chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Fatigue, Hypoaesthesia, Immobile
Clinical narrative: Information has been received from a registered pharmacist concerning a 55 year old female who on 28-OCT-2007 was vaccinated with PNEUMOVAX 23, 0.5 milliliter, intramuscular. Concomitant therapy included FLUZONE. "Within 3 days of the vaccination", the patient developed fever, chills, swelling and numbness in her left arm and leg, soreness at the injection site. The patient recovered from the most symptoms but was still experiencing numbness and tingling sensations on her left arm. The patient sought medical attention by seeing a physician. Follow-up information has been received from a registered pharmacist who reported that the patient was vaccinated with PNEUMOVAX 23, 0.5 milliliter, IM on left deltoid on 28-OCT-2007 (also reported as on 01-NOV-2007). On 01-NOV-2007 the patient was vaccinated with FLUZONE (Lot #U2513AA), 0.5 milliliter, IM on left deltoid. The pharmacist reported that on 01-NOV-2007 at 9:00 pm, during the first 3 days of the vaccinations, the patient developed fever, chills, exhaustion, left arm red, swollen and immobile most of that time. Currently the patient had numbness in left arm and leg and still had swelling, soreness in shoulder at injection site. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Oedema peripheral, Paraesthesia, Pyrexia
Clinical narrative: Information has been received from a registered pharmacist concerning a 55 year old female who on 28-OCT-2007 was vaccinated with PNEUMOVAX 23, 0.5 milliliter, intramuscular. Concomitant therapy included FLUZONE. "Within 3 days of the vaccination", the patient developed fever, chills, swelling and numbness in her left arm and leg, soreness at the injection site. The patient recovered from the most symptoms but was still experiencing numbness and tingling sensations on her left arm. The patient sought medical attention by seeing a physician. Follow-up information has been received from a registered pharmacist who reported that the patient was vaccinated with PNEUMOVAX 23, 0.5 milliliter, IM on left deltoid on 28-OCT-2007 (also reported as on 01-NOV-2007). On 01-NOV-2007 the patient was vaccinated with FLUZONE (Lot #U2513AA), 0.5 milliliter, IM on left deltoid. The pharmacist reported that on 01-NOV-2007 at 9:00 pm, during the first 3 days of the vaccinations, the patient developed fever, chills, exhaustion, left arm red, swollen and immobile most of that time. Currently the patient had numbness in left arm and leg and still had swelling, soreness in shoulder at injection site. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Hyperhidrosis, Influenza like illness, Malaise
Clinical narrative: Information has been received from a 76 year old female with an allergy to some antibiotics who, "years ago", was vaccinated with a dose of PNEUMOVAX (manufacturer unknown). "After getting the vaccine", the patient had a "shocking reaction". She was feeling generally ill with flu like symptoms and sweating for about 3 weeks. Subsequently, the patient recovered. No further information is available.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Mobility decreased, Pain, Skin discolouration
Clinical narrative: Information has been received from a 65 year old female consumer with an allergy to PHENOL, THIMEROSAL, and KEFLEX which "tears her guts up" and a history of shingles in both eyes in 202, who in early March 2008 was vaccinated with a dose of PNEUMOVAX. Concomitant therapies included LEVOXYL, WELLBUTRIN and ACETAMINOPHEN/HYDROCODONE BIARITRATE. Subsequently, over the next 12 hour period post vaccination the patient began to develop a hot red rash around the area of the injection site on the left arm. Then the patient developed swelling which became more and more painful. The swelling was the size of a softball and grew to the size of a cantaloupe. The patient could not raise her arm above her shoulder. The rash changed to a purple color. The patient was treated with BENADRYL and PREDNISONE for three days. The patient recovered on an unspecified date. It was reported that the patient was previously vaccinated with a dose of PNEUMOVAX at the age of 55 and the vaccine was well tolerated. No product quality complaint was involved. No further information information is available.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a 65 year old female consumer with an allergy to PHENOL, THIMEROSAL, and KEFLEX which "tears her guts up" and a history of shingles in both eyes in 202, who in early March 2008 was vaccinated with a dose of PNEUMOVAX. Concomitant therapies included LEVOXYL, WELLBUTRIN and ACETAMINOPHEN/HYDROCODONE BIARITRATE. Subsequently, over the next 12 hour period post vaccination the patient began to develop a hot red rash around the area of the injection site on the left arm. Then the patient developed swelling which became more and more painful. The swelling was the size of a softball and grew to the size of a cantaloupe. The patient could not raise her arm above her shoulder. The rash changed to a purple color. The patient was treated with BENADRYL and PREDNISONE for three days. The patient recovered on an unspecified date. It was reported that the patient was previously vaccinated with a dose of PNEUMOVAX at the age of 55 and the vaccine was well tolerated. No product quality complaint was involved. No further information information is available.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Injection site pain, Myalgia, Skin warm, Swelling
