chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Local reaction, Rash, Rash papular
Clinical narrative: Local reaction - rash on bilateral thighs - hip to knee pinpoint papule rash - no redness or swelling - similar papules under chin and around neck similar to heat or contact rash.
Sex: F
Vaccine: MNQ
Symptoms: Body temperature increased, Headache, Lymphadenopathy
Clinical narrative: Elevated temp, swollen glands, headache
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count, Pyrexia, Urine analysis
Clinical narrative: Pt had fever and went to ER night after received 3rd Gardasil injection - fever = 103 F. Given in ER - Acetominophen 1gm, Ibuprofen 600mg.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Decreased appetite, Injection site swelling
Clinical narrative: Decreased appetite, both arms swollen at injection site of Prevnar, DTaP, IPV - Benadryl, Tylenol and warm compresses
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Facial palsy, Immunology test, Lyme disease
Clinical narrative: Onset of peripheral type Bell (L) facial palsy. Negative Lyme Disease Western Blot. Put on  Prednisone 1 week po
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Erythema
Clinical narrative: Pt had reaction to DTP and IPV - left arm - redness cellulitis. Came to see Dr. on 7/26/07 - was treated with Augmentin 400 x5 day also to take Benadryl.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cold compress therapy, Erythema, Skin warm, Tenderness
Clinical narrative: red, hot, tender area upper (R) deltoid after receiving DTaP Told mother to apply cool compress and give Motrin for pain
Age: 0.3
Sex: M
Vaccine: DTPHEP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: AFTER SHOTS Patient's LEGS ON ALL THREE INJECTION SITES WERE RED HOT TO THE TOUCH SWELLED AND HURT TO TOUCH WHEN TAKED TO THE DOCTOR HE WAS GIVEN ANTIBOTICS AND I WAS TOLD IT WAS JUST A LITTLE REACTION, HE NEVER GOT BETTER HIS LEGS SWELLED AND BURST OPEN AND PUSS BEGAN TO POUR OUT I THEN TOOK HIM TO SEE A SPECIALIST IN ANOTHER COUNTY HE STILL HAS PROBLEMS AND THE NEXT SET OF SHOTS DID THE SAME THING. I HAVE BEEN TO A DOCTOR AND STILL NO ONE CAN TELL ME WHAT HAS HAPPENED THEY WANT TO WAIT AND SEE WHAT HAPPENS NEXT TIME HE IS GIVEN A SHOT, THERE WAS A CULTURE DONE AFTER THE FIRST SHOTS BUT DID NOT SHOW ANYTHING. Patient GET SEPTRA EVERYTIME HE GETS SHOTS NOW BUT THEY DOSEN'T SEEM TO HELP THEY STILL SWELL BURST AND POUR PUSS EVERYTIME. HE IS ALMOST 1 YR OLD AND STILL HAS SWOLLEN INFECTED SITES ON BOTH LEGS.
Age: 0.3
Sex: M
Vaccine: DTPHEP
Symptoms: Skin laceration
Clinical narrative: AFTER SHOTS Patient's LEGS ON ALL THREE INJECTION SITES WERE RED HOT TO THE TOUCH SWELLED AND HURT TO TOUCH WHEN TAKED TO THE DOCTOR HE WAS GIVEN ANTIBOTICS AND I WAS TOLD IT WAS JUST A LITTLE REACTION, HE NEVER GOT BETTER HIS LEGS SWELLED AND BURST OPEN AND PUSS BEGAN TO POUR OUT I THEN TOOK HIM TO SEE A SPECIALIST IN ANOTHER COUNTY HE STILL HAS PROBLEMS AND THE NEXT SET OF SHOTS DID THE SAME THING. I HAVE BEEN TO A DOCTOR AND STILL NO ONE CAN TELL ME WHAT HAS HAPPENED THEY WANT TO WAIT AND SEE WHAT HAPPENS NEXT TIME HE IS GIVEN A SHOT, THERE WAS A CULTURE DONE AFTER THE FIRST SHOTS BUT DID NOT SHOW ANYTHING. Patient GET SEPTRA EVERYTIME HE GETS SHOTS NOW BUT THEY DOSEN'T SEEM TO HELP THEY STILL SWELL BURST AND POUR PUSS EVERYTIME. HE IS ALMOST 1 YR OLD AND STILL HAS SWOLLEN INFECTED SITES ON BOTH LEGS.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus, Skin lesion
Clinical narrative: Patient presented to pharmacy on 07/30 stating that on 7/26 she had developed lesions on the legs, groin and stomach area. Possibly, the patient has more than fifty lesions between the knees and chest, with the highest concentration around the groin area. Pharmacist witnessed less than 10 lesion on right leg. Lesions are round, small (less than a dime in size), very itchy and not very raised. At different times, Patient applied Sarna Lotion and hair spray to try to improve symptoms. Patient also tried taking one Benadryl. Pharmacist suggested taking more Benadryl. On 7/30, upon examination by the pharmacist, injection site was one inch in diameter, red slightly raised, and not itchy. Patient denied exposure to any environmental triggers.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Large local reaction with swelling and erythema
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site warmth, Skin irritation
Clinical narrative: Client received a Tdap (Adacel) injection on 07/24/2007.  Vaccine was administered by IM route and was given in the left arm.  On Monday, July 30, the injection site began to itch, had "little bumps", and was warm to touch.  Today, August 1, client continued to scratch injection site, area was red and warm to touch. Slight appearance of skin irritation was noted through out site of approximately 2 x 2 inches.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Body temperature increased, Erythema, Oedema peripheral
Clinical narrative: TEMPERATURE 100.2                              RED SWOLLEN LEFT DELTOID
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Oedema peripheral, Pain in extremity
Clinical narrative: Patient reports that her right arm became sore immediately after HPV injection.  It remains sore from shoulder to elbow 10 days later.  It hurts to lift arm.  Patient reports it was swollen also.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Immediate post-injection reaction, Injection site pain, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Patient reports that her right arm became sore immediately after HPV injection.  It remains sore from shoulder to elbow 10 days later.  It hurts to lift arm.  Patient reports it was swollen also.
