chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Erythema, Headache, Hypokinesia, Pain in extremity
Clinical narrative: Information has been received from a health professional concerning a 39 year old male with irritable bowel syndrome, anxiety, arthritis, and no known drug allergies who on 07-NOV-2007 was vaccinated in the deltoid with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (Lot# 658451/0963U). Concomitant suspect therapy included finasteride, tablet. Other concomitant therapy included EFFEXOR and PROTONIX. On 07-NOV-2007, the patient experienced a fever, difficulty breathing, soreness of the arm, and difficulty moving the arm. On 12-NOV-2007, the patient was seen in the office and has another appointment to be seen again. No laboratory diagnostics were performed. At the time of the report, the outcome of the patient was unknown. No product quality was involved. Additional information is not expected. This is in follow-up to report (s) previously submitted on 7/10/2008.  Follow-up information received from a medical assistant indicated that he was a 39 year old male patient, weighing 175.8 pounds and 69 inches in height, who in the afternoon of 07-NOV-2007, was vaccinated with the first dose of PNEUMOVAX (Lot # 658451/0963U), 0.5 mL in the left deltoid.  There was an unspecified physical symptom at the time of vaccination.  On 08-NOV-2007 at 2:30 AM, the patient experience fever, soreness to left deltoid, decrease PPT 63%, redness to left deltoid, headache.  Treatment given to the patient was : TORADOL 60 mg, NAPROXEN 300 mg, VENTOLIN HFA and PREDNISONE.
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 39 year old male with irritable bowel syndrome, anxiety, arthritis, and no known drug allergies who on 07-NOV-2007 was vaccinated in the deltoid with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (Lot# 658451/0963U). Concomitant suspect therapy included finasteride, tablet. Other concomitant therapy included EFFEXOR and PROTONIX. On 07-NOV-2007, the patient experienced a fever, difficulty breathing, soreness of the arm, and difficulty moving the arm. On 12-NOV-2007, the patient was seen in the office and has another appointment to be seen again. No laboratory diagnostics were performed. At the time of the report, the outcome of the patient was unknown. No product quality was involved. Additional information is not expected. This is in follow-up to report (s) previously submitted on 7/10/2008.  Follow-up information received from a medical assistant indicated that he was a 39 year old male patient, weighing 175.8 pounds and 69 inches in height, who in the afternoon of 07-NOV-2007, was vaccinated with the first dose of PNEUMOVAX (Lot # 658451/0963U), 0.5 mL in the left deltoid.  There was an unspecified physical symptom at the time of vaccination.  On 08-NOV-2007 at 2:30 AM, the patient experience fever, soreness to left deltoid, decrease PPT 63%, redness to left deltoid, headache.  Treatment given to the patient was : TORADOL 60 mg, NAPROXEN 300 mg, VENTOLIN HFA and PREDNISONE.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning "2 or three out of five" elderly male patients "usually in their 70's," who, on unspecified dates, were vaccinated with doses of pneumococcal 23v polysaccharide vaccine (Lot# 658555/0964U). It was reported that most of the patients were previously vaccinated with pneumococcal 23v polysaccharide vaccine five years ago or more. Subsequently, the patients experienced swelling, pain, and tenderness in the injected arm. It was reported that the symptoms would sometimes spread to the underarm. The patients either called the office or were seen at the office. The patients were advised to use ice and TYLENOL if necessary. The patients recovered on unspecified dates. No product quality complaint was involved. This is one of five reports from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old female with a penicillin and cephalosporin allergy who on approximately 09-NOV-2007 was vaccinated intramuscularly with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (Lot #"0991U"). Concomitant vaccination on the same day included influenza virus vaccine (unspecified) (manufacturer unknown) into the other arm. On 09-NOV-2007, the patient developed swelling in both arms. On 20-NOV-2007, the patient was seen by the physician. She was treated with BENADRYL and heat pads. The patient contacted the pharmacist. On 12-NOV-2007, the patient recovered. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Tenderness
