from pain at the site of the shot radiating elbow to neck and difficulty turning his neck. The patient sought medical attention by a phone call. Follow up information has been received from the physician's assistant certified concerning the 38 year old patient also with bipolar disorder, common migraine, but no illness at time of vaccination and no adverse events following prior vaccination, who on 24-NOV-2009 was vaccinated SQ in the left deltoid with a first dose of PNEUMOVAX 23 (Lot number 664653/1337Y). Concomitant therapy also included EXCEDRIN. On 25-NOV-2009, the following day to vaccination, the patient experienced pain at the injection site radiating to elbow and neck and had difficulty turning his neck. The physician assistant stated the there was no rash and no Shortness of Breath. No relevant diagnostic test and laboratory data was reported. On 28-NOV-2009 the patient recovered. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Body temperature increased, Oedema peripheral, Pruritus, Rash macular
Clinical narrative: Information has been received from a physician concerning a patient who on 07-DEC-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot # 663889/0632Y).  On 07-DEC-2009 the patient had a temperature of 103F.  The patient's arm was swollen a few hours after vaccination, and the arm became more blotchy.  On 09-DEC-2009 the patient was seen at the office and the area was blotchy and itchy.  At the time of the report, the patient's outcome was unknown.  This is one of two reports from the same source.  No further information is available.
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 5 year old female with no medical history or drugs allergies, who on 19-NOV-2009 was vaccinated with a 0.5 mL dose of PNEUMOVAX 23 (lot # 662842/1296X), intramuscularly. On 19-NOV-2009, the patient developed an injection site reaction (right upper arm). The area was red, hot, swollen, painful had hives and was raised. The patient had woken up in the middle of the night because of the pain. The patient was treated with compresses. No laboratories studies performed. The patient visited the physician's office on 20-NOV-2009. The office hasn't heard back from the patient's parents so the nurse doesn't know the patient's present status. No product quality complaint was involved.  Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Injection site urticaria, Injection site warmth, Sleep disorder
Clinical narrative: Information has been received from a health professional concerning a 5 year old female with no medical history or drugs allergies, who on 19-NOV-2009 was vaccinated with a 0.5 mL dose of PNEUMOVAX 23 (lot # 662842/1296X), intramuscularly. On 19-NOV-2009, the patient developed an injection site reaction (right upper arm). The area was red, hot, swollen, painful had hives and was raised. The patient had woken up in the middle of the night because of the pain. The patient was treated with compresses. No laboratories studies performed. The patient visited the physician's office on 20-NOV-2009. The office hasn't heard back from the patient's parents so the nurse doesn't know the patient's present status. No product quality complaint was involved.  Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: FLUN3
Symptoms: Body temperature increased, Cough, Dizziness, Headache, Hyperhidrosis
Clinical narrative: A non-serious spontaneous report of tachycardic, diaphoretic, dizziness, fever, body aches, malaise, headache, vomiting, cough, and sore throat has been received from a physician concerning a 47-year-old male patient, subsequent to receiving FLUMIST. The patient's medical history and concomitant medications were not reported. On 18-OCT-2009, the patient received FLUMIST. On18-OCT-2009, the patient experienced dizziness, fever, body ache, malaise, headache, vomiting, cough, and sore throat. He went to the emergency room and was also found to be tachycardic with a heart rate of 120 beats per minute, diaphoretic, and intermittently febrile with a temperature of 100.9 F. The outcomes for the reported adverse events were not reported.
Age: 47.0
Sex: M
Vaccine: FLUN3
Symptoms: Malaise, Oropharyngeal pain, Pain, Pyrexia, Tachycardia
Clinical narrative: A non-serious spontaneous report of tachycardic, diaphoretic, dizziness, fever, body aches, malaise, headache, vomiting, cough, and sore throat has been received from a physician concerning a 47-year-old male patient, subsequent to receiving FLUMIST. The patient's medical history and concomitant medications were not reported. On 18-OCT-2009, the patient received FLUMIST. On18-OCT-2009, the patient experienced dizziness, fever, body ache, malaise, headache, vomiting, cough, and sore throat. He went to the emergency room and was also found to be tachycardic with a heart rate of 120 beats per minute, diaphoretic, and intermittently febrile with a temperature of 100.9 F. The outcomes for the reported adverse events were not reported.
