chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Joint range of motion decreased, Pain, Sensation of heaviness
Clinical narrative: Information has been received from an RN concerning a 76 year old retired white female with chronic obstructive pulmonary disease, asthma, gastroesophageal reflux disease and seasonal allergies who on 04NOV2003 at 4 PM was vaccinated IM in the left arm with a second 0.5ml dose of pneumococcal vaccine 23 polyvalent vaccine from a new vial. P1: 6 years ago. Concomitant therapy included omeprazole (Prilosec), Evista,  montelukast sodium and Advair. On 04NOV2003, the night of vaccination, the pt developed arm pain. On 05NOV2003, the next day, there was arm heaviness, redness and swelling below he site of injection. The treatment included ice to the area, and Tylenol or ibuprofen as needed. There was a product quality complaint involved. It was noted that the nurse noticed that the vaccine smelled differently. The nurse stated that she always noticed a slight chemical smell, but it was stronger with this particular vial. She stated that she administered several other doses from the same lot, and they did not smell as strong. She stated that the vaccine smelled 'like chemicals". She said that the vaccine appeared to be normal. Follow up information received form an RN indicated that on 04NOV2003 at approximately 10PM the pt was unable to sleep on her left arm due to pain. On the evening of 05NOV2003, the pt looked at her arm because "it hurt and felt heavy and I was unable to move it." Her left arm distal to the immunization site was red, swollen, and warm to the touch. The pt did not use ice to the area as recommended. The outcome was reported as recovered. No relevant diagnostic tests or lab data were reported. There were no adverse events following prior vaccinations. The records of testing prior to release of this lot have been checked by the QA and found to be satisfactory. The lot complies with the standards of the Center for biologics Evaluation and Research and was released. The reporter also indicated that the pt's husband experienced adverse experiences after vaccines with pneumococcal vaccine 23 polyvalent. No further information is expected.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Information has been received from an RN concerning a 78 year old white retired male with high cholesterol, a cardiac condition, a hx of pneumonia in the summer of 2003, and no known allergies who on 04NOV2003 at 4Pm was vaccinated IM in the right arm with a second 0.5ml dose of pneumococcal 23v polysaccharide vaccine from a new vial. P1: 6 years ago. Concomitant therapy included fluvastatin sodium and Toprol XL Tablets. On 05NOV2003 at 6AM, the next day, the pt's arm was red and swollen below site. The treatment included ice to the area, and Tylenol or as needed. There was a product quality complaint involved. It was noted that the nurse noticed that the vaccine smelled differently. The nurse stated that she always noticed a slight chemical smell, but it was stronger with this particular vial. She stated that she administered several other doses from the same lot, and they did not smell as strong. She stated that the vaccine smelled "like chemicals". She said that the vaccine appeared to be normal. Follow up information received from registered nurse indicated that the pt had no complaints of pain. However, he did observe redness and swelling on the right arm distal to the injection site. The pt did not use ice as recommended. The outcome was reported as recovered. No relevant diagnostic tests or laboratory data were reported. There were no adverse events following prior vaccinations. 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 Center for Biologics Evaluation and Research and was released. The reporter also indicated that the pt's wife experienced adverse experiences after vaccination with pneumococcal 23v polysaccharide vaccine. No further information is expected.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pyrexia
Clinical narrative: Information has been received form a health professional concerning a n81 year old female pt who in the PM on 03NOV2003 was vaccinated in the left deltoid with a first dose of pneumococcal vaccine 23 polyvalent vaccine. In was noted that in the AM on 04NOV2003 the patient developed a red, warm slightly edematous area at injection site. It was noted the pt has not taken her temperature, but feels "feverish". The pt was not ill at the time of vaccination. Unspecified medical attention was sought. Additional information is expected.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Laboratory test abnormal
Clinical narrative: Information has been received from a certified medical assistant concerning a 78 year old white male with hypothyroidism, increased PSA s/p laser surgery, no allergic reactions and no known drug allergies, and a history of laser surgery for prostate cancer who on 20Oct03 was vaccinated SC in the right arm with a first 0.5mL dose of pneumococcal 23v polysaccharide vaccine. There was no illness at the time of vaccination. Concomitant therapy on 02Oct03 included a first dose in the right deltoid of influenza virus vaccine. On 21Oct2003, one day after vaccination with pneumococcal 23v polysaccharide vaccine, the pt went to the emergency dept of the local hospital where he was treated for cellulitis and redness of his left arm. He was given cephalexin. On 24Oct03, the pt came to the office and was given ceftriaxone sodium (Rocephin) to take home. It was not known if the pt's symptoms had fully abated. No other information was provided. Unspecified medical attention was sought. There was no product quality complaint. Follow up information received from a certified medical assistant indicated that on 21Oct03 the pt developed cellulitis with redness of the left arm. The pt was seen at the hospital on 22Oct2003 and was given cephalexin 500mg PO. The pt was seen by another doctor on 24Oct03 and was given ceftriaxone sodium (Rochephin) 1 gram IM in the right gluteal. It was noted that the pt recovered. Upon internal review, cellulitis was considered to be an other important medical event. (OMIC) No further information is expected.
