chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Initial and follow-up information has been received from a pharmacist concerning a 65 year old female who on 10-OCT-2008 was vaccinated with the second dose of PNEUMOVAX (Lot# 660685/0619X) 0.5ml IM left deltoid. She had no drug reactions/allergies. The patient had no illness at the time of vaccination. On 11-OCT-2008 the patient developed an injection site reaction. The injection site was red, raised, hard and warm. The patient could not lift the injection site arm. The injection site reaction was 3 and 1/2 inches in length described as oblong. The patient was nauseous. She could not eat which lasted about 2 days. The patient was slight dizzy. Subsequently, the patient recovered. No further information was available.
Sex: M
Vaccine: PPV
Symptoms: Heart rate decreased, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a physician concerning a male patient who was vaccinated with a dose of PNEUMOVAX.  The physician reported that the patient experienced redness, swelling and pain at the injection site, on the arm, that extended to the shoulder and neck.  The patient also experienced fever.  Patient had a "decreased" pulse in the affected arm.  No other information was available at this time. The patient recovered.  This is one of three reports from the same source.  Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a physician concerning a male patient who was vaccinated with a dose of PNEUMOVAX nine months prior. The patient was vaccinated with another dose of PNEUMOVAX. The physician reported that the patient experienced redness, swelling and pain at the injection site, on the arm, that extended to the shoulder and neck. The patient also experienced fever. No other information was available at this time. The patient recovered. This is one three reports from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a 66 years old female patient who with sulfonamide allergy concerning that in 2007 she received the vaccine for pneumonia (manufacturer not specified; therapy route, site unknown). Right after the injection her arm started swelling up. It wasn't just swollen at the injection site, but rather her whole arm was really swollen. The arm was not painful; it was only painful during the injection. She bought medical attention and about a week after getting that vaccine the patient recovered. No further information is available.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pain
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with PNEUMOVAX and a day later he experienced body aches and soreness. Concomitant therapy included influenza virus vaccine *unspecified). The patient's outcome was not reported. The patient sought unspecified medical attention. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Arthropathy, Musculoskeletal pain, Pain in extremity
Clinical narrative: Information has been received from an office manager concerning a 64 year old male who on 14-OCT-2008 was vaccinated with a dose of 0.5 mL PNEUMOVAX into his left shoulder (intra articular).  Concomitant medication included VOLTAREN GEL.  On 14-OCT-2209 the patient developed sore arm after receiving the PNEUMOVAX in left shoulder.  The administration of the PNEUMOVAX into his left shoulder was discovered upon an office visit and examination on 15-OCT-2008.  The patient was instructed to apply VOLTAGEN GEL and ice packs as needed.  No other symptoms or treatment were reported. At the time of the report the patient had not recovered from sore arm.  No other information was available.  Follow-up information was received from the office manager.  On 14-OCT-2008 the patient was vaccinated with the first dose of PNEUMOVAX into his left shoulder deltoid.  Subsequently the patient experienced left shoulder pain and arthropathy.  The patient's left shoulder pain and arthropathy improved after steroid injection was given intraarticularly. The patient recovered from left shoulder pain and arthropathy.  The duration of left shoulder pain and arthropathy was 7 weeks.  No further information is available.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site mass, Swelling
Clinical narrative: Information has been received from a 63 year old female who in October 2007, was vaccinated with PNEUMOVAX 23 (lot # not provided) 0.5ml. On 14-Oct-2008, the patient received the second dose of PNEUMOVAX 23 (lot # not provided) 0.5ml. The patient had no drug allergy. Concomitant therapy included influenza virus vaccine (unspecified), ALTACE, simvastatin (MSD) and PROTONIX. Several hours after receiving the second dose, the patient developed a lump the size of a baseball at injection site. The patient visited doctor and was given BENADRYL. Swelling was reduced in size. The patient stated she did not experience any events after first dose. At the time of the report, on 15-OCT-2008, the patient was recovering from the lump at injection site. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Blood culture negative, Culture urine negative, Pyrexia, Urine analysis abnormal, White blood cell count increased
