chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 43 year old female mental health aide who on Oct 29, 2002 at 09:30 was vaccinated intradermally in the left forearm with a first dose of pneumococcal vaccine 23 polyvaleny (lot #644103/0710M). There was no concomitant medication and there was no illness as the time of vaccination. On Oct 30, 2002 at 08:00 the patient developed a 1.5in x  1in area of redness and soreness at the injection site. No treatment was required. On Nov 4, 2002 the patient recovered. the reporter indicated that there were no adverse events following prior vaccination. Additional information is not expected.
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a registered nurse concerning a female patient who at 09:30 on Oct 29, 2002 was vaccinated intradermally in the left forearm with a first dose of pneumococcal vaccine 23 polyvalent (lot # 644103/0710M). There was no illness at the time of vaccination. On Oct 30, 2002 at 08:00 the patient experience redness at the site (1 1/2 inches by 2 inches) and soreness. Subsequently, on Nov 08, 2002, the patient recovered. No treatment was required. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a female patient who at 09:30 on Oct 29, 2002 was vaccinated intradermally in the left forearm with a first dose of pneumococcal vaccine 23 polyvalent (lot # 644103/0710M). There was no illness at the time of vaccination. On Oct 30, 2002 at 08:00 the patient experience redness at the site (1 1/2 inches by 2 inches) and soreness. Subsequently, on Nov 08, 2002, the patient recovered. No treatment was required. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Info has been received from a woman in a medical office concerning an 81-year-old female pt with prior allergies to penicillin, nifedipine (Adalat), ace inhibitors, aspirin, sertraline hydrochloride (Zoloft), no symptoms with prior vaccinations and no illness at time of vaccination who on 02/13/2003 at 09:30 was vaccinated intramuscularly in the right deltoid with a 1st dose of pneumococcal vaccine 23 polyvalent (lot #643503/0541M). Concomitant therapy included irbesartan (AVAPRO), amlodipine besylate (NORVASC), rabeprazole sodium (ACIPHEX), naproxen (NOVADEX), furosemide and potassium (unspecified). On 02/13/2003 at 16:00 the pt developed a local reaction from the deltoid down to the elbow which is swollen, hot to the touch, "almost like cellulitis." Follow-up info revealed that the right deltoid was swollen and "tender to the touch". It was noted that the pt stated it took 3 to 3 1/2 weeks for the swelling to go down and she still had the tenderness. The pt presented to the physician on 03/20/2003, the physician's documentation revealed that there was no rash, "no swelling or palpable abnormality where vaccine was injected" and there was normal muscle bulk and tone. The pt was advised to use cold compresses and take acetaminophen (Tylenol) for pain. It was noted that the pt had not recovered from the tenderness, however it was also noted by the physician that this was a resolving "vaccine reaction" and he did not think the "itchy" sensation was related since it was in the biceps. Additional follow-up info revealed that the pt still had some residual tenderness and was "not scheduled to be seen again". Follow-up info revealed that as of 04/09/2003, the pt remained tender at the injection site, but had not had treatment. No further info is expected.
Age: 81.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site oedema, Injection site warmth, Pain
Clinical narrative: Info has been received from a woman in a medical office concerning an 81-year-old female pt with prior allergies to penicillin, nifedipine (Adalat), ace inhibitors, aspirin, sertraline hydrochloride (Zoloft), no symptoms with prior vaccinations and no illness at time of vaccination who on 02/13/2003 at 09:30 was vaccinated intramuscularly in the right deltoid with a 1st dose of pneumococcal vaccine 23 polyvalent (lot #643503/0541M). Concomitant therapy included irbesartan (AVAPRO), amlodipine besylate (NORVASC), rabeprazole sodium (ACIPHEX), naproxen (NOVADEX), furosemide and potassium (unspecified). On 02/13/2003 at 16:00 the pt developed a local reaction from the deltoid down to the elbow which is swollen, hot to the touch, "almost like cellulitis." Follow-up info revealed that the right deltoid was swollen and "tender to the touch". It was noted that the pt stated it took 3 to 3 1/2 weeks for the swelling to go down and she still had the tenderness. The pt presented to the physician on 03/20/2003, the physician's documentation revealed that there was no rash, "no swelling or palpable abnormality where vaccine was injected" and there was normal muscle bulk and tone. The pt was advised to use cold compresses and take acetaminophen (Tylenol) for pain. It was noted that the pt had not recovered from the tenderness, however it was also noted by the physician that this was a resolving "vaccine reaction" and he did not think the "itchy" sensation was related since it was in the biceps. Additional follow-up info revealed that the pt still had some residual tenderness and was "not scheduled to be seen again". Follow-up info revealed that as of 04/09/2003, the pt remained tender at the injection site, but had not had treatment. No further info is expected.
