chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a 66 year old male physician with no pertinent medical history and no drug reactions/allergies, who on 13-NOV-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported) SQ. Concomitant therapy included LIPITOR, montelukast sodium (MSD) and PRILOSEC. On 13-NOV-2010, the patient developed cellulitis 8 hours after receiving PNEUMOVAX 23. There were no lab diagnosis/studies performed. The patient sought unspecified medical attention. At the time of the report the patient had not recovered. Additional information has been requested.
Sex: M
Vaccine: PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning an adult male who on 24-JUN-2010 was supposed to get PNEUMOVAX 23 and by mistake received PREVNAR 13. The patient did not received PNEMOVAX 23, only PREVNAR 13 by mistake. The patient was not experiencing any known symptoms. No further information is available at this time of reporting. Follow-up information has been received from the pharmacist who reported that it was a case of the wrong product being grabbed by mistake. He stated that the two products did not look alike at all. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Dyspnoea, Feeling hot, Flushing, Nausea
Clinical narrative: Information has been received from a registered nurse concerning a 28 year old female patient with end stage renal failure (dialysis patient), who on 10-JUN-2010 was vaccinated with a dose of PNEUMOVAX 23 intravenously (Lot No. not reported). Following vaccination the patient experienced flushing, stomach ache and shortness of breath. Oxygen was supplied and the patient was reclined. The patient recovered shortly after these side effects but still complained of a stomach ache for about two hours. Once she left dialysis facility she noted that she was back to herself. Follow up information has been received from a registered nurse concerning a 20 year old female patient (previously reported as 28 year old), with end stage renal failure (ESRD), primary oxalosis and azithromycin allergy, who on 10-JUN-2010 was vaccinated with a first dose of PNEUMOVAX 23 (Lot # 65401/1320Y) IV at 13:30. Concomitant therapy included MANTOUX SKIN TEST (Lot #C3506AB) SQ in the forearm on 08-JUN-2010 at 12:00. On 10-JUN-2010, the patient became short of breath, nauseated and complained of stomach pain (that lasted several hours). The patient became flushed and hot. The symptoms were treated with oxygen. The patient laid back and dialysis continued. After a period of 10 minutes, the patient reported feeling better and stomach pain remained for four hours. It was reported that the patient did not seek medical attention. The patient recovered on the same day. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Inflammation, Swelling, Vaccination complication
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a first dose of PNEUMOVAX 23 (Lot# unknown) On an unspecified date the patient had a "reaction" to PNEUMOVAX 23. The patient had swelling, but was unaware of the site of inflammation. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Pain in extremity
Clinical narrative: Information has been received from an office administrator reported herself who was vaccinated with a dose of PNEUMOVAX 23 "a few years ago" and her arm was very painful. The discomfort lasted for several days. The patient recovered on an unspecified date. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a physician concerning a male patient "in his 60's" who on an unspecified date, was vaccinated with a dose of PNEUMOVAX 23 (Lot No. not reported) in his right arm. About 10 hours after vaccination the patient had symptoms of 101.5 degree fever, chills and rapid breathing. The injection site had swelling and redness. The patient also received a dose of ZOSTAVAX (Merck) (Lot No. not reported) on the same day as PNEUMOVAX 23 but in his left arm. The injection site area of the ZOSTAVAX (Merck) was sore. On an unspecified date, white count was 16,000. The patient sought medical attention at office visit. At the time of the report, the patient had not recovered from the events. Additional information has been requested.
