chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEPAB
Symptoms: Hepatic enzyme abnormal, Jaundice
Clinical narrative: This case was reported by a physician to a sales representative and described the occurrence of jaundice in an adult male pt who received Twinrix. On 9/9/04, the pt received a dose of Twinrix. At an and unspecified time, post/vax, the pt experienced jaundice. The pt was seen at a physician's office. Laboratory evaluation revealed elevated liver enzymes. The events were ongoing at the time of initial reporting. The reporting pharmacist considered the events to possible be related to vaccination with Twinrix. Comment: Jaundice and elevated liver enzymes were assessed as medically serious by Mfr.
Age: 51.0
Sex: M
Vaccine: HEPAB
Symptoms: Chest pain
Clinical narrative: This case was reported by a health professional to a sales representative and described the occurrence of chest heaviness in a 51 year old male patient who received hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix).  The patient's medical history was notable for diabetes.  The reporter also stated that the patient was afraid of needles.  On 09/30/2004, the patient received the first dose of Twinrix.  Approximately two hours following the first dose of Twinrix, on 09/30/2004, the patient experienced a heavy feeling in his chest.  The patient was seen in an emergency room.  The reporter stated that in the emergency room, they could not locate any cardiac problem and the patient was not admitted.  The patient then was seen by his regular physician.  The reporter stated that, the regular physician could not find any cardiac problems.  The event was ongoing at the time of initial reporting.
Age: 22.0
Sex: M
Vaccine: HEPAB
Symptoms: Injection site reaction, Myositis
Clinical narrative: This case was reported by a physician and described the occurrence of myositis at the injection site in a 22 year old male patient who received hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix).  The patient was previously healthy, with no history of adverse events following previous vaccinations and no known allergies.  There was no history of collagen vascular disease or muscle diseases.  On 09/08/2004, the patient received the first dose of Twinrix in the right deltoid muscle (lot HAB278A4).  Approximately one day after the first dose of Twinrix, on 09/09/2004, the patient experienced myositis that was localized to the right deltoid muscle.  The patient was seen by a physician one month after vaccination, on 10/08/2004.  The physician described the myositis as an injection site reaction.  The patient did not report any systemic symptoms, including fever.  The event was not disabling or incapacitating.  The event resolved on an unspecified date before 11/03/2004.  The immunization series with Twinrix was discontinued.  The physician considered the myositis to be related to vaccination with Twinrix.
Age: 53.0
Sex: F
Vaccine: HEPAB
Symptoms: Chills, Dizziness, Dysarthria, Fatigue, Headache
Clinical narrative: This case was reported by physician and described the occurrence of vomiting in a 52 year old female patient who received hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix).  This case was initially reported by a nurse.  Follow up was received from the primary care physician.  On 09/16/2004, the patient received the first dose of Twinrix in the right arm (lot HAB239A4).  At an unspecified time following the administration of Twinrix, on 09/16/2004, the patient experienced nausea, vomiting, headache, a low grade fever, chills, fatigue and dizziness.  On 09/18/2004, the events continued and the patient also experienced slurred speech, personality changes, tremors, tingling in the right side of her face when she turns her neck an certain way, photophobia, muscle weakness, and myalgia.  The patient was seen at the primary care physician's office on 09/21/2004.  Tests performed on 09/21/2004, were negative for west nile virus, and were normal for complete blood count, mean corpuscular volume and erythrocyte sedimentation rate.  A repeat test performed approximately 3 weeks later, on an unspecified date in October 2004 were normal for complete blood count, mean corpuscular volume and thyroid stimulating hormone.  The reporting physician stated there was, no additional evidence of a viral infection.  The immunization series with Twinrix was discontinued.  The events were ongoing at the time of follow up.  The physician considered the events to possibly be related to vaccination with Twinrix.
Age: 53.0
Sex: F
Vaccine: HEPAB
Symptoms: Histrionic personality disorder, Muscular weakness, Myalgia, Nausea, Paraesthesia
Clinical narrative: This case was reported by physician and described the occurrence of vomiting in a 52 year old female patient who received hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix).  This case was initially reported by a nurse.  Follow up was received from the primary care physician.  On 09/16/2004, the patient received the first dose of Twinrix in the right arm (lot HAB239A4).  At an unspecified time following the administration of Twinrix, on 09/16/2004, the patient experienced nausea, vomiting, headache, a low grade fever, chills, fatigue and dizziness.  On 09/18/2004, the events continued and the patient also experienced slurred speech, personality changes, tremors, tingling in the right side of her face when she turns her neck an certain way, photophobia, muscle weakness, and myalgia.  The patient was seen at the primary care physician's office on 09/21/2004.  Tests performed on 09/21/2004, were negative for west nile virus, and were normal for complete blood count, mean corpuscular volume and erythrocyte sedimentation rate.  A repeat test performed approximately 3 weeks later, on an unspecified date in October 2004 were normal for complete blood count, mean corpuscular volume and thyroid stimulating hormone.  The reporting physician stated there was, no additional evidence of a viral infection.  The immunization series with Twinrix was discontinued.  The events were ongoing at the time of follow up.  The physician considered the events to possibly be related to vaccination with Twinrix.
