chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Information has been received from a physician concerning a female over the age of 65 who on Sept 20 2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 649692/0371P). ON Sept 20 2004 the patient developed in injection site reaction. The reaction was described as red swollen arm from elbow to shoulder and a hot feverish arm. The patient also experienced body aches and chills. The patients events persisted. No treatment was given for the reaction. It was reported that this was the patients second pneumococcal 23v polysaccharide vaccine. The patients first vaccination has been at least 5 years previously and there had been no reaction to that vaccination. The physician reported that since this is the fifth reaction the practice has had in the past few months he would like an investigation in the the lot 0371P. The physician also reported that another patient had the same reaction after vaccination with pneumococcal 23v polysaccharide vaccine (lot 649692/0371P) (WAES0409USA01988). The physician also reported that 3 other patients had reactions after vaccination with pneumococcal 23v polysaccharide vaccine (lot 648139/0009P) (WAES0409USA00219, WAES0409USA00780). 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 was released. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site reaction, Oedema, Pain
Clinical narrative: Information has been received from a license practical nurse concerning two patients who were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649692/0371P). the reporter stated that the patients had developed a severe local reaction, and redness and swelling elbow to shoulder. This was a revaccination for both patients. The reporter wanted an investigation into the lot number. In follow up information the nurse reported that one of these patients was a retired white 67 year old female patient with hyperlipidemia and hypokalemia who was vaccinated into the deltoid at 3:15 on Sept 207 2004 with second dose of pneumococcal 23v polysaccharide vaccine (lot 649692/0371P). The patient was not ill at the time of vaccination. On Sept 27 2004 at 8:00pm she developed an arm that was sore, red, feverish and swollen from the shoulder to the elbow. The patient had recovered from her experiences. the second patient that had an experience after vaccination with pneumococcal 23v polysaccharide vaccine was assigned WAES0410USA03658. 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. The nurse also reported patient experiences following vaccination with pneumococcal 23v polysaccharide vaccine (WAES0409USA01988, WAES0409USA00219, WAES0409USA02427, WAES0409USA00780).
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site hypersensitivity, Injection site pain, Oedema, Tenderness
Clinical narrative: Information has been received from a registered nurse concerning a 71 year old white female patient with allergies to erythromycin and alprazolam (Xanax) who on Jul 08 2004 at  3:23 pm was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 647636/0944N), intramuscularly in the right deltoid. Concomitant therapy included pimecrolimus (Elidel). There was no illness at the time of vaccination. On Jul 08 2004 at 3:23 pm the patient developed soreness and redness at the site per patient. The patient reportedly recovered on jul 09 2004. It was also reported that on Jul 09 2004 the patient experienced swelling and tenderness that was significant enough that she could not lift her arm. The pain persisted for three to four weeks. Unspecified medical attention was sought. No additional information is expected.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a 79 year old caucasian female with polycythaemia and basal cell carcinoma who on 09/10/2004 was vaccinated with a first dose of pneumococcal 23V polysaccharide vaccine (lot 648139/0009P), intramuscularly in the left deltoid.  Concomitant therapy included clopidogrel bisulfate (Plavix), hydroxyurea (Hydrea), calcium, risedronate sodium (Actonel) and high blood pressure medication.  On 09/11/2004 the patient's left upper arm reddened and was warm to touch.  The patient did have local swelling.  The patient was treated with prednicarbate (Dermatop) cream and ice.  No product quality complaint involved.  The patient recovered.  No additional information is expected.
Age: 1.36
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Erythema multiforme, Pyrexia, Skin ulcer, Viral infection
Clinical narrative: An initial report was received in the USA, from another company (reference number WAES0506USA01457) on 7/27/05. An 18 month old female patient developed scattered pustules 56 days after vaccination. She had received a DAPTACEL injection route of administration and lot number unknown, the first dose of VARIVAX, lot number 648559/0444P given SC, and the first dose of MMR II, lot number 648559/0267P, given SC on 4/11/05. It was reported by a physician that the child was covered with hundreds of lesions from her scalp to her the soles of her feet, thought to be chicken pox. She had a fever of 103.6 degrees F. She was treated with acyclovir. Follow up information reported that the viral culture of the abdominal pustule showed no virus isolated after 14 days and the final diagnosis was erythema multiforme. She was also given Atarax. It was noted that the child was hospitalized for two days and completely recovered on the 6/13/05.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site pain
Clinical narrative: Patient complaint of injection site pain after injection, redness, redness resolved but pain persisted.