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Respiratory rate increased, White blood cell count increased
Clinical narrative: Information has been received from a physician concerning a male patient "in his 60's" who on an unspecified date, was vaccinated with a dose of PNEUMOVAX 23 (Lot No. not reported) in his right arm. About 10 hours after vaccination the patient had symptoms of 101.5 degree fever, chills and rapid breathing. The injection site had swelling and redness. The patient also received a dose of ZOSTAVAX (Merck) (Lot No. not reported) on the same day as PNEUMOVAX 23 but in his left arm. The injection site area of the ZOSTAVAX (Merck) was sore. On an unspecified date, white count was 16,000. The patient sought medical attention at office visit. At the time of the report, the patient had not recovered from the events. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with PNEUMOVAX 23. It was reported that "the patient had an allergic reaction after administration". It was unknown if the patient sought medical attention. At the time of the reporting, the patient's status was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician's assistant concerning a female patient who was vaccinated with a dose of PNEUMOVAX 23 roughly a year ago, in approximately 15-JUL-2009. Approximately one year ago,after vaccination the patient had a lot of swelling and redness in the upper arm around the injection site which developed into cellulitis which lasted for two to three weeks. The patient sought medical attention by going to the doctor's office. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Periarthritis
Clinical narrative: Information has been received from a physician concerning an around 60 year old male patient who on approximately 11-MAY-2010, "four weeks ago", was vaccinated IM with a dose of PNEUMOVAX 23 (lot# not reported). Four weeks after PNEUMOVAX 23 injection, the patient's shoulder began to hurt and he could hardly move the arm. On 08-JUN-2010 the physician diagnosed as frozen shoulder. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 6 month old patient who on 13-JUL-2010 was vaccinated with a dose of PNEUMOVAX 23 (0.5ml, lot # 662842/1296X) instead of a dose of PREVNAR by accident. This was a medication error. No adverse effects were reported. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a 67 year old male with no drug reactions/allergies and with hypothyroidism and hypercholesterolaemia who on 24-JUN-2010 was vaccinated intramuscularly into left deltoid with the second 0.5 mL dose of PNEUMOVAX 23 (LOT# 665902/1426Y, expiration 02-JUL-2011). Concomitant medication included simvastatin (MSD) and SYNTHROID. On 25-JUN-2010 the patient experienced redness, warmth, and tenderness at the injection site of the left upper arm. The patient was seen in the office on 25-JUN-2010 and was diagnosed with cellulitis. He was administered ROCEPHIN 1 gram injection while in the office and prescribed a course of KEFLEX. There was no lab diagnostics studies performed. The nurse added that the patient was administered his first dose of PNEUMOVAX 23 on 22-JUN-2009. At this time of reporting, the patient was not recovered. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect route of drug administration, Local swelling, Pain, Skin warm, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant reported that a 33 year old female patient who on 14-JUL-2010 was vaccinated inadvertently with a dose of PNEUMOVAX 23 instead of a TB test due to nursing error. The PNEUMOVAX 23 was given subdermally in her right forearm. The patient had a tennis ball size area of warmth, swelling and soreness. The patient sought medical attention by seeing in office. The physician had prescribed BENADRYL and ALLEGRA. At the time of report the patient's status was not recovered. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV, TTOX
Symptoms: Heart rate irregular, Injection site erythema, Injection site reaction, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 66 year old male with no relevant medical history or allergies who on 15-JUL-2010 was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (lot number 665707/1407Y) and a dose of tetanus toxoid shot. Other concomitant therapy included LIPITOR, NITROSTAT, aspirin, vitamin D (unspecified) and lisinopril-HCTZ (manufacturer unknown). On 16-JUL-2010 the patient experienced injection site reaction, fever and irregular heart rate. The patient's injection site was swollen and red. Unspecified medical attention was sought. No lab tests were performed. The outcome of the patient's events was unknown. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician and a certified medical assistant concerning a 49 year old female patient with no drug reactions or allergies who on 06-OCT-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot# 665925/0932Z) and a dose of FLUARIX in the other arm. Another concomitant therapy included ZOLOFT. The physician report that on 07-OCT-2010, the patient experienced swelling and warmth on the arm the dose of PNEUMOVAX 23 was administered in. The certified medical assistant reported that the patient experienced no injection site reaction on the arm that was vaccinated with FLUARIX. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. The physician's office requested a lot check. This is one of two reports from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 665925/0932Z were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Oedema peripheral
