chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Inflammation
Clinical narrative: Local inflammatory response throughout entire left  upper arm, loss of 2 duty days, resolving.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site rash, Urticaria
Clinical narrative: Welted rash around site of shot. Occurred 2-3 x's /wk for the first month after shot, mostly after working out. Currently is taking medication for rash that is possibly related to vaccination.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Skin reaction
Clinical narrative: Given smallpox vac  yesterday 4/27, Developed skin rxn 4/28
Age: 29.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Oedema
Clinical narrative: Large local rxn to elbow with erythema and swelling left arm. Tx with Motrin and Benadryl. Refer to Allergist.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Face oedema, Pain, Vaccine positive rechallenge
Clinical narrative: Swelling of nasal mucous and pain in upper dentition with some swelling
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Angioneurotic oedema
Clinical narrative: (tongue, hand, trunk: lasting <12hours) No associated hives. Angio-edema starting 1-2 weeks for anthrax #2 (FAV 076). Symptoms continued x 6 months and did not have specific relation to shots except temporal onset association. Last anthrax 9/03. Last angioedema 3/04.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Gastrointestinal disorder, Vomiting
Clinical narrative: Complained of GI upset at 4AM 7/29/04, progressing to vomiting- plans to follow up with PMD. PC to health department to question possibility of Hep B #3 injection and symptom onset.
Sex: F
Vaccine: HEP, TD
Symptoms: Feeling hot, Injection site induration, Muscle twitching, Musculoskeletal stiffness, Pain
Clinical narrative: 4 hours after shot felt like someone had hit her right arm. At 6:30 AM the next morning definite stiffness in arm. Arm twitched that evening even when she laid on her arm: twitching continued x 24 hours. Deltoid muscle swollen and firm. Warm to touch 7/30.
Sex: F
Vaccine: HEP, TD
Symptoms: Swelling
Clinical narrative: 4 hours after shot felt like someone had hit her right arm. At 6:30 AM the next morning definite stiffness in arm. Arm twitched that evening even when she laid on her arm: twitching continued x 24 hours. Deltoid muscle swollen and firm. Warm to touch 7/30.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular, Rash pustular
Clinical narrative: Various stages of scabbed and unscabbed papules and pustules.
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Crying, Irritability, Pyrexia
Clinical narrative: Received immunization at 9:00Am , around 2:30 pm started with crying spells lasting 1-3 hours and fever had continued with bouts of moderate irritability and crying.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Injection site warmth, Swelling, Viral infection
Clinical narrative: Pt seen by doctor on 7/27 for 4 yea old check up. Complained of increased swelling later that day. Flu 7/29 with large 6x8 cm circular warm area on leg where MMR received. Flu 7/30.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Discomfort, Erythema, Feeling hot, Swelling, Tenderness
Clinical narrative: Redness over his right thigh that is also swollen, warm and sensitive to touch. Complaint of slight discomfort.
Age: 18.0
Sex: M
Vaccine: DT, MEN
Symptoms: Headache, Musculoskeletal stiffness, Myalgia, Pyrexia
Clinical narrative: Fever 101-102 degrees intermittently for 48 hours after vaccination. Diffuse myalgia, headache, stiff neck. Resolved spontaneously.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Pain
Clinical narrative: 6/3/04: Pain in right arm from shoulders to wrist.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pyrexia, Swelling, Urticaria
Clinical narrative: Patient developed mild fever on Wednesday 7/28/04. T 99.8-100 degrees. Developed hives on Thursday 7/29/04 involving chest, shoulders, back of neck, under arms. Left arm reddened and slightly swollen.
Age: 1.4
Sex: M
Vaccine: HBHEPB
Symptoms: Agitation, Crying, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Mother reported episodes of inconsolable crying off and on since vaccine. Also reported warmth and redness at site with edema on 7/20: resolved by time of exam. Brought to clinic because of crying. At that time, was also found to have right otitis media and had fallen while running and hit head during this time.
Age: 1.4
Sex: M
Vaccine: HBHEPB
Symptoms: Otitis media
Clinical narrative: Mother reported episodes of inconsolable crying off and on since vaccine. Also reported warmth and redness at site with edema on 7/20: resolved by time of exam. Brought to clinic because of crying. At that time, was also found to have right otitis media and had fallen while running and hit head during this time.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Dyskinesia, Feeling hot, Muscle twitching, Pyrexia
Clinical narrative: Vaccinated 6 pm. Returned home was playful. Around 12 midnight called for mother. Was warm to touch , twitching and jerking. Mom gave Tylenol T1/2 after Tylenol 102.5. Symptoms persisted called ER, then took patient to ER. Diagnosed moderate reaction to vaccine. Discussed with mom to observe for. Mom contacted doctor again questioned viral infection.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Eye disorder, Pruritus, Rash
Clinical narrative: Scratch OT rough. Rash all over body. In her ears also. Right eye closed. went to hospital. Medicine given Cetirizine 1/ml lg 120m
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: Pt developed hives encompassing his entire body after the vaccines were given (within 24 hours).
