chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: HEP, HEPA, MMR, TD
Symptoms: Coagulation time shortened, Convulsion, Dizziness, Hypoaesthesia, Nausea
Clinical narrative: 6/25/03 at 2am body puffy, dizzy, nausea, vomited, then found in fetal position and had a seizure, unconscious for 20 seconds felt fine for 2 days then there was nausea, dizziness, blurry vision. Visited neurologist still have tingling/numbness on hands, feet shin, calf. Now being sent to allergist. Follow up on 10/28/2003: "Vaccine recipient did not recover from adverse events.  Numbness/tingling; weakness; Fatigue; Demyelination (brain)."
Age: 37.0
Sex: F
Vaccine: HEP, HEPA, MMR, TD
Symptoms: Oedema, Syncope, Vision blurred, Vomiting
Clinical narrative: 6/25/03 at 2am body puffy, dizzy, nausea, vomited, then found in fetal position and had a seizure, unconscious for 20 seconds felt fine for 2 days then there was nausea, dizziness, blurry vision. Visited neurologist still have tingling/numbness on hands, feet shin, calf. Now being sent to allergist. Follow up on 10/28/2003: "Vaccine recipient did not recover from adverse events.  Numbness/tingling; weakness; Fatigue; Demyelination (brain)."
Age: 1.5
Sex: M
Vaccine: DTP, IPV
Symptoms: Autism, Cognitive disorder, Sleep disorder
Clinical narrative: 18 months stopped sleeping through night. 18 months started losing speech-stopped saying words, only said sounds like "da, ga, woo." Diagnosed with autism.
Age: 47.0
Sex: M
Vaccine: IPV
Symptoms: Fatigue, Lymphadenopathy, Lymphoma
Clinical narrative: Enlarged lymphnodes, extreme fatigue. 36 years after polio vaccines. Groin mass right, biopsy performed. 4/25/96 results: follicular mixed small navel large cleared non Hodgkin's lymphoma. Cytoxyn, Nitoicristone, Thydurtme, Rituprn.
Age: 31.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: No reaction until 48 hours after shot then pt developed 3 cm x 3 cm swelling and redness around immunization site and severe pain radiating into forearm.
Age: 20.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis. 12 7/8 right leg, 11 7/8 left leg. Augmentin 600 4cc/Benadryl 1/2 tsp TID
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Cellulitis
Clinical narrative: Left thigh cellulitis 2 days post immunization.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Flushing, Nausea, Pruritus, Rash erythematous
Clinical narrative: Vaccinated 5/27/03. Reaction started 6/8/03. Red raised welps left upper arm, neck, right chest and back. Some raised areas itch. Felt flush at time. Couple episodes of nausea but no vomiting.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Muscle twitching, Muscular weakness
Clinical narrative: Twitching of muscles, sensation of vibration of legs, eyelids, other muscles. Subjective muscle weakness.  Follow up on 08/20/2003: "Immunization was given at local urgent care, not at office.  I don't have the requested information."
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Child vaccinated on 7/25/2003 with DTaP, IV Polio and MMR and developed swelling, redness and warmth at right thigh at injection site. Benadryl elixir 1 tsp every 4 hours for 3 days ordered 7/28/03 2:15 PM as well as Automepten? Elixir 1 1/2 tsp every 4 hours for T 101.5 F. Return to clinic in 1 week.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Pain
Clinical narrative: Vaccinated on 7/24/03 with DTaP, MMR, IPV. Redness and swelling and warm to touch. Rx with Tylenol 2 tsp every 4 hours for pain.
Age: 13.0
Sex: F
Vaccine: TD
Symptoms: Injection site induration, Tenderness
Clinical narrative: 25 x 5 cm area of muscle where injected is firm and tender. No erythema noted site of injectin is invisible.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Tenderness
Clinical narrative: Pt developed localized swelling, redness, warmth, mild tenderness in left anterior thigh within 48 hours of immunization.
Age: 35.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Back pain, Diarrhoea, Dyspnoea, Headache
Clinical narrative: Severe HA, diarrhea, SOB; feels like she is being suffocated; sore muscles in her back. States she was fine Thursday but Friday around lunch she had symptoms that got worse-went to Urgent Care early Monday morning. Referred to PMD for F/U.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site warmth, Pyrexia
Clinical narrative: T 100.3. Cellulitis post immunization. Left thigh 10 cm area red, hot, tender; induration. Put on Keflex 250 mg TID for 10 days.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Tenderness
Clinical narrative: T 100.3. Cellulitis post immunization. Left thigh 10 cm area red, hot, tender; induration. Put on Keflex 250 mg TID for 10 days.
Age: 1.3
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Child seen 7/22/03 with chicken pox.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Convulsion, Injection site erythema, Injection site oedema
Clinical narrative: Pt with large area of redness and swelling at injection site of DTaP. 24 hours after vaccine had brief generalized seizure.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis
Clinical narrative: Vaccine was given on 7/15/03. On 7/28/03 pt came in with a cellulitis of the leg (left) at the injection site. Was put on Duricef and told to come back if the reaction went beyond the Dr's markings. Came back 7/29/03. Reaction was larger and pt was given 1 gram of Rocephin IM. Was told to come back in AM, if reaction was bigger. Leg was much better, told to continue Duricef.