Clinical narrative: Information has been received from a nurse concerning a currently 74 year old male patient who on 14-SEP-2010 was vaccinated with a 0.5ml dose of PNEUMOVAX 23 (667136/0499Z) into his arm. Subsequently the patient experienced swelling of the injection site and arm. No medical attention was sought. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin discolouration
Clinical narrative: Information has been received from a physician concerning a 75 year old female who on 05-OCT-2010 (reported as "she got it yesterday") was vaccinated with a dose of PNEUMOVAX 23. On 05-OCT-2010 (reported as "yesterday", the patient experienced a violet, red area fairly widespread on her upper arm, no welts, just strange coloration. No known swelling or problems with the lymph nodes was observed. At the time of the report, the patient was recovering from the adverse event. This occurred 4-6 hours after injection. The patient sought an unknown medical attention. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Rash generalised, Urticaria
Clinical narrative: Information has been received from a nurse practitioner (Pharm. D.) concerning a male who on 23-NOV-2010 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot # not reported). The reporter stated that the patient experienced a rash and hives after receiving PNEUMOVAX 23 in November 2010 ("a couple days after 23-NOV-2010"). The patient was treated with steroid cream. At the time of reporting, the patient had not recovered from a rash and hives. The patient sought unspecified medical attention. Follow up information has been received from a pharmacist student concerning a male patient who on 23-NOV-2010 was vaccinated with the first 0.5 ml dose of PNEUMOVAX 23 (lot # not reported). The reporter stated that about 2 weeks after vaccination (also reported as "a couple days after 23-NOV-2010" by the nurse), the patient developed a generalized rash with urticaria. The patient was treated with steroid cream. At the time of reporting, the patient had not recovered from a generalized rash with urticaria. The patient sought unspecified medical attention. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction, Malaise
Clinical narrative: Information has been received from a registered nurse concerning a male patient over age 65 on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot#'s 663889/0632Y or 665924/0930Z). It was reported that on an unspecified date, the patient experienced a local site reaction (redness, swelling, and pain), generalized malaise and low-grade fever. The nurse reported that two patients (not specified which patients) received either dexamethasone (MSD) or dexamethasone as treatment (thought to be an allergic reaction). On an unspecified date, the patient recovered. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a male patient over age 65 on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot#'s 663889/0632Y or 665924/0930Z). It was reported that on an unspecified date, the patient experienced a local site reaction (redness, swelling, and pain), generalized malaise and low-grade fever. The nurse reported that two patients (not specified which patients) received either dexamethasone (MSD) or dexamethasone as treatment (thought to be an allergic reaction). On an unspecified date, the patient recovered. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Blood pressure decreased, Injection site swelling, Presyncope, Syncope
Clinical narrative: Information has been received from a physician concerning a 24-28 year old female who was vaccinated with PNEUMOVAX 23. Subsequently the patient experienced vasovagal episode. The patient fainted. There was also a drop in blood pressure and around the injection site there was swelling. The patient received unspecified medical attention. The patient recovered on an unspecified date. No further information is available.
Sex: M
Vaccine: PPV
Symptoms: Chills, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a male who was vaccinated with two 0.5 ml doses of PNEUMOVAX 23 (lot # not reported) subcutaneously. The patient received two doses total on the correct dosing schedule. Subsequently the patient developed chills and a fever from therapy on PNEUMOVAX 23. Therapy with PNEUMOVAX 23 was reported as discontinued. At the time of reporting, the outcome of the events was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PNC, PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 70 year old male patient who on 03-JAN-2011 was given a dose of PREVNAR instead of the PNEUMOVAX 23 in error. No adverse experience reported. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a consumer service representative from a company called physician sales and service reports that a physicians office reported to him that a patient experienced an adverse reaction to the PNEUMOVAX 23 (lot # 665924/0930Z). Adverse experienced unspecified. It was unspecified if the patient sought medical attention. At the time of reporting, the patient's outcome was not reported. This is an amended report, the fields of "vaccinated at" and "vaccine purchased with" have been entered as unknown. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Full blood count, Myalgia, Pain in extremity, Red blood cell sedimentation rate
