chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cough, Dyspnoea, Injection site pain, Lethargy, Myalgia
Clinical narrative: I was given the PPV and the Flu shot on 12-1-2003 at 1:00pm. Within 18 hours after receiving the PPV, I noticed general muscle aches (12-2-2003). Within 36 hours(12-3-2003) I developed a fever that ranged from 99.1 to 100.0 which lasted for approximately 20 hours. Accompanying this I had severe muscle aches particularly on the side that I received the shot (right), lethargy and extreme sensitivity and pain at the point of where the shot was given.  Cold packs were used with little effect. Mild difficulty with breathing and coughing was also noted.  I took 2 alleve in the morning and 2 tylenol in the evening. I was unable to touch and move my right arm until this morning (12-4-2003).    Today I feel much better with just mild muscle aches and tenderness at the area of the shot. I do not believe this reaction was due to the flu shot because I have never reacted to the past four flu shots I received and because of the severe right sided arm pain I had.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: I was given the PPV and the Flu shot on 12-1-2003 at 1:00pm. Within 18 hours after receiving the PPV, I noticed general muscle aches (12-2-2003). Within 36 hours(12-3-2003) I developed a fever that ranged from 99.1 to 100.0 which lasted for approximately 20 hours. Accompanying this I had severe muscle aches particularly on the side that I received the shot (right), lethargy and extreme sensitivity and pain at the point of where the shot was given.  Cold packs were used with little effect. Mild difficulty with breathing and coughing was also noted.  I took 2 alleve in the morning and 2 tylenol in the evening. I was unable to touch and move my right arm until this morning (12-4-2003).    Today I feel much better with just mild muscle aches and tenderness at the area of the shot. I do not believe this reaction was due to the flu shot because I have never reacted to the past four flu shots I received and because of the severe right sided arm pain I had.
Age: 49.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pruritus, Rash morbilliform
Clinical narrative: Shot administered at 9:00 AM In November around the 12th or 13th. At 3:00 AM next morning I broke in what looked like measles from my neck to the top of my legs. It continued to worsen until 2 days later I went to a dermatologist who gave me a shot of cortisone and some cream to help the itching. If took almost a week for it to completely go away. Since nothing else in my life had changed, other than the first flu shot I've ever had, I can only assume that it was the shot.
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site oedema, Injection site pain, Injection site reaction, Urine glucose false positive
Clinical narrative: It was reported that a 33 year old female received TD vaccine on 4/10/02. Pt reported a large local reaction of redness, swelling, and soreness on 4/13/02. Pt seen by a physician and diagnosed with cellulitis. Pt was given antibiotics to take at home and follow up in a week.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Cardiac arrest, Hypoaesthesia, Loss of consciousness, Myalgia, Throat tightness
Clinical narrative: From faxed correspondence received on 6/4/02, it was reported by a health care professional that a 36 year old female received Td vaccine (lot number U0375AA) to her left arm on 4/10/02. Patient reported that 16 hours after vaccination, she passed out and went into cardiac arrest. Additional information received from patient, she reported that she has a permanent pacemaker. She also reported that she's still experiencing numbness and aching in muscles, throat feeling closed sometimes, chest feels fluttery off and on. Additional information received on 7/19/02 through telephone contact with the reporter. She was able to verify that she did submit the report to VAERS> She is not in receipt of any additional information and to date there is no medical confirmation of this case.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Nausea, Pain, Pyrexia, Swelling
Clinical narrative: From faxed correspondence received on 7/17/02, it was reported that a 28 year old female received dose of TD ADS vaccine in the right deltoid on 7/1/02. Patient developed a local reaction of 2-inch circular area of erythema, swelling and pain. Patient also experienced fever of 101 degrees F, nausea, and vomiting. Patient recovered.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Vomiting
Clinical narrative: From faxed correspondence received on 7/17/02, it was reported that a 28 year old female received dose of TD ADS vaccine in the right deltoid on 7/1/02. Patient developed a local reaction of 2-inch circular area of erythema, swelling and pain. Patient also experienced fever of 101 degrees F, nausea, and vomiting. Patient recovered.
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Ear pain, Migraine, Pain
Clinical narrative: From faxed correspondence received on 8/12/02, it was reported that a 34 year old female received TD vaccine on 8/6/02. Patient experienced pain in her left arm that radiates down her left arm through pinky finger and across her shoulders and down right arm. Also complained of left ear pain with worsened migraine headaches. Patient scheduled to see a physician at 3 PM on 8/8/02 for evaluation.
Age: 13.0
Sex: M
Vaccine: TD
Symptoms: Chills, Injection site reaction, Pyrexia, Vomiting
Clinical narrative: It was reported that a 14 year old male pt received a Td ads adult vaccination on 7/29/02 at 9:40am in the left deltoid. The next day, 7/30/02 the pt experienced a temp of 100.2, chills, 6" local reaction, and emesis times two with a duration of two days. No further info was reported. It was reported that the pt recovered.
Age: 12.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site reaction, Irritability, Pyrexia, Somnolence
Clinical narrative: From telephone correspondence on 08/16/2002 and faxed correspondence received at AP on 10/07/2002, it was reported that a 12 year old female patient was vaccinated with TD ADS ADULT, Lot # U0529AA on 08/09/2002.  On 08/10/2002, the patient was seen at the physician's office with pain in her left hand, fussiness, drowsiness, and fever.  She was diagnosed with possible cellulitis of the left arm, placed on Amoxil and recovered.  See cases U2002-00643 and U2002-00916 with the same reporter.  The case is closed.