Age: 47.0
Sex: M
Vaccine: FLUN3
Symptoms: Vomiting
Clinical narrative: A non-serious spontaneous report of tachycardic, diaphoretic, dizziness, fever, body aches, malaise, headache, vomiting, cough, and sore throat has been received from a physician concerning a 47-year-old male patient, subsequent to receiving FLUMIST. The patient's medical history and concomitant medications were not reported. On 18-OCT-2009, the patient received FLUMIST. On18-OCT-2009, the patient experienced dizziness, fever, body ache, malaise, headache, vomiting, cough, and sore throat. He went to the emergency room and was also found to be tachycardic with a heart rate of 120 beats per minute, diaphoretic, and intermittently febrile with a temperature of 100.9 F. The outcomes for the reported adverse events were not reported.
Sex: U
Vaccine: HEPA, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a patient who on 02-DEC-2009 was vaccinated with a dose of PNEUMOVAX 23 and a dose of VAQTA in the same arm. On 02-DEC-2009 the patient experienced pain and swelling at injection site. On 03-DEC-2009 subsequently, the patient complained of pain and swelling at injection site, although the swelling had gone down since yesterday. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a 67 year old female patient with allergic reactions to CELEBREX and Darvocet who on 03-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot# 662842/1296X) SQ in her left arm. On 04-SEP-2009 the patient experienced left arm swollen, redness and pain at the injection site. The patient was told to apply cold pack and take TYLENOL and MOTRIN to lighten the feeling of pain. Medical attention was sought. At the time of the report, the patient recovered. This is one of several reports from the same source. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Conjunctivitis infective, Ear infection, Pyrexia
Clinical narrative: A non-serious spontaneous report of fever of 105 F, ear infection, and pinkeye has been received from a consumer concerning a five-year-old female, subsequent to FLUMIST. The patient's medical history and concomitant medication were not reported. The patient received FLUMIST on 14-Oct-2009. On 16-Oct-2009, the patient had a fever of 105 F. She had an ear infection the following day, and on 22-Oct-2009 had pinkeye. The outcome of the events was not reported.
Sex: M
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a pharmacist concerning a male who in 1991 was vaccinated with a dose of PNEUMOVAX 23.  In "1991" the patient experienced unspecified adverse reaction.  It was unknown if the patient sought medical attention.  The patient recovered.  No further information is available.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Information has been received from a nurse concerning a male who on 18-DEC-2009 was vaccinated with a dose of PNEUMOVAX 23 (LOT# 665402/1339Y). After vaccination, the patient experienced redness, swelling and itching around the elbow on the arm where the patient received the vaccine. The patient was treated with antibiotic (manufacturer unknown) and "DEPO". The patient was recovered on an unspecified date. Follow up information has been received from a registered nurse (RN) who reported that on 15-DEC-2009 at 2:15 PM the 75 year old retired male patient with no known allergy or illness at time of vaccination was vaccinated IM with a dose of PNEUMOVAX 23 (LOT# 665402/1339Y) in the right deltoid. Subsequently, the patient came in with complaint of soreness and stiffness of his right arm which developed on 18-DEC-2009 at 12:50 PM. It was reported that the patient's "bicep was very red". The physician diagnosed as an allergic reaction. The patient was given antibiotics (ABT) and allergy medication (unspecified). At the time of the report, the patient was recovered on an unspecified date. This is one of the two reports from the same source. Additional information is not expected.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a nurse concerning a male who on 18-DEC-2009 was vaccinated with a dose of PNEUMOVAX 23 (LOT# 665402/1339Y). After vaccination, the patient experienced redness, swelling and itching around the elbow on the arm where the patient received the vaccine. The patient was treated with antibiotic (manufacturer unknown) and "DEPO". The patient was recovered on an unspecified date. Follow up information has been received from a registered nurse (RN) who reported that on 15-DEC-2009 at 2:15 PM the 75 year old retired male patient with no known allergy or illness at time of vaccination was vaccinated IM with a dose of PNEUMOVAX 23 (LOT# 665402/1339Y) in the right deltoid. Subsequently, the patient came in with complaint of soreness and stiffness of his right arm which developed on 18-DEC-2009 at 12:50 PM. It was reported that the patient's "bicep was very red". The physician diagnosed as an allergic reaction. The patient was given antibiotics (ABT) and allergy medication (unspecified). At the time of the report, the patient was recovered on an unspecified date. This is one of the two reports from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site extravasation, No adverse event, Underdose
Clinical narrative: Information has been received from a pharmacist concerning a patient who on 15-DEC-2009 was vaccinated with an incomplete dose of PNEUMOVAX 23, IM. The vaccine leaked from the injection site during administration. No adverse effects were reported. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning an around 54 year old male patient with cardiovascular issues who about two weeks ago (approximately 18-NOV-2009) was vaccinated with the first 0.5 ml dose of PNEUMOVAX 23. Within 24 hours of receiving PNEUMOVAX 23, the patient developed a rash at the injection site. The patient called the office for medical attention. At the time of the report, the patient had recovered. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: A non-serious spontaneous report of fever has been received from a consumer/patient's parent concerning a seven-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported from this patient. The patient received FLUMIST on 21-Oct-2009 at about 3:30pm. On 22-Oct-2009, the patient woke up with a fever. Treatment was not provided.  The outcome of the event was not reported.