Clinical narrative: Information has been received from a physician concerning a 65 year old male with no drug allergies who on 06-Oct-2008, was vaccinated with PNEUMOVAX (lot # not provided), injection. Concomitant therapy included influenza virus vaccine. Two days after receiving vaccine, on 08-OCT-2008, the patient experienced fever of 103 degrees. A dip urinalysis was positive for nitrites and protein, negative for leukocytes and blood. The patient also had a blood test, which indicated that he had an elevated white count of 23000. In follow-up it was reported the patient was prescribed CIPRO 500 mg BID. Blood work revealed a white blood cell count (WBC) of 26, 2000 with shift. Urine culture was negative and blood cultures x2 were negative. Another white blood count test result was 26200 with shift. The patient also had a urine culture tests which all indicated negative. The patient was treated with "CYRO" 500 mg bid. On 10-OCT-2008, the patient's fever resolved and the patient fully recovered. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old male with a history of knee replacement 2 months ago who on 14-OCT-2008 was vaccinated with PNEUMOVAX, 0.5ml, very far up near left shoulder joint. On 14-OCT-2008 8PM the patient went to urgent care treatment center with complaints of pain and his shoulder locking up; and decrease mobility. The patient was treated with prednisone and KEFLEX, and was released. The patient was not hospitalized. Pharmacist states the patient was recovering from knee surgery so the patient took some OXYCONTIN but it did not relieve the pain in his shoulder. The patient's pain and his shoulder locking up; and decrease mobility persisted. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with a dose of PNEUMOVAX vaccine (route not reported). A few days later the patient developed a rash. The patient was given antibiotics. It was unspecified that if the patient recovered from rash. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a physician concerning a 49 year old female with a history of asthma who on 30-SEP-2008 was given a 0.5ml dose of PNEUMOVAX (Lot # 660685/0619X) subcutaneously for vaccination.  Concomitant therapy included ADVAIR, FLONASE, ADDERALL TABLETS, montelukast sodium (Merck) and NECON.  On 01-OCT-2008 the patient developed severe cellulitis.  The patient was seen in the physician's office for a well check up and the cellulitis is described as being 6 inches in diameter.  The patient not recovered from severe cellulitis at the time of report.  Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an 11 week old child who was vaccinated with one dose of PNEUMOVAX (lot # not reported) due to nursing error. The nurse reported that the nurse who gave the vaccine was a new employee who was not used to administering vaccines, and that this was a human error. No adverse effect reported. This is one of two reports received from the same source. No additional information is expected, the physician could not be contacted.
Age: 36.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Incorrect route of drug administration, Pain, Swelling
Clinical narrative: Information has been received from an unknown source concerning a 36 year old male who on 30-SEP-2008 was vaccinated intradermally with PNEUMOVAX (lot # not reported) 25mcg/0.5 mL instead of tuberculin purified protein derivative (manufacturer unspecified). Subsequently the patient experienced redness, swelling pain. No further information was available. This is one of two reports from received from the same source. Additional information is not expected.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 73 year old male who on 26-SEP-2008 was vaccinated with PNEUMOVAX vaccine (Lot # 658074/0961U) (Lot # originally reported by physician as 660685/0619X) IM in his right arm (dose not reported), the patient had COPD exacerbation at time of vaccination. Concomitant therapy included amyl nitrite, GLUCOPHAGE, paroxetine and lisinopril. On 26-SEP-2008 (also reported as 29-SEP-2008) the patient developed cellulitis in the arm, arm red, swollen, painful and warm. WBC 21800. The patient was treated with KEFLEX 500mg, three times a day for 10 days. At the time of the report the patient recovered from cellulitis in the arm. The patient sought medical attention at the office. This is one of several reports received from the same source. No further information is available.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: White blood cell count decreased
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 73 year old male who on 26-SEP-2008 was vaccinated with PNEUMOVAX vaccine (Lot # 658074/0961U) (Lot # originally reported by physician as 660685/0619X) IM in his right arm (dose not reported), the patient had COPD exacerbation at time of vaccination. Concomitant therapy included amyl nitrite, GLUCOPHAGE, paroxetine and lisinopril. On 26-SEP-2008 (also reported as 29-SEP-2008) the patient developed cellulitis in the arm, arm red, swollen, painful and warm. WBC 21800. The patient was treated with KEFLEX 500mg, three times a day for 10 days. At the time of the report the patient recovered from cellulitis in the arm. The patient sought medical attention at the office. This is one of several reports received from the same source. No further information is available.