Age: 1.8
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Pyrexia, Rash
Clinical narrative: Temp-100 degrees. Rash upper left arm. Red area 6 x 5 cm.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Pt received MMR and DTaP on 7/22/03. MMR in right lateral arm; DTaP in left lateral arm. Mom reports pt started getting erythema, swelling and warmth around DTaP site 2-3 hours after injection. Progressed to whole upper arm. Seen 7/24/03 - started on Benadryl and Prednisone.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Rash
Clinical narrative: Woke up AM of 7/23/03 left upper arm area swollen and red with rash. Mom called doctor. Started Benadryl 1 1/2 tsp QID and Cortisone cream top tid (to continue through 7/26/03).
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Tenderness
Clinical narrative: 9 cm diameter-reddish/pink area. Warm to touch, tender. Right thigh.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: Pt received vaccine in left arm on 7/14/03 - seen on 7/16/03 with erythema 5 x 5cm over on left upper arm, no complaints of pain or itch. No treatment recommended. Localized reaction.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, DTAP, HEPA, IPV, MMR
Symptoms: Erythema
Clinical narrative: Pt received vaccine in left arm on 7/14/03 - seen on 7/16/03 with erythema 5 x 5cm over on left upper arm, no complaints of pain or itch. No treatment recommended. Localized reaction.
Age: 1.4
Sex: F
Vaccine: DTAP
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Noticed golf ball size red, swollen area of left leg on 7/22/03 in AM. Brought in HD at 4:45 PM. Red swollen 6-7 cm area on left leg, warm to touch. To use Benadryl, Tylenol and warm washcloth to area. RTC 7/24 if no improvement. 7/24/03 child taken to HD area 7-8 cm still red, swollen and warm to touch. 7/25/03 PC to home. Mom states she took child to ER last night.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Large red area left arm about size of palm per mom.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever 103, local reaction at injection site. To ER if fever persists. Frothing at the mouth. Tylenol every 3 hours prn fever, check temp every 30 minutes.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site oedema, Pruritus
Clinical narrative: Swelling of left upper arm, warm, nontender, itchy.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Erythema with edema at site of vaccine left leg. Rx: Keflex susp. 250 mg po BID for 10 days.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PPV
Symptoms: Oedema, Rash erythematous
Clinical narrative: Pt received vaccines at approx 11 this morning. Mom states bumps to body started at 1400 with generalized redness. Returned to clinic at 1500 with redness, rash, and swelling of ears, lips and labia. Benadryl 1 tsp given po at 1615; Epinephrine 0.1 ml given sq at 1620.
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Received vaccine approx. 10 am.  At 6 pm, noticed macular, erythematous areas on lower legs.  Area approx. 6x8 cm left, 4x6 cm right.  Blanches.  Not painful, not pruritic.  Not present in morning when she dressed.
Age: 22.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Vaccination complication
Clinical narrative: significant autoinnoculation of left arm at elbow and left lower extremity at knee.  No evidence of generalized vaccinia.  Patient nearly recovered.  No loss of duty.  No secondary infection
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Abscess drainage, Urticaria
Clinical narrative: After getting shot #4 of my Anthrax series I got the normal lump and legion on my tricep.  4 Days later I was covered in hives and in the emergency room getting a shot of benadryl.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Pruritus
Clinical narrative: Redness and edema near injection site (right upper arm) along with itching. Area appx. 8" in length and 3" in width.
Age: 1.3
Sex: F
Vaccine: MMR, PNC
Symptoms: Dermatitis bullous
Clinical narrative: Patient developed several pox-like lesions.  No other symptoms.
Age: 38.0
Sex: M
Vaccine: SMALL
Symptoms: Laboratory test abnormal, Lymphadenopathy
Clinical narrative: PT WITH PAST HISTORY OF SMALLPOX VACCINATION (LAST ONE IN JANUARY 1983)  PT RECENTLY VACCINATED ON 7/21/03;EQUIVOCAL REACTION ON TAKE READ.  RE-VACCINATED ON 7/28/2003.  PATIENT WENT SCUBA DIVING 7/30/03, ASCENDED QUICKLY, AND SUFFERED PNEUMO-MEDIASTINUM.  SPIRAL CT SCAN SHOWED ENLARGED CHEST/MEDIASTINAL LYMPH NODES.
Age: 37.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Injection site oedema
Clinical narrative: Patient states that within 24 hours, rt arm site where he received anthrax shot begin swelling. By the 48 hour mark, the swelling was 2.5 inches wide with satelite swelling 3/4 inch away with .5 inch swelling.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR
Symptoms: Convulsion, Crying, Dyskinesia, Irritability, Pyrexia
Clinical narrative: Cranky and crying per mother early AM on 7/25/03.  Motrin administered at 5:00 AM and 11:00AM.  Temp did reach 102.  Seizuer activity noted by parents on 7/25 soon after administering dose of Motrin at 11:00.  Seizure activity consisted of body jerking and vocalizing.  Seizure lasted approx. 4 min.  Child does have a hx of a febrile seizure as an infant. Child remained febrile and "cranky" for several days.  Had been exposed to an apparent viral illness in the community with GI sx & fever. This child developed no GI sx. Sibling also had seizure activity following his vaccine the same day.  His seizure took place 7/23.  He received same vaccines with addition of PCV7. He did have diarrheal illness prior to vaccine. Mother thought was d/t teething.  He also developed fever of 101 prior to seizure activity.