Age: 36.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Erythema, Influenza like illness, Injection site erythema, Injection site oedema, Oedema
Clinical narrative: RECEIVED ANTHRAX SHOT #6 ON 22 FEB 03 WITHIN HOURS ENTIRE UPPER ARM WAS RED, OVERE NEXT TWO DAYS RENESS EXTENDED FROM SHUOLDER TO WRIST WTH SWELLING OF ENTIRE ARM AND HAND  RASH NEAR ELBOW. FLUE IKE SYMTOMS FOR 2 DAYS NO FEVER
Age: 36.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Rash, Rash erythematous
Clinical narrative: RECEIVED ANTHRAX SHOT #6 ON 22 FEB 03 WITHIN HOURS ENTIRE UPPER ARM WAS RED, OVERE NEXT TWO DAYS RENESS EXTENDED FROM SHUOLDER TO WRIST WTH SWELLING OF ENTIRE ARM AND HAND  RASH NEAR ELBOW. FLUE IKE SYMTOMS FOR 2 DAYS NO FEVER
Age: 36.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Erythema, Influenza like illness, Rash, Swelling
Clinical narrative: RECEIVED ANTHRAX SHOT #6 ON 22 FEB 03 WITHIN HOURS ENTIRE UPPER ARM WAS RED, OVERE NEXT TWO DAYS RENESS EXTENDED FROM SHUOLDER TO WRIST WTH SWELLING OF ENTIRE ARM AND HAND  RASH NEAR ELBOW. FLUE IKE SYMTOMS FOR 2 DAYS NO FEVER
Age: 43.0
Sex: F
Vaccine: HEPA, PPV, HEPA, PPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Pruritus
Clinical narrative: Info has been received from a health professional concerning a 43 year-old female pt with no known drug allergies, polycystic disease of the liver and kidneys, and is awaiting a kidney transplant, but is not on dialysis, who on 03/17/2003 at 11:15 AM was vaccinated by subcutaneous injection in the right arm with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #642008/1547L). Concomitant therapy administered on that same day 03/17/2003 at 11:15 included a 1st dose of hepatitis A vaccine (HAVRIX) (Lot #VHA720A4) administered by intramuscular injection in the left deltoid. Other concomitant therapy included atenolol, olmesartan medoxomil (BENICAR), hydrochlorothiazide (+) triamterene (MAXZIDE) and epoetin alfa (PROCRIT) (doses not reported). it was reported that on that day 03/17/2003, within one hour of vaccination (approx 12:15 PM) the pt noticed "itching" at injection site of arm and within 3 hours (approx 14:15 PM) she noticed a red ring and local swelling which was described as approx 4" in diameter. The reporter noted the pt's erythema and swelling continued throughout the day. It was reported the maximum swelling included erythema and "hot" feeling from the lower deltoid down to the elbow and around the diameter of the right arm. Improvement was noted within 20 hours but it was reported the pt had one week of swelling and pain. It was noted the pt did not have an illness at the time of vaccination, and the pt has not had any adverse events following prior vaccinations. The reporter indicated the pt recovered on 03/24/2003.
Age: 43.0
Sex: F
Vaccine: HEPA, PPV, HEPA, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pain, Pruritus
Clinical narrative: Info has been received from a health professional concerning a 43 year-old female pt with no known drug allergies, polycystic disease of the liver and kidneys, and is awaiting a kidney transplant, but is not on dialysis, who on 03/17/2003 at 11:15 AM was vaccinated by subcutaneous injection in the right arm with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #642008/1547L). Concomitant therapy administered on that same day 03/17/2003 at 11:15 included a 1st dose of hepatitis A vaccine (HAVRIX) (Lot #VHA720A4) administered by intramuscular injection in the left deltoid. Other concomitant therapy included atenolol, olmesartan medoxomil (BENICAR), hydrochlorothiazide (+) triamterene (MAXZIDE) and epoetin alfa (PROCRIT) (doses not reported). it was reported that on that day 03/17/2003, within one hour of vaccination (approx 12:15 PM) the pt noticed "itching" at injection site of arm and within 3 hours (approx 14:15 PM) she noticed a red ring and local swelling which was described as approx 4" in diameter. The reporter noted the pt's erythema and swelling continued throughout the day. It was reported the maximum swelling included erythema and "hot" feeling from the lower deltoid down to the elbow and around the diameter of the right arm. Improvement was noted within 20 hours but it was reported the pt had one week of swelling and pain. It was noted the pt did not have an illness at the time of vaccination, and the pt has not had any adverse events following prior vaccinations. The reporter indicated the pt recovered on 03/24/2003.
Age: 44.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Ear pain, Headache, Tinnitus
Clinical narrative: My ears started ringing a few days after my 2nd anthrax shot. I also have a dull ache in my ears and lower back of neck.