Age: 4.0
Sex: F
Vaccine: DTAPH, MM
Symptoms: Erythema, Induration, Pyrexia, Skin warm
Clinical narrative: erythema, warmth, indoration, systemic fever 103.1, in absence of any other signs of infection.
Age: 1.33
Sex: F
Vaccine: DTAP, PNC, VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: PT RECIEVED THE VARICELLA VACCINE 09/20/2004 & WAS DIAGNOSED WITH CHICKEN POX ON 08/01/2007.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: large local reaction versus cellulitis 15x20cm red hot area at the injection site, painful, also reported low grade fever
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Pyrexia
Clinical narrative: large local reaction versus cellulitis 15x20cm red hot area at the injection site, painful, also reported low grade fever
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Insomnia, Nodule, Pain, Pruritus
Clinical narrative: Shortly after Gardasil (HPV) vaccine was given in the right shoulder, she developed heaviness in that arm. At work she could only work with her left arm. About an hour later she started to develop large "bumps" al over her right arm which became itchy and painful. She later bought Benadryl but said she still could hardly sleep. She was seen in the office the next day. She had large erythematous nodules all over her right arm and forearm only. Not anywhere else. They were pruritic. She was given an Epinephrine injection subcutaneously immediately and prescribed hydroxyzine orally and triamcinolone 0.1% cream topically. She was instructed to go to the Emergency room if she developed signs of respiratory difficulty or if any of the symptoms worsened.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Sensation of heaviness
Clinical narrative: Shortly after Gardasil (HPV) vaccine was given in the right shoulder, she developed heaviness in that arm. At work she could only work with her left arm. About an hour later she started to develop large "bumps" al over her right arm which became itchy and painful. She later bought Benadryl but said she still could hardly sleep. She was seen in the office the next day. She had large erythematous nodules all over her right arm and forearm only. Not anywhere else. They were pruritic. She was given an Epinephrine injection subcutaneously immediately and prescribed hydroxyzine orally and triamcinolone 0.1% cream topically. She was instructed to go to the Emergency room if she developed signs of respiratory difficulty or if any of the symptoms worsened.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Haematochezia, Irritability
Clinical narrative: Patient presented with history of bloody streaks in stool, twice in the past 1 hour.  He has been fussy and colicky (but he has always been like this).  No vomiting or diarrhea.  Exclusively breastfeed.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a certified medical assistant concerning an adult patient (gender unknown) who on an unknown date was vaccinated (route unknown) with a dose of Pneumovax 23 (Lot # 651319/1007P). After receiving the vaccine, the patient developed cellulitis. The outcome of the patient's experience was not reported. Unspecified medical attention was sought. No product complaint was involved.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a physician concerning a 47 year old female with sinusitis, asthma and drug hypersensitivity to Ceftin who in approximately 2001 was vaccinated with a first dose of Pneumovax 23. The physician reported that her response "was not as expected." In July 2006, the patient was vaccinated with a second dose of Pneumovax 23. Subsequently, a recent titer showed response to 4 of the 12 Pneumovax 23 types tested. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Adverse drug reaction
Clinical narrative: Information has been received from a registered nurse concerning a male (age not reported) who on an unspecified date was vaccinated with Pneumovax 23. On an unspecified medical date, the patient experienced unspecified repeated reactions to Pneumovax 23. No further information was available at the time of reporting. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Initial and follow up information has been received from a nurse practitioner concerning a 55 year old female (previously reported as two patients) with a penicillin allergy and drug hypersensitivities to diazepam (VALIUM) and propoxyphene hydrochloride (DARVON). On 01-AUG-2006, at 15:44 PM, the patient was vaccinated subcutaneously in the right arm with Pneumovax 23 (Lot# 651173/1211R). At the time of vaccination, the patient was noted to have chronic obstructive pulmonary disease. On an unspecified date, the patient experienced a skin reaction that was a softball size swollen area at the injection site. The patient sought unspecified medical attention. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Information has been received from a county health registered nurse concerning a 72 year old female patient with allergies to dust and mold and asthma, who on 29-SEP-2006 at 09:10 was vaccinated intramuscularly with a second dose of Pneumovax 23 (lot# 654981/0674F).  Concomitant therapy given on the same day at 09:10 IM included a dose of influenza vaccine (unspecified) (batch# 69480).  There was no illness at the time of vaccination.  On 29-SEP-2006 at 17:00, the patient developed right arm swelling, red and tender from the shoulder to the elbow.  The symptoms lasted for 3 days.  The patient was treated symptomatically.  Subsequently, the patient recovered.  Additional information is not expected.