chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a nurse concerning a 38 year old female who on 18-JUN-2009 was vaccinated with the first dose of PNEUMOVAX 23, 0.5ml/IM. There was no concomitant medication. On 19-JUN-2009 the patient experienced redness at the injection site of the left upper arm. On 19-JUN-2009 the patient was seen in the office. The area of redness extended from the upper arm down to the elbow. No treatment was prescribed. At the report time the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Oedema, Pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female patient with a history of mononucleosis, splenectomy (no spleen) at age of five years old because of refractory idiopathic thrombocytopenic purpura, and no known drug allergies who on 23-JUN-2009 at 9:00 am was vaccinated with the first dose of PNEUMOVAX 23 (lot#662746/0625Y) 0/.5 ml on the left deltoid (route unknown). On 23-DEC-2008 patient had gotten PREVNAR then was to follow-up with PNEUMOVAX 23 from a recommendation from the patient's infectious disease specialist. That same date, at 3:30 pm patient came back to the office with a huge red knot on the left deltoid muscle at the injection site. The circle at the injection site was 5 inches across and 4 and 1/2 inches in height. The patient had a lot of pain, the red knot is a little red and it was swollen. Patient's pulse oximeter measurement was 100%. Patient was told to take BENADRYL and ibuprofen for the pain and swelling. At the time of this report patient had not yet recovered. Follow-up information received from the registered nurse practitioner via vaccine adverse experience report. It was reported that on 23-JUN-2009 at 9:00 am the patient also received the third dose of GARDASIL (lot# 659054/0315Y) intramuscularly on the right deltoid, along with PNEUMOVAX 23. Concomitant therapies included penicillin and ZOLOFT. At 15:30, on that same date, the patient was seen in the office for increased swelling and erythema to site. Circular edema 5 inches width, 4 1/2 inches in height. Full range of motion, no fever. Positive for non-pitting edema, slight pain on manipulation of arm but retains full range of motion. It was clarified that swelling was only on left deltoid. Right deltoid had no reaction. On 24-JUN-2009 patient reported that arm was feeling "better"; no new signs or symptoms. Reported resolving erythema and edema. No further information is available.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Headache, Injection site swelling, Pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 47 year old female with rhinitis allergic, sinusitis recurrent and Eustachian tube dysfunction who on 29-JUN-2009 was vaccinated with the first dose of PNEUMOVAX 23 (lot # 662874/1125X). Concomitant therapy included montelukast sodium, MAXIFEN and "meramyst". On an unspecified date, the patient developed fever (102-103 degrees F), body aches, headache and swelling at the injection site. The patient was given TYLENOL without relief the symptoms. On 03-JUL-2009, the physician made a house call since the patient had not improved. The patient sought unspecified medical attention in the office, she was given prednisone and had had slow improvement. The physician was asking for a lot check since this is the second patient who has experienced an adverse reaction to this lot number (WAES: 0907USA00945). A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of two reports from the same source. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Asthma, Chest discomfort, Condition aggravated, Dyspnoea, Respiratory tract congestion
Clinical narrative: Information has been received from a registered nurse concerning a 46 year old female patient with rhinitis allergic, chronic sinusitis and asthma who on 26-JUN-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot: 662874/1125X). Concomitant therapy included dexamethasone (MSD), ADVAIR, montelukast sodium (MSD), famotidine (MSD), VENTOLIN, MAXIFEN and ASMANEX. On 28-JUN-2009, the patient developed chest tightness, shortness of breath, chest congestion, and an increase in her asthma symptoms. The patient was seen in the emergency room and was diagnosed with an asthma flare and a sinus infection. The patient was discharged to home. The physician was asking for a lot check since this is the second patient who has experienced an adverse reaction to this lot number (WAES: 0907USA00923). A lot check has been requested. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. The  lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of two reports from the same source. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Sinusitis