Age: 4.0
Sex: M
Vaccine: HEPA, PNC
Symptoms: Swelling
Clinical narrative: Physician called on 08/01/2005 stated that patient was seen in office on 07/30/2005, came in with right upper arm swollen with clear liquid where vaccine was given.  Dr. stated that patient probably had a reaction from the vaccine given on 07/28/2005.
Age: 1.0
Sex: M
Vaccine: DTAP, PNC
Symptoms: Erythema, Pyrexia
Clinical narrative: Moderate severe erythema/edema, warmth at site, temper to 106.7.  Went to ER 07/29/2005.
Age: 1.04
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Rash on face, scalp, arms and abdomen that started 7/28/05.
Age: 5.0
Sex: M
Vaccine: TD
Symptoms: Unevaluable event
Clinical narrative: Pt was given adult dose of Tetanus diphtheria in right thigh in the ER. Never reported.
Age: 25.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site (5 X 5 cm). Given Benadryl.
Age: 36.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Hypoaesthesia, Paraesthesia, Skin burning sensation
Clinical narrative: Patient received hepatitis a, typhoid and yellow fever vaccines.  Within 20 minutes of receiving shots, patient complained of burning sensation on her face to the billing clerk but only reported numbness and tingling on both sides of her face to the nurses responding.  Vital signs stable.  Patient alert and oriented without any other complaints.  Rescue squad called.  Patient elected to drive self to clinic.  Called patient 8/4.  She said she received epinephrine and prednisone at clinic.  Patient says when she woke up this morning she felt fine without any numbness or tingling in her face.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Patient arrived at clinic and evaluted by doctor. Mom states on 08/27/2005 received varicella Imm at local health dept. and woke up in the moring with rash over body. Dx. from doctor Varicella induced rash- treated with Benadryl and Cool aveeno bath.
Age: 1.73
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Erythema, Rash pruritic, Urticaria
Clinical narrative: Rash present intermittently since 8/3/05 am.  Itching at the rash. Rash is present on the face, back, chest, abdomen, arms and legs.  No difficulty breathing.  Denies fever.  Doctor notes.  Erythematous wheals present on the left side of the face, abdomen and medial thighs and medial knees bilaterally.  No vesicles or petechiae, no fluctuant mass or drainage.
Age: 8.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Pneumococcal vaccine given following proper protocol without incident on 7/25/05. On 7/26/05 at approx. 10:00am received call from mother stating the injection site on left tricept was red and warm to touch. States no drainage from site. Mother stated she had Children's Motrin and was advised to give appropriate dose and apply cold compresses and to notify us of status of child. 7/26/05 3:30pm- Mother called concerned about elevated temp (103.7). Advised to give cool sponge bath and to contact her pediatrician if not improved after the next dose of Motrin and advised to call us with status of child. 7/27/05- Mother called and stated that she took child to doctor and was started on antibiotics. Mother expressed concern because child was still running a fever. Mother stated left arm had increased area of redness and swelling. She stated no drainage from site. 7/29/05- Mother called and stated she returned to the doctor on 7/28/05 for a re-check and that the child was admitted to hospital. Stated affected arm was red swollen and warm and without drainage. 8/1/05- Mother called and stated child was discharged from hospital on 7/30/05 with the diagnosis of cellulitis and that she was doing fine.
Age: 5.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Dysphagia, Pyrexia, Rash
Clinical narrative: 7 days post vaccine, developed a fever of 104, difficulty swallowing and generalized rash over the upper body. Seen in Emergency Room at  without a dx.
