chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 21 year old female patient who on 07-OCT-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot#667418/0978Z), IM, into the right arm (Exp. Date Unspecified). Concomitant therapy included a dose of FLUZONE given into the patient's left arm and a dose of ADACEL given into the patient's left arm. It was reported that the patient experienced fever and had a red swollen elbow as a result of being in therapy with PNEUMOVAX 23. Subsequently, the patient recovered from all these symptoms. The patient sought medical attention at the physician's office. Follow up information has been received from the physician and the medical assistant who stated that the 21 year old female patient with asthma and no illness at the time of vaccination received the dose of PNEUMOVAX 23 (Lot#667418/0978Z), IM, into the left arm (also reported as right arm by the medical assistant). Concomitant vaccines given on the same day included a dose of ADACEL (Lot # C3491AA) and a dose of FLUZONE (Lot # U3639DA) both given IM into the left arm. The physician stated that after receiving the vaccine the patient developed a skin reaction in her left upper arm. The area had been red, swollen, warm and tender. Vital signs reported were: BP: 110/60, LUE. Sitting, HR: 76 b/min. Temp: 97.9 F, Tympanic. A physical exam showed: GEM: Comfortably conversing and ambulating. Good eye contact. No acute distress. Mental status intact. Well-nourished and developed. Skin: 4 cm circular erythematous, swollen, tender (with rebound and guarding) patch over left upper arm (ventral, mid-section) at side of PNEUMOVAX 23 injection. The physician reported that the patient's skin reaction was slowly improving. She was advised symptomatic relief with ice/heat, ibuprofen and TYLENOL q6hr/p.r.n. Follow up information has been received from the medical assistant via a telephone call. It was confirmed that the vaccine dose of PNEUMOVAX 23 was given in right arm on 07-OCT-2010. This is one of several reports received from the same source. No further information is available.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site warmth, Joint swelling, Pyrexia, Skin reaction
Clinical narrative: Information has been received from a physician concerning a 21 year old female patient who on 07-OCT-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot#667418/0978Z), IM, into the right arm (Exp. Date Unspecified). Concomitant therapy included a dose of FLUZONE given into the patient's left arm and a dose of ADACEL given into the patient's left arm. It was reported that the patient experienced fever and had a red swollen elbow as a result of being in therapy with PNEUMOVAX 23. Subsequently, the patient recovered from all these symptoms. The patient sought medical attention at the physician's office. Follow up information has been received from the physician and the medical assistant who stated that the 21 year old female patient with asthma and no illness at the time of vaccination received the dose of PNEUMOVAX 23 (Lot#667418/0978Z), IM, into the left arm (also reported as right arm by the medical assistant). Concomitant vaccines given on the same day included a dose of ADACEL (Lot # C3491AA) and a dose of FLUZONE (Lot # U3639DA) both given IM into the left arm. The physician stated that after receiving the vaccine the patient developed a skin reaction in her left upper arm. The area had been red, swollen, warm and tender. Vital signs reported were: BP: 110/60, LUE. Sitting, HR: 76 b/min. Temp: 97.9 F, Tympanic. A physical exam showed: GEM: Comfortably conversing and ambulating. Good eye contact. No acute distress. Mental status intact. Well-nourished and developed. Skin: 4 cm circular erythematous, swollen, tender (with rebound and guarding) patch over left upper arm (ventral, mid-section) at side of PNEUMOVAX 23 injection. The physician reported that the patient's skin reaction was slowly improving. She was advised symptomatic relief with ice/heat, ibuprofen and TYLENOL q6hr/p.r.n. Follow up information has been received from the medical assistant via a telephone call. It was confirmed that the vaccine dose of PNEUMOVAX 23 was given in right arm on 07-OCT-2010. This is one of several reports received from the same source. No further information is available.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 49 year old female patient with a medical history of hepatitis B who on 05-OCT-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot#664476/1190Y) (Exp. Date: Unspecified), IM in the right arm. Concomitant therapy included Flu vaccine (unspecified) and ADACEL (administered during the same time; arm not specified). It was reported that the next day, on 06-OCT-2010, patient had had a red swelling in her arm that had been as big as her hand, and had a hard bump in the area of injection. It was also reported that the patient could not elevate her arm after receiving a dose of PNEUMOVAX 23 (Lot#664476/1190Y), IM. At the time of the report the patient was recovering. Follow up information has been received from the physician concerning the 49 year old patient with hepatitis B acute, who on 05-OCT-2010 at approximately 9:30 am was vaccinated intramuscularly into the right deltoid with a dose of PNEUMOVAX 23 (Lot#664476/1190Y). On the same day, the patient was vaccinated with a dose of FLUZONE (Lot # U3639DA) and ADACEL (Lot# C3491AA) both given intramuscularly into the left deltoid). On 06-OCT-2010 the patient experienced site red, hot swollen about as big as her hand, hard bump at injection site and a very sore arm, all on right arm. The patient was treated with ice and ibuprofen. On approximately 07-OCT-2010, the patient had recovered. The patient did not seek medical attention. This is one of several reports received from the same source. Additional information is not expected.