chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Abdominal pain, Fatigue, Headache, Lip swelling
Clinical narrative: Initial report received on 14 July 2009 from a consumer. A 19 year old female patient with an allergy to fish and beans received MENACTRA (lot number U2915AA) intramuscularly on 07 July 2009. On 09 July 2009 the patient developed a moderate headache, which was somewhat relieved with Ibuprofen. The patient also began having mid to low abdominal pain which would come and go. The patient complained of feeling tired and having swollen lips. The patient did not have lab work or diagnostics completed. The patient did not recover. List of Documents held by Sender: none.
Age: 19.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Abdominal pain lower, Fatigue, Lip swelling
Clinical narrative: Initial report received on 14 July 2009 from a consumer. A 19 year old female patient with an allergy to fish and beans received MENACTRA (lot number U2915AA) intramuscularly on 07 July 2009. On 09 July 2009 the patient developed a moderate headache, which was somewhat relieved with Ibuprofen. The patient also began having mid to low abdominal pain which would come and go. The patient complained of feeling tired and having swollen lips. The patient did not have lab work or diagnostics completed. The patient did not recover. List of Documents held by Sender: none.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Mild headaches all day long.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Oedema peripheral
Clinical narrative: Patient had some arm swelling that she stated was about the size of a lemon. Patient returned to pharmacy on 8/8/09 and swelling had gone down.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Dyspnoea, Erythema, Vomiting
Clinical narrative: 7 AM red face, trouble breathing 3 PM vomited denies diarrhea.  Given PREDNISONE at RCH per mom.  Gave Dehydration Protocol this AM.
Age: 10.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Pt fainted after receiving BOOSTRIX and VARIVAX vaccines. LOC < 30 sec.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Live vaccine administered less than one month apart.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Back pain, Body temperature increased, Chills, Feeling cold
Clinical narrative: This report was received from a health care professional on 28 July 2009.  A 13 year old female patient received MENACTRA (lot number U2926AA) in the left deltoid on 27 July 2009.  The patient awoke that evening feeling cold.  The next morning, the patient awoke with the following symptoms:  severe headache, chills, feeling cold, nausea, feeling achy all over, joint pain, pain in her back, knees, foot and injection site on left deltoid.  The patient also had pain in the left arm which prevented her from being able to lift it.  There was no redness or swelling of the left arm.  The patient's temperature was reported as 99.1 degrees Fahrenheit orally.  The patient's medical history includes allergies which were treated  with NASONEX and ZYRTEC.  At the time of the report, the patient was being evaluated by a health care provider.  List of documents held by sender:  none.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Injected limb mobility decreased, Injection site pain, Nausea, Pain
Clinical narrative: This report was received from a health care professional on 28 July 2009.  A 13 year old female patient received MENACTRA (lot number U2926AA) in the left deltoid on 27 July 2009.  The patient awoke that evening feeling cold.  The next morning, the patient awoke with the following symptoms:  severe headache, chills, feeling cold, nausea, feeling achy all over, joint pain, pain in her back, knees, foot and injection site on left deltoid.  The patient also had pain in the left arm which prevented her from being able to lift it.  There was no redness or swelling of the left arm.  The patient's temperature was reported as 99.1 degrees Fahrenheit orally.  The patient's medical history includes allergies which were treated  with NASONEX and ZYRTEC.  At the time of the report, the patient was being evaluated by a health care provider.  List of documents held by sender:  none.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Pain in extremity
Clinical narrative: This report was received from a health care professional on 28 July 2009.  A 13 year old female patient received MENACTRA (lot number U2926AA) in the left deltoid on 27 July 2009.  The patient awoke that evening feeling cold.  The next morning, the patient awoke with the following symptoms:  severe headache, chills, feeling cold, nausea, feeling achy all over, joint pain, pain in her back, knees, foot and injection site on left deltoid.  The patient also had pain in the left arm which prevented her from being able to lift it.  There was no redness or swelling of the left arm.  The patient's temperature was reported as 99.1 degrees Fahrenheit orally.  The patient's medical history includes allergies which were treated  with NASONEX and ZYRTEC.  At the time of the report, the patient was being evaluated by a health care provider.  List of documents held by sender:  none.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Crying, Hypophagia, Irritability, Laboratory test normal, Lethargy
Clinical narrative: Lethargy and poor feeding in the 1st 12 hours, late very irritable, high pitched, nonconsolable crying. Septic work up done.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Pruritus, Pruritus generalised, Rash generalised, Skin warm
Clinical narrative: Four days after vaccines (8/4/09), teen developed pruritus all over body at about 1pm. Five days after vaccines, teen developed red, itchy, warm, swollen rash all over body (including scalp & ears). Rash resolved without medications.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Swelling
Clinical narrative: Four days after vaccines (8/4/09), teen developed pruritus all over body at about 1pm. Five days after vaccines, teen developed red, itchy, warm, swollen rash all over body (including scalp & ears). Rash resolved without medications.
