chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician, via a company rep, concerning her mother, an 89 yr old female who about four years ago, in 2002 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot unk). The physician said her mother had a dose of pneumococcal 23v polysaccharide vaccine about four years ago and her vaccinated arm became swollen and painful. It was reported that the pt had received several doses of pneumococcal 23v polysaccharide vaccine in the past. The pt's present status was reported as recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning a 45 year old female who on 4/21/2006 was vaccinated route unknown with a dose of Pneumococcal 23v polysaccharide vaccine (lot 651321/1036P). The pt went back to the clinic 10 hours later, on 4/21/06 with severe pain and could not move her arm. At the time of the report treatment was unknown. Unspecified medical attention was sought. No product quality complaint was involved. Out come was not reported. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: PPV
Symptoms: Irritability, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning an approximately 4 week old neonate infant in the intensive care unit, who on approximately 30-APR-2006 was vaccinated with pneumococcal 23v polysaccharide vaccine, instead of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR).  The patient was febrile and fussy.  The pharmacist reported that the patient was in the hospital at the time of the experience.  The pharmacist indicated that the order for the vaccine was placed into the computer as "pneumococcal vaccine" without reference to the trade name.  The dispensing pharmacist did not know the difference between the vaccines, and the order was filled with pneumococcal 23v polysaccharide vaccine instead of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR).  The pharmacist stated that all orders for pneumococcal vaccines will be entered with the trade name instead of "pneumococcal vaccine" in order to prevent the event from occurring again.  The patient's symptoms resolved on an unspecified date.  Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a physician concerning a 78 year old adult female, with no known medical history and no known drug reactions/allergies reported, who on an unspecified date was vaccinated subcutaneously in the forearm with a dose of pneumococcal 23v polysaccharide vaccine (Lot# unknown).  The administering person thought that it was for "TB" tuberculin skin test.  Subsequently the patient developed swelling at the site.  Unspecified medical attention was sought.  At the time of this report the patient's swelling at the site had not improved.  Outcome was not reported.  No product quality complaint was involved.  Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Information has been received from a nurse, via a company representative, concerning a 65 year old male, with unknown medical history and unknown drug reaction/allergies, who in late APRIL was vaccinated (route unknown) with a dose of pneumococcal 23v polysaccharide vaccine (Lot#650302/1039P).  Concomitant therapy included ezetimibe (+) simvastatin (MSD).  In April 2006, the patient experienced swelling in left arm after receiving the vaccination.  The arm where the patient received the vaccination was red, hard and swollen halfway down his arm.  Unspecified medical attention was sought.  Outcome not reported.  No product quality compliant was involved.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a company representative from a physician concerning a female patient who on an unspecified date was re vaccinated (after 5 years) with pneumococcal 23v polysaccharide vaccine (Lot# not provided).  The patient recovered subsequently developed an unspecified injection site reaction.  The patient recovered from the injection site reaction with out any intervention.  Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: HEP, PPV, UNK
Symptoms: Erythema, Feeling hot, Pain
Clinical narrative: Information has been received from a pharmacist concerning a 24 year old male, with Human Immunodeficiency Vaccine, bipolar disorder, cleft palate and cleft lip, who on 01-MAY-2006 was vaccinated (route unknown) in the right deltoid with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot#651173/1211R).  Concomitant therapy on the same day included of dose Hepatitis B vaccine, recomb (MSD) (Lot3652403/0040F) In the deltoid, and a tuberculin purified protein derivative (PPD) in the right forearm.  Other  concomitant therapy included unnamed medications (therapy unspecified).  Later that day, on 01-MAY-2006 the patient experienced pain at the area was warm with erythema.  No fever was reported.  The patient was seen the next day and treated with cephalexin 500 mg, four times a day, for 10 days, and codeine for pain.  Subsequently, on an unspecified date, the patient recovered.  No product quality complaint was involved.  A lot check has been requested.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements and was released.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a registered nurse concerning an adult female (age unknown), with no reported medical history or drug reactions/allergies, who in December 2005, was vaccinated (ROUTE UNKNOWN) with a dose of pneumococcal 23v polysaccharide vaccine (Lot# not reported).  The nurse reported that a recent titer did not show seroconversion.  No product quality complaint was involved.  Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: HIBV, PPV