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site warmth, Mobility decreased, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 49 year old female patient with a medical history of hepatitis B who on 05-OCT-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot#664476/1190Y) (Exp. Date: Unspecified), IM in the right arm. Concomitant therapy included Flu vaccine (unspecified) and ADACEL (administered during the same time; arm not specified). It was reported that the next day, on 06-OCT-2010, patient had had a red swelling in her arm that had been as big as her hand, and had a hard bump in the area of injection. It was also reported that the patient could not elevate her arm after receiving a dose of PNEUMOVAX 23 (Lot#664476/1190Y), IM. At the time of the report the patient was recovering. Follow up information has been received from the physician concerning the 49 year old patient with hepatitis B acute, who on 05-OCT-2010 at approximately 9:30 am was vaccinated intramuscularly into the right deltoid with a dose of PNEUMOVAX 23 (Lot#664476/1190Y). On the same day, the patient was vaccinated with a dose of FLUZONE (Lot # U3639DA) and ADACEL (Lot# C3491AA) both given intramuscularly into the left deltoid). On 06-OCT-2010 the patient experienced site red, hot swollen about as big as her hand, hard bump at injection site and a very sore arm, all on right arm. The patient was treated with ice and ibuprofen. On approximately 07-OCT-2010, the patient had recovered. The patient did not seek medical attention. This is one of several reports received from the same source. Additional information is not expected.
Age: 36.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Information has been received from a 36 year old male registered pharmacist with codeine allergy and allergy-induced asthma, and a history of Gastrooesophageal reflux disease who in February 2010 was vaccinated intramuscularly with the first dose of PNEUMOVAX 23 (lot number 665904/0866Z, exp date 04-JUL-2011). On 19-OCT-2010 the pharmacist was vaccinated intramuscularly with the second dose of PNEUMOVAX 23 (lot number 665904/0866Z, exp date 04-JUL-2011). Concomitant medication included: PRILOSEC and vitamins (unspecified). On 19-OCT-2010 he developed soreness at the injection site, swelling, muscle pain and heat at the injection site that lasted 2 days. The pharmacist did not seek medical attention. There was no lab diagnostic test performed. At the time of report the patient's soreness at the injection site was not recovered. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 71 year old female patient with no known medical history and no known drug reactions/allergies who on 06-OCT-2010 was vaccinated IM in right arm with a 0.5ml dose of PNEUMOVAX 23 (Lot # 665924/0930Z, Exp. Date 17-JUL-2011). Concomitant therapy included pravastatin, levothyroxine and ZESTORETIC. On 07-OCT-2010 the patient experienced redness and swelling at the injection site. The patient sought medical attention by office visit. No diagnostic laboratory tests performed. On an unspecified date the patient recovered from redness at the injection site and swelling at the injection site. Medical assistant would like 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 were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available. This is one of several reports received from the same source.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a Registered Nurse concerning a female patient with no known drug allergies who on 07-FEB-2011 was vaccinated intramuscularly with the first dose of PNEUMOVAX 23 (lot #667995/1150Z expiration date: 04-MAR-2012). Subsequently the patient experienced injection site reaction of pain, swelling and warmth. Patient was given antimicrobial (unspecified). At the time of the report patient's status was unknown. By nurse's request, 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 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. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Erythema, Fatigue, Injection site pain, Pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 47 year old female with an allergy to sulfa drugs and quinolones who on 20-JAN-2011 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 (lot number 664864/1365Y, expiration date 24-MAR-2011). Concomitant therapy included influenza virus vaccine (unspecified) (manufacturer unknown), CYMBALTA and VERAMYST. On 21-JAN-2011 the patient experienced left arm redness, soreness at the injection site. Additionally patient experienced chills, body aches, fatigue and a "fever". The patient sought unspecified medical attention and was taking KEFLEX for treatment. At time of report, the patient was recovering. Follow-up information has been received from the nurse practitioner reporting that the 41 year old (previously reported as 47 years old by the same nurse) patient with asthma and no illness at the time of vaccination was vaccinated the first dose of PNEUMOVAX 23 at left upper arm. On 20-JAN-2011 PM (previously reported as "21-JAN-2011"), the patient began to experience pain at injection site, had a fever, chills, body ache for 2 days. Soreness at site recovered. All symptoms recovered on 22-JAN-2011. There were no diagnostics tests and laboratory data. No further information is available.