Age: 53.0
Sex: F
Vaccine: HEPAB
Symptoms: Photophobia, Pyrexia, Tremor, Vomiting
Clinical narrative: This case was reported by physician and described the occurrence of vomiting in a 52 year old female patient who received hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix).  This case was initially reported by a nurse.  Follow up was received from the primary care physician.  On 09/16/2004, the patient received the first dose of Twinrix in the right arm (lot HAB239A4).  At an unspecified time following the administration of Twinrix, on 09/16/2004, the patient experienced nausea, vomiting, headache, a low grade fever, chills, fatigue and dizziness.  On 09/18/2004, the events continued and the patient also experienced slurred speech, personality changes, tremors, tingling in the right side of her face when she turns her neck an certain way, photophobia, muscle weakness, and myalgia.  The patient was seen at the primary care physician's office on 09/21/2004.  Tests performed on 09/21/2004, were negative for west nile virus, and were normal for complete blood count, mean corpuscular volume and erythrocyte sedimentation rate.  A repeat test performed approximately 3 weeks later, on an unspecified date in October 2004 were normal for complete blood count, mean corpuscular volume and thyroid stimulating hormone.  The reporting physician stated there was, no additional evidence of a viral infection.  The immunization series with Twinrix was discontinued.  The events were ongoing at the time of follow up.  The physician considered the events to possibly be related to vaccination with Twinrix.
Sex: M
Vaccine: HEPAB
Symptoms: Injection site mass, Injection site reaction
Clinical narrative: This case was reported by a nurse to a sales representative and described the occurrence of an injection site reaction in an adult male pt who received hepatitis A inactivated & hepatitis B recombinant vaccine (Twinrix). On an unspecified date in 10/04, the pt received the 1st dose of Twinrix. At an unspecified time following the 1st administration of Twinrix, on the same day in 10/04, the pt experienced a "knot" at the injection site. The outcome of the event was not reported. The nurse considered the injection site reaction to possibly be related to vaccination with Twinrix.
Age: 40.0
Sex: M
Vaccine: HEPAB, TD, TYP, YF
Symptoms: Injection site pain, Neck pain
Clinical narrative: This case was reported by a physician and described the occurrence of a sore shoulder in a 40 year old male pt who received Twinrix. On 11/4/04, the pt received the first dose of Twinrix in the right deltoid. On the same day, the pt also received Typhim VI, in the right deltoid, TD vaccine, in the left deltoid and yellow fever vaccine, in the left arm. At an unspecified time following the administration of the vaccines, on 11/4/04, the pt experienced soreness in the right arm "at the site of injection" and soreness "that extended up towards the neck and shoulder on the right side". The pt was seen at a physician's office on 12/13/04. The physician stated that as of 12/13/04, "the soreness is still present and upon physical examination, the soreness is aggravated by turning his neck from side to side". Follow-up received on 3/11/05 from the reporting physician indicated that the pt was, "symptomatic for six weeks", however, the date that the events resolved was not provided. The reporting physician considered the events to possibly be related to vaccination with Twinrix and possibly associated with the overuse syndrome.
Sex: U
Vaccine: HEPAB
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a physician and described a pt who did not respond to the Twinrix immunization series. The physician initially reported "2 or 3 pts over the past couple of years"; however, no pt identifiers or dates were provided. On unspecified dates "several years ago", the pt received 3 doses of Twinrix. At an unspecified time after the 3rd injection, the pt "did not obtain an adequate titer level for hepatitis B". The physician reported that he "repeated the hepatitis B series and the pt did seroconvert". On follow-up received from the physician on 1/21/05, the physician stated, "No pts with complications from Twinrix".
Age: 38.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site mass, Injection site pain, Lymphadenopathy
Clinical narrative: This case was reported by a sales representative and described the occurrence of a sore gland on side of neck in an 18 year old female pt who received Twinrix. The reporter is the pt. On 1/13/05, the pt received the 2nd dose of Twinrix in the "upper left arm". At an unspecified time following the administration of Twinrix, on 1/13/05, the pt experienced soreness at the injection site. On 1/14/05, the pt experienced, "an inflammed nodule or gland on the neck". The injection site reaction resolved on 1/19/05 and the inflammed gland resolved on 1/29/05. The immunization series with Twinrix was discontinued. The sales representative considered the events to be related to vaccination with Twinrix.
Age: 24.0
Sex: F
Vaccine: HEPAB
Symptoms: Diarrhoea, Fatigue, Myalgia, Nausea
Clinical narrative: This case was reported by a consumer and described the occurrence of sore muscles in a 24 year old female pt who received Twinrix. The reporter is the pt. A physician or other health care professional has not verified this report. This pt experienced local injection site soreness following receipt of prior immunizations. On 2/8/05, the pt received the 3rd dose of Twinrix in the left arm. At an unspecified time following the 3rd dose of Twinrix, on 2/8/05, the pt experienced sore muscles. The following day, on 2/9/05, the pt experienced diarrhea, nausea and exhaustion. The pt was seen at a physician's office. The events had improved as of the time of initial reporting, 2/10/05.