Age: 1.06
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: RED, SWOLLEN LEFT THIGH, TENDER TO TOUCH, STARTING APPROX 15-20 HOURS AFTER INJECTION.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives diffusing with some count, no induration.  Went to ER - given Benadryl, and Prednisone.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site induration
Clinical narrative: Left deltoid tender, 1/2cm induration at vaccine site, no redness, not warm to touch.  Submitted per doctor's request.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Injection site pain
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning a 41 year old female who on 09/28/2004 was vaccinated intramuscularly in the right deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P).  On 09/28/2004, the patient was also vaccinated intramuscularly in the left deltoid with a dose of concomitant therapy influenza virus split virion 3v vaccine inactivated (Fluzone).  Other concomitant therapy included Necon, MSD, Biaxin, and Avelox.  Subsequently, 09/28/2004, she experienced tender redness and warmth from her shoulder down to her elbow with pain.  Unspecified medical attention was sought and it was reported that the adverse experience improved on therapy.  In follow up, the nurse reported that on the morning of 09/29/2004, the patient developed a large area of redness, warmth and tenderness at the site of vaccine given in the right arm/deltoid area.  The patient was seen in the physician's office.  On 10/18/2004, the patient recovered.  There was no product quality complaint involved.  No additional information is expected.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Angioneurotic oedema, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning a 65 year old female patient with hypertension, hypothyroidism, allergies to propoxyphene hydrochloride and tetracycline a history of pneumonia, who on 09/22/2004 was vaccinated intramuscularly in the left deltoid with a 1/2cc dose of pneumococcal 23v polysaccharide vaccine.  There was no illness at the time of vaccination.  Concomitant therapy included Altace, Synthroid, Econazole, Hydrocort, minerals and vitamins and calcium.  The patient had a previous immunization in 1999 with pneumococcal 23v polysaccharide vaccine.  On 09/22/2004 at 23:00, the patient phoned the physician and reported she had developed a red tender knot on the spot of injection.  She reported swelling and pain near the injection site which spread from her shoulder down to her elbow.  The patient was advised to take Benadryl and to use ice on 09/22/2004 before coming back into the office.  The patient was seen by the physician in the office on 09/23/2004.  From follow up information it was reported that the physician noted the left arm was erythematous with angioedema down from the shoulder to the elbow.  The physician outlined the area with a pen and it was noted that on 09/24/2004 the redness had traveled beyond the pen mark and fluid was building up near the elbow.  The patient went to the emergency room.  There were no laboratory tests performed.   There was no product quality complaint reported.  The patient recovered on 09/30/2004.   Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant concerning a 68 year old female with non-remarkable past medical history and no drug allergies, who on an unspecified date was vaccinated intramuscularly in the right arm with a dose of PNEUMOVAX 23.  Concomitant therapy included LIPITOR and amlodipine LOTREL.  Subsequently the patient developed severe swelling at the injection site and redness.  The patient was instructed to visit the emergency room, but was not admitted to the hospital.  No laboratory or diagnostic studies were performed.  After several days swelling was gone and the redness dissapated.  The reported was concerned about the lot being tainted in some way.  It was also reported that a male patient and two unidentifiable patients developed severe swelling at the site and redness after being vaccinated with doses of PNEUMOVAX 23 from the same 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 industry standards and was released.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Injection site pain
Clinical narrative: Information has been received from a health professional concerning a female patient who on 09/21/2004 was vaccinated intramuscularly with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine.  Subsequently the patient developed redness, soreness and pain at injection site.  Unspecified medical attention was sought.
