chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a pharmacist concerning a female who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The reporter indicated that two weeks prior to vaccination, the pt was vaccinated with the flu vaccine. The pt developed cellulitis the next day after vaccination with pneumococcal 23v polysaccharide vaccine. The pt was treated with PO Keflex and completely recovered within 24 hours. The reporter did not know if pneumococcal 23v polysaccharide vaccine was given in the same arm that the pt received the flu vaccine. There was no product quality complaint involved.  The pharmacist also reported additional pts who had similar experiences following exposure to pneumococcal 23v polysaccharide vaccine. Additional info has been requested.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 77 year old Japanese female with hypertension and a hx of atrial fibrillation, congestive heart failure, and lung cancer who on 18OCT2003 at 11:30 am was vaccinated SC in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included Procardia, Counadin, Lanoxin and nitroglyceria.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Neck pain
Clinical narrative: Information has been received from a physician concerning a 70 year old Japanese female with high blood pressure and a hx of adverse reaction to Lopid, Colestid, Lozol, Esidrex, Dyazide, Harmonyl, Procardia, Questran, Zestril who on 22OCT2003 at 10:00 am was vaccinated SC in the left deltoid with a second dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included losartan potassium HCTZ, Hydrazine. Tenex, potassium chloride, Betagan, Xalatan. ON 25OCT2003, the pt developed redness and swelling where the shot was given on the arm and had neck pain on the left side. It was also noted that the pt had not recovered and the neck was still sore as of 27OCT2003. Unspecified medical attention was sought and a prescription drug was required. A product quality complaint was not involved. Follow up information was received from a registered nurse which indicated that on 22OCT2003 at 3pm, five hours after injection, the pt developed swelling and redness. The next day there was redness and swelling still . The pt developed left sided neck pain a day later and could not put her head down. It was noted to be painful. The next day the pain on the left neck traveled to the right side of the neck. the pain gradually subside don 04NOV2003. The pt was considered recovered on 04NOV2003. The physician also reported that tow other pts experienced similar rxns. No further information is expected.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 75 year old retired white female pt with no allergies and no pat medical hx who on 28OCT2003 at 15:00 was vaccinated IM in the deltoid with a dose of pneumococcal vaccine 23 polyvalent. There was no illness at the time of vaccination. On 28OCT2003 at 22:00, the pt developed a severe local reaction. The reaction went all the way down the arm and was described as "cellulitis-like". The reporter stated the swelling in the left arm and redness went to cellulitis. Medical attention was sough, but lab tests were not performed. The pt was being treated with antibiotics and was "recovering with sequalea" at the time of the report. A product quality complaint was not involved. The reporter also mentioned a second patient who had a local post vaccination with dose of pneumococcal vaccine 23 polyvalent. Additional info has been requested.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Influenza like illness, Oedema, Pain, Pyrexia
Clinical narrative: Information has been received form a licensed visiting nurse concerning a 70 year old Caucasian female with a medical hx of an allergy to sulfa drugs and osteoporosis who on 27OCT2003 at 14:00 was vaccinated IM in the right deltoid with a first dose of pneumococcal vaccine 23 polyvalent. concomitant therapy on 27 OCT 2003 at 14:00 included an IM dose in the left deltoid of influenza virus whole virion 3v vaccine inactivated. Other concomitant medications included Actonel, Omnicef for headache, possible sinus problem and Rhinocort. Illnesses at the time of vaccination were sinus pressure and headache with no temperature. On 27OCT2003, in the evening (previously reported as 28OCT2003) when the pt left the office, 20 minutes after the injection, she reported that she had no "adverse rxns" and that the "site was healthy", however, the pt reported her am begain swelling later that day. On 28OCT2003, she developed pain redness and swelling to the area below the deltoid muscle (previouisly described as swelling of right arm, 2-3 inches below the injection site and a 4-5 inche wide in band with raised, red, welt and mild flu like symptoms, described as body aches and a low grade temperature). It was noted that on 29OCT2003, on examination she had "a sleeve below deltoid muscle with demarcation noted that on 29OCT2003, on examination she had "a sleeve below deltoid muscle with demarcation line inferiorly." There was diffuse erythema and mild edema over medial aspect of upper arm. There was no tenderness to the deltoid muscle and the pt reproted decreased pain. It was noted that treatment was not known at this time. It was also noted that the duration was 4-5 days and the pt recovered on approximately 01NOV2003. Unspecified medical attention was sought. There was no product quality complaint involved. No further information is expected.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash erythematous, Swelling, Urticaria