Age: 15.0
Sex: M
Vaccine: TD
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Pain
Clinical narrative: From telephone correspondence on 08/16/2002 and faxed correspondence received at AP on 10/07/2002, it was reported that a 15 year old adolescent male was vaccinated with TD ADS ADULT, Lot # U0529AA, on 08/13/2002.  He was seen at the office on 08/15/2002 with two days of generalized aching, with large amount of swelling, redness, and soreness of left arm.  He was diagnosed with cellulitis and put on Keflex.  Patient recovered.  See case # U2002-00643 and U2002-00915 with same reporter.  The case is closed.
Age: 12.0
Sex: M
Vaccine: HEP, TD
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received on 08/16/2002 concerning a 12 year old male patient who was vaccinated with a dose of TD ADS ADULT (Lot # U0814AA) IM in the left deltoid and a dose of Hepatitis B (Lot # 0357M, manufacturer Merck) IM in the right deltoid on 08/14/2002.  On 08/15/2002, patient developed an area of redness, swelling and tender to touch in the left deltoid, which was diagnosed as cellulitis.  Patient was treated with Augmentin 500mg twice a day for 5 days.  Outcome was not reported.  See cases U2002-00798 and U2002-00800, same reporter.
Age: 10.0
Sex: M
Vaccine: TD
Symptoms: Cellulitis, Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Information has been received on 08/16/2002 concerning a 10 year old male patient who was vaccinated with a dose of TD ADS ADULT (Lot # U0814AA) on 08/08/2002.  Vaccine was administered IM in the left arm.  On 08/09/2002, patient developed a red, swollen and warm to touch area in the left arm which was diagnosed as cellulitis secondary to injection.  Patient was treated with Augmentin ES 600/5 2 teaspoons twice a day for 7 days.  See cases U2002-00799 & U2002-00800, same reporter.
Age: 30.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pain, Sedation
Clinical narrative: From faxed correspondence received at AP on 10/04/2002, it was reported that a 30 year old female patient received TD ADS ADULT on 08/21/2002 for a puncture wound in the right distal upper arm.  On 08/22/2002, the patient called reporting a throbbing in her arm at the deltoid site, which was painful, red and swollen.  That evening she experienced tightness in her neck, headache, occular pressure, loss of appetite and a temperature of 101F.  On 08/23/2002, she was afebrile (97.8F), but still not feeling well and complained of generalized aches and feeling sedated.  The pain and redness still present in arm, which remained very sore when palpated.  The patient did not go to work on 08/22/2002 or 08/23/2002.  As of 08/27/2002, the adverse events were improved, but not resolved.
Age: 58.0
Sex: M
Vaccine: TD
Symptoms: Hypokinesia, Injection site erythema, Musculoskeletal stiffness
Clinical narrative: From faxed correspondence received at AP on 10/04/2002, it was reported that a 58 year old male received TD ADS ADULT (Lot # U0526AA) in the left deltoid on 08/12/2002 at approximately 09:30 AM.  The patient was vaccinated following a puncture wound in the right index finger with a retained metal foreign body.  The patient was started on Keflex 500mg one tablet orally four times a day.  He was referred to a hand specialist for foreign body removal, which was performed on 08/13/2002 with a nerve block (unspecified).  At a follow-up appointment on 08/20/2002, the patient complained of "side effect to TD which became very stiff, sore, unable to move arm through weekend."  Td injection site erythema was noted at that time.  The patient reportedly stayed home from work on 08/19/2002.  As of 08/23/2002, the adverse events were still resolving.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, MMR, DTAP, HBHEPB, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: This report was received from manufacturer for Infanrix and was assigned manufacturer report #A0379840A. This was originally reported by a registered nurse concerning a 15 month old male with no past medical history who on 08/28/2002 at 9:30 AM was vaccinated with a dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast). Concomitant therapy at that time included a dose of MMR II (MSD). Other therapy at that time included a 4th dose of diphtheria toxoid/pertussis vaccine/tetanus (Infanrix) (lot #DTPA545B9), in the upper left leg. On 08/28/2002, at 4:30 PM, the pt's left leg had a "very" red, swollen area which measured 8.5 cm x 9 cm which was warm to touch, and had a knot. The pt had a temperature of 99.5 degrees F and was fussy. The pt was seen in the ER. As of 09/04/2002, the pt's events had improved but the leg still had a knot and the child was fussy. It was also noted that the pt had experienced no adverse events following previous immunizations. Follow-up info reported that "this child did not have a reaction to [Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast)]." No further info is expected.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, MMR, DTAP, HBHEPB, MMR
Symptoms: Irritability, Pyrexia
Clinical narrative: This report was received from manufacturer for Infanrix and was assigned manufacturer report #A0379840A. This was originally reported by a registered nurse concerning a 15 month old male with no past medical history who on 08/28/2002 at 9:30 AM was vaccinated with a dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast). Concomitant therapy at that time included a dose of MMR II (MSD). Other therapy at that time included a 4th dose of diphtheria toxoid/pertussis vaccine/tetanus (Infanrix) (lot #DTPA545B9), in the upper left leg. On 08/28/2002, at 4:30 PM, the pt's left leg had a "very" red, swollen area which measured 8.5 cm x 9 cm which was warm to touch, and had a knot. The pt had a temperature of 99.5 degrees F and was fussy. The pt was seen in the ER. As of 09/04/2002, the pt's events had improved but the leg still had a knot and the child was fussy. It was also noted that the pt had experienced no adverse events following previous immunizations. Follow-up info reported that "this child did not have a reaction to [Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast)]." No further info is expected.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, MMR, DTAP, HBHEPB, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site mass, Injection site oedema, Irritability