Age: 41.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 47 year old female with an allergy to sulfa drugs and quinolones who on 20-JAN-2011 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 (lot number 664864/1365Y, expiration date 24-MAR-2011). Concomitant therapy included influenza virus vaccine (unspecified) (manufacturer unknown), CYMBALTA and VERAMYST. On 21-JAN-2011 the patient experienced left arm redness, soreness at the injection site. Additionally patient experienced chills, body aches, fatigue and a "fever". The patient sought unspecified medical attention and was taking KEFLEX for treatment. At time of report, the patient was recovering. Follow-up information has been received from the nurse practitioner reporting that the 41 year old (previously reported as 47 years old by the same nurse) patient with asthma and no illness at the time of vaccination was vaccinated the first dose of PNEUMOVAX 23 at left upper arm. On 20-JAN-2011 PM (previously reported as "21-JAN-2011"), the patient began to experience pain at injection site, had a fever, chills, body ache for 2 days. Soreness at site recovered. All symptoms recovered on 22-JAN-2011. There were no diagnostics tests and laboratory data. No further information is available.
Age: 84.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning an 84 year old male with leukaemia and no drug reaction/allergies who on 09-FEB-2011 was vaccinated with PNEUMOVAX 23 (lot no. 667695/1028Z, exp date 28-JAN-2012), 0.5ml, im. Concomitant therapy included GLEEVEC. On 10-FEB-2011 the patient experienced pain at site of injection, fever "99 degrees f." and had swelling from upper left arm to hand. The patient sought unspecified medical attention, and treated with ROCEPHIN, 2g, once a day, IV. No lab diagnostics studies performed were given. At the time of report, the patient's symptoms persisted. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Discomfort, Erythema, Sunburn
Clinical narrative: Information has been received from a nurse practitioner concerning a 66 year old male patient with diabetes and high blood pressure and familial heart disease and a history of heart bypass who on 16-DEC-2010 was vaccinated with PNEUMOVAX 23 and influenza virus vaccine (unspecified) (manufacturer unknown). Concomitant therapy included NOVOLIN 70/30, metoprolol, CELEBREX, "osteoarthritis" and enalapril maleate (manufacture unknown). On 17-DEC-2010 the patient notice that had redness on his left tricep and bicep. The nurse practitioner described it as "looks like sunburn" in appearance. The injection site itself and the left deltoid muscle did not appear red. The patient reported that he was in minimal discomfort. His laboratory data was significant for a temperature of 98.7 Farenheit on 18-DEC-2010. As of 18-DEC-2010 his right tricep and bicep were still red, and the nurse was considering starting him on BACTRIM. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Injection site pain, Malaise, Mobility decreased
Clinical narrative: Information has been received from a nurse concerning a 33 year old female patient with fibromyalgia, migraine headache, anaemia, hypothyroidism and drug allergies to AUGMENTIN, BIAXIN and BACTRIM who on 09-DEC-2010 was vaccinated IM with PNEUMOVAX 23 (lot # 667416/0956Z). Concomitant therapy included ACIPHEX, montelukast sodium (MSD), CELEBREX, LYRICA, SYNTHROID, BENTYL and gabapentin. On 13-DEC-2010 the patient reported having fever, chills, body ache, nausea, a stuffy nose and generally not feeling well. The patient also had a topical reaction. She had two areas near the injection site. One was 1 cm below the site and was 1 cm across. The other was 8 cm below the injection site and was 3 cm across. Both areas were papular with an irregular border. The sites were painful and the patient had difficulty raising her arm. They treated the patient with TORADOL, PHENERGAN and ROCEPHIN. They have not seen the patient again so did not know her current situation. Follow up information has been received from the registered nurse reporting that the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot # 667416/0956Z) by subcutaneous injection at the left arm. She developed left arm redness and significant left arm pain the day after vaccination (on 10-DEC-2010). The patient also had a 1 cm papular reddened area 1 cm below injection site and a second 3 cm area 8 cm below injection site. At the time of reporting, the outcome was unknown. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Nasal congestion, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 33 year old female patient with fibromyalgia, migraine headache, anaemia, hypothyroidism and drug allergies to AUGMENTIN, BIAXIN and BACTRIM who on 09-DEC-2010 was vaccinated IM with PNEUMOVAX 23 (lot # 667416/0956Z). Concomitant therapy included ACIPHEX, montelukast sodium (MSD), CELEBREX, LYRICA, SYNTHROID, BENTYL and gabapentin. On 13-DEC-2010 the patient reported having fever, chills, body ache, nausea, a stuffy nose and generally not feeling well. The patient also had a topical reaction. She had two areas near the injection site. One was 1 cm below the site and was 1 cm across. The other was 8 cm below the injection site and was 3 cm across. Both areas were papular with an irregular border. The sites were painful and the patient had difficulty raising her arm. They treated the patient with TORADOL, PHENERGAN and ROCEPHIN. They have not seen the patient again so did not know her current situation. Follow up information has been received from the registered nurse reporting that the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot # 667416/0956Z) by subcutaneous injection at the left arm. She developed left arm redness and significant left arm pain the day after vaccination (on 10-DEC-2010). The patient also had a 1 cm papular reddened area 1 cm below injection site and a second 3 cm area 8 cm below injection site. At the time of reporting, the outcome was unknown. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Rash papular, Skin reaction