Clinical narrative: Information has been received from a nurse concerning a 66 year old female with a drug allergy to SUDAFED and hip osteopenia, who on 14-MAY-2008 was vaccinated intramuscularly into the left deltoid with a dose of PNEUMOVAX (659199/1541U).  Concomitant suspect therapy included an intramuscular vaccination into the right arm with a dose of ZOSTAVAX (Lot # 658844/0204X).  On 14-MAY-2008, the night of vaccination, the patient experienced pain at the injection area and muscle aches. On 16-MAY-2008, two days later, the muscle aches continued and the injected arm was red and hot requiring an office visit.  The injection site itself was not red, but the area two inches below and extending downward to the elbow and halfway around the upper arm was red and hot to touch.  At the time of this report.  The patient's outcome remained unknown. No product quality complaint was involved.  Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injected limb mobility decreased, Injection site reaction, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 4 year old old female with asthma who on 04-Jun-2008 was vaccinated (route unknown) with a dose of PNEUMOVAX (lot# 659149/1383U). There was no concomitant medication. On 04-Jun-2008 the patient experienced fever of 102.8, chills, and injection site reaction 30 minutes post vaccination. The patient is refusing to move her arm. The patient was taken to the emergency room, but not admitted. No laboratory diagnostic studies were performed. The outcome was reported as not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 23 year old female with asthma and seasonal allergies and no illnesses at the time of vaccination who on 17-JUN-2008 at 10:55 am was vaccinated IM in the left deltoid with the first dose of PNEUMOVAX 23 (Lot # 656233/0200U). Concomitant therapy included albuterol, ADVAIR, FLONASE, CROMOLYN and LORANIL. On 19-JUN-2008 at 4:00 am the patient experienced hives on and off. On 19-JUN-2008 unspecified medical attention was sought in the ER. The patient was treated with Prednisone, BENADRYL and ZANTAC. It was reported that on 09-Jul-2008, the patient recovered from hives. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Body temperature increased, Chest X-ray normal, Full blood count normal, Pyrexia
Clinical narrative: Information has been received from a certified medical assistant concerning a 65 year old female who on 04-AUG-2008 was vaccinated with PNEUMOVAX 23 (lot# unknown at this time), and ZOSTAVAX (Merck) (lot#658859/0411X). The medical assistant reported that the patient has had fever daily since receiving the vaccines. On 08-AUG-2008 the patient had a temperature of 101.2F. On 11-AUG-2008 her temperature was 101F and on 12-AUG-2008 a temperature of 99.3F. The patient was taking TYLENOL and ADVIL for fever. Labs and diagnostics studies performed included chest x-ray and CBC (complete blood count) which were normal. On 12-AUG-2008, at the time of the reporting, the patient was seen by the physician and the patient had not recovered. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Radicular pain
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 56 year old female with chronic obstructive pulmonary disease (COPD), gastrooesophageal reflux disease ("GERDS") and no illness at the time of vaccination, who on 04-SEP-2008 was vaccinated IM with a dose of PNEUMOVAX 23 (lot # 659487/1960U) in her left arm about 2:30 PM. On 04-SEP-2008, at 11:59 (also reported as 12:00) PM, pain in left arm work her up. The pain was "sharp and aches from injection site down, throbs from time to time" and "all the way from the shoulder to fingers." The pain scored 920 on a scale "1-10". The physician also reported that the patient had extreme pain in the arm but there was no redness, fever or swelling. The physician was contacted by the patient. The physician defined it as "radicular pain." At the time of the report the patient had not recovered from "pain in the arm" defined as "radicular pain". No further information was available.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of PNEUMOVAX.  Subsequently, the patient experienced a rash all over the body.  Unspecified medical attention was sought.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Follow up information was received from the physician who reported that the patient was a 52 year old male with an allergy to PENICILLIN who on 25-AUG-2008 was vaccinated with a dose of PNEUMOVAX in his left arm.  No illness was reported at the time of vaccination.  On 25-AUG-2008 the patient experienced a rash all over the body.  The patient recovered in about 48 hours, on 27-AUG-2008.  This is one to two reports from the same source.  Additional information is not expected.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of PNEUMOVAX.  Subsequently, the patient experienced a rash all over the body.  Unspecified medical attention was sought.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Follow up information was received from the physician who reported that the patient was a 54 year old male with no known pre-existing allergies, birth defects, medical conditions who on 26-AUG-2008 was vaccinated with a dose of PNEUMOVAX in his arm.  No illness was reported at the time of vaccination.  On 26-AUG-2008 the patient experienced a rash all over the body.  The patient recovered in about 48 hours.  This is one of two reports from the same source.  Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 73 year old female with a shellfish allergy and no medical history who in 1999 received a first dose of PNEUMOVAX 23. On 16-SEP-2008, the patient was vaccinated IM with second 0.5 ml dose of PNEUMOVAX 23 (Lot# 658673/0990U). Concomitant therapy included ACTONEL and ADVAIR. That same day, the patient experienced erythema, soreness and swelling and injection site. No laboratory diagnostic studies were performed. The patient was prescribed BENADRYL and topical triamcinolone. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information is not expected.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 53 year old male patient with hyperactive airway disease, hypertension and diabetes mellitus who on 20-SEP-2008 was vaccinated with a dose of PNEUMOVAX (lot n. 659150/1384U (also reported as 659149/1383U) in the right deltoid at 16:00 pm.  On 21-SEP-2008, the patient developed swelling, warmth and redness to site.  The patient saw the doctor.  On 24-SEP-208, the patient recovered from swelling, warmth and redness to site.  This is one of several reports from the same source.  Additional experienced is not expected.