Clinical narrative: Information has been received from a certified medical assistant concerning a 74 year old female patient with hypothyroidism, hypercholesterolaemia, an allergy to IV dye and drug hypersensitivity's to ACTIFED, PAXIL and LIPITOR (the reporter stated that the patient is currently on PAXIL and LIPITOR even though both are listed as allergies) who on 14-NOV-2007, was vaccinated subcutaneously with a second dose of pneumococcal 23v polysaccharide vaccine (Lot# 658673/0990U). Concomitant therapy included SYNTHROID, lorazepam, PAXIL, LIPITOR, ZANTAC, and DULCOLAX. On 15-NOV-2007, after her second dose with the vaccine, the patient developed redness and tenderness. The patient's arm was sore with a red area about the size of 4 by 8 inches. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient's outcome was unknown. It was also reported that on 15-OCT-1997, the patient was vaccinated IM with a first dose of pneumococcal 23v polysaccharide vaccine (Lot# reported as "435-954"). No product quality complaint was involved. Additional information is not expected.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site streaking, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a 72 year old white male with no relevant medical history, allergies or illness at time of vaccination who on 24-OCT-2007 was vaccinated in the left deltoid muscle (route not reported) with a 2nd dose of the pneumococcal 23v polysaccharide vaccine (lot#658493/0991U). There was no concomitant medication usage. On 25-OCT-2007, 1 day post vaccination, the patient developed swelling, increased redness, heat and red streaks at the injection site. No diagnostic lab test were performed. The patient recovered on an unspecified date. No additional information is expected.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial and follow up information has been received from a Licensed Visiting Nurse concerning a 50 year old male patient, who on an unknown date was given a dose of pneumococcal 23v polysaccharide vaccine by the intravenous route, while at a dialysis clinic. No symptoms were noted. No further information was provided. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning an elderly patient (gender unknown) "usually in their 70's" with an allergy to penicillin, who, on an unspecified date, was vaccinated with dose of pneumococcal 23v polysaccharide vaccine (Lot# 658555/0964U). Subsequently, the patient experienced swelling, pain, and tenderness in the injected arm. It was reported that the symptoms may have spread to the underarm. The patient either called the office or was seen at the office. The patient were advised to use ice and TYLENOL if necessary. The patient recovered on an unspecified  date. No product quality complaint was involved. This is one of five reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning an elderly patient (gender unknown) "usually in their 70's," who, on an unspecified date, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot#658555/0964U). Subsequently, the patient developed welts. The patient called the office. The patient was advised to use ice and TYLENOL if necessary. The patient recovered on unspecified dates. No product quality complaint was involved. This is one of five reports from the same source. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local reaction, Pain, Swelling
Clinical narrative: Information has been received from a pharmacist concerning a male patient who on 20-NOV-2007 was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot# 657039/0698U). On approximately 20-NOV-2007, within 24 hours of receiving the vaccine, the patient developed a localized reaction of redness, swelling and pain. Recovery status of the patient was not reported. The patient sought unspecified medical treatment. It was reported that this patient may be a liver failure patient. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Pain, Swelling
Clinical narrative: Information has been received from a pharmacist concerning a male patient who on 08-NOV-2007 was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot# 655669/1128F). On approximately 09-NOV-2007, within 24-48 hours of receiving the vaccine, the patient developed pain, swelling, and cellulitis. Recovery status of the patient was not reported. The patient sought unspecified medical attention. It was reported that this patient may be a liver failure patient. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a Nurse Practitioner concerning a female patient in her 70's who was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine. The physician reported that the patient who received the injection experienced "arm swelling at the injection site." The patient sought unknown medical intervention. No further information was provided. The outcome was unknown. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain, Influenza like illness, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a healthcare worker concerning a male patient who sometime between 26-OCT-2007 and 03-DEC-2007, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot# 658555/0964U). Subsequently, within 24 hours of receiving the vaccine, the patient experienced localized reaction around the injection site, pain and swelling. The patient also experienced flu-like symptoms of fever and abdominal pain for 72 hours. Blood work was done but results were not reported. The patient was seen in the office for unspecified medical attention. Subsequently, on an unspecified date, the patient recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a healthcare worker concerning a patient who sometime between 26-OCT-2007 and 03-DEC-2007, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot# 658555/0964U). Subsequently, within 24 hours of receiving the vaccine, the patient experienced localized reaction around the injection site, pain and swelling. The patient was seen in the office for unspecified medical attention. Subsequently, on an unspecified date, the patient recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a health care professional concerning a patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine lot # 659083/1418U. Subsequently, the patient experienced a reaction around the injection site extended to forearm. The outcome was unknown. The health care worker has requested a lot check. 