Age: 44.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Ear pain, Neck pain, Tinnitus
Clinical narrative: My ears started ringing a few days after my 2nd anthrax shot. I also have a dull ache in my ears and lower back of neck.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 69 year old male with no medical history and no allergies who on Feb 14, 2003 at 14:30 was vaccinated intramuscularly in the right deltoid with a second dose of pneumococcal vaccine 23 polyvalent (lot #643251/0445M). Concomitant vaccination given intramuscularly in the left deltoid included a dose of influenza virus vaccine (Fluzone) (lot #U0949AA). There were no other concomitant medications. There was no illness at the time of vaccination. There were no adverse events following priori vaccinations. On the morning of Feb 15, 2003 the patient's right upper arm became red, swollen, and painful to move. The redness and swelling extended from the shoulder to below the elbow. The symptoms began improving 4 days after the shot was given on Feb 18, 2003. It was noted that the patient recovered. Additional information is not expected.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Joint range of motion decreased, Oedema, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 69 year old male with no medical history and no allergies who on Feb 14, 2003 at 14:30 was vaccinated intramuscularly in the right deltoid with a second dose of pneumococcal vaccine 23 polyvalent (lot #643251/0445M). Concomitant vaccination given intramuscularly in the left deltoid included a dose of influenza virus vaccine (Fluzone) (lot #U0949AA). There were no other concomitant medications. There was no illness at the time of vaccination. There were no adverse events following priori vaccinations. On the morning of Feb 15, 2003 the patient's right upper arm became red, swollen, and painful to move. The redness and swelling extended from the shoulder to below the elbow. The symptoms began improving 4 days after the shot was given on Feb 18, 2003. It was noted that the patient recovered. Additional information is not expected.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Hypokinesia, Injection site erythema, Injection site oedema, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 69 year old male with no medical history and no allergies who on Feb 14, 2003 at 14:30 was vaccinated intramuscularly in the right deltoid with a second dose of pneumococcal vaccine 23 polyvalent (lot #643251/0445M). Concomitant vaccination given intramuscularly in the left deltoid included a dose of influenza virus vaccine (Fluzone) (lot #U0949AA). There were no other concomitant medications. There was no illness at the time of vaccination. There were no adverse events following priori vaccinations. On the morning of Feb 15, 2003 the patient's right upper arm became red, swollen, and painful to move. The redness and swelling extended from the shoulder to below the elbow. The symptoms began improving 4 days after the shot was given on Feb 18, 2003. It was noted that the patient recovered. Additional information is not expected.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Info has been received from a registered nurse concerning a 69 year old male pt with no known allergies, no relevant medical history and no illness at time of vaccination who had first dose of pneumococcal vaccine 23 polyvalent in 1997 and on 02/14/2002 received a 2nd dose of pneumococcal vaccine 23 polyvalent (643251/0445M) intramuscularly in the right deltoid. Concomitant therapy that day at 2:30 PM included a dose of influenza virus vaccine (Fluzone) (lot #U0949AA) intramuscularly in the left deltoid. On 02/15/2003 the pt developed a red arm, swollen from upper shoulder to and including the elbow. The pt's arm was very painful and difficult to move. On 02/17/2003 (day 4) when the pt contacted the office, the reaction was beginning to subside. It was noted that ibuprofen (Advil) was suggested, but probably not taken. The reporter had a concern about the lot and was hesitant to use the remainder of the vials. The reporter requested that lot be "looked at". Follow up info revealed that the pt had no symptoms following prior vaccination and on 02/15/2003 in the AM, "the morning after shots were given", the pt's right upper arm was red, swollen and painful to move. The redness and swelling extended from shoulder to below elbow. No diagnostic tests were reported. It was noted that symptoms began improving "4 days after shots were given" and subsequently the pt 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 info has been requested.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Joint range of motion decreased, Oedema, Pain
Clinical narrative: Info has been received from a registered nurse concerning a 69 year old male pt with no known allergies, no relevant medical history and no illness at time of vaccination who had first dose of pneumococcal vaccine 23 polyvalent in 1997 and on 02/14/2002 received a 2nd dose of pneumococcal vaccine 23 polyvalent (643251/0445M) intramuscularly in the right deltoid. Concomitant therapy that day at 2:30 PM included a dose of influenza virus vaccine (Fluzone) (lot #U0949AA) intramuscularly in the left deltoid. On 02/15/2003 the pt developed a red arm, swollen from upper shoulder to and including the elbow. The pt's arm was very painful and difficult to move. On 02/17/2003 (day 4) when the pt contacted the office, the reaction was beginning to subside. It was noted that ibuprofen (Advil) was suggested, but probably not taken. The reporter had a concern about the lot and was hesitant to use the remainder of the vials. The reporter requested that lot be "looked at". Follow up info revealed that the pt had no symptoms following prior vaccination and on 02/15/2003 in the AM, "the morning after shots were given", the pt's right upper arm was red, swollen and painful to move. The redness and swelling extended from shoulder to below elbow. No diagnostic tests were reported. It was noted that symptoms began improving "4 days after shots were given" and subsequently the pt 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 info has been requested.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Hypokinesia, Injection site erythema, Injection site oedema, Pain
Clinical narrative: Info has been received from a registered nurse concerning a 69 year old male pt with no known allergies, no relevant medical history and no illness at time of vaccination who had first dose of pneumococcal vaccine 23 polyvalent in 1997 and on 02/14/2002 received a 2nd dose of pneumococcal vaccine 23 polyvalent (643251/0445M) intramuscularly in the right deltoid. Concomitant therapy that day at 2:30 PM included a dose of influenza virus vaccine (Fluzone) (lot #U0949AA) intramuscularly in the left deltoid. On 02/15/2003 the pt developed a red arm, swollen from upper shoulder to and including the elbow. The pt's arm was very painful and difficult to move. On 02/17/2003 (day 4) when the pt contacted the office, the reaction was beginning to subside. It was noted that ibuprofen (Advil) was suggested, but probably not taken. The reporter had a concern about the lot and was hesitant to use the remainder of the vials. The reporter requested that lot be "looked at". Follow up info revealed that the pt had no symptoms following prior vaccination and on 02/15/2003 in the AM, "the morning after shots were given", the pt's right upper arm was red, swollen and painful to move. The redness and swelling extended from shoulder to below elbow. No diagnostic tests were reported. It was noted that symptoms began improving "4 days after shots were given" and subsequently the pt 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 info has been requested.