Clinical narrative: Information has been received from a nurse concerning a 33 year old female patient with fibromyalgia, migraine headache, anaemia, hypothyroidism and drug allergies to AUGMENTIN, BIAXIN and BACTRIM who on 09-DEC-2010 was vaccinated IM with PNEUMOVAX 23 (lot # 667416/0956Z). Concomitant therapy included ACIPHEX, montelukast sodium (MSD), CELEBREX, LYRICA, SYNTHROID, BENTYL and gabapentin. On 13-DEC-2010 the patient reported having fever, chills, body ache, nausea, a stuffy nose and generally not feeling well. The patient also had a topical reaction. She had two areas near the injection site. One was 1 cm below the site and was 1 cm across. The other was 8 cm below the injection site and was 3 cm across. Both areas were papular with an irregular border. The sites were painful and the patient had difficulty raising her arm. They treated the patient with TORADOL, PHENERGAN and ROCEPHIN. They have not seen the patient again so did not know her current situation. Follow up information has been received from the registered nurse reporting that the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot # 667416/0956Z) by subcutaneous injection at the left arm. She developed left arm redness and significant left arm pain the day after vaccination (on 10-DEC-2010). The patient also had a 1 cm papular reddened area 1 cm below injection site and a second 3 cm area 8 cm below injection site. At the time of reporting, the outcome was unknown. Additional information has been requested.
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 syringe for flu-like symptoms, pre-filled syringes. 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 cleaned within 1 week. No information is available. This is one of several reports received from the same source.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth, Myalgia
Clinical narrative: Information has been received from a nurse concerning a 74 year old female patient with asthma and no drug reactions or allergies who on 08-DEC-2010, was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 (Lot# 667914/1067Z). Concomitant therapy included NEXIUM, albuterol, ADVAIR and montelukast sodium (MSD). It was reported that within a couple of days after the vaccine was given, the patient developed cellulitis and had to go to the emergency room. There were no lab diagnostics studies performed. At the time of the report, the patient was recovering. Information was received from a nurse and medical records concerning a 74 year old female (5'2", 152 lbs.) with no known drug allergies, asthma and a history of contact dermatitis who on 08-DEC-2010 at 3:00 pm. was vaccinated intramuscularly (left deltoid) with PNEUMOVAX 23 (Lot# 667914/1067Z). On 11-DEC-2010, the patient was seen by a physician for myalgias, fever, and spot where injection was given had gotten redder, hotter, and more painful. The patient was diagnosed with cellulitis and was started on dicloxacillin. The patient was admitted to the emergency room 12-DEC-2010 for worsening cellulitis and was placed on intravenous antibiotics. It was reported that the patient has recovered (date of recovery was not provided). This is one of two reports from the same source. Additional information is not expected. All available medical records will be provided upon request.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 74 year old female patient with asthma and no drug reactions or allergies who on 08-DEC-2010, was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 (Lot# 667914/1067Z). Concomitant therapy included NEXIUM, albuterol, ADVAIR and montelukast sodium (MSD). It was reported that within a couple of days after the vaccine was given, the patient developed cellulitis and had to go to the emergency room. There were no lab diagnostics studies performed. At the time of the report, the patient was recovering. Information was received from a nurse and medical records concerning a 74 year old female (5'2", 152 lbs.) with no known drug allergies, asthma and a history of contact dermatitis who on 08-DEC-2010 at 3:00 pm. was vaccinated intramuscularly (left deltoid) with PNEUMOVAX 23 (Lot# 667914/1067Z). On 11-DEC-2010, the patient was seen by a physician for myalgias, fever, and spot where injection was given had gotten redder, hotter, and more painful. The patient was diagnosed with cellulitis and was started on dicloxacillin. The patient was admitted to the emergency room 12-DEC-2010 for worsening cellulitis and was placed on intravenous antibiotics. It was reported that the patient has recovered (date of recovery was not provided). This is one of two reports from the same source. Additional information is not expected. All available medical records will be provided upon request.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Lymphadenopathy, Oedema peripheral