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning an 35 year old female who on 02-OCT-2008 was vaccinated with PNEUMOVAX 23 (lot # 658673/0990U) IM into right deltoid. Subsequently the patient experienced pain down her arm after vaccination. The patient went to her primary care physician but no treatment was given. The outcome of the patient was unknown. Follow up information has been received from the pharmacist who indicated that on 02-NOV-2008 the patient experienced significant pain starting in shoulder and radiating down arm and to hand (right side only). The pain resolved without medical treatment within 7 days. No further hospitalization or doctor visits reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a 78 year old male who on 02-OCT-2008 was vaccinated with PNEUMOVAX 23 (lot # 658673/0990U). The patient experienced pain in the arm after PNEUMOVAX 23 was given. The patient contacted pharmacist for medical attention. The pharmacist also reported another adverse event concerning PNEUMOVAX 23 (WAES # 0810USA04172). Follow-up information has been received from a pharmacist concerning a 78 year old male who on 02-OCT-2008, at 12:55, was vaccinated IM with PNEUMOVAX 23 (lot # 658673/0990U) into the right deltoid. On 2-OCT-2008, the patient experienced "severe" pain all the way down arm and swelling at injection site, the size of a grape-fruit". Pain not received by any OTC products. Swelling down in 24 hours, pain persisted for 5-7 days (improved over time). No further information is available.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning a 77 year old female patient with no medical history who was on 02-OCT-2008 vaccinated with a second 0.5ml dose of PNEUMOVAX 23 (Lot #) in right arm intramuscularly. Her first dose of PNEUMOVAX 23 (Lot # was not reported) was given more than 5 years ago. Concomitant therapy included influenza virus vaccine (unspecified) in left arm. On 02-OCT-2008 the patient experienced arm pain at the injection site in right arm. The patient not recovered. The patient sought medical attention by phone call. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dizziness, Flushing, Paraesthesia oral
Clinical narrative: Information has been received from a pharmacist concerning a 69 year old female who on 08-OCT-2008 was vaccinated with PNEUMOVAX 23 (dose, route unspecified). Concomitant therapy included influenza virus vaccine (unspecified). Subsequently "within a minute or so" the patient experienced feeling flushed, dizzy, and felt tingling in her gums and tongue. She sat down for about 20 minutes and the symptoms improved. The patient sought medical attention in the pharmacy. Subsequently, the patient recovered without treatment. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Lymphadenopathy, Malaise, Oedema peripheral, Tenderness
Clinical narrative: Information has been received from a pharmacist concerning a 69 year old male who on 04-OCT-2008 was vaccinated with PNEUMOVAX 23. Concomitant therapy included FLUVIRIN. On 05-OCT-2008 the patient experienced left arm was swollen, left arm was tender, injection site reaction and not feeling well. On 06-OCT-2008 the patient experienced left lymph nodes in the neck became swollen. Subsequently, the patient recovered from left arm was swollen, left arm was tender, left lymph nodes in the neck became swollen, injection site reaction and not feeling well. Follow up information was received from the pharmacist who reported that the patient was 68 year old who on 04-OCT-2008 was vaccinated intramuscularly in her left arm with a first dose of PNEUMOVAX 23 (lot# 662100/0742X). Secondary suspect therapy included a dose of FLUVIRIN vaccinated intramuscularly in his left arm on the same day. No illness was reported at the time of the vaccination. One day after vaccination, the patient experienced arm swelling and did not feel well. Two days after vaccination, his arm swelling became more serious and lymph nodes in neck became swollen and the patient felt sick. The patient was told to take BENADRYL. At the time of this report, the patient recovered. Additional information is not requested.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 62 year old female who on 07-OCT-2008 was vaccinated with a dose of PNEUMOVAX (lot # 660685/0619X).  On 08-OCT-2008 the patient had a "softball size, red swollen injection site".  The patient sought medical attention and was diagnosed with cellulitis.  The patient was treated with BENADRYL and antibiotics.  As of 16-OCT-2008, the patient was recovering.  Follow-up information was received from a registered nurse (R.N.).  It was reported that the patient with gastrooesophageal reflux disease, chronic cystitis, diverticulosis, a history of right-sided breast cancer and no illness at time of vaccination who was vaccinated in the left lower deltoid with a first dose of PNEUMOVAX (lot # 660685/0619X) and a first dose of FLUZONE (U28UAA) in the left upper deltoid at 16:00 on 07-OCT-2008.  Both injections were given in left arm due to breast mastectomy.  At 13:00 08-OCT-2008, the patient experienced redness, swelling and pain at injection site, in lower arm after vaccination.  The patient was advised to use cool compress and OTC antihistamine.  Patient's outcome was unknown.  This is one of several reports received from the same source.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a physician concerning an 83 year old male with a history of chronic obstructive pulmonary disease (COPD) who on approximately 14-OCT-2008 was vaccinated with PNEUMOVAX 23 (lot number: 660718/0551X) 0.5ml (route not reported). On 14-OCT-2008 the patient's arm was swollen from his wrist to his elbow on the arm where injected with PNEUMOVAX 23. Subsequently, the patient recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Information has been received from a registered pharmacist concerning a male patient who on 22-OCT-2008 was vaccinated subcutaneously with 0.5 ml PNEUMOVAX (lot # 655765/0061U).  The patient developed redness and swelling around the elbow area a couple of days after vaccination.  The affected area ranges from 6 inches above to 6 inches below the elbow.  The patient sought medical attention by contacting pharmacy.  No information is available on physician.  