chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Tenderness
Clinical narrative: Information has been received form a registered nurse concerning a 71 year old white male who hypothyroidism and penicillin, sulfa and emycin allergies who on 18JUL2003 was vaccinated IM in the left deltoid with a second dose of pneumococcal vaccine 23 polyvalent. There was no concomitant medication or illness at the time of vaccination. On 19JUL2003 the pt developed a site reaction on his arm that was swollen, red, hot and tender to touch. There was no treatment required for the adverse event and no lab tests were performed. There was no product quality complaint involved. Unspecified medical attention was sought. Follow up information indicated that the pt was advised to take Benadryl and the pt recovered on 22JUL2003. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Injection site reaction, Swelling
Clinical narrative: Information has been received from a pharmacist concerning a "greater than 65 years" pt wit a medical history of "compromised" immunity who on 23JUL2003 was vaccinated wit a second dose of pneumococcal vaccine 23 polyvalent. It was also noted that the pt's immunity was compromised and the "the revaccination was needed. On 23JUL2003, the pt developed injection site rxn; with redness and swelling of the entire arm". the pt was seen in the ER and released. Unspecified medical attention was sought. There was no product quality complaint involved. No further pt information was available at the time of this report. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Depressed level of consciousness, Malaise
Clinical narrative: Information has been received form a licensed practical nurse concerning a "very healthy" 67 year old female pt with no known allergies and no significant past medical hx who on 07JUL203 was vaccinated with dose of pneumococcal vaccine 23 polyvalent. There was no concomitant medication. Subsequently in July 2003, the pt developed weakness, malaise and decreased alertness. Unspecified medical attention was sought, but no treatment was required. As of 29JUL2003, the weakness, malaise and decreased alertness had not abated. A product quality complaint was not involved. The reporter noted that the pt's husband also had similar experience following vaccination with dose of pneumococcal vaccine 23 polyvalent.. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Depressed level of consciousness, Malaise
Clinical narrative: Information has been received form a licensed practical nurse concerning a "very healthy" 67 year old male pt with no known allergies and no significant past medical hx who on 07JUL203 was vaccinated with dose of pneumococcal vaccine 23 polyvalent. There was no concomitant medication. Subsequently in July 2003, the pt developed weakness, malaise and decreased alertness. Unspecified medical attention was sought, but no treatment was required. As of 29JUL2003, the weakness, malaise and decreased alertness had not abated. A product quality complaint was not involved. The reporter noted that the pt's wife also had similar experience following vaccination with dose of pneumococcal vaccine 23 polyvalent.. Additional information has been requested.
Age: 69.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Malaise, Swelling, Tenderness
Clinical narrative: Information has been received from a wholesaler calling on behalf of physician concerning three patients who were each vaccinated SC with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the patients developed inflammation around the injection site that included redness and soreness. Unspecified medical attention was sought. A product quality complaint was not involved. Follow up information was received from an MD concerning the three pt(s), which included a 69 year old patient, who between 01JUN2003 and 04JUN2003 were each vaccinated SC with a a dose of pneumococcal vaccine 23 polyvalent. Subsequently in approximately June 2003, all three pts developed local swelling, malaise and were not feeling well, "i.e. local reaction". Within three to five days, all three pts had recovered with no residual problems. The reporter noted, "we had 2 more bottles of the same batch, will return". The records of testing prior to release of this lot have been checked by QA and found be to satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The other two patients included a 68 year old patient and an 89 year old patient. Additional information has been requested.
Age: 89.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Malaise, Swelling, Tenderness
Clinical narrative: Information has been received from a wholesaler calling on behalf of physician concerning three patients who were each vaccinated SC with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the patients developed inflammation around the injection site that included redness and soreness. Unspecified medical attention was sought. A product quality complaint was not involved. Follow up information was received from an MD concerning the three pt(s), which included a 89 year old patient, who between 01JUN2003 and 04JUN2003 were each vaccinated SC with a a dose of pneumococcal vaccine 23 polyvalent. Subsequently in approximately June 2003, all three pts developed local swelling, malaise and were not feeling well, "i.e. local reaction". Within three to five days, all three pts had recovered with no residual problems. The reporter noted, "we had 2 more bottles of the same batch, will return". The records of testing prior to release of this lot have been checked by QA and found be to satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The other two patients included a 68 year old patient and an 69 year old patient. Additional information has been requested..