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 release. Follow up telephone message received from the pharmacist. She reported that they were initially concerned about the lot as they saw a few reactions. However, they had since decided there was nothing wrong with the lot and were no longer interested in a lot check. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a healthcare worker concerning a female who sometime between 26-OCT-2007 and 03-DEC-2007, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot# 658555/0964U). Subsequently, within 24 hours of receiving the vaccine, the patient experienced localized reaction around the injection site, pain and swelling. The patient was seen in the office for unspecified medical attention. Subsequently, on an unspecified date, the patient recovered. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Muscular weakness, Pain in extremity
Clinical narrative: Information has been received from a physician concerning his 80 year old female neighbor (not his patient) who in approximately November 2007, was vaccinated IM with a 2nd dose of pneumococcal 23v polysaccharide vaccine. Subsequently, she developed an injection site reaction, the symptoms included low fever, local tenderness and or pain, arm weakness, swelling and redness. She told her neighbor (physician) but it was unknown if she sought medical attention. At the time of the report the patient was improving. She had received a first dose of pneumococcal 23v polysaccharide vaccine approximately one year ago. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning his 80 year old female neighbor (not his patient) who in approximately November 2007, was vaccinated IM with a 2nd dose of pneumococcal 23v polysaccharide vaccine. Subsequently, she developed an injection site reaction, the symptoms included low fever, local tenderness and or pain, arm weakness, swelling and redness. She told her neighbor (physician) but it was unknown if she sought medical attention. At the time of the report the patient was improving. She had received a first dose of pneumococcal 23v polysaccharide vaccine approximately one year ago. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Hyperaemia, Oedema, Swelling, Tenderness
Clinical narrative: Information has been received concerning a 75 year old male with no pertinent medical history, who on 22-OCT-2007 was vaccinated IM in the right deltoid, with a second dose of pneumococcal 23v polysaccharide vaccine (lot #658449/0989U) (first dose administered in 1999). There was no illness at the time of vaccination. On 23-OCT-2007, at 8:00 am, the patient developed "swelling, edema, hyperemia were significant, tenderness minor." Treatment included quinolones (manufacturer not specified) for 5 days, and the patient recovered within 3 days. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Hyperaemia, Immediate post-injection reaction, Oedema, Rash, Swelling
Clinical narrative: Information has been received concerning a 75 year old male with no pertinent medical history, who on 22-OCT-2007 was vaccinated IM in the right deltoid, with a second dose of pneumococcal 23v polysaccharide vaccine (lot #658449/0989U) (first dose administered in 1999). There was no illness at the time of vaccination. On 23-OCT-2007, at 8:00 am, the patient developed "swelling, edema, hyperemia were significant, tenderness minor." Treatment included quinolones (manufacturer not specified) for 5 days, and the patient recovered within 3 days. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Hyperaemia, Oedema, Swelling, Tenderness
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient developed a rash. The rash started to appear immediately after the administration of the vaccine and spread across the entire arm. The rash appeared on the arm where the vaccine was administered but it was unknown whether it was the right or left arm. At the time of this report the outcome was unknown. No product quality complaint was involved. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 7/30/2008.  Information has been received from a physician concerning a 75 year old retired male patient with no medical history of drug allergies reported, who on 22-OCT-2007 was vaccinated intramuscularly into the right deltoid with a second dose of PNEUMOVAX (Lot # 658449/0989U.)  It was reported that the first dose of PNEUMOVAX was given in 1999.  On 23-OCT-2007 at 08:00, the patient developed a rash, swelling, edema and hyperemia which were significant.  Tenderness was minor.  The rash started to appear immediately after the administration of the vaccine and spread across the entire arm.  The rash appeared on the arm where the vaccine was administered.  The patient was treated with quinolones for five days and recovered within three days.  No product quality complaint was involved.  No further information is available.