Age: 14.0
Sex: F
Vaccine: PPV
Symptoms: Anaphylactic reaction, Dyspnoea, Feeling hot, Injection site oedema, Tenderness
Clinical narrative: Information has been received from a RN concerning a 14 year old white female with a penicillin allergy who on 20Nov03 at 1:00PM was vaccinated SC in the right upper extremity with a second dose of pneumococcal 23v polysaccharide vaccine.  There was no illness at the time of vaccination. Concomitant therapy included enalapril maleate (+) felodipine (Lexxel) and amphetamine aspartate (+) amphetamine sulfate (+) dextroamphetamine saccharate (+) dextroamphetamine sulfate (Adderall).  On 21Nov03, the pt presented at the office with shortness of breath and other symptoms of an anaphylactoid reaction. The pt was given epinephrine and was considered fully recovered on 21Nov03 at 12:10PM A product quality complaint was not involved. Additional information was received from the RN which indicated that the pt was seen in the office by a physician assistant. The nurse indicated that the pt recovered but was not sure if the pt was treated with diphenhydramine hydrochloride (Benadryl) or epinephrine in the office. Follow up information was received from the physician assistant who indicated that on 21Nov03 at 12:01PM, the pt arrived at the clinic acutely dyspinec and wheezing. The vaccine site was markedly swollen, hot, and quite, tender. The pt was treated with SC epinephrine and prednisone. No diagnostic laboratory tests were performed. The pt recovered was considered recovered on 21Nov03. It was also noted that neither the pt or her siblings had any adverse events following prior vaccination. No further information is expected.
Age: 14.0
Sex: F
Vaccine: PPV
Symptoms: Wheezing
Clinical narrative: Information has been received from a RN concerning a 14 year old white female with a penicillin allergy who on 20Nov03 at 1:00PM was vaccinated SC in the right upper extremity with a second dose of pneumococcal 23v polysaccharide vaccine.  There was no illness at the time of vaccination. Concomitant therapy included enalapril maleate (+) felodipine (Lexxel) and amphetamine aspartate (+) amphetamine sulfate (+) dextroamphetamine saccharate (+) dextroamphetamine sulfate (Adderall).  On 21Nov03, the pt presented at the office with shortness of breath and other symptoms of an anaphylactoid reaction. The pt was given epinephrine and was considered fully recovered on 21Nov03 at 12:10PM A product quality complaint was not involved. Additional information was received from the RN which indicated that the pt was seen in the office by a physician assistant. The nurse indicated that the pt recovered but was not sure if the pt was treated with diphenhydramine hydrochloride (Benadryl) or epinephrine in the office. Follow up information was received from the physician assistant who indicated that on 21Nov03 at 12:01PM, the pt arrived at the clinic acutely dyspinec and wheezing. The vaccine site was markedly swollen, hot, and quite, tender. The pt was treated with SC epinephrine and prednisone. No diagnostic laboratory tests were performed. The pt recovered was considered recovered on 21Nov03. It was also noted that neither the pt or her siblings had any adverse events following prior vaccination. No further information is expected.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a RN concerning a 66 year old female with no significant medical history and no known drug allergies who on 11/15/03 at 13:25 was vaccinated IM in the right deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (Lot #646159/0287N). Concomitant vaccine therapy given IM in the right deltoid included a dose of influenza virus split virion 3v vaccine inactivated (Fluzone)(batch #76566).  There was no illness at the time of vaccination. On 11/18/03 at 14:30 the pt developed a local reaction described as a red and swollen right tricep area. There was no cellulitis. Unspecified medical attention was sought and the pt was to be given cephalexin (Keflex) if the symptoms worsened. It was noted that the exact date of the first administration of pneumococcal 23v polysaccharide vaccine was unknown. No product quality complaint was involved. Follow up information reported that the pt did not take the prescribed antibiotics and recovered. It was also reported that another female pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot #646159/0287N) and developed injection site cellulitis (WAES #0311USA02521).  Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a RN concerning a 23 year old female pt with asplenia and no past medical history of any allergies who on 19Nov03 at 1643 was vaccinated IM in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. On 16Nov03 at 1643 with a dose of influenza virus split virion 3v vaccine inactivated. Concomitant medication included birth control pills. On 16Nov03 at 2030 the pt developed a cellulitis at the injection site of the arm that was vaccinated with the pneumococcal 23v polysaccharide vaccine. The pt was diagnosed with a cellulitis of the left arm. Unspecified medical attention was sought and the pt was treated with oral cephalexin and then changed to gatifloxacin for the cellulitis. Subsequently, the pt recovered. A product quality complaint was involved. Upon internal review, cellulitis of the left arm was determined to be an other important medical event. It was also reported that another female pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed injection site redness and swelling. No further information is expected.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Lymphangitis