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Injection site erythema, Injection site inflammation, Nausea
Clinical narrative: Information has been received form a physician and a nurse concerning a 39 year old female with an allergy to penicillin who on 25JUL2003 was vaccinated in the left deltoid with a first dose of pneumococcal vaccine 23 polyvalent.  On 26JUL2003, 24 hours past vaccination, the pt experienced injection site redness and swelling, fever and nausea. The pt was seen in a walk in clinic on 26JUL2003, and was prescribed the abx "Levoquin" for 5 days. Subsequently, the pt recovered. A product quality complaint was not involved. Additional information was received from the physician which indicated that on the evening of 25JUL2003 the pt's arm was sore. On 26JUL2003 the arm was red and inflamed. The pt had a fever of 100.7 and had complaints of nausea and fatigue. On 27JUL2003 the arm was still sore, red and inflamed. It was noted that the patient stated that she felt better. No further information is expected.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Swelling, Tenderness
Clinical narrative: Information has been received form a physician and a nurse concerning a 39 year old female with an allergy to penicillin who on 25JUL2003 was vaccinated in the left deltoid with a first dose of pneumococcal vaccine 23 polyvalent.  On 26JUL2003, 24 hours past vaccination, the pt experienced injection site redness and swelling, fever and nausea. The pt was seen in a walk in clinic on 26JUL2003, and was prescribed the abx "Levoquin" for 5 days. Subsequently, the pt recovered. A product quality complaint was not involved. Additional information was received from the physician which indicated that on the evening of 25JUL2003 the pt's arm was sore. On 26JUL2003 the arm was red and inflamed. The pt had a fever of 100.7 and had complaints of nausea and fatigue. On 27JUL2003 the arm was still sore, red and inflamed. It was noted that the patient stated that she felt better. No further information is expected.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 68 year old male with chronic obstructive pulmonary disease currently requiring hospitalization who on 7/24/03 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. On 7/26/03, two days after the vaccination, the patient was found to also have developed a low grade fever. On 8/7/03, it was reported that the fever had been somewhat responsive to acetaminophen, but had also continued to the present. No other information was available. No product quality complaint was involved. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Hypersensitivity, Urticaria
Clinical narrative: Information has been received from an LPN concerning a 54 year old white female with allergies to penicillin , dibromopropamidine isethionate + promethazine, doxycline calcium, sulfa, iodine and IV contrast who on 14JUL2003 at 3:00 pm was vaccinated SC in the left upper arm with a first dose of pneumococcal vaccine 23 polyvalent. At the time of vaccination, the pt had "bronchospastic dis." The pt called back the next day on 15JUL2003 and reported (also reported as "within 24 hours of vaccination) a large red area on the left upper arm that was warm to touch with no blister (previously reported as urticaria). The pt was seen over about a three week pd. None of the reactions were severe but appeared to be a type three allergic reaction. Unspecified medical attention was sought and no treatment was required. There was no product quality complaint involved. The physician also mentioned two other patient who had a similar experience following exposure to pneumococcal vaccine 23 polyvalent. Follow up information indicated that the pt recovered.
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Somnolence
Clinical narrative: Information has been received from a consumer who is the grandmother of a female who in approximately July 2003, "about a month ago", was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the pt developed "fatigue and drowsiness" since she was given the vaccine. It was noted that medical attention was not sought. It was also noted that the "caller would not provide any further information about herself or about her granddaughter". There was no product quality complaint involved.