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 53 year old female with no other pertinent medical history and no known allergies or adverse drug reactions reported. On 04-OCT-2006, the patient was vaccinated intramuscularly into the left arm with 0.5 mL of Pneumovax 23 (Lot# 651399/0486F). There were no concomitant medications reported. On 05-OCT-2006, the patient developed a fever, chills, body ache and a headache after immunization. The patient sought unspecified medical attention. On 06-OCT-2006, the patient had recovered from the events. The office was requesting a lot check, as they did not feel comfortable continuing to use this vial. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Centers for Biologics Evaluation and Research and was released by the regulatory agency. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 55 year old male with no other pertinent medical history and no known allergies or adverse drug reactions reported.  On 03-OCT-2006, the patient was vaccinated intramuscularly in the right arm with 0.5 mL of PNEUMOVAX (Lot# 651399/0486F).  There were no concomitant medications reported.  On 04-OCT-2006, the patient developed a fever, chills, body ache, headache, swelling and redness at the injection site.  The patient sought unspecified medical attention.  On 05-OCT-2006, the patient had recovered from the events.  The office was requesting a lot check, as they did not feel comfortable continuing to use this vial.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements and was released by the regulatory agency.  Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 55 year old male with no other pertinent medical history and no known allergies or adverse drug reactions reported.  On 03-OCT-2006, the patient was vaccinated intramuscularly in the right arm with 0.5 mL of PNEUMOVAX (Lot# 651399/0486F).  There were no concomitant medications reported.  On 04-OCT-2006, the patient developed a fever, chills, body ache, headache, swelling and redness at the injection site.  The patient sought unspecified medical attention.  On 05-OCT-2006, the patient had recovered from the events.  The office was requesting a lot check, as they did not feel comfortable continuing to use this vial.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements and was released by the regulatory agency.  Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pain in extremity, Swelling
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old female with no other past medical history reported.  On 09-OCT-2006, in the AM, the patient was vaccinated with 0.5 mL of PNEUMOVAX (Lot# 651399/0486F).  Subsequently the patient experienced arm pain (also reported as pain with movement of arm), swelling the size of her hand and had redness at the site of the PNEUMOVAX vaccine.  The patient had no fever.  It was reported that the patient had no primary care physician (PCP).  The patient was advised on the need for a medical evaluation and was recommended for an emergency room (ER) referral.  At the time of this report, the outcome of the events were unknown.  Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Body temperature increased, Oedema peripheral, Pain in extremity, Pyrexia, Urticaria
Clinical narrative: Information has been received from a 71 year old female consumer with osteoporosis, cholesterol high, and arthritis who in 1998 was vaccinated with Pneumovax 23 (manufacturer unknown). At that time, she developed a fever. On 03-OCT-2006, the patient received revaccination with Pneumovax 23 in her arm. On 03-OCT-2006, she was also administered influenza virus vaccine (unspecified) in the other arm. Later that day, on 03-OCT-2006, she developed a swollen arm with red welts and a fever of 99.6 degrees Fahrenheit (F). She took ADVIL and used ice on her arm. On 04-OCT-2006, her arm continued to be swollen and her fever went up to 100.5 F. She sought medical attention. Her physician's office recommended hot compresses and she took BENADRYL. On 05-OCT-2006, she continued to have arm pain and swelling. At the time of reporting she was recovering. The consumer reported that she felt the events required intervention to prevent serious criteria (Other Important Medical Events). Additional information was received via phone call from the physician who reported that the patient's experience was not serious and was not considered to be an Other Important Medical Event. He described the patient's experience as "a little red arm". The patient was treated with an antibiotic. The physician had not heard back from the patient and assumed that the patient had recovered. Additional information was received from the physician who reported he had not seen the patient for the reaction and was unclear on the details of the reaction. The physician believed the patient got a little bit of a red arm at the injection site. No additional information is expected.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood pressure, Electrocardiogram, Fatigue, Heart rate, Hypertension