Age: 1.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC
Symptoms: Convulsion, Dyskinesia, Irritability, Pyrexia
Clinical narrative: Child became cranky on 7/23.  Noted to have fever of 100.5 (ax)on 7/23 at 7 PM.  Mother administered Motrin po.  Soon after, child was noted to have seizure activity consisting of full body jerking and vocalization.  Seizure lasted approx. 4 min.  Fever and fussiness continued for 2 days with highest noted temp of 101.  Sibling who received vaccine same day also developed fever on 7/25 and had seizure activity.
Age: 5.0
Sex: M
Vaccine: DTPHIB, IPV, MMR
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site oedema, Pruritus
Clinical narrative: INJECTION SITE WARM,RED,SWOLLEN, MILDLY ITCHY
Age: 1.9
Sex: F
Vaccine: HEP
Symptoms: Rash, Urticaria
Clinical narrative: HYPERSENSTIVITY RASH WITH LARGE UTICARIAL LESIONS OVER TRUNK, FACE, AND EXTREMITIES.  NO EVIDENCE YET OF ERYTHEMA MULTIFORME.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Coma, Hypotonia, Vomiting
Clinical narrative: RECEIVED PEDIARIX VACCINE (DTAP-IPV-HEP B)APPROX 10:30 AM ON 07/30/2003. APPROX 4HRS LATER WAS FEEDING AND VOMITED LARGE AMOUNT, THEN IMMEDIATELY BECAME LIMP AND UNRESPONSIVE FOR 5-10 MINUTES. BROUGHT IMMEDIATELY TO LOCAL ER, WHERE SHE WAS FULLY RECOVERED ON ARRIVAL. CURRENTLY ASYMPTOMATIC.
Age: 0.04
Sex: F
Vaccine: HEP
Symptoms: Apnoea, Cardiac arrest, Cardiomegaly, Decreased appetite, Dyspnoea
Clinical narrative: Greater than 12 hours after vaccine given patient developed decreased feeding and a single episode of vomiting. Approximately four hours after vomiting,and after patient was asleep, and not watched by parents, parents noted child had gasping, irregular repirations. Parents bundled child a took child by private car to the nearest emergency room, but did not observe child on the way. Upon entrance to the ER, child was noted to be asystolic and apneic. Full resucitative efforts failed. Autopsy Report received on 10/16/2003 states COD is cardiomegaly.
Age: 0.04
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Greater than 12 hours after vaccine given patient developed decreased feeding and a single episode of vomiting. Approximately four hours after vomiting,and after patient was asleep, and not watched by parents, parents noted child had gasping, irregular repirations. Parents bundled child a took child by private car to the nearest emergency room, but did not observe child on the way. Upon entrance to the ER, child was noted to be asystolic and apneic. Full resucitative efforts failed. Autopsy Report received on 10/16/2003 states COD is cardiomegaly.
Age: 19.0
Sex: M
Vaccine: HEPA, SMALL, TYP
Symptoms: Cow pox
Clinical narrative: GENERALIZED VACCINIA
Age: 39.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Cardiovascular disorder, Deep vein thrombosis, Muscle spasms, Pulmonary embolism, Thrombosis
Clinical narrative: Pt was adminstered shots. It's unclear which body, if any, was tracking him for smallpox adverse events and which body, if any, should report his death after smallpox and anthrax. He wasn't treated by any doctor, as his death was sudden. Pt complained of soreness in leg within one month of smallpox and anthrax vaccinations. He was advised to take aspirin or go to clinic to check for blood clots. He chose not to go. Within days, he died of sudden pulmonary blood clot.
Age: 39.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Atherosclerosis, Mesenteric vein thrombosis, Respiratory arrest, Thrombosis
Clinical narrative: Pt was adminstered shots. It's unclear which body, if any, was tracking him for smallpox adverse events and which body, if any, should report his death after smallpox and anthrax. He wasn't treated by any doctor, as his death was sudden. Pt complained of soreness in leg within one month of smallpox and anthrax vaccinations. He was advised to take aspirin or go to clinic to check for blood clots. He chose not to go. Within days, he died of sudden pulmonary blood clot.
Age: 39.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Lung disorder, Pain, Thrombosis
Clinical narrative: Pt was adminstered shots. It's unclear which body, if any, was tracking him for smallpox adverse events and which body, if any, should report his death after smallpox and anthrax. He wasn't treated by any doctor, as his death was sudden. Pt complained of soreness in leg within one month of smallpox and anthrax vaccinations. He was advised to take aspirin or go to clinic to check for blood clots. He chose not to go. Within days, he died of sudden pulmonary blood clot.
Age: 0.75
Sex: F
Vaccine: DTAP, HEP, IPV, UNK, DTAP, HBPV, HEP, IPV, PNC, TTOX
Symptoms: Encephalopathy, Hepatomegaly, Multi-organ failure, Pneumonia
Clinical narrative: Information has been received from an investigator concerning a 9 month old female who was enrolled in a phase IV Daptacel study was vaccinated on 12/27/02 with a dose of hep B virus vaccine. This report was part of a post-marketing surveillance program. Concomitant vaccination on 12/27/02 included a second dose of Daptacel, a dose of IPOL, a dose of Haemophilus influenzae vaccine (+) tetanus toxoid and a dose of Prevnar. On 6/8/03 the pt died. The cause of death was multi-organ failure due to near drowning 163 days post vaccination. The even of drowning was reported by the investigator as unrelated to the study vaccine. The relationship of multiple organ failure and near drowning to the other vaccines was not reported. Additional info is expected.