Age: 75.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a registered pharmacist concerning a 75 year old male family member who in October 2002, was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. On the same day the pt was also vaccinated with a dose of influenza virus vaccine. Shortly after the injection, the pt complained of injection site sensitivity and says that the site is still sensitive. No medical attention was sought and no treatment was required. No diagnostic studies were performed. On 13AUG2003 it was reported that the pt had not recovered. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a consumer concerning a female who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent and "experienced an adverse reaction" also described as "experienced side effects". It was unknown if medical attention was sought. There was no product quality complaint involved. No additional information was provided. No further information is expected.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Erythema, Feeling hot, Hypersensitivity, Injection site vesicles
Clinical narrative: Information has been received from a licensed practical nurse concerning an 84 year old white retired female with no known drug allergies who on 06AUG2003 at 10:45 AM was vaccinated with SC in the upper left arm with a first dose of pneumococcal vaccine 23 polyvalent. At the time of vaccination , the pt had black stools and was experiencing fatigue. Within 24 hours of vaccination, the pt developed urticaria. The pt also developed vesicles around the injection site. The pt was seen over about a three week pd. The rxn was not severe but appeared to be a type three allergic reaction. Unspecified medical attention was sought and no treatment was required. There was no product quality complaint involved. Follow up information indicated that the pt recovered with a steroid injection. Additional follow up information indicated that on 06AUG2003, the pt developed a large red swollen area on her left upper arm that was warm to touch and had water blisters. She presented to the office on 07AUG2003. The reporter indicated that the pt recovered. The physician also reported that two other patients had similar experiences following exposure to pneumococcal vaccine 23 polyvalent.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Swelling, Urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning an 84 year old white retired female with no known drug allergies who on 06AUG2003 at 10:45 AM was vaccinated with SC in the upper left arm with a first dose of pneumococcal vaccine 23 polyvalent. At the time of vaccination , the pt had black stools and was experiencing fatigue. Within 24 hours of vaccination, the pt developed urticaria. The pt also developed vesicles around the injection site. The pt was seen over about a three week pd. The rxn was not severe but appeared to be a type three allergic reaction. Unspecified medical attention was sought and no treatment was required. There was no product quality complaint involved. Follow up information indicated that the pt recovered with a steroid injection. Additional follow up information indicated that on 06AUG2003, the pt developed a large red swollen area on her left upper arm that was warm to touch and had water blisters. She presented to the office on 07AUG2003. The reporter indicated that the pt recovered. The physician also reported that two other patients had similar experiences following exposure to pneumococcal vaccine 23 polyvalent.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Information has been received form a nurse concerning a pt who on 21AUG2003 was vaccinated IM with a dose of pneumococcal vaccine 23 polyvalent. On 22AUG2003 the pt notified the physician's office to report that she had developed redness and itching at the site. Unspecified medical attention was sought and it was unknown if a prescription drug was required. No product quality complaint was involved. It was also reported that another pt was vaccinated with a dose of pneumococcal vaccine 23 polyvalent and developed a fever, itching and redness at the injection site. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: Injection site warmth, Nausea, Pyrexia, Tenderness, Vomiting
Clinical narrative: Information has been received from a physician concerning an 8 year old white male with a hx of a rash due to BACTRIM who on 29MAY2003 was vaccinated IM in the LA with the first dose 0.5ml of pneumococcal vaccine 23 polyvalent. There was no illness at the time of vaccination. At 16:30 on 30MAY2003, within 48 hours of being vaccinated, the pt developed a temperature of 105 degrees and a very large, warm, tender reaction locally at the site. The pt also had nausea and had vomited at least once. Upon examination, there was no indication of respiratory infection or other cause for the patient's elevated temperature. The physician also reported that the pt had low pneumococcal titer levels. The pt was treated with Tylenol 500 mg q 6 hours, ibuprofen 200 mg q6 and short course of prednisone 20 mg twice daily for 48 hours. It was noted that the pt had an uneventful course. Subsequently, the pt recovered from his events. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Pruritus, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a pt who on 22AUG2003 was vaccinated IM with a dose of pneumococcal vaccine 23 polyvalent. On 22AUG2003 the pt developed a fever of 102F, and itching and redness at the site of the injection. Unspecified medical attention was sought and it was unknown if a prescription drug was required. No product quality complaint was involved. It was also reported that another pt was vaccinated wit a dose of pneumococcal vaccine 23 polyvalent and developed itching and redness at the injection site. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Hypersensitivity, Pain