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old male with no known drug allergies and a hx of lower back pain, colon polyps and rosacea who on 24NOV2003 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent vaccine.  The pharmacist indicated that the next day, on 25NOV2003, the pt went to  the hospital ER and was diagnosed with lymphangitis and was treated and released. Treatment included Keflex qid for seven days. A product quality complaint was not involved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Joint range of motion decreased, Malaise, Swelling
Clinical narrative: Information has been received from an RN concerning a 66 year old white female health educator with a sulfa allergy who on 10NOV2003 at 16:30 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent vaccine. Prior vaccination on 27OCT2003 included a dose of influenza virus vaccine. There were no adverse events following prior vaccinations and there was no illness at the time of vaccination. On 10NOV2003 at 19:30, the pt's left upper arm became very tender and it hurt to move it. On 10NOV2003 at 21:30, the patient developed chills and shaking. The pt applied ice to her arm and went to bed. The following morning, the pt's entire upper arm was red and swollen all the way down to the elbow. The pt still "felt lousy", but there was no fever. The pt took ibuprofen to help with her symptoms. Unspecified medical attention was sought, but laboratory tests were not performed. The sxs lasted for the next two days with a gradual return to normal. On 13NOV2003, the pt recovered. A product quality complaint was not involved. Additional info is not expected.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness, Tremor
Clinical narrative: Information has been received from an RN concerning a 66 year old white female health educator with a sulfa allergy who on 10NOV2003 at 16:30 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent vaccine. Prior vaccination on 27OCT2003 included a dose of influenza virus vaccine. There were no adverse events following prior vaccinations and there was no illness at the time of vaccination. On 10NOV2003 at 19:30, the pt's left upper arm became very tender and it hurt to move it. On 10NOV2003 at 21:30, the patient developed chills and shaking. The pt applied ice to her arm and went to bed. The following morning, the pt's entire upper arm was red and swollen all the way down to the elbow. The pt still "felt lousy", but there was no fever. The pt took ibuprofen to help with her symptoms. Unspecified medical attention was sought, but laboratory tests were not performed. The sxs lasted for the next two days with a gradual return to normal. On 13NOV2003, the pt recovered. A product quality complaint was not involved. Additional info is not expected.
Age: 28.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Fatigue, Injection site reaction, Joint range of motion decreased, Pyrexia
Clinical narrative: Information has been received form an RN concerning a 28 year old white female with no allergies or medical hx who on 19NOV2003, at 11:30 am, was vaccinated IM in the right deltoid with a first dose of pneumococcal vaccine 23 polyvalent vaccine. Concomitant vaccine at 11:30 am included a dose IM in the left deltoid of influenza virus vaccine: Fluvarin. There was no illness at the time of vaccination. Subsequently, the pt developed moderate to severe soreness, erythema, swelling and low grade fever. It was noted that both pts received doses from the same vial but  the lot number was not available. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information indicated that on 19NOV2003 at 20:00 the pt had increasing soreness at the injection site and felt fatigued. Her right upper arm was red and blotchy and she was swollen form the shoulder to the elbow. The next day she was unable to raise the right arm. No labs or diagnostic tests were done. She recovered in approximately 2-3 days. The reporter also mentioned another pt who experienced a similar rxn. Additional information is not expected.
Age: 28.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash macular, Swelling, Tenderness
Clinical narrative: Information has been received form an RN concerning a 28 year old white female with no allergies or medical hx who on 19NOV2003, at 11:30 am, was vaccinated IM in the right deltoid with a first dose of pneumococcal vaccine 23 polyvalent vaccine. Concomitant vaccine at 11:30 am included a dose IM in the left deltoid of influenza virus vaccine: Fluvarin. There was no illness at the time of vaccination. Subsequently, the pt developed moderate to severe soreness, erythema, swelling and low grade fever. It was noted that both pts received doses from the same vial but  the lot number was not available. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information indicated that on 19NOV2003 at 20:00 the pt had increasing soreness at the injection site and felt fatigued. Her right upper arm was red and blotchy and she was swollen form the shoulder to the elbow. The next day she was unable to raise the right arm. No labs or diagnostic tests were done. She recovered in approximately 2-3 days. The reporter also mentioned another pt who experienced a similar rxn. Additional information is not expected.