Symptoms: Erythema, Oedema, Pyrexia, Swelling
Clinical narrative: Information has been received from a physician concerning a 50 year old female who on 02-APR-2006 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot#650330/0748P). Concomitant therapy that day included Hib conj vaccine (OMPC) (manufacturer unknown), in the thigh.  Both areas within 24 hours had redness and swelling of area.  At the site of pneumococcal 23v polysaccharide vaccine the patient had induration for two to three days.  The site was also edematous, purplish and reddish.  A low grade fever was also reported.  Unspecified medical attention was sought.  Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a healthcare worker concerning a male who on 09-MAY-2006 was vaccinated with pneumococcal 23v polysaccharide (lot#651319/1007P).  Subsequently, on 10-MAY-2006 the patient experienced cellulitis of the upper arm.  The patient was recovering.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Oedema, Pruritus, Swelling
Clinical narrative: Information has been received from a healthcare worker concerning a female patient who "last week" was vaccinated with pneumococcal 23v polysaccharide vaccine (lot#651321/1036P).  Subsequently, the patient experienced swelling of the injection arm, edema, redness, heat and itching.  The patient also had a rash.  Ice packs, ibuprofen (ADVIL) and acetaminophen (TYLENOL) were the recommended treatments.  Subsequently, the patient recovered.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received anonymously regarding a patient who was vaccinated with pneumococcal 23v polysaccharide vaccine.  Subsequently the patient experienced redness at injection site.  No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Abscess, Bacterial infection, Skin reaction
Clinical narrative: Information has been received from a physician concerning a patient who "4-5 years ago " was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  Subsequently, the patient had a skin reaction, an abscess developed and the affected area was indurated and drained.  It was also reported that "staphylococcal was found at the site".  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a pharmacist, and via a company rep, concerning a pt (age and gender not reported) with an unk medical history, who within the past 6 weeks was vaccinated (route unk) with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot number not reported). The reporting pharmacist indicated that within the past 6 weeks the pt developed cellulitis. The pharmacist reported that the pt may have received the vaccine from a multi dose vial or from a single dose vial. The pt was admitted to the hospital because of the reaction but no details were provided. Outcome was not reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a pharmacist, and  via a company representative, concerning a patient (age and gender not reported) with an unknown medical history, who "within the last six weeks" was vaccinated (route unknown) with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot# unknown).  It was reported that the patient experienced a severe local reaction just after receiving the shot.  The pharmacist reported that "within the last six weeks" the patient developed a cellulitis reaction.  It was reported that the patient may have received the vaccine from a multi dose vial or from a single dose vial.  The outcome was not reported.  No product quality complaint was involved.  Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a male patient who on 16-MAY-2006 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  The physician stated that the patient passed out an hour after receiving the vaccination.  The patient's outcome was not reported.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a healthcare worker concerning a female who on 10-MAY-2006 was vaccinated with pneumococcal 23v polysaccharide vaccine.  On 11-MAY-2006 the patient experienced cellulitis.  The patient was recovering.  Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site vesicles, Pruritus
Clinical narrative: Information has been received from a physician, via a company representative, concerning an approximately 45 year old female, with an unknown medical history, who on 12-APR-2006 was vaccinated (route unknown) with a single dose of pneumococcal 23v polysaccharide vaccine (Lot#650649/0790P). Following the vaccination, on 12-APR-2006, the patient developed at the injection site, skin that was very hot, raised, blistered, painful and itchy.  Unspecified medical attention was sought.  Outcome was not reported.  No product quality complaint was involved.  Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Joint range of motion decreased, Tenderness
Clinical narrative: Information has been received from a physician, via a company representative, concerning an approximately 36 year old female, with an unknown medical history, who on 17-MAY-2006 was vaccinated with a single dose of pneumococcal 23v polysaccharide vaccine (Lot#650649/0790P).  Following the vaccination, on 17-MAY-2006, the patient developed at the injection site, skin that was very red, tender and swollen.  The patient also had difficulty raising her arm.  Unspecified medical attention was sought.  Outcome was not reported.  No product quality complaint was involved.  Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Information has been received from a medical assistant concerning a male patient who in April 2006, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  In April 2006, the patient experienced a painful, lump at the injection site (2 on his shoulder and 1 on his arm pit).  Unspecified medical attention was sought.  The patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Pain, Swelling