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site swelling
Clinical narrative: Prominent swelling of upper left arm at site of infection. No further care except Motrin. Local care.
Sex: F
Vaccine: PPV, TD
Symptoms: Dry skin, Erythema, Pruritus, Skin burning sensation, Skin exfoliation
Clinical narrative: had immunizations on 7/15. One week later had redness , dryness, itchy, burning on face, cheeks, forehead. Now is peeling. No signs of infection. Afebrile.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Anorexia, Blister, Irritability, Pyrexia, Rash
Clinical narrative: Started with a fever of 102 degrees, increased irritability, crankiness, loss of appetite, fever, lowered on Sunday but other symptoms persisted. Rash began to develop. Monday morning small blisters appeared in various parts of the body.
Sex: M
Vaccine: TD
Symptoms: Rash, Rash erythematous, Rash macular, Skin reaction
Clinical narrative: MD visit for on going observation rash extensive raised macules in gigantic confluent patches, erythematous mostly on trunk and LE and arms with relative sparing face > buttocks. Also on soles of feet/ hands plus a few areas of excoriation.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: On 7/13/04 vaccine administered. on 7/14/04 client's daughter called to say client's arm was "red, warm and swollen to the elbow". On 7/15/04, she called again and said "It's alright now."
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: left arm immediately began swelling after administration of vaccine. Site red, swollen, warm to touch. Given oral Benadryl. Monitored in office for 30 minutes.
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Diagnosed with chicken pox.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Muscular weakness
Clinical narrative: Muscle weakness in the arm lasting 2 to 3 weeks.
Age: 1.6
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The leg receiving the DTaP became red and swollen 24 hours after shot. By 48 hours, the redness had moved laterally out from the injection site. The thigh was red and swollen and hot; 5-6" diameter.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Area of vaccine red, swollen and hot to touch.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Right deltoid area had redness and slight swelling, warm to touch, but not hot. Mother reported first noticed today 7/28/04. Patient reported areas itched.
Age: 2.7
Sex: F
Vaccine: UNK
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: 130mm by 230mm erythematous, hard, swollen left leg. No other symptoms. Cellulitis, large reaction. Topical cream and oral Benadryl. Augmentin 400mg/5ml, 3/4 teaspoon BID for five days. Orapred 15mg/5ml, 2 teaspoons OID for 24 hours.
Age: 23.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Skin nodule
Clinical narrative: Redness noted 7/26/04; harden area 7/20/04.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Per phone call from mom 7/28/04 11:46, dime size red bumps at injection site. Will use cool compress to site; Tylenol as needed. Return to clinic if worsens.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Urticaria
Clinical narrative: Generalized urticaria; no angioedema.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Malaise, Pyrexia, Rash morbilliform
Clinical narrative: Patient developed arthralgia, malaise 8 days after vaccination. Rash developed 10 days after vaccination. Rash description is consistent with a case of the measles. Max fever 102 on 7/29/04.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: 5"x5" area of erythema and induration on right thigh; fever of 102.8.
Age: 26.0
Sex: M
Vaccine: TD, VARCEL
Symptoms: Diplopia, Guillain-Barre syndrome
Clinical narrative: Received phone call from a medical director that a first year resident was being seen by neurology for possible work up of Guillain Barre Syndrome. Resident first complained of double vision; patient said possible Miller-Fisher Syndrome.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 24 hours after immunization, area red/swollen; went to ER. Rx given of Keflex and instructed to use Benadryl. Follow up with PCP on 8/2/04. Keflex discontinued 8/2/04 by PCP. Zyrtec given.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning an 89 year old female with dementia and hypertension who on 4/29/03 (previously reported as 4/30/03) was vaccinated in the left deltoid with a second dose of pneumococcal vaccine 23 polyvalent (lot # 645249/1196M). Concomitant therapy included antidepressants (therapy unspecified), anti-psychotics (therapy unspecified), anti-hypertensives (therapy unspecified) and pain medication. It was also reported that on 11/17/02 the patient may have been vaccinated with an initial dose of pneumococcal vaccine 23 polyvalent but the reporter was unsure if it was actually given to the patient. On 4/30/03 the patient's right or left deltoid (stated as right, but reporter noted vaccine was given on the left) became slightly swollen, firm and warm to touch (previously reported as no adverse symptoms were noted). The patient denied discomfort. Medical attention was sought and no treatment was required. Subsequently, the patient recovered. No further information is expected.