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a healthcare worker concerning a male who on 26-SEP-2008 was vaccinated with PNEUMOVAX (lot #658074/0961U) 0.5 mL/one dose IM. On 26-SEP-2008 after receiving the dose of PNEUMOVAX, the patient experienced swelling, pain, cellulitis and fever in the arm of PNEUMOVAX. The healthcare worker reported that the patient was seen in the practice. At the time of reporting the patient had not recovered from swelling, pain cellulitis and fever. No further information was provided. This is one of two reports received from the same source. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Myalgia
Clinical narrative: Information has been received from a nurse concerning an 82 year old retired female with high blood pressure, thyroid issues and possible hydrochlorothiazide allergy who on 03-OCT-2008 at 12:00 was vaccinated with PNEUMOVAX 23 (lot # 660717/0224X), 0.5ML, IM in the right deltoid. Concomitant vaccination included FLULAVAL (lot# AFLLA188AA-ID) in the left deltoid. Additional concomitant therapy included LOTREL, SYNTHROID, ZYRTEC, ARTHROTEC, TOPROL XL TABLETS, doxepin HCl, aspirin, omeprazole (MSD), albuterol and MAXIDE. Subsequently, the patient experienced severe pain and muscle aches on the right arm at 18:00 on 03-OCT-2008. The patient was not able to life her arm because of the pain. The patient called the hospital and was instructed to take TYLENOL. The patient called the office on 08-OCT-2008 and she was feeling much better. No lab diagnostics study was performed. Follow up information has been received from a registered nurse concerning an 82 year old retired female with high blood pressure, thyroid issues, possible hydrochlorothiazide allergy and pseudocholinesterase deficiency who on 03-OCT-2008 at 12:00 was vaccinated with the first dose of PNEUMOVAX 23 vaccine (lot # 660717/0224X), 0.5ML, IM in the right deltoid. Concomitant vaccination included FLULAVAL (lot# AFLLA188AA-ID) IM in the left deltoid on 03-OCT-2008 at 11:55. Additional concomitant therapy (LOTREL, SYNTHROID, ZYRTEC, ATHROTEC, TOPROL XL TABLETS, doxepine HCl, aspirin, omeprazole (MSD), albuterol and MAXIDE. Subsequently, the patient experienced terrible pain in the right arm on 03-OCT-2008 at 18:00, muscle ache on 03-OCT-2008 and "unable to move arm" due to pain and muscle ache. The terrible pain, muscle ache in the right arm and "unable to move arm" lasted several days and was treated with TYLENOL. The patient was better on 08-OCT-2008. No lab diagnostics study was performed. No further information is available.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Initial and follow-up information has been received  from a healthcare worker concerning a 26 year old female who on 01-OCT-2008 (previously reported as 03-OCT-2008) was vaccinated with a 0.5 ml dose of PNEUMOVAX (LOT# 658673/0990U;  also reported as:  9733401), intramuscularly in the right upper arm.  There was no concomitant medication.  In the evening of 03-OCT-2008 the patient experienced as swollen, itchy bump at the injection site.  The area got larger and on 08-OCT-2008 the patient was seen in the office and the injection site was warm to touch, red and itchy.  The area had radiated down the arm and was about the size of a baseball.  On 13-OCT-2008, the patient experienced fever, swelling at the location of the injection and pain.  The patient recovered from fever, pain and swelling at the location of injection on 27-OCT-2008.  There were no lab diagnostic studies performed.  The patient sought unspecified medical attention.  Additional information is not expected.