Age: 13.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Body temperature increased, Inflammation, Pruritus, Rhinorrhoea, Tenderness
Clinical narrative: Tenderness, inflammation, runny nose, sl. temp. Itching x3 days.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Erythema to L deltoid with edema no induration, tender to palpation placed on Orapred and Benadryl.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Oedema peripheral, Pain in extremity, Tenderness
Clinical narrative: Swollen left arm- inflammation and tender still sore and swollen 2 days later. Pain in arm started on way home from clinic after Varicella given.
Age: 5.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Cough, Dyspnoea, Wheezing
Clinical narrative: Patient had cough and shortness of breath. No cyanosis. No use of accessory muscles of respiration. On exam RR 24/min, O2 sat 99% in room air, BP 100/60 mmHg. Air entry equal bilat. Wheeze (+). Treated with albuterol nebulizer and ATROVENT nebulizer. Repeated after 20 minutes. Oral prednisone 20 mg. Responded well.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema
Clinical narrative: 2 inch by 4 inch erythematous on (L) arm.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Left lateral thigh SC with 3 inch in diameter indurated, erythematous, warm circular reaction site.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Full blood count normal, Lymphadenopathy
Clinical narrative: Multiple large masses of lymph nodes over skull.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Urticaria
Clinical narrative: Localized redness and swelling at injection site with hives and itching.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Erythema, Oedema peripheral, Pain, Tenderness
Clinical narrative: Left leg upper medial side swollen, tender, red, painful.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Paraesthesia, Rash, Tracheal disorder, Urticaria
Clinical narrative: Received Hepatitis A #1 vaccine on 8/5/09 in L arm around 7PM complains of tingling in R hand. Woke on 8/6/09 with red rash on face that extended to neck and antrum chest. Hive/ rash - No respiratory problems.
Age: 57.0
Sex: U
Vaccine: HEP
Symptoms: Rash maculo-papular
Clinical narrative: Noted to have maculopapular rash 1 day after Hep B administration on L deltoid area.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: 3rd Hepatitis B administered 7 weeks after 2nd dose.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Live vaccines administered less than a month apart.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 5 X 8 cm erythema at site of VARIVAX Palp heat
Age: 68.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, Wrong drug administered
Clinical narrative: Pt. given VARIVAX instead of ZOSTAVAX given IM instead of SQ
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 5 X 8 erythema at site of VARIVAX Palp heat
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Induration, Skin reaction
Clinical narrative: Local skin reaction with warmth, discomfort and induration.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: L arm red in area vaccinated not warm to touch, feels well TYLENOL PRN, warm compress. Prn.