Age: 55.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site haemorrhage, Injection site reaction, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: This case was reported by a nurse and described the occurrence of an injection site reaction in a 55 year old female pt who received Twinrix. The pt's medical history was notable for hepatitis C positivity. Concurrent medications included Nifedipine to treat hepatitis C. On 4/25/05, the pt received the first dose of Twinrix in the right arm (lot AHAVBA015BA). The nurse reported that, "at time of vaccination", on 4/25/05, "the pt had just finished exercising and muscles were stiff". "The nurse stated that, "as soon as needle was pulled out, "the pt experienced an injection site reaction characterized as bleeding and swelling. The nurse stated that, "the arm is swollen around the injection site-about the size of a half dollar." The injection site reaction was ongoing at the time of initial reporting, 4/25/05.
Age: 49.0
Sex: M
Vaccine: HEPAB
Symptoms: Coordination abnormal
Clinical narrative: This case was reported by a physician and described the occurrence of ataxic gait in a 48 year old male subject who received Twinrix. On 4/26/05, the subject received the 2nd dose of Twinrix (AHABA026AA. On 4/27/05, at 05:30, the pt contacted the physician and reported an abnormal ataxic gait. The physician reported that, "the afternoon of 4/27/05, a follow-up phone call revealed that the pt's gait is normal; ataxia is gone". The reporting physician considered the ataxic gait to not be related to vaccination with Twinrix. This vaccinee had no adverse events following receipt of the 1st dose of Twinrix.
Age: 47.0
Sex: M
Vaccine: HEPAB
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a 47 year old male pt who did not respond to Twinrix. On 4/26/02, the pt received the 1st dose of Twinrix (HAB218B6. Concurrently, the same day, the pt also received TD. On 6/3/02, the pt received the 2nd dose of Twinrix (HAB218B6). Concurrently, on the same day, the pt received IPOL. Approximately 7.5 months later, on 12/16/02, the pt received the 3rd dose of Twinrix (HAB222A6). This administration is later than the recommended interval of 6 months between the 1st and 3rd doses of Twinrix. Approximately 28 months following the administration of the 3rd dose of Twinrix, on an unspecified date in 4/05, a hepatitis B surface antiboy titer was "negative". The nurse reported on follow-up received on 5/16/05, that she, "offerred to give the pt a dose of hepatitis B vaccine to see if his body would produce antibody response. The pt was not interested in doing this. We accepted that his body now has immune memory to hepatitis B".
Age: 21.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site reaction, Urticaria
Clinical narrative: This case was reported by a nurse to a sales representative and described the occurrence of injection site hives in a 21 year old female subject who was vaccinated with combined hepatitis A, hepatitis B for prophylaxis.  The subject had no known allergies.  Concurrent medications included Ibuprofen, Paracetamol and Guaiphensin for unspecified drug indications.  On an unspecified date in 2005, on or after 01/18/2005 and on or before 05/03/2005, the subject received 3 dose of Twinrix.  The site of the Twinrix administration was not provided.  The same day that she received the Twinrix, on an unspecified date or after 01/18/2005 an on or before 05/03/2005, the subject experienced a hive like rash at the injection site.  The injection site hives resolved on an unspecified date in 2005, on or after 01/18/2005 and on or before 05/03/2005.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Tenderness
Clinical narrative: Received 2 of her 3 pre-kindegarten immunizations in her L deltoid (either DTaP, IPV, or MMR).  Two days after administration, she developed marked erythema, induration, warmth, and tenderness of her L forearm- which required hospitalization for IV antibiotics.  She responded well to IV and then po antibiotics as well as benadryl with decreased swelling, redness, warmth, and tenderness.  It was unclear whether this was an infectious vs allergic reaction.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Chest pain, Dizziness, Dyspnoea, Hypoaesthesia, Medication error
Clinical narrative: Began to have difficulty breathing, tingling in left arm (injection site) traveling up left side into neck and head. Dizziness.  Tongue felt numb on left side, heaviness in chest. Contacted PCP-advised ER treatment immediately.  Symptoms remained for 24 hours - re-occured when an item containing bakers yeast was consumed.  Have not eaten bread or baked items since.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia
Clinical narrative: Began to have difficulty breathing, tingling in left arm (injection site) traveling up left side into neck and head. Dizziness.  Tongue felt numb on left side, heaviness in chest. Contacted PCP-advised ER treatment immediately.  Symptoms remained for 24 hours - re-occured when an item containing bakers yeast was consumed.  Have not eaten bread or baked items since.
Age: 65.0
Sex: M
Vaccine: MMR, PPV, TTOX
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pyrexia
Clinical narrative: A 65 year old male patient received a 0.5 ml dose of a pneumococcal vaccine in the right lateral thigh during an INS physical on 05/02/2005. On 05/03/2005 he experienced hardness, pain and redness at the injection site and also a fever.
