chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning an approximately 65 year old female patient with no pertinent medical history and no known drug allergies, who on 24-JUL-2009 was vaccinated with the second dose (as the physician thought) of PNEUMOVAX 23 (Lot: 662599/1076X). There was no concomitant medication. In 2009 the patient developed pain and swelling from elbow to shoulder of the arm where PNEUMOVAX 23 was administered. The patient sought unspecified medical attention. The physician did not have the patient's chart at the time of reporting. At the time of reporting on 27-JUL-2009, the patient status was unknown. The physician requested a lot check to be conducted because he does not feel comfortable using the vaccine. This is one of several reports from the same source. Additional information has been requested. A standard lot check investigation was performed. All in-process quality checks for the lot number 662599/1076X 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.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a physician and nurse concerning a 71 year old male with prostate cancer and no drug allergy who in 2002 was vaccinated with the first dose of PNEUMOVAX 23. On 29-JUL-2009, the patient received the second dose of PNEUMOVAX 23. Concomitant therapy included AGGRENOX, NORVASC, metformin, TOPROL XL TABLETS, simvastatin, CASODEX, HYTRIN and hydrochlorothiazide. Subsequently the patient developed cellulitis at the injection site. The patient had visited the office and was being treated with KEFLEX. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Fatigue, Malaise, Palpitations
Clinical narrative: Information has been received from a 69 years old female patient who in 2007 was vaccinated with a dose of PNEUMOVAX 23 (manufacturer unknown). Concomitant therapy included influenza virus vaccine (unspecified). The patient stated that on 2007 after receiving the vaccines, she had severe reactions such as racing heartbeat, redness in the face, tiredness and feeling unwell. At the time of reporting the patient had recovered. Additional information has been received from a physician concerning a 69 year old female patient who on 2007 was vaccinated with PNEUMOVAX 23. The physician reported that the patient did not report any reaction of the vaccine to his office. This was the first time they have learned of this. No additional information is expected.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from the physician concerning an 82 year old female retired patient with osteoporosis and mastocytosis and a history of herniated disc who on 20-JUL-2009 11:00 am was vaccinated intramuscular with the second dose of PNEUMOVAX 23 (lot # 662874/1125X). Concomitant therapy included vitamins (unspecified), OS-CAL + D, ESTRACE and ACTONEL. On 20-JUL-2009 14:00 the patient experienced erythema and swelling of left upper arm around injection site. The patient was treated with ice to swelling. The patient's arm was swollen from shoulder to elbow. No deterioration in rem. The patient had sought medical attention and had recovered on 24-JUL-2009. Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with PNEUMOVAX 23 (lot # not provided). The patient experienced redness and swelling of the arm at the injection site after receiving the vaccine. The patient had sought unspecified medical attention. On an unspecified date the patient recovered from redness and swelling of the arm at the injection site. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a 12 month old patient who was vaccinated with a dose of PNEUMOVAX 23 instead of PREVNAR. The nurse mentioned it was busy and both products were in the same box. No adverse effect reported. At the report time the outcome was unknown. Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a pharmacist concerning a male with a history of "recent knee surgery" who on 03-AUG-2009 was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported). The pharmacist reported that on 03-AUG-2009, the patient had an injection site reaction in the area where PNEUMOVAX 23 was given. At the time of reporting the patient had not recovered from the event. The patient sought medical attention by visiting his physician. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a registered nurse with pneumonia in the past, who 7 years ago received a dose of PNEUMOVAX and her unspecified arm was sore the next day for 2 weeks. The patient took ADVIL. Subsequently, the patient recovered. No further information is available.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a 64 year old female consumer with diabetes and drug hypersensitivity who couple days ago, on 03-AUG-2009, was vaccinated with a single dose of PNEUMOVAX 23. Concomitant therapy included "allergy shot". It was reported that "after getting the vaccine" she experienced injection site reaction. The arm under the injection site became swollen and red and the muscle hurt. It was reported that she was taking BENADRYL and putting ice on the site and it has gotten much better. The patient did not seek medical attention. There was no laboratory diagnostic tests performed. It was reported that the patient was recovering at the time of the report. No further information is available.