Clinical narrative: Information has been received from a 61 year old female consumer with "sensitive skin", "topical reactions to soy and nickel" and environmental allergies who on 20-OCT-2006 was vaccinated with Pneumovax 23 (lot number 651404/0352F) in the left "post lateral SC" and Fluarix (lot 222AA) in the left deltoid. On 20-OCT-2006 the patient reported that her heart was "racing the whole day", felt like her arm was in a car accident since it was "severely sore" at injection site, and her blood pressure was "sky high" with readings of 190/50 and a pulse of 106. The clinic where the patient received the vaccination referred her to the Emergency Department. During the Emergency Department visit on 20-OCT-2006, an EKG was done (results not reported) and a circle was drawn around the swelling at the injection site. On 22-OCT-2006, the patient visited the Emergency Department again. The "large", "diffuse swelling moved" from the injection site and is "hanging off the elbow". It was reported that the physician from the second Emergency Department visit did not feel that the area was infected. The physician also advised the patient to take ibuprofen and keep the area elevated. The symptoms of heart racing were resolved as of this visit (also reported as "heart is also racing"). On 23-OCT-2006, the patient continued to have symptoms of swelling, exhaustion and "malaise". It was also noted that the patient had been previously vaccinated with Pneumovax 23 and Fluarix with no reported symptoms. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Malaise, No reaction on previous exposure to drug, Oedema peripheral
Clinical narrative: Information has been received from a 61 year old female consumer with "sensitive skin", "topical reactions to soy and nickel" and environmental allergies who on 20-OCT-2006 was vaccinated with Pneumovax 23 (lot number 651404/0352F) in the left "post lateral SC" and Fluarix (lot 222AA) in the left deltoid. On 20-OCT-2006 the patient reported that her heart was "racing the whole day", felt like her arm was in a car accident since it was "severely sore" at injection site, and her blood pressure was "sky high" with readings of 190/50 and a pulse of 106. The clinic where the patient received the vaccination referred her to the Emergency Department. During the Emergency Department visit on 20-OCT-2006, an EKG was done (results not reported) and a circle was drawn around the swelling at the injection site. On 22-OCT-2006, the patient visited the Emergency Department again. The "large", "diffuse swelling moved" from the injection site and is "hanging off the elbow". It was reported that the physician from the second Emergency Department visit did not feel that the area was infected. The physician also advised the patient to take ibuprofen and keep the area elevated. The symptoms of heart racing were resolved as of this visit (also reported as "heart is also racing"). On 23-OCT-2006, the patient continued to have symptoms of swelling, exhaustion and "malaise". It was also noted that the patient had been previously vaccinated with Pneumovax 23 and Fluarix with no reported symptoms. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Palpitations
Clinical narrative: Information has been received from a 61 year old female consumer with "sensitive skin", "topical reactions to soy and nickel" and environmental allergies who on 20-OCT-2006 was vaccinated with Pneumovax 23 (lot number 651404/0352F) in the left "post lateral SC" and Fluarix (lot 222AA) in the left deltoid. On 20-OCT-2006 the patient reported that her heart was "racing the whole day", felt like her arm was in a car accident since it was "severely sore" at injection site, and her blood pressure was "sky high" with readings of 190/50 and a pulse of 106. The clinic where the patient received the vaccination referred her to the Emergency Department. During the Emergency Department visit on 20-OCT-2006, an EKG was done (results not reported) and a circle was drawn around the swelling at the injection site. On 22-OCT-2006, the patient visited the Emergency Department again. The "large", "diffuse swelling moved" from the injection site and is "hanging off the elbow". It was reported that the physician from the second Emergency Department visit did not feel that the area was infected. The physician also advised the patient to take ibuprofen and keep the area elevated. The symptoms of heart racing were resolved as of this visit (also reported as "heart is also racing"). On 23-OCT-2006, the patient continued to have symptoms of swelling, exhaustion and "malaise". It was also noted that the patient had been previously vaccinated with Pneumovax 23 and Fluarix with no reported symptoms. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Breast tenderness, Erythema, Oedema peripheral, Pruritus
Clinical narrative: Initial and follow up information has been received from a health professional concerning a 63 year old male patient with no past medical history or allergies who on 17-OCT-2006 was vaccinated with a second dose of Pneumovax 23 (lot # 651357/0391F) IM into the right deltoid. Concomitant vaccination on 17-OCT-2006 included "yearly" dose of FLUZONE (lot # 42169NA) IM into the left deltoid. On 17-OCT-2006 the patient developed itching, redness and mild swelling and tender when pressed on at the elbow fold, approximately 5 inches below the injection site of the right deltoid. The reaction was noted in the injection site arm but not at the injection site and lasted approximately 72 hours. It was noted that the patient's wife (WAES # 0610USA12144) had an experience following vaccination with Pneumovax 23 (lot # 651357/0391F) and had requested a lot check. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the agency and was released by the regulatory agency. Additional information is not expected.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Pain, Pain in extremity, Skin warm