Age: 31.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Erythema, Injection site oedema, Pyrexia, Swelling, Tenderness
Clinical narrative: Information has been received from a registered nurse concerning a 31 year old white female with no past medical hx and no known drug allergies who on 19NOV2003 at 13:30 was vaccinated IM in he right deltoid with a first dose of pneumococcal vaccine 23 polyvalent vaccine. There was no illness at the time of vaccination. Concomitant therapy that day at 13:30 included a first dose of hepatitis A virus vaccine inactivated HAVRIX administered IM in the left deltoid. Subsequently, the pt developed moderate to severe soreness, erythema, swelling and low grade fever. It was noted that both pts received doses from the same vial but lot number was not available. Unspecified medical attention was sought. There was no product quality complaint involved. No relevant diagnostic tests or laboratory data were reported. It was not known if there were any adverse events following prior vaccinations of the pt or her siblings. Follow up information received from an RN indicated that on 19NOV2003 at approximately 20:30, the pt noted edema extending from the injection site on the right deltoid to the right axilla. It was noted to be sore and uncomfortable.  The outcome was reported as recovered after approximately 3 days. The reporter also mentioned another pt who experienced a similar rxn. No further information is expected.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain, Swelling
Clinical narrative: Information has been received from a health professional and an RN concerning a 35 year old female with a history of liver disease and a partial liver transplant (June 2003) who on 25NOV2003, at 15:30, was vaccinated IM in the left deltoid with the first dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included "routine unnamed medications." The health professional reported that in 2003, the pt developed swelling of the arm. The RN reported that on 25NOV2003, at 22:10, the pt's left arm became very painful. On 26NOV2003, the pt was seen in the office. At that time, the pt presented with faint erythema of her arm and moderate swelling of her entire left upper arm. The patient was started on prednisone taper and Bextra for the pain. Subsequently, the pt recovered form the arm pain, erythema and left upper arm swelling. It was noted that the pt's physician was concerned about this particular lot number. 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 Center for biologics Evaluation and Research and was released. The health professional also reported that another pt developed cellulitis after being vaccinated with dose of pneumococcal 23v polysaccharide vaccine. Additional info is not expected.
Age: 36.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a LPN concerning a 36 year old white self employed female with Hodgkin's Lymphoma who on 27Jan04, at approximately 15:30, was vaccinated SC in the right arm with the second dose of pneumococcal 23v polysaccharide vaccine. Illness at the time of vaccination included swelling of the left wrist. The LPN reported that on 29Jan04, at 14:50, the pt developed warmth, redness, swelling and hardness at injection site. On 30Jan04, the pt was seen by a physician where she was administered local care to the injection site that consisted of ice compresses, diphenhydramine HC1 (Benadryl) and ibuprofen (Advil). Subsequently, the pt recovered from her events and at the time of this report was noted to be well with no further symptoms. Additional information is not expected.
Age: 36.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Feeling hot, Injection site mass, Oedema
Clinical narrative: Information has been received from a LPN concerning a 36 year old white self employed female with Hodgkin's Lymphoma who on 27Jan04, at approximately 15:30, was vaccinated SC in the right arm with the second dose of pneumococcal 23v polysaccharide vaccine. Illness at the time of vaccination included swelling of the left wrist. The LPN reported that on 29Jan04, at 14:50, the pt developed warmth, redness, swelling and hardness at injection site. On 30Jan04, the pt was seen by a physician where she was administered local care to the injection site that consisted of ice compresses, diphenhydramine HC1 (Benadryl) and ibuprofen (Advil). Subsequently, the pt recovered from her events and at the time of this report was noted to be well with no further symptoms. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: TD
Symptoms: Dysphonia, Hypercalcaemia, Laryngeal oedema, Pericardial effusion, Vocal cord paralysis