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Information has been received from an office worker concerning a 44 year old (reported as 45 year old) female with asthma, aspergillosis, penicillin allergy, tetracycline allergy, azithromycin allergy, COMPAZINE hypersensitivity and REGLAN hypersensitivity who on 17-AUG-2009 was vaccinated with the first dose of PNEUMOVAX 23 (lot # reported as 08743X). On 26-AUG-2009 the patient experienced redness and swelling in her arm which was also hot to touch. The patient also experienced soreness and was unable to lift her arm. At the time of the report, the patient recovered on an unspecified date. Follow up information has been received from the office worker and medical records concerning a 44 year old (previous reported as 45 year old) female with asthma, penicillin allergy, allergic reaction to antibiotics, drug hypersensitivity, sleep apnoea, bronchopulmonary aspergillosis allergic, rhinitis allergic, oedema, cough, liver disorder, overweight, no social history (smoking, alcohol, drug use and caffeine) and anxiety disorder and a history of colitis, liver fatty, metabolic syndrome, migraine, supraventricular tachycardia, oesophageal reflux, candidiasis, caesarean section, cholecystectomy, intestinal adhesions, psoriatic arthritis, gastritis and gastrointestinal erosion who on 3:00 pm on 17-AUG-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot # 662263/0743X) in her left arm. Concomitant therapy included AMBIEN, ZANTAC, ZITHROMAX, CIPRO, BACTRIM DS TABLETS, Epi EZ Pen, ZOFRAN, albuterol, ALVESCO, SYMBICORT, XOPENEX, lidocaine, PROAIR HFA, hydrochlorothiazide, HYCODAN and KAPIDEX. On 24-AUG-2009 the patient experienced a local reaction to the vaccine. Her left arm was sore, red, swollen and hot to touch. She was unable to lift her arm. There was no temperature noted. At the time of the report, the patient recovered on 28-AUG-2009. No further information is available.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Body temperature increased, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a nurse concerning a 78 year old female who on 10-AUG-2009 was vaccinated with PNEUMOVAX 23 (LOT # 661527/0112Y). On 11-AUG-2009 the patient experienced back pain and an injection site reaction and pain in her arm where the vaccine was given. The outcome of the events persisted. The patient called the physician's office and was planning to come in to be seen. Follow-up information has been received from a registered nurse via medical records who reported that the patient was a retired female patient with hypertension, hypothyroidism, osteoporosis, gastroesophageal reflux disease (GERD), cholesterol levels raised and penicillin allergy. There was no illness at the time of vaccination. Concomitant therapy included SYNTHROID, PREVACID, CRESTRO, calcium (unspecified) and vitamin D (unspecified), losartan potassium-HCTZ (MSD), FISH OIL, aspirin, BONIVA and CENTRUM SILVER. ON 10-AUG-2009, the patient also experienced generalized myalgias, elevated temperature and localized edema at her injection site. The physician considered that the patient experienced PNEUMOVAX 23 allergy. The patient was told to use warm moist compress to injection site, increase fluids and have a rest. No lab diagnostic studies were performed. Subsequently, the patient recovered from these events on 13-AUG-2009. Additional information is not expected.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: Information has been received from a nurse concerning a 78 year old female who on 10-AUG-2009 was vaccinated with PNEUMOVAX 23 (LOT # 661527/0112Y). On 11-AUG-2009 the patient experienced back pain and an injection site reaction and pain in her arm where the vaccine was given. The outcome of the events persisted. The patient called the physician's office and was planning to come in to be seen. Follow-up information has been received from a registered nurse via medical records who reported that the patient was a retired female patient with hypertension, hypothyroidism, osteoporosis, gastroesophageal reflux disease (GERD), cholesterol levels raised and penicillin allergy. There was no illness at the time of vaccination. Concomitant therapy included SYNTHROID, PREVACID, CRESTRO, calcium (unspecified) and vitamin D (unspecified), losartan potassium-HCTZ (MSD), FISH OIL, aspirin, BONIVA and CENTRUM SILVER. ON 10-AUG-2009, the patient also experienced generalized myalgias, elevated temperature and localized edema at her injection site. The physician considered that the patient experienced PNEUMOVAX 23 allergy. The patient was told to use warm moist compress to injection site, increase fluids and have a rest. No lab diagnostic studies were performed. Subsequently, the patient recovered from these events on 13-AUG-2009. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Inappropriate schedule of drug administration, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a healthcare worker concerning a 66 year old female with Diabetes Type 2 and "Balerian allergy", who in October 2008, was vaccinated with her first dose of PNEUMOVAX (0.5ml, IM left deltoid, lot # unspecified), and a second dose (0.5ml, IM left deltoid, lot # unspecified) on 27-AUG-2009.  Concomitant medication included "other medications for diabetes".  On 28-AUG-2009 the patient had swollen area at the injection site of left arm.  The reporter stated this was an overdose due to the fact that the first dose of PNEUMOVAX was administered in October 2008, and the second dose was administered on 27-AUG-2009.  The patient sought unspecified medical attention.  At the time of the report, the patient was not recovered.  Follow up information has been received from a registered nurse indicating that the patient with no illness at time of vaccination, was vaccinated with her second dose of PNEUMOVAX (lot # 662687/0983X) in the left arm.  The patient had pain, redness and swelling at injection site, and complained of headache.  The reactions occurred after vaccine error.  At the time of the report, the patient was recovered.  No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Dizziness, Headache, Injection site pain, Pain