Age: 15.0
Sex: F
Vaccine: UNK
Symptoms: Hyperhidrosis, Hypotension, Presyncope
Clinical narrative: Presyncope, Hypotension, diaphoresis
Age: 55.0
Sex: M
Vaccine: TYP
Symptoms: Alanine aminotransferase increased, Anaemia, Anti-cyclic citrullinated peptide antibody positive, Aspartate aminotransferase increased, Blood culture negative
Clinical narrative: 55 year old staff physician, active duty and in generally excellent health, predeployment, who finished the 4-dose oral typhoid vaccine (starting 9 Jul 09, every other day with no other vaccines as prescribed). After the 1st dose, in retrospect but at the time not associating it with the vaccine, he noted reduced exercise tolerance that evening doing his usual run and with each passing day, as he took the rest of the doses, he noted worsening malaise, fatigue with new onset headache that worsened with lying down, temperature to 100.6 degrees F, some chills and night sweats but NO RIGORS or GI symptoms, generalized myalgias, and sleep disturbance due to headache pain. HE DENIED ANY nausea, vomiting, diarrhea or abdominal pain. Temperature resolved by day 6 but headache continued, myalgias and fatigue decreased but spouse noted increased irritability. By day 7, the headache severity was >8/10, "unrelenting", without photophobia, and myalgias, fatigue was continuing to improve. Physical exam was normal. Day 8 received a lumbar puncture and brain MRI to rule out meningitis (normal). By day 10 all symptoms were resolved. By 31 July, all laboratory abnormalities had normalized (transient anemia, thrombocytopenia, transaminitis (with normal bilirubin and muscle enzymes). Had measurable (low level) anti-smooth muscle and anti-CCP. Cultures and ID serologies non-diagnostic. COMMENTS: Extensive external consultations: Concurrence of infectious disease, special experts and manufacturer representative provided information that makes cause of clinical presentation as a vaccine strain infection highly improbable if not impossible, particularly in a non-immune suppressed individual. To date, infectious disease testing for other concomitant causal infections has not identified a potential cause but some still pending.
Age: 55.0
Sex: M
Vaccine: TYP
Symptoms: Blood lactate dehydrogenase increased, Body temperature increased, Borrelia burgdorferi serology negative, C-reactive protein increased, CSF test normal
Clinical narrative: 55 year old staff physician, active duty and in generally excellent health, predeployment, who finished the 4-dose oral typhoid vaccine (starting 9 Jul 09, every other day with no other vaccines as prescribed). After the 1st dose, in retrospect but at the time not associating it with the vaccine, he noted reduced exercise tolerance that evening doing his usual run and with each passing day, as he took the rest of the doses, he noted worsening malaise, fatigue with new onset headache that worsened with lying down, temperature to 100.6 degrees F, some chills and night sweats but NO RIGORS or GI symptoms, generalized myalgias, and sleep disturbance due to headache pain. HE DENIED ANY nausea, vomiting, diarrhea or abdominal pain. Temperature resolved by day 6 but headache continued, myalgias and fatigue decreased but spouse noted increased irritability. By day 7, the headache severity was >8/10, "unrelenting", without photophobia, and myalgias, fatigue was continuing to improve. Physical exam was normal. Day 8 received a lumbar puncture and brain MRI to rule out meningitis (normal). By day 10 all symptoms were resolved. By 31 July, all laboratory abnormalities had normalized (transient anemia, thrombocytopenia, transaminitis (with normal bilirubin and muscle enzymes). Had measurable (low level) anti-smooth muscle and anti-CCP. Cultures and ID serologies non-diagnostic. COMMENTS: Extensive external consultations: Concurrence of infectious disease, special experts and manufacturer representative provided information that makes cause of clinical presentation as a vaccine strain infection highly improbable if not impossible, particularly in a non-immune suppressed individual. To date, infectious disease testing for other concomitant causal infections has not identified a potential cause but some still pending.