Clinical narrative: Information has been received from a licensed practical nurse concerning a 64 year old male patient with diabetes, hypertension and dyslipidemia and with no drug reactions or allergies who on 12-OCT-2010, was vaccinated IM in the left arm with a dose of PNEUMOVAX 23 (Lot# 665400/1315Y). Concomitant therapy included sitagliptin phosphate (MSD), allopurinol, LOVAZA and ACTOPLUS MET. It was reported that the patient developed joint pain and muscle aches after vaccination with PNEUMOVAX 23. The pain was asymmetrical over his body and he was walking with a cane. The patient had severe right thigh pain. The patient had not had a fever. He was prescribed TYLENOL and ice application. The day of vaccination the patient was seen for a small superficial abscess in front of his left ear. He was prescribed LEVAQUIN for the abscess. On an unspecified date the patient had a complete blood cell count and erythrocyte sedimentation rate (no results provided). At the time of the report, the patient was recovering. The patient sought medical attention. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Walking aid user
Clinical narrative: Information has been received from a licensed practical nurse concerning a 64 year old male patient with diabetes, hypertension and dyslipidemia and with no drug reactions or allergies who on 12-OCT-2010, was vaccinated IM in the left arm with a dose of PNEUMOVAX 23 (Lot# 665400/1315Y). Concomitant therapy included sitagliptin phosphate (MSD), allopurinol, LOVAZA and ACTOPLUS MET. It was reported that the patient developed joint pain and muscle aches after vaccination with PNEUMOVAX 23. The pain was asymmetrical over his body and he was walking with a cane. The patient had severe right thigh pain. The patient had not had a fever. He was prescribed TYLENOL and ice application. The day of vaccination the patient was seen for a small superficial abscess in front of his left ear. He was prescribed LEVAQUIN for the abscess. On an unspecified date the patient had a complete blood cell count and erythrocyte sedimentation rate (no results provided). At the time of the report, the patient was recovering. The patient sought medical attention. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Erythema, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 56 year old female health employee, smoker, who on 05-OCT-2010 was vaccinated with a first dose of PNEUMOVAX 23 (Lot # 667418/0978Z), 0.5 mL SC in the left upper arm. There was no concomitant medication. On 05-OCT-2010 the patient developed erythema, soreness and mild inflammation at the injection site. The patient was seen on 06-OCT-2010 and she had no elevated temperature. Patient was told to put cold compresses on her arm and to elevate it. She was re-evaluated on 07-OCT-2010 and she had almost complete resolution. Follow up information has been received from an advanced practical nurse. It was reported that on 05-OCT-2010 afternoon the female patient was vaccinated with the first dose of PNEUMOVAX 23 (Lot # 667418/0978Z) SC in the left arm and with the second dose of AFLURIA (lot number 11049121A) IM in the left arm. On 06-OCT-2010 morning the patient presented and complained of soreness at the injection site. The patient experienced localized erythema and swelling without posterior aspect. Oral temperature was 99.4. The patient was given TYLENOL and cold compresses with relief. On 07-OCT-2010 the patient presented decreased soreness, erythema and swelling. At the time of the report the patient had recovered. No further information is expected.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 56 year old female health employee, smoker, who on 05-OCT-2010 was vaccinated with a first dose of PNEUMOVAX 23 (Lot # 667418/0978Z), 0.5 mL SC in the left upper arm. There was no concomitant medication. On 05-OCT-2010 the patient developed erythema, soreness and mild inflammation at the injection site. The patient was seen on 06-OCT-2010 and she had no elevated temperature. Patient was told to put cold compresses on her arm and to elevate it. She was re-evaluated on 07-OCT-2010 and she had almost complete resolution. Follow up information has been received from an advanced practical nurse. It was reported that on 05-OCT-2010 afternoon the female patient was vaccinated with the first dose of PNEUMOVAX 23 (Lot # 667418/0978Z) SC in the left arm and with the second dose of AFLURIA (lot number 11049121A) IM in the left arm. On 06-OCT-2010 morning the patient presented and complained of soreness at the injection site. The patient experienced localized erythema and swelling without posterior aspect. Oral temperature was 99.4. The patient was given TYLENOL and cold compresses with relief. On 07-OCT-2010 the patient presented decreased soreness, erythema and swelling. At the time of the report the patient had recovered. No further information is expected.