Clinical narrative: This report was received from manufacturer for Infanrix and was assigned manufacturer report #A0379840A. This was originally reported by a registered nurse concerning a 15 month old male with no past medical history who on 08/28/2002 at 9:30 AM was vaccinated with a dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast). Concomitant therapy at that time included a dose of MMR II (MSD). Other therapy at that time included a 4th dose of diphtheria toxoid/pertussis vaccine/tetanus (Infanrix) (lot #DTPA545B9), in the upper left leg. On 08/28/2002, at 4:30 PM, the pt's left leg had a "very" red, swollen area which measured 8.5 cm x 9 cm which was warm to touch, and had a knot. The pt had a temperature of 99.5 degrees F and was fussy. The pt was seen in the ER. As of 09/04/2002, the pt's events had improved but the leg still had a knot and the child was fussy. It was also noted that the pt had experienced no adverse events following previous immunizations. Follow-up info reported that "this child did not have a reaction to [Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast)]." No further info is expected.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, MMR, DTAP, HBHEPB, MMR
Symptoms: Pyrexia
Clinical narrative: This report was received from manufacturer for Infanrix and was assigned manufacturer report #A0379840A. This was originally reported by a registered nurse concerning a 15 month old male with no past medical history who on 08/28/2002 at 9:30 AM was vaccinated with a dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast). Concomitant therapy at that time included a dose of MMR II (MSD). Other therapy at that time included a 4th dose of diphtheria toxoid/pertussis vaccine/tetanus (Infanrix) (lot #DTPA545B9), in the upper left leg. On 08/28/2002, at 4:30 PM, the pt's left leg had a "very" red, swollen area which measured 8.5 cm x 9 cm which was warm to touch, and had a knot. The pt had a temperature of 99.5 degrees F and was fussy. The pt was seen in the ER. As of 09/04/2002, the pt's events had improved but the leg still had a knot and the child was fussy. It was also noted that the pt had experienced no adverse events following previous immunizations. Follow-up info reported that "this child did not have a reaction to [Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast)]." No further info is expected.
Age: 52.0
Sex: M
Vaccine: HEPA, TD, TYP, YF
Symptoms: Asthenia, Chills, Laboratory test abnormal, Pain, Pyrexia
Clinical narrative: From information received via email, it was reported that a 52 year old male patient was vaccinated on 11/29/02 at 09:30 AM with TD ADS ADULT (lot #U0817AA) IM in the right arm, TYPHIM Vi (lot # U1073) IM in the right arm, YF VAX (lot # UB3155AA) SC in the left arm, and HAVRIX (lot # VHA737AU) IM in the right arm. On 12/1/02 in the PM, the patient experienced transient fever of 100 F, which only occurred in the evenings. Additionally, he complained of weakness, night sweats, chills, and achiness. He was seen by his primary care physician and a CBC was ordered. The results of the CBC were normal. The physician thought the symptoms may be caused by Lyme Disease and placed the patient on Doxycycline. The patient was afebrile at the time of the office visit, but reportedly continued to have symptoms. Additioinal lab testing was completed including a repeat CBC, as well as LFT's, electrolytes and kidney function tests. The results of these test were normal except for minimally elevated alkaline phosphatase and BUN levels. The patient was then seen by his internist and reported that further testing was done and came back completely normal, however, he was continuing to experience symptoms.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Crying, Injection site erythema, Injection site pain, Screaming, Somnolence
Clinical narrative: Information has been received from a consumer and a physician concerning a 60 day old male, who had no illness at the time of vaccination, with no known allergies or medical history who on 12/20/02, at 1100 was vaccinated IM in the left thigh with a first dose of Haemophilus B conjugate vaccine (+) hep B vaccine recombinant (643884/0741). Concomitant therapy included vaccination IM in the left thigh with a first dose of IPOL (W0196) and vaccination IM in the right thigh with a first dose of Infanrix (574A2). On 12/20/02, at 1720, the pt began crying for three hours after receiving the vaccine. The pt also had swelling and redness where he received the shot. The physician reports, per phone interaction with consumer that the pt had a lot of pain in the leg and the leg was red and swollen. Treatment was with Tylenol. The pt was not seen by the physician and lab/diagnostic tests were performed. At the time of this report, the outcomes were unknown. Additional info is not expected.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Injection site erythema, Injection site oedema, Oedema peripheral, Pain, Screaming
Clinical narrative: Information has been received from a consumer and a physician concerning a 60 day old male, who had no illness at the time of vaccination, with no known allergies or medical history who on 12/20/02, at 1100 was vaccinated IM in the left thigh with a first dose of Haemophilus B conjugate vaccine (+) hep B vaccine recombinant (643884/0741). Concomitant therapy included vaccination IM in the left thigh with a first dose of IPOL (W0196) and vaccination IM in the right thigh with a first dose of Infanrix (574A2). On 12/20/02, at 1720, the pt began crying for three hours after receiving the vaccine. The pt also had swelling and redness where he received the shot. The physician reports, per phone interaction with consumer that the pt had a lot of pain in the leg and the leg was red and swollen. Treatment was with Tylenol. The pt was not seen by the physician and lab/diagnostic tests were performed. At the time of this report, the outcomes were unknown. Additional info is not expected.