Age: 0.75
Sex: F
Vaccine: DTAP, HEP, IPV, UNK, DTAP, HBPV, HEP, IPV, PNC, TTOX
Symptoms: Multi-organ failure
Clinical narrative: Information has been received from an investigator concerning a 9 month old female who was enrolled in a phase IV Daptacel study was vaccinated on 12/27/02 with a dose of hep B virus vaccine. This report was part of a post-marketing surveillance program. Concomitant vaccination on 12/27/02 included a second dose of Daptacel, a dose of IPOL, a dose of Haemophilus influenzae vaccine (+) tetanus toxoid and a dose of Prevnar. On 6/8/03 the pt died. The cause of death was multi-organ failure due to near drowning 163 days post vaccination. The even of drowning was reported by the investigator as unrelated to the study vaccine. The relationship of multiple organ failure and near drowning to the other vaccines was not reported. Additional info is expected.
Sex: M
Vaccine: OPV
Symptoms: Dyspnoea, Lung disorder, Respiratory failure
Clinical narrative: A legal complaint was received from an attorney regarding an adult male decedent. The decedent history includes exposure to asbestos and asbestos-containing products. According to the legal complaint, "sometime in the 1950's, decedent was administered OPV or IPV." On or about September 2001, at 60 years of age, the decedent was reportedly diagnosed with mesothelioma. The legal complaint states that the "contaminated vaccine products were toxic and carcinogenic" and that the "decedent's exposure to asbestos, asbestos-containing products, and SV40 virus caused severe and permanent injury to the plaintiff, including, but not limited to breathing difficulties, asbestosis, lung and/or other cancer, mesothelioma, and/or other lung damage." On 11/8/01, the decedent died. The autopsy reported cause of death was respiratory failure due to malignant mesothelioma of pleura.
Sex: M
Vaccine: HEP
Symptoms: Autism, Nervous system disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of autism spectrum disorder in a male pt who received hep B vaccine recombinant (Engerix B) for prophylaxis. A physician or other health care professional has not verified this report. The pt received the 1st dose of Engerix B on 3/30/98 (2427A2). He received the 2nd dose of Engerix B (2567A9) on  10/9/98, six months after the first injection rather than the recommended interval of one month. On an unspecified date, he received his 2rd dose of Engerix B (2515A2). His attorney alleged that "as a result of the pt's exposure to thimerosal from the above vaccines, he sustained neurological injuries and as a result of those injuries has been diagnosed with autism spectrum disorder." The outcome of the event is unknown. Other medically serious report (OMIC).
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Decreased appetite, Dermatitis bullous, Fatigue, Headache
Clinical narrative: Information has been received from an employee health registered nurse concerning a 43 year old female with no known drug allergies and insulin dependent diabetes mellitus (type I) who on 6/10/03 at approximately 3:45pm, was vaccinated SC in the right deltoid with a first dose of varicella virus vaccine live (644563/1147M). The reporter indicated that on 6/21/03 the pt presented to the ER with chickenpox lesions. The pt reported having joint pains and aches in her major muscle groups. She had a headache and possibly had a low-grade fever but but did not document a temperature. The pt had "about 12 or so" fluid-filled lesions. She had one lesion on her earlobe, three or four on her back/shoulder blade area and six around the injection site which swelled to the "size of a tennis ball." On 6/23/03 the pt called off from work. The reporter noted that she did not see the pt, but got the details from the phone. It was indicated that no treatment was required for the event. At the time of the report, no improvement was seen. It was also noted that it was unknown if the pt was pregnant. A product quality complaint was not involved. Follow up info, including medical records, was received from the employee health registered nurse which indicated that the vaccination was given on 6/10/03 after vaccine literature was reviewed and consent was signed. The pt telephoned the reporter in the a.m. of 6/23/03 and stated that she began feeling ill (headache, feverish and tired) and noted six "bumps" at the injection site at 8am on 6/21/03. The pt went to a pediatric nurse at the hospital for confirmation of chickenpox and went home. The pt began to have several days of increased blood sugars (300 to 500), joint aches, lack of appetite, was tired easily, had no endurance and low grade fever. The pt had skilled home care until 6/30/03 to confirm an improving status, draw a specimen for a complete blood cell count, check her diabetic status, etc." It was also noted that home care visits were ordered by the pt's physician because of her elevated blood sugars and the physician felt that she should have someone checking in on her as she lived approximately 45 minutes from the hospital. On 6/30/03 a urinalysis revealed a glucose of 3+ and a urine reducing substance of 3+. The pt was subsequently discharged from home care. The home care registered nurse's discharge note for prognosis read "excellent" and only limitation "endurance," complete blood cell count within normal limits. It was also noted that the pt had no history of adverse events following prior vaccination. The pt recovered on 7/1/03 and returned to work on 7/7/03. Upon internal review, increased blood sugars was considered to be an other important medical event (OMIC). No further info is expected.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site oedema, Injection site rash, Laboratory test abnormal, Pyrexia