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning an 80 year old female with no allergies or drug reactions, no illness at the time of vaccination and a history of an aortic valve replacement and a coronary bypass (May 2005) who on 31-OCT-2006 at 10:00 A.M. the patient was vaccinated intramuscularly in the left arm with a 0.5 ml dose of Pneumovax 23 (lot #651149/0088F).  Concomitant therapy included FLUVIRIN, CENTRUM SILVER, DETROL LA, LASIX, OS-CAL, lisinopril (manufacturer unknown), TOPROL XL TABLETS, potassium (unspecified), aspirin, OCUVITE.  On 01-NOV-2006 the patient contacted the home care agency to report that "several hours" after the vaccination, her "whole left arm was painful with movement".  The patient stated that there was no swelling or redness but she did feel "chills".  She did not take her temperature.  She self-medicated herself twice with LORTAB with some improvement in the discomfort.  The patient stated to the nurse "I'm feeling much better and I don't need to see my doctor".  No lab tests were performed.  On 07-NOV-2006 the patient recovered.  No product quality complaint was involved.  In follow-up it was reported that the patient received the Pneumovax 23 at 10:00 A.M. and on 31-OCT-2006, the patient received FLUVIRIN (Lot # 71830) Chiron, intramuscularly into the right arm.  The patient reported that on 31-OCT-2006 at 5:00 P.M., she noticed that her left arm was painful upon movement, no swelling or redness noted at the injection site.  She reported that she began to chill but did not take her temperature.  Her arm was so painful that she took a LORTAB that she had on hand.  She went to bed at 9:00 P.M. and did sleep well.  On 01-NOV-2006, her arm was still painful upon movement and was slightly warm to touch.  There was no swelling or redness noted.  The patient took another LORTAB this A.M. and felt she did not need to see the physician.  It was reported that the patient recovered.  Additional information has been requested.  Correct lot # for PNEUMONIA vax.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information has been received from a licensed practical nurse concerning an approximately 51 year old female with no relevant medical history reported who on 17-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot 651357/0391F). There was no concomitant medication. On 19-OCT-2006, the patient developed 3 areas of redness and swelling. The area was tender when pressed on just above elbow fold. The reaction was noted in the injection site arm but not at the injection site. The patient sought unspecified care with a private physician. On 20-OCT-2006, the patient was still recovering. Additional information received indicated that the patient requested a lot check be performed on lot 651357/0391F. The records of testing prior to release of the lot in question have been rechecked and were 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: 74.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning a 74 year old female with a thyroid condition, hypertension, cardiac condition and an allergy to contrast dye who on 23-OCT-2006 was vaccinated intramuscularly with a first dose of Pneumovax 23 (lot #651437/0899F).  Concomitant therapy included a dose of influenza virus vaccine (unspecified) and multiple unspecified medications.  That same day the patient experienced pain, induration of 6-8 cm, redness and warmth at the injection site and decreased use of her arm.  Unspecified medical attention was sought.  No lab studies were performed.  Treatment included cool compresses and TYLENOL.  At the time of report, the patient was recovering.  No product quality complaint was involved.  The records of testing prior to release of the lot in question have been checked and found to be satisfactory.  The lot met the requirements of the agency and was released.  No additional information is available.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Body temperature increased, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial information from the consumer and follow-up information from a physician has been received concerning a 65 year old female with an allergy to penicillin and no medical history who on 16-OCT-2006 was vaccinated subcutaneously with a 0.5 ml dose of Pneumovax 23 (lot #651399/0486F).  Concomitant therapy given in the opposite arm included a dose of influenza virus vaccine (unspecified).  On 19-OCT-2006 at 0800 the patient experienced redness, swelling and pain at the injection site, chills, fever of 103, pain in the shoulder and neck, and severe pain and swelling in the arm.  Unspecified medical attention was sought.  The patient was treated with BENADRYL.  No lab studies were performed.  Subsequently the patient recovered.  No product quality complaint was involved.  Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Musculoskeletal pain, Neck pain, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Initial information from the consumer and follow-up information from a physician has been received concerning a 65 year old female with an allergy to penicillin and no medical history who on 16-OCT-2006 was vaccinated subcutaneously with a 0.5 ml dose of Pneumovax 23 (lot #651399/0486F).  Concomitant therapy given in the opposite arm included a dose of influenza virus vaccine (unspecified).  On 19-OCT-2006 at 0800 the patient experienced redness, swelling and pain at the injection site, chills, fever of 103, pain in the shoulder and neck, and severe pain and swelling in the arm.  Unspecified medical attention was sought.  The patient was treated with BENADRYL.  No lab studies were performed.  Subsequently the patient recovered.  No product quality complaint was involved.  Additional information is not expected.