Age: 12.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant concerning a 12 year old male with no medical history who on the afternoon of 4/14/03 was vaccinated in the right deltoid with a first dose of pneumococcal vaccine 23 polyvalent (lot # 643783/0709M). The patient had sinusitis at the time of vaccination. Within the first 24 hours post vaccination, later that evening, the patient developed a site reaction on the right deltoid that was 3"x1.5" in diameter, red and patchy, slightly swollen, and warm to the touch. Unspecified medical attention was sought and the patient was treated with a dexamethasone dose pack. It was unknown if the patient recovered. No product quality complaint was noted. it was also reported that the patient's 9 year old siblings was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (lot # 643783/0709M) and also developed a site reaction. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 63 year old female patient who on 6/2/03 at 15:00 was vaccinated with a 0.5 ml dose of pneumococcal vaccine 23 polyvalent intra-articularily. It was noted that the patient developed intense pain/warmth at site and was treated symptomatically. It was noted that the patient went to the emergency room. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Feeling cold, Injection site inflammation, Insomnia, Lethargy, Malaise
Clinical narrative: Information has been received from a registered nurse concerning a 56 year old white female who on 5/29/03 was vaccinated IM in the right arm (deltoid) with a second booster dose of pneumococcal vaccine 23 polyvalent 0.5ml/dose (lot number 643503/0541M). On 5/30/03 the patient started to get a sore arm. Later that night, the patient could not sleep, felt extremely cold and had chattering teeth. On 5/31/03 the patient felt lethargic and ill. That evening, she slept for 10 hours. On 6/1/03 the patient felt better but her arm was still sore and inflamed. Unspecified medical attention was sought. There was no product quality complaint involved. The nurse also reported on another patient who experienced a similar reaction with pneumococcal vaccine 23 polyvalent (lot # 643503/0541M). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a CMA concerning a 60 year old female who on 06/02/03 was vaccinated IM in the deltoid with a 0.5 dose of pneumococcal 23 polyvalent (Lot # 644219/1079M). On approximately 06/02/03 the pt developed soreness at the injection site, redness, swelling and the anterior aspect of the arm had redness that radiated to the axilla area. The pt also complained of being tired. On 06/04/03, the pt was seen in the physician's office and no treatment was required. No product quality complaint was involved. It was also reported that a 55 year old female was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 644219/1079M) and developed soreness at the injection site, redness, swelling, being tired, and had pain in her hands and feet (WAES #0306USA00991).  Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a CMA concerning a 55 year old female who on 06/02/03 was vaccinated IM in the deltoid with a 0.5 dose of pneumococcal vaccine 23 polyvalent (Lot # 644219/1079M). On approximately 06/02/03 the pt developed soreness at the injection site, redness, swelling, and the anterior aspect of the arm had redness that radiated to the axilla area. She developed a fever of 101 and also complained of being tired and had pain in her hands and feet. On 06/04/03, the pt was seen in the physician's office and no treatment was required. No product quality complaint was involved. It was also reported that a 60 year old female was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 644219/1079M) and developed soreness at the injection site, redness, swelling, and being tired (WAES #0306USA00519).  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site erythema, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Information has been received from a female pt who on 06/05/03 was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent (P1: 6 years prior). Three to four hours post vaccination on 06/05/03, the pt was not able to raise her arm, her arm was stiff, she developed a red area with a 3 inch diameter at the site of vaccination and soreness. On 06/05/03, an analgesic was taken prior to going to sleep. As of 06/06/03, the pt's arm was still stiff and she was still not able to raise her arm. On 06/06/03 an analgesic was taken prior to going to sleep. On 06/09/03, the pt's adverse experiences had resolved. The pt was able to lift and move her arm. Additional information is not expected.