Age: 75.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Hyperaemia, Immediate post-injection reaction, Oedema, Rash, Swelling
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient developed a rash. The rash started to appear immediately after the administration of the vaccine and spread across the entire arm. The rash appeared on the arm where the vaccine was administered but it was unknown whether it was the right or left arm. At the time of this report the outcome was unknown. No product quality complaint was involved. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 7/30/2008.  Information has been received from a physician concerning a 75 year old retired male patient with no medical history of drug allergies reported, who on 22-OCT-2007 was vaccinated intramuscularly into the right deltoid with a second dose of PNEUMOVAX (Lot # 658449/0989U.)  It was reported that the first dose of PNEUMOVAX was given in 1999.  On 23-OCT-2007 at 08:00, the patient developed a rash, swelling, edema and hyperemia which were significant.  Tenderness was minor.  The rash started to appear immediately after the administration of the vaccine and spread across the entire arm.  The rash appeared on the arm where the vaccine was administered.  The patient was treated with quinolones for five days and recovered within three days.  No product quality complaint was involved.  No further information is available.
Age: 13.0
Sex: F
Vaccine: PPV
Symptoms: Allergy test, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning an approximately 13 year old female patient who on approximately 16-DEC-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The physician reported that approximately six hours after receiving the pneumococcal 23v polysaccharide vaccine patient developed generalized swelling in the same arm that the vaccine was given. This swelling lasted for approximately 18 hours and then went away. It was reported that the "patient was currently undergoing testing by an allergist for titer." Unspecified medical attention was sought by the patient. No further information was provided regarding this. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a 64 year old white female with adult onset diabetes, hypertension, arthritis, depression and allergy to aspirin. On an unspecified date, the patient was previously vaccinated with pneumococcal 23v polysaccharide vaccine (the number of previous doses was unknown). On 15-JAN-2008, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (lot # 659150/1384U) 0.5 mL IM in the right arm at 3 PM. Concomitant therapy included simvastatin (MSD), EFFEXOR, COREG and metformin. On 15-JAN-2008, the night of the injection, the patient developed pain, and redness and swelling from the injection site to the elbow. The patient was having trouble moving her arm due to the pain. The patient sought medical attention (office visit). No diagnostic tests were performed. At the time of reporting, the patient had not recovered. Follow-up information was received from the licensed practical nurse. The patient was seen by the physician on 16-JAN-2008 for these complaints and medication refills. She was treated with MEDROL dose pack and analgesics. The outcome of the events was not reported. No additional information is expected.
Age: 31.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Tuberculin test
Clinical narrative: Information has been received from a health professional concerning a 31 year old female with a history of asthma who on 07-JAN-2008 was vaccinated IM in the left deltoid with the first dose of pneumococcal 23v polysaccharide vaccine (654977/0888F). Concomitant therapy included influenza virus vaccine (unspecified) IM in the right deltoid. On approximately 07-JAN-2008 the patient experienced injection site reaction and came back to the employee health department on 09-JAN-2008. Per the reporter, the injection site reaction was very painful, warm and red. Swelling at the injection site was 11cm wide and 7 cm long. The patient sought unspecified medical attention. Subsequently, the patient recovered from injection site reaction. The patient had been treating self with BENADRYL. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Erythema, Nausea, Pain, Skin warm
Clinical narrative: Information has been received from a physician concerning his adult daughter with no drug allergies, who on 01-JAN-2008 was vaccinated intramuscularly with a dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. On 01-JAN-2008, the patient developed redness, pain, local heat, weakness and nausea a short time after being vaccinated. The patient did not seek medical attention. No laboratory diagnostics were performed. The patient recovered on an unspecified date. No product quality complaint was involved. This is one of three reports from the same source. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Erythema, Nausea, Pain, Skin warm