At the time of the report (27-OCT-2008) the patient has not recovered.  No further information is available.  Correspondence attempts are unsuccessful.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Injection site streaking, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a female with PREDNISONE allergy, SULFONAMIDE allergy and an allergy to strawberries and a history of ulcer who "10 years ago" was vaccinated with a first dose of PNEUMOVAX.  The patient received her second dose of PNEUMOVAX on 14-OCT-2008.  Concomitant therapy included ATIVAN.  Subsequently the patient developed an injection site reaction.  The patient was vaccinated with PNEUMOVAX in the right arm where she had swelling at the site and  "a line from the site going under her arm".  The patient had been applying ice to the area. The patient's swelling at the site and "a line from the site going under her arm" persisted.  The patient also received a flu vaccine in the left arm on the same day.  The patient made a phone call to the pharmacist for medical attention.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Induration, Muscular weakness, Pyrexia
Clinical narrative: Information has been received from a female with a history of injection site redness, swelling and soreness after vaccination with FLUZONE on 14-Oct-2008 who on 23-Oct-2008 was vaccinated with PNEUMOVAX. Subsequently the patient's arm became red from her shoulder to her elbow and hard to the touch. The patient started having fever and chills and muscle weakness. Follow up information received from a registered nurse at the office indicated that the office has no record of either the PNEUMOVAX or FLUZONE, there was no physician order in the patient's chart for the vaccinations. The office also stated that there was no office visit or record of complaint regarding the above mentioned adverse effects. No further information is available.
Age: 62.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Blood culture negative, Blood lactate dehydrogenase increased, Cellulitis, Chills, Erythema
Clinical narrative: Information has been received from a registered nurse concerning a male (age unknown), who on 12-SEP-2008 was vaccinated SQ in the right arm with a first dose of PNEUMOVAX 23. Concomitant vaccinations included ADACEL (Lot# C2966AA) administered in the left arm. Concomitant therapy included GLUCOPHAGE. On 12-SEP-2008 the patient experienced fever and chills. The patient's left arm was red and swollen from elbow to shoulder and axilla. The patient developed cellulitis and was treated with KEFLEX. The patient was seen at the office. At the time of the report, the patient had not recovered. No product quality complaint was involved. Follow-up information received from the registered nurse indicated that the patient was a 62 year old male with no medical history or allergy. At a routine visit on 12-SEP-2008, the patient was vaccinated with his first dose of PNEUMOVAX 23 SQ in the right arm (reported "no reaction"). Secondary suspect therapy included the second dose of ADACEL (lot# C2966AA) SQ in the left arm on 12-SEP-2008. The patient's brother called on 17-SEP-2008, reporting that the patient developed fever, chills, redness and edema of the left arm. The patient was seen that day and was placed on KEFLEX. There was no improvement by 19-SEP-2008 so the patient was sent to the emergency room. The redness had spread into axilla and frontal chest. The test results showed that: On 19-SEP-2008, the white blood cell count (WBC) was 12.0 (normal range: 4.8-10.8). On 19-SEP-2008, the absolute blood neutrophil count (NE absolute) was 9.0 (normal range: 1.5-7.5). On 19-SEP-2008, the serum L-lactate test result was 1.0 mmol/L (normal range: 0.4-2.0). Blood cultures showed that from 20-SEP-2008 to 24-SEP-2008 there was no growth. The doctor received a call from emergency room that the patient had signed out without treatment. The physician's office staff called the patient on 20-SEP-2008 and the patient reported that he was "a lot better". Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Neutrophil count increased, Oedema peripheral, Pyrexia, White blood cell count increased
Clinical narrative: Information has been received from a registered nurse concerning a male (age unknown), who on 12-SEP-2008 was vaccinated SQ in the right arm with a first dose of PNEUMOVAX 23. Concomitant vaccinations included ADACEL (Lot# C2966AA) administered in the left arm. Concomitant therapy included GLUCOPHAGE. On 12-SEP-2008 the patient experienced fever and chills. The patient's left arm was red and swollen from elbow to shoulder and axilla. The patient developed cellulitis and was treated with KEFLEX. The patient was seen at the office. At the time of the report, the patient had not recovered. No product quality complaint was involved. Follow-up information received from the registered nurse indicated that the patient was a 62 year old male with no medical history or allergy. At a routine visit on 12-SEP-2008, the patient was vaccinated with his first dose of PNEUMOVAX 23 SQ in the right arm (reported "no reaction"). Secondary suspect therapy included the second dose of ADACEL (lot# C2966AA) SQ in the left arm on 12-SEP-2008. The patient's brother called on 17-SEP-2008, reporting that the patient developed fever, chills, redness and edema of the left arm. The patient was seen that day and was placed on KEFLEX. There was no improvement by 19-SEP-2008 so the patient was sent to the emergency room. The redness had spread into axilla and frontal chest. The test results showed that: On 19-SEP-2008, the white blood cell count (WBC) was 12.0 (normal range: 4.8-10.8). On 19-SEP-2008, the absolute blood neutrophil count (NE absolute) was 9.0 (normal range: 1.5-7.5). On 19-SEP-2008, the serum L-lactate test result was 1.0 mmol/L (normal range: 0.4-2.0). Blood cultures showed that from 20-SEP-2008 to 24-SEP-2008 there was no growth. The doctor received a call from emergency room that the patient had signed out without treatment. The physician's office staff called the patient on 20-SEP-2008 and the patient reported that he was "a lot better". Additional information is not expected.
