chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Nonspecific reaction
Clinical narrative: Information has been received from a physician and an Alaska native female (age 62 at time of reporting), with allergies to unspecified "pain killers," asthma with increasing problems over the past year, chronic obstructive pulmonary disease, allergic rhinitis, hypertension, gastrooesophageal reflux disease, degenerative bone disease and a history of extreme swelling of her legs, extreme joint pain and shortness of breath while on therapy with amlodipine positive skin tests to aero-allergans, headaches, itching and breathing problems (not further specified) while on therapy with morphine and codeine, breathing problems (not further specified) while on therapy with trifluoperazine hydrochloride (STELAZINE) and unspecified reactions while on therapy with aspirin (+) butalbital (+) caffiene (FIORINAL), pentazocine lactate (TALWIN) and sulfa, who on an unspecified date was vaccinated with a dose of pneumococcal vaccine 23 polyvalent.  Subsequently the patient experienced a reaction (not further specified).  The outcome was not reported.  Follow up information from the physician indicated that there was no information in their records regarding the patient having received a dose of pneumococcal vaccine 23 polyvalent.  No further information is expected.  On 02/20/2003, the physician and patient also reported the experience of the patient while on therapy with montelukast sodium (WAES # 0302USA02296).
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Injection site mass, Injection site oedema, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 60 year old white female who on 03/31/2003 was vaccinated in the left arm with a 0.5ml dose of pneumococcal vaccine 23 polyvalent (Lot # 644218/1027M).  On approximately 03/31/2003, the patient developed a fever, swelling, a sore area hot to the touch that was hard with bruising and a big lump.  On approximately 04/02/2003, "a couple of days later", the patient recovered after being treated with unspecified antibiotics.  It was also noted that an 82 year old male patient was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 64421/1027M) and developed the same symptoms (WAES # 0304USA01006).  No further information is expected.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a health professional concerning a 56 year old female who on 04/11/2003 (also noted as Friday 04/09/2003) was vaccinated with a 0.5ml dose of pneumococcal vaccine 23 polyvalent.  On 04/13/2003 the patient did not have a fever.  The patient noted that she was last vaccinated with a dose of pneumococcal vaccine 23 polyvalent (manufacturer unknown) four and a half years ago and asked if she could have been vaccinated too soon.  The patient was referred to her primary medical doctor or to the local emergency room.  On 05/05/2003, it was reported by a RN that there was no other additional information which she had to offer.  On 05/09/2003 it was reported that the patient did not give her phone number or her physician's name.  No further information is expected.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy, Myalgia, Oedema
Clinical narrative: Information has been received on 04/16/2003 from a 32 year old female consumer with an autoimmune disorder who on approximately 04/02/2003, two weeks ago, was vaccinated SC with a 0.5ml dose of pneumococcal vaccine 23 polyvalent.  There was no concomitant medication.  On approximately 04/02/2003, "soon after" the vaccination, the patient developed soreness and swelling in her left shoulder, which soon went away.  On approximately 04/09/2003, one week ago, the patient developed a swollen and sore lymph node in her armpit.  As of the report on 04/16/2003, the patient did not recover from the swollen and sore lymph node in her armpit.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a 61 year old female consumer with hypertension, fibromyalgia and chronic fatigue syndrome who on 03/10/2003 was vaccinated with a third dose of pneumococcal vaccine 23 polyvalent.  Concomitant therapy included levothyroxine Na (SYNTROID), valsartan (DIOVAN), amlodipine besylate (NORVASC), omeprazole (PRILOSEC), estrogens, conjugated (PREMARIN), acetaminophen (+) propoxyphene napsylate (DARVOCET-N) and diazepam (VALIUM). Subsequently, the patient reported that her arm swelled from the injection site to her elbow.  She reported that she has been weak and tired "ever since".  No additional patient information was provided.  Unspecified medical attention was sought.  Additional information has been requested. 02/18/2010 On 27-MAY-2008 at 1600, the patient received a fourth dose of PNEUMOVAX. On that same evening she developed aches and swelling on the left arm at the injection site. The next day, it was red around the swelling area and very sore. She also soad that she had melanoma prior to PNEUMOVAX and it came back to the left arm after her 2nd dose of PNEUMOVAC. Unspecified medical attention was sought. No laboratory diagnositc studies wer performed. At the time of this report, the patient had not recovered.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Oedema, Pain