Clinical narrative: Information has been received from an employee health registered nurse concerning a 43 year old female with no known drug allergies and insulin dependent diabetes mellitus (type I) who on 6/10/03 at approximately 3:45pm, was vaccinated SC in the right deltoid with a first dose of varicella virus vaccine live (644563/1147M). The reporter indicated that on 6/21/03 the pt presented to the ER with chickenpox lesions. The pt reported having joint pains and aches in her major muscle groups. She had a headache and possibly had a low-grade fever but but did not document a temperature. The pt had "about 12 or so" fluid-filled lesions. She had one lesion on her earlobe, three or four on her back/shoulder blade area and six around the injection site which swelled to the "size of a tennis ball." On 6/23/03 the pt called off from work. The reporter noted that she did not see the pt, but got the details from the phone. It was indicated that no treatment was required for the event. At the time of the report, no improvement was seen. It was also noted that it was unknown if the pt was pregnant. A product quality complaint was not involved. Follow up info, including medical records, was received from the employee health registered nurse which indicated that the vaccination was given on 6/10/03 after vaccine literature was reviewed and consent was signed. The pt telephoned the reporter in the a.m. of 6/23/03 and stated that she began feeling ill (headache, feverish and tired) and noted six "bumps" at the injection site at 8am on 6/21/03. The pt went to a pediatric nurse at the hospital for confirmation of chickenpox and went home. The pt began to have several days of increased blood sugars (300 to 500), joint aches, lack of appetite, was tired easily, had no endurance and low grade fever. The pt had skilled home care until 6/30/03 to confirm an improving status, draw a specimen for a complete blood cell count, check her diabetic status, etc." It was also noted that home care visits were ordered by the pt's physician because of her elevated blood sugars and the physician felt that she should have someone checking in on her as she lived approximately 45 minutes from the hospital. On 6/30/03 a urinalysis revealed a glucose of 3+ and a urine reducing substance of 3+. The pt was subsequently discharged from home care. The home care registered nurse's discharge note for prognosis read "excellent" and only limitation "endurance," complete blood cell count within normal limits. It was also noted that the pt had no history of adverse events following prior vaccination. The pt recovered on 7/1/03 and returned to work on 7/7/03. Upon internal review, increased blood sugars was considered to be an other important medical event (OMIC). No further info is expected.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Convulsion, Pyrexia
Clinical narrative: It was reported that an 18 months old male pt received a Daptacel vaccination (C1354BA) and IPOL (W0290-2), sometime between the hours of 11:30-12:00pm on the morning of 7/7/03. The next morning at 8am, the pt developed a fever of 100.2 degrees F and experienced a seizure. The pt was taken to the hospital, given Tylenol and was sent home. It was reported that the pt has fully recovered from these events. The reporter of this case is the same reporter of case 2003-01488. Seriousness criteria-other medically significant (OMIC). Follow up on 12/29/03: "From additional information received on 12/12/03 through telephone contact with the responsible physician it was reported that the physician's telephone number provided in the previous version was incorrect.  The correct telephone number was provided, as well as the fax number and address.  No other information was reported." A 15-day follow up report received 01/09/2004 adds: From additional info received on 12/29/2003 from a physician, it was reported that the pt received his 4th dose of Daptacel, administered intra-muscularly in the left thigh and his 3rd dose of IPOL, administered subcutaneously in the right thigh on 07/07/2003 at 11:30 AM. It was reported that the pt's birth weight was 8 pounds and 4 ounces and that the pt has one brother. The pt experienced a fever and seizures on 07/08/2003 at 8:00 AM. He was diagnosed with his 1st episode of febrile seizures rule out vaccine induced seizures. No relevant diagnostic tests were performed. Concomitant medications at the time of vaccination included Children's Tylenol for pain. The pt's pre-existing medical conditions included speech delay and fine motor delay. The mother's niece had a history of febrile seizures as well. No other info was provided at this time.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Bipolar I disorder, Chills, Headache, Loss of consciousness
Clinical narrative: A registered dietitian reported that a 27 year old male received injections of Dryvax and anthrax vaccines in 2003 while in overseas. Within hours of receiving the vaccines, he developed severe headaches, chills, and passed out. When he woke up, he was combative. He was hospitalized and diagnosed with bipolar disorder. The pt was subsequently discharged from the duty. No further info was available at the date of this report. The report indicated that her son experienced chills following vaccination with the same vaccines. See related report HQWYE252029JUL03.
Age: 1.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Autism, Pyrexia, Social avoidant behaviour
Clinical narrative: On 10/4/2000, pt had high fever 105 that lasted for 5 days. Since then he has started withdrawal and  has progress into autism. He was diagnosed with autism in August 2002. Receiving ABA intemention. Follow up on 10/31/2003: "Vaccine recipient did not recover from adverse events.  Autistic behaviors - lack of eye contact, socialization ability, language delay, repetative behaviors (eg. language and hooked on numbers), digestive problems and picky eating, sensory dysfunction.  We found measel antivirus still in his body in addition to mercury due to vaccinations."
Age: 63.0
Sex: M
Vaccine: TD
Symptoms: Feeling hot, Headache, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Pt developed pain, swelling, erythema at vaccine site 1 day after injection. He had headaches and subjective fevers for 2 days after. On exams, afebrile, normal neuro exam. 11 x 12cm area induration, erythema, warmth and tenderness at injection site.