Age: 55.0
Sex: M
Vaccine: TYP
Symptoms: Chills, Complement factor C1 increased, Cryptococcus antigen, Cytomegalovirus test negative, Enterovirus serology test
Clinical narrative: 55 year old staff physician, active duty and in generally excellent health, predeployment, who finished the 4-dose oral typhoid vaccine (starting 9 Jul 09, every other day with no other vaccines as prescribed). After the 1st dose, in retrospect but at the time not associating it with the vaccine, he noted reduced exercise tolerance that evening doing his usual run and with each passing day, as he took the rest of the doses, he noted worsening malaise, fatigue with new onset headache that worsened with lying down, temperature to 100.6 degrees F, some chills and night sweats but NO RIGORS or GI symptoms, generalized myalgias, and sleep disturbance due to headache pain. HE DENIED ANY nausea, vomiting, diarrhea or abdominal pain. Temperature resolved by day 6 but headache continued, myalgias and fatigue decreased but spouse noted increased irritability. By day 7, the headache severity was >8/10, "unrelenting", without photophobia, and myalgias, fatigue was continuing to improve. Physical exam was normal. Day 8 received a lumbar puncture and brain MRI to rule out meningitis (normal). By day 10 all symptoms were resolved. By 31 July, all laboratory abnormalities had normalized (transient anemia, thrombocytopenia, transaminitis (with normal bilirubin and muscle enzymes). Had measurable (low level) anti-smooth muscle and anti-CCP. Cultures and ID serologies non-diagnostic. COMMENTS: Extensive external consultations: Concurrence of infectious disease, special experts and manufacturer representative provided information that makes cause of clinical presentation as a vaccine strain infection highly improbable if not impossible, particularly in a non-immune suppressed individual. To date, infectious disease testing for other concomitant causal infections has not identified a potential cause but some still pending.
Age: 55.0
Sex: M
Vaccine: TYP
Symptoms: Epstein-Barr virus antibody negative, Exercise tolerance decreased, Fatigue, Haematocrit decreased, Headache
Clinical narrative: 55 year old staff physician, active duty and in generally excellent health, predeployment, who finished the 4-dose oral typhoid vaccine (starting 9 Jul 09, every other day with no other vaccines as prescribed). After the 1st dose, in retrospect but at the time not associating it with the vaccine, he noted reduced exercise tolerance that evening doing his usual run and with each passing day, as he took the rest of the doses, he noted worsening malaise, fatigue with new onset headache that worsened with lying down, temperature to 100.6 degrees F, some chills and night sweats but NO RIGORS or GI symptoms, generalized myalgias, and sleep disturbance due to headache pain. HE DENIED ANY nausea, vomiting, diarrhea or abdominal pain. Temperature resolved by day 6 but headache continued, myalgias and fatigue decreased but spouse noted increased irritability. By day 7, the headache severity was >8/10, "unrelenting", without photophobia, and myalgias, fatigue was continuing to improve. Physical exam was normal. Day 8 received a lumbar puncture and brain MRI to rule out meningitis (normal). By day 10 all symptoms were resolved. By 31 July, all laboratory abnormalities had normalized (transient anemia, thrombocytopenia, transaminitis (with normal bilirubin and muscle enzymes). Had measurable (low level) anti-smooth muscle and anti-CCP. Cultures and ID serologies non-diagnostic. COMMENTS: Extensive external consultations: Concurrence of infectious disease, special experts and manufacturer representative provided information that makes cause of clinical presentation as a vaccine strain infection highly improbable if not impossible, particularly in a non-immune suppressed individual. To date, infectious disease testing for other concomitant causal infections has not identified a potential cause but some still pending.