Clinical narrative: Information has been received from a RN concerning a female with allergies to ciprofloxacin hydrochloride (CIPRO), penicillin (unspecified), codeine, and "sulfa" who on 04/16/2003 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent.  Concomitant therapy that day included an "allergy shot".  On 04/16/2003, shortly after receiving the vaccination, the patient experienced pain at the site, swelling radiating up the arm to the shoulder, redness, hives and nausea.  The patient was instructed to take diphendydramine hydrochloride (BENADRYL) and "call if anything worsens".  The reporter indicated that "the condition is improving but not totally resolved."  Unspecified medical attention was sought.  Follow up information received from a nurse manager indicated that the "patient had redness, edema, warmth, pain and in the entire arm for the first 72 hours following the vaccination".  It was noted that the patient applied ice packs and took oral diphenhydramine hydrochloride (BENADRYL) to help relieve the symptoms.  After the first 72 hours, the patient had redness and pain in the arm and shoulder for approximately 5 days.  It was reported that the patient continued to use heat/cold and take oral diphenhydramine hydrochloride (BENADRYL) to relieve the redness and pain.  There were no labs performed.  The reporter indicated that "the patient is fine".  No further information is expected.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Information has been received from a 78 year old female patient who on 01/16/2003 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 645249/1196M).  Concomitant therapy included atorvastatin calcium (LIPITOR) 10mg daily and latanoprost (XALATAN) 0.005% opthalmic administration at bedtime.  Subsequently on 01/16/2003, the patient developed severe pain from her upper shoulder to her wrist.  Unspecified medical attention was sought.  The patient was treated with prednisone 10 mg, diphenhydramine hydrochloride (BENADRYL) and acetaminophen (+) hydrocodone bitartrate (VICODIN) 500mg.  Subsequently, the patient recovered.  No further information is available.
Age: 40.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Pain
Clinical narrative: Info has been received from a licensed practical nurse concerning a 40 year-old male volunteer firefighter with no known drug allergies and no known medical conditions who on 12/02/2002 at 19:00 was vaccinated intramuscularly in the deltoid with a first dose of pneumococcal vaccine 23 polyvalent (lot #643251/0445M). There was no illness at the time of vaccination and no symptoms following prior vaccination with the pt or his siblings. Concomitant therapy on 12/02/2002 at 19:00 included an intramuscular dose in the "opposite deltoid" of influenza virus vaccine (FLUZONE) (Batch #U0925AA). Both doses were "given with a 25 guage, 1" needle". It was noted that 2 hours after the vaccine was given he spent 20 hours at a fire scene and was engaged at times in "heavy physical labor". On 12/03/2002 at 21:00, the pt developed swelling, pain, erythema and "induration from elbow to shoulder". The duration was 1 week and he did not require medical care as a result of this. It was also noted that the nurse had suspected that this "activity played a major role in their reactions". The pt recovered on 12/09/2002. The nurse also reported on 9 other pts that were vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (lot #643251/0445M) and developed induration (WAES #0212USA01192, 0212USA01193, 0212USA00729, 0212USA00825, 0304USA02076, 0304USA02077, 0304USA02078, 0304USA02079 and 0304USA02081). No further info is expected.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Injection site induration, Pain
Clinical narrative: Info has been received from a licensed practical nurse concerning a 32-year-old male volunteer firefighter with no known allergies and no known medical conditions who on 12/02/2002 at 19:00 was vaccinated intramuscularly in the deltoid with a 1st dose of pneumococcal vaccine 23 polyvalent (lot #643251/0445M). The dose was "given with a 25 guage, 1" needle". There was no concomitant medication. There was no illness at the time of vaccination and no symptoms following prior vaccinations with the pt or his siblings. It was noted that 2 hours after the vaccine was given, he spent 20 hours at a fire scene and was engaged at times in "heavy physical labor". On 12/03/2003 at 21:00, he developed pain and "induration from elbow to shoulder", but did not require medical care as a result of this. It was also noted that the nurse suspected the "activity played a major role in their reactions". The pt recovered on 12/06/2002, after 48 hours. The also reported on 9 other pts that were vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (lot #643251/0445M) and developed induration (WAES #0212USA01192, 0212USA01193, 0212USA00729, 0304USA00825, 0304USA02075, 0304USA02077, 0304USA02078, 0304USA02079 and 0304USA02081. No further info is expected.