Sex: F
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: Information has been received from a female pharmacist who on 01Oct04 was vaccinated with pneumococcal 23v polysaccharide vaccine. Subsequently. the pt developed a rash around the injection site and all over her body. The pt went to the ER care clinic and received a prednisone injection fexofenadine hydrochloride (Allegra). The rash subsided after she was given the prednisone injection at the clinic but the rash developed again after one day. Unspecified medical attention was sought. No product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Initial and follow up information has been received from a licensed practical nurse (LPN) concerning a male who on 22Sep2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 647271/1138N). On approx 23Sep04 the pt developed redness from his shoulder to his wrist (site unspecified), and reported that the area was very painful and appeared to be swollen. The pt's events persisted. In follow up, the LPN reported that the pt was seen in the physician's office, and was administered oral prednisolone and diphenhydramine (Benadryl) as a precautionary measure. Subsequently, the pt had complete resolution within 24-48 hrs. The LPN reported that the pt had received vaccinations with pneumococcal 23v polysaccharide vaccine in the past without incident. No further information is expected. The LPN also reported a male pt who developed similar events after vaccination with pneumococcal 23v polysaccharide vaccine (lot647271/1138N) (WAES0409USA02081).
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a physician concerning an 80 year old male who in approx Sept 2004, was vaccinated with a dose pneumococcal 23v polysaccharide vaccine (lot 647654/0865N). Post-vaccination, the pt developed an injection site reaction which included upper arm swelling and redness that persisted for 5 days. Unspecified medical attention was sought. The pt was given unspecified antibiotics to treat an infection in case it is not just a local reaction. The pt's outcome was not reported. The reporter stated that he would like an investigation into the lot to see if other problems were reported. 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 and was released. It was also reported that two female pt's (WAES0410USA01073 and WAES0410USA01074) developed injection site reactions after vaccination with pneumococcal 23v polysaccharide vaccine from the same lot. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Medication error
Clinical narrative: Information has been received from a certified medical assistant concerning a 77 year old male who, on an unspecified date, was vaccinated IM in the right arm with a dose of pneumococcal 23v polysaccharide vaccine (lot 647655/0869N). Subsequently the was seen in the doctor's office for severe swelling at the injection site and redness at the site.  The pt's outcome was not reported. The reporter was concerned about the being tainted in some way. It was also reported that a female (WAES0410USA00293) and two unidentifiable pt's (WAES0410USA00499) developed severe swelling at the site and redness after vaccination with doses of pneumococcal 23v polysaccharide vaccine from the same 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 and was released. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site pain
Clinical narrative: Information has been received from a health professional concerning a 74 year old female patient who on Sep 21 2004 was vaccinated IM with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 647724/0946N). Subsequently in approximately Sept 2004, the patient developed redness, soreness and pain at injection site. Unspecified medical attention was sought.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site pain
Clinical narrative: Information has been received from a health professional concerning a 52 year old female patient who on Sept 29 2004 was vaccinated IM with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P). Subsequently in approximately Sept 2004, the patient developed redness, soreness and pain in the injection site. Unspecified medical attention was sought. The reporter would like an investigation into the lot number. The health care professional reported similar experienced for three other patients (WAES04100USA00320, WAES0410USA00566, WAES0410USA00568). 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: Cellulitis, Injection site reaction
Clinical narrative: Information has been received from a health professional concerning a 63 year old female patient who on Sept 22 2004 was vaccinated IM with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot # 647724/0946N). Subsequently in approximately Sept 2004, the patient developed cellulitis and was treated with levofloxacin (Levaquin). Unspecified medical attention was sought. The reporter would like an investigation into the lot number. The health care professional reported similar experiences for three other patients (WAES0410USA00566, WAES0410USA00567, WAES041USA00320). 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.
Sex: U
Vaccine: PPV
Symptoms: Headache, Pyrexia
Clinical narrative: Information has been received from  a physician concerning a patient who on June 03 2004 and Jul 20 2004 was vaccinated with a first and second dose of pneumococcal 23v polysaccharide vaccine, during a six week period. On June 03 2004, in the period immediately following vaccination, the patient developed a right sided headache and a fever. The symptoms resolved after a (short while), however, it was noted that since the immediate period the patient has reported to the physician that they suffer from an occasional headache. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a 51 year old female registered pharmacist with no past medical history or drug allergies, who on Sept 21 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (first lot # 647635/0864N, second lot # not available) from two different vials that were combined into one syringe. On Sept 21 2004 the patient developed a fever above 100F. the patient took diphenhydramine hydrochloride (Benadryl) and ibuprofen. She also developed a raised spot that was bigger than her hand, The spot was red and hot. At the time of this report, the patient had not contacted her physician. On Sept 25 2004 the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Blood glucose increased, Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning a healthy patient over 65 years old who was recently vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 647029/0460P). Subsequently, the patient developed a red, swollen hot arm from the shoulder down to the elbow and had a high glucose level. Unspecified medical attention was sought. No product quality complaint was involved. The out come was unknown. It was also reported that 4 other patients were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 647029/0460P) and developed AE's WAES0408USA01647). No further information is expected.