Age: 63.0
Sex: M
Vaccine: TD
Symptoms: Pain, Pyrexia
Clinical narrative: Pt developed pain, swelling, erythema at vaccine site 1 day after injection. He had headaches and subjective fevers for 2 days after. On exams, afebrile, normal neuro exam. 11 x 12cm area induration, erythema, warmth and tenderness at injection site.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Skin ulcer
Clinical narrative: Fever 99.0 one day. Few scattered lesions.  Vaccination 01/2000.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Dizziness, Flushing, Headache, Nausea
Clinical narrative: Headache, weakness, dizziness, nausea, skin flushing.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Face oedema, Pruritus, Urticaria
Clinical narrative: Few welts starting 7/26/03. 7/29/03 onset of neck and check swelling with itching. On 7/29/03 Epinephrine 0.3 mg given SQ. Solumedrol 250 mg IV. Benadryl 50 mg IV. Prednisone 60 mg PO.
Age: 7.0
Sex: M
Vaccine: RAB
Symptoms: Rash, Somnolence
Clinical narrative: 7/22/03 1:30 PM Mother of pt called and stated that about 3 hours after pt received the first of his second post-exposure rabies on Mon. 07/21/2003, he became sleepy and slept for 2 1/2 hours. He normally does not take naps. He also developed a rash on his face and neck-he denies any trouble breathing or swallowing. Mother states no fever and acts normally. She reported it to her pediatrician. The rash has not changed since it first appeared and is otherwise behaving normally. Dr was contacted and advised to either have the mother give him 50 mg Benadryl prior to vaccine or get a titer done with the possibility of having to receive another dose later. The mother decided to give the Benadryl and have him receive his final vaccine on Thurs. 7/24/03. 7/24/03 Mother gave child Benadryl to child prior to 2nd shot. Tolerated well. 7/28/03 Spoke with mother on phone. Child tolerated the shot well. When they arrived home, child slept 1/2 hour-no rash was noted. Mother stated that child had this rash once before when he ate strawberries.
Age: 1.75
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site erythema, Injection site mass, Injection site oedema
Clinical narrative: Red swollen lump where injection given. 2 cm in size. Antibiotic given to Tx area. EES given for 10 days. Spot clearing as of 7/23/03.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site induration, Paraesthesia, Pruritus, Urticaria
Clinical narrative: Erythema with induration at MMR injection site; itching, followed by periorbital tingling and hives on right leg and right face at ear. Benadryl 50 mg PO 12:15 PM. Epinephrine 1:1000 lm/IM 1:00 PM, medial dose. Symptoms responded, reduced within 1 hour.
Age: 18.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Injection site erythema, Injection site induration, Pruritus
Clinical narrative: Erythema with induration, itchiing at MMR injection site beginning one hour after injection. Cold compress and topical hydrocortisone ointment applied. Symptoms reduced in 1 hour.
Age: 59.0
Sex: F
Vaccine: LYME
Symptoms: Arthritis, Cataract, Fatigue, Hypoacusis, Night sweats
Clinical narrative: Fluctuating hearing loss, arthritis in hands, elbows, shoulders and hips. Night sweats-developed cataracts in both eyes, general fatigue and soreness, droop in left side of face and fuzzy thinking. Long term Lyme in 6/03.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site oedema
Clinical narrative: Right deltoid swollen.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Lymphadenopathy, Pyrexia
Clinical narrative: Large local reaction in left thigh with redness, firmness-up to 6cm. Large firm lymph nodes in left groin, tender. Right side clear. Low grade temp up to 100 degrees F.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR
Symptoms: Tenderness
Clinical narrative: Large local reaction in left thigh with redness, firmness-up to 6cm. Large firm lymph nodes in left groin, tender. Right side clear. Low grade temp up to 100 degrees F.
Age: 1.0
Sex: F
Vaccine: HBHEPB, IPV, MMR
Symptoms: Injection site erythema, Rash papular
Clinical narrative: 2 cm erythema left thigh. Generalized papular exanthem, sparing palms and soles.
Age: 12.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site oedema, Rash
Clinical narrative: Within hours after injection arm became red, swollen, hard knot. Saw MD 7/24/03. Instructed to use ice observe. On 7/28/03 reported arm remained swollen and with rash per mother. Also noted this child has very sensitive skin.
Age: 1.25
Sex: M
Vaccine: DTAP, MMR, PNC
Symptoms: Lethargy, Pyrexia
Clinical narrative: Temp to 104 degrees, lethargy, possible MMR reaction.
Age: 1.25
Sex: M
Vaccine: DTAP, MMR, PNC
Symptoms: Pyrexia, Rash
Clinical narrative: Onset of increased temp to 103 degrees 10 days prior to administration, with rash.
Age: 17.0
Sex: F
Vaccine: RAB
Symptoms: Chest discomfort, Confusional state, Headache, Pyrexia, Thirst
Clinical narrative: 15 hours after vaccine-awoke with headache, confusion (slight), temp 100.4 degrees, thirst, chest discomfort. Took Tylenol and tepid shower. Felt better one hour later. Totally recovered by later in AM.
Age: 0.8
Sex: M
Vaccine: PNC
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Developed fever 102 degrees rectal within 24 hours of Prevnar vaccine. Also diarrheal stools.
Age: 41.0
Sex: M
Vaccine: MEN
Symptoms: Injection site erythema, Injection site induration, Pain
Clinical narrative: Erythema-moderate, large area (3" diameter) of injection site. Induration-moderate in area of injection site. Pain-above average: required Motrin (400 mg) for 3 days.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pain, Rash
Clinical narrative: Complained of leg pain, rash. Dx shingles, Rx Zovirax.