Clinical narrative: Information has been received from a registered nurse concerning a 46 year old female patient with rhinitis allergic, chronic sinusitis and asthma who on 26-JUN-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot: 662874/1125X). Concomitant therapy included dexamethasone (MSD), ADVAIR, montelukast sodium (MSD), famotidine (MSD), VENTOLIN, MAXIFEN and ASMANEX. On 28-JUN-2009, the patient developed chest tightness, shortness of breath, chest congestion, and an increase in her asthma symptoms. The patient was seen in the emergency room and was diagnosed with an asthma flare and a sinus infection. The patient was discharged to home. The physician was asking for a lot check since this is the second patient who has experienced an adverse reaction to this lot number (WAES: 0907USA00923). A lot check has been requested. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. The  lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of two reports from the same source. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: PER, PPV, TTOX
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 39 year old female patient with asthma and allergic reaction to erythromycin who on 08-JUL-2009 was vaccinated with her first dose of PNEUMOVAX 23 on right arm (lot # 662667/1435X). Concomitant therapy included "unspecified diphtheria", tetanus toxoid, pertussis vaccine (unspecified, left arm), "PROAIR" and diazepam. On 09-JUL-2009 the patient developed a red, hot, and painful area on her arm at injection site and body aches, headaches and dizziness. The patient had sought medical attention via phone call. A lot check for PNEUMOVAX 23 was requested. This is one of several reports received from the same source. Follow up information has been received from the registered nurse reported that the patient had recovered. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements and was released. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: PER, PPV, TTOX
Symptoms: Pain
Clinical narrative: Information has been received from a registered nurse concerning a 39 year old female patient with asthma and allergic reaction to erythromycin who on 08-JUL-2009 was vaccinated with her first dose of PNEUMOVAX 23 on right arm (lot # 662667/1435X). Concomitant therapy included "unspecified diphtheria", tetanus toxoid, pertussis vaccine (unspecified, left arm), "PROAIR" and diazepam. On 09-JUL-2009 the patient developed a red, hot, and painful area on her arm at injection site and body aches, headaches and dizziness. The patient had sought medical attention via phone call. A lot check for PNEUMOVAX 23 was requested. This is one of several reports received from the same source. Follow up information has been received from the registered nurse reported that the patient had recovered. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements and was released. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a 67 year old female with no drug allergies and no medical history on 16-JUL-2009 was vaccinated intramuscularly with the second 0.5ml dose of PNEUMOVAX 23 (lot #662667/1435X). A few hours after vaccination, the patient experienced redness, soreness, warmth, induration and severe itching at the injection site. The redness extends from the left shoulder to "about one half way down the left arm". The medical assistant is not sure if treatment was prescribed. At the time of reporting, the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a 65 years old female with sulfonamide allergy and no medical history who on 15-JUL-2009 was vaccinated intramuscularly with the second 0.5mL dose of PNEUMOVAX 23 (lot# 662667/1435X). There was no concomitant medication. On 15-JUL-2009 the patient experienced redness, soreness and warmth at the injection site several hours after receiving her second dose of PNEUMOVAX 23. The patient was seen in the office of 16-JUL-2009 and the redness extends from the right shoulder to the right elbow. The medical assistant is not sure if treatment was prescribed. At the time of reporting, the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Abasia, Arthropathy, Dysstasia, Fall, Guillain-Barre syndrome
Clinical narrative: Information has been received from a medical assistant concerning a 71 year old male with codeine allergy who on 22-APR-2009 was vaccinated with a 0.5 mL dose of PNEUMOVAX 23 (lot #661897/1333X), intramuscularly into the right deltoid. Secondary suspect therapy given on 22-APR-2009 included a dose of Tdap (unspecified). Concomitant therapy included CRESTOR, NIASPAN, triamterene, hydrochlorothiazide (manufacturer unknown), aspirin, METROGEL, ranitidine, ezetimibe (MSD), metoprolol, NORVASC and colchicine. There was no illness at the time of vaccination. There were no adverse events following prior vaccination. The patient developed GUILLAIN-BARRE SYNDROME on 26-MAY-2009. The patient fell because his knees buckled. He experienced weakness in his legs and numbness in his hands. The physician referred him to a neurologist. The neurologist diagnosed him with GUILLAIN-BARRE SYNDROME. The patient was admitted into a hospital on 22-JUN-2009 and was released on 09-JUL-2009. The patient's wife stated told the medical assistant that her husband almost died. He was still unable to walk and can only stand for short periods of time. The patient had X rays, and a neck and head magnetic resonance imaging ruled out stroke (results not reported). At the time of this report the patient had not recovered. GUILLAIN-BARRE SYNDROME was considered to be disabling. Additional information has been received from a medical assistant who reported that per the patient's physician, the 71 year old male patient had recovered (date unspecified). Additional information has been received from a physician who reported that on 02-JUN-2009, the patient developed GUILLAIN-BARRE SYNDROME and was hospitalized for 5 days. In August 2009 the patient recovered. GUILLAIN-BARRE was considered to be as life threatening. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Hypoaesthesia, Muscular weakness, Nuclear magnetic resonance imaging normal, X-ray