Age: 27.0
Sex: M
Vaccine: PPV
Symptoms: Injection site induration, Pain
Clinical narrative: Info has been received from a licensed practical nurse concerning a 27 year-old male volunteer firefighter with no known allergies and no known medical conditions who on 12/02/2002 at 19:00 was vaccinated intramuscularly in the deltoid with a 1st dose of pneumococcal vaccine 23 polyvalent (lot number 643251/0445M). The dose was "given with a 25 guage, 1" needle". There was no concomitant medication. There was no illness at the time of vaccination and no symptoms following prior vaccinations with the pt or his siblings. It was noted that 2 hours after the vaccine was given, he spent 20 hours at a fire scene and was engaged at times in "heavy physical labor". On 12/03/2002 at 21:00 the pt developed pain and "induration from elbow to shoulder", but did not require medical care as a result of this. It was also noted that the nurse suspected the "activity played a major role in their reactions". The pt recovered on 12/06/2002 after 48 hours. The nurse also reported on 9 other pts that were vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (lot #643251/0445M) and developed induration (WAES #0212USA01192, 0212USA01193, 0212USA00729, 0212USA00825, 0304USA02075, 0304USA02076, 0304USA02078, 0304USA02079 and 0304USA02081. No further info is expected.
Age: 45.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site induration, Musculoskeletal stiffness, Pain
Clinical narrative: Info has been received from a licensed practical nurse concerning a 45 year old male volunteer firefighter with no known drug allergies and no known medical conditions who on 12/02/2002 at 19:00 was vaccinated intramuscularly in the deltoid with a 1st dose of pneumococcal vaccine 23 polyvalent (lot #643251/0445M). On 12/02/2002 at 19:00 concomitant therapy included an intramuscular dose in the "opposite deltoid" of influenza virus vaccine (FLUZONE) (Batch #U0925AA). There were no other concomitant medications. Both doses were "given with a 25 guage, 1" needle". There was no illness at the time of vaccination and no symptoms following prior vaccinations with the pt or his siblings. It was noted that 2 hours after the vaccine was given, he spent 20 hours at a fire scene and was engaged at times in "heavy physical labor". On 12/03/2002 at 21:00, the pt developed extremity stiffness, pain and "induration from elbow to shoulder". The duration was 24 hours and he did not require medical care as a result of this. It was also noted that the nurse had suspected the "activity played a major role in their reactions". The pt recovered on 12/05/2002. The nurse also reported on 9 other pts that were vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (643251/0445M) and developed induration (WAES #0212USA01192, 0212USA01193, 0212USA00729, 0212USA00825, 0304USA02075, 0304USA02076, 0304USA02077, 0304USA02079 and 0304USA02081. No further info is expected.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a LPN concerning a male firefighter who on 12/02/2002 at 19:00 was vaccinated IM in the deltoid with a first dose pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M).  On 12/02/2002 at 19:00 concomitant therapy included an IM dose in the "opposite deltoid" of influenza virus vaccine (FLUZONE) (Batch # U0925AA).  Both doses were "given with a 25 guage, 1 " needle".  It was noted that 2 hours after receiving the vaccine, he spent the next 20 hours at a fire scene and was engaged at times in "heavy physical labor".  It was noted that the patient was unable to be contacted for a complete interview and the patient's fire department captain reported the symptoms.  On 12/03/2002 at 21:00 the patient developed pain, redness, swelling at the injection site, "induration from elbow to shoulder" and did not require medical care as result of this.  It was also noted that the nurse had suspected the "activity played a major role in their reactions".  The nurse also reported on 9 other patients that were vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (LOT #: 643251/0445M) and developed induration (WAES #'s: 0212USA01192, 0212USA01193, 0212USA00729, 0212USA00825, 0304USA02075, 0304USA02076, 0304USA02077, 0304USA02078, 0304USA02081).  No further information is expected.