Clinical narrative: Information has been received form a licensed visiting nurse concerning a 70 year old Caucasian female with a medical hx of an allergy to sulfa drugs and osteoporosis who on 27OCT2003 at 14:00 was vaccinated IM in the right deltoid with a first dose of pneumococcal vaccine 23 polyvalent. concomitant therapy on 27 OCT 2003 at 14:00 included an IM dose in the left deltoid of influenza virus whole virion 3v vaccine inactivated. Other concomitant medications included Actonel, Omnicef for headache, possible sinus problem and Rhinocort. Illnesses at the time of vaccination were sinus pressure and headache with no temperature. On 27OCT2003, in the evening (previously reported as 28OCT2003) when the pt left the office, 20 minutes after the injection, she reported that she had no "adverse rxns" and that the "site was healthy", however, the pt reported her am begain swelling later that day. On 28OCT2003, she developed pain redness and swelling to the area below the deltoid muscle (previouisly described as swelling of right arm, 2-3 inches below the injection site and a 4-5 inche wide in band with raised, red, welt and mild flu like symptoms, described as body aches and a low grade temperature). It was noted that on 29OCT2003, on examination she had "a sleeve below deltoid muscle with demarcation noted that on 29OCT2003, on examination she had "a sleeve below deltoid muscle with demarcation line inferiorly." There was diffuse erythema and mild edema over medial aspect of upper arm. There was no tenderness to the deltoid muscle and the pt reproted decreased pain. It was noted that treatment was not known at this time. It was also noted that the duration was 4-5 days and the pt recovered on approximately 01NOV2003. Unspecified medical attention was sought. There was no product quality complaint involved. No further information is expected.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Rash, Swelling face, Vomiting
Clinical narrative: Information has been received from a certain MA concerning a 54 year old male who on 10OCT2003 was vaccinated in the left deltoid with a dose of pneumococcal vaccine 23 polysaccharide vaccine. On 12OCT2003, about two days later, the pt developed a fine, red rash on his trunk, facial swelling and vomiting. Medical attention was sought and the pt was treated with abx. Within 5 days, all symptoms were reported to have resolved and it was reported  that the pt had recovered. No product quality complaint was involved. Additional info has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Tenderness
Clinical narrative: Information has been received from a LPN concerning a retired 66 year old white female with non insulin dependent diabetes mellit8s, hyperlipidemia, high cholesterol, hypertension, an  allergy to Bactrim and sulfa meds and Dx 250.00, 272.0, 401.9 who on 16OCT1998 was vaccinated with a first dose of pneumococcal vaccine 23 polysaccharide vaccine and on 29OCT2003 at 10:45am was vaccinated IM in the right deltoid with a second dose of pneumococcal vaccine 23 polysaccharide vaccine. The pt reported that she was not sure if this was her second or third dose of pneumococcal vaccine 23 polysaccharide vaccine.  In the am, on 29OCT2003 the pt was also vaccinated in the left arm with a dose of Fluvirin. Other concomitant therapy included Glucophage, Lipitor and Zestril. The pt returned to the physician's office at 14:45 with a local rxn described as swelling about 3 inches in diameter, with slight redness, warmth and tenderness.  There was no fever. The pt was prescribed Benadryl and Zyrtec. On 01NOV2003 the pt recovered. A product quality complaint was not involved. Follow up information was received from the LPN which indicated that on 29OCT2003, in the pm, the pt developed redness, swelling and warmth at the injection site. It was reported that the pt recovered on 05NOV2003. No additional information is expected.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Diarrhoea, Lymphadenitis, Nausea, Pain, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a pharmacist concerning a female patient who was part of a group of "24 reported reactions" out of 200 vaccinated employees and was vaccinated "during the first week of October, 2003" wit a dose dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy "during the first week of October, 2003, included influenza virus vaccine. It was noted that all of them received both vaccines in the same arm at their request. The patient developed inflamed lymph nodes. Other complaints were sore throat, nausea, vomiting, diarrhea and aches all over. It was noted that many spent the "entire weekend in bed after being vaccinated on a Friday and some missed work for a few says after that". The pharmacist suggest Ibuprofen or Tylenol for the "symptoms" and to follow up with their physicians. The reporter expressed concern about the particular lot of vaccine and mentioned that the patients were vaccinated "all from Lot 0676M". Unspecified medical treatment was sought. There was no products quality complaint involved. Follow up information indicated that the reporter did not have more information to add to the reports as she did not speak directly to any of the 24 patients in this case. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter also mentioned two other patient and 21 patient who were parts of the 24 "reported  reactions" and were vaccinated with dose of pneumococcal 23v polysaccharide vaccine.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Vomiting