Age: 0.4
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 4 month old male who on 08-OCT-2008 at about 12:00 was vaccinated with a dose of PNEUMOVAX (LOT# 658074/0803U) accidentally rather than PREVNAR. The patient received his first dose of PREVNAR in August 2008 (2 months ago) and was to receive dose 2 when the error occurred. The registered nurse indicated that it would be helpful if the "labeling could be bigger" to prevent future errors. Within 72 hours post vaccination, the patient experienced a cold. However, the nurse did not think that there was a link to the vaccination. The patient's outcome was unknown. It was not specific if the patient sought medical attention. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a male adult over 50 years old, who in October ("past week") received a first dose of 0.5 ml PNEUMOVAX vaccine (lot # 660718/0551X, route and injection site unknown). The day after the injection, the patient sought medical attention in the office with pain, redness and swelling at the injection site. No treatment was required for him. The patient recovered on an unspecified day. Additional information has been requested. This is one of 3 reports from a same source.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 66 year old female with allergy to "sulfa" and penicillin who on 14-OCT-2008 was vaccinated with PNEUMOVAX 23 vaccine, Lot # 657413/0380U, intramuscularly in right deltoid). It was reported by the registered nurse, that on 14-OCT-2008 the patient developed an adverse reaction. The patient's injection site arm because warm and red several hours after vaccination with PNEUMOVAX 23 vaccine. The reaction was at the injection site, but inner aspect of the injection site arm. Patient took BENADRYL for the symptoms. The patient sought medical attention, she called and returned to the office. At the time of the report the patient was recovering. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a female patient who in 2003 was vaccinated with a dose of PNEUMOVAX and had no reaction. On an unspecified date, the patient was vaccinated with another dose of PNEUMOVAX. It was reported by the registered nurse that the patient had an injection site reaction after PNEUMOVAX was given. The patient had a "softball size red swollen area and had fever". At the time of the report, the patient was recovered on an unspecified date. Follow up information has been received from a registered nurse on 27-JAN-2009. It was reported that on 11-SEP-2008, the 82 year old female patient was vaccinated intramuscularly with a second dose of PNEUMOVAX into the left arm (Lot # 660685/0619X) at 11:16. The patient called back to office to stating that on 12-SEP-2008 had swelling at injection site (left arm), very warm to touch. The patient stated that the area was the size of a softball. The patient felt feverish and had flu-like symptoms. On 15-SEP-2008, the patient had recovered. This is one of several cases from the same source. Additional information is not expected.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Influenza like illness, Nausea, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 56 year old female who on 09-OCT-2008 was vaccinated with PNEUMOVAX 23 vaccine (lot # 660685/0619X). On 10-OCT-2008 the patient experienced nausea, a large injection site reaction, the arm was red swollen, sore, warm to touch and flu like symptoms. Subsequently, the patient recovered on unspecified date. This is one of several reports from the same source. Follow up information was received from a registered nurse. It was reported the patient with Parkinson's disease and osteoporosis was vaccinated intramuscularly in the right deltoid with a first dose of PNEUMOVAX 23 vaccine on 09-OCT-2008 at 2:41 pm. On 10-OCT-2008 the patient's right arm was red swollen, warm to touch and tender. The patient had "flu like symptoms" for two days following injection. No further information was available.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Tenderness
Clinical narrative: Information has been received from a registered nurse concerning a 56 year old female who on 09-OCT-2008 was vaccinated with PNEUMOVAX 23 vaccine (lot # 660685/0619X). On 10-OCT-2008 the patient experienced nausea, a large injection site reaction, the arm was red swollen, sore, warm to touch and flu like symptoms. Subsequently, the patient recovered on unspecified date. This is one of several reports from the same source. Follow up information was received from a registered nurse. It was reported the patient with Parkinson's disease and osteoporosis was vaccinated intramuscularly in the right deltoid with a first dose of PNEUMOVAX 23 vaccine on 09-OCT-2008 at 2:41 pm. On 10-OCT-2008 the patient's right arm was red swollen, warm to touch and tender. The patient had "flu like symptoms" for two days following injection. No further information was available.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 66 year old female who on 08-OCT-2008 was vaccinated with PNEUMOVAX vaccine (lot # 660685/0619X) (dose and site was not reported). The patient was vaccinated with FLUZONE vaccine (unspecified) on the same day. On 10-OCT-2008 the patient experienced an injection site reaction: a golf ball site area that was red and swollen, fever and was vomiting. The patient sought medical attention on unspecified date. At the time of reporting the patient was recovering. This is one of several reports from the same source. Follow up information was received from a registered nurse. It was reported the patient who was a female with hypertension, gastroesophageal reflux disease and hyperlipidaemia and a history of atrial fibrillation on 08-OCT-2008 at 10:00am was vaccinated intramuscularly into the left deltoid with a first dose of PNEUMOVAX vaccine. Concomitant therapy included a fourth dose of FLUZONE vaccine, lot # U2811AA which was vaccinated intramuscularly into the left deltoid on 08-OCT-2008 at 10:01 am. On 10-OCT-2008 the patient presented to the office with complaints of left arm redness and pain in upper deltoid region, "area 2" wide x 3" length". The patient was advised TYLENOL, ice packs for comfort measures. On unknown date, the patient recovered. No further information is available