Age: 42.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Cellulitis, Headache, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a RN concerning a 42 year old white female diabetic mellitus counselor with diabetes, asthma, and hypothyroidism and no known drug allergies who on 06/09/03 was vaccinated SC on the outer aspect of her left upper arm with a second dose of pneumococcal vaccine 23 polyvalent (643249/0358M). It was noted that the pt had been vaccinated with at least one previous dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy on 06/09/03 included tetanus toxoid (Batch # Td88)(manufacturer unknown) administered in her left deltoid. There was no known illness at the time of vaccination. On the afternoon of 06/10/03, the pt developed swelling and redness at the injection site, a headache, pain, a fever and localized edema. On 06/11/02 (during today's visit) she was seen and treated for cellulitis. It was reported that upon exam in clinic her temperature was 99.2 degrees F with an 11cm in diameter erythema and general swelling extending several centimeters beyond the erythema. The area was soft and warm. Lab data included: WBC 12.4, neutrophils 80.2, lymphocytes 11.0, eosinophils 0.9, and a blood culture showed no growth. ON 06/12/03 the pt recovered. There was no product quality complaint involved. Follow up information received on 07/08/03 from a RN indicated that she was diagnosed with cellulitis. She was treated with cephalexin (Keflex). The pt recovered within one to two days. The reporter initially indicated that the cellulitis was an other important medical event because the pt received antibiotics which was a medical intervention. However, upon follow up, the reporter indicated that she did not feel that cellulitis required medical/surgical intervention to prevent death, life-threatening illness, hospitalization, or a significant disability/incapacity.  No further information is expected.
Age: 42.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Laboratory test abnormal, Pyrexia, White blood cell count increased
Clinical narrative: Information has been received from a RN concerning a 42 year old white female diabetic mellitus counselor with diabetes, asthma, and hypothyroidism and no known drug allergies who on 06/09/03 was vaccinated SC on the outer aspect of her left upper arm with a second dose of pneumococcal vaccine 23 polyvalent (643249/0358M). It was noted that the pt had been vaccinated with at least one previous dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy on 06/09/03 included tetanus toxoid (Batch # Td88)(manufacturer unknown) administered in her left deltoid. There was no known illness at the time of vaccination. On the afternoon of 06/10/03, the pt developed swelling and redness at the injection site, a headache, pain, a fever and localized edema. On 06/11/02 (during today's visit) she was seen and treated for cellulitis. It was reported that upon exam in clinic her temperature was 99.2 degrees F with an 11cm in diameter erythema and general swelling extending several centimeters beyond the erythema. The area was soft and warm. Lab data included: WBC 12.4, neutrophils 80.2, lymphocytes 11.0, eosinophils 0.9, and a blood culture showed no growth. ON 06/12/03 the pt recovered. There was no product quality complaint involved. Follow up information received on 07/08/03 from a RN indicated that she was diagnosed with cellulitis. She was treated with cephalexin (Keflex). The pt recovered within one to two days. The reporter initially indicated that the cellulitis was an other important medical event because the pt received antibiotics which was a medical intervention. However, upon follow up, the reporter indicated that she did not feel that cellulitis required medical/surgical intervention to prevent death, life-threatening illness, hospitalization, or a significant disability/incapacity.  No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: Information has been received from a hospital buyer concerning an adult female with no allergies who on 06/10/03 was vaccinated with pneumococcal vaccine 23 polyvalent (Lot # 644219/1079K), in the left arm. This was reported to be the only vaccination that the pt received this day. Subsequently, the pt developed a sore left arm with a 6 inch radius around the arm that was red, puffy and swollen arm. The pt sought medical attention and was treated with cephalexin (Keflex) and diphenhydramine HC1 (Benadryl). There were no lab diagnostic test performed. It was noted that the pt "gets a pneumococcal vaccine 23 polyvalent every year." The reporter stated that "she is holding the rest of this multi-dose vaccine and would like lot 1079M check[ed]."  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: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site abscess, Injection site erythema, Injection site induration, Injection site necrosis, Injection site oedema
Clinical narrative: Information has been received from a medical assistant concerning a 66 year old male pt with hyperlipidemia, benign prostatic hypertrophy, hypothyroidism, and a history of coronary artery bypass graft (CABG), who on 06/06/03 at approximately 10:00AM was vaccinated IM in the right deltoid with a 0.5mL, first dose of pneumococcal vaccine 23 polyvalent (Lot # 645255/1212M). Concomitant medications include doxazosin mesylate (Cardura), hydrochlorothiazide (+) lisinopril (Zestoretic), sildenafil citrate (Viagra), simvastatin, potassium chloride, and levethyroxine sodium (Synthroid). It was noted the pt was well, and did not have any illness at the time of vaccine was administered. It was noted that the pt's medical record indicated he then "felt ill" that evening (06/06/03), and developed a sore arm at the injection site. The pt was seen in the physician's office on 06/12/03, and reported that he had a blister that had ulcerated on his arm at the area of the pneumococcal vaccine 23 polyvalent injection. The medical assistant reporter that on 06/12/03, the physician had noted in the record, that the pt had a 5 cm area of erythema with an indurated area of necrosis of surface skin on his right deltoid. The physician also noted in the record that it "looked like a second degree burn" (also reported by a MA as necrotic area size of a nickel in right upper arm at injection site). The pt was treated with mupirocin (Bactroban)2x/day. The MA noted he was unsure if the pt had recovered. The MA noted the pt had not yet been seen again in the office. A product quality complaint was not reported.  