chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Delirium, Injection site erythema, Injection site hypersensitivity, Injection site swelling, Multiple sclerosis
Clinical narrative: Severe itching, redness, swelling at injection sight.  Parasthesia left arm. 4/15/99 Neurology Appt 16 Jun 99 Optic Neuritis 11 Aug 99 Optic Neuritis 3 Feb 00 Diagosis of Multiple Sclerosis with confirmed lesions on MRI 3 Feb 00
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Optic neuritis, Paraesthesia, Pruritus
Clinical narrative: Severe itching, redness, swelling at injection sight.  Parasthesia left arm. 4/15/99 Neurology Appt 16 Jun 99 Optic Neuritis 11 Aug 99 Optic Neuritis 3 Feb 00 Diagosis of Multiple Sclerosis with confirmed lesions on MRI 3 Feb 00
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Feeling hot, Injection site infection, Pain
Clinical narrative: Pt received influenza vaccine in right arm and pneumovax in left arm at clinic.  Documented in chart that pt did not have a reaction after immunizations.  Pt presented to clinic 24 hours later with swollen, painful, warm, erythematous, macular rash on RUE.  Reaction was first noted 1 day after shot in the same area of injection.  Pt was not febrile.  Pt denied allergies to eggs and has had the flu vaccine in the past without complications.  Physician suspected that it was cellulitis and possibly an infection.  Pt was given cephalexin, APAP, and diphenhydramine.  Pt reported 4 days later that the reaction had improved.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash macular, Swelling
Clinical narrative: Pt received influenza vaccine in right arm and pneumovax in left arm at clinic.  Documented in chart that pt did not have a reaction after immunizations.  Pt presented to clinic 24 hours later with swollen, painful, warm, erythematous, macular rash on RUE.  Reaction was first noted 1 day after shot in the same area of injection.  Pt was not febrile.  Pt denied allergies to eggs and has had the flu vaccine in the past without complications.  Physician suspected that it was cellulitis and possibly an infection.  Pt was given cephalexin, APAP, and diphenhydramine.  Pt reported 4 days later that the reaction had improved.
Sex: U
Vaccine: HEP, SMALL, TYP
Symptoms: Erythema multiforme
Clinical narrative: Erythema Multiforme Minor.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Chest discomfort, Condition aggravated, Dyspnoea, Heart rate increased
Clinical narrative: Approximately 15 minutes after vaccination, patient complained of tightness in her chest and difficulty breathing.  Nurse administered epi-pen 0.3 mg at 9:52 am. On call MD was called.  At 9:55 BP 150/80, pulse 125, RR 32.  At 10:05 BP 130/68, Pulse 100, RR 28.   No wheezing or rales noted.  Repiratory distress resolved post epi-pen.  Patient has a history of receiving flu vaccine in 2003 without incident.  EMS called and transferred patient to hospital.  Patient was evaluated and admitted at hospital with diagnosis of Sickle Cell Crisis and Asthma.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperventilation, Wheezing
Clinical narrative: Approximately 15 minutes after vaccination, patient complained of tightness in her chest and difficulty breathing.  Nurse administered epi-pen 0.3 mg at 9:52 am. On call MD was called.  At 9:55 BP 150/80, pulse 125, RR 32.  At 10:05 BP 130/68, Pulse 100, RR 28.   No wheezing or rales noted.  Repiratory distress resolved post epi-pen.  Patient has a history of receiving flu vaccine in 2003 without incident.  EMS called and transferred patient to hospital.  Patient was evaluated and admitted at hospital with diagnosis of Sickle Cell Crisis and Asthma.
Age: 47.0
Sex: M
Vaccine: HEPAB
Symptoms: Erythema, Rash macular, Rash pruritic
Clinical narrative: Developed a pinkish macular pruritic rash appearing mostly in patches on back, trunk and legs. It is most prominent on the back side of his kneejoint. The rash started approximately 72 hours after the second dose of Trinrix.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Cough, Nasopharyngitis, Pyrexia, Rash
Clinical narrative: 3-4 days after receiving his MMR and Varivax patient broke out into a rash all over his body. There was no associated fever initially. Fever  showed after the rash appeared associated with cough and cold. Fever treated with Tylenol.
Age: 1.04
Sex: F
Vaccine: PPV, VARCEL
Symptoms: Cellulitis, Injection site oedema, Injection site warmth
Clinical narrative: Swollen around immun site/warm to touch 2 1/2x3cm. Cellulitis over area. Pt given Keflex250/5 1tsp PO BID.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site induration, Rash erythematous
Clinical narrative: Erythematous rash left deltoid area with mild induration. Lasted 4-5 days.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site induration, Injection site oedema, Rash erythematous
Clinical narrative: Erythematous rash, left deltoid area. Swollen and sore at injection site 5-6cm, induration. Lasted 4-5 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Arm became red, swollen, and sore at injection site. 6x5cm with induration lasting 4-5 days.