Age: 55.0
Sex: M
Vaccine: TYP
Symptoms: Hepatitis B surface antigen negative, Hepatitis B test negative, Hepatitis C antibody negative, Hepatitis C test negative, Influenza serology
Clinical narrative: 55 year old staff physician, active duty and in generally excellent health, predeployment, who finished the 4-dose oral typhoid vaccine (starting 9 Jul 09, every other day with no other vaccines as prescribed). After the 1st dose, in retrospect but at the time not associating it with the vaccine, he noted reduced exercise tolerance that evening doing his usual run and with each passing day, as he took the rest of the doses, he noted worsening malaise, fatigue with new onset headache that worsened with lying down, temperature to 100.6 degrees F, some chills and night sweats but NO RIGORS or GI symptoms, generalized myalgias, and sleep disturbance due to headache pain. HE DENIED ANY nausea, vomiting, diarrhea or abdominal pain. Temperature resolved by day 6 but headache continued, myalgias and fatigue decreased but spouse noted increased irritability. By day 7, the headache severity was >8/10, "unrelenting", without photophobia, and myalgias, fatigue was continuing to improve. Physical exam was normal. Day 8 received a lumbar puncture and brain MRI to rule out meningitis (normal). By day 10 all symptoms were resolved. By 31 July, all laboratory abnormalities had normalized (transient anemia, thrombocytopenia, transaminitis (with normal bilirubin and muscle enzymes). Had measurable (low level) anti-smooth muscle and anti-CCP. Cultures and ID serologies non-diagnostic. COMMENTS: Extensive external consultations: Concurrence of infectious disease, special experts and manufacturer representative provided information that makes cause of clinical presentation as a vaccine strain infection highly improbable if not impossible, particularly in a non-immune suppressed individual. To date, infectious disease testing for other concomitant causal infections has not identified a potential cause but some still pending.
Age: 55.0
Sex: M
Vaccine: TYP
Symptoms: Irritability, Malaise, Mononucleosis heterophile test negative, Myalgia, Night sweats
Clinical narrative: 55 year old staff physician, active duty and in generally excellent health, predeployment, who finished the 4-dose oral typhoid vaccine (starting 9 Jul 09, every other day with no other vaccines as prescribed). After the 1st dose, in retrospect but at the time not associating it with the vaccine, he noted reduced exercise tolerance that evening doing his usual run and with each passing day, as he took the rest of the doses, he noted worsening malaise, fatigue with new onset headache that worsened with lying down, temperature to 100.6 degrees F, some chills and night sweats but NO RIGORS or GI symptoms, generalized myalgias, and sleep disturbance due to headache pain. HE DENIED ANY nausea, vomiting, diarrhea or abdominal pain. Temperature resolved by day 6 but headache continued, myalgias and fatigue decreased but spouse noted increased irritability. By day 7, the headache severity was >8/10, "unrelenting", without photophobia, and myalgias, fatigue was continuing to improve. Physical exam was normal. Day 8 received a lumbar puncture and brain MRI to rule out meningitis (normal). By day 10 all symptoms were resolved. By 31 July, all laboratory abnormalities had normalized (transient anemia, thrombocytopenia, transaminitis (with normal bilirubin and muscle enzymes). Had measurable (low level) anti-smooth muscle and anti-CCP. Cultures and ID serologies non-diagnostic. COMMENTS: Extensive external consultations: Concurrence of infectious disease, special experts and manufacturer representative provided information that makes cause of clinical presentation as a vaccine strain infection highly improbable if not impossible, particularly in a non-immune suppressed individual. To date, infectious disease testing for other concomitant causal infections has not identified a potential cause but some still pending.
Age: 55.0
Sex: M
Vaccine: TYP
Symptoms: Nuclear magnetic resonance imaging brain normal, Parvovirus B19 serology negative, Red blood cell count decreased, Rickettsia antibody, Sleep disorder
Clinical narrative: 55 year old staff physician, active duty and in generally excellent health, predeployment, who finished the 4-dose oral typhoid vaccine (starting 9 Jul 09, every other day with no other vaccines as prescribed). After the 1st dose, in retrospect but at the time not associating it with the vaccine, he noted reduced exercise tolerance that evening doing his usual run and with each passing day, as he took the rest of the doses, he noted worsening malaise, fatigue with new onset headache that worsened with lying down, temperature to 100.6 degrees F, some chills and night sweats but NO RIGORS or GI symptoms, generalized myalgias, and sleep disturbance due to headache pain. HE DENIED ANY nausea, vomiting, diarrhea or abdominal pain. Temperature resolved by day 6 but headache continued, myalgias and fatigue decreased but spouse noted increased irritability. By day 7, the headache severity was >8/10, "unrelenting", without photophobia, and myalgias, fatigue was continuing to improve. Physical exam was normal. Day 8 received a lumbar puncture and brain MRI to rule out meningitis (normal). By day 10 all symptoms were resolved. By 31 July, all laboratory abnormalities had normalized (transient anemia, thrombocytopenia, transaminitis (with normal bilirubin and muscle enzymes). Had measurable (low level) anti-smooth muscle and anti-CCP. Cultures and ID serologies non-diagnostic. COMMENTS: Extensive external consultations: Concurrence of infectious disease, special experts and manufacturer representative provided information that makes cause of clinical presentation as a vaccine strain infection highly improbable if not impossible, particularly in a non-immune suppressed individual. To date, infectious disease testing for other concomitant causal infections has not identified a potential cause but some still pending.