Age: 15.0
Sex: F
Vaccine: TD, TD
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: From initial information received on 1/9/03, it was reported that a 15 year old female patient received TD ADS ADULT (lot number U0820AA) in the left arm on 1/7/03. The patient was seen in doctor's office the next day with site swelling, redness, and induration measuring 4cm. She also complained of weakness in the left hand, facial flushing, temperature of 99.5 degrees F, nausea, and headache. These adverse reactions are unresolved.
Age: 15.0
Sex: F
Vaccine: TD, TD
Symptoms: Flushing, Headache, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: From initial information received on 1/9/03, it was reported that a 15 year old female patient received TD ADS ADULT (lot number U0820AA) in the left arm on 1/7/03. The patient was seen in doctor's office the next day with site swelling, redness, and induration measuring 4cm. She also complained of weakness in the left hand, facial flushing, temperature of 99.5 degrees F, nausea, and headache. These adverse reactions are unresolved.
Age: 15.0
Sex: F
Vaccine: TD, TD
Symptoms: Muscular weakness, Nausea, Pyrexia
Clinical narrative: From initial information received on 1/9/03, it was reported that a 15 year old female patient received TD ADS ADULT (lot number U0820AA) in the left arm on 1/7/03. The patient was seen in doctor's office the next day with site swelling, redness, and induration measuring 4cm. She also complained of weakness in the left hand, facial flushing, temperature of 99.5 degrees F, nausea, and headache. These adverse reactions are unresolved.
Age: 51.0
Sex: F
Vaccine: HEP, HEPA, TD, TYP, YF, HEP, HEPA, TD, TYP, YF, HEP, HEPA, TD, TYP, YF
Symptoms: Pharyngitis, Tongue oedema
Clinical narrative: It was reported that a 51 year old female received Yellow Fever, Td, Typhim VI, hep B and hep A vaccine on 5/23/02. Approximately 2-3 hrs after vaccines received, pt called the clinic and stated that her throat was feeling fuller and tongue was tingling. Clinic instructed pt to go to the ER. Pt was treated with Prednisone and anithistamine at the ER and released. Pt has past history of sulfa, PCN, codeine, Motrin allergies, ahnd anaphylaxis to Motrin in past. Pt currently on Chlorpheniramine HMG prn, Prempro, vitamin E 400mg, vitamin C 500mg, folic acid 400mg, calcium 900mg, vitamin B 1000mg and multivitamin. From additional info received at manufacturer on 11/26/02, it was reported that the pt received 2nd dose of hep B vaccine (0034M) in the left deltoid on 6/20/02. Pt received Td in the right deltoid, Typhim VI in the left deltoid, Yellow Fever SC in the left arm as dose #1, hep A in the left deltoid as dose #1 and hep B in the right deltoid, all in the morning of 5/23/02. Pt started having the adverse events at 1:55pm on 5/23/02. Pt recovered, no illnesses were present at time of vaccination. Current condition of pt per source reporter: Before 6/20/02 visit per #2 hep B, her regular internist gave her Medroprednisolone 4mm plus Chlorophemairamine 6/19/02 pm, 6/20/02 am and pm and 6/23/02 am and pm. She did not have any problems after vaccines. She received #3 hep B and #2 hep A She also received Chlorophenairamine an dMedroprednisolone prior to appt. She could not remember exactly how she was instructed to take it. I called her on 11/21/02 4pm and she had a hoarse voice since 11/20/02, but does not know what it was from, otherwise she is fine. Case is clsoed.
Age: 51.0
Sex: F
Vaccine: HEP, HEPA, TD, TYP, YF, HEP, HEPA, TD, TYP, YF, HEP, HEPA, TD, TYP, YF
Symptoms: Hypersensitivity, Pharyngeal oedema, Pruritus, Tongue oedema
Clinical narrative: It was reported that a 51 year old female received Yellow Fever, Td, Typhim VI, hep B and hep A vaccine on 5/23/02. Approximately 2-3 hrs after vaccines received, pt called the clinic and stated that her throat was feeling fuller and tongue was tingling. Clinic instructed pt to go to the ER. Pt was treated with Prednisone and anithistamine at the ER and released. Pt has past history of sulfa, PCN, codeine, Motrin allergies, ahnd anaphylaxis to Motrin in past. Pt currently on Chlorpheniramine HMG prn, Prempro, vitamin E 400mg, vitamin C 500mg, folic acid 400mg, calcium 900mg, vitamin B 1000mg and multivitamin. From additional info received at manufacturer on 11/26/02, it was reported that the pt received 2nd dose of hep B vaccine (0034M) in the left deltoid on 6/20/02. Pt received Td in the right deltoid, Typhim VI in the left deltoid, Yellow Fever SC in the left arm as dose #1, hep A in the left deltoid as dose #1 and hep B in the right deltoid, all in the morning of 5/23/02. Pt started having the adverse events at 1:55pm on 5/23/02. Pt recovered, no illnesses were present at time of vaccination. Current condition of pt per source reporter: Before 6/20/02 visit per #2 hep B, her regular internist gave her Medroprednisolone 4mm plus Chlorophemairamine 6/19/02 pm, 6/20/02 am and pm and 6/23/02 am and pm. She did not have any problems after vaccines. She received #3 hep B and #2 hep A She also received Chlorophenairamine an dMedroprednisolone prior to appt. She could not remember exactly how she was instructed to take it. I called her on 11/21/02 4pm and she had a hoarse voice since 11/20/02, but does not know what it was from, otherwise she is fine. Case is clsoed.