Clinical narrative: Information has been received from a pharmacist concerning a female patient who was part of a group of "24 reported reactions" out of 200 vaccinated employees and was vaccinated "during the first week of October, 2003" wit a dose dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy "during the first week of October, 2003, included influenza virus vaccine. It was noted that all of them received both vaccines in the same arm at their request. The patient developed inflamed lymph nodes. Other complaints were sore throat, nausea, vomiting, diarrhea and aches all over. It was noted that many spent the "entire weekend in bed after being vaccinated on a Friday and some missed work for a few says after that". The pharmacist suggest Ibuprofen or Tylenol for the "symptoms" and to follow up with their physicians. The reporter expressed concern about the particular lot of vaccine and mentioned that the patients were vaccinated "all from Lot 0676M". Unspecified medical treatment was sought. There was no products quality complaint involved. Follow up information indicated that the reporter did not have more information to add to the reports as she did not speak directly to any of the 24 patients in this case. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter also mentioned two other patient and 21 patient who were parts of the 24 "reported  reactions" and were vaccinated with dose of pneumococcal 23v polysaccharide vaccine.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Diarrhoea, Dyspnoea, Nausea, Pain, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a pharmacist concerning a patient who was part of a group of "24 reported reactions" out of 200 vaccinated employees and was vaccinated "during the first week of October, 2003" with a dose dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy "during the first week of October, 2003, included influenza virus vaccine. It was noted that all of them received both vaccines in the same arm at their request.  The patient "had trouble breathing. Other complaints were sore throat, nausea, vomiting, diarrhea and aches all over. It was noted that many spent the entire weekend in bed after being vaccinated on a Friday and some missed work for a few days after that". The pharmacist suggested Ibuprofen or Tylenol for the "symptoms" and to follow up with their physicians. The reporter expressed concern about the particular lot of vaccine and mentioned that the patients were vaccinated "all from Lot 0676M". Unspecified medical treatment was sought. There was no product quality complaint involved. Follow information indicated that the reporter did not have more information to add to the reports as she did not speak directly to any of the 24 patients in this case. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter also mentioned two other patient and 21 patient who were parts of the 24 "reported reactions" and were vaccinated with dose of pneumococcal 23v polysaccharide. Additional information has been requested.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Vomiting
Clinical narrative: Information has been received from a pharmacist concerning a patient who was part of a group of "24 reported reactions" out of 200 vaccinated employees and was vaccinated "during the first week of October, 2003" with a dose dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy "during the first week of October, 2003, included influenza virus vaccine. It was noted that all of them received both vaccines in the same arm at their request.  The patient "had trouble breathing. Other complaints were sore throat, nausea, vomiting, diarrhea and aches all over. It was noted that many spent the entire weekend in bed after being vaccinated on a Friday and some missed work for a few days after that". The pharmacist suggested Ibuprofen or Tylenol for the "symptoms" and to follow up with their physicians. The reporter expressed concern about the particular lot of vaccine and mentioned that the patients were vaccinated "all from Lot 0676M". Unspecified medical treatment was sought. There was no product quality complaint involved. Follow information indicated that the reporter did not have more information to add to the reports as she did not speak directly to any of the 24 patients in this case. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter also mentioned two other patient and 21 patient who were parts of the 24 "reported reactions" and were vaccinated with dose of pneumococcal 23v polysaccharide. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Information has been received from a consumer who is a female who on 10OCT2003 was vaccinated with dose of pneumococcal 23v polysaccharide. In October 2003, the pt developed extensive arm swelling, redness and pain which lasted for three to four days. The reporter also mentioned three females who received a dose of pneumococcal 23v polysaccharide at the same time and experienced similar symptoms and men (our husbands) who received a dose of pneumococcal 23v polysaccharide and had minimal discomfort. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Information has been received from a licensed PRN concerning a female who in October, 2003, "couple of weeks ago" was vaccinated in the he arm with a dose of pneumococcal 23v polysaccharide and was evaluated at the office for a red, swollen and painful arm. Unspecified medical attention was sought. Subsequently, the symptoms resolved and the pt recovered. There was no product quality complaint involved. Follow up info received from an LPN indicated that the outcome is recovered. The reporter expressed concern about the particular lot of vaccine and requested a lot check on 1026M. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter also mentioned that three other pts were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and experienced a similar rxn. Additional information is expected.