Clinical narrative: Information has been received from a physician concerning an 83 year old white female who on 08-MAY-2006 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (0.5 ML) (lot#651328/1046P), intramuscularly.  On 08-MAY-2006, "that night"  the patient experienced chills, swelling, mildly red, and throbbing pain of the right deltoid area.  On 09-MAY-2006 the patient  was seen by a physician.  On 10-MAY-2006, the patient recovered.  Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Pain, Swelling
Clinical narrative: Information has been received from a physician concerning a 70 year old white female who on 10-MAY-2006 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (0.5 ml) (lot#651328/1046P), intramuscularly.  On 11-MAY-2006 the patient experienced deltoid area swelling, redness, throbbing pain, and chills. On 11-MAY-2006 her arm felt better.  On 12-MAY-2006 the patient recovered.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Joint range of motion decreased, Myalgia
Clinical narrative: Information has been received from a registered nurse concerning a white adult patient who on an unspecified date was vaccinated intramuscularly with a 0.5 ml first dose of pneumococcal 23v polysaccharide vaccine (lot650330/0748P).  Subsequently, the patient developed a very sore arm to the point of having trouble lifting the arm.  The patient recovered in 4 to 5 days.  No additional information is expected.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site pain, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 55 year old male with high blood pressure, high cholesterol and no allergies who on 22-MAY-2006a was vaccinated subcutaneously with a second 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot#650453/0791P).  Concomitant therapy included "many medications".  On 23-MAY-2006 the patient developed pain at the injection site and a fever. On 24-MAY-2006 the patient was seen in the office and noted to have cellulitis of the left arm ( at the site of injection and the inner arm, with fluid at the elbow).  He also had a fever and was achy.  He was treated with cephalexin (KEFLEX) and soaks to the area.  No lab tests were performed.  It was noted that 6 years prior (in 2000) the patient was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine and had no adverse reactions.  At the time of report the patient had not yet recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Joint range of motion decreased
Clinical narrative: Initial and follow up information has been received from a physician and a health care worker concerning a 54 year old male with high cholesterol, who in approximately the year 2000 was vaccinated with pneumococcal 23v polysaccharide vaccine with reportedly, no adverse reaction.  On 23-OCT-2005, the patient was vaccinated, subcutaneously in the right arm, with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine on (Lot#650453/0791P).  Concomitant therapy included atorvastatin calcium (LIPITOR).  The physician reported that the next day (24-OCT-2005), the patient was not able to move the arm.  The patient was to be seen in the physician's office on 24-MAY-2006.  The patient sought unspecified medical attention.  At the time of the report, the patient had not recovered.  The physician reported that this patient is the second of two patients.  Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Contusion
Clinical narrative: Information has been received from a registered nurse concerning a 61 year old female with seasonal allergies who on 18-MAY-2006 was vaccinated into the right hip, at the head of the femur, with a dose of pneumococcal 23v polysaccharide vaccine.  Concomitant vaccination included a dose of tetanus toxoid.  Other concomitant therapy included " LEXAPRIL" and fexofenadine hydrochloride (ALLERGA).  The nurse reported that the patient presented on 24-MAY-2006 with a bruised right hip.  The patient also told the nurse that she was having difficulty sitting.  At the time of the report, the patient had not recovered.  Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Information has been received from a licensed visiting nurse concerning a male who on 24-MAY-2006 was vaccinated intramuscularly in the right arm with a 0.5 ml of pneumococcal 23v polysaccharide vaccine (lot#653284/0002F).  On 24-MAY-2006, following vaccination, the patient experienced pain in right arm.  Unspecified medical attention was sought.  At the time of this report, the outcome of the event was unknown.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a licensed visiting nurse concerning a patient who on 17-MAY-2006 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (0.5 ml) (lot3653284/0002F), intramuscularly.  Subsequently, the patient experienced cellulitis.  Unspecified medical attention was sought.  The patient recovered.  Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a female patient "in her 40's" who in the "past two weeks" was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot#651329/1047P).  In the "past two weeks" the patient experienced vomiting and local swelling at the injection site.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a female patient " in her 60's" who in the "past two weeks" was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot#651329/1047P).  In the 'past two weeks" the patient experienced vomiting and local swelling at the injection site.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Swelling