Age: 51.0
Sex: F
Vaccine: HEP, HEPA, TD, TYP, YF, HEP, HEPA, TD, TYP, YF, HEP, HEPA, TD, TYP, YF
Symptoms: Paraesthesia
Clinical narrative: It was reported that a 51 year old female received Yellow Fever, Td, Typhim VI, hep B and hep A vaccine on 5/23/02. Approximately 2-3 hrs after vaccines received, pt called the clinic and stated that her throat was feeling fuller and tongue was tingling. Clinic instructed pt to go to the ER. Pt was treated with Prednisone and anithistamine at the ER and released. Pt has past history of sulfa, PCN, codeine, Motrin allergies, ahnd anaphylaxis to Motrin in past. Pt currently on Chlorpheniramine HMG prn, Prempro, vitamin E 400mg, vitamin C 500mg, folic acid 400mg, calcium 900mg, vitamin B 1000mg and multivitamin. From additional info received at manufacturer on 11/26/02, it was reported that the pt received 2nd dose of hep B vaccine (0034M) in the left deltoid on 6/20/02. Pt received Td in the right deltoid, Typhim VI in the left deltoid, Yellow Fever SC in the left arm as dose #1, hep A in the left deltoid as dose #1 and hep B in the right deltoid, all in the morning of 5/23/02. Pt started having the adverse events at 1:55pm on 5/23/02. Pt recovered, no illnesses were present at time of vaccination. Current condition of pt per source reporter: Before 6/20/02 visit per #2 hep B, her regular internist gave her Medroprednisolone 4mm plus Chlorophemairamine 6/19/02 pm, 6/20/02 am and pm and 6/23/02 am and pm. She did not have any problems after vaccines. She received #3 hep B and #2 hep A She also received Chlorophenairamine an dMedroprednisolone prior to appt. She could not remember exactly how she was instructed to take it. I called her on 11/21/02 4pm and she had a hoarse voice since 11/20/02, but does not know what it was from, otherwise she is fine. Case is clsoed.
Age: 18.0
Sex: M
Vaccine: DT, HEP, MMR, HEP, MMR, TD
Symptoms: Dehydration, Diarrhoea
Clinical narrative: A nurse reported that an 18 year old male experienced diarrhea after receiving an injection of Engerix B. The vaccine provider submitted a report to the state dept of health. The subject's medical history included celiac sprue and allergies to chocolate and nuts. The subject experienced no adverse events following previous immunizations. No concurrent medications were reported. On 7/22/02, the subject received his first injection of Engerix B. On the same date, he received injections of TD and MMR II. Later that evening, the subject experienced diarrhea. The subject's mother called the physician's office and reported that the subject was also dehydrated and that she was giving him fluids. Additional info was received on 12/17/02. On 7/29/02, the subject was evaluated by an unspecified specialist and was treated with unspecified steroids. On 8/6/02, the mother stated that the subject was "doing much better." The nurse reported that there were no complications. The nurse stated that the diarrhea and dehydration were possibly related to Engerix B administration and possibly related to celiac disease. The Engerix B immunization series was discontinued. As of 12/17/02, the events had resolved. The nurse indicated that the events jeopardized the subject or required intervention; therefore, this subject has been reclassified as serious (OMIC). The case is closed.
Age: 1.01
Sex: M
Vaccine: HBHEPB, PNC, HBHEPB, PNC, HBHEPB, PNC
Symptoms: Cough, Gait disturbance, Hypoaesthesia, Insomnia, Pyrexia
Clinical narrative: Information has been received form a RN concerning a 12 month old male who on 6/19/03 was vaccinated with a third dose of Comvax (645024/1169M). Concomitant vaccination on the same day included a third dose of Prevnar. The pt's mother called the office to report that her child experienced a tic an that he was walking differently. The reporter indicated that approximately five days after vaccination, on 6/24/03, the child was seen in the office and was noted to have a tic which was described as twitching and blinking of his eyes. The nurse noted that it was not a seizure. The mother noted that the child walked differently also. The nurse reported that it was difficult to determine if the child was walking differently since he was so young. A month later it was documented when seen in the office with a slight improvement noted by the mother. The pt was then seen by a neurologist with negative findings. He did not receive any treatment. It was noted that there was "no further treatment at this time." The reporter indicated that the child received Comvax and Prevnar previously with no adverse symptoms noted. The nurse reported that the pt was getting better but had not recovered completely A product quality complaint was not involved. Additional info has been requested.
Age: 1.01
Sex: M
Vaccine: HBHEPB, PNC, HBHEPB, PNC, HBHEPB, PNC
Symptoms: Gait disturbance, Muscle twitching, Tic
Clinical narrative: Information has been received form a RN concerning a 12 month old male who on 6/19/03 was vaccinated with a third dose of Comvax (645024/1169M). Concomitant vaccination on the same day included a third dose of Prevnar. The pt's mother called the office to report that her child experienced a tic an that he was walking differently. The reporter indicated that approximately five days after vaccination, on 6/24/03, the child was seen in the office and was noted to have a tic which was described as twitching and blinking of his eyes. The nurse noted that it was not a seizure. The mother noted that the child walked differently also. The nurse reported that it was difficult to determine if the child was walking differently since he was so young. A month later it was documented when seen in the office with a slight improvement noted by the mother. The pt was then seen by a neurologist with negative findings. He did not receive any treatment. It was noted that there was "no further treatment at this time." The reporter indicated that the child received Comvax and Prevnar previously with no adverse symptoms noted. The nurse reported that the pt was getting better but had not recovered completely A product quality complaint was not involved. Additional info has been requested.