Clinical narrative: Information has been received from a nurse concerning a 44 year old female patient with asthma and no drug reactions or allergies who on 13-DEC-2010, was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 (Lot# 667914/1067Z). Concomitant therapy included WELLBUTRIN and albuterol. Subsequently, a couple of days after the patient had received the vaccines, the patient developed cellulitis. There were no lab diagnostics studies performed. At the time of the report, the patient was recovering. The patient did not seek medical attention. Information has been received from a nurse and medical records concerning a 44 year old female nurse practitioner with migraine headaches and a history of mild postpartum depression (1997) and infertility (status-post multiple IVF attempts) who was vaccinated with PNEUMOVAX 23 on 13-DEC-2010, (Lot# 667914/1067Z). Concurrent medications included TERAZOL 7 vaginal cream, fluoxetine, PEN-VEE K, and LEXAPRO. Office note from 15-DEC-10 showed patient's symptoms included left arm swelling, redness and swollen axilla lymph nodes. The patient was diagnosed with cellulitis of arm. The patient's treatment included ROCEPHIN 1 gram, given on left gluteus. The nurse reported that patient caught the cellulitis "early" and started on antibiotics right away. This is one of two reports from the same source. Additional information is not expected. All available medical records will be provided upon request.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray normal, Erythema, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 27 year old female patient who on 03-JAN-2011 was accidentally vaccinated with a 0.1 mg dose of PNEUMOVAX 23 (lot number 666025/0932Z, expiration date: 18-JUL-2011) in the left forearm instead of a tuberculosis (TB) test. The patient's relevant medical history, concomitant medications and past drug history were unknown. On 03-JAN-2011, after the patient got the PNEUMOVAX 23, she got a reaction around the site, redness, swelling and itching. It was unknown if there was any relevant laboratory data. As of 03-JAN-2011 she would not be getting any more PNEUMOVAX 23 and she had redness, swelling and itching on her forearm. At the time of this report, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Information has been received from a medical assistant and medical records, concerning a 27 year-old, female who on 03-JAN-2011 was accidentally administered PNEUMOVAX 23, 0.1 ml, in the left forearm, instead of TUBERSOL for an tuberculosis (TB) test. The patient returned to the office 1 - 2 hours later with redness and severe swelling at injection site. She was treated with BENADRYL, 50 mg, intramuscularly (IM), and SOLUMEDROL 125 mg, IM. The patient was sent to a hospital for chest x-ray that was negative. Went to after hours clinic with increased swelling and pain. She was informed to continue BENADRYL. The redness subsided, but there was more swelling. The patient applied ice packs and, within two days, the signs and symptoms were gone. No continuing effects. On 05-JAN-2011, the patient recovered. All medical records will be available upon request. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain, Pruritus, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a 27 year old female patient who on 03-JAN-2011 was accidentally vaccinated with a 0.1 mg dose of PNEUMOVAX 23 (lot number 666025/0932Z, expiration date: 18-JUL-2011) in the left forearm instead of a tuberculosis (TB) test. The patient's relevant medical history, concomitant medications and past drug history were unknown. On 03-JAN-2011, after the patient got the PNEUMOVAX 23, she got a reaction around the site, redness, swelling and itching. It was unknown if there was any relevant laboratory data. As of 03-JAN-2011 she would not be getting any more PNEUMOVAX 23 and she had redness, swelling and itching on her forearm. At the time of this report, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Information has been received from a medical assistant and medical records, concerning a 27 year-old, female who on 03-JAN-2011 was accidentally administered PNEUMOVAX 23, 0.1 ml, in the left forearm, instead of TUBERSOL for an tuberculosis (TB) test. The patient returned to the office 1 - 2 hours later with redness and severe swelling at injection site. She was treated with BENADRYL, 50 mg, intramuscularly (IM), and SOLUMEDROL 125 mg, IM. The patient was sent to a hospital for chest x-ray that was negative. Went to after hours clinic with increased swelling and pain. She was informed to continue BENADRYL. The redness subsided, but there was more swelling. The patient applied ice packs and, within two days, the signs and symptoms were gone. No continuing effects. On 05-JAN-2011, the patient recovered. All medical records will be available upon request. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered pharmacist (R.PH.) concerning a number of patients who on unknown dates were vaccinated with PNEUMOVAX 23 (lot # not reported). The reporter stated that the hospital had to quarantine a lot of PNEUMOVAX 23 because if was thought to be causing cellulitis in a number of patients who had received the vaccination. It was unknown if the patient sought medical attention. Follow-up information has been received which reported the patient was a 36 years old female. The patient might have been given Tdap (manufacture unknown). The lot number for PNEUMOVAX 23 may have been 667692/1110z. The patient was given TYLENOL and BENADRYL. This is one of several reports received from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. No further information is available.