Clinical narrative: Information has been received from a medical assistant concerning a 71 year old male with codeine allergy who on 22-APR-2009 was vaccinated with a 0.5 mL dose of PNEUMOVAX 23 (lot #661897/1333X), intramuscularly into the right deltoid. Secondary suspect therapy given on 22-APR-2009 included a dose of Tdap (unspecified). Concomitant therapy included CRESTOR, NIASPAN, triamterene, hydrochlorothiazide (manufacturer unknown), aspirin, METROGEL, ranitidine, ezetimibe (MSD), metoprolol, NORVASC and colchicine. There was no illness at the time of vaccination. There were no adverse events following prior vaccination. The patient developed GUILLAIN-BARRE SYNDROME on 26-MAY-2009. The patient fell because his knees buckled. He experienced weakness in his legs and numbness in his hands. The physician referred him to a neurologist. The neurologist diagnosed him with GUILLAIN-BARRE SYNDROME. The patient was admitted into a hospital on 22-JUN-2009 and was released on 09-JUL-2009. The patient's wife stated told the medical assistant that her husband almost died. He was still unable to walk and can only stand for short periods of time. The patient had X rays, and a neck and head magnetic resonance imaging ruled out stroke (results not reported). At the time of this report the patient had not recovered. GUILLAIN-BARRE SYNDROME was considered to be disabling. Additional information has been received from a medical assistant who reported that per the patient's physician, the 71 year old male patient had recovered (date unspecified). Additional information has been received from a physician who reported that on 02-JUN-2009, the patient developed GUILLAIN-BARRE SYNDROME and was hospitalized for 5 days. In August 2009 the patient recovered. GUILLAIN-BARRE was considered to be as life threatening. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 36 year old male with no pertinent medical history and no drug allergies who on 13-AUG-2009 was vaccinated with a 0.5ml dose of PNEUMOVAX (lot # 662842/1296X).  There was no concomitant medication.  On 13-AUG-2009 the patient developed "raised and lump" at the injection site which was painful.  The patient couldn't lift his arm.  The next day the physician gave the patient a shot of DEPO-MEDROL (manufacturer unknown) 40mg and LEVAQUIN (manufacturer unknown).  Unspecified medical attention was sought.  No lab diagnostic studies were performed.  At the time of the report, the patient had not recovered.  Follow-up information has been received from a health professional concerning a 38 year old (also reported as 36 year old) male patient with no drug allergies and no medical history who at 11:00 AM on 13-AUG-2009 was vaccinated with the first dose PNEUMOVAX (lot #662842/1296X) IM into the left deltoid.  By evening around 1:00 PM on 13-AUG-2009, the patient's arm was too sore to lift, red, swollen and painful.  Next day, there was an approximately 4 inch size swollen redness raised.  The redness was going from the left deltoid to the patient's under arm.  It was very painful under arm.  The patient was given a 40mg dose of DEPO-MEDROL IM into the right glut and a treatment with LEVAQUIN (manufacturer unknown).  On 16-AUG-2009, the patient recovered.  Follow-up information has been received from a health professional indicated that the patient with no per-existing allergies, birth defects, medical conditions who was in for healthy male exam.  The patient was vaccinated with PNEUMOVAX at 11:00am on 13-AUG-2009.  By evening the patient's arm was too sore to lift, red, swollen and painful.  Next day there were approximately four swollen red raised redness going from the deltoid to under arm.  It was very painful under arm.  The patient was given 40 mg dose of DEPO-MEDROL IM into the right glut and a treatment with LEVAQUIN (manufacturer unknown).  The patient had sought medical attention, doctor visit.  There were no relevant diagnostic tests performed.  On 16-AUG-2009, the patient recovered.  Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Chest X-ray, Cough, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 65 year old male patient with chronic gingivitis who on 28-AUG-2009 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 662667/1435X). Concomitant therapy included ASPIRINE and a tetracycline medication. On 28-AUG-2009 the patient developed achiness, cough and fever as high as 102.4 F. Chest X ray was performed and the result was inconclusive. The patient sought medical attention with the physician by call and office visit. The patient was treated with ZITHROMAX. At the time of the report the patient was recovering. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Oedema peripheral