Clinical narrative: Information has been received from a physician concerning his adolescent son with asthma and no drug allergies, who on 01-JAN-2008 was vaccinated intramuscularly with a dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. On 01-JAN-2008, the patient developed redness, pain, local heat, weakness and nausea a short time after being vaccinated. The patient did not seek medical attention. No laboratory diagnostics were performed. The patient recovered on an unspecified date. No product quality complaint was involved. This is one of three reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PNC
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a healthcare professional concerning a patient (age and gender not specified) who was scheduled to be vaccinated with a dose of pneumococcal 23v polysaccharide vaccine, however, due to nursing error, the patient was administered PREVNAR. There were no symptoms noted. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, CD4 lymphocytes, Chest X-ray abnormal, Heart rate, Oxygen saturation
Clinical narrative: Initial and follow-up information has been received from a nurse practitioner and a 44 year old white disabled male smoker with hyperlipidemia, chronic back pain, disk disease L5 in 2006, dyslipidemia, Human Papilloma viral infection, human immunodeficiency virus, occasional alcohol use, fatigue, insomnia, and no known drug allergies, who on 21-SEP-2007 at approximately 10:00 was vaccinated IM in the right arm with a second dose of pneumococcal 23v polysaccharide vaccine. At the time of the vaccination the patient was ill with HIV, HPV, fatigue dyslipidemia and insomnia. The patient's temperature was normal at the time of the vaccination. Concomitant therapies included cyclobenzaprine hydrochloride (MSD), TRUVADA, VICODIN, LEXIVA, gemfibrozil, loperamide hydrochloride. On 21-SEP-2007 at 11:30 (also reported as between 13:00 and15:00) the patient developed a high fever of 104.6, chills, and contacted his physician (also reported to be 101.3 at noon and Friday night, then Saturday morning it was 104.6). The patient denied chest pain, nausea, vomiting, dyspnea, and dysphagia. The patient took 100mg of ADVIL as advised by his physician. The physician advised the patient to take ADVIL 600 mg, three times a day "push" fluids, and go to the emergency room if the symptoms worsened. It was reported that the patient had recently had his CD-4 count taken and it was 387. The patient denied ever having pneumocystis carinii pneumonia. The patient had no complaint of abdominal pain, no lightheadedness, or dizziness. The patient's symptoms had worsened and he went to the emergency room on 24-SEP-2007. The patient's main complaint was body aches. It was reported that the patient was awake, alert, and oriented. The patient pulse oximetry was 97% on room air, respiratory rate was 16, pulse 120, the initial blood pressure was 147/88, temperature was 100.6, re-check temperature was 100.1, the patient's skin was hot and flushed, and subtle right upper lobe infiltrate on a chest x-ray. The patient was hydrated intravascularly, given unspecified antibiotics intravenously, and given the first dose of AVELOX, intravenously. The patient was given AVELOX oral for a 10-day course of treatment. The patient was also given a albuterol/ATROVENT aerosol. The patient was diagnosed with community-acquired pneumonia in the right upper lobe, and human immunodeficiency virus by history. The follow-up plan of care was reviewed with the patient and the patient voiced an understanding of the plan. The patient was discharged from the emergency room with a family member/friend and with prescriptions for AVELOX 400 mg, hydrocodone/homatropine syrup 5/1.5mg/5mL, and albuterol inhaler 17 gm. Subsequently, on an unspecified date, the patient recovered from fever and chills. The patient recovered from pneumonia on 17-OCT-2007 and was prescribed Z-PAK. No product quality complaint was involved. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Pneumonia, Respiratory rate
Clinical narrative: Initial and follow-up information has been received from a nurse practitioner and a 44 year old white disabled male smoker with hyperlipidemia, chronic back pain, disk disease L5 in 2006, dyslipidemia, Human Papilloma viral infection, human immunodeficiency virus, occasional alcohol use, fatigue, insomnia, and no known drug allergies, who on 21-SEP-2007 at approximately 10:00 was vaccinated IM in the right arm with a second dose of pneumococcal 23v polysaccharide vaccine. At the time of the vaccination the patient was ill with HIV, HPV, fatigue dyslipidemia and insomnia. The patient's temperature was normal at the time of the vaccination. Concomitant therapies included cyclobenzaprine hydrochloride (MSD), TRUVADA, VICODIN, LEXIVA, gemfibrozil, loperamide hydrochloride. On 21-SEP-2007 at 11:30 (also reported as between 13:00 and15:00) the patient developed a high fever of 104.6, chills, and contacted his physician (also reported to be 101.3 at noon and Friday night, then Saturday morning it was 104.6). The patient denied chest pain, nausea, vomiting, dyspnea, and dysphagia. The patient took 100mg of ADVIL as advised by his physician. The physician advised the patient to take ADVIL 600 mg, three times a day "push" fluids, and go to the emergency room if the symptoms worsened. It was