Clinical narrative: No seriousness criteria was reported. Based upon medical judgement this case is considered serious: medically significant event (OMIC). From initial information received on 7/27/04 from a health care professional regarding an adverse event occurring, it was reported that a 68 year old female patient received a booster dose of TD ADS ADULT, lot number U1185AA, administered IM in the left deltoid on 6/17/04. Three days later, on 6/20/04, the patient complained of hoarseness and was subsequently diagnosed with vocal cord paralysis. A CT scan of her larynx showed swelling. She is to have an endoscopy procedure in the future. The patient has not recovered from these events. From additional information received on 9/13/04 from a health care professional, it was reported that the patient had a parathyroidectomy in February 2000, patient was diagnosed with hypercalcemia. She was referred to another physician who ordered a computed tomography scan of the larynx and neck and scheduled a biopsy. Cardiac and pulmonary work up was within normal limits. The patient ws admitted to the hospital on 6/30/04 and discharged on 7/2/04. A 2-dimensional echocardiogram was within normal limits except a trivial percardial effusion. Pulmonary function tests and computed tomography of the chest were within normal limits.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Anaphylactic reaction
Clinical narrative: Patient experienced an anaphylactic reaction. Follow up 8/13/04: He came in this morning. He was given Varivax 1, DTaP 4, HIB 4; 15 minutes later he started swelling, having difficulty breathing, and broke out in hives. They presented back to the clinic; he was given epinephrine 1:1000, .1ml SQ, 1.2 teaspoon Benadryl and nebulizer treatment of 083% Albuterol. Within 30 minutes he was breathing easier, swelling was going down, he had persistent hives. I kept him here two hours and had him come back at 1:00. He looks good. His breathing is relaxed, no hives or edema. I told them this is very rare and I will report it.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Skin ulcer
Clinical narrative: MMR injection given in R T thigh on 7/27/04. Family noted red area late evening on 07/27/04. Applied warm compresses-large red circle with ulcerated center noted on 7/28/04. Return appt. 7/29/04.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Feeling hot, Pain, Paraesthesia
Clinical narrative: To ER on 07/24/04 after receiving TD on 7/19/04. Tingling in arm, weakness, sharp dull pain, heat sensation upper arm. Used Motrin for some relief. Weakness now resolving in arm. Physician reported not sure from TD.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Localized reaction to right thigh. 23" in length 26 1/2 diameter. Pt treated with Augmentin 400/5 6cc Bib x 10 days for cellulitis.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: 5x5cm red swollen area warm to touch.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema, Tenderness
Clinical narrative: Red, swollen, tender left arm
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Redness of left arm, developed 24-48 hours after vaccination (in the area of IPV vac ) No tenderness, mild pruritus only. Redness resolved by 4 days after vaccines.
Age: 1.08
Sex: M
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Thrombocytopenic purpura
Clinical narrative: Immune Thrombocytopenic purpura Dx on 7/29/04
Age: 7.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Headache, Vomiting
Clinical narrative: 1) vomiting 2) headache
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Erythema, Injection site mass, Injection site reaction, Oedema, Tenderness
Clinical narrative: Local Reaction to injection site LD 07/28/04. Left arm swollen, red, tender left deltoid.  Where DTaP was given 7/26- No systemic symptoms. No fever, no chills, no breathing difficult, large area of redness, swelling and some degree induration which is covering most of the deltoid and upper arm and extending to medial aspect of left arm as well. Dx Augmentin 250/5ml 1 teaspoon or if systemic symptoms occur on 7/30/04. Child arm less swollen still red doing ok.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Blindness, Rash
Clinical narrative: Called by pt on 06/4/04 loss of vision, joint pain, rash on legs. Went through extensive testing told probably tetanus given.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Erythema, Feeling hot, Injection site mass, Oedema
Clinical narrative: 1) 4x3" oblong knot/swelling, red, warm to touch right arm. 2) Tyl every 4 hours, Atwax 12.5mg, every 4-6 hours, Prelone 3x day. Rev on Friday
Age: 2.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Erythema, Feeling hot, Injection site mass, Oedema, Pain
Clinical narrative: 1) Right thigh at DTaP inj site 3in x 2in oblong knot/swelling red, sore, warm to touch. 2) Rx Benadryl, cold compression, Tylenol F/U on Friday.