Age: 41.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a LPN concerning a 41 year old white male volunteer firefighter with no known allergies and no known medical conditions who on 12/02/2002 at 19:00 was vaccinated IM in the deltoid with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M).  On 12/02/2002 at 19:00 concomitant therapy included an IM dose in the "opposite deltoid" of influenza vaccine (FLUZONE) (Batch # U0925AA). Both doses were "given with a 25 guage 1" needle".  Other concomitant medications were propranolol HCl (INDERAL), doxepin HCl and alprazolam (XANAX).  There was no illness at the time of vaccination and no symptoms following prior vaccinations with the patient or his siblins.  It was noted that 2 hours after the vaccine was given, he spent 20 hours at a fire scene and was engaged at times in "heavy physical labor".  On 12/03/2002 at 21:00 the patient developed pain, redness, swelling, "induration from elbow to shouler" and did not require medical care as result of this.  It was also noted that the nurse had suspected the "activity played a major role in their reactions".  The patient recovered on 12/09/2002 after 1 week.  The nurse also reported on 9 other patients that were vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M) and developed induration (WAES #'s: 0212USA01192, 0212USA01193, 0212USA00729, 0212USA00825, 0304USA02075, 0304USA02076, 0304USA02077, 0304USA02078, 0304USA02079).  No further information is expected.
Age: 9.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Oedema, Pain
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 9 year old female patient who on 04/18/2003 was vaccinated in the left arm with a dose of pneumococcal vaccine 23 polyvalent (Lot # 645249/1196M).  By 04/19/2003 in the early AM, the patient had developed pain and swelling in the left arm and "could not bend arm".  Unspecified medical attention was sought, but no tx was given.  By 04/21/2003, the symptoms had resolved.  The reporter also mentioned three other patients that had adverse experiences post vaccination with pneumococcal vaccine 23 polyvalent (Lot # 645249/1196M) (WAES # 0304USA02519, 0304USA02520, 0304USA02521).  The reporter expressed a concern with the lot.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema
Clinical narrative: Information has been received from a 56 year old female consumer with scleroderma and "no allergic reactions" who on 04/11/2003 was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent.  Concomitant therapy included lisinopril (PRINIVIL), warfarin and pantoprazole sodium (PROTONIX).  Subsequently, the patient developed substantial swelling of her arm and the skin on the opposite side of her arm from the injection site became very red.  The reporter indicated that her first vaccination with pneumococcal vaccine 23 polyvalent was a number of years ago but the exact date was unknown.  The reporter contacted her physician regarding the date of vaccination, but the records were not able to be located.  It was also indicated that she had no adverse reaction the first time she was vaccinated.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 15 year old female patient who on 04/23/2003 was vaccinated in the arm with a dose of pneumococcal vaccine 23 polyvalent (Lot # 645249/1196M).  Within hours on 04/23/2003, the patient developed severe pain and swelling in the arm of the injection.  Unspecified medical attention was sought.  The reporter also mentioned three other patients that had adverse experiences post vaccination with pneumococcal vaccine 23 polyvalent (Lot # 645219/1196M) (WAES #'s: 0304USA02307, 0304USA02520, 0304USA02521).  The reporter expressed a concern with the lot.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: PPV
Symptoms: Oedema, Pain
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 16 year old female patient who on 04/23/2003 was vaccinated in the arm with a dose of pneumococcal vaccine 23 polyvalent (Lot # 645249/1196M).  Within hours on 04/23/2003, the patient developed severe pain and swelling in the arm of the injection.  Unspecified medical attention was sought.    The reporter also mentioned three other patients that had adverse experiences post vaccination with pneumococcal vaccine 23 polyvalent (Lot # 645249/1196M) (WAES # 0304USA02307, 0304USA02519, 0304USA02521).  The reporter expressed a concern with the lot.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Additional information has been requested.