Age: 1.01
Sex: M
Vaccine: HBHEPB, PNC, HBHEPB, PNC, HBHEPB, PNC
Symptoms: Gait disturbance, Tic
Clinical narrative: Information has been received form a RN concerning a 12 month old male who on 6/19/03 was vaccinated with a third dose of Comvax (645024/1169M). Concomitant vaccination on the same day included a third dose of Prevnar. The pt's mother called the office to report that her child experienced a tic an that he was walking differently. The reporter indicated that approximately five days after vaccination, on 6/24/03, the child was seen in the office and was noted to have a tic which was described as twitching and blinking of his eyes. The nurse noted that it was not a seizure. The mother noted that the child walked differently also. The nurse reported that it was difficult to determine if the child was walking differently since he was so young. A month later it was documented when seen in the office with a slight improvement noted by the mother. The pt was then seen by a neurologist with negative findings. He did not receive any treatment. It was noted that there was "no further treatment at this time." The reporter indicated that the child received Comvax and Prevnar previously with no adverse symptoms noted. The nurse reported that the pt was getting better but had not recovered completely A product quality complaint was not involved. Additional info has been requested.
Age: 8.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Erythema multiforme, Face oedema, Oedema peripheral, Rash, Urticaria
Clinical narrative: Erythema multiforme.  Swelling of lips and hands, urticarial rash to buttocks and post thigh spread to palms of hand and soles of feet.
Age: 0.33
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Patient received 4 vaccines on 10/08/2003 and was found dead in her crib on 10/11/2003. The autopsy report received on 3/24/04 states SIDS.
Age: 71.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site mass, Muscle spasms, Pain, Pruritus
Clinical narrative: From initial correspondence received at the manufacturer on 27/Feb/2003 from the patient, it was reported that a 71 year-old female received a TD adult vaccination administered in her left arm during the evening of 29/Jan/2003. Approximately 3 days after receipt of the shot (Feb 2003) the patient developed red skin and formation of a hard lump on her arm and severe itching. Her left arm became very irritated and painful. Physician on first contact attempt did see patient. Patient self-treated with ointments for relief of itching skin. On 09/Feb/2003, the pt's legs began to ache in the thigh area. The condition became worse as the day continued. Symptoms were less severe when patient was standing. The pain intensified greatly upon sitting down down. The muscles in her thighs were in severe painful spasm condition. Pain became more excruciating upon sitting or lying down. Ice was applied to the back of the pt's thighs until midnight. On 12/Feb/2003 the pt was prescribed "PROPO-N/APAP 100-65 TAB MALL-Darvocet-N 100", which she took until 16/Feb/2003. The pain ceased on 17/Feb/2003. The patient reportedly recovered from this experience.
Age: 71.0
Sex: F
Vaccine: TD
Symptoms: Skin irritation
Clinical narrative: From initial correspondence received at the manufacturer on 27/Feb/2003 from the patient, it was reported that a 71 year-old female received a TD adult vaccination administered in her left arm during the evening of 29/Jan/2003. Approximately 3 days after receipt of the shot (Feb 2003) the patient developed red skin and formation of a hard lump on her arm and severe itching. Her left arm became very irritated and painful. Physician on first contact attempt did see patient. Patient self-treated with ointments for relief of itching skin. On 09/Feb/2003, the pt's legs began to ache in the thigh area. The condition became worse as the day continued. Symptoms were less severe when patient was standing. The pain intensified greatly upon sitting down down. The muscles in her thighs were in severe painful spasm condition. Pain became more excruciating upon sitting or lying down. Ice was applied to the back of the pt's thighs until midnight. On 12/Feb/2003 the pt was prescribed "PROPO-N/APAP 100-65 TAB MALL-Darvocet-N 100", which she took until 16/Feb/2003. The pain ceased on 17/Feb/2003. The patient reportedly recovered from this experience.