reported that the patient had recently had his CD-4 count taken and it was 387. The patient denied ever having pneumocystis carinii pneumonia. The patient had no complaint of abdominal pain, no lightheadedness, or dizziness. The patient's symptoms had worsened and he went to the emergency room on 24-SEP-2007. The patient's main complaint was body aches. It was reported that the patient was awake, alert, and oriented. The patient pulse oximetry was 97% on room air, respiratory rate was 16, pulse 120, the initial blood pressure was 147/88, temperature was 100.6, re-check temperature was 100.1, the patient's skin was hot and flushed, and subtle right upper lobe infiltrate on a chest x-ray. The patient was hydrated intravascularly, given unspecified antibiotics intravenously, and given the first dose of AVELOX, intravenously. The patient was given AVELOX oral for a 10-day course of treatment. The patient was also given a albuterol/ATROVENT aerosol. The patient was diagnosed with community-acquired pneumonia in the right upper lobe, and human immunodeficiency virus by history. The follow-up plan of care was reviewed with the patient and the patient voiced an understanding of the plan. The patient was discharged from the emergency room with a family member/friend and with prescriptions for AVELOX 400 mg, hydrocodone/homatropine syrup 5/1.5mg/5mL, and albuterol inhaler 17 gm. Subsequently, on an unspecified date, the patient recovered from fever and chills. The patient recovered from pneumonia on 17-OCT-2007 and was prescribed Z-PAK. No product quality complaint was involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female patient over the age of 65 who on an unknown date was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient developed swelling localized at the injection site and it appeared as a hard lump. It was also reported that the patient also experienced a fever that lasted for about a week. Unspecified medical attention was sought. On an unknown date, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 69.0
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site urticaria, Injection site warmth, Musculoskeletal pain
Clinical narrative: Information has been received from an RN concerning a 69 year old patient who in November or December 2007 was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine, lot #657626/1084U. The patient commented that the injection was painful and 1-2 days later developed warmth and localized hives at the injection site. The patient also reported pain from the shoulder to the breast area. Medical attention was sought. The patient was recovering. The nurse indicated that 2 additional patients had identical adverse experiences from pneumococcal 23v polysaccharide vaccine, lot #1084U, and requested a lot check to ensure the product was safe to use. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 1.3
Sex: U
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a 15 month old patient who on 08-JAN-2008 was vaccinated with pneumococcal 23v polysaccharide vaccine instead of PREVNAR (Wyeth) by accident. Per the reporter the office keeps all of the vaccines in the same refrigerator and someone new grabbed the wrong vile. The new person has since been re-trained. The patient was not given PREVNAR and is doing fine. Subsequently, on 08-JAN-2008 the patient experienced inappropriate age and wrong vaccine administered. The patient is not experiencing any known symptoms and no further information is available. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Erythema, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from an other health professional concerning a 56 year old white female patient with multiple sclerosis and a penicillin allergy who on 20-DEC-2007 at 2:30 pm, was vaccinated SC into the left arm with a first dose of pneumococcal 23v polysaccharide vaccine (Lot# 658493/0991U). On 20-DEC-2007 at 12:00 pm, the patient experienced a lot of pain and swelling in the arm. It was also reported that the patient experienced redness, hot in the area, chills and fever. It was reported that there was no death or complications. There was no laboratory diagnostic studies. On 10-JAN-2008, the patient recovered. At the time of this report, the patient's pain was not addressed. Additional information is not expected.
Age: 55.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Skin warm
Clinical narrative: Information has been received from an other health professional concerning a 56 year old white female patient with multiple sclerosis and a penicillin allergy who on 20-DEC-2007 at 2:30 pm, was vaccinated SC into the left arm with a first dose of pneumococcal 23v polysaccharide vaccine (Lot# 658493/0991U). On 20-DEC-2007 at 12:00 pm, the patient experienced a lot of pain and swelling in the arm. It was also reported that the patient experienced redness, hot in the area, chills and fever. It was reported that there was no death or complications. There was no laboratory diagnostic studies. On 10-JAN-2008, the patient recovered. At the time of this report, the patient's pain was not addressed. Additional information is not expected.