Age: 2.8
Sex: M
Vaccine: PPV
Symptoms: Gait disturbance, Pain
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 33 month old male patient with sickle cell anemia who on 04/22/2003 was vaccinated in the thigh with a dose of pneumococcal vaccine 23 polyvalent (Lot # 645249/1196M).  Subsequently on approximately 04/22/2003, the patient developed pain in the same leg that was vaccinated.  The patient did not want the leg touched and he was not bearing any weight on that leg.  The pain was "not sickle hurt". Unspecified medical attention was sought, but no treatment was given.  The reporter also mentioned three other patients that had adverse experiences post vaccination with pneumococcal vaccine 23 polyvalent (Lot # 645249/1196M) (WAES # 0304USA02307, 0304USA02519, 0304USA02520).  The reporter expressed a concern with the lot.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Myalgia
Clinical narrative: Information has been received from a 63 year old female patient with no relevant medical history who on 04/29/2003 was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent.  The patient stated that "earlier in life", "could not provide year", she received a prior pneumococcal vaccine (manufacturer unknown) and had no reaction.  Concomitant medication included levothyroxine Na (SYNTHROID).  On 04/29/2003 the patient developed deep soreness in her arm muscle "immediately after receiving the vaccine".  The patient stated that "the pain continued all evening" and she could not lift her arm above her head.  It was noted that the pain was from her neck to her groin by the end of the night.  The patient also stated that the "pain seems to be gong away".  Unspecified medical attention was sought.  No product quality complaint was reported.  Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a health professional concerning a 69 year old female with diabetes, dyslipidaemia and hypertension NOS who on 11/20/2002 was revaccinated with pneumococcal vaccine 23 polyvalent (Lot # 640576-0923L).  On 11/21/2002 the patient experienced a severe site reaction which the physician called cellulitis.  The patient sought medical attention and was treated with cephalexin (KEFLEX).  The health professional also reported that the patient's sister received pneumococcal vaccine 23 polyvalent (WAES # 0211USA02297) and developed cellulitis.  Additonal information has been requested.  The health professional also reported that the patient's sister received pneumococcal vaccine 23 polyvalent (WAES # 0211USA02297) and developed cellulitis.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema
Clinical narrative: Information has been received from a RN concerning a 66 year old female who on 05/08/2003 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent.  On 05/08/2003 the patient developed a red, swollen left arm.  Unspecified medical attention was sought.  No product quality complaint was noted.  Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Information has been received from a certified medical assistant concerning a 59 year old male who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. The reporter indicated that the pt developed an erythematous site reaction and a fever after vaccination. The reporter also asked if this would be a "contraindication for a dose five years from now." Unspecified medical attention was sought. Additional info has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Influenza like illness, Injection site pain, Joint range of motion decreased, Oedema peripheral
Clinical narrative: Information has been received from a RN nurse concerning a 78 year old female physician  with hypertension, hypothyroidism, osteoporosis, spondylolisthesis, and a positive tuberculin purified protein derivative test and a history of vaginal bleeding who on 4/30/03 was in the office for a routine visut and was vaccinated in the left arm with the second dose of pneumococcal vaccine 23 polyvalent (643784/0676M), P1: in 1998. On 4/30/03, in the first 24 hrs following vaccination, the pt "felt like she had the flu." It was reported that the pt experienced pain at the injection site which lasted for 7 days. The arm was reported as being swollen, hot, and difficult to use. The reporter indicated that the reaction spread to the elbow and "this continued for 6-7 days." On 5/3/03, the third day after vaccination, the pt develped a "superimposed, blanching rash that looked like Scarlet fever but did not peel like Scarlet fever" in the area. It was also noted that on approximately 5/14/03, two weeks after vaccination, the pt was still experiencing pain with pressure. Unspecified medical attention was sought. No additional pt info was provided. There was no product quality complaint. Follow up information received from a registered nurse indicated that the injection on 4/30/03 was a painful injection. Within one hour, it became extremely painful, was deep red, swollen, and hot around 7/8th of the left arm. It was spreading almost to the elbow. For the first 24 hours after injection, the patient had flu-like symptoms. It was also reported that the patient had difficulty using her arm. On about the third day, approximately 5/2/03, there was a superimposed, blanching rash. Symptoms continued for 6-7 days. The pain remained for seven days. Two weeks after the injection, the patient still had pain with pressure and the skin was brawny. On about day 10 to 12, approximately 5/9/03 to 5/11/03, the patient was very pruritic. It was noted that the patient recovered on approximately 6/4/03. No further information is expected.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Information has been received from a RN nurse concerning a 78 year old female physician  with hypertension, hypothyroidism, osteoporosis, spondylolisthesis, and a positive tuberculin purified protein derivative test and a history of vaginal bleeding who on 4/30/03 was in the office for a routine visut and was vaccinated in the left arm with the second dose of pneumococcal vaccine 23 polyvalent (643784/0676M), P1: in 1998. On 4/30/03, in the first 24 hrs following vaccination, the pt "felt like she had the flu." It was reported that the pt experienced pain at the injection site which lasted for 7 days. The arm was reported as being swollen, hot, and difficult to use. The reporter indicated that the reaction spread to the elbow and "this continued for 6-7 days." On 5/3/03, the third day after vaccination, the pt develped a "superimposed, blanching rash that looked like Scarlet fever but did not peel like Scarlet fever" in the area. It was also noted that on approximately 5/14/03, two weeks after vaccination, the pt was still experiencing pain