Sex: M
Vaccine: HEP
Symptoms: Respiratory disorder
Clinical narrative: Information has been received from a physician concerning a male child with allergies to sulfates who was vaccinated with a first dose of hepatitis B virus vaccine. The physician noted that he did not give the vaccination and that the child received it as his primary care physician's office. The reporter indicated that the patient had a lot of respiratory problems after vaccination as a reaction to what he believed to be the aluminum hydroxyphosphate sulfate in the vaccine. The physician was not sure what treatment the patient received for the respiratory problem, but he thought that the child may have gone to the ER, although he was not sure. Upon internal review, a lot of respiratory problems was considered to be an other important medical event (OMIC). Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, HEPA, IPV, MMR
Symptoms: Cellulitis, Erythema, Feeling hot, Pyrexia, Swelling
Clinical narrative: Patient developed swelling, redness, and warmth to left upper arm soon after receiving vaccinatinos. Also had fever to 102. Suspected arthus reaction but could not rule out cellulitis. Treated with Clindamycin and antihistamines. MMR vaccine wsa given in the R thigh and all others in L arm. Elsewhere in the same record it is noted that per a call to the immunization clinic, their general procedure is to give DTaP and IPV in L arm, MMR in R arm and Flu/Hep A in either arm. Per annual report- I have not had contact with this patient since they were discharged from the hospital.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, HEPA, IPV, MMR
Symptoms: Type III immune complex mediated reaction
Clinical narrative: Patient developed swelling, redness, and warmth to left upper arm soon after receiving vaccinatinos. Also had fever to 102. Suspected arthus reaction but could not rule out cellulitis. Treated with Clindamycin and antihistamines. MMR vaccine wsa given in the R thigh and all others in L arm. Elsewhere in the same record it is noted that per a call to the immunization clinic, their general procedure is to give DTaP and IPV in L arm, MMR in R arm and Flu/Hep A in either arm. Per annual report- I have not had contact with this patient since they were discharged from the hospital.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Asthma, Condition aggravated, Headache, Pain
Clinical narrative: Body aches, low grade fever, stomach ache, headache, sore throat which began soon after shot. Asthma attack began 11/21/03 (10 days after flu shot). (1st asthma hospitalization for this patient in 6 years.) Failed to clear after 4 days home management and oral steroid. The follow up received on 12/24/03 states URI and pharyngitis were not evident on date of vaccination. Symptoms began within 24 hrs after vaccination. Tx PCN. Later erythromycin and Solu-Medrol. VAccine provider-pcp does not expect a discharge summary will be available-overnight hospitalization.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Body aches, low grade fever, stomach ache, headache, sore throat which began soon after shot. Asthma attack began 11/21/03 (10 days after flu shot). (1st asthma hospitalization for this patient in 6 years.) Failed to clear after 4 days home management and oral steroid. The follow up received on 12/24/03 states URI and pharyngitis were not evident on date of vaccination. Symptoms began within 24 hrs after vaccination. Tx PCN. Later erythromycin and Solu-Medrol. VAccine provider-pcp does not expect a discharge summary will be available-overnight hospitalization.
Age: 23.0
Sex: M
Vaccine: TYP
Symptoms: Arthropathy, Gastroenteritis, Hyperglycaemia, Myelitis transverse, Pyrexia
Clinical narrative: Tranverse myelitis-symptoms began 10/27/03. The medical record received on 2/18/04 confirms diagnosis of transverse myelitis. Also states gastroenteritis, L knee hyperextension injury, hyperglycemia due to steroid therapy, fever, salmonella bacteremia, and klebsiella UTI. Pt fully recovered. Returned to active duty.
Age: 23.0
Sex: M
Vaccine: TYP
Symptoms: Sepsis, Urinary tract infection
Clinical narrative: Tranverse myelitis-symptoms began 10/27/03. The medical record received on 2/18/04 confirms diagnosis of transverse myelitis. Also states gastroenteritis, L knee hyperextension injury, hyperglycemia due to steroid therapy, fever, salmonella bacteremia, and klebsiella UTI. Pt fully recovered. Returned to active duty.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Convulsion, Electroencephalogram abnormal, Encephalopathy, Tourette's disorder, Tremor
Clinical narrative: Seizures and tremors (less than 48) hours after vaccines. Increased to 50 or more a day. No fever. His seizures are better, but his encephalopathy has evolved into Tourette's syndrome they feel now. You may have access to medical records- already signed release form to you. Follow up report received on 01/25/2005 indicates patient has not recovered still has tics, ocd's, siezures, adhd, general anxiety, learning disability, aggression, angry, irritable. Had streop (scarlet fever) in May 2003, strep was still in his system at time of vaccines, MMR and strep don't mix and triggered his PANDAS.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Viral infection
Clinical narrative: Seizures and tremors (less than 48) hours after vaccines. Increased to 50 or more a day. No fever. His seizures are better, but his encephalopathy has evolved into Tourette's syndrome they feel now. You may have access to medical records- already signed release form to you. Follow up report received on 01/25/2005 indicates patient has not recovered still has tics, ocd's, siezures, adhd, general anxiety, learning disability, aggression, angry, irritable. Had streop (scarlet fever) in May 2003, strep was still in his system at time of vaccines, MMR and strep don't mix and triggered his PANDAS.
Age: 13.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Swelling, Tenderness
Clinical narrative: Left upper arm swollen with red streak; tender to touch. Erythematous streak running anterior to axilla. Dianosis: possible allergic reaction.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot, Loss of consciousness
Clinical narrative: About 20 minutes after the shot, my boyfriend and I were driving home and my arm where I received the shot felt hot then my whole body felt hot. I started feeling dizzy and then passed out for approximately 2 minutes. I came to. We stopped driving so I could get some air.
