chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning a 36 year old female with history of "immunosuppression of unspecified etiology" who on 12-FEB-2002 was vaccinated with her first dose of PNEUMOVAX 23 and on 25-FEB-2010 was vaccinated intramuscularly with her second 0.5 ml dose of PNEUMOVAX 23 (Lot # 664537/1193Y). It was reported that one day after receiving the PNEUMOVAX 23, on 26-FEB-2010, the patient experienced an injection site reaction, she was seen at the office exhibiting redness, swelling and severe pain at the injection site and down the arm. No treatment was prescribed. The patient recovered within one week, on approximately 05-MAR-2010. No diagnostic tests were performed. This report is related with WAES # 1003USA00920, WAES # 1003USA00981, WAES # 1003USA00982 and WAES # 1003USA00984, same source, same adverse experience. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 36 year old female with history of "immunosuppression of unspecified etiology" who on 12-FEB-2002 was vaccinated with her first dose of PNEUMOVAX 23 and on 25-FEB-2010 was vaccinated intramuscularly with her second 0.5 ml dose of PNEUMOVAX 23 (Lot # 664537/1193Y). It was reported that one day after receiving the PNEUMOVAX 23, on 26-FEB-2010, the patient experienced an injection site reaction, she was seen at the office exhibiting redness, swelling and severe pain at the injection site and down the arm. No treatment was prescribed. The patient recovered within one week, on approximately 05-MAR-2010. No diagnostic tests were performed. This report is related with WAES # 1003USA00920, WAES # 1003USA00981, WAES # 1003USA00982 and WAES # 1003USA00984, same source, same adverse experience. Additional information has been requested.
Age: 91.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, No reaction on previous exposure to drug, Oedema peripheral
Clinical narrative: Information has been received from a healthcare worker concerning a 91 year old female patient with hypertension, high cholesterol, meniere's disease, iron deficiency, hypothyroidism and drug hypersensitivity to PRAVACHOL and a history of basal cell carcinoma, anaemia and dry eyes who on 03-FEB-2004 was vaccinated intramuscularly with her first dose PNEUMOVAX 23 (Lot # 665270/1398Y). Concomitant therapy included CENTRUM SILVER, hydrochlorothiazide (manufacturer unspecified), NORVASC, iron (unspecified) and vitamin D (unspecified). It was reported that the patient who received the second dose of PNEUMOVAX 23 developed swelling, pain and redness at the injection site in the right arm. No diagnostic tests were performed. At the time of the report the patient had not recovered. The patient sought medical attention by a phone call. Follow up information received from a physician indicated that the patient was a retired female who on 20-JAN-2010 was vaccinated intramuscularly with a second dose of PNEUMOVAX 23 (lot # 665270/1398Y). The patient developed right arm swelling within hours of injection. According with the reporter this never happened before. The patient recovered from right arm swelling on 21-JAN-2010. The outcome of pain and redness at the injection site were not reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Incorrect route of drug administration, Injection site cellulitis
Clinical narrative: Information has been received from a pharmacist concerning a 74 year old (previously reported as 68 year old) female patient who on approximately 01-JAN-1010, "three weeks ago", was vaccinated with a first SQ dose of PNEUMOVAX 23. After getting the vaccine, the patient developed cellulitis on a "pretty significant area of her arm". The patient sought unspecified medical attention. At the time of the report, the patient was recovering. Information has been received from a registered pharmacist who indicated that the patient with no illness at the time of vaccination on 31-DEC-2009 at 15:00 was vaccinated with a dose of PNEUMOVAX 23 (lot# 663441/0504Y) in her right upper arm and a first SQ dose of ZOSTAVAX (Merck) (MSD) (lot# 664274/0959Y) in her left upper arm. On 01-JAN-2010 the patient developed cellulitis. The patient sought medical attention by a doctor visit. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from an office purchaser concerning a female patient who in February 2007, was vaccinated with a dose of PNEUMOVAX 23. The same day after the PNEUMOVAX 23 was given, the patient experienced severe pain in the arm where the PNEUMOVAX 23 was given. It was reported the the patient claimed she had had pain in her arm since she was given the PNEUMOVAX 23. But the office purchaser stated she had claimed to have pain in her arm before the injection was given. The patient sought medical attention via office visit. At the time of the report, the patient was not recovered.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who in the last month (approximately in September 2009) was vaccinated intramuscularly with 0.5 ml of PNEUMOVAX 23 (Lot # 663126/0464Y). According to the reporter, in the "same day as vaccination or the following day", the patient developed as injection site reaction. The affected area was red, painful and very hot. The patient recovered on an unspecified date. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Pyrexia, Rhinorrhoea, Sinusitis