Age: 60.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a 60 year old male with penicillin allergy and allergic reaction to antibiotics who on 13-OCT-2008 was vaccinated with PNEUMOVAX 23 vaccine. Concomitant therapy included influenza virus vaccine (unspecified) in the opposite arm. On 13-OCT-2008 the patient experiences swelling, pain and redness at the injection site. The patient reported to the pharmacist that the area affected looked like 2 welts, one on each side of the injection site. This is the second patient of 2 patients who developed swelling, pain and redness at the injection site after receiving PNEUMOVAX 23 vaccine. The patient had made phone call for medical attention. The pharmacist was requesting a lot check on lot # 0619X. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: Information has been received from a nurse concerning an 88 year old female patient with hypertension and reflux and no known drug allergies who on 13-OCT-2008 was vaccinated with the first dose of PNEUMOVAX (lot# 659199/1541U).  There was no concomitant medication.  On 13-OCT-2008 the patient experienced ill.  The patient stated that she was ill for two days.  No lab diagnostic studies were performed.  At the time of this report, she was improving.  The patient sought medical attention via telephone.  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 agency.  Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Musculoskeletal stiffness, Swelling
Clinical narrative: Information has been received from a physician concerning a 53 year old female with rheumatoid arthritis who on 22-AUG-2008 was vaccinated with PNEUMOVAX (lot # 657143/0380U). Concomitant therapy included Tdap. It is unknown if the patient was vaccinated PNEUMOVAX in past or had any reactions in the past. Subsequently, in 2008 the patient experienced pain, redness and swelling at the site, and then stiffness and swelling down the arm to the wrist. The event resolved in a couple of weeks. She recovered, did not die, no antibiotics needed or hospitalized. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Mass
Clinical narrative: Information has been received from a health professional concerning a 64 year old female received a dose of PNEUMOVAX 23 vaccine (lot # 662020/0614X). The patient experienced lump, size of "dollar", and redness at injection site. Patient administered ice packs and BENADRYL for event. Patient recovered. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a laboratory technician concerning a female patient who was subcutaneously vaccinated with a standard dose of PNEUMOVAX 23 on 07-OCT-2008. Within 3 days the patient developed what was diagnosed as cellulitis. She was placed on an unspecified antibiotics and was recovering. The patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Pain in extremity
Clinical narrative: Information has been received from a certified medical assistant and a healthcare worker, concerning a 63 year old female patient who in October 2003, was vaccinated with PNEUMOVAX.  The certified medical assistant reported that on 15-OCT-2008, the patient was vaccinated with a second dose of PNEUMOVAX (lot #661528/0867X).  On 16-OCT-2008 the patient experienced injection site reaction with redness and had pain in her arm.  On 17-OCT-2008, the patient was seen by the doctor and her reaction was getting better but still red.  This is one of several reports, received from the same source.  Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: HPV4, PPV
Symptoms: Pain, Sinus congestion
Clinical narrative: Information has been received from a registered nurse concerning a 52 year old female co-worker with no known allergies or pertinent medical history who on 15-OCT-2008 was vaccinated with PNEUMOVAX 23. Concomitant therapy included GARDASIL 0.5 ml IM. The registered nurse reported that the patient developed unspecified body aches on 16-OCT-2008 and sinus congestion on 17-OCT-2008 after receiving PNEUMOVAX 23 on 15-OCT-2008. No other symptoms reported. The patient's unspecified body aches and sinus congestion persisted. The patient did not seek treatment. No lab diagnostics were performed. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site warmth, Lymph node pain, Malaise, Pain, Pain in extremity
Clinical narrative: Information has been received from a 43 year old female with allergic reaction to tetracycline who in the fall of 2003 was vaccinated with the first dose of PNEUMOVAX 23 vaccine, IM. On 13-OCT-2008, the patient was revaccinated with PNEUMOVAX 23 vaccine (Lot# 658449/0989U) in her right arm. Concomitant therapy included influenza virus vaccine, in the left arm (name and manufacturer unspecified). On 13-OCT-2008 the patient experienced high fever, pain in lymph nodes, her left side hurt, high injection site heat, extreme pain and heaviness in her arm, malaise, not feeling good and achiness after getting revaccinated in right arm. The patient had symptoms by the afternoon. At the time of the report, the patient was recovering. The patient did not seek medical attention. This is one of several reports received from the same source. No further information is available.