Age: 43.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered pharmacist (R.PH) concerning a number of patient who on unknown dates were vaccinated with PNEUMOVAX 23 (lot # not reported). The reporter stated that the hospital had to quarantine a lot PNEUMOVAX 23 because it was thought to be causing cellulitis in a number of patients who had received the vaccination. It was unknown if the patients sought medical attention. Follow-up information has been received which reported the patient was a 43 years old female. The patient might have been given Tdap (manufacture unknown). The lot number of PNEUMOVAX 23 may have been 667692/1110Z. The patient was given nothing. This is one of several reports received from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. No further information is available.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Fatigue, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: Information has been received from a medical assistant concerning a 41 year old female patient with asthma who on 07-DEC-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 667916/1066Z, expire date 12-MAR-2010), 0.5 ml, intramuscularly in the left deltoid. Suspect vaccine included FLULAVAL (Lot #, expire date and route not reported) administered in the same arm in the same day as PNEUMOVAX 23. The medical assistant stated that patient had had the flu shot in the past with no negative event noted. On 09-DEC-2010 the patient contacted the office and reported that she experienced swelling in the upper shoulder left side and pain in her deltoid where the PNEUMOVAX 23 was administered. The patient also reported feeling tired and weak. The medical assistant stated that patient came into the office on 08-DEC-2010 and physician examined patient and noted swelling in the left clavicle, swelling in a lymph node and swelling at the injection site. Physician treated patient with prednisone, MOTRIN, AUGMENTIN and BENADRYL. The medical assistant stated that patient returned to the office on 11-DEC-2010 and was better. There was no laboratory diagnostics studies performed. Follow-up information was received from the medical assistant concerning the 41 year old female patient with asthma, allergy to VICODIN and codeine and no history of being allergic to PNEUMOVAX 23 who on 07-DEC-2010 at 8:00 a.m. was vaccinated with a dose of PNEUMOVAX 23 (Lot # 667916/1066Z, expire date 12-MAR-2010), 0.5 ml., intramuscularly in the left deltoid. Suspect vaccine included FLULAVAL (Lot #, expire date and route not reported) administered in the same arm in the same day as PNEUMOVAX 23. The medical assistant stated that on 08-DEC-2010 at 3:15 p.m., (also reported as four hours) after receiving PNEUMOVAX 23 and FLULAVAL, the patient developed painful swelling over the left clavicle. Medical assistant added that the swelling was very painful. The patient also had pains in the left deltoid where the PNEUMOVAX 23 and FLULAVAL were given. There was no breathing difficulty. The patient had no history of being allergic to this vaccine. On 11-DEC-2010, the patient recovered. This is one of two reports from the same source. Additional information is not expected.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Swelling
Clinical narrative: Information has been received from a medical assistant concerning a 41 year old female patient with asthma who on 07-DEC-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 667916/1066Z, expire date 12-MAR-2010), 0.5 ml, intramuscularly in the left deltoid. Suspect vaccine included FLULAVAL (Lot #, expire date and route not reported) administered in the same arm in the same day as PNEUMOVAX 23. The medical assistant stated that patient had had the flu shot in the past with no negative event noted. On 09-DEC-2010 the patient contacted the office and reported that she experienced swelling in the upper shoulder left side and pain in her deltoid where the PNEUMOVAX 23 was administered. The patient also reported feeling tired and weak. The medical assistant stated that patient came into the office on 08-DEC-2010 and physician examined patient and noted swelling in the left clavicle, swelling in a lymph node and swelling at the injection site. Physician treated patient with prednisone, MOTRIN, AUGMENTIN and BENADRYL. The medical assistant stated that patient returned to the office on 11-DEC-2010 and was better. There was no laboratory diagnostics studies performed. Follow-up information was received from the medical assistant concerning the 41 year old female patient with asthma, allergy to VICODIN and codeine and no history of being allergic to PNEUMOVAX 23 who on 07-DEC-2010 at 8:00 a.m. was vaccinated with a dose of PNEUMOVAX 23 (Lot # 667916/1066Z, expire date 12-MAR-2010), 0.5 ml., intramuscularly in the left deltoid. Suspect vaccine included FLULAVAL (Lot #, expire date and route not reported) administered in the same arm in the same day as PNEUMOVAX 23. The medical assistant stated that on 08-DEC-2010 at 3:15 p.m., (also reported as four hours) after receiving PNEUMOVAX 23 and FLULAVAL, the patient developed painful swelling over the left clavicle. Medical assistant added that the swelling was very painful. The patient also had pains in the left deltoid where the PNEUMOVAX 23 and FLULAVAL were given. There was no breathing difficulty. The patient had no history of being allergic to this vaccine. On 11-DEC-2010, the patient recovered. This is one of two reports from the same source. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure increased, Flushing, Palpitations, Paraesthesia, Pruritus