Age: 51.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: A 51 year old female patient received 0.5ml of a pneumococcal vaccine during her doctor's visit on 05/02/2005. On 05/03/20005 she experienced chills for approximately 6 hours in the late afternoon. On 05/04/2005 the injection site on her left upper arm was red, hard and slightly swollen.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: A 43 year old male patient received a pneumococcal vaccine during his visit for an upper respiratory infection on 05/02/2005. He called the triage nurse on 05/03/2005 complaining of pain from the injection site radiating up his arm. The patient was given a same day appointment for evaluation but when he presented he was not seen due to copay issues. On 05/04/2005 the nurse spoke with the patient and he stated that the pain had stopped and denied any redness, swelling or heat at the injection site.
Age: 11.0
Sex: F
Vaccine: MNQ, MNQ, MNQ
Symptoms: Arthralgia, Dizziness, Infection parasitic, Injection site pain, Meningitis
Clinical narrative: From initial information received on 07/Jun/2005 from the pt's parent, who is also a physician, regarding an adverse event occurring in the USA, it was reported that an 11 year old female pt received a dose of Menactra, lot number U1573AC, administered in the left deltoid on 01/Jun/2005. One day later, on 02/Jun/2005, the pt developed pain at the injection site. On 03/Jun/2005 the pt developed neck pain and she was seen by a physician. She was treated with Advil and the pain was relieved. On 04/Jun/2005 the pt again developed neck pain, as well as dizziness, left knee pain and a fever of 101.8 degrees Fahrenheit. The symptoms persisted and the pt was taken to the ER on 06/Jun/2005. Her sed rate was elevated at 17 (normal range 0-10) and her glucose was 189. At the time of this report, the symptoms of neck pain, fever, and knee pain were still present. The pt's recovery status is listed as not recovered. From additional received on 29/Jun/2005 from the pt's parent, it was reported that the pt developed Lyme meningitis symptoms two days after receiving Menactra. The pt's cerebrospinal fluid (CSF) was positive, with 110 WBC. The pt's symptoms included Bell's Palsy. It was reported that the child was well prior to vaccination. It was not reported if the pt has recovered from these events. Based upon the new medical information received on 29/Jun/2005, this case is being upgraded to serious (OMIC).
Age: 11.0
Sex: F
Vaccine: MNQ, MNQ, MNQ
Symptoms: Neck pain, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: From initial information received on 07/Jun/2005 from the pt's parent, who is also a physician, regarding an adverse event occurring in the USA, it was reported that an 11 year old female pt received a dose of Menactra, lot number U1573AC, administered in the left deltoid on 01/Jun/2005. One day later, on 02/Jun/2005, the pt developed pain at the injection site. On 03/Jun/2005 the pt developed neck pain and she was seen by a physician. She was treated with Advil and the pain was relieved. On 04/Jun/2005 the pt again developed neck pain, as well as dizziness, left knee pain and a fever of 101.8 degrees Fahrenheit. The symptoms persisted and the pt was taken to the ER on 06/Jun/2005. Her sed rate was elevated at 17 (normal range 0-10) and her glucose was 189. At the time of this report, the symptoms of neck pain, fever, and knee pain were still present. The pt's recovery status is listed as not recovered. From additional received on 29/Jun/2005 from the pt's parent, it was reported that the pt developed Lyme meningitis symptoms two days after receiving Menactra. The pt's cerebrospinal fluid (CSF) was positive, with 110 WBC. The pt's symptoms included Bell's Palsy. It was reported that the child was well prior to vaccination. It was not reported if the pt has recovered from these events. Based upon the new medical information received on 29/Jun/2005, this case is being upgraded to serious (OMIC).
Age: 11.0
Sex: F
Vaccine: MNQ, MNQ, MNQ
Symptoms: Arthralgia, Blood glucose increased, CSF test abnormal, Dizziness, Facial palsy
Clinical narrative: From initial information received on 07/Jun/2005 from the pt's parent, who is also a physician, regarding an adverse event occurring in the USA, it was reported that an 11 year old female pt received a dose of Menactra, lot number U1573AC, administered in the left deltoid on 01/Jun/2005. One day later, on 02/Jun/2005, the pt developed pain at the injection site. On 03/Jun/2005 the pt developed neck pain and she was seen by a physician. She was treated with Advil and the pain was relieved. On 04/Jun/2005 the pt again developed neck pain, as well as dizziness, left knee pain and a fever of 101.8 degrees Fahrenheit. The symptoms persisted and the pt was taken to the ER on 06/Jun/2005. Her sed rate was elevated at 17 (normal range 0-10) and her glucose was 189. At the time of this report, the symptoms of neck pain, fever, and knee pain were still present. The pt's recovery status is listed as not recovered. From additional received on 29/Jun/2005 from the pt's parent, it was reported that the pt developed Lyme meningitis symptoms two days after receiving Menactra. The pt's cerebrospinal fluid (CSF) was positive, with 110 WBC. The pt's symptoms included Bell's Palsy. It was reported that the child was well prior to vaccination. It was not reported if the pt has recovered from these events. Based upon the new medical information received on 29/Jun/2005, this case is being upgraded to serious (OMIC).