Follow up information received from the physician reported that the pt's arm became sore on 06/06/03 at 16:30 and by the next morning the pt's arm was red, swollen and erythematous. The physician noted the pt then had an area of necrosis of the skin over the injection site. When the pt was seen on 06/12/03 he had a 5cm area of erythema with a 4cm area of skin slough/necrosis within it. The physician reported the pt recovered on 07/11/03.  No further information is expected.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Malaise
Clinical narrative: Information has been received from a medical assistant concerning a 66 year old male pt with hyperlipidemia, benign prostatic hypertrophy, hypothyroidism, and a history of coronary artery bypass graft (CABG), who on 06/06/03 at approximately 10:00AM was vaccinated IM in the right deltoid with a 0.5mL, first dose of pneumococcal vaccine 23 polyvalent (Lot # 645255/1212M). Concomitant medications include doxazosin mesylate (Cardura), hydrochlorothiazide (+) lisinopril (Zestoretic), sildenafil citrate (Viagra), simvastatin, potassium chloride, and levethyroxine sodium (Synthroid). It was noted the pt was well, and did not have any illness at the time of vaccine was administered. It was noted that the pt's medical record indicated he then "felt ill" that evening (06/06/03), and developed a sore arm at the injection site. The pt was seen in the physician's office on 06/12/03, and reported that he had a blister that had ulcerated on his arm at the area of the pneumococcal vaccine 23 polyvalent injection. The medical assistant reporter that on 06/12/03, the physician had noted in the record, that the pt had a 5 cm area of erythema with an indurated area of necrosis of surface skin on his right deltoid. The physician also noted in the record that it "looked like a second degree burn" (also reported by a MA as necrotic area size of a nickel in right upper arm at injection site). The pt was treated with mupirocin (Bactroban)2x/day. The MA noted he was unsure if the pt had recovered. The MA noted the pt had not yet been seen again in the office. A product quality complaint was not reported.  Follow up information received from the physician reported that the pt's arm became sore on 06/06/03 at 16:30 and by the next morning the pt's arm was red, swollen and erythematous. The physician noted the pt then had an area of necrosis of the skin over the injection site. When the pt was seen on 06/12/03 he had a 5cm area of erythema with a 4cm area of skin slough/necrosis within it. The physician reported the pt recovered on 07/11/03.  No further information is expected.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a RN concerning a 72 year old female hospital volunteer who on 04/30/03 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 642720/0172M). The reporter indicated that within 24 hours the pt developed swelling, redness and possible cellulitis at the injection site.  The pt was treated with IV cefazolin sodium (Ancef). Unspecified medical attention was sought. The pt subsequently recovered. A product quality complaint was not involved. Upon internal review, possible cellulitis was determined to be an other important medical event (OMIC). Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: Information has been received from a RN concerning a 56 year old female employee with no known drug allergies who on 06/16/03 was vaccinated with pneumococcal vaccine 23 polyvalent (Lot # 642720/0172M). There was no concomitant medication. On 06/17/03 the pt developed pruritus, redness and swelling at the injection site. Subsequently, one to two days later, the pt's symptoms resolved. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema
Clinical narrative: Information has been received from a nurse and a woman in a physician's office concerning a 66 year old white male, a minister with neuronitis, gout and drug allergies to IVP dye, PCN and aspirin, and past medical history of elevated uric acid, and renal calculi (kidney stones), who on 06/17/03 was vaccinated in the right arm (also reported as right deltoid) with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 645853/0256N). Concomitant medications included probenecid (manufacturer unknown) 500mg every day, colchicine 0.6mg every day, meclizine 12.5mg every 8 hours as needed, Nizoral shampoo 00.2%, hydrocortisone cream 0.2%, and Triamcinolone cream 0.1%. The physician indicated that on approximately 06/19/03 (also reported as 06/18/03 AM) the pt developed redness and swelling of the right arm below the deltoid, reported as "in area close to pneumococcal vaccine 23 polyvalent injection site", but not specifically at the injection site. The physician "thinks the nurse (temporary staff, not his regular nurse), administered the vaccine at an incorrect site, and doctor was unable to confirm exactly how given". The physician recommended ice and other therapies for the pt. No lab tests or diagnostic studies were performed. It was noted that there were no acute illness at the time of vaccination, and the pt had no known events following prior vaccination. Follow up information reported the pt recovered.  There was no product quality complaint. Unspecified medical attention was sought.  No additional information is expected.