with pressure. Unspecified medical attention was sought. No additional pt info was provided. There was no product quality complaint. Follow up information received from a registered nurse indicated that the injection on 4/30/03 was a painful injection. Within one hour, it became extremely painful, was deep red, swollen, and hot around 7/8th of the left arm. It was spreading almost to the elbow. For the first 24 hours after injection, the patient had flu-like symptoms. It was also reported that the patient had difficulty using her arm. On about the third day, approximately 5/2/03, there was a superimposed, blanching rash. Symptoms continued for 6-7 days. The pain remained for seven days. Two weeks after the injection, the patient still had pain with pressure and the skin was brawny. On about day 10 to 12, approximately 5/9/03 to 5/11/03, the patient was very pruritic. It was noted that the patient recovered on approximately 6/4/03. No further information is expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Oedema, Urticaria
Clinical narrative: Information has been received from a woman in a medical office concerning a patient who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 643503/0541M).  Subsequently, within a day of administration, the patient developed a large hive at the injection site with a red, hot area from the injection site to the elbow and was "having symptoms" and swelling around the upper arm.  Medical attention was sought and the patient was treated with ice packs and OTC cortisone cream.  It was reported that the conditions resolved.  The reporter would like a lot number check.  On 05/08/2003 it was reported that no further information was available at this time. No product quality complaint was noted.  The records of testing prior to release of this lot have been checked by quality assurance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  It was also noted that two other patients were vaccinated with a dose of varicella virus vaccine live (Lot # 643503/0541M) and developed a large hive at the injection site with a red, hot area from the injection site to the elbow (WAES # 0305USA00925).  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with a "larger than recommended dose" of pneumococcal vaccine 23 polyvalent.  The reporter indicated that the patient "later developed Complex Regionalized Pain Syndrome".  No patient specific information was available.  Unspecified medical attention was sought.  The was no product quality complaint.  Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Information has been received from a MA concerning an 82 year old female with hypertension who on 04/22/2003 at 1:30PM was vaccinated IM with a second 0.5mL dose of pneumococcal vaccine 23 polyvalent (Lot # 644219/1079M - multidose vial).  Concomitant therapy included levothyroxine Na (SYNTHROID).  On 04/23/2003 at 12 noon the patient developed swelling, redness and induration from the injection site down to the elbow.  It was noted that the patient recovered.  No relevant diagnostic tests or laboratory data were reported.  There was no product quality complaint.  Unspecified medical attention was sought.  The reporter also indicated that two other patients were vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 644219/1079M) and developed swelling, redness, and induration from the injection site down to the elbow (WAES # 0305USA02389 & 0305USA02391).  No further information is expected.
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a physician concerning an 8 year old male child with no relevant medical history reported who on 05/16/2003 was vaccinated IM in the tricep muscle with a dose of pneumococcal vaccine 23 polyvalent.  There was no concomitant medication.  On 05/16/2003 the child developed a "very bad local reaction".  It was noted by the physician that he was holding his arm in a "sling-like" position.  The child was treated
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Information has been received from a medical assistant concerning a 78-year-old female with hypertension who on 04/10/2003 at 1:30pm was vaccinated in the left deltoid with a first 0.5mL dose of pneumococcal vaccine 23 polyvalent (Lot # 644219/1079M - multidose vial).  There was no illness at the time of vaccination.  There was no concomitant medication.  On 04/02/2003 at 08:00AM the patient developed a severe local reaction to the injection of the vaccine.  It was noted that the patient developed swelling, redness, and induration from the injection site to the elbow.  Unspecified medical attention was sought.  The reporter indicated that the patient recovered.  There were no adverse events following prior vaccinations of the patient or her siblings.  There was no product quality complaint.  The reporter also indicated that two other patients were vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 644219/1079M) and developed swelling, redness, and induration from the injection site down to the elbow (WAES # 0305USA01833 & WAES # 0305USA02391).  No further information is expected.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Information has been received from a registered nurse concerning an 81-year-old white female with hypertension and no known allergies who on 05/13/2003 at 10:30AM was vaccinated IM in the left deltoid with a second 0.5mL dose of pneumococcal vaccine 23 polyvalent (Lot # 644219/1079M - multidose vial).  There was no illness at the time of vaccination.  The patient received the first dose of pneumococcal vaccine 23 polyvalent in approximately 1995, also reported as 15 years ago, and had no reaction at that time.  On approximately 05/13/2003, 12 hours after immunization, the patient developed swelling, redness, and induration from the injection site down to the elbow.  The patient was treated with antibiotics and antihistamines.  It was reported that the patient is "better" and is recovering.  There was no product quality complaint.  Follow up information indicated that on 05/13/2003 at 18:00, within 12 hours of vaccination, the patient developed an erythematous, edematous rash in the affected arm.  The patient was prescribed antibiotics and antihistamines and was reported as "better".  It was noted that the patient recovered on 06/03/2003.  It was reported that the patient developed a rash after vaccination with one dose of tetanus vaccine 25 years ago.  The reporter also indicated that two other patients were vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 644219/1079M) and developed swelling, redness, and induration from the injection site down to the elbow (WAES # 0305USA01833 & WAES # 0305USA02389).  No further information is expected.