Age: 1.33
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Grand mal convulsion, Pyrexia
Clinical narrative: Child had fever 100-101 (04/01/04) and had grand mal seizures. Child has had 8 seizures since 4/1/04 always accompanied by fever.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Information has been received from an LPN concerning a 69 year old female with hypothyroidism, atrial fibrillation, arthritis, mitral valve prolapse and an allergy to sulfa medications who on 05NOV2003 was vaccinated with a first or second dose of dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included Betapace, sulindac, Synthroid, and Altace. On 06NOV2003 the pt awoke with a local rxn described as erythema the size of a grapefruit. Unspecified medical attention was sought and the area was treated with ice. No product quality complaint was involved.  It was also noted that another female pt was vaccinated with a dose of peumococcal 23v polysaccharide vaccine and developed cellulitis. It was noted that the physician was concerned about the size of the rxns since both pts received doses from the same lot number. 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. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received form a physician concerning a 70 year old female with no medical hx or allergies wh on 04NOV2003 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medicaiton. On 06NOV2003 the pt complained that the injection site and the area two inches below the injection site was red, swollen, and warm. The physician advised the pt to treat the condition with an ice pack. There were no lab diagnostic studies performed and a product quality complaint was not involved. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site induration, Injection site mass, Injection site swelling, Swelling
Clinical narrative: Information has been received from a 64 year old female consumer with an allergy to sulfa products and no pertinent medical hx who recently, in approximately November 2003, was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. It was reported that her arm began to swell around the injection site. Her arm got really swollen, the lump got as big as her hands and it was hard as a rock and warm to touch. It was also very painful. The reporter indicated that on 07NOV2003 it seemed a little abated an the swelling was going down. Unspecified medical attention was sought. the pt does not have a physician. No product quality complaint was involved. It was reported that the pt was recovering with sequalea. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Pain
Clinical narrative: Information has been received from a health professional concerning a 22 year old female receptionist who "over the past two weeks" was vaccinate with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the pt developed LA pain that went down to her fingers and numbness of all of her arm and fingers. Unspecified medical attention was sought. No product quality complaint was involved.  The reporter expressed a concern with the lot. It was also reported that 3 other pts were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed adverse reactions ranging from a localized red mark to the pts not being able to lift their arm. 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 Center for Biologics Evaluation and research and was released.  Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Dry mouth, Skin exfoliation, Swelling face
Clinical narrative: Information has been received from a physician's office and a 71 year old female consumer in a technical sales with a hx of similar rxn to products that contain formaldehyde who on 11FEB2003 was vaccinated IM with a 0.5 ml dos eof pneumococcal 23v polysaccharide vaccine. concomitant therapy included Levoxyl, generic Librax, Triamterene and lovastatin. There was no illness at the time of vaccination. Approximately three weeks after being vaccinated, the pt reported that her lips began to bubble, crack and peel. She reported that she tried chap stick, Blistex and antibiotic ointment but her condition had not improved. Her physician had not recommended any other treatment. No diagnostic studies were performed. It was reported that the physician's office did not see the pt regarding this event. Subsequently, the pt recovered. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a LPN concerning a 48 year old female who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 646159/0287N). Concomitant vaccine therapy in the opposite arm included a dose of influenza virus vaccine (unspecified). About 6-8 hours post-vaccination the pt developed an injection site reaction with upper arm soreness and swelling. Unspecified medical attention was sought. No other information was provided. No product quality complaint was involved. It was also reported that another pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 646159/0287N) and developed an injection site reaction (WAES #0311USA01000).  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a LPN concerning a 64 year old female with diabetes, gastroesophageal reflux disease (GERD) and an allergy to PCN who on 10/17/03 was vaccinated with a first or second dose of pneumococcal 23v polysaccharide vaccine (Lot #644105/0820M). Concomitant therapy included glipizide (Glucotrol), lansoprazole (Prevacid), and oxybutynin chloride (Ditropan). Subsequently, the pt developed cellulitis of the left upper arm. Unspecified medical attention was sought and the pt was treated with an unspecified antibiotic. Subsequently, the pt's condition resolved. No product quality complaint was involved. Upon internal review, cellulitis of the left upper arm was determined to be an other important medical event (OMIC). It was also reported that another female pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot #644105/0820M) and developed a local reaction with erythema (WAES # 0311USA00696).  It was noted that the physician was concerned about the size of the reactions since both pt's received doses from the same lot number. 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: 62.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Injection site erythema, Injection site oedema, Injection site warmth, Rash
Clinical narrative: Information has been received from a RN concerning a 62 year old Caucasian female with a medical history of hypertension, asthma and "acid reflux" who on 11/05/03 was vaccinated IM in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (Lot # 645646/0068N)(P1: 10 years prior). There was no illness at the time of vaccination and no adverse events following prior vaccination. Subsequently, on approximately 11/05/03, the pt developed a rash, severe cough, local swelling, redness and heat also reported as red and inflamed at the injection site. Unspecified medical attention was sought, but the pt was not hospitalized. A product quality complaint was not involved. No further information is requested.