Age: 43.0
Sex: M
Vaccine: FLUN3
Symptoms: Facial palsy
Clinical narrative: A serious spontaneous report of Bell's Palsy has been received from a registered nurse concerning a 43-year-old male patient, subsequent to receiving FLUMIST. The patient's medical history and concomitant medications were not reported. On 28-Sep-2009, the patient received FLUMIST. On 01-Oct-2009, the patient presented to the emergency room and was diagnosed with Bell's Palsy. The outcome for the reported adverse event was not reported.
Age: 66.0
Sex: F
Vaccine: FLUX(H1N1), PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered pharmacist concerning a 66 year old female patient with chronic obstructive pulmonary disease, sulfa, iodine and codeine reaction/allergy who on 19-NOV-2009 was intramuscularly vaccinated with a 0.5 mL dose of PNEUMOVAX 23 (Lot#662661/0978X). Concomitant therapy included H1N1. The pharmacist reported that after received the PNEUMOVAX 23, on 21-NOV-2009, the patient experienced red and swollen at the injection site. No lab tests were performed. The patient called to the pharmacist for medical attention. "3-4 days after the start of the reaction", the patient had recovered. Follow up information has been received from the pharmacist that reported that the patient did not need to saw her doctor and that the symptoms resolved. No further information is expected.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 54 year old male patient with moderate to persistent asthma and allergy to penicillin, aspirin, sulfa and NAPROSYN who on 11-JUN-2009 was vaccinated with a first 0.5 ml IM dose of PNEUMOVAX 23 (Lot # 665300/1314Y) and on 18-DEC-2009 was vaccinated with PNEUMOVAX 23 (Lot # not reported). Concomitant therapy included XOLAIR, NASACORT, ZYFLO CR and SYMBICORT. On 18-DEC-2009 the patient experienced body aches after the second dose of PNEUMOVAX. The patient sought unspecified medical attention. On 21-DEC-2009 the patient recovered. No laboratory or diagnostic studies were performed. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy
Clinical narrative: A non-serious spontaneous report of administered FLUMIST to pregnant patient was received from a consumer concerning a 15-year-old female. The patient's medical and obstetrical history were not provided. The patient received FLUMIST on 06-Oct-2009 and later reported that she was seven weeks pregnant. Laboratory test, date of LMP and estimated date of delivery were not reported. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experienced any adverse events during the pregnancy.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Blood test, Dry eye, Ear pain, Facial pain, Facial palsy
Clinical narrative: Information has been received from a 65 year old male patient with no pertinent medical history and no known drug allergies who on 03-DEC-2009 was vaccinated with a 0.5ml dose of PNEUMOVAX 23 vaccine (lot# not reported).  There was no concomitant medication.  On 04-DEC-2009 the patient woke up with the left side of his face completely paralyzed.  He went to the emergency room on 05-DEC-2009 and was diagnosed with Bell's Palsy.  Since then he had had severe pain around his left ear and cheekbone and as well a dry eye and also had a dull ache at the top of his head.  His physician prescribed VALTREX (manufacturer unspecified) and prednisone (manufacturer unspecified) but the paralysis had not gotten any better.  "Blood work up" was performed but the outcome was not reported.  Follow up information has been received from a physician and medical records concerning a 65 year old male patient with no history of diabetes or facial pain, and "some" hypersensitivity to hearing in left ear who on 03-DEC-2009, at 12:30 PM was vaccinated IM into the right deltoid with a first 0.5ml dose of PNEUMOVAX 23 vaccine (lot# 664653/1337Y).  There was no illness at the time of vaccination.  On 04-DEC-2009, the patient experienced Bell's Palsy which occurred the day after vaccination.  On 07-DEC-2009, the patient was seen by a neurologist.  The neurologist reported that on 04-DEC-2009 (also reported as three days ago), the patient woke up with an odd sensation on the left side of his face and by mid afternoon, he was having difficulty moving the muscles of his left side of his face.  He was subsequently seen in the emergency room where he underwent an evaluation and then placed on prednisone and VALTREX for a period of five days.  It was noted that the day prior to the onset of his Bell's palsy, he had received a PNEUMOVAX 23 vaccine shot.  Otherwise he had not been under any other health issues.  No fevers had been reported.  A detailed neurological examination was performed and there was severe weakness of the muscles on the left side of his face.  However, his neurological examination otherwise did not reveal any other findings.  The neurologist impression stated that the patient had developed a complete Bell's Palsy on the left side of his face.  Subsequently, at the time of the report, the patient recovered on an unspecified date.  Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Neurological examination abnormal