Clinical narrative: Information has been received from a CMA concerning a male pt with no allergies and no past medical history who on 08/25/03 was vaccinated SC with a 0.5mL dose of pneumococcal vaccine 23 polyvalent (Lot # 644220/1119M). There was no concomitant medication. Subsequently on approximately 08/25/03, the pt developed pain and had an "allergic reaction". The pt went to the ER where he was treated with antibiotics. No lab tests were performed. Subsequently, the pt fully recovered. A product quality complaint was not involved. The reporter also mentioned a second pt that had a similar reaction post vaccination with a dose of pneumococcal vaccine 23 polyvalent (Lot # 644220/1119M)(WAES #0309USA00031). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a CMA concerning a female pt with no allergies and no past medical history who on 08/14/03, was vaccinated SC with a 0.5mL dose of pneumococcal vaccine 23 polyvalent (Lot # 644220/1119M). There was no concomitant medication. Subsequently, in August 2003, the pt developed slight pain. Later in August 2003, the pt had an "allergic reaction" and went to the ER. On 08/26/03, the pt developed site pain, redness around the site and felt like the area was a bruise. On 08/26/03, the pt returned to the medical office, but she did not require any medical attention. No lab tests were performed. Subsequently, the pt fully recovered. A product quality complaint was not involved. The reporter also mentioned a second pt that had a similar reaction post vaccination with a dose of pneumococcal vaccine 23 polyvalent (Lot # 644220/1119M)(WAES # 0308USA02694).  Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site vesicles, Injection site warmth
Clinical narrative: Information has been received from a RN concerning a 36 year old white male food service worker with allergies to egg, protein, milk, latex-based paint and "other environmental allergies of different sorts" (the pt denied any medication allergies) who on 08/27/03 in the AM was vaccinated ID (also reported as SC) in the left arm with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 644107/0955M). The pt had presented for Mantoux skin test that was required for his pre-employment work-up, but was accidentally given pneumococcal vaccine 23 polyvalent ID by mistake. Subsequently, the pt developed a site reaction in the left arm that included a red, swollen and warm injection site. On 08/29/03, the pt was referred to the department of health for a "positive Mantoux skin test" and was seen by the reporting nurse. The pt's left forearm was very edematous, firm, red, tender to touch, with vesiculation at the injection site. The arm were the injection was given was also described as having a hot, red and warm area from the wrist to the elbow. The onset date was noted to be 08/28/03 in the PM. The reporter noted that the pt had a "dramatic reaction" to pneumococcal vaccine 23 polyvalent, not a positive Mantoux or reaction to tuberculin was originally thought. The pt went to the ER for treatment and an antibiotic was given. Within one week, the pt recovered. A product quality complaint was not involved. Additional information is not expected.
Age: 36.0
Sex: M
Vaccine: PPV
Symptoms: Injury
Clinical narrative: Information has been received from a RN concerning a 36 year old white male food service worker with allergies to egg, protein, milk, latex-based paint and "other environmental allergies of different sorts" (the pt denied any medication allergies) who on 08/27/03 in the AM was vaccinated ID (also reported as SC) in the left arm with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 644107/0955M). The pt had presented for Mantoux skin test that was required for his pre-employment work-up, but was accidentally given pneumococcal vaccine 23 polyvalent ID by mistake. Subsequently, the pt developed a site reaction in the left arm that included a red, swollen and warm injection site. On 08/29/03, the pt was referred to the department of health for a "positive Mantoux skin test" and was seen by the reporting nurse. The pt's left forearm was very edematous, firm, red, tender to touch, with vesiculation at the injection site. The arm were the injection was given was also described as having a hot, red and warm area from the wrist to the elbow. The onset date was noted to be 08/28/03 in the PM. The reporter noted that the pt had a "dramatic reaction" to pneumococcal vaccine 23 polyvalent, not a positive Mantoux or reaction to tuberculin was originally thought. The pt went to the ER for treatment and an antibiotic was given. Within one week, the pt recovered. A product quality complaint was not involved. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacist and RN concerning a 65 year old retired white female with no known drug allergies and degenerative joint disease of the back who in August 2003, was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 6456247/1171M). It was reported that on 08/28/03, the pt complained of redness at the injection site. Unspecified medical attention was sought. Subsequently, the pt recovered. The pharmacist also reported that another pt developed shortness of breath, a flushed face, arm swelling, warmness and cellulitis after being vaccinated with a dose of pneumococcal vaccine 23 polyvalent from Lot # 645247/1171M (WAES # 0309USA00493).  Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Dyspnoea, Flushing, Injection site warmth, Oedema