Sex: F
Vaccine: PPV
Symptoms: Fatigue
Clinical narrative: Information has been received from a health professional concerning a female pt who on 10/31/03 was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (Lot # 647654/0865N). Concomitant therapy included bisoprolol fumarate/HCTZ (Ziac). On 11/02/03 the pt experienced extreme fatigue. The nurse reported that the pt "felt wiped out and could barely left her head". No local symptoms were noted. Unspecified medical attention was sought and no treatment was required. It was reported that the therapy was "discontinued". There was no product quality complaint involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a LPN concerning a female in her late 60's who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 646159-0287N). Concomitant vaccine therapy in the opposite arm included a dose of influenza virus vaccine (unspecified). About 6-8 hours post-vaccination the pt developed an injection site reaction with upper arm soreness, and swelling. It was also reported that the pt developed cellulitis. Unspecified medical attention was sought. No other information was provided. No product quality complaint was involved. It was also reported that another pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 646156/0287N) and developed an injection site reaction (WAES # 0311USA00849).  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Rash, Skin exfoliation
Clinical narrative: Information has been received from a 64 year old female with diabetes mellitus insulin-dependent and allergies to diphenhydramine hydrochloride (Benadryl), tetracycline, and PCN who on 10/28/03 in the AM was vaccinated IM in the left arm with a first 0.5mL dose of pneumococcal 23v polysaccharide vaccine (Lot # 642749/0111M). There was no concomitant medication. Subsequently, after vaccination, the pt experienced soreness at the site of injection. The pt also reported a rash that developed "two days later" that eventually spread from her arm to her neck, back, stomach, and face. The pt indicated that the rash was "now beginning to peel". Diphenhydramine hydrochloride (Benadryl) was used as treatment for the rash, however the pt experienced a rash from that as well. Medical attention was sought. No diagnostic tests or lab data were reported. The outcome was reported as recovered with sequelae. There was no product quality complaint involved. Follow up information received from the physician indicated that on 10/30/03 the pt was initially swollen and erythematous at the injection site. The pt then developed a widespread diffuse, erythematous urticarial type rash with desquamation. The pt recovered on 11/14/03.  Follow up information received on 12/04/03 indicated that the pt's skin "is now very rubbery feeling". It was noted that "her physician says that it looks like she will be having new skin." No further information is expected.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Information has been received from a 64 year old female with diabetes mellitus insulin-dependent and allergies to diphenhydramine hydrochloride (Benadryl), tetracycline, and PCN who on 10/28/03 in the AM was vaccinated IM in the left arm with a first 0.5mL dose of pneumococcal 23v polysaccharide vaccine (Lot # 642749/0111M). There was no concomitant medication. Subsequently, after vaccination, the pt experienced soreness at the site of injection. The pt also reported a rash that developed "two days later" that eventually spread from her arm to her neck, back, stomach, and face. The pt indicated that the rash was "now beginning to peel". Diphenhydramine hydrochloride (Benadryl) was used as treatment for the rash, however the pt experienced a rash from that as well. Medical attention was sought. No diagnostic tests or lab data were reported. The outcome was reported as recovered with sequelae. There was no product quality complaint involved. Follow up information received from the physician indicated that on 10/30/03 the pt was initially swollen and erythematous at the injection site. The pt then developed a widespread diffuse, erythematous urticarial type rash with desquamation. The pt recovered on 11/14/03.  Follow up information received on 12/04/03 indicated that the pt's skin "is now very rubbery feeling". It was noted that "her physician says that it looks like she will be having new skin." No further information is expected.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Information has been received from a 42 year old white female consumer with a history of a food allergy, sulfur allergy and allergy to Levaquin who on 11/10/03 at 3:00pm, was vaccinated SC in the right (also reported as IM) with a 0.5mL first dose of pneumococcal 23v polysaccharide vaccine (Lot # 646159/0287N). Concomitant therapy included fluvoxamine maleate (Luvox), levothyroxine Na (Synthroid) and ethinyl estradiol/norgestimate (Ortho Tri-cyclen). There was no illness at the time of vaccination. Within 48 hours the pt experienced hives (also reported as prickly spots). The pt reported that she is being treated with Benadryl for the hives. Medical attention was sought. It was unknown if labs or diagnostics were done. It was reported that the pt was recovering with sequelae.  No product quality complaint was involved. Follow up information received from the physician indicated that the pt did not come in for a office visit. She reported to the physician that she had prickly spots all over. There were no labs or diagnostic tests done. It was reported that the pt recovered. Additional information is not expected.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a CMA concerning a 45 year old female with a drug allergy to PCN, codeine and a "vaccine preservative" who in 1995 was vaccinated with a first dose and on 11/11/03 was vaccinated IM with a second 0.5mL dose of pneumococcal 23v polysaccharide vaccine (Lot # 646322/0530N). Concomitant therapy included levothyroxine Na (Synthroid), fexofenadine hydrochloride (Allegra) and "nerve medicine". Two hours after the vaccination, the pt developed a local reaction that was described as her arm was raised, warm and painful at the injection site. The pt put ice on it and took fexofenadine hydrochloride (Allegra). She reported that it felt a little better. No prescription drug was required. No diagnostic studies were performed. The physician's office requested an investigation into this lot number. No product quality complaint was involved. 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 another female pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed a local reaction with redness and swelling of her arm (WAES #0311USA01956).  Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Laboratory test abnormal, Leukocytosis, Paraesthesia, Pyrexia