Age: 61.0
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a licensed practical nurse concerning a 61 year old patient who on 04/21/2003 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 644106/0819M).  On 04/22/2003, "about 24 hours later", the patient developed cellulitis.  Unspecified medical attention was sought.  It was noted that the patient was recovering.  There was no product quality complaint involved.  Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a LPN concerning a patient between the age of 60 and 65 years who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 640981/1050L).  Subsequently the patient developed "severe local reactions at the injection site."  Follow up information received stated that the patient's entire upper arm became red and swollen.  Unspecified medical attention was sought.  The patient was treated
Age: 60.0
Sex: U
Vaccine: PPV
Symptoms: Erythema, Oedema
Clinical narrative: Informatin has been received from a LPN concerning a patient between the age of 60 and 65 years who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 640981/1050L).  Subsequently the patient developed "severe local reactions at the injection site."  Follow up information received stated that the patient's entire upper arm became red and swollen.  Unspecified medical attention was sought.  The patient was treated with ice/diphenhydramine hydrochloride (BENADRYL).  The reporter noted that the patient recovered.  The reporter also mentioned 3 other patients between the ages of 60 and 65 years that had similar experiences following vaccination with a dose of pneumococcal vaccine 23 polyvalent (Lot # 640981/1050L) (WAES #'s: 0204USA02771, 0306USA02582, 0306USA02584).  Additional information is not expected.
Age: 60.0
Sex: U
Vaccine: PPV
Symptoms: Erythema, Oedema
Clinical narrative: Information has been received from a LPN concerning a patient between the age of 60 and 65 years who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 640981/1050L).  Subsequently, the patient developed "severe local reactions at the injection site."  Follow up information received stated that the patient's entire upper arm became red and swollen.  Unspecified medical attention was sought.  The patient was treated with ice/diphenhydramine hydrochloride (BENADRYL).  The reporter noted that the patient recovered.  The reporter also mentioned 3 other patients between the ages of 60 and 65 years that had similar experiences following vaccination with a dose of pneumococcal vaccine 23 polyvalent (Lot # 640981/1050L) (WAES # 0204USA02771, 0306USA02582, 0306USA02583).  Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a physician concerning a female patient who in approximately September 2002, was vaccinated with a dose of pneumococcal vaccine 23 polyvalent.  In approximately September 2002, the patient developed cellulitis at the injection site.  The patient was treated with antibiotics.  It was also reported that one male patient developed cellulitis at the injection site (WAES # 0212USA00380), one female patient developed cellulitis at the injection site in the left arm for two days (WAES # 0302USA00556), and one female patient developed cellulitis at the injection site (WAES # 0211USA02439).  The symptoms of two of the patients cleared up without event.  Two patients were seen over the weekend within "a day or two of injection" and at the time of this report follow up had not occurred.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema, Pain
Clinical narrative: Information has been received from a physician concerning an adult female patient who "within the last 2 months" in approximately October 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 643249/0358M).  Subsequently in approximately October 2002, the patient developed very sore arms, redness and swelling that went from her shoulders down her entire arm.  The patient sought unspecified medical attention and was treated with anti-inflammatory agents (unspecified).  Subsequently, all of the patient's symptoms resolved.  The physician indicated that in his "many, many years" of experience with vaccinations, he had never seen such "an inordinate amount of reports" of "severe reactions" to pneumococcal vaccine 23 polyvalent has he had recently.  He requested a lot check of Lot # 643249/0358M.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  The physician also mentioned that 2 other female patients (WAES # 0211USA00016, 0306USA02609) a male patient (WAES # 0211USA00320) had experiences following vaccination with pneumococcal vaccine 23 polyvalent (Lot # 643246/0358M).  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema, Pain