Clinical narrative: Information has been received from a 65 year old male patient with no pertinent medical history and no known drug allergies who on 03-DEC-2009 was vaccinated with a 0.5ml dose of PNEUMOVAX 23 vaccine (lot# not reported).  There was no concomitant medication.  On 04-DEC-2009 the patient woke up with the left side of his face completely paralyzed.  He went to the emergency room on 05-DEC-2009 and was diagnosed with Bell's Palsy.  Since then he had had severe pain around his left ear and cheekbone and as well a dry eye and also had a dull ache at the top of his head.  His physician prescribed VALTREX (manufacturer unspecified) and prednisone (manufacturer unspecified) but the paralysis had not gotten any better.  "Blood work up" was performed but the outcome was not reported.  Follow up information has been received from a physician and medical records concerning a 65 year old male patient with no history of diabetes or facial pain, and "some" hypersensitivity to hearing in left ear who on 03-DEC-2009, at 12:30 PM was vaccinated IM into the right deltoid with a first 0.5ml dose of PNEUMOVAX 23 vaccine (lot# 664653/1337Y).  There was no illness at the time of vaccination.  On 04-DEC-2009, the patient experienced Bell's Palsy which occurred the day after vaccination.  On 07-DEC-2009, the patient was seen by a neurologist.  The neurologist reported that on 04-DEC-2009 (also reported as three days ago), the patient woke up with an odd sensation on the left side of his face and by mid afternoon, he was having difficulty moving the muscles of his left side of his face.  He was subsequently seen in the emergency room where he underwent an evaluation and then placed on prednisone and VALTREX for a period of five days.  It was noted that the day prior to the onset of his Bell's palsy, he had received a PNEUMOVAX 23 vaccine shot.  Otherwise he had not been under any other health issues.  No fevers had been reported.  A detailed neurological examination was performed and there was severe weakness of the muscles on the left side of his face.  However, his neurological examination otherwise did not reveal any other findings.  The neurologist impression stated that the patient had developed a complete Bell's Palsy on the left side of his face.  Subsequently, at the time of the report, the patient recovered on an unspecified date.  Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a 74 year old female consumer with no pertinent medical history and allergic reaction to codeine who in October 2008 and in October 2009, was vaccinated with the first and second doses of PNEUMOVAX 23. Secondary suspect vaccination included a dose of influenza virus split virion 3v vaccine inactivated (MSD) a week before receiving the second dose of PNEUMOVAX 23 (duration and dose not reported). Other concomitant therapies included XANAX and LEXAPRO. The patient had no adverse reaction after the first dose of PNEUMOVAX 23. In October 2009, after receiving the second dose of PNEUMOVAX 23, the patient experienced redness, pain and swelling of her arm "as big as a tennis ball" at the injection site. It was noted that the patient received both of the PNEUMOVAX 23 doses in another country. The patient was evaluated in an unspecified emergency room, and was not admitted to the hospital. No lab diagnostic studies were performed.  The patient stated that she recovered within a few days of receiving the second dose of PNEUMOVAX 23 in October 2009. No further information is available.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pain, Swelling
Clinical narrative: Information has been received from a consumer concerning her 66 year old sister with no drug reactions or allergies and a history of walking pneumonia who in 2005 was vaccinated with a first dose of PNEUMOVAX 23.  On 27-NOV-2009 the patient was vaccinated with the second dose of PNEUMOVAX 23.  Within 4-5 hours the patient developed throbbing pain and swelling at the injection site expending to the finger tips.  The patient was seen by her physician the next morning and was given a cortisone shot.  No laboratory diagnostic studies were performed.  At the time of reporting, the swelling at the site had resolved (04-DEC-2009) but the swelling persisted from the elbow to the wrist.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 67 year old female consumer with breast cancer and ovarian cancer and a history of shingles who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included "a tetanus vaccine" (detail not specified). Two weeks after receiving the PNEUMOVAX 23 and the tetanus vaccination, the patient developed shingles. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. No further information is available.