Clinical narrative: Information has been received from a nurse practitioner concerning a 65 year old female who on 01-FEB-2011 was vaccinated with PNEUMOVAX 23. On 01-FEB-2011 once the patient received PNEUMOVAX 23 she experienced a tingling in her arm, flushing and itching in her neck and face, increased blood pressure and palpitations. The patient was given "unknown medication" for treatment of adverse events, and she did not seek medical attention. The patient present status was unknown. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Oedema peripheral, Vomiting
Clinical narrative: Information has been received from a Registered Pharmacist concerning a 57 year old female with a history of being admitted to hospital for nausea and vomiting and no drug reactions or allergies, who on approximately 18-JAN-2010, was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (lot # 667690/1158Z, expiration date: 26-JAN-2012). There was no concomitant medication. On 18-JAN-2011 the patient's arm became swollen after receiving the PNEUMOVAX 23. Patient received "supportive" treatment for the arm became swollen. No Lab Diagnostic studies were performed. At the time of the report, patient was recovering from arm became swollen. Patient sought unspecified medical attention. Additional information has been requested.
Age: 87.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information has been received from an office manager concerning an 87 year old male, with no drug reactions or allergies, who "5 - 6 years ago", was vaccinated with a first dose of PNEUMOVAX 23 (lot # and expire date unknown). On 19-OCT-2010, the patient was vaccinated with a second dose of PNEUMOVAX 23 (lot # 665402/1339Y, expire date 22-MAY-2011), subcutaneously. Concomitant therapy included COUMADIN. Patient complained of a swollen and red arm after receiving second dose of PNEUMOVAX 23. There were not laboratory diagnostics studies performed. The patient sought medical attention by telephone. At the time of the report, the patient was recovering. This is one from several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Injection site warmth, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N) who inquired if patients who have had pneumonia were at a greater risk to experience injection site reactions or systemic adverse effects after receiving PNEUMOVAX 23. Attempts are being made to verify the existence of identifiable patients. Follow-up was received from a licensed practical nurse who reported that the patient had pneumonia before and when he was vaccinated on an unspecified date with a dose of PNEUMOVAX 23 (Lot# not reported), on an unspecified date, he had arm redness, it was extremely swollen, hot and feverish at the injection site and his whole arm. At the time of the report the patient's outcome was unknown. It was unknown if the patient sought medical attention. This is one of several cases from the same source. Additional information is not expected.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Information has been received from a medical assistant concerning a 47 year old female with rheumatoid arthritis and sulfa allergy who on 11-OCT-2010 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (lot#665924/0930Z). Concomitant therapy included nifedipine, HUMIRA and TOPAMAX. On 12-OCT-2010 the patient developed redness and swelling at injection site and had myalgia from her neck to right wrist. Unspecified medical attention was sought via office visit. There were no laboratory diagnostics studies performed. At the time of this report, the patient had recovered from redness at injection site, swelling at injection site and myalgia from her neck to her wrist. The medical assistant requested a lot check. 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. Follow-up information has been received from a medical assistant and medical records concerning the 47 year old female patient who on 11-OCT-2010 at 13:30 was vaccinated IM with the first dose of PNEUMOVAX 23 into her right deltoid and a dose of influenza (manufacture unknown) (lot # 111816P1). The patient previously was vaccinated with a dose of influenza (manufacture unknown) (lot # U32098AA) on 23-SEP-2009. On 13-OCT-2010 (previously reported as 12-OCT-2010), the patient experienced redness and swelling 6 cm diameter around injection site with myalgia. On an unspecified date, the patient recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Erythema, Local swelling, Pain, Tenderness