Age: 5.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Headache, Injection site pain, Lethargy, Pyrexia
Clinical narrative: Information has been received from an RN concerning a 5 year old white male pt with a medical hx of an allergy to mite dust, allergic rhino sinusitis , chronic otitis media with effusion and asthma who on 27OCT2003 at 15:30 was vaccinated IM in he left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy on 27OCT2003 at 15:30 included an IM first dose in the right deltoid of influenza virus split virion 3v vaccine inactivated. Other concomitant medication were fluticasone propionate + salmeterol xinafoate 100/50 BID. On 29SEP2003 a dose of pneumococcal vaccine (Prevnar) as administered at a different office. The pt's mother reported the patient was "very restless" for 2 hours with vaccination of PCV7 on 29SEP2003. On October 27, 2003, between 17:30 and 18:30, the patient complained of pain at the left arm injection site and had a fever about 3 hours after vaccination. On 28OCT2003, the pt developed a T104 degrees, was shaking, lethargic, complained of a frontal headache and a painful left arm. On 29OCT2003, the patient vomited once described as large amount of phlegm, temperature at 13:30 and 105.4, it was noted again that the pt complained of frontal headache and his left arm was red and swollen. On 30OCT2003, the fever and headache were decreased and the left arm was swollen, red and painful. On 01NOV2003, the left arm was still sore and the fever and headache were gone. No treatment was required for the symptoms, however it was noted that the pt was using ibuprofen (Motrin) prn and cool compresses locally to the left arm. It was noted that on 12NOV2003, the pt had recovered, however, it was also noted on 12NOV2003, only the left arm was a "little tender". Unspecified medical attention was sought. There was no product quality complaint was involved. Follow up information revealed at the pt office visit on 20DEC2003, the tenderness at the left arm was one and the pt had recovered. It was noted that there were no further symptoms. No further information is expected.
Age: 5.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Restlessness, Swelling, Tenderness, Tremor
Clinical narrative: Information has been received from an RN concerning a 5 year old white male pt with a medical hx of an allergy to mite dust, allergic rhino sinusitis , chronic otitis media with effusion and asthma who on 27OCT2003 at 15:30 was vaccinated IM in he left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy on 27OCT2003 at 15:30 included an IM first dose in the right deltoid of influenza virus split virion 3v vaccine inactivated. Other concomitant medication were fluticasone propionate + salmeterol xinafoate 100/50 BID. On 29SEP2003 a dose of pneumococcal vaccine (Prevnar) as administered at a different office. The pt's mother reported the patient was "very restless" for 2 hours with vaccination of PCV7 on 29SEP2003. On October 27, 2003, between 17:30 and 18:30, the patient complained of pain at the left arm injection site and had a fever about 3 hours after vaccination. On 28OCT2003, the pt developed a T104 degrees, was shaking, lethargic, complained of a frontal headache and a painful left arm. On 29OCT2003, the patient vomited once described as large amount of phlegm, temperature at 13:30 and 105.4, it was noted again that the pt complained of frontal headache and his left arm was red and swollen. On 30OCT2003, the fever and headache were decreased and the left arm was swollen, red and painful. On 01NOV2003, the left arm was still sore and the fever and headache were gone. No treatment was required for the symptoms, however it was noted that the pt was using ibuprofen (Motrin) prn and cool compresses locally to the left arm. It was noted that on 12NOV2003, the pt had recovered, however, it was also noted on 12NOV2003, only the left arm was a "little tender". Unspecified medical attention was sought. There was no product quality complaint was involved. Follow up information revealed at the pt office visit on 20DEC2003, the tenderness at the left arm was one and the pt had recovered. It was noted that there were no further symptoms. No further information is expected.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Influenza like illness, Malaise
Clinical narrative: Information has been received form a human resources department employee concerning a male pt who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant vaccination at the same time included a dose of influenza virus vaccine. Subsequently, the pt reported getting sick and feeling bad. The patient felt so bad after the shots that he "went to bed". At the time of the report, the pt was back at work and was feeling better. A product quality complaint was not involved. The human resources department employee mentioned this pt was one of more than 25 pts who had similar experiences post vaccination with pneumococcal 23v polysaccharide. Followup information was received from the administering nurse. The nurse noted that this population was needy and that many of the pts had long histories of being incarcerated. According to the nurse, none of the patients were bed ridden. The nurse described the patients' reported experiences as "flu like symptoms". Subsequently, the patients all recovered an none of them required treatment. Additional information is not expected.