Age: 11.0
Sex: F
Vaccine: MNQ, MNQ, MNQ
Symptoms: Injection site pain, Meningitis, Neck pain, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: From initial information received on 07/Jun/2005 from the pt's parent, who is also a physician, regarding an adverse event occurring in the USA, it was reported that an 11 year old female pt received a dose of Menactra, lot number U1573AC, administered in the left deltoid on 01/Jun/2005. One day later, on 02/Jun/2005, the pt developed pain at the injection site. On 03/Jun/2005 the pt developed neck pain and she was seen by a physician. She was treated with Advil and the pain was relieved. On 04/Jun/2005 the pt again developed neck pain, as well as dizziness, left knee pain and a fever of 101.8 degrees Fahrenheit. The symptoms persisted and the pt was taken to the ER on 06/Jun/2005. Her sed rate was elevated at 17 (normal range 0-10) and her glucose was 189. At the time of this report, the symptoms of neck pain, fever, and knee pain were still present. The pt's recovery status is listed as not recovered. From additional received on 29/Jun/2005 from the pt's parent, it was reported that the pt developed Lyme meningitis symptoms two days after receiving Menactra. The pt's cerebrospinal fluid (CSF) was positive, with 110 WBC. The pt's symptoms included Bell's Palsy. It was reported that the child was well prior to vaccination. It was not reported if the pt has recovered from these events. Based upon the new medical information received on 29/Jun/2005, this case is being upgraded to serious (OMIC).
Age: 11.0
Sex: F
Vaccine: MNQ, MNQ, MNQ
Symptoms: White blood cell disorder
Clinical narrative: From initial information received on 07/Jun/2005 from the pt's parent, who is also a physician, regarding an adverse event occurring in the USA, it was reported that an 11 year old female pt received a dose of Menactra, lot number U1573AC, administered in the left deltoid on 01/Jun/2005. One day later, on 02/Jun/2005, the pt developed pain at the injection site. On 03/Jun/2005 the pt developed neck pain and she was seen by a physician. She was treated with Advil and the pain was relieved. On 04/Jun/2005 the pt again developed neck pain, as well as dizziness, left knee pain and a fever of 101.8 degrees Fahrenheit. The symptoms persisted and the pt was taken to the ER on 06/Jun/2005. Her sed rate was elevated at 17 (normal range 0-10) and her glucose was 189. At the time of this report, the symptoms of neck pain, fever, and knee pain were still present. The pt's recovery status is listed as not recovered. From additional received on 29/Jun/2005 from the pt's parent, it was reported that the pt developed Lyme meningitis symptoms two days after receiving Menactra. The pt's cerebrospinal fluid (CSF) was positive, with 110 WBC. The pt's symptoms included Bell's Palsy. It was reported that the child was well prior to vaccination. It was not reported if the pt has recovered from these events. Based upon the new medical information received on 29/Jun/2005, this case is being upgraded to serious (OMIC).
Age: 11.0
Sex: F
Vaccine: MNQ, MNQ, MNQ
Symptoms: Dizziness, Facial palsy, Headache, Meningitis, Neck pain
Clinical narrative: From initial information received on 07/Jun/2005 from the pt's parent, who is also a physician, regarding an adverse event occurring in the USA, it was reported that an 11 year old female pt received a dose of Menactra, lot number U1573AC, administered in the left deltoid on 01/Jun/2005. One day later, on 02/Jun/2005, the pt developed pain at the injection site. On 03/Jun/2005 the pt developed neck pain and she was seen by a physician. She was treated with Advil and the pain was relieved. On 04/Jun/2005 the pt again developed neck pain, as well as dizziness, left knee pain and a fever of 101.8 degrees Fahrenheit. The symptoms persisted and the pt was taken to the ER on 06/Jun/2005. Her sed rate was elevated at 17 (normal range 0-10) and her glucose was 189. At the time of this report, the symptoms of neck pain, fever, and knee pain were still present. The pt's recovery status is listed as not recovered. From additional received on 29/Jun/2005 from the pt's parent, it was reported that the pt developed Lyme meningitis symptoms two days after receiving Menactra. The pt's cerebrospinal fluid (CSF) was positive, with 110 WBC. The pt's symptoms included Bell's Palsy. It was reported that the child was well prior to vaccination. It was not reported if the pt has recovered from these events. Based upon the new medical information received on 29/Jun/2005, this case is being upgraded to serious (OMIC).