Sex: M
Vaccine: PPV, PPV
Symptoms: Cough, Headache, Nausea
Clinical narrative: Info has been received from a pt concerning her husband with no known drug allergies and no past medical history who on 10/04/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (manufacturer unknown). Caller was unsure if it was the pneumococcal vaccine 23 polyvalent. On that same evening, the pt developed a cough, fever, sore throat, cold sweats and chills. Subsequently the pt went to the ER and since that time, as felt sick. The pt sought unspecified medical attention. Additional info has been requested. The wife also reported on her experience (WAES #0210USA02582).
Sex: M
Vaccine: PPV, PPV
Symptoms: Chills, Cough, Hyperhidrosis, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Info has been received from a pt concerning her husband with no known drug allergies and no past medical history who on 10/04/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (manufacturer unknown). Caller was unsure if it was the pneumococcal vaccine 23 polyvalent. On that same evening, the pt developed a cough, fever, sore throat, cold sweats and chills. Subsequently the pt went to the ER and since that time, as felt sick. The pt sought unspecified medical attention. Additional info has been requested. The wife also reported on her experience (WAES #0210USA02582).
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Chills, Cough, Headache, Injection site erythema, Injection site oedema
Clinical narrative: Info has been received from a female with no known drug allergies and no past medical history who on 10/04/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (manufacturer unknown). The pt was unsure if it was the pneumococcal vaccine 23 polyvalent. Subsequently, the pt developed a cough, fever, sore throat, cold sweats, chills and her arm that she got the shot in became swollen and painful. Subsequently, the pt went to the ER and since that time has reported to continue to feel sick. The pt sought unspecified medical attention. Additional info has been requested. The wife also reported info on her husband's experience (WAES #0210UA02854).
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site pain, Muscle spasms, Nausea, Pharyngolaryngeal pain
Clinical narrative: Info has been received from a female with no known drug allergies and no past medical history who on 10/04/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (manufacturer unknown). The pt was unsure if it was the pneumococcal vaccine 23 polyvalent. Subsequently, the pt developed a cough, fever, sore throat, cold sweats, chills and her arm that she got the shot in became swollen and painful. Subsequently, the pt went to the ER and since that time has reported to continue to feel sick. The pt sought unspecified medical attention. Additional info has been requested. The wife also reported info on her husband's experience (WAES #0210UA02854).
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Chills, Cough, Hyperhidrosis, Injection site oedema, Pain
Clinical narrative: Info has been received from a female with no known drug allergies and no past medical history who on 10/04/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (manufacturer unknown). The pt was unsure if it was the pneumococcal vaccine 23 polyvalent. Subsequently, the pt developed a cough, fever, sore throat, cold sweats, chills and her arm that she got the shot in became swollen and painful. Subsequently, the pt went to the ER and since that time has reported to continue to feel sick. The pt sought unspecified medical attention. Additional info has been requested. The wife also reported info on her husband's experience (WAES #0210UA02854).
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Info has been received from a female with no known drug allergies and no past medical history who on 10/04/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (manufacturer unknown). The pt was unsure if it was the pneumococcal vaccine 23 polyvalent. Subsequently, the pt developed a cough, fever, sore throat, cold sweats, chills and her arm that she got the shot in became swollen and painful. Subsequently, the pt went to the ER and since that time has reported to continue to feel sick. The pt sought unspecified medical attention. Additional info has been requested. The wife also reported info on her husband's experience (WAES #0210UA02854).
Age: 0.22
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea
Clinical narrative: Pt found not breathing by mother while asleep the night after the shots were administered. Transported by ambulance to closest ER and was pronounced D.O.A. Initial diagnosis of SIDS with autopsy pending.  Autopsy Report received on 12/01/2003 ruled out SIDS and states COD is undetermined.