Clinical narrative: Information has been received from a physician concerning a 65 year old female who was vaccinated with pneumococcal 23v polysaccharide vaccine.  Subsequently, the patient experienced skin reaction around the injection site.  The injection site was red, erythematous, indurated and the center of the site appeared bluish.  It was also reported that the patient "about a month ago" had a "huge, red, swollen reaction".  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Oedema, Pruritus, Swelling
Clinical narrative: Information has been received from a healthcare worker concerning a patient who "last week" was  vaccinated with pneumococcal 23v polysaccharide vaccine (lot#651321/1036P).  Subsequently, the patient experienced swelling of the injection arm, edema, redness, heat, and itching.  Ice packs, ibuprofen (ADVIL) and acetaminophen (TYLENOL) were the recommended treatments.  Subsequently, the patient recovered.  Additional informational has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Oedema, Pruritus, Swelling
Clinical narrative: Information has been received from a healthcare worker concerning a patient who "last week" was vaccinated with pneumococcal 23v polysaccharide vaccine (lot#651321/1036P).  Subsequently, the patient experienced swelling of the injection arm, edema, redness, heat, and itching.  Ice packs, ibuprofen (ADVIL) and acetaminophen (TYLENOL) were the recommended treatments.  Subsequently, the patient recovered.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a pharmacist, and via a company representative, concerning a patient (age and gender unknown), with unknown medical history, who "within the last six weeks" was vaccinated (route unknown) with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot# unknown).  It was reported that the patient experienced a severe local reaction just after receiving the shot.  The pharmacist reported that "within the last six weeks" the patient developed a cellulitis reaction.  It was reported that the patient may have received the vaccine from a multi dose vial or from single dose vial.  The outcome was not reported.  No product quality complaint was involved.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: A company representative reported that a physician reported that on an unspecified date a patient (not otherwise specified) was vaccinated with the pneumococcal 23v polysaccharide vaccine (Lot# not provided).  The patient developed cellulitis and was treated with unspecified anti-inflammatory medication.  Subsequently, the patient recovered from the cellulitis.  Addition information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant concerning an adult patient who was vaccinated with pneumococcal 23v polysaccharide vaccine (0.5 ml) (IM). Subsequently the patient experienced injection site reaction with injection site redness, warmth and soreness within a day of vaccination. Unspecified medical attention was sought. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician, via a company representative, concerning a patient who on an unspecified date was vaccinated (route unknown) with dose of pneumococcal 23v polysaccharide vaccine (Lot # 649697/1038P).  "Within the last 2 months", the patient developed "redness and swelling of the arm where the injection was given". Subsequently, on an unspecified date, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a RN concerning an adult pt with an unk medical history and unk drug reactions/allergies, who over the last ten days in Oct 2005, was vaccinated IM with a 0.5mL dose pneumococcal 23v polysaccharide vaccine (lot unk). Subsequently, in Oct 2005 the pt developed a local reaction at the injection site including soreness, warmth, erythema and swelling. Unspecified medical attention was sought. The pt was reported to be recovering. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a RN concerning an adult pt with an unk medical history and unk drug reactions/allergies, who over the last ten days in Oct 2005, was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot unk). Subsequently, in Oct 2005 the pt developed a local reaction at the injection site including soreness, warmth, erythema and swelling. Unspecified medical attention was sought. The pt was reported to be recovering. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: Information has been received from a pharmacy purchaser concerning a senior citizen pt (age and gender not specified) who was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 650452/0753P) in a senior center during an immunization clinic. On an unspecified date, recently, the pt developed severe pain at the injection site, so much so that the pt could not sleep at night. It was also reported that the pt had swelling present. It was unk if the pt sought unspecified medical attention. At the time of the report, the outcome of the events were unk. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning an adult female who in August 2005, was vaccinated IM with 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 647661/0055R). In August 2005, the pt developed injection site reaction to include pain, local warmth, redness and swelling. The pt's were reported as recovered. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician regarding a patient who, along with 6 other patients, in October/November 2005, was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot# 650331/0749P and 649989/0579P). Some patients were first time vaccinated while others received a previous injection at least 5 years ago. Concomitantly they were vaccinated in separate sites with a dose of influenza virus vaccine  (unspecified). Subsequently, the patient developed severe local reactions.  The patient was reported as recovered.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. In additional, a review of the Quality Control Quarantine/Rejection System revealed that there were no open Quarantines registered against this lot/fill. There was no product quality complaint involved. Additional information ahs been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a pt (age and gender not reported) with unk medical history and unk allergies who in approx Dec 2004 (winter 2004) was vaccinated IM in the arm with pneumococcal 23v polysaccharide vaccine (lot unk). Subsequently, the pt developed severe vaccine (lot unk). Subsequently, the pt developed severe local injection site reactions in the same arm the injection was given but below the actual site of injection. It was reported that the pt recovered on an unk date. The pt sought unspecified medical attention. There was no product quality complaint involved. No additional information is expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning an adult patient who in approximately February 2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot# 649695/0512P). In approximately February 2005, the patient experienced injection site reactions describes as swelling, soreness, warmth, erythema and induration. Unspecified medical attention was sought. It was noted that the patient was treated with levofloxacin (LEVAQUIN). Subsequently, the patient recovered. A lot check will be performed. No product quality complaint was involved. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a health professional concerning an adult patient who in approximately February 2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot# 649695/0512P). In approximately February 2005, the patient experienced injection site reactions describes as swelling, soreness, warmth, erythema and induration. Unspecified medical attention was sought. It was noted that the patient was treated with levofloxacin (LEVAQUIN). Subsequently, the patient recovered. A lot check will be performed. No product quality complaint was involved. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Information has been received from a RN concerning an adult pt who on 02Nov05 was vaccinated with pneumococcal 23v polysaccharide vaccine (0.5ml) (SC) (lot 649912/0529P). On 02Nov05 the pt experienced injection site soreness, warmth, erythema, swelling and general malaise. The pt was considered to be recovering. Unspecified medical attention was sought. Attempts are being made to obtain additional information to distinguish the individual pt's mentioned in this report. Additional information will be provided if available.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse via a company representative regarding a patient (gender and age not specified) who in approximately 2004 received the pneumococcal 23v polysaccharide vaccine (Lot# not provided). subsequently, the patient developed localized erythema and painful swelling. The out come was unknown. No further information is available.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling, Medication error
Clinical narrative: Information has been received from a registered nurse concerning a patient "over the age of 65 years" who was vaccinated on 09-FEB-2006 with pneumococcal 23v Polysaccharide vaccine (.25 cc), intradermally. "Within 8 hours post vaccination", the patient had local site reaction of swelling. It was noted that most clients injection site was left arm. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: MMR, IPV, MMR
Symptoms: Cough, Febrile convulsion, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Initial report receive from another manufacturer on 7/19/2006, who had received the original report from a health care professional. The manufacturers project report number is WAES0604USA03397. A 12 month old male patient who had no allergies, and no current illness, had received a third subcutaneous dose of Ipol, lot number Y0576, in the left leg and a first subcutaneous 0.5 ml dose of measles mumps and rubella II vaccine, lot number 650350/0970R, in the left thigh on 4/4/2006 at 13:30on, In 4/19/2006, 14 days post immunization, the patient experienced a febrile seizure at home. Concurrent symptoms included fever of 103.5 deg F, increased heart rate of 160, runny nose and cough. The parents called 911 and while in route to the hospital the patient had another febrile seizure. Treatment received in the emergency room included Ibuprofen and Acetaminophen Tylenol. The patients temperature subsequently went down to 100.1 Deg F. A CBC, BNP and blood cultures were performed. Per the reporter, the blood work was essentially normal. On 4/21/2006, 16 days post immunization, the patient woke up with a rash on his head and body, no fever was present at that time. On 4/24/2006, it was reported that the patients rash was going away and he subsequently recovered from these adverse events. The reporter considered the patients adverse events to be other medical important events (OMIC).