Age: 32.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Chills, Cough, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning a 32 year old female with chronic autoimmune disorder, multiple chemical sensitivities, chronic fatigue syndrome and "no known drug allergies" who on 17-OCT-2008 was vaccinated with a 0.5ml dose of PNEUMOVAX 23 intramuscularly in the right arm (lot# 661040/0397X). On 18-OCT-2008 the patient went to the ER for generalized body aches. Her right deltoid area had an affected area the size of a baseball that was red, tender to touch, and swollen. Patient was diagnosed with cellulitis and is being treated with BACTRIM DS and KEFLEX. The area has cleared up but the patient is still on the treatment. The patient recovered on an unspecified date. Follow-up information was received. It was reported that the patient was a female film producer with fibromyalgia who was vaccinated intramuscularly with a first dose of PNEUMOVAX 23 in the right deltoid at 16:00 and a first dose of AFLURIA (lot # 01349111A) in the left deltoid at 16:02. There was no illness at the time of vaccination. Reporter stated that the vaccines were given on patient's request. Subsequently, patient experienced pain, swelling and redness at injection site, started within 24 hours, gradually getting worse. Patient used OTC pain medicine and ice to site with no relief. Patient continued to get worse and went to ER on 20-OCT-2008. She developed blow and chills prior to ER visit. She also started with throat swelling. Patient was seen at physician's office on 22-OCT-2008. She still with vaccine site swelling erythema 9x9 cm. On 24-OCT-2008, she developed dry cough and upper symptoms were getting worse. Patient was seen by the physician on 28-OCT-2008, she started with BIAXIN XL 500 mg twice daily. She experienced fever and wheezing cough seen by physician. The symptoms resolved on 04-NOV-2008. No further information is available.
Age: 32.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Pain, Pharyngeal oedema, Pyrexia, Upper respiratory tract infection
Clinical narrative: Information has been received from a pharmacist concerning a 32 year old female with chronic autoimmune disorder, multiple chemical sensitivities, chronic fatigue syndrome and "no known drug allergies" who on 17-OCT-2008 was vaccinated with a 0.5ml dose of PNEUMOVAX 23 intramuscularly in the right arm (lot# 661040/0397X). On 18-OCT-2008 the patient went to the ER for generalized body aches. Her right deltoid area had an affected area the size of a baseball that was red, tender to touch, and swollen. Patient was diagnosed with cellulitis and is being treated with BACTRIM DS and KEFLEX. The area has cleared up but the patient is still on the treatment. The patient recovered on an unspecified date. Follow-up information was received. It was reported that the patient was a female film producer with fibromyalgia who was vaccinated intramuscularly with a first dose of PNEUMOVAX 23 in the right deltoid at 16:00 and a first dose of AFLURIA (lot # 01349111A) in the left deltoid at 16:02. There was no illness at the time of vaccination. Reporter stated that the vaccines were given on patient's request. Subsequently, patient experienced pain, swelling and redness at injection site, started within 24 hours, gradually getting worse. Patient used OTC pain medicine and ice to site with no relief. Patient continued to get worse and went to ER on 20-OCT-2008. She developed blow and chills prior to ER visit. She also started with throat swelling. Patient was seen at physician's office on 22-OCT-2008. She still with vaccine site swelling erythema 9x9 cm. On 24-OCT-2008, she developed dry cough and upper symptoms were getting worse. Patient was seen by the physician on 28-OCT-2008, she started with BIAXIN XL 500 mg twice daily. She experienced fever and wheezing cough seen by physician. The symptoms resolved on 04-NOV-2008. No further information is available.