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Asthma, Drug hypersensitivity, Hypertension, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 55 year old white female with asthma, obsessive-compulsive disorder, hypertension, and an allergy to hydrochlorothiazide (+) losartan potassium (WAES# 0703USA00751) who on 27-OCT-2006 was vaccinated IM into the left deltoid with a dose of Pneumovax 23 (lot# 651374/0485F). Concomitant therapy included NORVASC, ANAFRANIL, and CLARITIN-D. On 27-OCT-2006, the patient's left arm was swollen, red, and painful from the injection site to the inner elbow. The physician recommended warm soaks to the area. No diagnostic laboratory tests were performed. On 29-OCT-2006, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Obsessive-compulsive disorder, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning a 55 year old white female with asthma, obsessive-compulsive disorder, hypertension, and an allergy to hydrochlorothiazide (+) losartan potassium (WAES# 0703USA00751) who on 27-OCT-2006 was vaccinated IM into the left deltoid with a dose of Pneumovax 23 (lot# 651374/0485F). Concomitant therapy included NORVASC, ANAFRANIL, and CLARITIN-D. On 27-OCT-2006, the patient's left arm was swollen, red, and painful from the injection site to the inner elbow. The physician recommended warm soaks to the area. No diagnostic laboratory tests were performed. On 29-OCT-2006, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old female with type II diabetes, emphysema, hypertension, atrial fibrillation and a sulfa allergy who on 25-OCT-2006 at 10:00 was vaccinated IM into the right deltoid with a second dose of Pneumovax 23 (lot# 651374/0485F).  Concomitant therapy included digoxin, ezetimibe (+) simvastatin (MSD), SPIRIVA, ADVAIR, ALDACTONE TABLETS and AVANDIA.  Illness at the time of vaccination included an upper respiratory infection.  On 26-OCT-2006, the patient experienced swelling in the arm from the injection site to the inner elbow and redness, pain and the area was hot to the touch.  The patient was diagnosed with right arm cellulitis from the injection site to the inner elbow.  The physician prescribed KEFLEX and recommended warm soaks to the area.  No diagnostic studies were performed.  On 28-OCT-2006, the patient recovered.  No product quality complaint was involved.  Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old female with type II diabetes, emphysema, hypertension, atrial fibrillation and a sulfa allergy who on 25-OCT-2006 at 10:00 was vaccinated IM into the right deltoid with a second dose of Pneumovax 23 (lot# 651374/0485F).  Concomitant therapy included digoxin, ezetimibe (+) simvastatin (MSD), SPIRIVA, ADVAIR, ALDACTONE TABLETS and AVANDIA.  Illness at the time of vaccination included an upper respiratory infection.  On 26-OCT-2006, the patient experienced swelling in the arm from the injection site to the inner elbow and redness, pain and the area was hot to the touch.  The patient was diagnosed with right arm cellulitis from the injection site to the inner elbow.  The physician prescribed KEFLEX and recommended warm soaks to the area.  No diagnostic studies were performed.  On 28-OCT-2006, the patient recovered.  No product quality complaint was involved.  Additional information is not expected.
Age: 7.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Headache, Injection site erythema, Injection site reaction, Injection site swelling, Nausea
Clinical narrative: Information has been received from a licensed practical nurse concerning a 7 year old male patient with chronic asthma who on 30-OCT-2006 was vaccinated subcutaneously with a dose of Pneumovax 23 (Lot# 654981/0674F).  Concomitant vaccination the same day in the other arm included a dose of influenza virus vaccine (unspecified).  On 31-OCT-2006 the patient presented with an injection site reaction from the vaccination from Pneumovax 23.  The nurse reported the symptoms consisted of "very red and very swollen area down to his elbow".  The nurse also reported that he had nausea and vomiting with severe headache.  The physician prescribed ZYRTEC and PHENERGAN.  On 02-NOV-2006, the patient was prescribed KEFLEX because the red area was getting larger. He completely recovered by 04-NOV-2006.  The caller requested a lot check of the vaccine "to see if other patients had experienced AE's from this particular lot number".  The nurse further clarified that there were no other patients in her office who had any problems with this lot number.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.
Age: 7.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 7 year old male patient with chronic asthma who on 30-OCT-2006 was vaccinated subcutaneously with a dose of Pneumovax 23 (Lot# 654981/0674F).  Concomitant vaccination the same day in the other arm included a dose of influenza virus vaccine (unspecified).  On 31-OCT-2006 the patient presented with an injection site reaction from the vaccination from Pneumovax 23.  The nurse reported the symptoms consisted of "very red and very swollen area down to his elbow".  The nurse also reported that he had nausea and vomiting with severe headache.  The physician prescribed ZYRTEC and PHENERGAN.  On 02-NOV-2006, the patient was prescribed KEFLEX because the red area was getting larger. He completely recovered by 04-NOV-2006.  The caller requested a lot check of the vaccine "to see if other patients had experienced AE's from this particular lot number".  The nurse further clarified that there were no other patients in her office who had any problems with this lot number.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.