Age: 1.01
Sex: M
Vaccine: MMR, IPV, MMR
Symptoms: Cough, Febrile convulsion, Heart rate increased, Pyrexia, Rash
Clinical narrative: Initial report receive from another manufacturer on 7/19/2006, who had received the original report from a health care professional. The manufacturers project report number is WAES0604USA03397. A 12 month old male patient who had no allergies, and no current illness, had received a third subcutaneous dose of Ipol, lot number Y0576, in the left leg and a first subcutaneous 0.5 ml dose of measles mumps and rubella II vaccine, lot number 650350/0970R, in the left thigh on 4/4/2006 at 13:30on, In 4/19/2006, 14 days post immunization, the patient experienced a febrile seizure at home. Concurrent symptoms included fever of 103.5 deg F, increased heart rate of 160, runny nose and cough. The parents called 911 and while in route to the hospital the patient had another febrile seizure. Treatment received in the emergency room included Ibuprofen and Acetaminophen Tylenol. The patients temperature subsequently went down to 100.1 Deg F. A CBC, BNP and blood cultures were performed. Per the reporter, the blood work was essentially normal. On 4/21/2006, 16 days post immunization, the patient woke up with a rash on his head and body, no fever was present at that time. On 4/24/2006, it was reported that the patients rash was going away and he subsequently recovered from these adverse events. The reporter considered the patients adverse events to be other medical important events (OMIC).
Age: 1.01
Sex: M
Vaccine: MMR, IPV, MMR
Symptoms: Rhinorrhoea
Clinical narrative: Initial report receive from another manufacturer on 7/19/2006, who had received the original report from a health care professional. The manufacturers project report number is WAES0604USA03397. A 12 month old male patient who had no allergies, and no current illness, had received a third subcutaneous dose of Ipol, lot number Y0576, in the left leg and a first subcutaneous 0.5 ml dose of measles mumps and rubella II vaccine, lot number 650350/0970R, in the left thigh on 4/4/2006 at 13:30on, In 4/19/2006, 14 days post immunization, the patient experienced a febrile seizure at home. Concurrent symptoms included fever of 103.5 deg F, increased heart rate of 160, runny nose and cough. The parents called 911 and while in route to the hospital the patient had another febrile seizure. Treatment received in the emergency room included Ibuprofen and Acetaminophen Tylenol. The patients temperature subsequently went down to 100.1 Deg F. A CBC, BNP and blood cultures were performed. Per the reporter, the blood work was essentially normal. On 4/21/2006, 16 days post immunization, the patient woke up with a rash on his head and body, no fever was present at that time. On 4/24/2006, it was reported that the patients rash was going away and he subsequently recovered from these adverse events. The reporter considered the patients adverse events to be other medical important events (OMIC).