Age: 32.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Wheezing
Clinical narrative: Information has been received from a pharmacist concerning a 32 year old female with chronic autoimmune disorder, multiple chemical sensitivities, chronic fatigue syndrome and "no known drug allergies" who on 17-OCT-2008 was vaccinated with a 0.5ml dose of PNEUMOVAX 23 intramuscularly in the right arm (lot# 661040/0397X). On 18-OCT-2008 the patient went to the ER for generalized body aches. Her right deltoid area had an affected area the size of a baseball that was red, tender to touch, and swollen. Patient was diagnosed with cellulitis and is being treated with BACTRIM DS and KEFLEX. The area has cleared up but the patient is still on the treatment. The patient recovered on an unspecified date. Follow-up information was received. It was reported that the patient was a female film producer with fibromyalgia who was vaccinated intramuscularly with a first dose of PNEUMOVAX 23 in the right deltoid at 16:00 and a first dose of AFLURIA (lot # 01349111A) in the left deltoid at 16:02. There was no illness at the time of vaccination. Reporter stated that the vaccines were given on patient's request. Subsequently, patient experienced pain, swelling and redness at injection site, started within 24 hours, gradually getting worse. Patient used OTC pain medicine and ice to site with no relief. Patient continued to get worse and went to ER on 20-OCT-2008. She developed blow and chills prior to ER visit. She also started with throat swelling. Patient was seen at physician's office on 22-OCT-2008. She still with vaccine site swelling erythema 9x9 cm. On 24-OCT-2008, she developed dry cough and upper symptoms were getting worse. Patient was seen by the physician on 28-OCT-2008, she started with BIAXIN XL 500 mg twice daily. She experienced fever and wheezing cough seen by physician. The symptoms resolved on 04-NOV-2008. No further information is available.
Age: 2.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Blood culture negative, Differential white blood cell count abnormal, Haematocrit normal, Haemoglobin normal, Injection site cellulitis
Clinical narrative: Information has been received from a office manager concerning a 26 month old female with allergy to AMOXICILLIN and no pertinent medical history, who on 30-OCT-2008 was vaccinated with PNEUMOVAX (lot # 659150/1384U), 0.5 ml via intramuscular.  Concomitant medication included SINGULAIR.  On 31-OCT-2008 the patient developed fever of 100F and a 3 cm area of swelling of the right thigh 1 day after administration of PNEUMOVAX.  On 31-OCT-2008 the patient was seen in the office and was prescribed ZITHROMAX.  On 01-NOV-2008 the patient was seen again and the reaction had increased to include the entire right thigh.  The patient was continued on ZITHROMAX and was given an injection of ROCEPHIN in the office.  On 04-NOV-2008, an xray of the right thigh and hip revealed "possible osteomyelitis".  On 04-NOV-2008, the patient was evaluated and monitored in a hospital emergency room on that day but was not admitted to the hospital.  On 04-NOV-2008 she was released from the emergency room.  On 10-NOV-2008 and 18-NOV-2008 the patient was seen in the office and was recovering.  No further information provided.  Follow up information was received on 20-NOV-2008 which reported:  Caller is the consumer's mother.  On 30-OCT-2008 she stated that her daughter developed a fever on the day that she received the injection.  On 31-OCT-2008 the patient was brought back to the doctor and was given an antibiotic, she also developed " a red circle about the size of a half dollar" on her right thigh at the injection site and she was unable to stand on that leg because of the pain.  On 01-NOV-2008 the redness had spread to her groin and down to her knee.  She was brought to a hospital that evening but was not admitted.  While at the hospital, she was diagnosed with cellulitis.  She had a fever that night of 104 degrees.  The red area became hot to the touch and he developed a "hard knot" at the injection site that "grew to the size of a baseball."  On 04-NOV-2008 she went back to the doctor, and was sent to the hospital for an x-ray and blood work.  Her CBC was "normal", but her ESR was "elevated." The radiologist said that she may have had  osteomyelitis caused by an abscess at the injection site.  On an unspecified date, the patient went to another hospital for another x-ray and an ultrasound.  The doctor confirmed that it was cellulitis, not osteomyelitis.  Presently, the knot is getting smaller and she still complains of pain when it is touched.  Follow up information was reported on 21-NOV-2008:  there was still some swelling and tenderness, so the patient has not yet fully recovered.  This is one of several reports concerning the same source.  Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, White blood cell count increased, X-ray limb abnormal