Age: 55.0
Sex: M
Vaccine: TYP
Symptoms: Smooth muscle antibody positive, Syphilis test negative, Thrombocytopenia, Transaminases increased, Vaccine positive rechallenge
Clinical narrative: 55 year old staff physician, active duty and in generally excellent health, predeployment, who finished the 4-dose oral typhoid vaccine (starting 9 Jul 09, every other day with no other vaccines as prescribed). After the 1st dose, in retrospect but at the time not associating it with the vaccine, he noted reduced exercise tolerance that evening doing his usual run and with each passing day, as he took the rest of the doses, he noted worsening malaise, fatigue with new onset headache that worsened with lying down, temperature to 100.6 degrees F, some chills and night sweats but NO RIGORS or GI symptoms, generalized myalgias, and sleep disturbance due to headache pain. HE DENIED ANY nausea, vomiting, diarrhea or abdominal pain. Temperature resolved by day 6 but headache continued, myalgias and fatigue decreased but spouse noted increased irritability. By day 7, the headache severity was >8/10, "unrelenting", without photophobia, and myalgias, fatigue was continuing to improve. Physical exam was normal. Day 8 received a lumbar puncture and brain MRI to rule out meningitis (normal). By day 10 all symptoms were resolved. By 31 July, all laboratory abnormalities had normalized (transient anemia, thrombocytopenia, transaminitis (with normal bilirubin and muscle enzymes). Had measurable (low level) anti-smooth muscle and anti-CCP. Cultures and ID serologies non-diagnostic. COMMENTS: Extensive external consultations: Concurrence of infectious disease, special experts and manufacturer representative provided information that makes cause of clinical presentation as a vaccine strain infection highly improbable if not impossible, particularly in a non-immune suppressed individual. To date, infectious disease testing for other concomitant causal infections has not identified a potential cause but some still pending.
Age: 55.0
Sex: M
Vaccine: TYP
Symptoms: Vitamin A normal
Clinical narrative: 55 year old staff physician, active duty and in generally excellent health, predeployment, who finished the 4-dose oral typhoid vaccine (starting 9 Jul 09, every other day with no other vaccines as prescribed). After the 1st dose, in retrospect but at the time not associating it with the vaccine, he noted reduced exercise tolerance that evening doing his usual run and with each passing day, as he took the rest of the doses, he noted worsening malaise, fatigue with new onset headache that worsened with lying down, temperature to 100.6 degrees F, some chills and night sweats but NO RIGORS or GI symptoms, generalized myalgias, and sleep disturbance due to headache pain. HE DENIED ANY nausea, vomiting, diarrhea or abdominal pain. Temperature resolved by day 6 but headache continued, myalgias and fatigue decreased but spouse noted increased irritability. By day 7, the headache severity was >8/10, "unrelenting", without photophobia, and myalgias, fatigue was continuing to improve. Physical exam was normal. Day 8 received a lumbar puncture and brain MRI to rule out meningitis (normal). By day 10 all symptoms were resolved. By 31 July, all laboratory abnormalities had normalized (transient anemia, thrombocytopenia, transaminitis (with normal bilirubin and muscle enzymes). Had measurable (low level) anti-smooth muscle and anti-CCP. Cultures and ID serologies non-diagnostic. COMMENTS: Extensive external consultations: Concurrence of infectious disease, special experts and manufacturer representative provided information that makes cause of clinical presentation as a vaccine strain infection highly improbable if not impossible, particularly in a non-immune suppressed individual. To date, infectious disease testing for other concomitant causal infections has not identified a potential cause but some still pending.