Age: 70.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Body temperature increased, Chills, Erythema, Laboratory test, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning a 70 year old female who on 04-NOV-2006 was vaccinated with a second dose of Pneumovax 23, 0.5 ml, IM in the right deltoid and influenza virus vaccine (unspecified), IM, left arm. Previous vaccination with Pneumovax 23 was about 8-9 years ago. On 04-NOV-2006 about 2-3 hours after vaccination, the patient experienced soreness, redness, pain and swelling of the right arm. On 05-NOV-2006, the day after vaccination, the patient experienced chills, shakiness and low grade fever. The patient visited an urgent care center where she was ordered an antibiotic and BENADRYL. Four days later, the patient visited the urgent care center again since her arm was still hurting. The patient was then ordered Prednisone. On an unspecified date, laboratory tests were performed with results not reported. The nurse spoke with the patient on 13-NOV-2006 and the patient mentioned that her symptoms were improving. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: Information has been received from a registered nurse concerning a 70 year old female who on 04-NOV-2006 was vaccinated with a second dose of Pneumovax 23, 0.5 ml, IM in the right deltoid and influenza virus vaccine (unspecified), IM, left arm. Previous vaccination with Pneumovax 23 was about 8-9 years ago. On 04-NOV-2006 about 2-3 hours after vaccination, the patient experienced soreness, redness, pain and swelling of the right arm. On 05-NOV-2006, the day after vaccination, the patient experienced chills, shakiness and low grade fever. The patient visited an urgent care center where she was ordered an antibiotic and BENADRYL. Four days later, the patient visited the urgent care center again since her arm was still hurting. The patient was then ordered Prednisone. On an unspecified date, laboratory tests were performed with results not reported. The nurse spoke with the patient on 13-NOV-2006 and the patient mentioned that her symptoms were improving. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site pain
Clinical narrative: Information has been received from an office manager concerning a 5 year old male patient with no medical history or allergies, who on 13-NOV-2006 at 16:00, was vaccinated into the right thigh with a first dose of Pneumovax 23 (lot# 651321/1036P). Concomitant therapy included a dose of influenza virus vaccine (unspecified). On 13-NOV-2006 at 22:30 the patient developed pain at the injection site. Subsequently, the patient developed cellulitis. At the time of this report, the patient recovered from injection site pain but the outcome of cellulitis was unknown. Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Hypokinesia, Injection site cellulitis, Pain
Clinical narrative: Information has been received from an occupational therapist concerning her 79 year old mother, with hypertension, who on 17-NOV-2006 in the afternoon was vaccinated with a second dose of Pneumovax 23 (1.0 ml) (lot # 655053/0743F), in the right deltoid. Concomitant therapy included "blood pressure" in the right deltoid. Concomitant therapy included "blood pressure", "glaucoma eye drops", alendronae sodium (MSD), ZESTERIL, hydrochlorothiazide, and FLUARIX (lot # AFLUA218BA) given IM in the deltoid. Subsequently, the patient developed cellulitis from injection site to wrist area. The patient was seen in urgent care center on 19-NOV-2006 and was given ROCEPHIN intramuscularly and then was started on KEFLEX (PO) on 20-NOV-2006. The patient had pain with movement, redness, and swelling. At the time of the report, the patient was recovering. There were no relevant diagnostic tests or laboratory data. Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: Information has been received from an occupational therapist concerning her 79 year old mother, with hypertension, who on 17-NOV-2006 in the afternoon was vaccinated with a second dose of Pneumovax 23 (1.0 ml) (lot # 655053/0743F), in the right deltoid. Concomitant therapy included "blood pressure" in the right deltoid. Concomitant therapy included "blood pressure", "glaucoma eye drops", alendronae sodium (MSD), ZESTERIL, hydrochlorothiazide, and FLUARIX (lot # AFLUA218BA) given IM in the deltoid. Subsequently, the patient developed cellulitis from injection site to wrist area. The patient was seen in urgent care center on 19-NOV-2006 and was given ROCEPHIN intramuscularly and then was started on KEFLEX (PO) on 20-NOV-2006. The patient had pain with movement, redness, and swelling. At the time of the report, the patient was recovering. There were no relevant diagnostic tests or laboratory data. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 68 year old female who on 09-NOV-2006, at 13:15, was vaccinated with IM, into the right deltoid, with a 0.5ml first dose of Pneumovax 23 concomitantly with a dose of Fluvirin IM into the left arm. On 09-JAN-2006, at 14:15 the patient experienced pain in the right arm and shoulder. The patient unable to life her arm by 15-NOV-2006. On 20-NOV-2006, the patient was referred to a rehabilitation specialist. The patient was treated with IM cortisone and ADVIL. Subsequently, the patient recovered. No further information is available.