Age: 0.6
Sex: F
Vaccine: DTAP, PNC
Symptoms: Agitation, Crying
Clinical narrative: Unconsolable crying for several hours.  Seen in ER, kept under observation.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Received immunization Wednesday 07/23, on Thur. lump on right deltoid Fri, redness and swollen-hot to touch.  Measured 5cm x 51/2cm.  Area of redness 1 1/2cm then white ring and then redness again.  Patient mom given dipidone AF cream to put on twice daily.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 07/03/2003: 24 mm. Induration on 35 mm. erythematous base right deltoid.  Prescribed with warm, moist heat and 1mg claritin/d.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema, Pain
Clinical narrative: Mother of patient reports the night of 07/28/2003 patient had pain of left arm and on 07/29/2003 had redness and swelling of left upper arm, and was seen by a MD in the ER.  They gave him Benadryl and Tylenol and he will see his primary MD today.  Observed redness and swelling of left
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Eyelid oedema, Hypoaesthesia
Clinical narrative: Left eyelid swelling, left facial and left upper extremity numbness (down sensitivity to light touch).
Age: 4.0
Sex: M
Vaccine: DTAPH, HEPA
Symptoms: Cellulitis
Clinical narrative: Cellulitis Left thigh.  Taken to ER 07/30/2003-Rocephin 1gm IV.  Seen at office 07/31/2003-repeat Rocephin 08/01/2003.  Discharge heplock.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema
Clinical narrative: Patient had redness, swelling to site after 1 week of administration date.  Mom states patient had a red ring.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Had rash on face and neck.  Required antibiotic therapy.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Body temperature increased, Rash, Urticaria
Clinical narrative: 05/12/2003 @ 10:00:  Need Hib #3, MMR #1, Varicella #1. 05/13/2003 @ 18:00:  Rash noticed on left hand, irritable; 20:30: Taken to ER-rash over entire body from neck down.  Could not be comforted.  Afebrile.  Diagnosed with hives in ER was treated with oral Benadryl and discharged at 23:30.
Age: 34.0
Sex: F
Vaccine: TYP
Symptoms: Anorexia, Diarrhoea, Nausea, Vomiting
Clinical narrative: On 07/15/2003 client took 1st dose of oral Typhoid-vivotif Berna 30 minutes later she experienced nausea, vomiting, and diarrhea.  It is unknown if client had fever.  By 07/17/2003 client reported nausea and lack of appetite.  No other symptoms.  07/18/2003 client reported having a "cold" and she felt the Vivotif Berna had "lowered my immune system".  07/22/2003 client reports "getting over a cold".  No other doses taken.
Age: 5.0
Sex: F
Vaccine: HEPA, PNC, VARCEL
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Redness, swelling and hot to touch (6.5 x 4.5 cm).
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Urticaria
Clinical narrative: 4 pox to back, chest, face, arm and 4cm x 6 cm welt at the site of injection.  Treatment: unknown.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Immediate hive after administration of sub cutaneous varivax.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site warmth, Oedema
Clinical narrative: Patient had Td on 06/19/2003.  Patient states developed swelling, slight tenderness, heat and redness at site on 06/21/2003.  Patient had left supraclavicular pain and up lymph node this area.  Td injection in left deltoid.  Soft lump, mild erythematous, hot and mildy tender, non-indurated.  4 cm diameter at left deltoid with enlarged and tender left supraclaulcer lymph on 06/26/2003.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Pain
Clinical narrative: Patient had Td on 06/19/2003.  Patient states developed swelling, slight tenderness, heat and redness at site on 06/21/2003.  Patient had left supraclavicular pain and up lymph node this area.  Td injection in left deltoid.  Soft lump, mild erythematous, hot and mildy tender, non-indurated.  4 cm diameter at left deltoid with enlarged and tender left supraclaulcer lymph on 06/26/2003.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PPV, DTAP, IPV, MMR, PPV
Symptoms: Body temperature increased, Crying, Pain, Vomiting
Clinical narrative: Temperature 103 07/23/2003 Temperature 105-106 07/24/2003 Uncontrollable crying, complained of pain at both injection sites but no localized reaction.  No redness, no swelling.  Vomit x 1.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PPV, DTAP, IPV, MMR, PPV
Symptoms: Crying, Injection site pain, Pyrexia, Vomiting
Clinical narrative: Temperature 103 07/23/2003 Temperature 105-106 07/24/2003 Uncontrollable crying, complained of pain at both injection sites but no localized reaction.  No redness, no swelling.  Vomit x 1.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Malaise, Pyrexia
Clinical narrative: Within 24 hours, fever, severe malaise, and arthralgia.  Administered 07/22/2003.  Symptoms are continuing to worsen.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Body temperature increased, Erythema, Oedema, Rash
Clinical narrative: About 6 x 6 erythamatous rash with local temperature up and mild swelling left thigh.  Non tender.  No fever.  Treated: Tylenol/Benadryl as needed.
Age: 5.4
Sex: M
Vaccine: DTAP, HEP, IPV, MMR, VARCEL
Symptoms: Oedema, Skin discolouration
Clinical narrative: Entire upper arm swollen and discolored.  No fever, no red streaking.