Age: 54.0
Sex: M
Vaccine: LYME
Symptoms: Deafness, Immune system disorder
Clinical narrative: This case was reported by a physician and described the occurrence of autoimmune sensorineural hearing loss in a 54 year old male pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. In March 2002 the pt received the 2nd dose of LYMErix. Approximately 3 weeks post-immunization, the pt experienced sudden hearing loss. The pt was evaluated at a tertiary care center. The physicians at the tertiary care center could not find "any other good explanation" for the haring loss, "except a possible autoimmune response" to LYMErix, and a diagnosis of autoimmune sensorineural hearing loss was made. The autoimmune sensorineural hearing loss was treated with prednisone. The event persisted as of 7/24/03. Sensorineural hearing loss is considered by manufacturer to be medically serious (OMIC). The follow up received on 8/14/03 states the sensorineural hearing loss had improved. The physician considered the event to be medically serious. He indicated that the event was possibly related to LYMErix administration, or to a "possible viral syndrome at about the time of hearing loss." The LYMErix immunization series was discontinued.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Muscle disorder, Myasthenic syndrome
Clinical narrative: Information has been received from a grandmother concerning her now 5 year old grandson with an antibiotic allergy, who in approximately 1999 at the age of 18 months was vaccinated SC with a dose of MMR II. A few months after receiving the vaccine the pt developed myasthenia gravis. It was reported that "now" the pt had a feeding problem and facial muscular problems. The pt had not yet recovered from his experiences. It was noted that the pt had been taking "some medication" for treatment but recently stopped taking all medication. Upon internal review myasthenia gravis was considered to be an important medical event (OMIC). Additional info has been requested. THe follow up received on 8/5/03 from the physician indicated that she did not have the pt's chart and therefore did not have any dates available. The physician confirmed that the pt did receive a dose of MMR II. It wsa reported that the pt was diagnosed with myasthenia gravis and subsequently had a thymectomy. The pt was treated with monthly IVGG injections, prednisone, and Imuran. He was weaned off of the prednisone over the past month. The physician noted that she did not think that the myasthenia gravis was related to MMR II. The physician stated that she would provide additional info. Upon internal review myasthenia gravis was considered to be an important medical event (OMIC). Additional info is expected.  In follow up info the physician indicated that the pt began with a swallowing dysfunction in November of 1999, developed ptosis in December of 1999 and was diagnosed with myasthenia gravis in January 2000. The physician reported that the pt required a prolonged hospialization (several days). It was also reported that the pt's experiences resulted in a persistent or significant disability/ incapacity. It was noted that the pt had not recovered. Additional info is expected.
Age: 51.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Abdominal pain, Constipation, Groin pain, Guillain-Barre syndrome, Ileus
Clinical narrative: He had fever and weakness about three hours after vaccinated on 10/16/00 and never received treatment until 3/24/01 and was not drained in the spine. Abdominal pain, along with constipation. At this time, he has an ileus, and his other complaint is left groin pain, which has be undiagnosed. He kept going into shock up until December. I think his sed rate was still high even though it was in the normal range because his heart was infected, and they didn't send him home with no antibiotics. GBS caused from the vaccines.
Age: 51.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Infection, Red blood cell sedimentation rate increased, Shock
Clinical narrative: He had fever and weakness about three hours after vaccinated on 10/16/00 and never received treatment until 3/24/01 and was not drained in the spine. Abdominal pain, along with constipation. At this time, he has an ileus, and his other complaint is left groin pain, which has be undiagnosed. He kept going into shock up until December. I think his sed rate was still high even though it was in the normal range because his heart was infected, and they didn't send him home with no antibiotics. GBS caused from the vaccines.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Area with redness, edema and increased warmth. Denied pain in left thigh.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis
Clinical narrative: Has large cellulitis on left deltoid. Unknown sign and symptoms - sent to child's PCP.
Age: 39.0
Sex: M
Vaccine: HEPAB, TD
Symptoms: Rash erythematous, Skin irritation
Clinical narrative: Noted that night on irritation on chest-tender-not itchy and noted slight pinkness. In AM noted red round rash-and 3 other nickel size, slightly raised tender areas. Treated with Claritin and took Benadryl MS for 2 nights. Gradually symptoms subsided.
Sex: M
Vaccine: HIBV, PNC
Symptoms: Feeling hot, Injection site erythema, Pain
Clinical narrative: 7 cm x 7 cm erythema, warm, sore. Rx-None
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Infection transmission via personal contact, Skin ulcer
Clinical narrative: Pt was in training at Coast Guard 4/16-7/25/03. Exposed to vaccinia while wrestling with another trainee recently vaccinated for smallpox. Seen in ER on 7/26 with lesions on beard, chin and neck. Rx with antibiotics and no improvement. Specimens to ODH-presumptive vaccinia. Lesions scabbed, no increased temperature, as of 7/30.
Age: 23.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Angioneurotic oedema, Urticaria
Clinical narrative: Chronic urticaria and angioedema starting one month after 4th anthrax immunization and 1st smallpox.
Age: 55.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site reaction
Clinical narrative: Smallpox vaccine scab lasted longer than 8 weeks (8 weeks and 3 days). Vaccine date: 5/29/03, scab fell of on 07/27/03.
Age: 72.0
Sex: M
Vaccine: TYP
Symptoms: Asthenia, Dry mouth, Pyrexia
Clinical narrative: On approximately 6/11/2003, pt had fever of up to 102.5 degrees afternoons for 1 week, then felt "weak" for 1 week, with a dry mouth. He has since recovered.