Age: 1.0
Sex: M
Vaccine: FLU3, IPV, MMR, VARCEL
Symptoms: Lethargy, Pyrexia
Clinical narrative: On 11/19/2003 mother reported that child ran fever 104-105 on 10/18/2003 and 10/19/2003 with lethargy, fever completely gone by Tuesday 10/21/2003.  Child seen both days in ER.  Mom gave Tylenol for fever.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Cellulitis, Dysphagia, Heart rate increased, Pruritus
Clinical narrative: About 10 minutes after giving flu vaccine, patient presented with red streaks on both arms and blotches around neck with generalized itching.  However patient was not in distress.  I gave her 50mg of Benadryl/Liquid checked her BP and HR 155/95 and 80bpm.  15 minutes later: 122/80 & 72bpm.  About this time MD was getting a prescription and I asked if he would look at her he felt she would be OK.  I had suggested the patient should get Benadryl and if symptoms return to take 25-50mg every 4-6 hours as needed.  MD told the patient the same thing.  I checked her BP 122/50, pulse 72.  Her red blotches and streaks were almost resolved before she left.  Patient said she was feeling better.  However after this occurred patient admitted that she had a mild reaction to a previous flu shot 2 years ago.  I told her she should not receive anymore flu shots without seeing a physician.  P.S. 12/04/2003: Called patient to get more info from her.  She informed me she had gone to the ER later on 11/20/2003 because she felt she couldn't swallow.  However they only gave her IV fluids according to patient no meds were given.  Symptoms resolved and she left 2 hours later.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Rash macular
Clinical narrative: About 10 minutes after giving flu vaccine, patient presented with red streaks on both arms and blotches around neck with generalized itching.  However patient was not in distress.  I gave her 50mg of Benadryl/Liquid checked her BP and HR 155/95 and 80bpm.  15 minutes later: 122/80 & 72bpm.  About this time MD was getting a prescription and I asked if he would look at her he felt she would be OK.  I had suggested the patient should get Benadryl and if symptoms return to take 25-50mg every 4-6 hours as needed.  MD told the patient the same thing.  I checked her BP 122/50, pulse 72.  Her red blotches and streaks were almost resolved before she left.  Patient said she was feeling better.  However after this occurred patient admitted that she had a mild reaction to a previous flu shot 2 years ago.  I told her she should not receive anymore flu shots without seeing a physician.  P.S. 12/04/2003: Called patient to get more info from her.  She informed me she had gone to the ER later on 11/20/2003 because she felt she couldn't swallow.  However they only gave her IV fluids according to patient no meds were given.  Symptoms resolved and she left 2 hours later.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain
Clinical narrative: Within 36 hours of patient receiving flu vaccine, she had acute onset of redness of hands and feet with complaint of pain and inability to bear weight on feet. Admitted to hospital.
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Appears to be cellulitis.  Seeing her PMD today.
Age: 0.4
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC
Symptoms: Drug administration error
Clinical narrative: Inactivated polio vaccine ordered; inactivated influenza vaccine given (0.5mL).
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain
Clinical narrative: Discomfort in the back of both thighs, back of both knees and both calves (left worse than right).
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Bronchitis, Cough, Headache, Hyperhidrosis, Pain
Clinical narrative: Arm sore 3 days, then cough, severe sore throat, hot, cold sweats, headache.  11/25th vomiting, went to MD, had bronchitis, low grade fever, sick at stomach, spitting up yellow phlegm.  Gave me antibiotic and cough syrup.  11/30/2003, feel better but not 100%.  Been sick 11 days, more questionable.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Pharyngolaryngeal pain, Pyrexia, Rhinorrhoea, Stomach discomfort, Vomiting
Clinical narrative: Arm sore 3 days, then cough, severe sore throat, hot, cold sweats, headache.  11/25th vomiting, went to MD, had bronchitis, low grade fever, sick at stomach, spitting up yellow phlegm.  Gave me antibiotic and cough syrup.  11/30/2003, feel better but not 100%.  Been sick 11 days, more questionable.
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Significant discomfort/pain at injection site when left arm/shoulder is moved.  Arose morning after administration and still present 10 days later.
Age: 28.0
Sex: M
Vaccine: FLU3, TD
Symptoms: Erythema, Injection site pain, Oedema
Clinical narrative: Patient reports swelling, redness at isolated site distal to left deltoid injection site on inner aspect left arm.  Area is 2x2inch with possible punctate center.  Using NSAIDS, ice.  Area tender but no decreased range of motion, no evidence of cellulitis.
Age: 28.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Injection site erythema, Oedema, Pain, Rash macular
Clinical narrative: Patient arm increased sore, feels fatigued late PM after received dose.  Right upper arm red and blotchy, swollen shoulder-elbow, unable to raise right arm next day.  Denies respiratory symptoms.  Advised to take Aleve or Ibuprofen and Benadryl as needed.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Pruritus
Clinical narrative: Itching all over for 12 hours.  Tired, patient reports feeling funny, tired and tongue felt funny day after shot.  No hives or swelling or tongue noted upon exam.  No egg allergy.  Afebrile.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Crying
Clinical narrative: Unconsolable cry.  First 24 hours after immunizations.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Mild varicella post vaccine.  Followed exposure to shingle in a relative.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Dyskinesia, Hydrocephalus, Staring
Clinical narrative: Patient seen 08/26/2003 and received injections at about noon.  Mom reported at 22:00 that night after sleeping approximately 1 hour in car seat, patient had jerking of all extremities and staring into space for 10-15 seconds.  She then slept all night.  Patient brought to office for evaluation 08/28/2003.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Convulsion, Dyskinesia, Neurological symptom
Clinical narrative: Blinking, grimacing, does not know colors as well as before.  No staring, local seizure activity, myoclonic jerking.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema, Tenderness
Clinical narrative: Patient reports 4 days post vaccination after injection of pneumovax reaction.  Arm on back of left arm, not injection site, became reddened, some swelling and tender to touch x 2 days ago, then resolved.  No other symptoms to report.