Age: 9.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Information has been received from a CMA concerning a 9 year old pt who on 04/14/03 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (Lot #643783/0709M). Within the first 24 hours post vaccination, the pt developed a site reaction that was 3x5 inches in diameter, red and patchy, slightly swollen, and warm to the touch. Unspecified medical attention was sought and the pt was treated with a dexamethasone dose pack. No product quality complaint was noted. It was also reported that the pt's 12 year old brother was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 643783/0709M) and also developed a site reaction (WAES #0305USA01027).  Follow up information revealed that there was "no further information to offer in this case". No additional information is expected.
Age: 25.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site oedema, Injury
Clinical narrative: Information has been received from a RN concerning a 25 year old white male pt with no drug allergies who on 06/24/03 at 8:30AM was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 645853/0256N), "Intradermally instead of PPD" in the left forearm. Subsequently on 06/25/03 in the AM, the pt developed a swollen area at the site and also had 12x30 cm redness of arm. It was reported that the pt had "arm cellulitis." The pt was given cephalexin (Keflex) and was given a "new TB (PPD)" which was negative. Additionally it was reported that a nurse inadvertently administered pneumococcal vaccine 23 polyvalent rather than the PPD tuberculin skin test. The nurse indicated that a similarity in the product's names contributed to the confusion. No further information is expected.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injury
Clinical narrative: Information has been received from a pharmacist concerning a 73 year old white retired female in a nursing home with mitral valve prolapse and a history of a left total knee replacement who on 06/26/03 in the evening, also reported as 06/26/03 in the AM or 06/27/03 in the morning was vaccinated ID in the left forearm with a first 0.1mL dose of pneumococcal vaccine 23 polyvalent. The reporter indicated that "they thought it was mantoux". Concomitant medications included "tape", "IVP dye", azithromycine (Zithromax), PCN, Codeine, mercury, iodine, ranitidine hydrochloride (Zantac), sucralfate (Carafate), and levofloxacine (Levaquin). Areas of the arm have swelling and redness. No further information was provided. Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that the reporter confirmed that there was no "confusion" regarding the appearance or name of the product, and the error did not result from any confusion as to the proper dosing of the product. It was noted that the medication error resulted from a procedural error in their office. The nurse intended to vaccinate the pt with pneumococcal vaccine 23 polyvalent, but inadvertently used the "mantoux" administration procedures (0.1mL liquid injected ID).  Additional follow up information indicated that on 06/27/03 in the AM the pt developed redness and irritation around the injection site. No other symptoms were noted. The pt stated that she had some itching at times. No relevant diagnostic tests or lab data were reported.  The pt was reported as recovered on 06/29/03.  No further information is expected.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Muscular weakness, Pain
Clinical narrative: Information has been received from a Pharm D concerning a 67 year old Pacific Islander female who on 06/18/03 was vaccinated IM with a 0.5mL first dose of pneumococcal vaccine 23 polyvalent (Lot # 644220/1119M). The reporter indicated that "now", ten days after vaccination on 06/27/03, the pt "still has arm pain and weakness."  At the time of the report, the pt was unable to lift her vaccinated arm at all. Unspecified medical attention was sought and no treatment was required. There were no diagnostic tests or lab results. A product quality complaint was not involved. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Information has been received from a RN concerning an 80 year old Caucasian female with scoliosis, hypertension, hyperthyroid, chronic obstructive pulmonary disease, asthma and PCN allergy and a history of cardiac failure congestive and diverticulosis who on 07/01/03 in the AM was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent (Lot # 645255/1212M) (IM), in the left deltoid. Concomitant therapy included calcium carbonate (OS-CAL), aspirin, minerals (unspecified) (+) vitamins (unspecified) (Centrum), levothyroxine Na (Synthroid), citalopram hydrobromide (Celexa) and metoprolol succinate (Toprol XL tablets). On 07/01/03 the pt experienced an injection site reaction with chills, headache, left arm red, hot and swollen under arm (shoulder) to elbow. The pt sought medical attention. The pt was treated with diphenhydramine HC1 (Benadryl) and cool compresses (PRN) and the pt reportedly recovered. It was noted that the pt had been vaccinated with a dose of pneumococcal vaccine 23 polyvalent, "in the 1990's". 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 had a similar reaction (WAES #0307USA01185).  Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Hypokinesia, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 61 year old female who on 07/01/03 around 1500 was vaccinated IM with a first dose of pneumococcal vaccine 23 polyvalent. On 07/01/03 by 1900, the pt's arm was painful from her elbow to her shoulder, and it also felt numb around the injection site. There was no fever, and the arm was not red or swollen. It was reported that the pt was also "having difficulty using the arm". It was also noted that "the pain does seem to have lessened somewhat from two days ago". No other information was provided. Unspecified medical attention was sought.  There were no lab diagnostic studies performed. There was no product quality complaint.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Information has been received from a RN concerning an elderly pt who last week, on an unspecified date in approximately July 2003, was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent (Lot # 645246/0029N). The pt developed local swelling, redness and warmth. The RN reported the pt was not hospitalized although treatment was required. It was noted the pt was treated with diphenhydramine HC1 (Benadryl). It was noted that the pt was previously immunized with a dose of pneumococcal vaccine 23 polyvalent "about 5 years ago". The RN expressed concern about the lot of pneumococcal vaccine 23 polyvalent, and she required a lot check. No additional information was provided. Unspecified medical attention was sought. 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 reporter also mentioned another pt who had similar experiences following vaccination with pneumococcal vaccine 23 polyvalent (WAES # 0307USA01204).