Clinical narrative: A non-serious spontaneous report of sinusitis has been received from a mother concerning a five-year-old female patient subsequent to FLUMIST administration. The patient has no relevant medical history and does not use concomitant medications. She did not receive any other vaccinations with FLUMIST. On 24-Oct-2009, the patient received FLUMIST. At 6:00 PM on the same day, the patient developed a fever of 102.9, a bad cough and runny nose. On 26-Oct-2009, the patient was seen by her physician. She was diagnosed with sinusitis and treated with an antibiotic (name unknown). On 30-Oct-2009, the events resolved and the patient returned to school. The outcome of the event sinusitis, was resolved. Additional information was received on and incorporated into the narrative: event term changed to sinusitis, event details, treatment and medical history.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who in the last month (approximately in September 2009) was vaccinated intramuscularly with 0.5 ml of PNEUMOVAX 23 (Lot # 663126/0464Y). According to the reporter in the "same day as vaccination or the following day" the patient developed an injection site reaction. The affected area was red, painful and very hot. The patient recovered on an unspecified date. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Appetite disorder, Epistaxis, Fatigue
Clinical narrative: A non-serious, spontaneous report of nosebleeds, tired and hungry has been received from the patient's mother concerning a 12-year-old male patient subsequent to FLUMIST administration. Medical history and concomitant medications were not reported. On 22-Oct-2009 at 3:00pm, the patient received FLUMIST. The next day, 23-Oct-2009, the patient developed nosebleeds. At 12:05 PM, the patient had a nosebleed lasting 25 minutes (first 10 minutes, mostly clotted blood was present). At 2:15 PM, he had another nosebleed and then one more 30 minutes prior to receiving the report from the mother. She indicated the patient also felt tired and hungry. The outcome of the events was not reported.
Age: 40.0
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a medical assistant concerning a 40-60 year old patient who approximately 01-MAR-2010 ("within the past week") was vaccinated with a dose of PNEUMOVAX 23 (lot# 665270/1398Y). On the same night of the vaccination, the patient developed cellulitis at the injection site and was treated with an antibiotic. There were no laboratory diagnostics studies performed. At the time of this report, the patient's outcome was unknown. This is one of several reports from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Headache, Influenza, Influenza serology positive, Oropharyngeal pain, Pyrexia
Clinical narrative: A non-serious spontaneous report of positive for influenza was received from a physician concerning a five-year-old male, subsequent to FLUMIST. No medical history or concomitant medications were reported. The patient received a single dose of FLUMIST on 19-SEP-2009. Two days later on 21-SEP-2009 the patient presented with a fever of 103, headache, sore throat, sneezing and nasal drainage. He was being treated with various medications for these symptoms. The patient tested positive for influenza. No outcome was provided.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: A non-serious spontaneous report of positive for influenza was received from a physician concerning a five-year-old male, subsequent to FLUMIST. No medical history or concomitant medications were reported. The patient received a single dose of FLUMIST on 19-SEP-2009. Two days later on 21-SEP-2009 the patient presented with a fever of 103, headache, sore throat, sneezing and nasal drainage. He was being treated with various medications for these symptoms. The patient tested positive for influenza. No outcome was provided.
Age: 67.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received form a reporter concerning a patient who was vaccinated with PNEUMOVAX 23 (manufacturer unknown). On an unspecified date, the patient experienced severe cellulitis and needed urgent care. The outcome of the patient was not reported. This report was received from Watson Pharmaceuticals. Follow-up information received from a L.P.N. concerning the 67 year old patient who on 11-FEB-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot number 665400/1315Y). The patient was not diagnosed with cellulitis. The patient reported that her arm was red at the injection site and she went to an Urgent Care for treatment. The L.P.N. did not known what type of treatment the patient received at the Urgent Care Facility. The patient was not hospitalized. The L.P.N. did not know if the patient's reactions was disabling or life-threatening. At the time of the report, the patient had recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a 90 year old female who approximately 3 or 4 years ago was vaccinated with a dose of PNEUMOVAX 23. Post vaccination, the patient arrived home and developed hives. The patient went back to the doctor office the same day for medical attention. At the time of the report, the patient had fully recovered. No further information available.