Sex: M
Vaccine: PNC
Symptoms: Cellulitis, Injection site oedema, Injection site warmth, Pyrexia
Clinical narrative: Pt has swelling, redness, low grade fever, streaks up, warmth to left arm on sunday 03/13/2005..Seen by on call physician. Placed on Cephalexin 250mg/5ml 1tsp PO TID x 7 days starting 03/13/2005
Sex: M
Vaccine: YF
Symptoms: Abdominal pain, Nausea, Renal failure
Clinical narrative: Father reported for child severe nausea, abdominal pain resulting in kidney failure.
Age: 0.74
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Injection site mass, Pyrexia
Clinical narrative: This report was received from a registered nurse (RN) and was assigned manufacturer report number HQWYE332114JAN04.  The report was concerning an 8 month old male patient who on 05/19/2003 was vaccinated with a dose of Hepatitis B virus vaccine rHBsAG (yeast).  On 05/19/2003 the patient developed a fever of 104F, an injection site lump and redness. Subsequently, the patient recovered.  This was originally reported by a registered nurse.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal discomfort, Dehydration, Diarrhoea, Fatigue, Influenza like illness
Clinical narrative: Information has been received from GalxoSmithkline and was assigned manufacturer report number A0526A23A. The was originally reported by a safety specialist concerning a 22 year old white female with coeliac sprue, a food allergy to gluten and a sensitivity to yeast who on 09/07/2004 at 13:00 was vaccinated IM in her upper right arm with a first dose of Hepatitis B virus vaccine rHBsAg(yeast)(lot#646999/0999N). There was no illness at the time of vaccination. Concomitant therapy included fluticasone propionate(+) salmeterol xinafoate (Advair), fluticasone propionate (Flonase), fexofenadine hydrochloride (Allegra) and ethinyl estradiol(+) Levonorgestrel (Triphasil). Within minutes of vaccination the patient experienced dizziness. The evening of 09/07/2004 at 15"00 the patient developed diarrhea, pyrexia, stomach discomfort, fatigue, influenza like illness, unspecified pain, and tremors. The patient also developed dehydration. The events resolved 12hours later on09/08/2004. The patient can be considered recovered. It was reported that the patient had no adverse event following prior vaccination.  No furhter information is available.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: Information has been received from GalxoSmithkline and was assigned manufacturer report number A0526A23A. The was originally reported by a safety specialist concerning a 22 year old white female with coeliac sprue, a food allergy to gluten and a sensitivity to yeast who on 09/07/2004 at 13:00 was vaccinated IM in her upper right arm with a first dose of Hepatitis B virus vaccine rHBsAg(yeast)(lot#646999/0999N). There was no illness at the time of vaccination. Concomitant therapy included fluticasone propionate(+) salmeterol xinafoate (Advair), fluticasone propionate (Flonase), fexofenadine hydrochloride (Allegra) and ethinyl estradiol(+) Levonorgestrel (Triphasil). Within minutes of vaccination the patient experienced dizziness. The evening of 09/07/2004 at 15"00 the patient developed diarrhea, pyrexia, stomach discomfort, fatigue, influenza like illness, unspecified pain, and tremors. The patient also developed dehydration. The events resolved 12hours later on09/08/2004. The patient can be considered recovered. It was reported that the patient had no adverse event following prior vaccination.  No furhter information is available.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Condition aggravated, Eczema
Clinical narrative: PT HAD A FLARE OF HIS ECZEMA AFTER VACCINE ADMINISTRATION.
Age: 44.0
Sex: M
Vaccine: SMALL
Symptoms: Eczema
Clinical narrative: APPROXIMATELY 2 WEEKS AFTER SVP VACCINATION DEVELOPED DYSHYDROTIC ECZEMA ON HIS FEET, THEN HANDS, AND NOW ECZEMA ON HIS FACE/GROIN.
Sex: F
Vaccine: HEP
Symptoms: Laboratory test abnormal, Monarthritis, Neutropenia, Pharyngitis, Pneumonia
Clinical narrative: Information has been received from a physician concerning a female patient who in 1998 was vaccinated with a dose of hepatitis B virus vaccine rHBsAG (yeast). Six to eight months after vaccination she developed neutropenia and from the administration date " to the present" she has experienced pneumonia, pharyngitis and monarticular arthritis. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from the physician indicated that she did not patient and does not know who administered the vaccine, so she can not provide any additional information. Additional information is not expected.
Age: 0.64
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Rash, Urinary tract infection
Clinical narrative: Information has been received from a consumer concerning her 7 month old daughter who on 08/14/2001, 11/19/2001, and 01/09/2002 was vaccinated with a first, second, and third dose of Hepatitis B virus vaccine RHBSAG (yeast) (lot number 640323/0753L0 , 640323/0753L, and 641449/1230L respectively).  The patient's vaccination history was noted to include a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid, a dose of poliovirus vaccine inactivated (Vero) (IPOL), and an "RV shot" on 02/27/2001, a first, second, and third dosse of Hib conj vaccine (OMPC) (MSD) on 02/2001 (lot # 638138/1548K [also reported as "1548KO"]), 05/01/2001 (lot # 639437/0929L0, and 01/2002 (lot #639437/0929L) respectively, a dose of measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) on l04/01/2002 (lot # 638706/0745L [also reported as "0745LO"]), and a dose of varicella virus vaccine live (Oka/Merck) (MSD) on 01/09/2002 (lot # 638244/0466L).  The mother reported that each time the patient ' had a shot (any shot)" she experienced a rash around the diaper area and a fever [Hib conj vaccine (OMPC) (MSD) (WAES # 0401USA01373), measles virus vaccine live (Moraten) (+) mumps virus 0401USA01517), and varicella virus vaccine live (Oka/Merck) (MSD) (WAES# 0401USA01518)].  The mother eas told to "just wait through the fevers."  Subsequently, the patient recovered.  A product quality complaint was not involved.  Additional information was received from a physician who indicated that the hepatitis B virus vaccine RHBSAG (yeast) was not administered in his office. No further information is expected. The mother also reported that the patient developed a severe urinary infection after therapy with Hib conj vaccine (OMPC) (MSD) (WAES# 0401USA01373).