Sex: U
Vaccine: PPV
Symptoms: Axillary pain, Erythema, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who on an unspecified date was vaccinated with PNEUMOVAX 23 0.5 ml IM (LOT # 664556/1307Y, EXP 21-JAN-2011). The patient experienced injection site swelling and pain. Follow up information from the nurse practitioner who reported that apparently the patient encountered severe injection-site reactions (redness, swelling pain radiating to the armpit and difficulty moving the arm on the patient) after vaccination which eventually improved. The clinic would like Merck to initiate an investigation of this lot but they would not use the lot unless Merck checked it again. This is one of several reports received from the same source. At the time of the report, the patient was recovering. The nurse requested a lot check. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question (lot # 664556/1307Y) were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling, Swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who on an unspecified date was vaccinated with PNEUMOVAX 23 0.5 ml IM (LOT # 664556/1307Y, EXP 21-JAN-2011). The patient experienced injection site swelling and pain. Follow up information from the nurse practitioner who reported that apparently the patient encountered severe injection-site reactions (redness, swelling pain radiating to the armpit and difficulty moving the arm on the patient) after vaccination which eventually improved. The clinic would like Merck to initiate an investigation of this lot but they would not use the lot unless Merck checked it again. This is one of several reports received from the same source. At the time of the report, the patient was recovering. The nurse requested a lot check. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question (lot # 664556/1307Y) were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, Injection site reaction, Myalgia, Pain in extremity
Clinical narrative: Information has been received from a medical assistant concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot# not reported) that after delivered, had sat on the counter overnight and for half the next day before it was refrigerated. Subsequently, the patient complained of muscle soreness at the injection site and painful arm. The patient mentioned it on their next office visit. It was unknown if the patient sought sought medical attention. On an unspecified date the patient recovered. The medical assistant contacted during telephone follow-up could not supply the following information: patient name, date of birth, date of vaccination, lot number or date of event. This is one of several reports received from the same source. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, Injection site reaction, Myalgia, Pain in extremity
Clinical narrative: Information has been received from a medical assistant concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot# not reported) that after delivered, had sat on a counter overnight and for half the next day before it was refrigerated. Subsequently, the patient complained of muscle soreness at the injection site and painful arm. The patient mentioned it on their next office visit. It was unknown if the patient sought medical attention. On an unspecified date the patient recovered. The medical assistant contacted during telephone follow-up could not supply the following information: patient name, date of birth, date of vaccination, lot number or date of event. This is one of several reports received from the same source. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, Injection site reaction, Myalgia
Clinical narrative: Information has been received from a medical assistant concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot# not reported) that after delivered, had sat on the counter overnight and for half the next day before it was refrigerated. Subsequently, the patient complained of muscle soreness at the injection site and painful arm. The patient mentioned it on their next office visit. It was unknown if the patient sought medical attention. On an unspecified date the patient recovered. The medical assistant contacted during telephone follow-up could not supply the following information: patient name, date of birth, date of vaccination, lot number or date of event. This is one of several reports received from the same source. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, Injection site reaction, Myalgia, Pain in extremity
Clinical narrative: Information has been received from a medical assistant concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot# not reported) that after delivered, had sat on the counter overnight and for half the next day before it was refrigerated. Subsequently, the patient complained of muscle soreness at the injection site and painful arm. The patient mentioned it on their next office visit. It was unknown if the patient sought medical attention. On an unspecified date the patient recovered. The medical assistant contacted during telephone follow-up could not supply the following information: patient name, date of birth, date of vaccination, lot number or date of event. This is one of several reports received from the same source. No further information is available.
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a pharmacist concerning a male patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot# not reported). Subsequently the patient experienced severe swelling. At the time of this report, the patient's outcome was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site swelling, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a medical assistant (C.M.A.) concerning a 73 year old female with elevated cholesterol and hypertension, and adverse drug reaction to VICODIN and cyclobenzaprine hydrochloride (MSD), who on 13-OCT-2010 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 (lot # 665925/0932Z, expiration date 18-JUL-2011). Concomitant therapy included influenza virus vaccine (unspecified), PREMARIN, unnamed cholesterol medication, TRIAM/HCTZ and atenolol. On 14-OCT-2010 the patient's left arm was "blown up" from the shoulder at the injection site to the wrist. the arm was hot and she had difficulty moving it. The patient was treated with ice and BENADRYL. No lab/diagnostics studies were performed. The swelling was starting to go down today on 19-OCT-2010. The patient received PNEUMOVAX 23 (lot # not reported) in December 2004 and no reaction noted. The patient sought unspecified medical attention. The patient subsequently experienced adverse drug reaction while on therapy with cyclobenzaprine hydrochloride (MSD, WAES # 1010USA02714). This is one of several reports received from the same source. The doctor was requesting a lot check since each patient received the same lot number. The doses were administered by different staff members. The doctor had four more vials of the vaccine and was concerned about using them because of the above reactions. 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. No further information is available.