Age: 28.0
Sex: M
Vaccine: MMR, TD
Symptoms: Erythema, Oedema, Pruritus, Rash
Clinical narrative: Pt was given 2 vaccinations Td and MMR on 7/22/03. On 7/23/03 pt complained of right antecubital rash, red and itching. On 7/24/03 rash with swelling noted. Pt took Benadryl pills on 7/25/03 and symptoms decreased.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Syncope
Clinical narrative: Pt had received Hep B #2 and Hep A #2. Pt fainted about 5 minutes later. Non-responsive. O2 administered. Immediately some response. But deep breathing continued. 911 called. Paramedics were unable to get pt to reply to P.O. stimuli. Pt was taken to mobile unit. About 15 minutes later, pt out of unit walking and responsive. Discharged to mom per car.
Age: 0.3
Sex: M
Vaccine: DTAP
Symptoms: Coma
Clinical narrative: After administering DTaP, pt became unresponsive. Several taps to infant's back. Pt started to respond. Mom was advised to take baby to ER for evaluation.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site oedema, Urticaria
Clinical narrative: Red, swelling, hives at site of injection approx 2-3 minutes after injection.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Eye oedema
Clinical narrative: Approx 1 hour after immunizations, pt's eyes were swollen (right eye extremely swollen), heart rate normal, B/P normal, O2 normal. Pt was playing as if he was fine, except for swelling.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Right deltoid became swollen, red and hot to touch. Treated with Benadryl and improvement already seen.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Area of redness around vaccine site-upper right arm-itchy.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Rash papular
Clinical narrative: Pt developed vesicular papular rash 7/16/03. Seen in office 7/17/03.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Rash papular
Clinical narrative: 7-8 slightly elevated papular rashes on chest, abdomen, armpits, groin. No other symptoms.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Contusion, Injection site erythema, Injection site swelling
Clinical narrative: Left deltoid redness and swelling noted with bruising which started in PM after injections. Referred to MD for evaluation.
Age: 2.2
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Swelling and redness at site of injection 9" long x 7" (around arm).
Age: 50.0
Sex: F
Vaccine: LYME
Symptoms: Musculoskeletal stiffness, Oedema, Pain, Paraesthesia
Clinical narrative: Swollen wrist first with pain then right followed by constant pain in both thumbs and hands falling asleep, tingling, on going body stiffness
Age: 50.0
Sex: F
Vaccine: LYME
Symptoms: Musculoskeletal stiffness, Oedema, Pain, Paraesthesia
Clinical narrative: Swollen wrist first left with pain then right followed by constant pain in both thumbs hands falling asleep, tingling, on going body stiffness.
Age: 50.0
Sex: F
Vaccine: LYME
Symptoms: Musculoskeletal stiffness, Oedema, Pain, Paraesthesia
Clinical narrative: Swollen wrist first left with pain then right followed by constant pain in both thumbs hands falling asleep, tingling, on going body stiffness
Age: 5.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Erythema, Oedema
Clinical narrative: Pt presented to clinic on 07/18/2003 with edema and redness to left thigh. Dad reported he had been putting warm packs (the kind you microwave) to leg. instructed dad to put ice packs on left thigh and to give Tylenol and Motrin.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC, VARCEL
Symptoms: Convulsion
Clinical narrative: Pt's mother called on Tuesday 07/29 and said her daughter had a seizure about 1 hour after injections. She did not seek medical attention.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Oedema
Clinical narrative: Received injections 07/28/2003; 07/29/2003 right arm tender and sore, 07/30/2003 upper arm reddened, warm and swollen around injection site to elbow.
Age: 1.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR
Symptoms: Erythema, Oedema
Clinical narrative: Local swelling with redness to left thigh
Age: 20.0
Sex: M
Vaccine: JEV, JEV
Symptoms: Headache, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Headache began 3 days post immunization. Progressed to stiff neck, fever 100.5, and severe headache. To ER: Spinal tap neg. CT also neg. Sx resolving 07/29/2003. Using Tylenol
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Pyrexia, Vomiting
Clinical narrative: Day of vaccines, fever of 99 degrees, vomited day after vaccine. 4 in red induration around one vaccine site.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Oedema, Pain
Clinical narrative: Top of right arm at shoulder swollen approximately 3 in. Hot to touch and painful.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Oedema
Clinical narrative: Left deltoid with redness, swelling, 3in long area
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Urticaria
Clinical narrative: Redness, soreness and hives- like rash to right deltoid at the site of the injection.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Feeling hot, Oedema, Pain, Rash maculo-papular
Clinical narrative: Swollen, red, hot,painful baseball size bump with red streaking
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Skin striae
Clinical narrative: Swollen, red, hot,painful baseball size bump with red streaking
Age: 1.6
Sex: M
Vaccine: DTAP, PNC
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: 7/24 10:30 PM started vomiting, lasted all night. Ate nothing, but tried milk and vomited that as well. Also had a temp of 102.5. Gave Tylenol at 9:30 AM 7/25. Took to ED 7/25 where received IV fluids for continued vomiting and diarrhea. 7/28 took to family physician who said "could possibly" be attributed to vaccinations.