Clinical narrative: Information has been received from a pharmacist and a RN concerning a retired 59 year old white female with increased cholesterol, reflux and chronic bronchitis who in August 2003, was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 645247/1171M). Illness at the time of vaccination included sinusitis. It was reported that on 09/01/03 the pt developed facial flushing, arm swelling, cellulitis, shortness of breath and was warm to the touch. The pt was seen in the ER and subsequently recovered from her events. The pharmacist also reported that another pt developed redness at the injection site after being vaccinated with a dose of pneumococcal vaccine 23 polyvalent from Lot # 645247/1171M (WAES # 0309USA00432).  Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a consumer, a 67 year old white female secretary with hypertension, arthritis, vertigo, osteoporosis (Dexa Scan Feb 2003-reported as doing better), and diverticular disease who on the morning of 09/03/03 at 10:00 was vaccinated with a first 0.5mL dose of pneumococcal vaccine 23 polyvalent. There was no illness at the time of vaccination. Concomitant therapy included rofecoxib (dose and indication not reported), lisinopril-HCTZ (dose and indication not reported) and Actonel. The consumer reported that by that afternoon, on 9/03/03 she had noticed a bruise about two inches below the injection site. On the evening of 09/03/03 she noticed "it had become painful". It was noted that on the following day (09/04/04) she noticed pain and tenderness throughout her bicep. On the evening of 09/04/03 she noticed that "it was red, raised and hot to touch". The reporter indicated that "today" (09/05/03) the pain has lessened and that it looked as though the swelling had moved to the back of her arm just above the elbow. The pt indicated she spoke with her physician and he gave her prednisone. Treatment was required for the adverse event, and it was indicated that the adverse event abated. The pt's outcome is not recovered. There was no product quality complaint involved. Follow up information received from a health care provider indicated that the adverse event onset was 09/03/03 at 12:30PM. On 09/03/03, the pt was in for a routine check. She was generally feeling fine, and "her knee is better after 3 Syndisc" injections". At the visit, the pt indicated that she would be traveling and wanted prophylaxis. At that time the pt's pneumococcal vaccine 23 polyvalent was up do date and she was given ciprofloxacine hydrochloride (Cipro) for travel precautions. On 09/05/03 it was noted that the pt had an allergic reaction to the pneumococcal vaccine 23 polyvalent approximately 2 hours after injection in the right arm. The pt developed warmth, swelling, and mild discomfort in her biceps. The pt was also mildly pruritic. The area was approximately 15x7cm raised erythematous non-vesicular area in the medial portion of the upper arm. The physician indicated that this is an allergy to pneumococcal vaccine 23 polyvalent. This improved over a couple of days. The pt was prescribed prednisone taper 30mg for 3 days and to cut off after 9 days. The pt was instructed to follow up with any problems. Additional follow up information indicated that the pt recovered on 09/20/03.  No further information is expected.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a consumer, a 67 year old white female secretary with hypertension, arthritis, vertigo, osteoporosis (Dexa Scan Feb 2003-reported as doing better), and diverticular disease who on the morning of 09/03/03 at 10:00 was vaccinated with a first 0.5mL dose of pneumococcal vaccine 23 polyvalent. There was no illness at the time of vaccination. Concomitant therapy included rofecoxib (dose and indication not reported), lisinopril-HCTZ (dose and indication not reported) and Actonel. The consumer reported that by that afternoon, on 9/03/03 she had noticed a bruise about two inches below the injection site. On the evening of 09/03/03 she noticed "it had become painful". It was noted that on the following day (09/04/04) she noticed pain and tenderness throughout her bicep. On the evening of 09/04/03 she noticed that "it was red, raised and hot to touch". The reporter indicated that "today" (09/05/03) the pain has lessened and that it looked as though the swelling had moved to the back of her arm just above the elbow. The pt indicated she spoke with her physician and he gave her prednisone. Treatment was required for the adverse event, and it was