Age: 36.0
Sex: F
Vaccine: FLUX, PPV, TDAP
Symptoms: Injected limb mobility decreased, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 36 year old female patient with asthma who on 09-SEP-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot#664476/1190Y) (Exp date: Unspecified), IM. Concomitant therapy included influenza virus vaccine (unspecified) and and ADACEL. It was reported that on 10-SEP-2010 the patient experienced fever, her arm was swelling from shoulder to wrist and she could not lift her left arm. The physician also reported that PNEUMOVAX 23 (lot#664476/1190Y), IM. was administered with influenza virus vaccine (unspecified) in the left arm patient and ADACEL was given in the patient's right arm. On 11-SEP-10 the patient recovered from all these symptoms. This is one of several reports received from the same source. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Information has been received from a healthcare worker concerning an 82 year old female patient who on approximately 21-OCT-2005 was vaccinated with a first dose of PNEUMOVAX 23 (Lot#665402/1339Y) (Exp 05-NOV-2011), SQ, second dose of PNEUMOVAX 23 was SC administered on 19-OCT-2010. Healthcare worker stated that on 19-OCT-2010 the patient had experienced pain and redness in arm which injection was given after receiving second dose of PNEUMOVAX 23 (Lot#665402/1339Y), SQ. 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. Follow up information has been received from the reported who stated that the patient had recovered. Additional information is not expected.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Insomnia, Malaise, Pain in extremity
Clinical narrative: Information has been received from a healthcare worker concerning an 89 year old female patient with no drug reactions/allergies, who in October 2004, was vaccinated with a first dose of PNEUMOVAX 23 (Lot #665402/1339Y) (Exp 22-MAY-2011), SQ. The healthcare worker reported that the patient had complained of a very sore arm and feeling very sick after receiving second dose of PNEUMOVAX 23 (Lot # 665402/1339Y) on 19-OCT-2010. Pain in her arm had kept her up all night. At the time of the report the patient was recovered. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Pain in extremity, Rash
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning a patient who, on an unspecified date, was vaccinated with a dose of PNEUMOVAX 23 (lot # 664864/1365Y, expire date not reported), 0.5 ml, intramuscularly. After immunization with PNEUMOVAX 23, the patient developed rash, pain and numbness of the arm. This patient also reported difficulty moving that same arm. The arm affected was the arm that this patient received PNEUMOVAX 23. The patient sought medical attention by telephone call. At the time of the report, the outcome of the patient was unknown. The pharmacist requested a lot check. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 664864/1365Y were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports from the same source. Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral
Clinical narrative: Information has been received from a Medical Assistant concerning an old male patient in his 80s who was vaccinated with PNEUMOVAX 23. The patient experienced a cellulitis reaction after being administered PNEUMOVAX 23. Therapy was discontinued. The patient did not seek medical attention. Follow up information was received concerning the patient with no illness at time of vaccination and pre-existing allergies, birth defects, medical conditions unknown who vaccinated with PNEUMOVAX 23 (exp. 03-JAN-2012) IM on deltoid. The patient experienced edema and redness to the arm below the injection site which cleared within 1 week. No further information is available. This is one of several reports received from the same source.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Oedema peripheral, Rash macular, Skin mass
Clinical narrative: Information has been received from a registered nurse (R.N) concerning a 52 years old female patient who on 13-OCT-2010 was vaccinated with a 0.5mL dose of PNEUMOVAX 23 (Lot number reported as 06510Z; expiration date February 2011). The nurse reported that on 13-OCT-2010 the patient experienced 2-3 hard "lumps" with swelling of the upper arm, with warmth and redness. Tenderness of the right arm extended down to the right forearm and hand. The duration of the symptoms was 5 days. At the time of report, the patient was recovering. The patient did not seek medical attention. Follow up information has been received from the Registered Nurse concerning the Bookkeeper female patient with no illness at time of vaccination and no pre-existing allergies, birth defects or medical conditions who on 13-OCT-2010 at 11:00 approximately was vaccinated intramuscularly in the right deltoid with a first dose of PNEUMOVAX 23 (665708/0651Z). The nurse reported that on 13-OCT-2010, the patient experienced swelling, botchy and tender. On 20-OCT-2010, the patient recovered. There were no laboratory tests or diagnostic studies performed. This is one of two reports from the same source. The nurse requested a lot check. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 665708/0651Z were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Tenderness