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Hepatic enzyme abnormal
Clinical narrative: Information has been received from an approximately 56 year old female registered nurse with hypothyroidism, hypertension, and arthritis who in 1988 was vaccinated with the 3 dose series of hepatitis B virus vaccine rHBsAG (yeast).  Concomitant therapy included levothyroxine Na (Synthroid), valsarten (Diovan) and valdecoxib (Bextra).  A titer was drawn in 1996 and 2000 (results not provided), and booster doses were given in 1996 and 2000.  In approximately January 2003, the patient had elevated liver enzymes during routine lab work.  On 01/26/2004, the patient received a third booster dose.  Unspecified medical attention was sought.  There was no product quality complain.  Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a health professional concerning a female patient with a latex allergy who on 02/13/2004 was vaccinated with a dose of Hepatitis B virus vaccine rHBsAG (yeast).  Concomitant therapy included a Mantoux tuberculosis test.  Late in the evening of 02/13/2004, the patient reported to the emergency room because of a reaction.  The nurse did not yet see or talk to the patient so did not have much information on the reaction but the patient does have a latex allergy.  The nurse knew that the emergency room administered promethazine hydrochloride (Phenergen) 25mg and diphenhydramine hydrochloride (benadryl) 50mg.  As of 02/2004, the nurse did not have any additional information.  There was no product quality complaint involved. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old male operating room technician who on 02/09/2004 was vaccinated in the left deltoid with a second dose of Hepatitis B virus vaccine rHBsAG (yeast) (646340/1015N).  It was reported that the patient experienced prolonged pain at injection site of three to four days.  Then five days after the injection he experienced a "pinching" sensation at the site of injection, which occurred for one day then resolved.  The patient stated his arm felt normal on 02/19/2004.  There was no product quality complaint reported.  No additional information was received.  Specified medical attention was sought.  No additional information is expected.
Sex: U
Vaccine: HEP
Symptoms: Cough
Clinical narrative: Information has been received from a pharmacy student concerning a child who was vaccinated with the first dose of hepatitis B virus vaccine rHBsAG (yeast) series and "has had a cough for the past month", since approximately February 2004.  No lot number was available.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was available.  Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity, Hypoaesthesia, Pain
Clinical narrative: Information has been received from a 31 year old white female registered nurse with no allergies or medical history "at the time" who in approximately October 1988 was vaccinated with a second dose of hepatitis B virus vaccine rHBsAG (yeast).  There were no other concomitant vaccinations.  There was no illness at the time of vaccination.  After vaccination, she developed numbness and pain across her arm and shoulders.  The pain lasted three months until it resolved.  She was treated wtih Ibuprofen for the pain.  Unspecified medical attention was sought.  It was noted that the patient recovered.  A product quality complaint was not involved.  Follow up information was received from the reporter who stated that she received her second dose of hepatitis B virus vaccine rHBsAG (yeast).  One week later, in October 1988, both arms and hands were numb.  It was follow approximately four days later with sever pain across her shoulders and down both arms.  The pain lasted six months.  She was treated by a doctor with ibuprofen (Motrin) (800mg qid).  Unspecified blood work was done.  The patient has since found out that she is allergic to horse serum.  It was noted that the patient had no adverse events following prior vaccination.  No further information is expected.
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Feeling hot, Pruritus, Rash
Clinical narrative: Information has been received from a medical technologist concerning a 29 year old male with no allergies or pertinent medical history who on 02/27/2004 was vaccinated in the deltoid with hepatitis B virus vaccine rHBsAG (yeast) (lot # 64634/1023N).  There was no concomitant medication.  The reporter indicated that she was unsure in which arm he was vaccinated.  The patient called the doctor's office on 03/03/2004 stating that he had a hot, itchy, pimple- like rash on the neck which then spread to his chin and around the ear to the back of the neck.  Unspecified medical attention was sought and no treatment was required.  No diagnostic laboratory tests were performed at the time of the report, the patient had not recovered.  A product quality complaint was no resolved.  Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Medication error, Rash
Clinical narrative: This is in follow-up to report(s) previously submitted on 3/7/2005. Information has been received from a consumer concerning her newborn niece (one day old) who on 03/08/2004 was vaccinated with an adult formulation of hepatitis B virus vaccine rHBsAG (yeast) (10mcg/ml).  Concomitant therapy that day included "another hepatitis vaccine" (manufacturer unknown).  On 03/09/2004 the patient had a "rash on her stomach around her navel. " The patient sought unspecified medical attention.   Additional information has been requested. This is an amended report. The patient's age of one day old has been added. This report is corrected, as amended.