Clinical narrative: Information has been received from a Registered Nurse concerning a female patient who on an unspecified date vaccinated with PNEUMOVAX 23 (dose and route not reported) (lot number: 662667/1435X). Subsequently the patient had a cellulitis-like reaction including of injection site pain, body aches, headache and dizziness after she received the vaccine (date not reported). It was reported the patient recovered. It was unspecified if the patient sought medical attention. A standard lot check investigation was performed for lot no 662667/1435X. All in-process quality checks for the lot number in question were satisfactory. In addition, an expended 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. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with 0.5 ml dose of PNEUMOVAX.  Subsequently the patient developed rash from elbow to shoulder on the arm that received the injection.  No lot number was provided.  The patient had sought unknown medical attention.  At the time of report the patient's status was unknown.  This is one of several reports from the same source.  On 15-SEP-2009 all telephone attempts to obtain follow-up information have been unsuccessful.  Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Information has been received from a Medical Assistant (M.A.) concerning a 66 year old male patient with osteoarthritis, emphysema, bronchitis chronic, rhinitis allergic, atrial fibrillation, sinusitis, hypertension and otitis external fungal who on 12-JAN-2009 was vaccinated with the first dose of PNEUMOVAX 23. On 10-AUG-2009 the patient was vaccinated with the second dose of PNEUMOVAX 23 (Lot # 662746/0625Y). It was reported that the patient developed left arm pain and injection site redness after his second vaccination with PNEUMOVAX 23. He was seen in the office on 12-AUG-2009 and treated with KEFLEX and a MEDROL dose pack. The outcome of the patient was not reported. Follow-up information has been received from a Medical Assistant (M.A.) who mentioned that the Doctor handled everything and the patient is doing well. Also was reported that the Doctor had asked for the case to be closed. No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Induration, Mass, Pain, Skin warm
Clinical narrative: Information has been received from a female patient who on "25-SEP-2008" was vaccinated with a "single dose" of PNEUMOVAX 23. "A couple days after receiving shot", the patient developed a "lump that was hard and warm, and it also hurt". The patient stated that "the lump went away after a month". The patient visited office for medical attention. At the time of the report, the patient was recovered. No further information is available.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Musculoskeletal pain, Myalgia, Pyrexia
Clinical narrative: Information has been received from a 62 year old male patient who on 08-SEP-2009 was vaccinated with one dose of PNEUMOVAX 23 (lot # 663012/1163X). Concomitant therapy included influenza virus vaccine (unspecified). On 08-SEP-2009 the patient experienced muscle pain in the shoulder and thumb sized red splotches. The patient did not seek for medical attention. At the time of the report, the patient was not recovered. Follow up information received from a physician indicated that he was a male patient with borderline hypertension who on 08-SEP-2009 was vaccinated intramuscularly with his second dose of PNEUMOVAX 23 in his left arm at 15:30. There were no illnesses reported at time of vaccination. Concomitant therapy included AFLURIA (Lot # 06449111A) given intramuscularly in the left arm at 15:30. According to the physician, on 11-SEP-2009 the patient had severe pain in his left shoulder, fever and blotchiness around injection site to elbow. The patient recovered on approximately 14-SEP-2009. No diagnostic tests were performed. This is one of several reports received from the same source. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 65 year old female who on 04-AUG-2009 was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included doxycycline. On 06-AUG-2009 the patient experienced cellulitis and a red, swollen, painful rash at the injection site after vaccination. Unspecified medical attention was sought. It was unspecified if lab studies were performed. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 0.62
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 7 month old patient who on 14-AUG-2009 was vaccinated with a dose of PNEUMOVAX 23 instead of PREVNAR due to an office error. No adverse reactions reported. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 0.38
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 20 week old patient who on 17-AUG-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 661934/1441X) instead of PREVNAR.  It was confirmed that this event was a result of human error, not product confusion.  No adverse effects were reported.  Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Information has been received from a registered nurse concerning a 78 year old female patient with chronic obstructive pulmonary disease and hypertension who on 01-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml by intramuscular route. The nurse reported that the patient developed local reaction after receiving the dose of PNEUMOVAX 23 and it was believed to be the first dose of PNEUMOVAX 23 for the patient. The nurse reported that on 01-SEP-2009 the injection site was very swollen, red and hot to touch. The nurse also reported that the patient had headache and he was restlessness all night. At the time of this report the patient had not recovered. On 02-SEP-2009 the patient sought medical attention in the physician's office, the nurse reported that the physician started patient on unspecified antibiotic during office visit. Additional information had been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Restlessness