Age: 11.0
Sex: F
Vaccine: MNQ, MNQ, MNQ
Symptoms: Pyrexia, Viral infection
Clinical narrative: From initial information received on 07/Jun/2005 from the pt's parent, who is also a physician, regarding an adverse event occurring in the USA, it was reported that an 11 year old female pt received a dose of Menactra, lot number U1573AC, administered in the left deltoid on 01/Jun/2005. One day later, on 02/Jun/2005, the pt developed pain at the injection site. On 03/Jun/2005 the pt developed neck pain and she was seen by a physician. She was treated with Advil and the pain was relieved. On 04/Jun/2005 the pt again developed neck pain, as well as dizziness, left knee pain and a fever of 101.8 degrees Fahrenheit. The symptoms persisted and the pt was taken to the ER on 06/Jun/2005. Her sed rate was elevated at 17 (normal range 0-10) and her glucose was 189. At the time of this report, the symptoms of neck pain, fever, and knee pain were still present. The pt's recovery status is listed as not recovered. From additional received on 29/Jun/2005 from the pt's parent, it was reported that the pt developed Lyme meningitis symptoms two days after receiving Menactra. The pt's cerebrospinal fluid (CSF) was positive, with 110 WBC. The pt's symptoms included Bell's Palsy. It was reported that the child was well prior to vaccination. It was not reported if the pt has recovered from these events. Based upon the new medical information received on 29/Jun/2005, this case is being upgraded to serious (OMIC).
Age: 19.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Loss of consciousness
Clinical narrative: From initial information received from a RN on 29/Jun/2005 regarding an adverse event, it was reported that an 18 year old female pt received a 0.5 ml dose of Menactra, lot number U114AB (not a valid lot number), administered IM in the left deltoid at 2:35 PM on 10/Jun/2005. Five minutes after receiving the vaccine, the pt lost consciousness. She was treated with epinephrine 0.5 mg subcutaneously and regained consciousness. She was transported to the ER for medical evaluation. The pt recovered from this event. (OMIC)
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cardio-respiratory arrest, Upper respiratory tract infection
Clinical narrative: Pt died 6 days after receiving vaccines. 7/21/05 Received medical records from ER which revealed patient arrived in full arrest & unable to resuscitate.  Parent reported mild upper respiratory symptoms for a few days prior to death.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Lacrimation increased, Rash
Clinical narrative: From initial information received on 01/Jul/2005 from a HCP regarding an adverse event occurring in the USA, it was reported that a 12 year old male pt received a dose of Decavac, lot number U1563AA, administered IM in the left deltoid on 27/Jun/2005. One day later, on 28/Jun/2005, the pt developed puffy eyes, a facial rash and a rash on his neck and chest. The pt was seen by a physician and was treated with Benadryl and prednisone per os. He was also administered Solu-Medrol 125 mg IM. Per the reporter, the pt did not have any respiratory distress. It was not reported if the pt has recovered from these events. (OMCI)
Age: 20.0
Sex: M
Vaccine: HEP, MNQ, TD
Symptoms: Abdominal pain upper, Arthritis, Headache, Musculoskeletal stiffness, Pain
Clinical narrative: From initial information received on 01/JUL/2005 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 19 year old pt received a dose of Decavac, lot number U1221DA, a dose of Menactra, lot number U1575AA, and a dose of Hepatitis B, on 27/Jun/2005. The route and site of administrations were not provided for any products. Ten days later, the pt was diagnosed with disabling arthritis. The pt also complained of headache and stomach ache. Reportedly, the pt's lab tests were within normal limits. At the time of this report, the pt has not recovered from these events. From additional information received later on 01/Jul/2005 from a HCP, it was reported that the actual date of vaccination was on 17/Jun/2005 and the adverse event onset was on 27/Jun/2005. Reportedly, the pt becomes extremely stiff when he sits for long periods and has difficulty getting up. He also has difficulty ambulating and "look a mess" and is experiencing "a lot of pain". The physician prescribed Toradol for the pain. (OMIC)
Age: 0.05
Sex: F
Vaccine: HEP
Symptoms: Condition aggravated, Dyspnoea, Medication error
Clinical narrative: Information has been received from a LPN and certified MA concerning a 15 day old female pt who was born with respiratory distress, who on 07-JUN-2005 or 012-Jun-2005 was vaccinated (grandmother also reported immediately at birth) with the first dose 0.5 ml dose of hepatitis B virus vaccine rHBsAg (yeast) and then transferred that same day to another hospital because of the respiratory distress problem from birth. On 20-JUN-2005 at the other hospital the pt received a second vaccination of hepatitis b vaccine. The nurse reported that the pt's grandmother had reported the event but did not mention to the nurse that there were any medical problems as a result of the two doses of vaccine. It was reported that the pt was hospitalized for the respiratory distress she had at birth (worsening) and there was no relation between the respiratory distress and vaccination. No further information regarding the adverse event or the pt's outcome was available at the time of this report. There was no product quality complaint reported. Additional information has been requested.