Age: 43.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a 43 year old female with allergic reaction to tetracycline who in the fall of 2003 was vaccinated with the first dose of PNEUMOVAX 23 vaccine, IM. On 13-OCT-2008, the patient was revaccinated with PNEUMOVAX 23 vaccine (Lot# 658449/0989U) in her right arm. Concomitant therapy included influenza virus vaccine, in the left arm (name and manufacturer unspecified). On 13-OCT-2008 the patient experienced high fever, pain in lymph nodes, her left side hurt, high injection site heat, extreme pain and heaviness in her arm, malaise, not feeling good and achiness after getting revaccinated in right arm. The patient had symptoms by the afternoon. At the time of the report, the patient was recovering. The patient did not seek medical attention. This is one of several reports received from the same source. No further information is available.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Information has been received from a retired 70 year old nurse with no medical history and drug reactions/allergies who on 15-OCT-2008 was vaccinated with PNEUMOVAX 23 by SQ. There was no concomitant medication. Subsequently the patient experienced soreness, warmth and redness extending from the deltoid to half down her forearm. The nurse mentioned that this was her third PNEUMOVAX 23 injection. She did not recall the dates of the first two doses. The patient sought medical attention to the pharmacist. At the time of the report, the patient was recovering from the adverse experience. No further information is available.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect route of drug administration, Local reaction
Clinical narrative: Information has been received from a health professional concerning a 57 year old female who on 26-SEP-2008 was vaccinated with PNEUMOVAX, mistakenly intradermally (lot # 659487/1960U). On 26-SEP-2008 the patient experienced local reaction. The patient sought unspecified medical attention. The patient outcome was unknown. Additional information has been requested.
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 laboratory technician concerning a female patient who was subcutaneously vaccinated with a dose of PNEUMOVAX 23 vaccine on 13-OCT-2008. The patient called office on 16-OCT-2008 to report "an area at the injection site 2 & 1/2 to 3 inches around that was red, sore, swollen, and warm". Her treatment and outcome were unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a female with shellfish allergy and latex allergy who on unspecified dates was vaccinated with the first and second doses of PNEUMOVAX 23. There was no concomitant medication. The patient developed swelling and redness at the injection site as well as dyspnea, after receiving her second dose of PNEUMOVAX 23. The patient was evaluated and treated at a local emergency room but details are not available. On an unspecified date, the patient fully recovered. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: Information has been received from a physician concerning an 87 year old female who on "on Friday", 17-OCT-2008, was vaccinated with PNEUMOVAX 23 vaccine (Lot# 657525/0554U). Concomitant therapy included ATENOLOL, thyroid, simvastatin (MSD), and vitamins (unspecified). On 17-OCT-2008 the patient experienced "severe adverse effects". The patient was on her way to the Emergency room at the time of report. The exact nature of the patient's adverse effects were unspecified by the reporter. The physician was requesting a lot check for Lot# 658525/0554U). Additional information has been received from the physician's secretary concerning the doctor did not think the patient's reactions were caused by PNEUMOVAX 23 vaccine. 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 Biologic Evaluation and Research and was released. Additional information has been requested. This is one of two reports received from the same source.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Information has been received from a physician and a nurse practitioner concerning a 85 year old female retired without illness at time of vaccination who on 14-OCT-2009 was vaccinated with the first dose of PNEUMOVAX 23 vaccine (Lot n.657042/1345U) intramuscularly in the right arm at 3:00 pm. 3 days after receiving a dose of PNEUMOVAX 23 vaccine, on 17-OCT-2008, the patient experienced considerable pain, swelling, itching and redness around the injection site at 8:00 am. The patient didn't have fever. The patient did not seek medical attention. On an unspecified date, the patient recovered. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 70 year old female patient with niacin, cephalosporin and CODEINE allergies, who about six years (approximately 2002) was vaccinated with the first dose of PNEUMOVAX.  There was no concomitant medication.  In approximately 2002, 507 days after vaccination, the patient experienced swelling and inflammation from her right upper arm to her wrist.  The patient no  had any laboratory test done.  Two weeks after the onset date in approximately 2002, the patient recovered.  The patient was seen.  Follow-up information was received from the pharmacist who reported that she had no further information.  She reported that the incident was 6 + years ago and not at her facility.  No further information is available.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Anxiety, Headache, Incorrect route of drug administration, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 50 year old female who on 26-SEP-2008 was vaccinated with PNEUMOVAX (lot # 659487/1960U), mistakenly intradermally. On 26-SEP-2008 the patient experienced pain in arm, headache for a weekend, anxiety for long term effect possibility. The patient required emergency room or doctor visit. The outcome was unknown. No further information is available.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site oedema, Injection site pruritus, Local reaction