Clinical narrative: Information has been received from a registered nurse concerning a 78 year old female patient with chronic obstructive pulmonary disease and hypertension who on 01-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml by intramuscular route. The nurse reported that the patient developed local reaction after receiving the dose of PNEUMOVAX 23 and it was believed to be the first dose of PNEUMOVAX 23 for the patient. The nurse reported that on 01-SEP-2009 the injection site was very swollen, red and hot to touch. The nurse also reported that the patient had headache and he was restlessness all night. At the time of this report the patient had not recovered. On 02-SEP-2009 the patient sought medical attention in the physician's office, the nurse reported that the physician started patient on unspecified antibiotic during office visit. Additional information had been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Injection site reaction, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a certified medical assistant concerning a 66 year old male patient who in February 2009 was vaccinated with his first dose of PNEUMOVAX 23. On 08-Sep-2009 was vaccinated with a second dose of PNEUMOVAX. A few hours later he developed localized redness and swelling at the injection site. It is unknown which arm was involved. On 10-SEP-2009, the patient sought medical attention by a phone call. No treatment was recommended. No lab diagnostic studies were performed. Follow up information was received on 11-SEP-2009 from a pharmacy intern, reporting that the patient was recovering and also reported that the patient experienced fever and extreme tiredness along with the injection site reaction. According to the pharmacy intern, the patient was "getting better" but was not yet recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: PNC, PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 4 month old patient who on 17-AUG-2009 was vaccinated with a dose of PNEUMOVAX 23 along with a dose of PREVNAR due to an office error. Additional information had been requested.
Age: 46.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Information has been received from a registered pharmacist concerning a 46 year old female patient with pertinent medical history reported as none and no known drug allergies who on 01-SEP-2009 was vaccinated  with a dose PNEUMOVAX 23 (lot # 661529/0868X) 0.5ml, intramuscularly into left deltoid. She may have received a prior dose of PNEUMOVAX 23 at least 5 years ago. There was no concomitant medication. On 01-SEP-2009 after administration of vaccine the patient experienced pain, redness, swelling and warmth at the site of injection. The patient stated she felt excruciating pain when she rolled on the arm while asleep. The patient sought medical attention via phone. Her symptoms had improved on 02-SEP-2009. At the time on the report on 02-SEP-2009 the patient was recovering. There were no laboratories diagnostics studies performed. Follow-up information has been received regarding a case in litigation concerning the 46 year old female patient with asthma and no pertinent medical history or allergies. The patient's concomitant therapy included an influenza virus vaccine (unspecified) administered on 01-SEP-2009. No further information is available.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Information has been received from a licensed practical nurse concerning a 66 year old female patient with allergy to Morphine and a history of osteopenia and arthritis who on 19-MAY-2008 was vaccinated intramuscularly in her left arm with a first 0.5 mL dose of PNEUMOVAX 23 (Lot number was not provided). Concomitant therapy included alendronate sodium (MSD). On unknown date, the patient had a "local allergic" reaction after vaccination. The patient had redness and swelling on her left arm at the injection site after receiving her first dose of PNEUMOVAX 23. The patient sought medical attention by visiting the physician's office. No laboratory diagnostic studies were performed. At the time of the report, the patient recovered from the events. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Injection site erythema, Injection site movement impairment, Injection site pain
Clinical narrative: Information has been received from a 56 year old female medical assistant with hypertension, asthma, hypercholesterolaemia, penicillin allergy and a history of heart attack in 2006 and stroke in 2007 who in approximately 2007 or 2008 was vaccinated with a first dose of PNEUMOVAX 23 (lot # not reported). On 01-SEP-2009 she received second dose of PNEUMOVAX 23 (lot # 662905/1162X.) 0.5ml, intramuscularly into left arm. Concomitant therapy included PROCARDIA XL, trazadone HCl, spironolactone, PLAVIX, CELEXA and IMDUR. On 02-SEP-2009 the following day after vaccination she was having chills and her temperature was 100.6 degrees. The arm which was vaccinated was achy, red, had red streaks and looked it had cellulitis. It hurt to move that arm. The arm was warm to the touch and felt like a softball. The physician put her on BACTRIM and she had been icing her arm but her symptoms have not improved. She also took TYLENOL PM last night. The patient sought medical attention office visit. At the time of the report on 03-SEP-2009 the patient had not recovered. There were no laboratories diagnostic studies performed. This is one of two reports from the same source. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site streaking, Injection site warmth