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old male patient with sulfonamide allergy and a history of immunodeficiency who on 30-AUG-2009 was vaccinated with PNEUMOVAX 23 (lot # 662667/1435X) (unspecified dose and route). The nurse practitioner reported that then developed a swollen arm and cellulitis at the injection site. The patient sought medical attention in a clinic for follow up. At the time of this report the patient's outcome was recovering. Follow up information has been received from the nurse practitioner concerning the 19 year old male patient with common variable immunodeficiency who on 30-AUG-2009 was vaccinated with a dose of PNEUMOVAX 23, subcutaneous route in the left upper arm at 2:45 pm. There was no illness at the time of vaccination. It was unknown if the patient experienced an adverse event following prior vaccination. The nurse practitioner reported that 2-3 days later, on approximately 01-SEP-2009, the patient developed swelling in his left arm and was diagnosed with cellulitis. The patient did not required hospitalization. At the time of this report the patient's outcome was unknown. Follow up information has been received from the nurse practitioner concerning the 19 year old male patient who on 30-AUG-2009 was vaccinated with a dose of PNEUMOVAX 23. The nurse stated that a phone call was received from the patient's mother 3-4 days after giving the PNEUMOVAX 23 and she said that the patient was diagnosed with cellulitis at the injection site and he "was doing ok". No further information is expected.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Laboratory test abnormal, Mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a 69 year old female with no known drug allergies and no reported medical history, who on 01-SEP-2009 was vaccinated with the second dose of PNEUMOVAX 23 (Lot # 662905/1162X) 0.5 ml, I.M. There was no concomitant medication. On 01-SEP-2009 the patient's arm turned red, was sore and had decreased mobility after administration of her second dose of PNEUMOVAX 23. She later experienced excruciating pain and her arm became very red. The patient was examined by her primary care physician and diagnosed with cellulitis. The patient stated to the pharmacist that a test to confirm cellulitis was performed. The patient was treated with AUGMENTIN. As of 11-SEP-2009, the patient was recovering. Follow-up information was received from another staff pharmacist, who reported that on 01-SEP-2009 the patient also received a flu shot (97841P2A). On 16-SEP-2009, the physician's office receptionist pulled the chart and reported that the patient was seen on 02-SEP-2009 and was given a prescription for AUGMENTIN. The patient's recovery status was unknown, as the patient has not been heard from since the 02-SEP-2009 office visit. The patient's arm sore, turned red, decreased mobility and cellulitis were considered to be disabling by the reporting pharmacist because the patient could not move her arm. This is one of two reports from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old female patient who on 17-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23 and developed a localized rash on her arm. Follow up information has been received from a health professional concerning a 66 year old female retired nurse with no known allergies and a history of pain, swelling and redness after vaccination with tetanus toxoid vaccine (manufacturer unknown), who on 16-SEP-2009 (also reported by a pharmacist as on 17-SEP-2009) was vaccinated IM with a first dose of PNEUMOVAX 23 into the right arm in the morning (AM) (lot number: 661577/1161X). There was no illness at the time of vaccination. On 16-SEP-2009 at 18:00, the patient developed chills, low grade fever, entire upper arm hot and swollen. The health professional reported that two days later, the patient had red band around arm and she was still sore but she reported that she was getting better. At the time of the report the outcome of for chills, low grade fever, entire upper arm hot and swollen, red band around arm and arm sore was reported as recovered. Additional information is no expected.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old female patient who on 17-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23 and developed a localized rash on her arm. Follow up information has been received from a health professional concerning a 66 year old female retired nurse with no known allergies and a history of pain, swelling and redness after vaccination with tetanus toxoid vaccine (manufacturer unknown), who on 16-SEP-2009 (also reported by a pharmacist as on 17-SEP-2009) was vaccinated IM with a first dose of PNEUMOVAX 23 into the right arm in the morning (AM) (lot number: 661577/1161X). There was no illness at the time of vaccination. On 16-SEP-2009 at 18:00, the patient developed chills, low grade fever, entire upper arm hot and swollen. The health professional reported that two days later, the patient had red band around arm and she was still sore but she reported that she was getting better. At the time of the report the outcome of for chills, low grade fever, entire upper arm hot and swollen, red band around arm and arm sore was reported as recovered. Additional information is no expected.