Age: 67.0
Sex: F
Vaccine: FLUX(H1N1), PPV
Symptoms: Headache, Injected limb mobility decreased, Musculoskeletal chest pain, Pain, Pain in extremity
Clinical narrative: Information has been received from a 67 year old female consumer who on "29-DEC-2009 or 30-DEC-2009", was vaccinated with a single dose of PNEUMOVAX 23. The patient stated that "I received PNEUMOVAX 23 in one arm, the specific arm was unspecified, and H1N1 (manufacturer unspecified) vaccine in the other arm either on December 29th, 2009 or December 30th, 2009. Then about 6 hours after vaccination I had severe pain in my arm and I could not move it up, down, or lay on my side. I then had pain in my ribs, diaphragm, achiness all over my body and a headache". The patient called the physician for medical attention. The consumer reported that "the pain was getting a lot less severe but she still was having headaches". No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a female consumer who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (manufacturer unknown) and had an unspecified reaction. The patient's outcome was unknown. It was unknown if the patient sought medical attention. It was also reported that on an unspecified date the patient had a reaction to tetanus vaccine (manufacturer unspecified). No further information is available.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site reaction, No reaction on previous exposure to drug, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a male patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot# 664864/1365Y). Subsequently, the patient developed injection site reaction after receiving PNEUMOVAX 23. The patient developed arm swelling, redness and pain. It was unknown if the patient sought medical attention. The patient was not hospitalized. At the time of the report, the patient's status was unknown. Follow-up information has been received from the registered nurse concerning a 79 year old male patient with hypertension, osteoarthritis, hypercholesterolaemia and allergies to LIPITOR, WELCHOL and PRAVACHOL and a history of prostate cancer (1995) and pulmonary embolism who was vaccinated with previous dose of PNEUMOVAX 23 in 2003 without problem. In 23-DEC-2009, the patient was vaccinated with a dose of PNEUMOVAX 23 in his left arm. Concomitant therapy included metoprolol, COUMADIN and ZESTRIL. No other vaccines were given. It was reported that there was no serious criteria. At the time of the report, the patient was fully recovered. This is one of several reports received from the same source. No further information is available.
Age: 92.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a registered nurse concerning a male patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot # 664864/1365Y). Subsequently, the patient developed injection site reaction after receiving PNEUMOVAX 23. The patient developed arm swelling, redness and pain. It was unknown if the patient sought medical attention. The patient was not hospitalized. At the time of the report, the patient's status was unknown. Follow-up information has been received from the registered nurse concerning a 92 year old male patient with hypertension, degenerative joint disease, osteoarthritis, peripheral neuropathy, Restless Leg Syndrome, chronic obstructive pulmonary disease, gastrooesophageal reflux disease and allergies to penicillin, aspirin, sulfa and erythromycin and a history of prostate cancer and gastrointestinal bleeding who on 04-FEB-2003 was vaccinated with previous dose of PNEUMOVAX 23 vaccine without problem. Recent dose of PNEUMOVAX 23 was administered in his left arm on 06-JAN-2010. Concomitant therapy included PROTONIX, COMBIVENT and FLOMAX. There were no other vaccines given at the same time. It was reported that there was no serious criteria. At the time of the report, the patient was fully recovered. This is one of several reports received from the same source. No further information is available.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a male patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot# 664864/1365Y). Subsequently, the patient developed injection site reaction after receiving PNEUMOVAX 23. The patient developed arm swelling, redness and pain. It was unknown if the patient sought medical attention. The patient was not hospitalized. At the time of the report, the patient's status was unknown. Follow-up information was received from the registered nurse concerning an 81 year old male patient with no known drug allergies, hypertension, coronary artery disease (CAD) and renal dysfunction and a history of colon polyps who on 06-JAN-2010 was vaccinated with recent dose of PNEUMOVAX 23 in his left arm. Concomitant therapy included TOPROL XL tablets, simvastatin, lisinopril, aspirin, niacin, nitroglycerin and HYDRODIURIL. No other vaccines were given. It was reported that there were no serious criteria. At the time of the report, the patient was fully recovered. This is on of several reports received from the same source. No further information is available.