indicated that the adverse event abated. The pt's outcome is not recovered. There was no product quality complaint involved. Follow up information received from a health care provider indicated that the adverse event onset was 09/03/03 at 12:30PM. On 09/03/03, the pt was in for a routine check. She was generally feeling fine, and "her knee is better after 3 Syndisc" injections". At the visit, the pt indicated that she would be traveling and wanted prophylaxis. At that time the pt's pneumococcal vaccine 23 polyvalent was up do date and she was given ciprofloxacine hydrochloride (Cipro) for travel precautions. On 09/05/03 it was noted that the pt had an allergic reaction to the pneumococcal vaccine 23 polyvalent approximately 2 hours after injection in the right arm. The pt developed warmth, swelling, and mild discomfort in her biceps. The pt was also mildly pruritic. The area was approximately 15x7cm raised erythematous non-vesicular area in the medial portion of the upper arm. The physician indicated that this is an allergy to pneumococcal vaccine 23 polyvalent. This improved over a couple of days. The pt was prescribed prednisone taper 30mg for 3 days and to cut off after 9 days. The pt was instructed to follow up with any problems. Additional follow up information indicated that the pt recovered on 09/20/03.  No further information is expected.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Information has been received from a LPN concerning a 56 year old Caucasian female with neuropathy, leukopenia, osteoporosis, urinary incontinence, atrial fibrillation and allergies to Evista, Betadine, NSAIDS, Prevacid, Paxil, Celexa, Biaxen and adhesives. On 08/25/03 at 9:45 AM the pt was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (Lot # 643784/0676M) in the left deltoid. Concomitant therapy included alendronate sodium. On 08/26/03 the pt developed lymph node swelling and tenderness with a low grade fever. The pt also developed injection site warmth and erythema. Subsequently, the pt recovered on 08/28/03.  It was also reported that the pt was seen by a physician in 10/03 and no symptoms were noted. It was noted that the pt did not experience any adverse events following prior vaccinations. There was no product quality complaint involved. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a pt who about 2 weeks ago, in 08/03, was vaccinated IM from a multidose vial with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine. Subsequently the pt developed localized swelling around the injection site which was described as painful, ring-like cellulitis and a fever of 102 deg F. Subsequently after a week, the pt had a complete recovery and was in "good" condition. Medical attention was sought and the pt was placed on an antibiotic (unspecified) for the cellulitis. No further information was provided. No product quality complaint was involved. It was also reported that 5 other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and also developed cellulitis (WAES # 0309USA01722 through 0309USA01724, 0311USA002365 & 0311USA02366).  It was also noted that of the 6 total pt's 5 received a booster dose and one had the first vaccination with the pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Febrile convulsion, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a pt who about 2 weeks ago, in 08/03 was vaccinated IM from a multidose vial with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the pt developed localized swelling around the injection site which was described as painful, ring-like cellulitis and a fever of 102 degrees F. Subsequently after a week, the pt had a complete recovery and was in "good" condition. Medical attention was sought and the pt was placed on an antibiotic (unspecified) for the cellulitis. No further information was provided. No product quality complaint was involved. It was also reported that 5 other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and also developed cellulitis (WAES # 0309USA01513, 0309USA01723, 0209USA01724, 0311USA02365 & 0311USA02366). It was also noted that of the 6 total pt's 5 received a booster dose and one had the first vaccination with the pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a pt who "this week", in September 2003 was vaccinated IM from a multidose vial with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the pt developed localized swelling around the injection site which was described as painful, ring-like cellulitis and a fever of 102 degrees F. Subsequently after a week, the pt had a complete recovery and was in "good" condition. Medical attention was sought and the pt was placed on an antibiotic (unspecified) for the cellulitis. No further information was provided. No product quality complaint was involved. It was also reported that 5 other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and also developed cellulitis (WAES # 0309USA01513, 0309USA01722, 0209USA01724, 0311USA02365 & 0311USA02366). It was also noted that of the 6 total pt's 5 received a booster dose and one had the first vaccination with the pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a pt who "this week", in 08/03 was vaccinated IM from a multidose vial with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the pt developed localized swelling around the injection site which was described as painful, ring-like cellulitis and a fever of 102 degrees F. Subsequently after a week, the pt had a complete recovery and was in "good" condition. Medical attention was sought and the pt was placed on an antibiotic (unspecified) for the cellulitis. No further information was provided. No product quality complaint was involved. It was also reported that 5 other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and also developed cellulitis (WAES # 0309USA01513, 0309USA01722, 0209USA01723, 0311USA02365 & 0311USA02366). It was also noted that of the 6 total pt's 5 received a booster dose and one had the first vaccination with the pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injury