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 65 year old female who on 19-DEC-2006 was vaccinated with the first dose of Pneumovax 23 (lot #651356/0089F), IM in the left arm.  Concomitant medication included ROBITUSSIN, omeprazole (MSD), aspirin, BONIVA (previously not reported).  At the time of vaccination the patient had an upper respiratory tract infection (URI).  On 20-DEC-2006 (also reported as 21-DEC-2006), the patient experienced 5.5" wide x 9.25" long erythematous, swollen area at injection site.  The patient was seen in the emergency room.  The patient did not have shortness of breath, difficulties in swallowing, fever or other irritations.  The patient was treated with warm soaks, ibuprofen or TYLENOL, MEDROL, 4 mg, twice a day tomorrow and 4 mg once a day on day 3.  The patient recovered from the events.  The causality of the event was not reported.  Erythematous, swollen area at injection site was considered to be an other important medical event.  Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pyrexia, Skin warm
Clinical narrative: Initial and follow-up information has been received from a licensed practical nurse (LPN) concerning a 58 year old female with an allergy to sulfonamide, non-steroidal anti-inflammatory drugs, and lidocaine who on 15-DEC-2006 was vaccinated IM in the right arm with a dose of Pneumovax 23 (lot #651331/0577R).  The patient was vaccinated with a dose of influenza virus vaccine (unspecified) on the same day.  Other concomitant therapy included albuterol and FLONASE.  On 15-DEC-2006, at 17:00, the patient developed redness, warmth, and one inch thick swelling, over 4 in. X 8 in. area, in the arm she received vaccination with Pneumovax 23.  The patient also developed a low grade fever, and subsequently, was diagnosed with cellulitis.  The patient was treated with unspecified antibiotics.  The outcome of the patient's cellulitis was unknown.  No further information is expected.
Age: 75.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Cellulitis, Injection site erythema, Injection site warmth, Oedema peripheral, Pyrexia
Clinical narrative: Initial and follow up information has been received from a licensed practical nurse (LPN) concerning a 75 year old female with a history of stroke, PVD, GERD and high cholesterol who on 14-DEC-2006 was vaccinated IM into the right arm with a second dose of Pneumovax 23 (lot #651331/0577R).  The patient was vaccinated with a dose of tetanus toxoid on the same day.  Other concomitant therapy included LIPITOR, prednisone, and PRILOSEC.  There was no illness at the time of vaccination.  On approximately 14-DEC-2006, the patient developed swelling in the arm she received vaccination with Pneumovax 23, and a low grade fever.  On 15-DEC-2006 there was erythema and heat distal to the injection site on the right upper arm.  The patient was diagnosed with cellulitis, required a doctor's visit and was treated with antibiotics.  The outcome of the patient's experience was recovered on an unspecified date.  Additional information is not expected.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Chills, Erythema, Fatigue, Hypokinesia, Pain
Clinical narrative: Information has been received from a health professional concerning a 53 year old female with no pertinent medical history who on 04-NOV-2006, at 11:30, was vaccinated intramuscularly, into the right arm, with a first dose of Pneumovax 23 (lot #651400/0618F) concomitantly with a first dose of FLUVIRIN (lot #70384) intramuscularly into the left arm.  On 04-NOV-2006, at approximately 16:30, the patient experienced chills, fatigue, fever of 101.2 and redness, swelling and soreness in the affected arm.  The patient was unable to lift her arm above her head.  The patient was seen by her personal physician who placed her on therapy with BACTRIM.  There were no laboratory or diagnostic tests performed.  By 05-NOV-2006 the patient's arm was less swollen and red and the patient was released her physician to go on vacation.  Subsequently the patient recovered on 07-NOV-2006.  No additional information is expected.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: Information has been received from a health professional concerning a 53 year old female with no pertinent medical history who on 04-NOV-2006, at 11:30, was vaccinated intramuscularly, into the right arm, with a first dose of Pneumovax 23 (lot #651400/0618F) concomitantly with a first dose of FLUVIRIN (lot #70384) intramuscularly into the left arm.  On 04-NOV-2006, at approximately 16:30, the patient experienced chills, fatigue, fever of 101.2 and redness, swelling and soreness in the affected arm.  The patient was unable to lift her arm above her head.  The patient was seen by her personal physician who placed her on therapy with BACTRIM.  There were no laboratory or diagnostic tests performed.  By 05-NOV-2006 the patient's arm was less swollen and red and the patient was released her physician to go on vacation.  Subsequently the patient recovered on 07-NOV-2006.  No additional information is expected.