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning an approximately 25 year old female patient with diabetes who in "November or December 2009", was vaccinated in the deltoid with a dose of PNEUMOVAX 23 (lot number not reported). In "November or December 2009", the patient had an injection site reaction after vaccination. The symptoms were swelling and redness radiating to her elbow. It was unknown if medical attention was sought. On an unspecified date, the patient recovered. Follow-up information received from the nurse's office which reported that the patient was vaccinated the PNEUMOVAX 23 at another office and they had no details of the event. No additional information is available.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Headache, Hyperhidrosis, Injection site pain, Nausea
Clinical narrative: Information has been received from a licensed practical nurse concerning a 70 year old female patient with soy and ZETIA allergy and a history of hypothyroidism who on an unspecified date in 2001 was vaccinated intramuscularly with the first dose of PNEUMOVAX 23 (lot# not reported). On 25-JAN-2010 the patient was vaccinated intramuscularly with the second dose of PNEUMOVAX 23 (lot# 665402/1339Y). Concomitant therapy included SYNTHROID. On 25-JAN-2010, at night, the patient experienced nausea, sweats and dizziness. On 26-JAN-2010 the patient developed arm pain at the injection and in the entire left arm. The patient called the office to see medical attention. There were no laboratory diagnostics studies performed. At the time of this report, the patient had not recovered. Follow up information has been received from the licensed practical nurse concerning the 70 year old female patient who on an unspecified date in November 2001 was vaccinated intramuscularly with the first dose of PNEUMOVAX 23 (lot# not reported). On 25-JAN-2010, in the morning, the patient was vaccinated intramuscularly with the second dose of PNEUMOVAX 23 (lot# 665402/1339Y) into the left deltoid. On 15-JAN-2010, in the afternoon, the patient had pain in left arm, nausea, dizziness and headache. On 01-FEB-2010 the patient recovered. This is one of several reports from the same source. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a licensed practical nurse concerning a 70 year old female patient with soy and ZETIA allergy and a history of hypothyroidism who on an unspecified date in 2001 was vaccinated intramuscularly with the first dose of PNEUMOVAX 23 (lot# not reported). On 25-JAN-2010 the patient was vaccinated intramuscularly with the second dose of PNEUMOVAX 23 (lot# 665402/1339Y). Concomitant therapy included SYNTHROID. On 25-JAN-2010, at night, the patient experienced nausea, sweats and dizziness. On 26-JAN-2010 the patient developed arm pain at the injection and in the entire left arm. The patient called the office to see medical attention. There were no laboratory diagnostics studies performed. At the time of this report, the patient had not recovered. Follow up information has been received from the licensed practical nurse concerning the 70 year old female patient who on an unspecified date in November 2001 was vaccinated intramuscularly with the first dose of PNEUMOVAX 23 (lot# not reported). On 25-JAN-2010, in the morning, the patient was vaccinated intramuscularly with the second dose of PNEUMOVAX 23 (lot# 665402/1339Y) into the left deltoid. On 15-JAN-2010, in the afternoon, the patient had pain in left arm, nausea, dizziness and headache. On 01-FEB-2010 the patient recovered. This is one of several reports from the same source. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a licensed practical nurse concerning a 60 year old female patient with asthma and allergy to AVELOX and PERCOCET who on 20-JAN-2010 was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (lot # 665402/1339Y). Concomitant therapy included montelukast sodium (MSD), inhalers and vitamins (unspecified). On an unspecified date, the patient developed severe left arm pain that radiated down the entire arm and the underneath of the arm. No local redness or swelling was noted. The patient called the office to seek medical attention. There were no laboratory diagnostics studies performed. At the time of this report, the patient had not recovered. Follow up information has been received from the licensed practical nurse concerning the 60 year old female patient who on 20-JAN-2010, in the morning, the patient was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (lot # 665402/1339Y) into the left deltoid. On 21-JAN-2010, the patient developed pain in left arm and under arm. On 25-JAN-2010 the patient recovered. This is one of several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Cardiac disorder, Dizziness, Hot flush, Renal disorder, Tremor
Clinical narrative: Information has been received from a female patient with psychiatric disorder and drug hypersensitivity to "pain killers and antidepressants" who on 21-JAN-2010 was vaccinated with a single dose of PNEUMOVAX 23 (Lot # 665300/1314Y). It was reported that on 26-JAN-2010 the patient experienced shaking and loss of bladder control. The reporter stated that she did not believe that these events were from the vaccine. At the time of the report the patient had recovered. It was unknown if the patient sought medical attention. It was also reported that the patient experienced hot flashes and dizziness while taking TRAMADOL and experienced heart and kidney problems while taking HALDOL and DEPAKOTE. No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Urinary incontinence
Clinical narrative: Information has been received from a female patient with psychiatric disorder and drug hypersensitivity to "pain killers and antidepressants" who on 21-JAN-2010 was vaccinated with a single dose of PNEUMOVAX 23 (Lot # 665300/1314Y). It was reported that on 26-JAN-2010 the patient experienced shaking and loss of bladder control. The reporter stated that she did not believe that these events were from the vaccine. At the time of the report the patient had recovered. It was unknown if the patient sought medical attention. It was also reported that the patient experienced hot flashes and dizziness while taking TRAMADOL and experienced heart and kidney problems while taking HALDOL and DEPAKOTE. No further information is available.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Arthropathy, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Limb discomfort
Clinical narrative: Information has been received from a registered pharmacist concerning a 42 year old female patient with no drug allergies or pertinent medical history who on 06-NOV-2009 was vaccinated IM in the left arm with a 0.5 ml dose of PNEUMOVAX 23 (Lot number 665270/1398Y). There was no concomitant medication. On 07-NOV-2009 the patient experienced irritation, pain and difficulty moving her left arm. The patient reported to the pharmacist that she felt that her left shoulder "pop" after a night of using ice on her arm as directed by her physician. At the time of the report the patient had not recovered. No laboratory tests were performed. The patient sought unspecified medical attention. Follow up information has been received from a physician concerning a 42 year old female patient with penicillin (PCN) allergy who on 06-NOV-2009 was vaccinated IM in the left arm with a 0.5 ml dose of PNEUMOVAX 23 (Lot number 665270/1398Y). On 06-NOV-2009 the patient complained of left arm pain during injection and for several weeks after. Physician reported that on her last visit, on 24-FEB-2010, the patient still had minimal soreness but almost improved in an 85-90 percent.  No further information is available.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a registered pharmacist concerning a 42 year old female patient with no drug allergies or pertinent medical history who on 06-NOV-2009 was vaccinated IM in the left arm with a 0.5 ml dose of PNEUMOVAX 23 (Lot number 665270/1398Y). There was no concomitant medication. On 07-NOV-2009 the patient experienced irritation, pain and difficulty moving her left arm. The patient reported to the pharmacist that she felt that her left shoulder "pop" after a night of using ice on her arm as directed by her physician. At the time of the report the patient had not recovered. No laboratory tests were performed. The patient sought unspecified medical attention. Follow up information has been received from a physician concerning a 42 year old female patient with penicillin (PCN) allergy who on 06-NOV-2009 was vaccinated IM in the left arm with a 0.5 ml dose of PNEUMOVAX 23 (Lot number 665270/1398Y). On 06-NOV-2009 the patient complained of left arm pain during injection and for several weeks after. Physician reported that on her last visit, on 24-FEB-2010, the patient still had minimal soreness but almost improved in an 85-90 percent.  No further information is available.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, No reaction on previous exposure to drug, Oedema peripheral, Tremor