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from doctor of pharmacy concerning a female patient in her late 70s or early 60s who on 27OCT2003 was vaccinated with a dose of pneumococcal 23v polysaccharide. Subsequently, on approximately 27OCT2003, the patient developed a severe local reaction. Unspecified medical attention was sought and treatment was required. The patient was "recovering with sequalea" at the time of the report.  A product quality complaint was not involved. The reporter also mentioned a second patient who had a local reaction post vaccination with pneumococcal 23v polysaccharide. Additional  information has been requested.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacist concerning an 84 year old female who on 01OCT2003 and 30OCT2003 was vaccinated with the first and second doses of pneumococcal 23v polysaccharide vaccine. The pt reported redness at the injection site after the second dose. No other information or lot numbers were available. Unspecified medical attention was sought. There were no product quality complaint. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation
Clinical narrative: Information has been received from a registered nurse concerning a 74 year old female with no medical hx of allergies who on 30OCT2003 was vaccinated with a second dose of pneumococcal 23v polysaccharide. Concomitant therapy included unnamed medications for the stomach. The reporter indicated that the patient was seen in the office on 31OCT2003 and her whole arm was inflamed from the wrist to the shoulder. It was unknown if treatment was required for the event. The reporter also noted that she was concerned about the lot number and has pulled the remaining vials in this lot form the stock. . The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The RN also indicated that two other female patient's had similar reactions after therapy with pneumococcal 23v polysaccharide vaccine and developed injection site redness, swelling and pain. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a RN concerning a 71 year old male with allergies to horse serum and tetanus who on 29OCT2003, at 09:00, was vaccinated IM in the right deltoid with the first dose of pneumococcal 23v polysaccharide vaccine. Illness at the time of vaccination included Helicobacter pylori gastritis and Hepatitis C. The RN reported that on 30OCT2003, at 11:00, the patient developed redness and an area of induration at the injection site. The pt was evaluated at the clinic, but no lab/diagnostic tests were performed. On approximately 01NOV2003, 2-3 days after onset, the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site reaction, Pain, Swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a male who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and "presented to office today", on 30OCT2003 with "the same local site reactions", a red, swollen and painful arm. Unspecified medical attention was sought.  There was no product quality complaint involved. Subsequently, the pt recovered. The reporter expressed concern about the particular lot of vaccine and requested a lot check on 1026M. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter also mentioned that three other pts were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and experience a similar reaction. Additional info has been requested.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Information has been received from a licensed prn concerning a male who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and presented today, on 30OCT2003 with the "same type local site reactions" a red, swollen and painful arm. Unspecified medical attention was sought. There was no product quality complaint involved. Subsequently the pt recovered. The reporter expressed concerns about the particular lot of vaccine and requested a lot check on 1026M. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter also mentioned that three other pts were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and experience a similar reaction. Additional info has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: Information has been received from a licensed LPN concerning a female with no allergies who in October of 2003 "was just vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and had more more serious reaction of itching, swelling, hives and was treated with an antihistamine. There was no illness at the time of vaccination. It was noted that the pt was being monitored in the office at the time of this report. Unspecified medical attention was sought. There was no product quality complaint involved. Subsequently, the pt recovered. The reporter expressed concerns about the particular lot of vaccine and requested a lot check on 1026M. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter also mentioned that three other pts were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and experience a similar reaction. Additional info has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pain, Pyrexia, Tenderness
Clinical narrative: Information has been received from a registered nurse concerning a female who on 29OCT2003 was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, in approximately October 2003, the pt complained of fever 100.3, pain, soreness and redness at the injection site. The pt went to the emergency room for evaluation where she was treated with abx and released. At the time of the report, the pt was "recovering with sequalea". A product quality complaint was not involved. Additional information has been requested.