Clinical narrative: Information has been received from a 56 year old female medical assistant with hypertension, asthma, hypercholesterolaemia, penicillin allergy and a history of heart attack in 2006 and stroke in 2007 who in approximately 2007 or 2008 was vaccinated with a first dose of PNEUMOVAX 23 (lot # not reported). On 01-SEP-2009 she received second dose of PNEUMOVAX 23 (lot # 662905/1162X.) 0.5ml, intramuscularly into left arm. Concomitant therapy included PROCARDIA XL, trazadone HCl, spironolactone, PLAVIX, CELEXA and IMDUR. On 02-SEP-2009 the following day after vaccination she was having chills and her temperature was 100.6 degrees. The arm which was vaccinated was achy, red, had red streaks and looked it had cellulitis. It hurt to move that arm. The arm was warm to the touch and felt like a softball. The physician put her on BACTRIM and she had been icing her arm but her symptoms have not improved. She also took TYLENOL PM last night. The patient sought medical attention office visit. At the time of the report on 03-SEP-2009 the patient had not recovered. There were no laboratories diagnostic studies performed. This is one of two reports from the same source. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant concerning a 76 year old female with no pertinent medical history reported and no known drug allergies who on 12-AUG-2009, was vaccinated intramuscularly into her right arm with a 0.5mL dose of PNEUMOVAX 23 (lot number 662667/1435X) and a dose of ZOSTAVAX (Merck) (MSD) (given into the left arm, route and lot number not reported). On the same day, the patient developed an injection site reaction after receiving PNEUMOVAX 23 on her right arm. The site was swollen, with redness and tenderness. The patient was given cephalexin and ELOCON. No lab studies were performed. At the time of reporting the patient was recovering from the swollen, with redness and tenderness at injection site. The patient sought medical attention by contacting the physician. Follow up information has been received from a physician concerning a 76 year old female no pertinent medical history reported and no known drug allergies who on 12-AUG-2009 was vaccinated intramuscularly into the right arm with a dose of PNEUMOVAX 23 (lot number 662667/1435X) and SC into the left arm with a dose of ZOSTAVAX (Merck) (MSD) (lot number 663881/0197Y). It was reported that the patient experienced erythema and swelling on the right arm (approximately 25-28cm, from shoulder to elbow) for 1 week with minimal pain. No lab studies were performed. Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Underdose
Clinical narrative: Information has been received from a registered pharmacist concerning a male patient who on an unspecified date was vaccinated with PNEUMOVAX 23 (lot number not reported). When the nurse withdrew the needle from the patient, half of the medication squirted out of the syringe. The nurse gave the PNEUMOVAX 23 intramuscularly to the patient. The patient was approximately 330lbs. No adverse reactions reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site pain, Injection site reaction, Injection site swelling, Musculoskeletal pain
Clinical narrative: Information ha been received from a registered nurse concerning a 66 year old female patient with no medical history but with allergies to sulfonamide and levofloxacin who on 17-AUG-2009 was vaccinated intramuscularly with a 0.5ml dose of PNEUMOVAX 23 (lot # 662748/1088X). Concomitant therapy included levothyroxine Na, fexofenadine hydrochloride, simvastatin (manufacturer unknown), NEXIUM, DIOVAN and ibuprofen. On the same day, after receiving the vaccination the patient developed an injection site reaction. The patient complained of pain and swelling. She applied some ice but later that day she started to have joint pain in her elbows, shoulders and wrists. The symptoms subsided after 24 hours. The patient called the office. No lab diagnostics studies were performed. At this time of reporting, the patient was recovering. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Body temperature increased, Chills, Injection site reaction, Malaise
Clinical narrative: Information has been received from a medical assistant concerning a physician in their office, who on 19-AUG-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot : 662842/1296X) intramuscularly. On 20-AUG-2009 the physician experienced fever, vomiting, and was not feeling well. The physician also had an injection site reaction. The physician had to cancel all his patients for the day. At the time of reporting on 20-AUG-2009, the patient's symptoms persisted. Follow up information has been received from medical assistant who requested a lot check on 662842/1296X. Follow-up information has been received from the physician with no known drug allergies or medical history who on 20-AUG-2009 (previously reported as 19-AUG-2009) was vaccinated with a dose of PNEUMOVAX 23 (Lot : 662842/1296X), IM in the left deltoid. There was no illness at the time of vaccination. Subsequently, on 21-AUG-2009 (previously reported as 20-AUG-2009) at 6:00 pm the physician experienced severe chills, fever 103 degree, body aches and weakness for 24-30 hr. There were no lab studies performed. At the time of the report, the physician reported that he recovered the next day. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 662842/1296X were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. This is one of several reports received from the same source.