Clinical narrative: Information has been received from a office manager concerning a 26 month old female with allergy to AMOXICILLIN and no pertinent medical history, who on 30-OCT-2008 was vaccinated with PNEUMOVAX (lot # 659150/1384U), 0.5 ml via intramuscular.  Concomitant medication included SINGULAIR.  On 31-OCT-2008 the patient developed fever of 100F and a 3 cm area of swelling of the right thigh 1 day after administration of PNEUMOVAX.  On 31-OCT-2008 the patient was seen in the office and was prescribed ZITHROMAX.  On 01-NOV-2008 the patient was seen again and the reaction had increased to include the entire right thigh.  The patient was continued on ZITHROMAX and was given an injection of ROCEPHIN in the office.  On 04-NOV-2008, an xray of the right thigh and hip revealed "possible osteomyelitis".  On 04-NOV-2008, the patient was evaluated and monitored in a hospital emergency room on that day but was not admitted to the hospital.  On 04-NOV-2008 she was released from the emergency room.  On 10-NOV-2008 and 18-NOV-2008 the patient was seen in the office and was recovering.  No further information provided.  Follow up information was received on 20-NOV-2008 which reported:  Caller is the consumer's mother.  On 30-OCT-2008 she stated that her daughter developed a fever on the day that she received the injection.  On 31-OCT-2008 the patient was brought back to the doctor and was given an antibiotic, she also developed " a red circle about the size of a half dollar" on her right thigh at the injection site and she was unable to stand on that leg because of the pain.  On 01-NOV-2008 the redness had spread to her groin and down to her knee.  She was brought to a hospital that evening but was not admitted.  While at the hospital, she was diagnosed with cellulitis.  She had a fever that night of 104 degrees.  The red area became hot to the touch and he developed a "hard knot" at the injection site that "grew to the size of a baseball."  On 04-NOV-2008 she went back to the doctor, and was sent to the hospital for an x-ray and blood work.  Her CBC was "normal", but her ESR was "elevated." The radiologist said that she may have had  osteomyelitis caused by an abscess at the injection site.  On an unspecified date, the patient went to another hospital for another x-ray and an ultrasound.  The doctor confirmed that it was cellulitis, not osteomyelitis.  Presently, the knot is getting smaller and she still complains of pain when it is touched.  Follow up information was reported on 21-NOV-2008:  there was still some swelling and tenderness, so the patient has not yet fully recovered.  This is one of several reports concerning the same source.  Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Cellulitis, Dysstasia, Erythema, Full blood count normal, Injection site nodule
Clinical narrative: Information has been received from a office manager concerning a 26 month old female with allergy to AMOXICILLIN and no pertinent medical history, who on 30-OCT-2008 was vaccinated with PNEUMOVAX (lot # 659150/1384U), 0.5 ml via intramuscular.  Concomitant medication included SINGULAIR.  On 31-OCT-2008 the patient developed fever of 100F and a 3 cm area of swelling of the right thigh 1 day after administration of PNEUMOVAX.  On 31-OCT-2008 the patient was seen in the office and was prescribed ZITHROMAX.  On 01-NOV-2008 the patient was seen again and the reaction had increased to include the entire right thigh.  The patient was continued on ZITHROMAX and was given an injection of ROCEPHIN in the office.  On 04-NOV-2008, an xray of the right thigh and hip revealed "possible osteomyelitis".  On 04-NOV-2008, the patient was evaluated and monitored in a hospital emergency room on that day but was not admitted to the hospital.  On 04-NOV-2008 she was released from the emergency room.  On 10-NOV-2008 and 18-NOV-2008 the patient was seen in the office and was recovering.  No further information provided.  Follow up information was received on 20-NOV-2008 which reported:  Caller is the consumer's mother.  On 30-OCT-2008 she stated that her daughter developed a fever on the day that she received the injection.  On 31-OCT-2008 the patient was brought back to the doctor and was given an antibiotic, she also developed " a red circle about the size of a half dollar" on her right thigh at the injection site and she was unable to stand on that leg because of the pain.  On 01-NOV-2008 the redness had spread to her groin and down to her knee.  She was brought to a hospital that evening but was not admitted.  While at the hospital, she was diagnosed with cellulitis.  She had a fever that night of 104 degrees.  The red area became hot to the touch and he developed a "hard knot" at the injection site that "grew to the size of a baseball."  On 04-NOV-2008 she went back to the doctor, and was sent to the hospital for an x-ray and blood work.  Her CBC was "normal", but her ESR was "elevated." The radiologist said that she may have had  osteomyelitis caused by an abscess at the injection site.  On an unspecified date, the patient went to another hospital for another x-ray and an ultrasound.  The doctor confirmed that it was cellulitis, not osteomyelitis.  Presently, the knot is getting smaller and she still complains of pain when it is touched.  Follow up information was reported on 21-NOV-2008:  there was still some swelling and tenderness, so the patient has not yet fully recovered.  This is one of several reports concerning the same source.  Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site swelling, Pain in extremity, Pyrexia, Red blood cell abnormality, Skin warm
Clinical narrative: Information has been received from a office manager concerning a 26 month old female with allergy to AMOXICILLIN and no pertinent medical history, who on 30-OCT-2008 was vaccinated with PNEUMOVAX (lot # 659150/1384U), 0.5 ml via intramuscular.  Concomitant medication included SINGULAIR.  On 31-OCT-2008 the patient developed fever of 100F and a 3 cm area of swelling of the right thigh 1 day after administration of PNEUMOVAX.  On 31-OCT-2008 the patient was seen in the office and was prescribed ZITHROMAX.  On 01-NOV-2008 the patient was seen again and the reaction had increased to include the entire right thigh.  The patient was continued on ZITHROMAX and was given an injection of ROCEPHIN in the office.  On 04-NOV-2008, an xray of the right thigh and hip revealed "possible osteomyelitis".  On 04-NOV-2008, the patient was evaluated and monitored in a hospital emergency room on that day but was not admitted to the hospital.  On 04-NOV-2008 she was released from the emergency room.  