Clinical narrative: Information has been received from a physician concerning an adult female patient who "within the last 2 months" in approximately October 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 643249/0358M).  Subsequently in approximately October 2002, the patient developed very sore arms, redness and swelling that went from her shoulders down her entire arm.  The patient sought unspecified medical attention and was treated with anti-inflammatory agents (unspecified).  Subsequently, all of the patient's symptoms resolved.  The physician indicated that in his "many, many years" of experience with vaccinations, he had never seen such "an inordinate amount of reports" of "severe reactions" to pneumococcal vaccine 23 polyvalent as he had recently.  He requested a lot check of Lot # 643249/0358M.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  The physician also mentioned that 2 other female patients (WAES # 0211USA00016, 0306USA02608) a male patient (WAES # 0211USA00320) had experiences following vaccination with pneumococcal vaccine 23 polyvalent (Lot # 643249/0358M).  Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a RN concerning a adult male patient who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 641532/1353L).  Subsequently, the patient developed swelling, redness and soreness at the injection site.  It was reported that the patient sought medical attention.  The outcome of the patient's swelling, redness and soreness at the injection site was unknown.  The reporter expressed a concern regarding the lot.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  The reporter also mentioned a second male patient that had a similar experience following vaccination with pneumococcal vaccine 23 polyvalent (Lot # 641532/1353L) (WAES # 0211USA00052).  Additional information has been requested.
Age: 82.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a patient ("aged between 82-90 years") who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 641130/1161L).  In October 2002, the patient experienced swelling, pain and redness at the injection site.  Unspecified medical attention was sought.  A product quality complaint was not involved.  The physician also reported another patient that had similar reaction after being vaccinated with a dose of pneumococcal vaccine 23 polyvalent (WAES # 0210USA01570).  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received on 10/09/2002 from a medical supplier on behalf of 2 physicians concerning a female patient who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently the patient developed "severe redness in an area 2-3 inches around the injection site," and flu-like symptoms.  The patient sought unspecified medical attention.  It was reported that two other females had a similar reaction (WAES # 0210USA01012, 0306USA02723).  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received on 10/09/2002 from a medical supplier on behalf of 2 physicians concerning a female patient who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently the patient developed "severe redness in an area 2-3 inches around the injection site," and flu-like symptoms.  The patient sought unspecified medical attention.  It was reported that two other females had a similar reaction (WAES # 0210USA01012, 0306USA02722).  Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Oedema, Pain, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 59 year old retired white female with controlled mitral valve prolapse who on the morning of 12/11/2002 was vaccinated in the left deltoid with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 644104/0873M).  there was no illness at the time of vaccination.  Comcomitant medication included hormone replacement therapy.  On the evening of 12/11/2002 the patient developed a fever of 102F, nausea, had a left arm that was all swollen, "ached all over", and had to stay in bed 2 days.  It was reported that on 12/14/2002 the patient recovered.  It was noted that 4 other patients received a dose of pneumococcal vaccine 23 polyvalent (MSD) and, subsequently, experienced adverse events (WAES # 0301USA00947, 0301USA01143).  Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a MA concerning a male patient who on 12/05/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 644103/0710M).  On 12/07/2002 the patient developed cellulitis and was treated with injections of ceftriaxone sodium (Rocephin).  The reporter expressed a concern regarding the lot number.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Unspecified medical attention was sought.  It was also reported that another male patient was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 644103/0710M) and developed cellulitis (WAES # 0212USA00848).  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema
Clinical narrative: Information has been received from an NP concerning an adult female who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 641116/1160L).  Subsequently, the patient developed redness and swelling.  The patient was treated with warm compress, acetaminophen (TYLENOL) and diphenhydramine HCl (BENADRYL).  The nurse indicated that she would like a lot check performed on lot # 641116/1160L.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  It was also reported that four other adult females (WAES # 0210USA02724, 0210USA02963, 0210USA02964, 0303USA02211) and a male (WAES # 0303USA02104) had a similar experience.  No additional information is expected.