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Information has been received from a medical assistant concerning a physician in their office, who on 19-AUG-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot : 662842/1296X) intramuscularly. On 20-AUG-2009 the physician experienced fever, vomiting, and was not feeling well. The physician also had an injection site reaction. The physician had to cancel all his patients for the day. At the time of reporting on 20-AUG-2009, the patient's symptoms persisted. Follow up information has been received from medical assistant who requested a lot check on 662842/1296X. Follow-up information has been received from the physician with no known drug allergies or medical history who on 20-AUG-2009 (previously reported as 19-AUG-2009) was vaccinated with a dose of PNEUMOVAX 23 (Lot : 662842/1296X), IM in the left deltoid. There was no illness at the time of vaccination. Subsequently, on 21-AUG-2009 (previously reported as 20-AUG-2009) at 6:00 pm the physician experienced severe chills, fever 103 degree, body aches and weakness for 24-30 hr. There were no lab studies performed. At the time of the report, the physician reported that he recovered the next day. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 662842/1296X were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. This is one of several reports received from the same source.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Crying, Hyperhidrosis, Immediate post-injection reaction, Injected limb mobility decreased, Insomnia
Clinical narrative: Initial and follow-up information has been received from a physician and the consumer, a 67 year old female with doxycycline allergy who on an unspecified date was vaccinated with her first dose of PNEUMOVAX 23 (Lot # not reported). On 19-AUG-2009, the patient was vaccinated with her second doses of PNEUMOVAX 23 Lot# 661529/0868X. The patient received the second dose of PNEUMOVAX 23 "below the left shoulder joint" and the patient immediately stated that the "vaccine was given too high". On 20-AUG-2009, the patient complained of "instant pain and the symptoms worsened". Three hours later the patient had decreased limb ability/movement, pain in the left arm, sweating, nausea, fever chills and crying with insomnia all night. The patient's family called to primary care physician at 9:00 PM and the patient was told to take CELEBREX and to use ice packs on the shoulder joint". The patient went for a visit and was given and X-ray in the office of the shoulder (results were not provided) and a pain shot. The patient was also given prednisone 10 mg during six days. At the time of reporting, the patient's instant pain, decreased limb ability/movement, pain the left arm, sweating, nausea, fever chills and crying with insomnia all night persisted. No further information is available.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain in extremity, Pyrexia, X-ray
Clinical narrative: Initial and follow-up information has been received from a physician and the consumer, a 67 year old female with doxycycline allergy who on an unspecified date was vaccinated with her first dose of PNEUMOVAX 23 (Lot # not reported). On 19-AUG-2009, the patient was vaccinated with her second doses of PNEUMOVAX 23 Lot# 661529/0868X. The patient received the second dose of PNEUMOVAX 23 "below the left shoulder joint" and the patient immediately stated that the "vaccine was given too high". On 20-AUG-2009, the patient complained of "instant pain and the symptoms worsened". Three hours later the patient had decreased limb ability/movement, pain in the left arm, sweating, nausea, fever chills and crying with insomnia all night. The patient's family called to primary care physician at 9:00 PM and the patient was told to take CELEBREX and to use ice packs on the shoulder joint". The patient went for a visit and was given and X-ray in the office of the shoulder (results were not provided) and a pain shot. The patient was also given prednisone 10 mg during six days. At the time of reporting, the patient's instant pain, decreased limb ability/movement, pain the left arm, sweating, nausea, fever chills and crying with insomnia all night persisted. No further information is available.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site reaction, Malaise, Pain, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning two patients that on an unspecified dates were vaccinated with a dose of PNEUMOVAX (Lot : 662746/0625Y).  On unspecified dates the patients experienced fever, vomiting, and were not feeling well.  They also had an injection site reaction.  At the time of reporting on 20-AUG-2009, the patient's outcomes were unknown.  Additional information was received from the medical assistant who clarified the previous report, only one unspecified patient was vaccinated with a dose of PNEUMOVAX (Lot : 662746/0625Y).  Follow-up information has been received from a physician concerning an 81 year old female patient who on 14-AUG-2009 was vaccinated in the left deltoid with a dose of PNEUMOVAX (Lot number 662842/1296X (previously reported as lot number 662746/0625Y)).  On 15-AUG-2009 the patient experienced fever (102 degrees F) with chills and body aches.  At the time of the report the patient had recovered from fever, chills and body aches.  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 received from the same source.  No further information is available.