Age: 72.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dizziness, Dysphonia, Erythema, Fatigue, Feeling hot
Clinical narrative: Information has been received from a 72 year old female patient with gout, hypertension, cholesterol high and seasonal allergies who on Wednesday 23-SEP-2009 was vaccinated with the first dose of PNEUMOVAX 23 in right arm. Concomitant vaccination administered on the same day included a dose of influenza vaccine (unspecified) in left arm. Concomitant therapy included high blood pressure pill, water pill, gout medicine and cholesterol medicine. On 22-SEP-2009, the patient was given an allergy shot in her right arm. On Thursday 24-SEP-2009 the patient's right arm was swollen "half way around it, redness and it was itchy". It was reported that the patient also felt warmness in her chest, her throat was hoarse. And the patient felt tired and dizzy. The patient went to see the pharmacist who called her doctor. The doctor said to take TYLENOL and ice packs. There were no laboratory diagnostic studies performed. At the time of the report, the patient had not recovered. No further information is available.
Age: 72.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: Information has been received from a 72 year old female patient with gout, hypertension, cholesterol high and seasonal allergies who on Wednesday 23-SEP-2009 was vaccinated with the first dose of PNEUMOVAX 23 in right arm. Concomitant vaccination administered on the same day included a dose of influenza vaccine (unspecified) in left arm. Concomitant therapy included high blood pressure pill, water pill, gout medicine and cholesterol medicine. On 22-SEP-2009, the patient was given an allergy shot in her right arm. On Thursday 24-SEP-2009 the patient's right arm was swollen "half way around it, redness and it was itchy". It was reported that the patient also felt warmness in her chest, her throat was hoarse. And the patient felt tired and dizzy. The patient went to see the pharmacist who called her doctor. The doctor said to take TYLENOL and ice packs. There were no laboratory diagnostic studies performed. At the time of the report, the patient had not recovered. No further information is available.
Age: 49.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 49 year old patient who on 24-SEP-2009 in the morning was vaccinated with a dose of PNEUMOVAX 23 (lot #663889/0632Y). On 24-SEP-2009 in the afternoon the patient developed "red, warm and swollen arm from the bicep to the elbow, at the injection site where the vaccine was given." The patient spoke to the pharmacist. At the time of the report, the patient had not recovered. No further information is available.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a registered pharmacist concerning a 68 year old female patient with allergy to penicillin and codeine who at 16:30, on 25-SEP-2009 was vaccinated with a SC dose of PNEUMOVAX 23 (lot# 662314/0037Y). On the same day, the patient also received a IM dose of AFLURIA (lot # 06549UA). There was no illness at time of vaccination. On 26-SEP-2009 ("after two days"), the patient experienced a two inch round red painful ring around site of injection which increased to three inches at the third day. At the time of reporting, the patient recovered. The patient sought medical attention. Additional information is not expected.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient with penicillin allergy who in approximately 2001 "possibly 8 years ago", was vaccinated IM in the left arm with a dose 0.5 mL of PNEUMOVAX 23 (LOT # 661528/0867X). Concomitant therapy included influenza virus vaccine (unspecified). It was reported that on 03-OCT-2009 the patient developed redness and swelling on her left arm after receiving PNEUMOVAX 23. The patient was seen for an office visit. No laboratory or diagnostic tests were performed. The patient's final outcome was not reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 55 year old female with asthma and latex allergy who on 25-SEP-2009 was vaccinated with a 0.5ml dose of PNEUMOVAX 23 (lot # 663152/0024Y) IM. Concomitant therapy included PROAIR, montelukast sodium, ADVAIR, vitamin D (unspecified) and omega-3 marine triglycerides. On 26-SEP-2009 the patient experienced injection site redness, pain and swelling. There were no labs and diagnostic tests performed. The patient visited the office for medical attention. At the time of the report, the patient recovered, date unspecified. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 19 year old female with chronic asthma and no allergies, who on 16-SEP-2009 was vaccinated with a 0.5ml dose of PNEUMOVAX 23 (lot # 663152/0024Y) IM. Concomitant therapy included ZYRTEC,  PROAIR, ORTHO-CYCLEN and vitamin D (unspecified). On 17-SEP-2009 the patient experienced injection site redness and swelling. She also had fever. She went to the emergency room and was diagnosed with cellulitis. She was treated with KEFLEX and another unspecified antibiotic. Labs and diagnostic tests included complete blood count and chest X-ray tested for influenza and strep, result not reported. At the time of the report, the patient recovered on an unspecified date. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Injection site inflammation, Pyrexia, Skin warm
Clinical narrative: Information has been received from a registered nurse concerning a 64 year old male with allergic reaction to penicillin and a possible history of stent, who on 05-OCT-2009 was vaccinated intramuscularly in the right upper arm with a 0.5 ml dose of PNEUMOVAX 23 (lot # 662268/1134Y).  The same day the patient was vaccinated with a dose of AFLURIA in the left upper arm.  The nurse reported that when the employee returned to health facility on 07-OCT-2009 had inflammation below the injection site along with fever and chills.  The lower quarter of his upper arm into his forearm near his elbow was red and warm.  The nurse practitioner prescribed KEFLEX.  The employee was asked to come back the following day to health facility but if it was any worse to go to the emergency room.  The employee returned to health facility the next day and the symptoms improved on the proximal end but going into his forearm his symptoms were spreading.  The employee was sent to the emergency room.  It was unspecified if the employee had had PNEUMOVAX 23 in the past.  No further information is available.