Clinical narrative: Information has been received from a registered nurse concerning a 67 year old male patient with hypertension, polycythaemia vera, peripheral neuropathy, gastrooesophageal reflux disease, hyperuricaemia, erectile dysfunction, sinusitis, no known drug allergies and a history of kidney stones who in 2005 was vaccinated with a dose of PNEUMOVAX 23 "without problem". On 13-JAN-2010 the patient was vaccinated with a 0.5 ml IM dose of PNEUMOVAX 23 (Lot # 664864/1365Y) in his left arm. No other vaccines were given. That same day the patient was prescribed AUGMENTIN for his sinusitis. Concomitant therapy included VERELAN, ECOTRIN, folic acid and ALLOPURINOL. On 18-JAN-2010 the patient reported to the nurse that four hours after receiving PNEUMOVAX 23, on 13-JAN-2010, he became shaky and developed redness and swelling at the injection site; by 18-JAN-2010, shaking and redness were gone, but his left arm was still slightly swollen (recovering). It was unknown if the patient sought medical attention. This is one of several reports received from the same source. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a medical assistant concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23. Subsequently the patient experienced unspecified injection site reactions. The patient sought unknown medical attention. At the time of the report, the patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered nurse concerning a patient who between 09-MAR-2010 and 18-MAR-2010 received a 0.5 ml IM dose PNEUMOVAX 23 (lot# 664476/1190Y). Between 09-MAR-2010 and 18-MAR-2010, 24 hours after vaccination with PNEUMOVAX 23, the patient developed cellulitis reaction on their arms. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for  the lot number 664476/1190Y were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The nurse contacted during telephone follow-up could not supply the following information: patient names, dates of birth, dates of vaccination, dates of events and recovery status. Additional information has been requested.
Age: 90.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Influenza like illness
Clinical narrative: Information has been received from a physician concerning the 90 year old father of her best friend who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 and may also received the influenza virus vaccine (unspecified) (manufacturer unknown) at the same time. The physician reported that on an unspecified date, the patient developed "flu like" symptoms. It was unspecified if the patient sought medical attention and if lab tests were performed. At the time of the report, the patient outcome was unknown. No further information is available.
Age: 63.0
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered nurse concerning a patient who between 09-MAR-2010 and 18-MAR-2010 received a 0.5 ml IM dose of PNEUMOVAX 23 (lot# 664476/1190Y). Between 09-MAR-2010 and 18-MAR-2010, 24 hours after vaccination with PNEUMOVAX 23, the patient developed cellulitis reaction on his/her arms. The patient had to go to an emergency room but was not admitted into a hospital. At the time of the report, the outcome of the patients was unknown. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 664476/1190Y were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The nurse contacted during telephone follow-up could not supply the following information: patient name, date of birth, date of vaccination, date of events and recovery status. Follow up information has been received from a registered nurse who indicated that the 63 year old patient with cough and cold at the time of vaccination and no pre-existing allergies or medical conditions on 11-MAR-2010 at 10:00 a.m. was vaccinated with a first dose of PNEUMOVAX 23 (lot# 664476/1190Y) in the left arm. On 13-MAR-2010 the patient experienced cellulitis of arm and required emergency room visit. The patient was treated with clindamycin for seven days. Subsequently, on 16-MAR-2010, the patient recovered from cellulitis of arm. No laboratory or diagnostic studies were performed. This is one of several reports received from the same source. Additional information is not expected.