Age: 26.0
Sex: F
Vaccine: HEP, TD
Symptoms: Pain
Clinical narrative: Patient complained of severe right deltoid pain 5 days after TD.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Feeling hot, Injection site erythema, Injection site mass, Injection site pain, Joint range of motion decreased
Clinical narrative: Patient reported to clinic 6/11/03 complaining of tender and soreness of left arm where patient had received an MMR injection given on 7/12/2002.  Also complained of tenderness when moving left arm up.  All complaints started on 7/12/02  and have not sought med tx.  Patient stated left arm never has been red, hard knots, or warm to the touch.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Abdominal pain upper, Feeling hot, Oedema, Pain, Pyrexia
Clinical narrative: received Imm on 7/28, tues pm noted pain, swelling, and warm to touch left arm Deltoid area.  Had fever and stomach ache take to er 7/29 received benedryl and use warm compresses.
Age: 52.0
Sex: F
Vaccine: ANTH
Symptoms: Urticaria
Clinical narrative: GENERALIZED RASH DIAGNOSED WITH URTICARIA
Age: 60.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Erythema, Rash pustular
Clinical narrative: Noticed a pustule on an erythematous base at post vaccination day 90.  Became a scab, fell off after a week.  Then reoccurred 3-4 weeks later, followed the same pattern.  This cycle continued 3-4 times
Age: 60.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Injection site vesicles, Skin ulcer
Clinical narrative: Noticed a pustule on an erythematous base at post vaccination day 90.  Became a scab, fell off after a week.  Then reoccurred 3-4 weeks later, followed the same pattern.  This cycle continued 3-4 times
Age: 12.0
Sex: F
Vaccine: HEP, HEPA, TTOX
Symptoms: Convulsion, Loss of consciousness, Somnolence
Clinical narrative: On Tuesday July 29th at 10:00am patient had an immunization shot (tetanus, hepatitis A and epatitis B vaccine). They said she wasn't required to get the hepatitis shots but the new school kids coming into the district are. So I decided to get them with the tetanus shot that was due. On Wednesday at 6:00pm after she slept most of the day which she normally doesn't do, she was sitting on a chair and passed out then went into a seizure(her body stiffened up and her hands curled for about 1 minute) then she passed out for around 3 minutes. We called 911 and they took her into the Hospital for tests, in the ambulance they gave her glucose and said her blood sugar was alittle low(which could be from not getting a snack in the afternoon when she was sleeping) and that her blood pressure was a little low. At the hospital they did a EKG and a CAT scan on her brain which turned out ok. We went to have an EEG done 2 days later and the neurolgist wants to see her back in 1 month. We went to her primary care doctor to get the EEG referal and she wants to see her back in 1 week. She checked her out as well. Since the seizure she hasn't had anymore. She just has been sleeping more. She said she only had a couple sips of water on Wednesday the day she had the seizure.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Info has been received from a physician through a pharmaceutical company concerning a 46 year old female who in October 2001 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the pt developed cellulitis. Additional info has been requested.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Hypersensitivity, Malaise, Myalgia, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning an 81 year old female, with sulfa allergy, who on 9/10/02 at 11:00 was vaccinated with the first dose of pneumococcal vaccine 23 polyvalent (lot # 640576/0923L), administered in the left deltoid. Concomitant therapy included simvastatin, atenolol, levothyroxine Na and fluoxetine HCl. There was no illness at the time of vaccination. Subsequently, that same day at 17:00, the patient experienced severe swelling of the entire arm, pain involving the arm from shoulder to elbow, fever, myalgia and malaise. The patient sought medical attention. It was reported, on 9/?/02, that the patient is now being treated for cellulitis and an allergic reaction. Lab testing, including CBC and ESR, was performed. Results were not reported. At the time of report, the outcome was unknown (to be determined). It was noted that the patient did not experience adverse events following any prior vaccinations. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been rechecked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning an 81 year old female, with sulfa allergy, who on 9/10/02 at 11:00 was vaccinated with the first dose of pneumococcal vaccine 23 polyvalent (lot # 640576/0923L), administered in the left deltoid. Concomitant therapy included simvastatin, atenolol, levothyroxine Na and fluoxetine HCl. There was no illness at the time of vaccination. Subsequently, that same day at 17:00, the patient experienced severe swelling of the entire arm, pain involving the arm from shoulder to elbow, fever, myalgia and malaise. The patient sought medical attention. It was reported, on 9/?/02, that the patient is now being treated for cellulitis and an allergic reaction. Lab testing, including CBC and ESR, was performed. Results were not reported. At the time of report, the outcome was unknown (to be determined). It was noted that the patient did not experience adverse events following any prior vaccinations. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been rechecked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot
Clinical narrative: Information has been received from a medical assistance concerning an 81 year old female with hypertension, seasonal allergies, hypothyroidism and degenerative joint disease who on 9/23/02 at 14:00 was vaccinated IM in the right arm with a dose of pneumococcal vaccine 23 polyvalent (642719/0376M). There was no illness at the time of vaccination. Concomitant medications included omeprazole, estrogens, Premarin, Synthroid, Diovan, Paxil and an unspecified therapy. On 9/24/02 at 17:00 the pt developed a 9x16 area of redness and warmth approximately 4cm beneath the injection site, from biceps to triceps. The pt was going to be seen in the doctor's office on 9/25/02. It was also reported that another pt (WAES0209USA02504), vaccinated on the same day and from the same lot, developed the same symptoms. Additional info has been requested.