Age: 0.3
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 16 week female patient who on 02-DEC-2009 was vaccinated with a dose of PNEUMOVAX 23 (662785/1124X) instead of PREVNAR by human error. There was no adverse event reported. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious spontaneous report of ER gave FLUMIST to a 54-year-old patient was received from a licensed practical nurse concerning a 54-year-old female. The patient's medical history and concomitant medications were not provided. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event was considered resolved.
Age: 41.0
Sex: M
Vaccine: FLUN3
Symptoms: Tinnitus
Clinical narrative: A non-serious spontaneous report of ringing in ears has been received from a consumer concerning himself, a 41-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 12-Oct-2009. On 14-Oct-2009, the patient developed ringing in the ears. Treatment for the event was not provided. The outcome of the event is not resolved.
Age: 62.0
Sex: F
Vaccine: FLU(H1N1), PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Information has been received from a Registered Nurse concerning a 62 year old female with chronic obstructive pulmonary disease, CELEBREX allergy, CIPRO allergy, LEVAQUIN allergy and LIPITOR allergy who on 17-DEC-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot # 664864/1365Y), 0.5ml, subcutaneously into left arm. On the same day on 17-DEC-2009 the patient received a dose of influenza virus A (antigen type unspecified) vaccine (H1N1) into right arm. Concomitant therapy included multiple medicines. On 17-DEC-2009 the patient experienced a localized red, circular, hot, itching and some swelling reaction. On 20-DEC-2009 the patient recovered from localized red, circular, hot, itching and some swelling reaction. On 21-DEC-2009 the patient sought medical attention contacted the nurse by phone. There were no laboratories diagnostics studies performed. This is one of two reports from the same source. Follow up information has been received from the registered nurse concerning the 62 year old female patient who on 17-DEC-2009 was vaccinated with the first dose of PNEUMOVAX 23, subcutaneous route-left arm (lot # 664864/1365Y), at the private doctor's office/hospital with private funds and 04:30 pm. On the same day on 17-DEC-2009 the patient received the first dose of influenza virus A (antigen type unspecified) vaccine (H1N1) intramuscular route - right arm (lot # 102147P1) at the private doctor's office/hospital with private funds and 04:30 pm. On 17-DEC-2009 the patient experienced a localized swollen, red, itchy, circular and hot reaction at the injection site at 06:00 pm. At the time of the report the patient recovered. No further information is available.
Sex: U
Vaccine: FLUN3
Symptoms: Nasal congestion, Sinus headache
Clinical narrative: A non-serious spontaneous report of one side of my nose completely blocked and lot of sinus pressure has been received from a consumer concerning a patient (age and gender unknown), subsequent to FLUMIST. The patient's past medical history includes deviated nasal septum. No concomitant medications have been reported for this patient. The patient received FLUMIST on 20-Oct-2009 for unknown indication. Two days after receiving FLUMIST, one side of the patient's nose was completed blocked and the patient had a lot of sinus pressure. Treatment for the events was not provided. The outcome of the events was not reported.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a 44 year old female patient with unknown relevant medical history and drug history, who on 01-FEB-2010 was vaccinated in the left deltoid with a 0.5 ml dose of PNEUMOVAX 23 (lot number 663889/0632Y). Concomitant therapy included FLONASE, SINGULAIR, ADVAIR, LEXAPRO, RECLIPSEN and unspecified PROAIR. On 04-FEB-2010, three days after receiving PNEUMOVAX 23, the patient called the pharmacy and reported that her arm hurt really bad. On 05-FEB-2010 the patient called the pharmacy again and reported that her arm was so sore that she could hardly move it. As of 06-FEB-2010, the patient called and reported to the pharmacist that her arm was still sore. The pharmacist confirmed that there was no swelling or redness at the injection site. The pharmacist was going to refer the patient to her doctor for assistance. It was unknown if any laboratory tests were performed. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: FLUN3
Symptoms: Vaccination error
Clinical narrative: A non-serious spontaneous report of we gave FLUMIST to a 58-year-old person was received from a nurse concerning a 58-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 20-Oct-2009, the patient received FLUMIST. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Sex: U