On 10-NOV-2008 and 18-NOV-2008 the patient was seen in the office and was recovering.  No further information provided.  Follow up information was received on 20-NOV-2008 which reported:  Caller is the consumer's mother.  On 30-OCT-2008 she stated that her daughter developed a fever on the day that she received the injection.  On 31-OCT-2008 the patient was brought back to the doctor and was given an antibiotic, she also developed " a red circle about the size of a half dollar" on her right thigh at the injection site and she was unable to stand on that leg because of the pain.  On 01-NOV-2008 the redness had spread to her groin and down to her knee.  She was brought to a hospital that evening but was not admitted.  While at the hospital, she was diagnosed with cellulitis.  She had a fever that night of 104 degrees.  The red area became hot to the touch and he developed a "hard knot" at the injection site that "grew to the size of a baseball."  On 04-NOV-2008 she went back to the doctor, and was sent to the hospital for an x-ray and blood work.  Her CBC was "normal", but her ESR was "elevated." The radiologist said that she may have had  osteomyelitis caused by an abscess at the injection site.  On an unspecified date, the patient went to another hospital for another x-ray and an ultrasound.  The doctor confirmed that it was cellulitis, not osteomyelitis.  Presently, the knot is getting smaller and she still complains of pain when it is touched.  Follow up information was reported on 21-NOV-2008:  there was still some swelling and tenderness, so the patient has not yet fully recovered.  This is one of several reports concerning the same source.  Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Ultrasound scan abnormal, X-ray abnormal
Clinical narrative: Information has been received from a office manager concerning a 26 month old female with allergy to AMOXICILLIN and no pertinent medical history, who on 30-OCT-2008 was vaccinated with PNEUMOVAX (lot # 659150/1384U), 0.5 ml via intramuscular.  Concomitant medication included SINGULAIR.  On 31-OCT-2008 the patient developed fever of 100F and a 3 cm area of swelling of the right thigh 1 day after administration of PNEUMOVAX.  On 31-OCT-2008 the patient was seen in the office and was prescribed ZITHROMAX.  On 01-NOV-2008 the patient was seen again and the reaction had increased to include the entire right thigh.  The patient was continued on ZITHROMAX and was given an injection of ROCEPHIN in the office.  On 04-NOV-2008, an xray of the right thigh and hip revealed "possible osteomyelitis".  On 04-NOV-2008, the patient was evaluated and monitored in a hospital emergency room on that day but was not admitted to the hospital.  On 04-NOV-2008 she was released from the emergency room.  On 10-NOV-2008 and 18-NOV-2008 the patient was seen in the office and was recovering.  No further information provided.  Follow up information was received on 20-NOV-2008 which reported:  Caller is the consumer's mother.  On 30-OCT-2008 she stated that her daughter developed a fever on the day that she received the injection.  On 31-OCT-2008 the patient was brought back to the doctor and was given an antibiotic, she also developed " a red circle about the size of a half dollar" on her right thigh at the injection site and she was unable to stand on that leg because of the pain.  On 01-NOV-2008 the redness had spread to her groin and down to her knee.  She was brought to a hospital that evening but was not admitted.  While at the hospital, she was diagnosed with cellulitis.  She had a fever that night of 104 degrees.  The red area became hot to the touch and he developed a "hard knot" at the injection site that "grew to the size of a baseball."  On 04-NOV-2008 she went back to the doctor, and was sent to the hospital for an x-ray and blood work.  Her CBC was "normal", but her ESR was "elevated." The radiologist said that she may have had  osteomyelitis caused by an abscess at the injection site.  On an unspecified date, the patient went to another hospital for another x-ray and an ultrasound.  The doctor confirmed that it was cellulitis, not osteomyelitis.  Presently, the knot is getting smaller and she still complains of pain when it is touched.  Follow up information was reported on 21-NOV-2008:  there was still some swelling and tenderness, so the patient has not yet fully recovered.  This is one of several reports concerning the same source.  Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Feeling abnormal, Injection site induration, Injection site swelling, Lethargy
Clinical narrative: Information has been received from an office manager and the patient's mother concerning a 5 year old male, with no known allergies and no pertinent medical history, who on 30-OCT-2008 was vaccinated with PNEUMOVAX (lot # 659150/1384U) 0.5 ml intramuscularly in the left deltoid.  Concomitant medications include SINGULAIR.  On 31-OCT-2008 the patient developed a 2 x 3 cm raised area at injection site of the left deltoid.  The patient was seen in the office on 01-NOV-2008 and was prescribed OMNICEF.  The patient's mother reported that her son started "feeling bad" the day after he was given PNEUMOVAX.  The patient developed a fever and was lethargic.  He was "favoring his left arm" (the arm he was vaccinated in).  He went to the hospital on 01-NOV-2008 and was diagnosed with cellulitis but was not admitted.  He also developed a knot at the injection site.  The area of the knot and the cellulitis was about 2" x 4".  As of 20-NOV-2008, the cellulitis is gone, the knot is smaller and he was using his left arm.  The patient had seen the doctor a couple times about these events since he was given the injection.  This is one of several reports from the same source.  Additional information has been requested.