Clinical narrative: Information has been received from a RN concerning a 73 year old retired white female with no medical history who on 06/17/03 at 8:30 was vaccinated IM in the left deltoid with the second dose of pneumococcal 23v polysaccharide vaccine (Lot # 641804/0035M). Concomitant vaccinations on that same day and time included and ID dose in the left forearm of tuberculin purified protein derivative (PPD Tine Test) (Lot # 0042). Other concomitant therapy included, verapamil, hydrochlorothiazide (manufacturer unknown), omeprazole (Prilosec), alendronate sodium, thyroid (armour thyroid tablets), multivitamins (unspecified) and cetirizine HC1 (Zyrtec). There was no illness at the time of vaccination. The RN reported that on 09/17/03, the pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine that had expired on 08/16/03.  The RN also reported that on 09/18/03, the pt developed soreness at the injection site. Unspecified medical attention was sought and no lab/diagnostic tests were performed. On 09/19/03, the pt recovered from the injection site soreness.  Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a RN concerning a 65 year old white female pt with no relevant medical history who on 09/17/03 at 16:30 was vaccinated IM in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 645246/0029N). There was no illness at the time of vaccination. On 09/17/03, at 17:30, "several hours later", the pt developed swelling with an increased "circumference >1", redness, and pain at the injection site, described as it hurt to wear clothing and the pain extended from her shoulder to elbow. There were no relevant diagnostic studies performed. The pt took ibuprofen (therapy unspecified)(previously reported as no treatment was required). There was "no MD eval.". "The symptoms lasted for 2 days before the beginning to resolve, the duration was 7 days and the pt recovered on 09/23/03. There was no product quality complaint involved. No other information was provided. No further information is expected.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cold sweat, Heart rate increased
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old female who on 09/15/03 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (manufacturer unknown). The pharmacist reported that on 09/15/03, after being vaccinated, the pt felt "clammy" and developed an increased heart rate. Unspecified medical attention was sought. At the time of this report, the outcome was unknown.  Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Information from a physician concerning a 71 year old male pt with a history of immunization with a first dose of pneumococcal 23v polysaccharide vaccine in 1997 who on 08Sep03 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. On09Sept03 the pt was seen in the office with a very red, warm and swollen (about 20cm in diameter site) arm. There was no therapy prescribed and the swelling went away in a day or two. The pt was seen again in the office for follow up. It was noted that the pt had no systemic symptoms. The reporter requested analysis of the vial or retention stock. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The reporter also indicated a similar experience with another pt. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Hypoaesthesia, Injection site erythema, Pain
Clinical narrative: Information has been received from a registered pharmacist and a woman from a physician's office concerning a 64 year old female who on 16Sep03 was vaccinated IM in the left deltoid with a first 0.5ml dose of pneumococcal 23v polysaccharide vaccine. On 18Sep03 at 1517, shortly after vaccination, the pt complained of his left upper arm as pink and warm to the touch. It was also reported that the pt had redness throughout the vaccinated arm which was also painful to the touch. The pt also had numbness down to the fingers. The reaction began to subside in an hour. Unspecified medical attention was sought and the pt was informed to use ice to the upper extremity and diphenhydramine (Benadryl) prn. It was reported that the pt agreed to this. No prescription drug was required. Subsequently, the pt recovered. The date of recovery was unknown because the pt never called back the physician's office. No product quality complaint was involved. It was also reported that another pt was vaccinated IM with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine and developed redness, pain, numbness and an elevated temperature. No further information is expected.