Age: 80.0
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from an RN concerning an 80 yr old pt who on an unspecified date was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The RN reported that the pt developed fever and swelling at the injection site. The pt complained of the symptoms after receipt of the pneumococcal 23v polysaccharide vaccine . The RN reported that she did not have access to the pt medical records and knows nothing of the pts history. There was no product quality complaint involved.  Unspecified medical attention was sought. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin discolouration, Swelling
Clinical narrative: Information has been received from an office manager concerning a 73 year old female pt with no allergies and no past medical hx who on 03NOV2003 was vaccinated in the left arm with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included alendronate sodium and Celebrex. On 04NOV2003, the pt presented to the medical office because her left arm had swelled from her elbow to her shoulder. The patient  also had a large 3x4 inch dark red area also described as a red spot, surrounded by a dark pink area on her arm. The pt was treated by the physician with Benadryl and Keflex. No lab tests were performed. At the time of the report, the pt had not recovered. A product quality complaint was not involved. The reporter requested replacement for the vaccine, but was unable to provide the lot number. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from an RN concerning an 83 year old female with allergies to sulfa and iodine and no other medical hx who on 30OCT2003 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine. Concomitant vaccination in the "other arm" included a dose of influenza virus vaccine. Concomitant medication included aspirin. The reporter indicated that the pt developed a reddened area around the injection site with edema. No treatment was required for the event. The reporter also noted that she was concerned about the lot number and has pulled the remaining vials in this lot from the stock. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter also mentioned that two other female pts had similar reactions after therapy with  pneumococcal 23v polysaccharide vaccine and experience a similar reaction. Additional info has been requested.
Age: 43.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from an RN concerning an 43 year old female with no medical hx or allergies who on 30OCT2003 was vaccinated with a first dose of pneumococcal 23 v polysaccharide vaccine. Concomitant vaccination in "the other arm" included a dose of influenza virus vaccine. There was no other concomitant medication. The reporter indicated that the pt developed a reddened area around the injection site with edema. No treatment was required for the event. The reporter also noted that she was concerned abut the lot number and has pulled the remaining vials in this lot form the stock.  The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter also mentioned that two other female pts had similar rxns after therapy with pneumococcal 23v polysaccharide vaccine. Additional info has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site induration, Injection site reaction, Injection site swelling, Tenderness
Clinical narrative: Information has been received from a licensed practical nurse concerning a 66 year old white female pt with no illness at the time of vaccination who on 27OCT2003 was vaccinated IM in the Right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. The LPN reported that on 28OCT2003 the pt developed red, hard, sore right arm with swelling, and tightness on or near the injection site, almost down to the elbow. The pt was treated with ice and Advil. It was noted the pt came to the MD's office on 29OCT2003. The pt recovered. There was no product quality complaint reported. Unspecified medical attention was sought. No additional information is expected. The LPN also reported two other pt who had similar experiences following vaccination with pneumococcal 23v polysaccharide vaccine.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Angioneurotic oedema, Erythema, Feeling hot, Paraesthesia, Swelling
Clinical narrative: Information has been received form a medical office concerning a 70 year old female with allergies to PCN and Demerol who on 27OCT2003 was vaccinated in the left deltoid with a dose of pneumococcal vaccine 23 polyvalent. Concomitant medication included Nexium, nonsteroidal anti-inflammatory drug and estrogens. On 29OCT2003, the pt was seen with left upper extremity swelling , warmth and redness, was afebrile and had no infection. She was diagnosed with angioedema. The pt was seen again on 30OCT2003 and 05NOV2003 and had developed paresthesia of the upper arm and the swelling was decreased. It was noted hat an EMG was scheduled for next week if there was no improvement. Treatment included Benadryl and Medrol dose pack. Medical treatment was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient between the age of 68 and 78 years old who on 10/17/03 at a flu clinic was revaccinated in the arm with a dose of pneumococcal 23v polysaccharide vaccine (lot # 646159/0287N). Concomitant vaccine therapy included a normal adult dose of influenza virus vaccine. Subsequently, within hours of the vaccination, the patient developed redness, swelling and pain at the injection site in the arm where the pneumococcal 23v polysaccharide vaccine had been given. The patient was treated in the emergency room with IV ceftriaxone sodium. The patient was later seen by her own physician and has since recovered. It was also reported that the patient thought that it had been more than 5 years since she was vaccinated, however, it was also reported that in January 2001 she had been vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. No product quality complaint was involved. Upon internal review, redness, swelling and pain at the injection site were determined to be other important medical events (OMIC). It was also reported that three other female patients were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 646159/0287N) and also developed redness, swelling and pain at the injection site. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a a retired 86 year old white female with no medical hx and no allergies who on 29SEP2003 was vaccinated IM in the left deltoid with a first dose of pneumococcal vaccine 23 polyvalent. There was no illness at the time of vaccination. There was no adverse events following prior vaccinations. On 29SEP2003, within hours of the vaccination, the pt developed a serious rxn with injection site redness, swelling, and pain. It was reported that the pt developed cellulitis from the mid-forearm to the shoulder and extending into the axilla and upper back. the pt was seen at a clinic and treated with NSAID's and local ice. Subsequently, the pt recovered. The duration was reported from 4 hours to 6 days. No product quality complaint was involved. It was also reported that three other female pts were vaccinated with a dose of pneumococcal vaccine 23 polyvalent vaccine and developed injection site redness, swelling and pain. No further information is expected.