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated on an unspecified date with a dose of pneumococcal 23v polysaccharide vaccine (lot 649693/0486P). Subsequently the patient developed local and systemic reactions. Unspecified medical attention was sought and the patient was treated with ibuprofen (Advil). The patients out come was not reported. There was no product quality complaint involved. It was also reported that another male patient (WAES0410USA01363) developed local and systemic reactions after vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity
Clinical narrative: Information has been received from a certified medical assistant concerning a 63 year old female who on Aug 25 2004, was vaccinated intramuscularly in the left arm with a first dose of pneumococcal 23v polysaccharide vaccine (lot 646078/0257N). it was reported that on Aug 26 2004, the patient developed a 1.5 inch diameter, approximately 3-4 cm, red site reaction several hours after receiving vaccination. The patient was treated with acetaminophen (Tylenol). The patient iced the site for the afternoon. The patient ws called and was fine the next day, the reaction was totally resolved within 72 hours. No additional information is expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Hypokinesia, Injection site oedema, Injection site pain, Insomnia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 70 year old white female with new onset diabetes mellitus and osteoporosis who on Sept 25 2004 was vaccinated intramuscularly with a first dose of pneumococcal 23v polysaccharide vaccine (lot 645255/1212M). On Sept 25 2004, the patient developed pain in shoulder near the injection site with swelling. The affected arm was sore, red and swollen. it was hard to raise the arm and to sleep on that side for about 3 days. The patient sought medical attention and was treated with ice, acetaminophen (Tylenol) and ibuprofen. The patient subsequently recovered. The nurse also reported 2 other patients who had similar symptoms post vaccination with pneumococcal 23v polysaccharide vaccine (lot 645255/1212M) ( Waes0411USA01576, WAES0411USA01577). No additional information is expected.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Information has been received from a physician concerning an 72 year old female who in approximately Sept 2004, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 647654/0865N). Post vaccination, the patient developed an injection site reaction which included upper arm swelling and redness that persisted for 5 days. Unspecified medical attention was sought. the patient was given unspecified antibiotics to treat an infection in case it is not just a local reaction. The patients outcome was not reported. The reporter stated that he would like an investigation into the lot to see if other problems were reported. 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 reported that a male patient (WAES0410USA01073) and another female patient WAES0410USA01074) developed injection site reactions after vaccination with pneumococcal 23v polysaccharide vaccine from the same lot. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Infection, Injection site hypersensitivity, Injection site oedema
Clinical narrative: Information has been received from a physician concerning an 79 year old female who in approximately Sept 2004, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 647654/0865N). Post vaccination, the patient developed an injection site reaction which included upper arm swelling and redness that persisted for 5 days. Unspecified medical attention was sought. The patient was given unspecified antibiotics to treat an infection in case it is not just a local reaction. The patients outcome was not reported. The reporter stated that he would like an investigation into the lot to see if other problems were reported. 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 reported that a male patient (WAES0410USA00473) and another female patient (WAES0410USA01073) developed injection site reactions after vaccination with pneumococcal 23v polysaccharide vaccine from the same lot. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Oedema, Rash
Clinical narrative: Information has been received from a healthcare worker concerning a 61 year old male patient who on Sept 23 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 647029/0460P). On Sept 23 2004 the patient had a swollen arm. On Sept 24 2004 the patient developed a rash all over the body. Unspecified medical attention was sought. No product quality complaint involved. It was reported to be unknown if this was the first or second vaccination. It was also reported that another patient had a similar reaction (WAES0411USA00241). Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female with sickle cell disease who on Oct 05 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649111/0287P). During the night of Oct 05 2004, the patient developed a severe local site reaction. Unspecified medical attention was sought. The patient was treated with ibuprofen, diphenhydramine HCL. and cool towels with no success at the time of this report. The office would like an investigation as to whether there had been more than the usual number of reported problems with lot 649111/0287P. 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. The nurse also reported 2 other patients who had similar reactions post vaccination with lot 649111/0287P (WAES0410USA01823). Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 74 yr old female pt who at the end of Sep or beginning of Oct 2004, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot number 649694/0386P). The pt developed a 3 inch area below the injection site which was swollen, red and looked like cellulitis. Unspecified medical attention was sought. The pt was treated with unspecified antihistamines. Subsequently, the pt recovered. The nurse requested that a lot check be performed on lot 649694/0358P. It was reported that the pt's injection site swelling, erythema and cellulitis were considered other medical events (OMIC). 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 and was released. The nurse also reported 4 additional pt's who developed injection site swelling, erythema and cellulitis post vaccination with pneumococcal 23v polysaccharide vaccine (WAES0410USa01622, 0401USA01623, 0410USA01624, 0410USA01625). Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 55 year old male who on an unspecified date was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P). Subsequently the patient developed local and systemic reactions. Unspecified medical attention was sought and the patient was treated with ibuprofen (Advil). The patients outcome was not reported. There was no product quality complaint involved. It was also reported that another male patient (WAES0410USA00782) developed local and systemic reactions after vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Ecchymosis, Erythema, Oedema, Pain
Clinical narrative: Information has been received from a health professional concerning a 58 year old white female with diabetes, high cholesterol and hypertension who on Oct 05 2004 at 3:: was vaccinated in the left arm with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P). there was no illness at the time of vaccination. Concomitant therapy included glyburide (+) metformin hydrochloride (Glucovance), lisinopril (manufacturer unknown), atorvastatin calcium (Lipitor), pioglitazone HCL (ACTOS) and asprin. On Oct 07 2004 the patient developed a sore arm. The left arm had erythema and swelling proximal to the elbow. There was a small ecchymosis at the deltoid muscle. Unspecified medical attention was sought and the patient was treated with cetirizine hydrochloride (Zyrtec) and acetaminophen (Tylenol). No diagnostic test were performed. Subsequently, the patient recovered. it was reported that the patient may have received the vaccine on Feb 27 2004 but she does not remember if she received it or not. No product quality complaint was involved. No further information is expected.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a LVN concerning a 72 year old female pt who at the end of September or beginning of October 2004, was vaccinated with a dose of Pneumovax 23 (lot number 649694/0386P). The pt developed a 3 inch area below the injection site which was swollen, red, and "looked like cellulitis". Unspecified medical attention was sought. The pt was treated with unspecified antihistamines. Subsequently, the pt recovered. The nurse requested that a lot check be performed on lot 649694/0368P. It was reported that the pt's injection site swelling, erythema, and cellulitis were considered other  medical events (OMIC). The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. the lot complies with the standards of the CBER and was released. The nurse also reported 4 additional patients who developed injection site swelling, erythema, and cellulitis post vaccination with Pneumovax 23 (WAES0410USA01334, WAES0410USA01623, WAES0410USA01624, WAES0410USA01625). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 65 yr old female pt who at the end of Sept or beginning of Oct 04, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot number 649694/0386P). The pt developed a 3 inch area below the injection site which was swollen, red, and looked like cellulitis. Unspecified medical attention was sought. The pt was treated with unspecified antihistamines. Subsequently, the pt recovered. The nurse requested that a lot check be performed on lot 649694/0368P. It was reported that the pt's injection site swelling, erythema, and cellulitis were considered other medical events. 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 and was released. The nurse also reported 4 additional pt's who developed injection site swelling, erythema and cellulitis post vaccination with pneumococcal 23v polysaccharide vaccine (WAES0410USA01334, 0410USA01622, 0410USA01624, 0410USA01625). Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 63 yr old female pt who at the end of Sept or beginning of Oct 2004, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot number 649694/0386P). The pt developed a 3 inch area below the injection site which was swollen, red and looked like cellulitis. Unspecified medical attention was sought. The pt was treated with unspecified antihistamines. Subsequently, the pt recovered. The nurse requested that a lot check be performed on lot 649694/0368P. It was reported that the pt's injection site swelling, erythema and cellulitis were considered other medical events (OMIC). 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 and was released. The nurse also reported 4 additional pt's who developed injection site swelling, erythema and cellulitis post vaccination with pneumococcal 23v polysaccharide vaccine (WAES0410USA01334, 0410USA01622, 0410USA01623, 0410USA01625). Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a licensed visiting nurse concerning an 82 year old male patient who at the end of September or beginning of October 2004, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 649694/0386P). The patient developed a 3 inch area below the injection site which was swollen, red, and looked like cellulitis. Unspecified medical attention was sought. The patient was treated with unspecified antihistamines. Subsequently, the patient recovered. The nurse requested that a lot check be performed on lot 649694/0368P. It was reported that the patient's injection site swelling, erythema, and cellulitis were considered other medical events (OMIC). 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 nurse also reported 4 additional patients who developed injection site swelling, erythema, and cellulitis post vaccination with pneumococcal 23v polysaccharide vaccine (WAES 0410USA01334, 0410USA01622, 0410USA01623, 0410USA01624). Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Oedema, Pain
Clinical narrative: Information has been received from a 78 year old female with no past medical history and no allergies who on Oct 08 2004 was vaccinated with pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. On Oct 08 2004 the patient experienced redness, soreness and swelling. the patient was reported to be recovering. No medical attention was sought. No product quality complaint was involved. There was no relevant diagnostic test or laboratory data. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Information has been received from a pharmacist concerning a 77 yr old male pt who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine while he was a hospital inpatient. Subsequently, the pt developed a localized cellulitis. He was treated with an antibiotic for his cellulitis. It was noted that the pt improved after antibiotic therapy and had recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Eye disorder, Face oedema, Medication error
Clinical narrative: Information has been received from an office manager concerning a 42 year old female registered nurse who on Oct 11 2004 was exposed to pneumococcal 23v polysaccharide vaccine (lot 647654/0865N). the nurse entered into the vial, then when she was pulling the syringe out of the vial the vaccine sprayed out and got into her eye, The nurse's eye closed up, she had swelling in her face and she was short of breath. the nurse's eye was washed out. On Oct 12 2004 the nurse was seen by a physician in the office and no vision problems were noted. The nurse was reportedly recovering. It was also reported that another nurse had pulled a syringe out of the same vial and was sprayed on her hand (WAES0410USA01354). Additional information has been requested.
Age: 42.0
Sex: U
Vaccine: PPV
Symptoms: Bursitis, Hypokinesia, Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a physician and a licensed practical nurse concerning a patient who was vaccinated on an unspecified date with a dose of pneumococcal 23v polysaccharide vaccine (either lot 647797/0987N or 649698/0371P). Subsequently the patient developed bursitis and inability to move the arm and vomiting, The nurse also reported that the site was red, swollen and painful. The patient was treated with ice and anti inflammatory, The patients outcome was not reported. The physician reported that there seemed to be an increased in the number of AE's associated with these recent lots of pneumococcal 23v polysaccharide. Additionally, it was reported that several  also reported as 15-20 patients developed AE,s after vaccination with pneumococcal 23v polysaccharide vaccine from the same lots (WAES0410USA02100). The records of testing prior to release of these lots have been checked by Quality Assurance and found to be satisfactory, The lots comply with the standards of the Center for Biologics Evaluation and Research and were released. Additional information has been requested.