Age: 0.02
Sex: M
Vaccine: HEP
Symptoms: Cough, Pyrexia, Rhinorrhoea, Sneezing, Upper respiratory tract infection
Clinical narrative: Information has been received from a physician concerning a 16 week old male with a history of forceps delivery bradycardia and a family history of asthma who on 04/25/2003 was vaccinated with a dose of hepatitis B virus rHBsAG (yeast) (manufacturer unknown).  On approximately 08/09/2003 the patient developed a dry cough, sneezing, rhinorrhea and wheezing at night.  On the morning of 08/16/2003 the patient's mother took his temperature which was 100 degrees F (rectally).  At 11:45 that morning the infant was seen by a physician.  The infant was active, feeding well, had no distress with breathing, and no skin rashes, nausea, vomiting, or diarrhea.  He was making 6 wet diapers/day.  He was not in contact with anyone who was sick.  His physical examination was within normal limits.  The physician noted that the patient had a probable viral URI.  Instructions were given for reassurance and to continue to monitor the infant.  It there was any worsening of his fever, lethargy, new rash or nausea/vomiting/diarrhea he was to return to the health center.  Additional information has been requested.  It was also reported that the patient's mother was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) during her pregnancy with him (WAES #0210USA01768).
Age: 0.02
Sex: M
Vaccine: HEP
Symptoms: Wheezing
Clinical narrative: Information has been received from a physician concerning a 16 week old male with a history of forceps delivery bradycardia and a family history of asthma who on 04/25/2003 was vaccinated with a dose of hepatitis B virus rHBsAG (yeast) (manufacturer unknown).  On approximately 08/09/2003 the patient developed a dry cough, sneezing, rhinorrhea and wheezing at night.  On the morning of 08/16/2003 the patient's mother took his temperature which was 100 degrees F (rectally).  At 11:45 that morning the infant was seen by a physician.  The infant was active, feeding well, had no distress with breathing, and no skin rashes, nausea, vomiting, or diarrhea.  He was making 6 wet diapers/day.  He was not in contact with anyone who was sick.  His physical examination was within normal limits.  The physician noted that the patient had a probable viral URI.  Instructions were given for reassurance and to continue to monitor the infant.  It there was any worsening of his fever, lethargy, new rash or nausea/vomiting/diarrhea he was to return to the health center.  Additional information has been requested.  It was also reported that the patient's mother was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) during her pregnancy with him (WAES #0210USA01768).
Age: 0.11
Sex: F
Vaccine: HEP
Symptoms: Crying, Screaming
Clinical narrative: Information has been received from a nurse practitioner concerning a 6 week old white female infant who on 03Mar04 was vaccinated with a 0.5ml second dose of hep B virus vaccine rHBsAg (yeast) (lot 648251/1286N). There was no concomitant medication or illness at the time of vaccination. On 03Mar04 from 10:00PM to 3:00AM the pt cried inconsolably, also described as the mother was unable to console the infant. It was noted that the infant had no fever, no vomiting and no rash. It was noted that no medicine was given. Subsequently, the pt recovered on 04Mar04. There were no relevant diagnostic test or lab date. No further information is expected.
Sex: F
Vaccine: HEP
Symptoms: Feeling hot, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a certified medical assistant concerning a female pt who was vaccinated with a dose of hep B virus vaccine rHBsAg (yeast) (lot640335/1255L). The pt called to report that several hours post vaccination she developed swelling and soreness at the injection site and stated that the area was warm to the touch. The pt was advised to take OTC acetaminophen (Tylenol). No product quality compliant was involved. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Hypersensitivity, Hypertension, Injection site erythema, Liver function test abnormal
Clinical narrative: Information has been received from a physician concerning a 33 year old white female with increased liver function tests, headaches, hypertension, and shellfish, penicillin, and seasonal allergies who in June 2003 and on 14Jul03 was vaccinated in the left deltoid with the first and second dose of hep B virus vaccine rHBsAg (yeast) (lot640335/1255L for both doses). On 16Mar04 at 10:00AM, the pt was vaccinated in the left deltoid with a third dose of hep B virus vaccine rHBsAg (yeast) (lot 640335/1255L). The pt experienced a dime sized area of redness at the injection site. Four to five hours later, the pt had a fever of 101 degrees F. That night, the fever went up to 102. 5 degrees F. At the time of the report, the fever persisted. Unspecified medical attention was sought. A product quality complaint was not involved. Follow up information was received from a health professional in the physician's office who indicated that on 17Mar04 at 9:00PM, the pt developed a fever and chills. She felt awful with aches and pain. There was a dime sized area of erythema at the injection site. It was noted that the pt recovered on 19Mar04. No further information is expected.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Myalgia, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 33 year old white female with increased liver function tests, headaches, hypertension, and shellfish, penicillin, and seasonal allergies who in June 2003 and on 14Jul03 was vaccinated in the left deltoid with the first and second dose of hep B virus vaccine rHBsAg (yeast) (lot640335/1255L for both doses). On 16Mar04 at 10:00AM, the pt was vaccinated in the left deltoid with a third dose of hep B virus vaccine rHBsAg (yeast) (lot 640335/1255L). The pt experienced a dime sized area of redness at the injection site. Four to five hours later, the pt had a fever of 101 degrees F. That night, the fever went up to 102. 