Clinical narrative: Information has been received from a physician concerning his 74 year old wife who on 10/02/03 was vaccinated with a third dose of pneumococcal 23v polysaccharide vaccine (Lot # 644220/1119M). Concomitant therapy included alendronate sodium and aspirin. It was noted that the pt received the second dose of pneumococcal 23v polysaccharide in 1984. After vaccination the pt experienced chills, a fever of 102.6, vomiting and paresthesia (date not specified). The reporter indicated that 12 days after vaccination the pt was taken to the ER and extensive tests were performed. A chest x-ray was normal, a rapid strep test was positive, and a blood culture revealed polymorphonuclear leukocytes 81%, lymphocytes 15%, and monocytes 2%. The pt was not admitted to the hospital but was treated with erythromycin and azithromycin (Z-pak). The client was recovering but had a relapse of fever and was hospitalized on 10/23/03 for four days. Extensive tests were taken including an ultrasound of the gall bladder, abdomen and pelvis (results not reporter), two blood cultures (results not reported), an erythrocyte sedimentation rate which was normal, and an echocardiogram which was normal but with some calcification.  The pt was released from the hospital on 10/27/03 with a discharge diagnosis of fever of unknown origin. It was noted that the event abated and the pt was recovering with sequelae. A product quality complaint was not involved. Follow up information was received from a nurse in the physician's office. The reporter indicated that the physician felt that the pt's symptoms had nothing to do with the pneumococcal 23v polysaccharide vaccine. The reporter noted that the pt had been having "problems" before the vaccination because of cat bites that she had received and was on an antibiotic because of the bites. The office had not heard from the pt since 10/03 and it was assumed that the pt had recovered. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning his 74 year old wife who on 10/02/03 was vaccinated with a third dose of pneumococcal 23v polysaccharide vaccine (Lot # 644220/1119M). Concomitant therapy included alendronate sodium and aspirin. It was noted that the pt received the second dose of pneumococcal 23v polysaccharide in 1984. After vaccination the pt experienced chills, a fever of 102.6, vomiting and paresthesia (date not specified). The reporter indicated that 12 days after vaccination the pt was taken to the ER and extensive tests were performed. A chest x-ray was normal, a rapid strep test was positive, and a blood culture revealed polymorphonuclear leukocytes 81%, lymphocytes 15%, and monocytes 2%. The pt was not admitted to the hospital but was treated with erythromycin and azithromycin (Z-pak). The client was recovering but had a relapse of fever and was hospitalized on 10/23/03 for four days. Extensive tests were taken including an ultrasound of the gall bladder, abdomen and pelvis (results not reporter), two blood cultures (results not reported), an erythrocyte sedimentation rate which was normal, and an echocardiogram which was normal but with some calcification.  The pt was released from the hospital on 10/27/03 with a discharge diagnosis of fever of unknown origin. It was noted that the event abated and the pt was recovering with sequelae. A product quality complaint was not involved. Follow up information was received from a nurse in the physician's office. The reporter indicated that the physician felt that the pt's symptoms had nothing to do with the pneumococcal 23v polysaccharide vaccine. The reporter noted that the pt had been having "problems" before the vaccination because of cat bites that she had received and was on an antibiotic because of the bites. The office had not heard from the pt since 10/03 and it was assumed that the pt had recovered. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a LPN concerning a 70 year old Caucasian female pt with no known allergies who on 11/10/03 was vaccinated SC in the left arm with a dose of pneumococcal 23v polysaccharide vaccine. On 11/12/03, the pt developed a local site reaction of redness, a swollen arm and tenderness to touch. The left arm became red, warm to touch and edematous with complaints of pain, redness and edema radiating from the shoulder area down to the left elbow. The pt was treated with Duricef 500mg for 7 days. No further complaints were noted. Subsequently, the pt recovered. A product quality complaint was not involved. Additional information is not expected.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a health professional concerning a female who on 10/31/03 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 645646/0068N). This was a revaccination with pneumococcal 23v polysaccharide vaccine. Concomitant therapy that day included a dose of influenza virus vaccine (Unspecified). Subsequently the pt developed local redness, swelling, and pain. The pt went to the ER, but was not admitted to the hospital. No additional information was provided. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.