Age: 86.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Oedema peripheral, Rash
Clinical narrative: Information has been received from a pharmacist concerning an 86 year old male with chronic obstructive pulmonary disease and penicillin allergy and a history of cardiac failure congestive, who on 03-FEB-2010 was vaccinated with a dose of 0.5ml PNEUMOVAX 23, SC. The therapy was started since "about 5 year ago". Concomitant therapy included ZANTAC, NASONEX, lisinopril, simvastatin (MSD), potassium (unspecified) and aspirin. The patient experienced swelling and redness at the injection site that extended past his elbow. There were no labs or diagnostic tests performed. The patient visited the office for medical attention. The patient was given a dexamethasone (MSD) shot. At the time of the report, the patient had not recovered. Follow up information has been received from a pharmacist concerning the male patient who was vaccinated with a dose of PNEUMOVAX 23. The patient developed significant rash on extremity where vaccine was administered. The patient received dexamethasone (MSD) injection. The outcome was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a patient who on 03-FEB-2010 was intramuscularly vaccinated in the deltoid muscle with a dose of PNEUMOVAX 23. The pharmacist reported that some time after received the PNEUMOVAX 23, the patient experienced large area of swelling and induration at the injection site in the deltoid muscle. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a pharmacist concerning a 79 year old female with "many allergies" unspecified, who was vaccinated with a dose of PNEUMOVAX 23. The patient had "allergic" reaction after PNEUMOVAX 23 in 1997, but unspecified what type of reaction. The patient received unspecified medical attention. The patient recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot number 664478/1191Y). Subsequently the patient experienced injection site reaction after vaccination, which consisted of the area of warmth, redness, and swollen. The patient called the office but did not come into the office. There were no lab studies were performed. At the time of the report, the patient had recovered (date unspecified). The reporter requested a lot check for lot# 664478/1191Y due to the patient's adverse experiences. A lot check was initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot number 664478/1191Y). Subsequently the patient experienced injection site reaction after vaccination, which consisted of the area of warmth, redness, and swollen. The patient called the office but did not come into the office. There were no lab studies were performed. At the time of the report, the patient had recovered (date unspecified). The reporter requested a lot check for lot # 664478/1191Y due to the patient's adverse experiences. A lot check was initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot number 664478/1191Y). Subsequently the patient experienced injection site reaction after vaccination. The patient came to the office. The size of the reaction was approximately "50 cents" and consisted of the area of warmth, redness, and swollen. There were no lab studies were performed. At the time of the report, the patient had recovered (date unspecified). The reporter requested a lot check for lot # 664478/1191Y due to the patient's adverse experiences. This is one of several reports from the same source. A lot check was initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a registered nurse (R.N) concerning a 69 year old male patient who in approximately February 2010, was vaccinated with a second dose of PNEUMOVAX 23 (dose and route not reported, lot number 664653/1337Y). Concomitant medications not reported. Nurse reported the patient complained about severe arm pain. Patient could not  move his arm. The patient recovered from the events. The nurse was concerned about the lot number and thought they may have received a "bad lot". She indicated that the office gives a lot of this vaccines and found it odd there were 3 patients who had similar experience in a short amount of time. The reporter did not specify if the patient sought medical attention. This is one of 3 reports from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a healthcare worker concerning a 59 year old female patient with allergies to DEMEROL and adhesive tape who on 23-MAR-2010 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (lot# 665707/1407Y). Concomitant therapy included LIPITOR, lisinopril and HCTZ. Subsequently, the patient developed a fever of 102.2 degrees F. and swelling of her arm at the injection site after receiving the PNEUMOVAX 23. The reporter did not know if the patient had ever received PNEUMOVAX 23 in past. The patient sought medical attention via phone call. At the time of the report, the patient was recovering from these events. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 59 year old male patient with hypertension, chronic obstructive pulmonary disease (COPD) and "cholesterol" who on 01-APR-2010 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23. Concomitant vaccination included a dose of DTAP. On 02-APR-2010 the patient experienced fever, headache and nausea after getting PNEUMOVAX 23. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 5 year old female patient with no relevant history or preexisting medical conditions and relevant past drug history unknown who on 05-APR-2010, was vaccinated IM with a 0.25 ml dose of PNEUMOVAX 23 for recurrent middle ear infections. An ENT (ear nose throat) specialist recommended PNEUMOVAX 23. The nurse who administered the PNEUMOVAX 23 decided to administer the vaccine as a split dose as follows: 0.25 ml on 05-APR-2010 followed by 0.25 ml on 09-APR-2010. There were no relevant concomitant medications. It was reported that on 05-APR-2010, within hours of receiving the PNEUMOVAX 23 in the mentioned manner, the patient's arm showed redness and tenderness at the site of injection. As of 08-APR-2010, the patient continued to experience redness and tenderness at the injection site. There were no relevant laboratory tests performed due to the events. The reporting physician was going to recommend the patient not to be administered with the second half of the remaining dose of PNEUMOVAX 23 vaccine on 09-APR-2010 and that they would wait until the events resolved and then revaccinate the patient. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a medical assistant concerning a female patient who on an unknown date was vaccinated with a dose of PNEUMOVAX 23 (lot# 665300/1314Y or 663012/1163X). Subsequently the patient developed cellulitis and went to the Emergency Room. It was reported that the patient took two unknown antibiotics. At the time of the report, the outcome of the patient was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pain in extremity