Age: 19.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Erythema, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Information has been received from a physician concerning his 19 year old daughter who on 24-AUG-2009 was vaccinated with a dose of PNEUMOVAX 23 and a dose of influenza virus vaccine (unspecified) in the same arm. Concomitant therapy included hormonal contraceptives (unspecified), EFFEXOR, SEROQUEL, VALIUM, and methylphenidate. On 24-AUG-2009 the patient developed swelling, hives, fever, pain at injection sites, myalgia and arthralgia and continued to have complaints. The physician placed her arm into a sling to immobilize the arm. There were no labs and diagnostic tests performed. The patient saw physician for medical attention. At the time of the report, the patient's status was not recovered. Follow up information has been received from a physician concerning the patient with no pertinent medical history and no drug allergies, who on 24-AUG-2009 was vaccinated with the first dose of PNEUMOVAX 23 (lot # 662041/0612X) IM in the right arm. On 24-AUG-2009 the patient developed fever, swelling, erythema and myalgia. The patient had recovered on 27-AUG-2009. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Swelling, Urticaria
Clinical narrative: Information has been received from a physician concerning his 19 year old daughter who on 24-AUG-2009 was vaccinated with a dose of PNEUMOVAX 23 and a dose of influenza virus vaccine (unspecified) in the same arm. Concomitant therapy included hormonal contraceptives (unspecified), EFFEXOR, SEROQUEL, VALIUM, and methylphenidate. On 24-AUG-2009 the patient developed swelling, hives, fever, pain at injection sites, myalgia and arthralgia and continued to have complaints. The physician placed her arm into a sling to immobilize the arm. There were no labs and diagnostic tests performed. The patient saw physician for medical attention. At the time of the report, the patient's status was not recovered. Follow up information has been received from a physician concerning the patient with no pertinent medical history and no drug allergies, who on 24-AUG-2009 was vaccinated with the first dose of PNEUMOVAX 23 (lot # 662041/0612X) IM in the right arm. On 24-AUG-2009 the patient developed fever, swelling, erythema and myalgia. The patient had recovered on 27-AUG-2009. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a Certified Medical Assistant (C.M.A.) concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23. It was reported that "yesterday", on 26-AUG-2009, the patient developed an injection site reaction after receiving PNEUMOVAX 23. It was reported that the patient had local redness and swelling at the injection site. The patient sought unspecified medical attention. The outcome of the patient was not reported. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Movement disorder
Clinical narrative: Information has been received from an office manager concerning a 45 year old female patient with a drug allergy to "ALLOVERA" (therapy unspecified), neoplasm of kidney and ureter, mixed high lipidemia, migraines, gastrooesophageal reflux disease (GERD), mild facial pain syndrome, obesity, sciatica and depression, who on 25-AUG-2009 was vaccinated IM in the left arm with the first dose of PNEUMOVAX 23 (Lot number 663936/0508Y). Concomitant therapy included PERCOCET, SEROQUEL, vitamins (unspecified), iron (unspecified), BIATON (therapy unspecified) and tizanidine hydrochloride. The patient was seen originally on 25-AUG-2009 for a bladder infection and was given CIPRO and then was administered the vaccine. Two hours after the dose, the patient called the office and mentioned that left arm had swollen up and she could not move it. The patient was instructed to apply ice to the area. During the evening "the swelling got worse" and the patient was seen in the emergency room. Emergency room treatment was not specified. It was noted that the patient was hospitalized (clarified as not hospitalized in follow up). The patient had a follow up appointment in the office on 28-AUG-2009. No lab diagnostics studies were performed. At the time of reporting, the patient was recovering. Follow up information has been received from the office manager on 01-SEP-2009, who stated that on 25-AUG-2009, the patient did not received any concomitant vaccinations when the PNEUMOVAX 23 was administered.  On 25-AUG-2009, the patient called the office and mentioned that her left arm was swollen and she could not move it. The patient was instructed to apply ice to the area. On the evening of 25-AUG-2009, the patient went to the Emergency Room. The patient was treated with prednisone and BENADRYL. The patient was not admitted to the hospital. On 28-AUG-2009, the patient cancelled her follow up visit to see the physician. The patient reported that she felt better. The patient was recovering. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Joint range of motion decreased, Oedema