5 degrees F. At the time of the report, the fever persisted. Unspecified medical attention was sought. A product quality complaint was not involved. Follow up information was received from a health professional in the physician's office who indicated that on 17Mar04 at 9:00PM, the pt developed a fever and chills. She felt awful with aches and pain. There was a dime sized area of erythema at the injection site. It was noted that the pt recovered on 19Mar04. No further information is expected.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Anorexia, Anxiety, Back pain, Chest pain, Dysphagia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 30 year old white female medical assistant student with penicillin allergy and no pertinent medical history who on20Jan04 was vaccinated IM in the deltoid with a first dose of hep B virus vaccine rHBsAg (yeast) (lot 645173/1210M). Three hours post vaccination, the pt developed anxiety, heart racing and a panic attack (also described as severe anxiety reaction, palps, nervous). Over the course of 8 weeks the pt stated that she developed blurred vision, muscle weakness, numbness and tingling of her feet and arms, water mouth, shortness of breath, fatigue, irritability, anxiety, chest pain, increased blood pressure, back ache, loss of appetite, mental fog and difficulty swallowing. The pt went to the ER three different times. The hospital performed an EKG which was normal and the pt was diagnosed with anxiety. The pt was not hospitalized. She stated that someone told her that her symptoms could be from mercury. She stated that she had not recovered (the outcome was also reported as unk). No product quality complaint was involved. The reporter also stated that another person in her class was vaccinated with a dose of hep B virus vaccine rHBsAg (yeast) and experienced the same symptoms (WAES0404USA0001). Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Fatigue, Heart rate increased, Hypertension, Hypoaesthesia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 30 year old white female medical assistant student with penicillin allergy and no pertinent medical history who on20Jan04 was vaccinated IM in the deltoid with a first dose of hep B virus vaccine rHBsAg (yeast) (lot 645173/1210M). Three hours post vaccination, the pt developed anxiety, heart racing and a panic attack (also described as severe anxiety reaction, palps, nervous). Over the course of 8 weeks the pt stated that she developed blurred vision, muscle weakness, numbness and tingling of her feet and arms, water mouth, shortness of breath, fatigue, irritability, anxiety, chest pain, increased blood pressure, back ache, loss of appetite, mental fog and difficulty swallowing. The pt went to the ER three different times. The hospital performed an EKG which was normal and the pt was diagnosed with anxiety. The pt was not hospitalized. She stated that someone told her that her symptoms could be from mercury. She stated that she had not recovered (the outcome was also reported as unk). No product quality complaint was involved. The reporter also stated that another person in her class was vaccinated with a dose of hep B virus vaccine rHBsAg (yeast) and experienced the same symptoms (WAES0404USA0001). Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Irritability, Mental impairment, Muscular weakness, Nervousness, Palpitations
Clinical narrative: Information has been received from a licensed practical nurse concerning a 30 year old white female medical assistant student with penicillin allergy and no pertinent medical history who on20Jan04 was vaccinated IM in the deltoid with a first dose of hep B virus vaccine rHBsAg (yeast) (lot 645173/1210M). Three hours post vaccination, the pt developed anxiety, heart racing and a panic attack (also described as severe anxiety reaction, palps, nervous). Over the course of 8 weeks the pt stated that she developed blurred vision, muscle weakness, numbness and tingling of her feet and arms, water mouth, shortness of breath, fatigue, irritability, anxiety, chest pain, increased blood pressure, back ache, loss of appetite, mental fog and difficulty swallowing. The pt went to the ER three different times. The hospital performed an EKG which was normal and the pt was diagnosed with anxiety. The pt was not hospitalized. She stated that someone told her that her symptoms could be from mercury. She stated that she had not recovered (the outcome was also reported as unk). No product quality complaint was involved. The reporter also stated that another person in her class was vaccinated with a dose of hep B virus vaccine rHBsAg (yeast) and experienced the same symptoms (WAES0404USA0001). Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Panic reaction, Paraesthesia, Salivary hypersecretion, Visual disturbance