Age: 51.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 51 year old male with asthma and no drug reactions/allergies who on 05-OCT-2009 was vaccinated intramuscularly in the left distal arm (deltoid region) with one dose of PNEUMOVAX 23 (lot # 662268/1134Y). The same day the patient was vaccinated in the left arm (different location than the PNEUMOVAX 23) with a dose of influenza virus vaccine(manufacturer unspecified). On 07-OCT-2009 and 08-OCT-2009 the patient developed chills and fever. The patient was seen on 09-OCT-2009 by the nurse practitioner and the injection site was red and warm. At the time of the report the patient was recovering. No laboratory diagnostics studies were performed. This is one of two reports received from the same source. No further information is available.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injected limb mobility decreased, Oedema peripheral
Clinical narrative: Information has been received from a licensed practical nurse with asthma who in mid October 2009 was vaccinated with the first 0.5ml dose of PNEUMOVAX 23 IM. A few hours after the vaccination, the patient developed cellulitis. The cellulitis impaired mobility of the arm and was from the shoulder to the elbow. The patient was treated with KEFLEX and the reaction resolved in about 5 days time. At the time of the report, the patient recovered. Follow-up information has been received from a 51 year old female licensed practical nurse with mild intermittent asthma and no illness at time of vaccination concerning herself who on 13-OCT-2009 was vaccinated with the first dose of PNEUMOVAX 23 (lot# 663214/0037Y) IM in the left deltoid. Concomitant therapy included FLOVENT 44, 2 puffs twice a day. On 13-OCT-2009 at 16:00, the patient experienced significant peripheral edema of left arm and arm immobility. The patient visited the doctor. The treatment was prednisone, KEFLEX, arm sling and ibuprofen (doses and duration of treatment therapy was not reported). The edema persisted for 4 days and the arm immobility lasted 3 days. There were no labs or diagnostic tests performed. The patient was reported as recovered on 18-OCT-2009. It was noted that the patient did not have any adverse event following prior vaccination. The cellulitis, peripheral edema of left arm and impaired mobility of the arm were considered to be other important medical events by the reporter. This is one of several reports from the same source. No further information is available. This is an amended report. The stop date of "edema arms" was changed to 16-OCT-2009. The stop date of "impaired mobility of the arm" was changed to 15-OCT-2009. The duration of "cellulitis" was changed to 6 days. For all the adverse events, disability was changed to No. This is an amended report. The source type of the primary and initial reporter has been changed from "Consumer" to "Other Health Professional".
Age: 49.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Ear disorder, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: Information has been received from a registered nurse concerning a 49 year old male with no known drug allergies and a history of hepatitis c who in 2001 and on 05-OCT-2009 was vaccinated IM with the first and second (lot#662268/1134Y) doses of PNEUMOVAX 23. Concomitant vaccination on 05-OCT-2009 included AFLURIA. Other concomitant therapy included interferon (unspecified) and ribavirin. On 06-OCT-2009 the patient experienced severe flu like symptoms, frontal headache, total body ache, sweating, sensitivity to light and sound, high fever of 102F, and chills. No lab diagnostic study was performed. On 08-OCT-2009, the patient recovered. Follow up information has been received from a nurse practitioner who reported that all the patient's symptoms resolved 2 days after received PNEUMOVAX 23. No further follow-up reported. No further information is available.