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Condition aggravated, Heart rate decreased, Heart rate irregular, Hypotension, Hypoxia
Clinical narrative: Baby was given 2 months immunization; immediately started crying inconsolably and had high-pitched and unusual screaming. She quickly grew completely pale and loss all color. She then went completely limp and had an absent response to environment, absent eye contact, absent response to external stimuli.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Pallor, Respiratory rate decreased, Skin discolouration
Clinical narrative: Baby was given 2 months immunization; immediately started crying inconsolably and had high-pitched and unusual screaming. She quickly grew completely pale and loss all color. She then went completely limp and had an absent response to environment, absent eye contact, absent response to external stimuli.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Agitation, Coma, High-pitched crying, Hypotonia, Pallor
Clinical narrative: Baby was given 2 months immunization; immediately started crying inconsolably and had high-pitched and unusual screaming. She quickly grew completely pale and loss all color. She then went completely limp and had an absent response to environment, absent eye contact, absent response to external stimuli.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Petit mal epilepsy
Clinical narrative: Baby was given 2 months immunization; immediately started crying inconsolably and had high-pitched and unusual screaming. She quickly grew completely pale and loss all color. She then went completely limp and had an absent response to environment, absent eye contact, absent response to external stimuli.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dyskinesia, Hypertonia, Hypoaesthesia, Hypotonia, Pain
Clinical narrative: Patient received Hep A in right arm. Then received HPV in left arm. C/O pain & numbness. Started walking down hall fainted and had tonic/clonic movement for 15 sec.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Syncope
Clinical narrative: Patient received Hep A in right arm. Then received HPV in left arm. C/O pain & numbness. Started walking down hall fainted and had tonic/clonic movement for 15 sec.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Hives about 6 hours after Menactra to ER Prednisone RF
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant concerning a 67 yr old white male who at 09:00 on 21Sep05 was vaccinated IM in the right deltoid with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0592P). It was reported that the pt had since developed pain, redness, swelling, and warmth at and around the injection site. On 23Sep05, the pt developed an allergic reaction with some erythema around elbow area. The pt saw the physician and was treated with gatifloxacin (Tequin) 400mg for 4 days to rule out cellulitis. On 23Sep05, the pt was considered recovered. No additional information is expected.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial and follow up information has been received from a physician, the husband of a 69 yr old female pt with no known medical history and no known drug reaction or allergies reported, who on 04Oct05 was vaccinated (route unk) in the deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot unk). On 05Oct05 the pt developed an injection site, cellulitis like reaction, characterized by erythema, tenderness, swelling and pain. It was also reported that the pt experienced warmth. The pt was treated with conservative treatment; NSAID's and cool compress. On 13Oct05 the pt recovered. No product quality complaint was involved. No further information is available.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Initial and follow up information has been received from a physician, the husband of a 69 yr old female pt with no known medical history and no known drug reaction or allergies reported, who on 04Oct05 was vaccinated (route unk) in the deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot unk). On 05Oct05 the pt developed an injection site, cellulitis like reaction, characterized by erythema, tenderness, swelling and pain. It was also reported that the pt experienced warmth. The pt was treated with conservative treatment; NSAID's and cool compress. On 13Oct05 the pt recovered. No product quality complaint was involved. No further information is available.
Age: 30.0
Sex: M
Vaccine: YF
Symptoms: Oedema
Clinical narrative: Swelling in both hands, severe. Began around 1:00 1:30am on 7/13/06. Improving but conditions still exists as of 7/13/06 11:00am.
Age: 24.0
Sex: F
Vaccine: HEP, HEPA, TYP, YF
Symptoms: Dizziness, Heart rate increased, Malaise, Pyrexia
Clinical narrative: Client c/o not feeling right, fever 102 on/off increased heart rate, dizziness on 7/14/06 pm out of town. Called on call MD who evaluated, client called on 7/17/06 with all stated info, as per client MD gave aspirin B/P not checked told pt heart rate is 20 times faster then normal must be from vaccines. Instructed to go to ER or MD for complete assessment.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Abasia, Anorexia, Aphasia, Hypotonia, Irritability