Clinical narrative: Information has been received from an office manager concerning a 79 year old female with hypertension, cholesterol high, asthma, rhinitis allergic and osteoarthritis and a history of diverticular disease, goiter nodular, carpal tunnel syndrome, lumbar spinal stenosis, lumbar radiculopathy, restless legs syndrome and vertigo who on 27-OCT-2005 was vaccinated with the first dose of PNEUMOVAX.  Concomitant therapy included TYLENOL, NASONEX, gabapentin, ergocalciferol, MIRAPEX, CARDIZEM, DIAZIDE, simvastatin (manufacturer unknown), FLOVENT and albuterol sulfate.  On 26-AUG-2009 the patient received the second dose of PNEUMOVAX (lot # 663936/0508Y).  Subsequently, the patient developed pain and swelling in the left arm, and "could not lift her arm".  The patient was seen in the emergency room and was hospitalized.  No lab diagnostics studies were performed.  The patient was given a sling and discharged home.  The patient was seen in the office on 27-AUG-2009 for follow up, no changes noted.  At the time of the report, the patient was recovering.  Follow-up information has been received from an office manager stated that on 26-AUG-2009, the patient did not receive any concomitant vaccinations when the PNEUMOVAX (lot # 663936/0508Y) was administered.  It was unknown if the patient was admitted to the hospital.  On 27-AUG-2009, the patient was seen by the physician.  The patient complained of left arm pain.  The physician documented that the patient's left deltoid muscle was tender to the touch with edema.  The patient had reduced range of motion on inspection.  The patient was treated with TYLENOL No3 with CODEINE.  On 31-AUG-2009, the patient was seen by the physician with complaints of pain in the deltoid muscle for 5 days.  The patient stated that the TYLENOL No3 with CODEINE did not control the pain.  The patient's treatment was switched to hydrocodone (unspecified) with TYLENOL, one table, every 4 hours.  The patient was recovering and had a scheduled follow-up visit with the physician in October 2009.  Follow-up information has been received from a physician concerning a patient with no illness at the time of vaccination who on 26-AUG-2009 at 2:05 PM was vaccinated with the first dose (previously reported as the second dose) of PNEUMOVAX (lot # 663936/0508Y) IM in the left deltoid.  On 26-AUG-2009 at 4:00 PM. the patient developed pain and swelling which affected the left upper extremity.  On approximately 01-SEP-2009, the patient recovered.  This is one of two reports from the same source.  Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Information has been received from an office manager concerning a 79 year old female with hypertension, cholesterol high, asthma, rhinitis allergic and osteoarthritis and a history of diverticular disease, goiter nodular, carpal tunnel syndrome, lumbar spinal stenosis, lumbar radiculopathy, restless legs syndrome and vertigo who on 27-OCT-2005 was vaccinated with the first dose of PNEUMOVAX.  Concomitant therapy included TYLENOL, NASONEX, gabapentin, ergocalciferol, MIRAPEX, CARDIZEM, DIAZIDE, simvastatin (manufacturer unknown), FLOVENT and albuterol sulfate.  On 26-AUG-2009 the patient received the second dose of PNEUMOVAX (lot # 663936/0508Y).  Subsequently, the patient developed pain and swelling in the left arm, and "could not lift her arm".  The patient was seen in the emergency room and was hospitalized.  No lab diagnostics studies were performed.  The patient was given a sling and discharged home.  The patient was seen in the office on 27-AUG-2009 for follow up, no changes noted.  At the time of the report, the patient was recovering.  Follow-up information has been received from an office manager stated that on 26-AUG-2009, the patient did not receive any concomitant vaccinations when the PNEUMOVAX (lot # 663936/0508Y) was administered.  It was unknown if the patient was admitted to the hospital.  On 27-AUG-2009, the patient was seen by the physician.  The patient complained of left arm pain.  The physician documented that the patient's left deltoid muscle was tender to the touch with edema.  The patient had reduced range of motion on inspection.  The patient was treated with TYLENOL No3 with CODEINE.  On 31-AUG-2009, the patient was seen by the physician with complaints of pain in the deltoid muscle for 5 days.  The patient stated that the TYLENOL No3 with CODEINE did not control the pain.  The patient's treatment was switched to hydrocodone (unspecified) with TYLENOL, one table, every 4 hours.  The patient was recovering and had a scheduled follow-up visit with the physician in October 2009.  Follow-up information has been received from a physician concerning a patient with no illness at the time of vaccination who on 26-AUG-2009 at 2:05 PM was vaccinated with the first dose (previously reported as the second dose) of PNEUMOVAX (lot # 663936/0508Y) IM in the left deltoid.  On 26-AUG-2009 at 4:00 PM. the patient developed pain and swelling which affected the left upper extremity.  On approximately 01-SEP-2009, the patient recovered.  This is one of two reports from the same source.  Additional information is not expected.