Age: 7.0
Sex: F
Vaccine: DT, HEPA
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Diagnosed as injection cellutitis.  Injection administered and prescription of antibiotic 1000 mg/day.
Age: 14.0
Sex: M
Vaccine: HEP, HEPA, TD, VARCEL
Symptoms: Anorexia, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Father reported temperatures to 104 degrees, light headedness, lost appetite, head aches with nausea and vomiting for the day after to 7 days after vaccination. No reports of swelling, redness or soreness at the injection site.
Age: 14.0
Sex: M
Vaccine: HEP, HEPA, TD, VARCEL
Symptoms: Vomiting
Clinical narrative: Father reported temperatures to 104 degrees, light headedness, lost appetite, head aches with nausea and vomiting for the day after to 7 days after vaccination. No reports of swelling, redness or soreness at the injection site.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Mother called reporting increase temp up to 103 with nausea and vomitting. Temps are controlled with Motrin and Tylenol. No reports or redness, swelling or pain at the injection site
Age: 0.19
Sex: M
Vaccine: DTP, HEP, OPV
Symptoms: Antisocial behaviour, Autism, Convulsion, Infantile spasms, Speech disorder
Clinical narrative: Patient was a perfectly healthy baby up until his set of shots at 2 months old... He began to have infantile spasms which started out small and progressed into harder seizures. The infantile spasms started within 5 days after the shots. We told pediatrician of our concerns and she continued to administer shots. On June 20, 1999 he was officially diagnosed with infantile spasms. He has received pet scans, mri, blood test, eegs, ltm eegs all of which came back perfect hypsarrhythmia was the only thing showing with no explaination of why. Since diagnoses and tests he has received treatments of all available drugs which all proved to be unsuccesful in controlling the seizures. He has also been on the keto diet which did not control the seizures, from Jan 2000 to Sept he had no seizures and no hyparrhythmia. Dr. assured us it was safe to give him immunizations again which on  Sept 12, 2000 he received another DTP shot within 2 days his seizures were back and worse than ever.... He has had many hospital stays and has been treated for serious side effects such as itp to certain drugs given him. He is now 5 years old and his infantile spasms has progressed into lgs he is develpomentally delayed and has recently been diagnosed with autism. His seizures are still uncontrolled but since we refuse to give him any more shots they have gone down to no more than 2 a day. We as parents truly believe the shots caused or aggravated an underlying seizure disorder and his autism which he started showing signs of in May 2000 when his mmr was given to him. Signs of autism were he lost his speech he no longer speeks the few words he knew and seemed to regress into his own world where he no longer knows how to smile or laugh or interact with people. Records are received from Medical Ctr. for admissions from 10/16/00 through 2/28/03. These records confirm a diagnosis of infantile spasms in 6/99 w/ evolution to intractable generalized seizures by 2/03 per follow-up exam w/ neurologist on 2/19/03. Prolonged EEG one week later noted high voltage chaotic and multi focal spikes. Records note that child had a hx for AEs w/ Klonopin and Tegretol in the form of a rash and also w/ Depakote in form of ITP. Records for long term EEG monitoring at Hospital indicate a finding of modified hypsarrhythmia. Also observed were clinical events associated w/ beta seizures.