Clinical narrative: Information regarding Prevenar was received from a consumer regarding a 2 month old male patient who developed a fever, became fussy, was not eating and is experiencing developmental delay. At 2 months of age, the patient received the first dose on 11/12/2004. The patient also received the first dose of Tripacel, the first dose of Comvax and the first dose of Ipol on 11/12/2004. Relevant medical history was not provided. Product was administered on 11/12/2004. Concomitant medications were not reported. On 11/12/2004 the patient developed a fever after receiving his vaccinations. Two weeks later, he stopped eating and was unable to keep his head up. The child became fussy. He was subsequently hospitalized for four nights and treated with unspecified antibiotics. The fever resolved. The mother reported that a physician informed her that the baby was developmental delay (medically important) (OMIC), which included symptoms of hypotonia low muscle tone. Additionally, the baby was not sitting up, walking or talking. Currently, the child can hold his head up. He has a nutritionist and feeding therapist to assist with eating. On 6/30/2006 the patient weight 20 pounds, 10 ounce. Outcome of the child's irritability and developmental delay is unknown. Caller noted that her doctor wanted her to ask the different manufacturers of the vaccines for information concerning adverse events such as these reported. No additional information was available at the time of this report.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Mental retardation severity unspecified, Pyrexia
Clinical narrative: Information regarding Prevenar was received from a consumer regarding a 2 month old male patient who developed a fever, became fussy, was not eating and is experiencing developmental delay. At 2 months of age, the patient received the first dose on 11/12/2004. The patient also received the first dose of Tripacel, the first dose of Comvax and the first dose of Ipol on 11/12/2004. Relevant medical history was not provided. Product was administered on 11/12/2004. Concomitant medications were not reported. On 11/12/2004 the patient developed a fever after receiving his vaccinations. Two weeks later, he stopped eating and was unable to keep his head up. The child became fussy. He was subsequently hospitalized for four nights and treated with unspecified antibiotics. The fever resolved. The mother reported that a physician informed her that the baby was developmental delay (medically important) (OMIC), which included symptoms of hypotonia low muscle tone. Additionally, the baby was not sitting up, walking or talking. Currently, the child can hold his head up. He has a nutritionist and feeding therapist to assist with eating. On 6/30/2006 the patient weight 20 pounds, 10 ounce. Outcome of the child's irritability and developmental delay is unknown. Caller noted that her doctor wanted her to ask the different manufacturers of the vaccines for information concerning adverse events such as these reported. No additional information was available at the time of this report.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Abasia, Agitation, Anorexia, Crying, Hypotonia
Clinical narrative: Information regarding Prevenar was received from a consumer regarding a 2 month old male patient who developed a fever, became fussy, was not eating and is experiencing developmental delay. At 2 months of age, the patient received the first dose on 11/12/2004. The patient also received the first dose of Tripacel, the first dose of Comvax and the first dose of Ipol on 11/12/2004. Relevant medical history was not provided. Product was administered on 11/12/2004. Concomitant medications were not reported. On 11/12/2004 the patient developed a fever after receiving his vaccinations. Two weeks later, he stopped eating and was unable to keep his head up. The child became fussy. He was subsequently hospitalized for four nights and treated with unspecified antibiotics. The fever resolved. The mother reported that a physician informed her that the baby was developmental delay (medically important) (OMIC), which included symptoms of hypotonia low muscle tone. Additionally, the baby was not sitting up, walking or talking. Currently, the child can hold his head up. He has a nutritionist and feeding therapist to assist with eating. On 6/30/2006 the patient weight 20 pounds, 10 ounce. Outcome of the child's irritability and developmental delay is unknown. Caller noted that her doctor wanted her to ask the different manufacturers of the vaccines for information concerning adverse events such as these reported. No additional information was available at the time of this report.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Irritability, Mental retardation severity unspecified, Pyrexia, Screaming, Speech disorder
Clinical narrative: Information regarding Prevenar was received from a consumer regarding a 2 month old male patient who developed a fever, became fussy, was not eating and is experiencing developmental delay. At 2 months of age, the patient received the first dose on 11/12/2004. The patient also received the first dose of Tripacel, the first dose of Comvax and the first dose of Ipol on 11/12/2004. Relevant medical history was not provided. Product was administered on 11/12/2004. Concomitant medications were not reported. On 11/12/2004 the patient developed a fever after receiving his vaccinations. Two weeks later, he stopped eating and was unable to keep his head up. The child became fussy. He was subsequently hospitalized for four nights and treated with unspecified antibiotics. The fever resolved. The mother reported that a physician informed her that the baby was developmental delay (medically important) (OMIC), which included symptoms of hypotonia low muscle tone. Additionally, the baby was not sitting up, walking or talking. Currently, the child can hold his head up. He has a nutritionist and feeding therapist to assist with eating. On 6/30/2006 the patient weight 20 pounds, 10 ounce. Outcome of the child's irritability and developmental delay is unknown. Caller noted that her doctor wanted her to ask the different manufacturers of the vaccines for information concerning adverse events such as these reported. No additional information was available at the time of this report.