Clinical narrative: Information has been received from a health professional concerning a 36 year old female who at 11:00 am on 26-SEP-2008 was vaccinated mistakenly intradermally with a dose of PNEUMOVAX 23 vaccine (lot # 659487/1960U). Subsequently, the patient experienced mild local reaction, and local reaction of erythema, edema and itching on 27-SEP-2008 and 03-OCT-2008 respectively. The patient sought medical attention. At the time of reporting, it was unknown if the patient recovered. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Anxiety, Cough, Hot flush, Incorrect route of drug administration, Injection site pain
Clinical narrative: Information has been received from an health care worker in a physician's office concerning a 57 year old female patient who on 11AM of 26-SEP-2008 was vaccinated with PNEUMOVAX, lot number was reported as 659487/1960U. However, the vaccine was mistakenly administered intradermally. On 28-SEP-2008 ( a contradictory AE onset date given as 26-SEP-2008), the patient experienced hot flashes, anxiety, nausea, dry cough, pink-brown discoloration, burning at site. At the time of the report, the outcomes of these experienced were unknown. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Skin discolouration
Clinical narrative: Information has been received from an health care worker in a physician's office concerning a 57 year old female patient who on 11AM of 26-SEP-2008 was vaccinated with PNEUMOVAX, lot number was reported as 659487/1960U. However, the vaccine was mistakenly administered intradermally. On 28-SEP-2008 ( a contradictory AE onset date given as 26-SEP-2008), the patient experienced hot flashes, anxiety, nausea, dry cough, pink-brown discoloration, burning at site. At the time of the report, the outcomes of these experienced were unknown. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 70 year old female with a history of hypertension, coronary artery disease, osteoarthritis and gastrooesophageal reflux who on 20-OCT-2008 was vaccinated with the second dose of PNEUMOVAX 23, intramuscularly. Subsequently, the patient developed an injection site reaction. The arm was swollen, red and tender. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Pain in extremity, Rash
Clinical narrative: Information has been received from a certified medical assistant concerning one adult female patient who on an unknown date was vaccinated with a dose of PNEUMOVAX 23 (Lot #660717/0224X). Subsequently, the patient experienced an injection site reaction. At the time of reporting the patient was recovering. The certified medical assistant reported that last year they never received any adverse reaction complaints and this year they had already received five complaints. The reporter has requested a lot check. In follow up, the medical assistant reported that the patient was female and was vaccinated on 13-OCT-2008. In October 2008, the patient experienced a sore arm and a rash that could be attributed to the injection. Subsequently, the patient recovered from the sore arm and rash. The medical assistant still administered additional patients using lot # 660717/0224X. However, she now administered it in the patients' hips instead of arms. No adverse events have been reported after she changed injection sites. A standard lot check investigation was performed. All in process quality checks for the lot number 660717/0224X was satisfactory. The lot number 660717/0224X met the requirements of the center and was released. This is one of several reports received from the same source. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect route of drug administration, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 43 year old female who at 11:00 AM on 26-SEP-2008 was vaccinated with PNEUMOVAX 0.5ml intradermally mistakenly (lot # 659487/1960U) instead of PPD (manufacturer unspecified).  At 12:30 on 26-SEP-2008 the patient experienced severe pain in arm, and continued to complain of pain in arm though not as severe throughout the week.  The patient sought medical treatment at ER.  This is one of several reports received from the same source.  Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Swelling