Age: 1.05
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Autism
Clinical narrative: Information has been received from a MA in a doctor's office concerning a 34 month old male with no known allergies or adverse reactions who on 15-SEP-2003 was vaccinated subcutaneously with MMR II (lot number 645629/0390N). Concomitant suspect therapy included Varivax. It was reported that the child was given MMR II and since had not been right. The MA reported that the pt had not been diagnosed but "they suspect autism." At the time of this report, the outcome of the event was unknown. Upon internal review, autism was considered to be an other important medical event (OMIC). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse concerning a pt who in approx June 2005 was vaccinated with a second dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Concomitant therapy included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and poliovirus vaccine. It was reported that the pt developed immediate hives (injection site). Medical attention was sought, and the pt was treated with diphenhydramine hydrochloride (Benadryl) Subsequently, the pt recovered. The reporter felt that the event was an other important medical event (OMIC). Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning her 5 year old son who was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). It was reported that the patient was diagnosed with autism after he was vaccinated. Unspecified medical attention was sought the patient's outcome was unknown. OMIC
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Cyanosis, Dyskinesia, Laboratory test abnormal, Opisthotonus, Tongue disorder
Clinical narrative: 20 minute episode of shaking head back and forth, punching movements, tongue thrusting and back arching. Added term from Discharge summary is cyanosis.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Tremor
Clinical narrative: 20 minute episode of shaking head back and forth, punching movements, tongue thrusting and back arching. Added term from Discharge summary is cyanosis.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Gastrointestinal disorder, Hyperhidrosis
Clinical narrative: Within 1-2 hrs after taking the flu vaccine in 2002, pt experienced diaphoresis and tachycardia; felt like she was going to pass out. Later, she experienced abdominal cramping and diarrhea. (similar GI symptoms after eating buckwheat pancakes a year ago).
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Tachycardia
Clinical narrative: Within 1-2 hrs after taking the flu vaccine in 2002, pt experienced diaphoresis and tachycardia; felt like she was going to pass out. Later, she experienced abdominal cramping and diarrhea. (similar GI symptoms after eating buckwheat pancakes a year ago).
Age: 43.0
Sex: F
Vaccine: ANTH
Symptoms: Cellulitis, Complement factor C3 increased, Complement factor C4, Complement factor abnormal, Feeling hot
Clinical narrative: 44 yr old female who received her anthrax vaccination SC over her right lower triceps region on 10/18/04. She noted redness, tenderness and swelling at the vaccine site that evening. The local reaction continued to increase in size and intensity, so on 21Oct she went back to the immunization clinic and was told that it was a normal reaction.  By the week end (23 and 24 Oct), the site was very painful and hot to the touch. She also experienced swelling and stiffness of her right hand and found it difficult to make a fist. She took Tylenol throughout the weekend and applied ice packs to the site. She also began experiencing generalized body aches and headaches. On 27Oct, she sought evaluation at the ER. She was diagnosed with cellulitis, started on Clindamycin and given a consult to Allergy and Immunology for evaluation of vaccine adverse reaction. On 10/29/03, she complains of tenderness, redness, swelling and warmth at vaccine site. She continues to have some swelling of the right hand when dependent, and her headache has continued almost constantly since the weekend. (She describes the headache as being different from a regular headache; it is like an electric shock across the frontal area with no associated symptoms except phonophobia; she has been taking Motrin which seems to help a little.) She denies fever, numbness or tingling in arm or hand, fatigue or joint pain. Follow-up Information: An initial VAERS report was filed on this patient in June 2005 by a healthcare provider at the vaccine Healthcare Center. This service member continues to experience headaches, but the swelling of right hand has resolved and the pain of her right hand is diminished. Here is a note after a telephone conversation on 12/4/06: Spoke to patient who is now retired. She has not been evaluated recently for her migraine headaches, but she continues to have episodes about 3 times/month. She is using Imitrex pills and nasal spray for severe headaches. She had also been taking Midrin pm, but when she ran out, she started taking her nortriptyline, which she was able to tolerate after a couple of weeks; noted she had less frequent headaches while taking, but has now run out of that too. Urged to follow up with PCM to resume nortriptyline use. VA disability determination for migraines is still pending. Had history of swollen and painful right hand; has been using paraffin soaks for hand pain pm with improvement; swelling has resolved. Has not taken the influenza vaccine this year.
Age: 43.0
Sex: F
Vaccine: ANTH
Symptoms: Full blood count, Haematocrit decreased, Haemoglobin normal, Headache, Hypokinesia
Clinical narrative: 44 yr old female who received her anthrax vaccination SC over her right lower triceps region on 10/18/04. She noted redness, tenderness and swelling at the vaccine site that evening. The local reaction continued to increase in size and intensity, so on 21Oct she went back to the immunization clinic and was told that it was a normal reaction.  By the week end (23 and 24 Oct), the site was very painful and hot to the touch. She also experienced swelling and stiffness of her right hand and found it difficult to make a fist. She took Tylenol throughout the weekend and applied ice packs to the site. She also began experiencing generalized body aches and headaches. On 27Oct, she sought evaluation at the ER. She was diagnosed with cellulitis, started on Clindamycin and given a consult to Allergy and Immunology for evaluation of vaccine adverse reaction. On 10/29/03, she complains of tenderness, redness, swelling and warmth at vaccine site. She continues to have some swelling of the right hand when dependent, and her headache has continued almost constantly since the weekend. (She describes the headache as being different from a regular headache; it is like an electric shock across the frontal area with no associated symptoms except phonophobia; she has been taking Motrin which seems to help a little.) She denies fever, numbness or tingling in arm or hand, fatigue or joint pain. Follow-up Information: An initial VAERS report was filed on this patient in June 2005 by a healthcare provider at the vaccine Healthcare Center. This service member continues to experience headaches, but the swelling of right hand has resolved and the pain of her right hand is diminished. Here is a note after a telephone conversation on 12/4/06: Spoke to patient who is now retired. She has not been evaluated recently for her migraine headaches, but she continues to have episodes about 3 times/month. She is using Imitrex pills and nasal spray for severe headaches. She had also been taking Midrin pm, but when she ran out, she started taking her nortriptyline, which she was able to tolerate after a couple of weeks; noted she had less frequent headaches while taking, but has now run out of that too. Urged to follow up with PCM to resume nortriptyline use. VA disability determination for migraines is still pending. Had history of swollen and painful right hand; has been using paraffin soaks for hand pain pm with improvement; swelling has resolved. Has not taken the influenza vaccine this year.