Age: 55.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Injection site erythema, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Information has been received from an other health professional concerning a 56 year old white female patient with multiple sclerosis and a penicillin allergy who on 20-DEC-2007 at 2:30 pm, was vaccinated SC into the left arm with a first dose of pneumococcal 23v polysaccharide vaccine (Lot# 658493/0991U). On 20-DEC-2007 at 12:00 pm, the patient experienced a lot of pain and swelling in the arm. It was also reported that the patient experienced redness, hot in the area, chills and fever. It was reported that there was no death or complications. There was no laboratory diagnostic studies. On 10-JAN-2008, the patient recovered. At the time of this report, the patient's pain was not addressed. Additional information is not expected.
Age: 55.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Erythema, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 55 year old female with multiple sclerosis, hypertension, depression, allergic rhinitis, osteoporosis, obstructive sleep apnoea syndrome, intervertebral disc degeneration and an allergy to penicillin who on 20-DEC-2007 was vaccinated SC with a dose of pneumococcal 23v polysaccharide vaccine (lot #658493/0991U). Concomitant therapy included enalapril maleate (MSD), alprazolam, PROVIGIL, LEXAPRO, PROMETRIUM, ACTONEL and REBIF. On approximately 20-DEC-2007, the patient developed localized swelling and pain that extended down her arm to her mid-arm. The affected area also had "minimum" redness and was warm. On 28-DEC-2007, the patient was examined in the physician's office and most of her symptoms were resolved except for a "little" redness at the injection site. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Skin warm
Clinical narrative: Information has been received from a medical assistant concerning a 55 year old female with multiple sclerosis, hypertension, depression, allergic rhinitis, osteoporosis, obstructive sleep apnoea syndrome, intervertebral disc degeneration and an allergy to penicillin who on 20-DEC-2007 was vaccinated SC with a dose of pneumococcal 23v polysaccharide vaccine (lot #658493/0991U). Concomitant therapy included enalapril maleate (MSD), alprazolam, PROVIGIL, LEXAPRO, PROMETRIUM, ACTONEL and REBIF. On approximately 20-DEC-2007, the patient developed localized swelling and pain that extended down her arm to her mid-arm. The affected area also had "minimum" redness and was warm. On 28-DEC-2007, the patient was examined in the physician's office and most of her symptoms were resolved except for a "little" redness at the injection site. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Injection site erythema, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Information has been received from a medical assistant concerning a 55 year old female with multiple sclerosis, hypertension, depression, allergic rhinitis, osteoporosis, obstructive sleep apnoea syndrome, intervertebral disc degeneration and an allergy to penicillin who on 20-DEC-2007 was vaccinated SC with a dose of pneumococcal 23v polysaccharide vaccine (lot #658493/0991U). Concomitant therapy included enalapril maleate (MSD), alprazolam, PROVIGIL, LEXAPRO, PROMETRIUM, ACTONEL and REBIF. On approximately 20-DEC-2007, the patient developed localized swelling and pain that extended down her arm to her mid-arm. The affected area also had "minimum" redness and was warm. On 28-DEC-2007, the patient was examined in the physician's office and most of her symptoms were resolved except for a "little" redness at the injection site. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a female with no pertinent medical history who on 01-DEC-2007 was vaccinated intramuscularly into the deltoid with a 0.5 mL first dose of pneumococcal 23v polysaccharide vaccine (Lot #659148/1382U). Concomitant vaccination on the same day included influenza virus vaccine (unspecified) into the other arm. On 03-DEC-2007, the patient called to report that the arm that she received the pneumococcal 23v polysaccharide vaccine was painful with a red line going down the under side of the arm from the armpit. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. At the time of the report the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Musculoskeletal pain
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated intramuscularly with pneumococcal 23v polysaccharide vaccine (65550/1005F). Subsequently the patient experienced chest and scapular pain 3-5 minuets post vaccination. Subsequently, the patient recovered from chest and scapular pain in about 15 minutes. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: Information has been received from a female who was vaccinated with pneumococcal 23v polysaccharide vaccine. Subsequently, the patient experienced an unspecified reaction. No further information was provided. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning an 86 year old white female with hypertension, anxiety, on anticoagulant therapy, on diuretic, and on potassium supplement who on an unspecified date was vaccinated with pneumococcal 23v polysaccharide vaccine (lot # 654977/0888F) IM. Concomitant therapy included lisinopril (MSD), LASIX, K-DUR, warfarin, AMIODARONA, ATIVAN and therapy unspecified for hypertension. On 01-NOV-2007, the patient experienced pain, redness, and swelling at the injection site and returned to the physician. On an unspecified date, the patient recovered. No further information is available.