Clinical narrative: Information has been received from a licensed practical nurse concerning a 30 year old white female medical assistant student with penicillin allergy and no pertinent medical history who on20Jan04 was vaccinated IM in the deltoid with a first dose of hep B virus vaccine rHBsAg (yeast) (lot 645173/1210M). Three hours post vaccination, the pt developed anxiety, heart racing and a panic attack (also described as severe anxiety reaction, palps, nervous). Over the course of 8 weeks the pt stated that she developed blurred vision, muscle weakness, numbness and tingling of her feet and arms, water mouth, shortness of breath, fatigue, irritability, anxiety, chest pain, increased blood pressure, back ache, loss of appetite, mental fog and difficulty swallowing. The pt went to the ER three different times. The hospital performed an EKG which was normal and the pt was diagnosed with anxiety. The pt was not hospitalized. She stated that someone told her that her symptoms could be from mercury. She stated that she had not recovered (the outcome was also reported as unk). No product quality complaint was involved. The reporter also stated that another person in her class was vaccinated with a dose of hep B virus vaccine rHBsAg (yeast) and experienced the same symptoms (WAES0404USA0001). Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Dysarthria, Facial palsy, Hypoaesthesia, Lacrimation increased, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a 46 year old Caucasian female with concurrent conditions of HIV, bipolar disorder, herpes zoster, chronic obstructive pulmonary disease, and allergies to cephalosporin, influenza vaccine, Thioridazine hydrochloride, metals, and seafood who on 3/29/04 at 12:15 was vaccinated IM in the right deltoid with a first dose of hepatitis B virus vaccine (lot # 646147/0626N). Adverse events following prior vaccinations at age 35 included hives/edema with influenza vaccine. Concomitant therapy included fluconazole, lorazepam, topiramate, aripiprazole, zolpidem tartrate, vitamins, oxycodone, albuterol sulfate (+) ipratropium bromide, pantoprazole sodium, lamivudine, zidovudine, lopinavir (+) ritonavir, and ferrous gluconate. On 3/29/04, at 12:25 PM (previously reported as 15:00), the patient immediately developed a watery eye and later, left eye droop (also reported as 10 minutes after the vaccine, eye watered, twitched, and droopy, facial numbness on left side and lip drooped). On 3/30/04, the patient was seen in the office with left sided facial droop and slurred speech (also reported as by next day full left sided facial droop and slurred speech). The diagnosis was Bell's Palsy. No treatment was required, however, it was noted that the patient was going to the emergency room. The patient was seen in the ER and was given steroids and acyclovir for Bell's Palsy. Unspecified medical attention was sought. There was no product quality complaint involved. The patient recovered on 5/20/04. The physician considered Bell's Palsy to be significantly disabling. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Anorexia, Anxiety, Back pain, Chest pain, Dysphagia
Clinical narrative: Information has been received from a medical assistant student concerning another student in her class who was vaccinated with a dose of hep B virus vaccine rHBsAg (yeast). Subsequently, the pt developed anxiety, heart racing, panic attack, blurred vision, muscle weakness, numbness and tingling of the feet and arms, a watery mouth, shortness of breath, fatigue, irritability, chest pain, increased blood pressure, back ache, loss of appetite, mental fog and difficulty swallowing. No further information is available. Additional information has been requested. The reporter also noted that she had been vaccinated with a dose of hep B virus vaccine rHBsAg (yeast) and experienced the same symptoms and was diagnosed with anxiety (WAES 0403USA02341).
Sex: U
Vaccine: HEP
Symptoms: Dyspnoea, Fatigue, Heart rate increased, Hypertension, Hypoaesthesia
Clinical narrative: Information has been received from a medical assistant student concerning another student in her class who was vaccinated with a dose of hep B virus vaccine rHBsAg (yeast). Subsequently, the pt developed anxiety, heart racing, panic attack, blurred vision, muscle weakness, numbness and tingling of the feet and arms, a watery mouth, shortness of breath, fatigue, irritability, chest pain, increased blood pressure, back ache, loss of appetite, mental fog and difficulty swallowing. No further information is available. Additional information has been requested. The reporter also noted that she had been vaccinated with a dose of hep B virus vaccine rHBsAg (yeast) and experienced the same symptoms and was diagnosed with anxiety (WAES 0403USA02341).
Sex: U
Vaccine: HEP
Symptoms: Irritability, Mental impairment, Muscular weakness, Panic reaction, Paraesthesia
Clinical narrative: Information has been received from a medical assistant student concerning another student in her class who was vaccinated with a dose of hep B virus vaccine rHBsAg (yeast). Subsequently, the pt developed anxiety, heart racing, panic attack, blurred vision, muscle weakness, numbness and tingling of the feet and arms, a watery mouth, shortness of breath, fatigue, irritability, chest pain, increased blood pressure, back ache, loss of appetite, mental fog and difficulty swallowing. No further information is available. Additional information has been requested. The reporter also noted that she had been vaccinated with a dose of hep B virus vaccine rHBsAg (yeast) and experienced the same symptoms and was diagnosed with anxiety (WAES 0403USA02341).
Sex: U
Vaccine: HEP
Symptoms: Salivary hypersecretion, Vision blurred
Clinical narrative: Information has been received from a medical assistant student concerning another student in her class who was vaccinated with a dose of hep B virus vaccine rHBsAg (yeast). Subsequently, the pt developed anxiety, heart racing, panic attack, blurred vision, muscle weakness, numbness and tingling of the feet and arms, a watery mouth, shortness of breath, fatigue, irritability, chest pain, increased blood pressure, back ache, loss of appetite, mental fog and difficulty swallowing. No further information is available. Additional information has been requested. The reporter also noted that she had been vaccinated with a dose of hep B virus vaccine rHBsAg (yeast) and experienced the same symptoms and was diagnosed with anxiety (WAES 0403USA02341).