Clinical narrative: Information has been received from a registered nurse (R.N) concerning a 52 years old female patient who on 13-OCT-2010 was vaccinated with a 0.5mL dose of PNEUMOVAX 23 (Lot number reported as 06510Z; expiration date February 2011). The nurse reported that on 13-OCT-2010 the patient experienced 2-3 hard "lumps" with swelling of the upper arm, with warmth and redness. Tenderness of the right arm extended down to the right forearm and hand. The duration of the symptoms was 5 days. At the time of report, the patient was recovering. The patient did not seek medical attention. Follow up information has been received from the Registered Nurse concerning the Bookkeeper female patient with no illness at time of vaccination and no pre-existing allergies, birth defects or medical conditions who on 13-OCT-2010 at 11:00 approximately was vaccinated intramuscularly in the right deltoid with a first dose of PNEUMOVAX 23 (665708/0651Z). The nurse reported that on 13-OCT-2010, the patient experienced swelling, botchy and tender. On 20-OCT-2010, the patient recovered. There were no laboratory tests or diagnostic studies performed. This is one of two reports from the same source. The nurse requested a lot check. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 665708/0651Z were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site rash, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 72 years old female patient with no drugs reactions or allergies who in approximately 2004 "5-6 years ago", was vaccinated subcutaneously with her first dose of PNEUMOVAX 23 (lot number unknown). Concomitant therapy included LIPITOR. The physician stated that on 19-OCT-2010 "after the patient was vaccinated subcutaneously with her second dose of PNEUMOVAX 23 (lot number 665402/1339Y; expiration date: 22-MAY-2011)", she complained her arm was red and painful. The patient also developed rash on her arm where injection was given. There were no laboratory tests performed. At the time of this report, the patient was recovering. The patient sought medical attention by a telephone call. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Malaise, Pruritus
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a dose of PNEUMOVAX 23 (lot #: 665300/1314Y, Exp: 08-May-2011). The physician reported that in approximately March 2011 the patient developed itching and a feeling of malaise. She had to go to the emergency room. The physician reported that the patient is recovered. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 665300/1314Y 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. The health care professional contacted during telephone follow up could not supply the following information: patient name or date of birth. This is one of several reports from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Nausea, Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 65 year old female patient who on 22-MAR-2011, was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml, (route not reported) (lot number 667995/1150Z Exp. date 04-MAR-2012). On approximately 22-MAR-2011, the patient experienced tenderness of the left arm, nausea and fever of 103.8. The patient sought unspecified medical attention. It was noted that the patient improved "after therapy was stopped". At the time of the report the patient was recovering. Follow up information has been received from a health professional concerning the 65 year old female patient with not acute chronic hypertension, diabetes mellitus, sickle cell trait, elevated cholesterol, osteoarthritis and allergy to DEMEROL with nausea, vomiting and heart rate, who on 27-OCT-2004, was vaccinated with the first dose of PNEUMOVAX 23 (route, expiration date and lot number not reported). On 22-MAR-2011, was vaccinated with a second dose of PNEUMOVAX 23, 0.5 ml, IM, in the left deltoid (lot number 667995/1150Z Exp. date 04-MAR-2012). Concomitant therapy included lisinopril (MSD), CRESTOR, MAXZIDE, HUMALOG and HUMULIN. On 23-MAR-2011 the patient woke with tenderness at injection site. Had fever to 103.8 and nausea. She returned for recheck on 25-MAR-2011, the patient was found afebrile and nausea was resolved. On exam the left arm was found with erythema, swelling and warmth. No laboratories were performed. At the time of the report the outcome of the patient with erythema in the left arm, swelling and warmth were not reported. The patient was advised with cool compresses to site and for pain and fever, the patient was advised to take TYLENOL and ADVIL, PRN. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Information has been received from a physician concerning a 65 year old female patient who on 22-MAR-2011, was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml, (route not reported) (lot number 667995/1150Z Exp. date 04-MAR-2012). On approximately 22-MAR-2011, the patient experienced tenderness of the left arm, nausea and fever of 103.8. The patient sought unspecified medical attention. It was noted that the patient improved "after therapy was stopped". At the time of the report the patient was recovering. Follow up information has been received from a health professional concerning the 65 year old female patient with not acute chronic hypertension, diabetes mellitus, sickle cell trait, elevated cholesterol, osteoarthritis and allergy to DEMEROL with nausea, vomiting and heart rate, who on 27-OCT-2004, was vaccinated with the first dose of PNEUMOVAX 23 (route, expiration date and lot number not reported). On 22-MAR-2011, was vaccinated with a second dose of PNEUMOVAX 23, 0.5 ml, IM, in the left deltoid (lot number 667995/1150Z Exp. date 04-MAR-2012). Concomitant therapy included lisinopril (MSD), CRESTOR, MAXZIDE, HUMALOG and HUMULIN. On 23-MAR-2011 the patient woke with tenderness at injection site. Had fever to 103.8 and nausea. She returned for recheck on 25-MAR-2011, the patient was found afebrile and nausea was resolved. On exam the left arm was found with erythema, swelling and warmth. No laboratories were performed. At the time of the report the outcome of the patient with erythema in the left arm, swelling and warmth were not reported. The patient was advised with cool compresses to site and for pain and fever, the patient was advised to take TYLENOL and ADVIL, PRN. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Arrhythmia, Oedema peripheral, Ultrasound Doppler normal
Clinical narrative: Information has been received from a healthcare worker concerning a 76 year old male patient with allergic reaction KEFLEX, CIPRO, sulfa and niacin and no pertinent medical history who in 2004 was intramuscularly vaccinated with 0.5 mL of the first dose of PNEUMOVAX 23 (Lot# and expiration not reported) and on 23-MAY-2011 was intramuscularly vaccinated with 0.5 mL of the second dose of PNEUMOVAX 23 (Lot# 670503/0386AA, expiration not reported). Concomitant therapy included COUMADIN, Lisinopril (manufacturer unknown), LUNESTA, omeprazole, TRAVATAN 004% and ezetimibe (MSD). It was reported that on 24-MAY-2011 after received the second dose of PNEUMOVAX 23 the patient experienced acute swelling on the upper arm of the right bicep area and arrhythmia. It was unknown if was unknown if the patient experienced any problems after received the first dose of PNEUMOVAX 23 in 2004. The patient sought medical attention by an office visit. A Doppler to rule out DVT-found to be negative was performed. BIAXIN 500 mg every 12 hours for 7 days was given as treatment for the adverse event. At the time of reporting the patient was recovering. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Paraesthesia, Rash macular
Clinical narrative: Information has been received from a pharmacist concerning a 47 year old male patient with heart disease and high cholesterol and no drug reaction or allergies who on 10-OCT-2010 was vaccinated IM in right deltoid with a dose of PNEUMOVAX 23 (lot #665904/0866Z). Concomitant therapy included PLAVIX and CRESTOR. On 11-OCT-2010 the patient developed a flat, blotchy redness to the right of the injection site, that extended to the armpit. It was "the size of a fist". It was "tingling and itchy". No lab diagnostics studies were performed. The pharmacist recommended BENADRYL. At the time of reporting, the patient was recovering after therapy. The patient sought unspecified medical attention. The patient's wife also received an injection from the same vial, but did not experience a rash. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Fatigue, Injection site cellulitis, Injection site pain, Injection site rash
Clinical narrative: Information has been received from a registered nurse concerning a 62 year old female patient with penicillin G allergy and no pertinent medical history who on 08-OCT-2010 was vaccinated IM with a 0.5ml dose of PNEUMOVAX 23 (lot # 667418/0978Z). There was no concomitant medication. On 08-OCT-2010 the patient experienced a cellulitis like reaction at the injection site after receiving PNEUMOVAX 23. The patient experienced severe pain and developed red spots on the site of injection to the left side of her chest. She had significant fatigue and loss of appetite. At the time of reporting, the patient was recovering. The patient sought unspecified medical attention. Additional information has been requested.