Age: 43.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site pain, Injection site swelling
Clinical narrative: 44 yr old female who received her anthrax vaccination SC over her right lower triceps region on 10/18/04. She noted redness, tenderness and swelling at the vaccine site that evening. The local reaction continued to increase in size and intensity, so on 21Oct she went back to the immunization clinic and was told that it was a normal reaction.  By the week end (23 and 24 Oct), the site was very painful and hot to the touch. She also experienced swelling and stiffness of her right hand and found it difficult to make a fist. She took Tylenol throughout the weekend and applied ice packs to the site. She also began experiencing generalized body aches and headaches. On 27Oct, she sought evaluation at the ER. She was diagnosed with cellulitis, started on Clindamycin and given a consult to Allergy and Immunology for evaluation of vaccine adverse reaction. On 10/29/03, she complains of tenderness, redness, swelling and warmth at vaccine site. She continues to have some swelling of the right hand when dependent, and her headache has continued almost constantly since the weekend. (She describes the headache as being different from a regular headache; it is like an electric shock across the frontal area with no associated symptoms except phonophobia; she has been taking Motrin which seems to help a little.) She denies fever, numbness or tingling in arm or hand, fatigue or joint pain. Follow-up Information: An initial VAERS report was filed on this patient in June 2005 by a healthcare provider at the vaccine Healthcare Center. This service member continues to experience headaches, but the swelling of right hand has resolved and the pain of her right hand is diminished. Here is a note after a telephone conversation on 12/4/06: Spoke to patient who is now retired. She has not been evaluated recently for her migraine headaches, but she continues to have episodes about 3 times/month. She is using Imitrex pills and nasal spray for severe headaches. She had also been taking Midrin pm, but when she ran out, she started taking her nortriptyline, which she was able to tolerate after a couple of weeks; noted she had less frequent headaches while taking, but has now run out of that too. Urged to follow up with PCM to resume nortriptyline use. VA disability determination for migraines is still pending. Had history of swollen and painful right hand; has been using paraffin soaks for hand pain pm with improvement; swelling has resolved. Has not taken the influenza vaccine this year.
Age: 43.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site warmth, Laboratory test abnormal, Migraine, Musculoskeletal stiffness, Musculoskeletal stiffness
Clinical narrative: 44 yr old female who received her anthrax vaccination SC over her right lower triceps region on 10/18/04. She noted redness, tenderness and swelling at the vaccine site that evening. The local reaction continued to increase in size and intensity, so on 21Oct she went back to the immunization clinic and was told that it was a normal reaction.  By the week end (23 and 24 Oct), the site was very painful and hot to the touch. She also experienced swelling and stiffness of her right hand and found it difficult to make a fist. She took Tylenol throughout the weekend and applied ice packs to the site. She also began experiencing generalized body aches and headaches. On 27Oct, she sought evaluation at the ER. She was diagnosed with cellulitis, started on Clindamycin and given a consult to Allergy and Immunology for evaluation of vaccine adverse reaction. On 10/29/03, she complains of tenderness, redness, swelling and warmth at vaccine site. She continues to have some swelling of the right hand when dependent, and her headache has continued almost constantly since the weekend. (She describes the headache as being different from a regular headache; it is like an electric shock across the frontal area with no associated symptoms except phonophobia; she has been taking Motrin which seems to help a little.) She denies fever, numbness or tingling in arm or hand, fatigue or joint pain. Follow-up Information: An initial VAERS report was filed on this patient in June 2005 by a healthcare provider at the vaccine Healthcare Center. This service member continues to experience headaches, but the swelling of right hand has resolved and the pain of her right hand is diminished. Here is a note after a telephone conversation on 12/4/06: Spoke to patient who is now retired. She has not been evaluated recently for her migraine headaches, but she continues to have episodes about 3 times/month. She is using Imitrex pills and nasal spray for severe headaches. She had also been taking Midrin pm, but when she ran out, she started taking her nortriptyline, which she was able to tolerate after a couple of weeks; noted she had less frequent headaches while taking, but has now run out of that too. Urged to follow up with PCM to resume nortriptyline use. VA disability determination for migraines is still pending. Had history of swollen and painful right hand; has been using paraffin soaks for hand pain pm with improvement; swelling has resolved. Has not taken the influenza vaccine this year.