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Flushing, Malaise
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female with a history of a "cardiac surgery" who on 07/07/03 was vaccinated IM with a dose of pneumococcal vaccine 23 polyvalent. On 07/07/03, immediately upon injection of the vaccine, the pt experienced flush, shortness of breath and malaise of very short duration. It was reported that the symptoms lasted less than 5 minutes and the pt completely recovered without treatment. The pt was not hospitalized. Unspecified medical attention was sought. Additional information has been requested.
Age: 68.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Malaise
Clinical narrative: Information has been received from a wholesaler calling on behalf of a physician concerning three pt's who were each vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 644106/0819M). Subsequently, the pt's developed inflammation around the injection site that included redness and soreness. Unspecified medical attention was sought. A product quality complaint was not involved. Follow up information was received from a physician concerning the three pt's, which included a 68 year old pt, who between 06/01/03 and 06/04/03 were each vaccinated SC with a dose of pneumococcal vaccine 23 polyvalent (Lot # 644106/0819M). Subsequently in approximately June 2003, all three pts developed local swelling, malaise and were not feeling well, "i.e. local reaction". Within three to five days, all three pt's had recovered with no residual problems. The reporter noted, "we had 2 more bottles of the same batch, will return". The records of testing prior to release of this lot have been checked by 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 other two pt's included a 69 year old pt (WAES # 0307USA03537) and an 89 year old pt (WAES #0307USA03535).  Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Information has been received from a RN concerning a 79 year old Caucasian female with a history of arrhythmia, tachycardia, high cholesterol, tinnitus, diarrhea, diverticulosis and breast cancer who on 07/01/03 in the AM was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent (Lot # 645255/1212M)(IM), in the left deltoid. Concomitant therapy included digoxin (Lanoxin), alprazolam (Xanax), polyethylene glycol 3350 (Miralax), letrozole (Femara), and calcium (unspecified). It was also noted that the pt had allergies to "brain scan dye", erthromycine (E-mycin), cefuroxime sodium (Keftab)(diarrhea), tamoxifen, meperdine HC1 (Demerol), disopyramide phosphate (Norpace) and cisapride (propulsid). On 07/01/03 the pt experienced left tricep and bicep warmth and erythema also described as "red swollen down to elbow". The pt sought medical attention. The pt was treated with Benadryl, antihistamines and ice/cool compresses (PRN). The reporting nurse inquired if there had been any concerns with this lot of pneumococcal vaccine 23 polyvalent (Lot # 645255/1212M). It was also noted that on 07/21/03 the pt developed a numb hand and it was reported that "don't know if it is related." It was reported that the pt recovered. 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 pt had similar symptoms (WAES # 0307USA00308).  Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: HIBV, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a "nurse" concerning a 34 year old white female pt with "chronic sinusitis" who on 05/21/03 at 9:45 was vaccinated in the right arm with a dose of pneumococcal vaccine 23 polyvalent (Lot # 645246/0029N). Concomitant therapy on 05/21/03 included an IM first dose in the left arm of Haemophilus B conjugate vaccine (Lot # 645971/0253N). On 05/21/03 at 1800 the pt developed increased fever and erythema and soreness at the injection site of the pneumococcal vaccine 23 polyvalent. Soreness at the site was a "2.5x3x0.1cm" area at the site of erythema. There was no relevant diagnostic lab data. It was noted that an infectious disease specialist ordered the vaccinations because the pt had been having recurrent infections and "they wanted to see what kind of antibodies she would build".  The pt recovered from the fever, erythema and soreness at the injection site. No further information is expected.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Information has been received form a registered nurse concerning an elderly patient who last week,on an unspecified date in approximately July 2003, was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent. The patient developed local swelling, redness and warmth. The registered nurse reported the patient was not hospitalized although treatment was required. It was noted that the patient was previously immunized with a dose of pneumococcal vaccine 23 polyvalent "about 5 years ago". The registered nurse expressed concern about the lot of pneumococcal vaccine 23 polyvalent , and she requested a lot check. No additional information was provided. Unspecified medical treatment was sought. 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 reporter also mentioned another patient who had similar experiences following vaccination with pneumococcal vaccine 23 polyvalent (WAES 0307USA00760).