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning a male pt with no allergies who on 13Feb04, at birth, was vaccinated with a dose of hep B virus vaccine rHBsAg (yeast) (manf unk). Subsequently in 2004, the pt broke out in hives. Unspecified medical attention was sought, but treatment was not required. A product quality complaint was not involved. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: HEP, TYP
Symptoms: Hot flush, Palpitations, Skin burning sensation
Clinical narrative: Information has been received from a RN concerning a 37 year old male with hayfever who on 21Apr04 at 3PM was vaccinated IM with a first 0.5ml dose of hep B virus vaccine rHBsAg (yeast) (lot 645420/0048N). There was no illness at the time of vaccination. Concomitant therapy that day at 3PM included a first dose typhoid vaccine (unspecified) PO to take home (batch #3000243). Additional concomitant medication included loratadine (Claritin) for hayfever and mometasone furoate (Nasonex). On 22Apr04 the pt developed heart palpitations. On 26Apr04 he developed a burning sensation traveling down his right leg. Unspecified medical attention was sought and no treatment was required. No product quality compliant was involved. Follow up information indicated that on 22Apr04 the pt felt hot flashes down his right leg from the knee down to the foot that was intermittent. He also had heart palpitations on that date. He was seen by his primary physician, who attributed the symptoms to cycling. It was noted to be mostly musculoskeletal in origin. The outcome was reported as recovered. No additional information is expected.
Sex: F
Vaccine: HEP
Symptoms: Similar reaction on previous exposure to drug, Unevaluable event
Clinical narrative: Information has been received from a RN concerning a white female with scoliosis who was vaccinated with a dose of hep b virus vaccine rHBsAg (yeast) (manufacturer unk). Subsequently, the pt developed a reaction. No further information is available. It was also reported that the pt was vaccinated with a dose of varicella vaccine live and a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (manf unk) and experienced adverse event. (WAES0402USA01468 and WAES0404USA02292, respectively).
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning an 17 year old white male student who on 20Aug1998, 28Sep98 and 19Feb1999 was vaccinated in the left deltoid with the first, second and third doses, respectively, of hep B virus vaccine rHBsAg (yeast) (lot 625398/0112H, 625718/0434H and 628746/1667H, respectively). There was no illness at the time of vaccination. The physician reported that on 05May04, while donating blood, the pt's screens were positive for hep B surface antigens and neg for hep B antibodies. At that time, the pt was informed the he was positive for hep B. Unspecified medical attention was sought, but no treatment required. At the time of this report, the outcome of the pt's hep b was unk but it was noted that the he was fine and was being monitored by a pediatrician. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 year old female pt without food or drug allergies, and a history of allergic rhinitis, eczema and environmental allergies, who on 02Jun97 was vaccinated with one dose of the series of hep B virus vaccine rHBsAg (yeast) (manf unk) (lot not available). Concomitant therapy administered on the same day included a dose of tuberculin purified protein derivative. There was no other concomitant medications. On 02Jun97 the pt developed a whole body rash. The licensed practical nurse reported that a dermatologist report followed the pt had an allergic response to hep vaccine. The pt was treated with (APARAX) 20mg QID and the symptoms resolved. There was no product quality complaint reported. The licensed practical nurse questioned whether the pt would have an adverse reaction to hep A virus vaccine inactivated since the pt had an adverse reaction (rash) after vaccination with hep B virus vaccine rHBsAg (yeast). No further information is available.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Aspartate aminotransferase increased, Pain
Clinical narrative: Information has been received from manf and assigned manf report number A050841A. It was reported that a 13 year old female whose past medical history included being fine prior to immunization on an unspecified date was vaccinated with a first dose of hep b virus vaccine rHBsAg (yeast) (Engerix B) (lot EG5353B2). There was no concomitant medication. Subsequently, the pt developed an increased aspartate aminotransferase level and chronic pain were unresolved. This report was originally reported by a consumer who is a relative of the pt. A physician or other health care professional has not verified this report. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Myalgia, Neck pain, Rash, Urticaria
Clinical narrative: Information has been received from a RN concerning a 24 year old female who on 23Apr04 was vaccinated with a first dose of hep B virus vaccine rHBsAg (yeast) (lot 645602/0751N) as part of a school requirement. There were no concomitant vaccinations on the same day. The nurse reported that the pt developed urticaria all over the body, myalgias, and neck pain and had to be seen in the ER on 26Apr04. She was started on oral prednisone. It was noted that the rash resolved in a couple days. Per the pt's last office visit on 21May04, she still had some joint and neck discomfort. The pt was due for a follow up visit on May04. It was indicated that the event abated and that the pt was recovering with sequelae. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Influenza
Clinical narrative: Information has been received from an adult female registered nurse who in 1997 was vaccinated with a dose of hep B virus vaccine rHBsAg (yeast) (lot number not available). She indicated that two weeks after vaccination, the pt developed the flu. She treated with antibiotics. No other information was available. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a health professional concerning a 50 year old male who on 07Apr04 was vaccinated in the right deltoid with a first dose of hep b virus vaccine rHBsAg (yeast) (lot 646601/1352N). It was noted that the pt had a pertinent medical history. Subsequently, the pt experienced a local reaction at the right deltoid including swelling at the site and redness at the site. It was reported that the pt did not return for his second dose until 09Jun04. Unspecified medical attention was sought. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Pyrexia