Age: 49.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain, Photophobia, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 49 year old male with no known drug allergies and a history of hepatitis c who in 2001 and on 05-OCT-2009 was vaccinated IM with the first and second (lot#662268/1134Y) doses of PNEUMOVAX 23. Concomitant vaccination on 05-OCT-2009 included AFLURIA. Other concomitant therapy included interferon (unspecified) and ribavirin. On 06-OCT-2009 the patient experienced severe flu like symptoms, frontal headache, total body ache, sweating, sensitivity to light and sound, high fever of 102F, and chills. No lab diagnostic study was performed. On 08-OCT-2009, the patient recovered. Follow up information has been received from a nurse practitioner who reported that all the patient's symptoms resolved 2 days after received PNEUMOVAX 23. No further follow-up reported. No further information is available.
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Information has been received from a nurse concerning a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23, 0.5 mL (route and lot # unknown), after vaccination the patient's whole arm was red and very sore. No lab diagnostics studies performed. The patient sought unspecified medical attention. At the time of this report the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23, 0.5 mL (route and lot # unknown), after vaccination the patient's whole arm was red and very sore. No lab diagnostics studies performed. The patient sought unspecified medical attention. At the time of this report the patient's outcome was unknown. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Information has been received from a medical assistant concerning a 74 year old male patient with hypercholesterolaemia and allergic to LIPITOR and PRAVACHOL who on 16-OCT-2009 was vaccinated intramuscularly with a 0.5ml dose of PNEUMOVAX 23 (lot# 665400/1315Y).Concomitant therapy included omega-3 marine triglycerides,
Age: 74.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a 74 year old male patient with hypercholesterolaemia and allergic to LIPITOR and PRAVACHOL who on 16-OCT-2009 was vaccinated intramuscularly with a 0.5ml dose of PNEUMOVAX 23 (lot# 665400/1315Y).Concomitant therapy included omega-3 marine triglycerides,
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Burning sensation, Immediate post-injection reaction, Injection site pain
Clinical narrative: Information has been received from a medical assistant concerning a 79 year old male with no illness at the time of vaccination and hypercholesterolaemia and drug reactions or allergies to benazepril, CRESTOR and indapamide who on 19-OCT-2009 at approximate 11:00 am was vaccinated in the deltoid with the first 0.5 ml dose of PNEUMOVAX 23 intramuscularly (Lot# 665400/1315Y). Concomitant therapy included LIPITOR, ezetimibe (MSD), fish oil, aspirin and slow K. The reporter mentioned that the patient later that day was experiencing "unusual pain" at the injection site of the right upper arm. No treatment was recommended. No laboratory or test diagnostics were performed. The patient called to the medical office on an unspecified date. At the time of reporting the patient's outcome was unknown. A standard lot check investigation had 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 physician who reported that the retired physician experienced immediate burning pain in injected arm that radiated gradually throughout his ipsilateral arm and forearm for 1x5 days. There were no laboratory diagnostic studies performed. At the time of the report, the patient recovered. No further information is expected.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a 76 year old female patient with no illness at the time of vaccination and no pre-existing allergies, birth defects or medical conditions, who on 27-OCT-2009 was vaccinated intramuscularly in the right deltoid with the second dose of PNEUMOVAX 23 (lot# 664000/0621Y). On 28-OCT-2009, the patient experienced "redness, warmth and a swollen area where the vaccine was given". "The size of the redness was 10cm but it was spread out." The patient visited the office for medical attention. It was unknown if any laboratory diagnostic studies were performed. At the time of the report, the patient had not recovered. Follow up information has been received from the medical assistant who reported that on 27-OCT-2009 (same day as PNEUMOVAX 23) the patient was vaccinated intramuscularly in the left deltoid with the sixth dose of influenza virus vaccine (Sanofi, lot number U3264DA). On 28-OCT-2009 the patient experienced a reaction to PNEUMOVAX 23 consisted of redness, warm to touch and swollen. It was unknown if the patient recovered. No further information is expected.