Age: 76.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a Certified Medical Assistant concerning a 76 year old male patient with drug allergy to triazolam who on 30-NOV-2007 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine lot # 659147/1381U. Concomitant therapy included influenza virus vaccine (unspecified), vitamins (unspecified) and zinc (unspecified). On 30-NOV-2007, the patient developed injection site redness, swelling, warmth and pain. Medical attention was sought by the patient. At the time of this report patient had not recovered. No other information was available at this time. Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a health care coordinator and a nurse concerning a 2 month old female with no pertinent medical history and no known allergies who on 06-NOV-2007 was vaccinated intramuscularly in the left thigh with pneumococcal 23v polysaccharide vaccine (0.5 mL). Concomitant vaccination on 06-NOV-2007 included Hib conj vaccine (unspecified carrier) (manufacturer unknown), poliovirus vaccine (manufacturer unknown), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown) and hepatitis B vaccine, recomb (manufacturer unknown). The nurse reported that the patient was supposed to receive PREVNAR when pneumococcal 23v polysaccharide vaccine was given by mistake. The nurse stated that the mistake occurred because the physician may have ordered the wrong vaccine and mentioned it can be confusing as far as which vaccine needs to be given to which age group. No adverse reaction was reported post vaccination. Medical attention was sought in the physician's office. In follow-up from the health worker, it was reported that the error was "strictly human error" on the medical assistant's part, two different ones unfortunately." The reporter stated that "it was not a matter of product confusion, the vaccines were in different containers on different shelves, the medical assistant just made a mistake." this is one of two reports from the same source. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 75 year old female who on 29-NOV-2007 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot# unknown). There was no concomitant medication. On 29-NOV-2007, the patient developed redness, swelling, warmth at injection site and pain at injection site after first immunization. Medical attention was sought. At the time of reporting the patient had not recovered. No other information was available at this time. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated intramuscularly with pneumococcal 23v polysaccharide vaccine (655500/1005F). Subsequently, the patient experienced pain near the injection site that lasted about 2 weeks until resolution. The patient had no other symptoms. The patient sought unspecified medical attention in the physician's office. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain, Pain in extremity, Skin warm
Clinical narrative: Information has been received from a physician concerning a 54 year old white male business owner, who on 25-OCT-2007 was vaccinated intramuscularly with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (Lot# 655765/0061U). Subsequently, the patient experienced pain, swelling, and red hot throbbing that spread down left arm to just above the wrist. The patient could not sleep. The patient recovered on an unspecified date. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated intramuscularly with pneumococcal 23v polysaccharide vaccine (655500/1005F). Subsequently, the patient experienced low fever, swelling, redness and pain just below the injection site on both the inner and outer aspect of the right arm. The patient sought unspecified medical attention in the physician's office. Per the reporter the patient is recovering from the low fever, swelling, redness and pain just below the injection site on both the inner and outer aspect of the right arm. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 60 year old male who on 07-JAN-2008 was vaccinated IM in the left arm with a dose of pneumococcal 23v polysaccharide vaccine, lot #658200/0804U. On 07-JAN-2008, after receiving the injection, the patient experienced pain and redness at and below the injection site. Medical attention was sought. His outcome was not reported. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Inflammation, Injection site erythema, Injection site warmth, Skin warm
Clinical narrative: Information has been received from a pharmacy technician and a licensed practical nurse concerning a female patient (age not reported) who on 29-NOV-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot# 657626/1084U). The licensed practical nurse reported that the patient was vaccinated at the same time in the same arm with a flu vaccine (unspecified). On 30-NOV-2007, the patient called the office to report that she had warmth and redness at the injection site and her arm was very inflamed and hot. The pharmacy technician noted that "it seemed like more patients had this experience this year than patients who received the vaccine last year." The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Adverse drug reaction, Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a pharmacy technician and a licensed practical nurse concerning a patient (age and gender not reported who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. It was reported that the patient experienced a "similar reaction" such as warmth and redness at the injection site. However, the licensed practical nurse stated that she could not supply further patient details, lot number severity and exact symptoms. The pharmacy technician noted that "it seemed like more patients had this experience this year than patients who received the vaccine last year." Additional information is not expected.