Age: 0.19
Sex: M
Vaccine: DTP, HEP, OPV
Symptoms: Thrombocytopenic purpura
Clinical narrative: Patient was a perfectly healthy baby up until his set of shots at 2 months old... He began to have infantile spasms which started out small and progressed into harder seizures. The infantile spasms started within 5 days after the shots. We told pediatrician of our concerns and she continued to administer shots. On June 20, 1999 he was officially diagnosed with infantile spasms. He has received pet scans, mri, blood test, eegs, ltm eegs all of which came back perfect hypsarrhythmia was the only thing showing with no explaination of why. Since diagnoses and tests he has received treatments of all available drugs which all proved to be unsuccesful in controlling the seizures. He has also been on the keto diet which did not control the seizures, from Jan 2000 to Sept he had no seizures and no hyparrhythmia. Dr. assured us it was safe to give him immunizations again which on  Sept 12, 2000 he received another DTP shot within 2 days his seizures were back and worse than ever.... He has had many hospital stays and has been treated for serious side effects such as itp to certain drugs given him. He is now 5 years old and his infantile spasms has progressed into lgs he is develpomentally delayed and has recently been diagnosed with autism. His seizures are still uncontrolled but since we refuse to give him any more shots they have gone down to no more than 2 a day. We as parents truly believe the shots caused or aggravated an underlying seizure disorder and his autism which he started showing signs of in May 2000 when his mmr was given to him. Signs of autism were he lost his speech he no longer speeks the few words he knew and seemed to regress into his own world where he no longer knows how to smile or laugh or interact with people. Records are received from Medical Ctr. for admissions from 10/16/00 through 2/28/03. These records confirm a diagnosis of infantile spasms in 6/99 w/ evolution to intractable generalized seizures by 2/03 per follow-up exam w/ neurologist on 2/19/03. Prolonged EEG one week later noted high voltage chaotic and multi focal spikes. Records note that child had a hx for AEs w/ Klonopin and Tegretol in the form of a rash and also w/ Depakote in form of ITP. Records for long term EEG monitoring at Hospital indicate a finding of modified hypsarrhythmia. Also observed were clinical events associated w/ beta seizures.
Age: 21.0
Sex: F
Vaccine: SMALL
Symptoms: Infection transmission via personal contact, Pruritus, Skin ulcer, Vaccination complication
Clinical narrative: Patient was not vaccinated.  Her husband received smallpox vaccine about two weeks prior to her ER visit of 03 August 04.  The husband used tweezers to debride the smallpox vaccination site.  The patient subsequently used the same tweezers to pluck her pubic hair.  On 31 July 04 the patient states she developed lesions in her pubic area.  At her ER visit, the physician noted one macerated pustular lesion in her pubic area.  She was treated with Zyrtec for itching.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Right arm 5.75x6 in area of induration and tenderness increase warmth, tender to touch Not >60% circumferential
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Severe localized reaction Red, erythemic entire upper arm, deltoid to elbow No c/o arthralgia
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Fatigue
Clinical narrative: After my third Anthrax shot I started having extreme fatigue.  I continue to feel fatigued.  I am always tired and even wake up feeling tired.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a 50 year old female pt who on 08OCT2003 was vaccinated in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant vaccine therapy administered on 08OCT2003 included a dose of influenza virus split virion 3v vaccine inactivated. The pt reported she had an allergic reaction to the shot She noted that her physician feels that it was probably a reaction to a preservative in the vaccine. The pt reported that the allergic rxn was not life threatening. The pt also reported she has not had an adverse event to another vaccine, and she did not have a cold, fever or acute illness at the time of vaccination. Additional information received from the pt reported she received the vaccine at a Drugstore, she indicated it was not prescribed by a physician. she also noted, "she did not see doctor after reaction, saw, RN". Unspecified medical attention was sought. No additional information is expected.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a LPN concerning a 72 year old Caucasian female with no allergies who on 10/28/03 was vaccinated IM in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (Lot # 647636/0944N). There was no illness at the time of vaccination. On 10/29/03, the pt developed right arm pain, tenderness, swelling and was unable to raise her arm. Treatment included anti-inflammatories and pain medication. Medical attention was sought. It was unknown if the pt recovered. The reporter also mentioned (WAES # 0311USA00842 & WAES # 0312USA00977) who experienced similar reactions after vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.