Age: 42.0
Sex: U
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician and a licensed practical nurse concerning a patient who was vaccinated on an unspecified date with a dose of pneumococcal 23v polysaccharide vaccine (either lot 647797/0987N or 649698/0371P). Subsequently the patient developed bursitis and inability to move the arm and vomiting, The nurse also reported that the site was red, swollen and painful. The patient was treated with ice and anti inflammatory, The patients outcome was not reported. The physician reported that there seemed to be an increased in the number of AE's associated with these recent lots of pneumococcal 23v polysaccharide. Additionally, it was reported that several  also reported as 15-20 patients developed AE,s after vaccination with pneumococcal 23v polysaccharide vaccine from the same lots (WAES0410USA02100). The records of testing prior to release of these lots have been checked by Quality Assurance and found to be satisfactory, The lots comply with the standards of the Center for Biologics Evaluation and Research and were released. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Erythema, Injection site induration, Oedema, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 52 year old female with COPD, HTN and GERD who on Oct 14 2004 was vaccinated intramuscularly in the right deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot 647657/0947N). Concomitant vaccine therapy given intramuscularly in the left deltoid included a dose of influenza virus split virion 3v vaccine inactivated (Fluzone) (lot U1410BA). There was no illness at the time of vaccination. That same day the patient developed shortness of breath, and erythema, induration and diffuse edema in the right upper arm. That night the patient visited the ER after developing a fever. After several days, the patient recovered. the patient did not have any adverse events following prior vaccinations. No product quality complaint was involved. No further information is expected.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: Information has been received from a physicians assistant concerning a 45 year old female who on Oct  12 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649111/0287P). On Oct 12 2004 the patient developed pain and edema at the injection site, high fever (as high a 101F), body aches and nausea. Unspecified medical attention was sought. The patients outcome was not reported. There was no product quality complaint. It was noted that the patient had been vaccinated previously with pneumococcal 23v polysaccharide vaccine in 2003. It was also reported that a male patient (WAES0411USA01403) had similar experiences following vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Oedema, Pain, Stomach discomfort
Clinical narrative: Information has been received from a female with a history of high blood pressure and allergies to penicillin, cholesterol medications and codeine, who on Oct 14 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 648139/0009P). Concomitant therapy included hydrochlorothiazide (+) Valsartan (Diovan HCT), metoprolol succinate (Toprol XL Tablets), raloxifene hydrochloride (Evista), levothyroxine Na (Levoxyl), rabeprazole sodium (Aciphex) and aspirin (Ecotrin). On Oct 14 2004 the patient developed pain and swelling in the entire upper arm and upset stomach. The patient reported that she did not seek medical attention and that she is recovering. No lab diagnostic studies were performed. No product quality complaint is involved. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Feeling hot, Hypersensitivity, Oedema, Pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 78 year old retired white female with no known drug allergies who on Oct 13 2004 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P), intramuscularly in the right deltoid. Concomitant therapy that day included a sixth dose of influenza virus split virion 3v vaccine inactivated (Fluzone) (lot U1411AA), intramuscularly in the left deltoid. The patient was seen on Oct 15 2004 with redness and pain in the right upper arm. The arm was swollen and warm to touch. Cellulitis was reported. The patient was treated with ciprofloxacin hydrochloride (Cipro) (500) (x 4 days). The reporter indicated that cellulitis was considered to be an other important medical event. There was no product quality complaint involved. The patient recovered. Follow up indicated that the cellulitis was not an was not an other important medical event. The nurse reported that 2 other female patients had similar experiences with pneumococcal 23v polysaccharide vaccine (WAES0410USA03089, WAES0410USA03090) in the past two weeks. No further information is available.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a physician concerning an approximately 79 year old female was was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P). Subsequently the patient complained of injection site pain, redness and swelling toward the elbow. Medical attention was sought and the patient was treated with compresses and ibuprofen (Advil). The AE's resolved after 5 days. No product Quality complaint was involved. It was also reported that within the same week tow other patients were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P) and developed AE,s (WAES0411USA00719, WAES0411USA00720). Additional information has been requested.