Age: 1.7
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Injection site erythema, Injection site oedema, Urticaria
Clinical narrative: Within minutes of receiving vaccinations child developed approx 1/2 inch raised hive above MMR injection site. Area of redness enlarged to about 1.5-2 inches. Child undressed and monitored. No respiratory distress. TC to 911 made at 1:27 PM. 0.25 ml Benadryl IM given in LL at 1:36 PM. Ambulance team arrived 1:42 PM. No further changes at injection site noted. Child transported with mother via ambulance to hospital. 7/3/03 F/U TC to child's mother. Child evaluated at ER and he was given a "steroid liquid". Child discharged home. Mother instructed to give Benadryl every 6 hours for 3 days and continue to monitor respirations and for hives. Mother reports child is doing well.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Feeling hot, Gait disturbance, Injection site erythema, Injection site oedema
Clinical narrative: Mom stated she noticed on Wed. 6/11/03 around 12 Noon swelling, redness of her son's right thigh and also warm to touch. Mom also stated child was limping, and she had to carry him to the pediatrician. Child seen by 2 other pediatricians and one infectious disease doctor. Mom stated child walking now, and swelling and redness has decreased.
Age: 18.0
Sex: M
Vaccine: HEP, MMR, TD, VARCEL
Symptoms: Dysphagia, Fatigue, Headache, Malaise, Pharyngolaryngeal pain
Clinical narrative: Pt complained of sore throat and fatigue the afternoon of his immunizations. Told his mother several days later that he's also had trouble swallowing, headache, malaise also. Mother unsure of duration of symptoms. Pt doing well now. Suggested to Mom that pt see his former allergist and have subsequent immunizations in Dr controlled setting.
Age: 4.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Infection
Clinical narrative: Chickenpox lesions
Age: 1.5
Sex: F
Vaccine: DTPHIB, MMR, VARCEL
Symptoms: Rash papular
Clinical narrative: Multiple red papules, varying sizes over entire body.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Arthralgia, Oedema peripheral, Pruritus
Clinical narrative: 36 hours after vaccination had edematous hands and feet with apparent arthralgia, involving affected appendages. Treated with ibuprofen with relief. 24 hours later generalized itch relieved with benadryl.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: Parent called saying baby had welts on legs and back. Had given Tylenol after shots. Parent also called PMD who said watch him. Called pt's family at 1:00 PM and they said he was doing OK and welts were diminishing.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Eyelid oedema, Face oedema, Injection site erythema, Pruritus, Rash papular
Clinical narrative: 0930 itching all over, swelling of face and eyelids. Small pruritic erythema blanching papules diffusely, no SOB, alert. 1009 Orapred 15/5 tsp po given, Benadryl 1/2 tsp po given, and Epinephrine 1:1000 0.2ml SQ given. 1030 rash subsided and swelling to face decreased.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Cough, Erythema, Fatigue, Irritability, Rash
Clinical narrative: On 5/6/03 reported by mother that child on 5/3/03 a red rash on abdomen, neck, face and back-had no fever. Child had a cough, was tired and fussy. Tylenol had been given since being vaccinated.
Age: 5.0
Sex: M
Vaccine: DT, IPV
Symptoms: Injection site mass, Oedema, Pyrexia
Clinical narrative: Low grade fever, swelling, knot
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: Right arm became swollen, slightly itchy and red on 7/23 according to mother. Seen in office today. Right arm from below shoulder to 1-2" above elbow red, swollen, warm with clear area elbow to shoulder anterior area upper arm.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Oedema
Clinical narrative: MMR vaccine given by employee health. Two weeks later employee had swelling in hands, finger, knee, ankles. Taking Advil.
Age: 48.0
Sex: F
Vaccine: ANTH
Symptoms: Dizziness
Clinical narrative: Dizzy
Age: 3.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Pt with onset of baseball size redness, warm to touch, tender. Benadryl, Tylenol/Motrin, cool compresses ordered.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site inflammation, Injection site oedema, Injection site vesicles
Clinical narrative: Noted 24 hours later swollen thigh mid-thigh to knee spanning joint. Spoke to Dr on call, then came in to see provider Monday afternoon. Site swollen, inflamed, no pain to palpitation, small amount exudate serous vesicles about 3" diameter on mid-thigh. Given Benadryl 1 1/4 tg.
Age: 2.7
Sex: F
Vaccine: HEPA
Symptoms: Dehydration, Diarrhoea, Haematochezia, Vomiting
Clinical narrative: Diarrhea, vomiting, blood in stool, dehydration.