Age: 66.0
Sex: U
Vaccine: PPV, PPV
Symptoms: Cellulitis, Chills, Pyrexia, Vaccination complication
Clinical narrative: Information has been received from a claims examiner concerning a patient who on 04-DEC-2009 was vaccinated with PNEUMOVAX 23. The patient reported adverse reactions to the vaccine, resulting in hospitalization. Medical attention was unspecified. At the time of the report, the patient's status was unknown. Follow-up information has been received from the consumer indicating that they received the vaccinations at a pharmacy and were told that they did not need prescription. Follow-up information was received from a pharmacist and a pharmacy manager concerning a 66 year old patient who on 04-DEC-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot number reported as 664069/0362Y which is not valid for PNEUMOVAX 23, but is valid for ROTATEQ (MSD)). The pharmacist stated that the patient was diagnosed with cellulitis (date not reported) and was hospitalized. The pharmacy manager stated that on 05-DEC-2009 the patient was admitted to a hospital. The patient complained of chills with a fever and the patient was diagnosed with cellulitis. The patient was treated with IV antibiotics. On 06-DEC-2009 the patient was discharged and was sent home with a prescription for amoxicillin. On an unspecified date the patient was admitted to another hospital and was treated with IV ROCEPHIN. It was not reported when the patient was discharged from this hospital. It was reported that the patient recovered (date not reported). This is one of several reports received from the same source. Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: PPV, PPV
Symptoms: Cellulitis, Chills, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a claims examiner concerning a patient who on 04-DEC-2009 was vaccinated with PNEUMOVAX 23. The patient reported adverse reactions to the vaccine, resulting in hospitalization. Medical attention was unspecified. At the time of the report, the patient's status was unknown. Follow-up information has been received from the consumer indicating that they received the vaccinations at a pharmacy and were told that they did not need prescription. Follow-up information was received from a pharmacist and a pharmacy manager concerning a 66 year old patient who on 04-DEC-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot number reported as 664069/0362Y which is not valid for PNEUMOVAX 23, but is valid for ROTATEQ (MSD)). The pharmacist stated that the patient was diagnosed with cellulitis (date not reported) and was hospitalized. The pharmacy manager stated that on 05-DEC-2009 the patient was admitted to a hospital. The patient complained of chills with a fever and the patient was diagnosed with cellulitis. The patient was treated with IV antibiotics. On 06-DEC-2009 the patient was discharged and was sent home with a prescription for amoxicillin. On an unspecified date the patient was admitted to another hospital and was treated with IV ROCEPHIN. It was not reported when the patient was discharged from this hospital. It was reported that the patient recovered (date not reported). This is one of several reports received from the same source. Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: PPV, PPV
Symptoms: Cellulitis, Chills, Pyrexia, Vaccination complication
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old patient who on 04-DEC-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot number 663998/0623Y). Pharmacist stated that the patient reported having "chills, fever and soreness" at the injection site after PNEUMOVAX 23 was given. The pharmacist reported that the patient was admitted in a regional medical center on 05-DEC-2009. The patient was treated for cellulitis and then sent home. On 06-DEC-2009 the patient worsened and went to the hospital. The patient was still in the hospital on 07-DEC-2009, but the pharmacist was not sure when the patient was discharged or what the patient's current status is. Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: PPV, PPV
Symptoms: Cellulitis, Chills, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old patient who on 04-DEC-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot number 663998/0623Y). Pharmacist stated that the patient reported having "chills, fever and soreness" at the injection site after PNEUMOVAX 23 was given. The pharmacist reported that the patient was admitted in a regional medical center on 05-DEC-2009. The patient was treated for cellulitis and then sent home. On 06-DEC-2009 the patient worsened and went to the hospital. The patient was still in the hospital on 07-DEC-2009, but the pharmacist was not sure when the patient was discharged or what the patient's current status is. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site swelling, Vaccination complication
Clinical narrative: Information has been received from a claims examiner concerning a patient who on 04-DEC-2009 was vaccinated with PNEUMOVAX 23. The patient reported adverse reactions to the vaccine, resulting in hospitalization. Medical attention was unspecified. At the time of the report, the patient's status was unknown. Follow-up information has been received from the consumer indicating that they were told that they did not need prescription for the PNEUMOVAX given at the pharmacy. Follow-up information was received from a pharmacist and a pharmacy manager concerning the 72 year old male patient who on 04-DEC-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot number reported as 664069/0362Y which is not valid for PNEUMOVAX 23, but is valid for ROTATEQ (MSD)). The pharmacist stated that the patient was diagnosed with cellulitis (date not reported) and was hospitalized. The pharmacy manager stated that the patient had swelling at the injection site. The patient was not treated and was not hospitalized. The patient reported that he had "cellulitis". The patient recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Hypoaesthesia, Muscle spasms, Pain in extremity
Clinical narrative: Pt. reports continued left arm pain with numbness.  Reports muscle spasms in left arm.  Chiropractor has adjusted back & arm without relief.  Unable to diagnose source of pain.  Referred back to health department by chiropractor.  Has not seen a medical or orthopedic doctor yet.