Clinical narrative: Information has been received from a physician concerning a 60 to 65 year old male patient who on 20-OCT-2008 was vaccinated with PNEUMOVAX 23 (lot # 658673/0990U). On 22-OCT-2008 the patient experienced severe arm pain, swelling and redness that looked like cellulitis. The patient sought unspecified medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant and a health care worker concerning an 82 year old female who in October 2003, was vaccinated with a dose of PNEUMOVAX 23. The certified medical assistant reported that on 08-OCT-2008, the patient was vaccinated with a second dose of PNEUMOVAX 23 (lot #661528/0867X). The certified medical assistant reported that on 09-OCT-2008, the patient saw the oncologist and had pain, warmth and redness of the arm. On 10-OCT-2008, the patient was seen in the physician's office and the symptoms had resolved. This is one of several reports, received from the same source. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant and a health care worker concerning a 61 year old male patient who on 08-OCT-2008 was vaccinated with the first dose of PNEUMOVAX 23 (lot # 661528/0867X), in his left arm. Concomitant vaccination included influenza virus vaccine (unspecified) in his right arm. The certified medical assistant reported that the patient's wife stated he experienced redness and warmth on left arm and it was getting better. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Induration, Malaise, Nausea
Clinical narrative: Initial and follow-up information has been received from a 63 year old female with allergic reaction to antibiotics, SULFONAMIDE and "others unspecified"  who on 17-OCT-2008 was vaccinated with PNEUMOVAX.  On 17-OCT-2008 the patient received PNEUMOVAX vaccine and right away started feeling sick, nauseous, and felt this tightness around the arm.  The arm became red, painful, very hot and hard to the touch.  The patient did not feel nauseous any more, pain and redness had decreased because of the antibiotics her doctor gave her, but it is still "itchy" and it "burns".  The patient sought medical attention.  Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pruritus, Skin warm
Clinical narrative: Initial and follow-up information has been received from a 63 year old female with allergic reaction to antibiotics, SULFONAMIDE and "others unspecified"  who on 17-OCT-2008 was vaccinated with PNEUMOVAX.  On 17-OCT-2008 the patient received PNEUMOVAX vaccine and right away started feeling sick, nauseous, and felt this tightness around the arm.  The arm became red, painful, very hot and hard to the touch.  The patient did not feel nauseous any more, pain and redness had decreased because of the antibiotics her doctor gave her, but it is still "itchy" and it "burns".  The patient sought medical attention.  Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Information has been received from a healthcare worker concerning a female who on 22-OCT-2008, "yesterday", was vaccinated with a dose of PNEUMOVAX 23. Suspect therapy included influenza virus vaccine (unspecified) given in the same arm as PNEUMOVAX 23. It was unknown if the patient had received PNEUMOVAX 23 in the past. It was reported that the patient had developed severe swelling, redness and pain of her arm that extended up to her neck. As of 23-OCT-2008, the patient's symptoms persisted. The patient called the office and sought unspecified medical attention. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 64 year old female patient who on 22-OCT-2008 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX (lot number 659199/1541U) (injection site not reported) and a dose of FLUVIRIN at the same injection site. concomitant therapy included CYMBALTA, TIZANIDINE HYDROCHLORIDE and BISOPROLOL FUMARATE/HCTZ. On 22-OCT-2008, later the same day of vaccination, the patient developed swelling, pain and redness at the injection site. The patient called the physician's office. Unspecified medical attention was sought. At time of the report, the patient's symptoms persisted. Follow up was received from the physician who reported the patient had swelling, severe pain and erythema at the injection site with radiation to the neck and down the length of the arm. In 2008, the patient recovered. No further information is expected.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Information has been received from a healthcare worker concerning a male who on 22-Oct-2008 was vaccinated subcutaneously with the first dose of PNEUMOVAX 23 (batch# 659147/1381U, injection site not reported). Subsequently, the patient's arm became red and very sore. At the time of the report (23-Oct-2008) the patient had not recovered. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Chills, Erythema, Injection site streaking, Lymphadenopathy, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 48 year old male who on 21-Oct-2008 was vaccinated with a dose of PNEUMOVAX 23 (lot# 660718/0551X), injection route and site not reported). Concomitant therapy included influenza virus vaccine (unspecified). Subsequently, the patient developed redness and swelling of his arm that extended to his "lymph nodes". The location of the affected lymph nodes was unknown. It is unknown if the patient has received PNEUMOVAX 23 in the past. Follow up information was received from a nurse concerning a 48-year-old male patient with anemia and a family history of breast cancer and prostate cancer who on 21-OCT-2008 was vaccinated intramuscularly in the right deltoid with a dose of PNEUMOVAX 23 (lot# 660718/0551X). He was concomitantly vaccinated intramuscularly in the left deltoid with the first dose of ADACEL (lot# C3033AA) at the same time. The patient woke early next day and experienced chills, body aches and redness on his arm. A puffy Red lines above area where injection given. The patient was treatment with TYLENOL, ice to arm. Symptoms better next day. Redness gone by 3rd day. Patient had been hospitalized in Feb-2007, there is possibility (small) he may have had vaccine there. Additional information has been requested.