Clinical narrative: Information has been received from a RN concerning a 56 year old healthy female who was vaccinated with a first and second dose of hep b virus vaccine rHBsAg (yeast). Subsequently, several days after vaccination with the first dose the pt developed fever and headache. The pt experienced fever and headache 5 days after the second dose. Unspecified medical attention was sought. No product quality complaint involved. No additional information is expected.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Cough, Dyspnoea, Myalgia, Nasal congestion
Clinical narrative: Information has been received from a RN concerning a 23 year old black LPN male pt with asthma who on 01Jun04 was vaccinated IM in the deltoid with a second dose of hep B virus vaccine rHBsAg (yeast) (lot 646157/0529). There was no illness at the time of vaccination. One to two days post vaccination, the pt developed a dry cough, low grade fever and congestion. Unspecified medical attention was sought and no treatment was required. At the time of report it was noted that the symptoms have remained. No product quality complaint was involved. There were nor relevant diagnostic tests or lab data. There were no adverse events following prior vaccinations. Follow up information received from a RN indicated that on 03Jun04, the pt developed a cough, head and chest congestion, fever, shortness of breath, and posterior thoracic pain in his muscles and joints. The outcome was reported as recovered on 14Jun04. No additional information is expected.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Information has been received from a RN concerning a 23 year old black LPN male pt with asthma who on 01Jun04 was vaccinated IM in the deltoid with a second dose of hep B virus vaccine rHBsAg (yeast) (lot 646157/0529). There was no illness at the time of vaccination. One to two days post vaccination, the pt developed a dry cough, low grade fever and congestion. Unspecified medical attention was sought and no treatment was required. At the time of report it was noted that the symptoms have remained. No product quality complaint was involved. There were nor relevant diagnostic tests or lab data. There were no adverse events following prior vaccinations. Follow up information received from a RN indicated that on 03Jun04, the pt developed a cough, head and chest congestion, fever, shortness of breath, and posterior thoracic pain in his muscles and joints. The outcome was reported as recovered on 14Jun04. No additional information is expected.
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a RN concerning a female pt who was vaccinated with a dose of hep b virus vaccine rHBsAg (yeast) (manf unk). Subsequently, the pt had a reaction to the vaccine. Additional information has been requested. The RN reported that the pt's mother had an adverse experience after therapy with hep B virus vaccine rHBsAg (yeast) (WAES0406USA01256).
Age: 68.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Pruritus, Sleep disorder
Clinical narrative: Information has been received from a RN concerning a 67 year old white female with no allergies or medical history who on 18May04 at 14:30PM was vaccinated IM in the left deltoid with a first dose of hep b virus vaccine rHBsAg (yeast) (lot 647547/0031P). Concomitant vaccination on the same day at 14:30PM included an IM first dose in the right deltoid of hep A vaccine (inactive) (lot 647701/1165N). There was no illness at the time of vaccination. Two weeks after vaccination, on approx 01Jun04, the pt experienced systemic itching of her skin, interrupting her sleep. There was no rash. The nurse reported that the symptoms had resolved. Unspecified medical attention was sought and no treatment required. A product quality complaint was not involved. Follow up was received from the RN who indicated that the pt came into the office on 18Jun04 to received her second dose of hep B virus vaccine rHBsAg (yeast) (manf unk). After questioning the pt, she stated that two weeks after her first doses of hep B virus vaccine rHBsAg (yeast) and hep A vaccine (inactive), on 27May04 at 20:30PM, she began to itch all over. No rash appeared but the itching kept her awake and she did not take any medication. The itching lasted two days only and she was okay. Subsequently, the pt recovered. No further information is expected.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a registered nurse concerning a 28 year old female employee with no allergies who on 06/15/2004 was vaccinated with a dose of hepatitis B virus vaccine rHBsAg(yeast)(lot#643399/0367P). There was not concomitant medication. On 06/21/2004, the patient developed a red, raised rash on both forearms and thighs. There was no itching or pain. On 06/28/2004, the patient was seen by the nurse. The rash was fading with brown spots slightly raised. Calamine (+) diphenhydramine hydrochloride lotion (Caladryl) was used on these areas by patient. The patient told the nurse she ate a lot of strawberries recently. A product quality complaint was not involved. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Decreased appetite, Nausea
Clinical narrative: Information has been received from aphysician concerning a 50+ year old female patient who on 06/30/2004 was vaccinated with a dose of hepatitis B virus vaccine rHBsAg(yeast)(lot# not available). The physician reported that the patient developed nausea and lack of appetitie (approximately 06/30/2004) after receiving the hep b virus vaccine rHBsAg(yeast). No treatment was required. The physician also mentioned that nine other patients were vaccinated with the same lot and none of them had anyproblems. No other information was available at the time of this report. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.