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site pain, Medication error
Clinical narrative: Information has been received from a physician concerning a 23 year old white female employee with no allergies or medical history who on 10JUL2203 at 10:00 am was vaccinated intradermally in the left forearm with a 0.1mg first dose of pneumococcal vaccine 23 polyvalent. There was no illness at the time of vaccine. The reporter indicated that the vaccination was inadvertently given ID instead of a tuberculin purified protein derivative PPD. The area had developed a three to four centimeter welt. Unspecified medical attention was sought and the pt was treated with cold compresses and Benadryl 50mg. At the time of the report, the pat had not recovered. No additional employee information was anticipated. A product quality complaint was not involved. Additional information was received from a physician's assistant which also indicated that the pat received an ID dose of  pneumococcal vaccine 23 polyvalent instead of PPD at her job site. The reporter indicated that she saw the pt for an adverse skin reaction for a work place injury. the reporter noted that on approximately 10JUL2003 the pt now had a local injection site hypersensitivity reaction which included erythema, itching, induration and pain. The reporter indicated that the patient recovered. Follow up information was received form the physician which indicated that at 10:00AM at 10JUL2003 the pt had local swelling and pruritus only. The patient was seen on 14JUL2003 and her arm looked fine and the swelling was completely resolved. There were no diagnostic tests or laboratory results. It was also noted that the pt had no adverse events following prior vaccination. The reporter indicated that the similarity in the products' names contributed to the confusion. No additional information is expected.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Skin reaction, Swelling, Urticaria
Clinical narrative: Information has been received from a physician concerning a 23 year old white female employee with no allergies or medical history who on 10JUL2203 at 10:00 am was vaccinated intradermally in the left forearm with a 0.1mg first dose of pneumococcal vaccine 23 polyvalent. There was no illness at the time of vaccine. The reporter indicated that the vaccination was inadvertently given ID instead of a tuberculin purified protein derivative PPD. The area had developed a three to four centimeter welt. Unspecified medical attention was sought and the pt was treated with cold compresses and Benadryl 50mg. At the time of the report, the pat had not recovered. No additional employee information was anticipated. A product quality complaint was not involved. Additional information was received from a physician's assistant which also indicated that the pat received an ID dose of  pneumococcal vaccine 23 polyvalent instead of PPD at her job site. The reporter indicated that she saw the pt for an adverse skin reaction for a work place injury. the reporter noted that on approximately 10JUL2003 the pt now had a local injection site hypersensitivity reaction which included erythema, itching, induration and pain. The reporter indicated that the patient recovered. Follow up information was received form the physician which indicated that at 10:00AM at 10JUL2003 the pt had local swelling and pruritus only. The patient was seen on 14JUL2003 and her arm looked fine and the swelling was completely resolved. There were no diagnostic tests or laboratory results. It was also noted that the pt had no adverse events following prior vaccination. The reporter indicated that the similarity in the products' names contributed to the confusion. No additional information is expected.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site induration, Lymph node pain, Pyrexia, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a 30 year old female pt who in the am of 12JUL2003 was vaccinated with dose of pneumococcal vaccine 23 polyvalent. In the afternoon of 12JUL2003, the pt returned to the medical office with a swollen arm. Unspecified medical attention was sought. A product quality complaint was not involved. Follow up information received from a different RN indicated that the pt was a 30 year old female teacher with no allergies no past medical conditions. The pt was vaccinated SC in the LUA with dose of pneumococcal vaccine 23 polyvalent. There was no illness at the time of vaccination and there were no adverse evens following prior vaccination . In the afternoon of 12JUL2003, the pt developed a low grade fever of 100.4, 100mm of erythema and induration, and arm and axillary lymph node pain. On 14JUL2003, the pt  was seen in the medical doctor's office. The pt was treated with two packs of Zithromax and  10 day course of Medrol.  The reporter noted that on 21JUL2003, the pt recovered form the low grade fever of 100.4, 100 mm of erythema and induration and arm and axillary lymph node pain. Additional information is not expected.