Age: 72.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 72 year old male patient with no known allergies with a history of immunization with a first dose of pneumococcal 23v polysaccharide vaccine in 1997 in which there was no reaction who on 9/16/03 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot # 645853/0256N). Concomitant therapy on 9/16/03, included influenza virus split virion 3v vaccine inactivated. Concomitant medication included levothyroxine sodium and enalapril. On 9/17/03 the patient telephoned the practice reporting that he had a swollen arm at the site of the injections, fever and chills. There was no therapy recommended. The physician spoke with the patient on the morning of 9/19/03, and the patient indicated that he is better, but not completely resolved. The reporter requested analysis of the vial or retention stock. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. The reporter indicated a similar experience with another patient. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypoaesthesia, Pain, Pyrexia
Clinical narrative: Information has been received from a pharmacist and a physician concerning a 66 year old female who on 9/17/03 at 1030 (previously reported as 9/22/03) was vaccinated IM in the left deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot # 646320/0531N). Shortly after the vaccination, the patient developed an elevated temperature, and redness throughout the vaccinated arm which was painful to the touch. The patient also had numbness down to the fingers. The reaction began to subside in an hour. Subsequently, the patient was seen by a physician who gave her rofecoxib and told her to apply moist heat. On 9/22/03 a follow up visit was scheduled where it was noted that the patient had recovered. No product quality complaint was involved. It was also reported that another patient was vaccinated IM with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot # 646320/0531N) and developed redness, pain and numbness. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pyrexia, Swelling
Clinical narrative: Information has been received from a registered nurse concerning an adult female patient with history not known who was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine 0.5ml (lot # 645255/1212M). It was noted that the patient called the office on 9/24/03 to schedule an appointment because she had a fever and her left arm was red, swollen, and hard. It was noted that everyone in the office was very concerned, the reporter expressed concern about the particular lot of vaccine and she commented that she has never seen a reaction like this in 31 years. The reporter also mentioned another patient who experienced a similar reaction with pneumococcal 23v polysaccharide vaccine (lot # 643249/0358M) and was hospitalized. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a registered nurse concerning an approximately 74 year old female patient who in 1994 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The patient reported to the nurse, "When I got the pneumonia shot, it made me sick." Unspecified medical attention was sought, but prescription drug treatment was not required. Subsequently, the patient recovered. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered nurse concerning a female patient with an allergy to sulfur medications who in 2002 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. Subsequently, in 2002, last year of vaccination, the patient developed a minor flare up of cellulitis. It was reported that the office was right on top of the reaction and it turned out fine. It was also reported that they thought it was interesting that this patient had an allergy to sulfur and wondered if this may have had anything to do with the reactions. It was also reported that 2 other patients were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed cellulitis. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Joint range of motion decreased, Smear cervix abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning a 43 year old female clerk (same place of employment as the reporter) with seasonal allergies, an allergy to sulfa and a history of anemia, type II diabetes mellitus, hyperlipidemia, hypertension, a recent abnormal PAP test, no adverse events following prior vaccinations and no illness at the time of vaccination who on 9/30/03 at 11:00 in an outpatient clinic was vaccinated IM in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot # 646320/0531N). Concomitant vaccination on 6/30/03 at 11:00 included an IM dose in the right deltoid of influenza virus split virion 3v vaccine inactivated with no adverse reaction. The patient had more than 20 previous doses of influenza virus split virion 3v vaccine inactivated with no problems. Concomitant medication included simvastatin, enalapril maleate, glyburide, and loratadine. On 6/30/03 at 11:00, immediately post vaccination, the patient experienced an injection site reaction. The area became swollen as the vaccine was being instilled. The area became huge, the size of a baseball and hard. The area was localized to the deltoid. There was progressive pain, swelling and decreased range of motion in the left shoulder/arm. Ice was applied and diphenhydramine hydrochloride 25mg was given. On 10/1/03, the patient was seen with increased swelling, pain in the arm and a limited range of motion. The patient had continued to use ice on the area. No further treatment was given by the reporting nurse practitioner and the patient planned to see the physician in the clinic later that day. The patient was treated by a medical doctor with amoxicillin (+) clavulanate potassium, an NSAID and acetaminophen (+) codeine phosphate. On approximately 10/14/03 the patient recovered from the pain, swelling, and decreased range of motion. The duration was noted to be approximately 2 weeks. A product quality complaint was not involved. The reporter also mentioned a second patient that had an experience post vaccination with pneumococcal 23v polysaccharide vaccine. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 643251/0445M). The patient had a sore arm that developed into an entire flu-like condition, that cleared up on the following day. The patient was treated with ibuprofen for pain relief and ice packs. It was noted that the patient recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information on 11/19/03 from the reporter indicated that two of the patient's may have had the vaccine a while ago and that she was not aware if any of the patients had any previous reactions to any other vaccines. The reporter expressed concern about the particular lot of vaccine. It was noted that several patients developed severe local reactions, from what appears to be the same lot and what appeared odd to the doctor was a man and his wife received pneumococcal 23v polysaccharide vaccine from two different lots and the male that had the different lot than the one mentioned had no adverse reaction but his wife complained of arm pain and tenderness. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. The reporter mentioned two other patients who developed a similar reaction after vaccination with pneumococcal 23v polysaccharide vaccine. No further information is expected.