Age: 36.0
Sex: F
Vaccine: IPV
Symptoms: Dysphagia, Dyspnoea, Rash
Clinical narrative: Pt developed a rash 5 minutes after shot given. Pt given 50 mg Benadryl IM. 35 minutes after shot pt became short of breath and it became hard for her to swallow. 911 called. Pt taken to the hospital.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site abscess
Clinical narrative: Abscess left thigh-spontaneously drained at home. Rx: Cephalexin 250/5 1 tsp po tid for 7 days.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Eye irritation, Pruritus, Urticaria
Clinical narrative: Within 30 minutes of administering vaccines, pt broke out in hives. Eyes became very itchy-face, legs, arms. Contacted allergist for advice. Hives starting to subside with Benadryl.
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Injection site erythema, Injection site oedema, Injection site warmth, Pain
Clinical narrative: Large, red, hot whelp at vaccine site on left arm, about the size of my palm. Tired, achy feeling for about 2 days. Low temperature 99+.
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: Large, red, hot whelp at vaccine site on left arm, about the size of my palm. Tired, achy feeling for about 2 days. Low temperature 99+.
Age: 24.0
Sex: M
Vaccine: MMR
Symptoms: Dyspnoea, Pharyngolaryngeal pain, Rash
Clinical narrative: 7/21/03: went to ER with difficulty breathing (pt has history of asthma) and skin eruptions began on 7/17/03. Rash began left forehead and midchest. Also complained of sore throat on 7/22/03. 7/25/03 followed up by MD. Given inhaler at hospital.
Age: 1.08
Sex: F
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Eye swelling, Face oedema, Grunting, Injection site swelling, Urticaria
Clinical narrative: 20 minutes after immunizations, mom heard grunting/wheezing sounds, observed eyes swollen shut, swollen lips and face. Drove immediately to ER. Back/arms covered with hives. Notice red mark, size of large pea, on upper portion of arm-not sure which arm. At ER Benadryl was given. She was monitored for 4.5 hours.
Age: 1.08
Sex: F
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Wheezing
Clinical narrative: 20 minutes after immunizations, mom heard grunting/wheezing sounds, observed eyes swollen shut, swollen lips and face. Drove immediately to ER. Back/arms covered with hives. Notice red mark, size of large pea, on upper portion of arm-not sure which arm. At ER Benadryl was given. She was monitored for 4.5 hours.
Age: 19.0
Sex: M
Vaccine: TD
Symptoms: Injection site mass, Tenderness
Clinical narrative: Woke up morning after receiving vaccine with 1/2" diameter "knot" at vaccination site. Tender to touch, no redness, no fever. By 7/28/03 at 5PM "knot" no longer noticeable, no tenderness at site. No medication taken during interval.
Age: 1.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC, VARCEL
Symptoms: Erythema, Irritability, Otitis media, Pyrexia, Rash
Clinical narrative: Rash began on back Tues. 7/22/03 and on Sat. 7/26/03 by 4PM spread to face, then to limbs, trunk. Fever, not measured Thurs night, also fussy. Treated for acute Otitis Media Friday with amoxicillin. Sunday, 7/27/03 at 5AM seen in ER. Dr did not think rash was due to amoxicillin. Rash apparent today-raised, red, merged on face, limbs, torso. Appears to be alert and no distress.
Age: 0.9
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Pyrexia, Screaming
Clinical narrative: Vaccines were given AM 6/18/03-per grandmother by 6PM 6/18/03 fever up to 104.0. >3 hours inconsolable crying/not drinking. Had OV 6/19, no other symptoms illness.
Age: 60.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Info has been received from a licensed practical nurse concerning a pt between the age of 60 and 65 years who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #640981/1050L). Subsequently the pt developed "severe local reactions at the injection site." Follow up info received stated that the pt's entire upper arm became red and swollen. Unspecified medical attention was sought. The pt was treated with ice/diphenhydramine hydrochloride (BENADRYL). The reporter noted that the pt recovered. The reporter also mentioned 3 other patients between the ages of 60 and 65 years that had similar experiences following vaccination with a dose of pneumococcal vaccine 23 polyvalent (Lot #640981/1050L) (WAES #0306USA02582, 0306USA02583 and 0306USA02584). Additional info is not expected.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Musculoskeletal discomfort, Myalgia
Clinical narrative: Information has been received from a woman in a doctor's office concerning a 32 year old male who on 05/14/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #641115/1159L). On 05/16/2002 the pt developed an inflamed right deltoid muscle, local redness, local soreness, local swelling and cellulitis. The pt was placed on PO, cephalexin (KEFLEX), 500 mg, and diphenhydramine hydrochloride (BENADRYL) for inflammation. Subsequently, the pt recovered. The reporter expressed a concern regarding the lot number. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. It was also noted that similar experiences occurred with other patients from the same source (WAES #0206USA00883 and 0206USA00884). No additional info has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: Info has been received from a woman in a doctor's office concerning a 74 year old female who on 05/14/2002 (also reported as 05/23/2002) was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #641115/1159L). "The next day", on 05/15/2002, or 05/24/2002, the pt developed local redness, local soreness and local swelling. Subsequently the pt recovered. Unspecified medical attention was sought. The reporter expressed a concern regarding the lot number. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evalation and Research and was released. It was also noted that similar experiences occurred with other patients from the same source (WAES #'s 0206USA00271 and 0206USA00884). Additional info has been requested.