Clinical narrative: Information has been received from a registered nurse concerning an approximately 68 year old female with cauda equina syndrome and supraventricular tachycardia who on 18-OCT-2010 was vaccinated with PNEUMOVAX 23 (lot #667912/0933Z) 0.5 ml single dose IM. Suspect vaccination at the same time, in the same arm included a dose of influenza virus vaccine (unspecified). Concomitant therapy included LYRICA, FLOMAX and atenolol. The registered nurse reported that the patient returned to the practice on 20-OCT-2010, complaining of swelling and tenderness below the injection site. Nurse reported that examination of the arm revealed an erythematous and swollen area, slightly raised, extending down to the elbow. At the time of the report, the patient was recovering. Physician's office would like a lot check on PNEUMOVAX 23 lot # 0933Z, expiring on 25-FEB-2012. A lot check has been initialized. This is one of several reports from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number (667912/0933Z) in question were satisfactory. The lot met the requirements for the Center for Biologics Evaluation and Research and was released. Follow up information was received from the nurse concerning a 67 year old male patient who on 18-OCT-2010 was vaccinated with PNEUMOVAX 23 (lot # 667912/0933Z). The patient reported same pain on the left deltoid area on 19-OCT-2010. The physician noted area of erythema measuring 8 cm in the greatest dimension inferior to the injection site. The patient was given ZYRTEC 10 mg daily. The nurse did not agree the patient was inappropriately vaccinated. Follow up information from the registered nurse reported that the patient was recovered from the events on 22-OCT-2010. No further information is available.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Information has been received from a medical assistant concerning a male patient who on an unspecified date was vaccinated with PNEUMOVAX 23 (Lot # 665924/0930Z, Exp. Date 17-JUL-2011). On an unspecified date "the patient who came into the office who had redness and swelling looked at". The patient's outcome was unknown. Medical assistant would like 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 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: 84.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a Registered Nurse concerning an 84 year old female patient with breast cancer and no drug reactions or allergies who on 28-JAN-2011 was vaccinated with PNEUMOVAX 23 0.5 mL intramuscularly. On 28-JAN-2011 the patient developed "swelling and redness on the upper arm where the injection was administered." The patient was given KEFLEX 500 mg 1 capsule four times daily for 10 days. "The patient was also given ADVIL and BENADRYL." Lab diagnostics included complete blood cell count "CBC test" (result not reported). The patient sought unspecified medical attention. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Headache, Nausea, Pyrexia, Rash, Vomiting
Clinical narrative: Information has been received from a pharmacist concerning a patient with chronic obstructive pulmonary disease (COPD) who on 26-OCT-2010 was vaccinated with single injection of PNEUMOVAX 23 (lot# 667418/0978Z). Subsequently the patient experienced fever, rash, headache, nausea and vomiting. The patient experienced these side effects for 3 to 4 days after the initial injection. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Antibody test abnormal, Microbiology test abnormal
Clinical narrative: Information has been received from a Licensed Practitioner Nurse concerning a 56 year old male patient with a history or "sinus issues" who on 07-DEC-2010 was vaccinated with a first dose of PNEUMOVAX 23 (lot#667914/1067Z). On 04-JAN-2011 a pneumococcal titer was done and was positive for only 4 pneumococcal types. It was unspecified if the patient sought medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site swelling, Wrong drug administered
Clinical narrative: Information has been received from a physician reporting himself. The physician vaccinated with PNEUMOVAX 23 instead of flu vaccine in error on an unspecified date. The physician experienced injection site reaction for past 2 days, swollen 3 by 2 inch area on his left arm and cellulitis like reaction around his axilla. The physician received a dose of PNEUMOVAX 23 vaccine 2 years ago without a problem. At the time of the report, the physician's outcome was not recovered. No further information is available.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Electromyogram normal, Joint range of motion decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging, Tendonitis
Clinical narrative: Information has been received from a physician concerning a 60 year old female with no pertinent medical history and no drug reactions or allergies who in approximately October 2010 (reported as about 3 months ago) was vaccinated IM with a dose of PNEUMOVAX 23 (lot number not provided). There was no concomitant medication. The patient was still experiencing shoulder pain. Patient complained of lateral shoulder pain over the deltoid region and decrease in range of motion. Tendonitis was diagnosed as well. Magnetic resonance imaging (MRI) was performed (result not provided). EMG was done and result came out normal. The patient sought unspecified medical attention and was treated with corticosteroid injection. At time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Oedema peripheral, Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a nurse concerning a 42 year old female who on 13-JAN-2011 was vaccinated with a dose of PNEUMOVAX 23 (lot no. 665401/1320Y) 0.5mL. On 13-JAN-2011, 3 hours after vaccination, the patient experienced pain, numbness and tingling in the arm with injection site. The patient also reported having a slight buildup of fluid in same arm the following day. No treatment was given. On 18-JAN-2011, the patient recovered from the symptoms. The patient sought unspecified medical attention. Additional information has been requested.