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a licensed visiting nurse concerning a patient who on 10-FEB-2010, "yesterday", was vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported). On 10-FEB-2010, "right after getting the vaccine" the patient experienced fever and significant swelling of the arm. The patient was administered an epinephrine shot and recovered. The nurse also stated that she will hold off on administering the PNEUMOVAX 23 with that lot number to the patients. Follow up information has been received from the licensed visiting nurse who indicated that the patient was vaccinated with PNEUMOVAX 23 (Lot # 665300/1314Y). The licensed visiting nurse thought that the patient had been treated with SOLUMEDROL and an antibiotic (unspecified). The licensed visiting nurse did not consider the patient's fever or swelling of the arm to be life-threatening. The licensed visiting nurse stated that according to the office's policy they were not administering PNEUMOVAX 23 with the lot # 665300/1314Y. The nurse also reported that the patient had not received an epinephrine shot, as previously reported. 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. This is one of two reports received from the same source. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pruritus, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 25 year old female with asthma who on 05-FEB-2010 was vaccinated intramuscularly with her initial 0.5 ml PNEUMOVAX 23 (lot# 664478/1191Y).Concomitant therapies included thyroid medications and unspecified asthma medications. On 06-FEB-2010 the patient developed local redness and itching at the injection site. On 07-FEB-2010 the patient developed a fever of 103F. The patient had sought unspecified medical attention. Subsequently, on an unspecified date the patient recovered. Follow up information was received from the Licensed practical nurse concerning the 25 year old female with hypothyroidism, asthma and no known drug allergies, who on 05-FEB-2010 was vaccinated with the first dose of PNEUMOVAX 23 (IM, in the left deltoid) and the first dose of FLUZONE (IM, in the deltoid, Sanofi, UT3252AA). On 06-FEB-2010 the patient developed a large red circle at injection site which was itching. The patient also had a fever of 103F. Symptoms resolved between 11-FEB-2010 and 15-FEB-2010. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 70 year old female patient who on 03-FEB-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665400/1315Y). It was reported that on 04-FEB-2010, the patient experienced redness and swelling around the injection site where the PNEUMOVAX 23 vaccine was given. According to the nurse, the patient also had fever. At the time of the report the patient had recovered. The patient sought medical attention by an office visit. This is one of several reports received from the same source. Follow up information has been received from the registered nurse who indicated that the patient was a retired female with no pre-existing allergies, birth defects or medical conditions who on 03-FEB-2010 was vaccinated with the first dose of PNEUMOVAX 23 (Lot # 665400/1315Y) into her right deltoid at 08:05 AM as part of preventive care. It was reported that on 04-FEB-2010, the patient's right deltoid was warm, red and edematous. The patient was treated with KEFLEX 500 MG TZD and cold compresses. At the time of the report the patient had recovered. No relevant diagnostic tests were performed. No further information is available.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 67 year old male who on 11-FEB-2010 was vaccinated with PNEUMOVAX 23 (lot# 665400/1315Y). On 12-FEB-2010 the patient experienced redness and swelling around the injection site where PNEUMOVAX 23 was given. The patient also reported a fever. The patient sought medical attention via office visit. At the time of the report, the patient's redness around the injection site and swelling around the site persisted. Follow-up information has been received from the registered nurse concerning a 67 year old retired male with no pre-existing allergies or conditions, who on 11-FEB-2010 at 7:10 AM was vaccinated intramuscularly into the right deltoid with a first dose of PNEUMOVAX 23 (lot# 665400/1315Y). It was reported that at the patient's deltoid of arm was redness and tenderness. The patient was treated with KEFLEX 500 mg four times a day and cold compresses. The patient's experience was required doctor visit. There was no laboratory test performed. Subsequently, the patient recovered. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a nurse concerning a patient who on an unspecified date was vaccinated with 0.5 ml injection of PNEUMOVAX 23 (lot # not reported). Subsequently the patient experienced extreme redness pain at the injection site. The patient's adverse experience improved on therapy. The patient went to the emergency room. Follow-up information has been received from a reporter who mentioned that the lot# for PNEUMOVAX 23 was 662270/1135Y. All telephone attempts to obtain follow up information have been  unsuccessful. Additional information has been requested.