Clinical narrative: Information has been received from a registered nurse, concerning her male friend patient, with no known medical history or allergies, who in "approximately 2006", was vaccinated subcutaneously with a dose of PNEUMOVAX 23 (dose and lot number not reported). No other vaccines were administered that day. The nurse did not know about concomitant therapy. The nurse reported that about a week later "in approximately 2006", the patient reported her that after vaccination, he had injection site swelling, injection site redness and heat at injection site; his arm was sore and he had body aches. The nurse reported that she thought the reaction had resolved in about 10 days. The nurse stated that the patient's friend received the same injection right after the patient did, and he did not have any problems. The nurse also stated that the patient had very little subcutaneous fat. The nurse also specified that she would not give PNEUMOVAX 23 subcutaneously; she only give it intramuscularly at the time of reporting. The patient outcome was unknown at the time of reporting. This is one of several reports from the same source. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a registered nurse (R.N) concerning a patient who in approximately February 2010, was vaccinated with a dose of PNEUMOVAX 23 (dose and route not reported, lot number 664653/1337Y). Concomitant medications not reported. Nurse reported the patient complained about severe arm pain. Patient said the arm pain lasted for two weeks. This may have been the patient's second vaccination with PNEUMOVAX 23. The nurse was concerned about the lot number and thought they may have received a "bad lot". The reporter did not specify if the patient sought medical attention. A lot check has been initiated. Follow up information has been received from the registered nurse regarding the 63 year old female patient who in approximately February 2010, was revaccinated with a second dose of PNEUMOVAX 23. At the time of the report, the patient had recovered. The registered nurse indicated that her office gives a lot of this vaccine and found it odd that there were three patients who had similar experiences in a short amount of time. The registered nurse contacted during telephone follow up could not supply the following information: date of birth, dates of vaccination and exact date of the event. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of 3 reports from the same source. Additional information is not expected.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a registered nurse (R.N) concerning a patient who in approximately February 2010, was vaccinated with a dose of PNEUMOVAX 23 (dose and route not reported, lot number 664653/1337Y). Concomitant medications not reported. Nurse reported the patient complained about severe arm pain. Patient said the pain was so bad he could not put his socks on. This may have been the patient's second vaccination with PNEUMOVAX 23. The nurse was concerned about the lot number and thought they may have received a "bad lot". The reporter did not specify if the patient sought medical attention. A lot check has been initiated. Follow up information has been received from the registered nurse regarding the male patient in his 60's who in approximately February 2010, was vaccinated with a first dose of PNEUMOVAX 23. At the time of the report, the patient had recovered. The registered nurse indicated that her office gives a lot of this vaccine and found it odd that there were three patients who had similar experiences in a short amount of time. The registered nurse contacted during telephone follow up could not supply the following information: date of birth, dates of vaccination and exact date of the event. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and released. This is one of 3 reports from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Nervous system disorder, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a medical assistant concerning a patient who in approximately February 2010, "about two months ago", was vaccinated with a dose of PNEUMOVAX 23 (lot # 665300/1314Y or 663012/1163X). Subsequently after receiving PNEUMOVAX 23, the patient developed cellulitis. It was also reported that the patient required an MRI due to continuing nerve problems (results not provided). The patient sought medical attention by an office visit. At the time of the report, the outcome of the patient was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a medical assistant concerning a patient who on an unknown date was vaccinated with a dose of PNEUMOVAX 23 (lot# 663012/1163X or 665300/1314Y). Subsequently the patient experienced cellulitis. The patient sought medical attention by an office visit. At the time of the report, the outcome of the patient was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a physician concerning a 62 year old female who sometime during the week of 12-APR-2010 was vaccinated with a dose PNEUMOVAX 23, 0.5 mL. Physician reported that sometime during the week of 12-APR-2010 and after receiving only one dose of PNEUMOVAX 23 the patient had a swollen arm and it was hot to the touch. The physician reported that the patient came back in the office later that she received PNEUMOVAX 23 and was given a cold pack and BENADRYL. At the time of reporting the patient had recovered.  Additional information has been requested.