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a "70 - 80 year old" female with "unknown allergies" and is a patient in a rehabilitation hospital, who on 13-JUN-2008 was vaccinated intramuscularly with a dose of PNEUMOVAX (Lot # 657145/1226U; site unreported). It is unknown if this was the patient's first vaccination with PNUEMOVAX. On an unspecified date, the patient developed an injection site reaction. The reaction was bright red, raised, warm to touch area of 3 - 6 cm at the injection site. The patient sought medical treatment by seeing the nurse and the injection site reaction was being treated with ice. The patient outcome was not reported. No additional information was provided. This is one of three reports from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Noticed round red spot size of a baseball on her arm.  Middle was hard to the touch and very warm.  This was in her left arm in the area of Chicken Pox vaccine.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Induration, Mass
Clinical narrative: (L) leg (pt seen @ urgent care) 2" diameter of redness around a knot - hard area decreases toward knee area with egg size lump per parent.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, PNC
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: Patient developed redness and swelling of L thigh 24-48 hours after administration of vaccine.  Pt. got his 2nd Hep A vaccine too early.  (4 months after the 1st vs 6 months after 1st).
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Skin reaction, Skin warm, Swelling, Urticaria
Clinical narrative: Vaccine given 8/4/09;  Seen on 8/6/09 with 12cmx9cm localized reaction- red, swollen, warm with central urticaria.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 2" x 3" raised erythema on L thigh, slightly tender to palpation.  No fever, otherwise acting normal.
Age: 18.0
Sex: F
Vaccine: HEPA, MMR, MNQ, TDAP
Symptoms: Cold sweat, Dizziness, Dreamy state, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: AFTER RECEIVING VACCINES, CLIENT FELT DIZZY. PATIENT OFFERED WATER AND HAD HER HEAD DOWN BETWEEN HER LEGS AND COLD COMPRESS APPLIED TO BACK OF NECK. AFTER RAISING HER HEAD UP AND VERBALIZING SHE FELT BETTER SHE BLACKED OUT FOR A FEW SECONDS. CLIENT WAS NOTED TO BE PALE AND CLAMMY. PATIENT WOKE UP AND ASSISTED TO FLOOR, WITH LEG HIGHER THAN HEART POSITION. CLIENT HAD VERBALIZED THAT SHE FELT LIKE SHE WAS IN A DREAM STATE. CLIENT FANNED WITH BOOKS FOR COOLER AIR AND CIRCULATION. HAD CLIENT STAY ON FLOOR FOR ABOUT 7 MINUTES AND SLOWLY SIT UP FOR ABOUT 5 MINUTES UNTIL CLIENT VERBALIZED THAT SYMPTOMS WERE GONE. MOM AND CLIENT ADVISED ON HAVING SOMETHING TO EAT AFTER LEAVING HEALTH DEPARTMENT
Age: 18.0
Sex: F
Vaccine: HEPA, MMR, MNQ, TDAP
Symptoms: Pallor
Clinical narrative: AFTER RECEIVING VACCINES, CLIENT FELT DIZZY. PATIENT OFFERED WATER AND HAD HER HEAD DOWN BETWEEN HER LEGS AND COLD COMPRESS APPLIED TO BACK OF NECK. AFTER RAISING HER HEAD UP AND VERBALIZING SHE FELT BETTER SHE BLACKED OUT FOR A FEW SECONDS. CLIENT WAS NOTED TO BE PALE AND CLAMMY. PATIENT WOKE UP AND ASSISTED TO FLOOR, WITH LEG HIGHER THAN HEART POSITION. CLIENT HAD VERBALIZED THAT SHE FELT LIKE SHE WAS IN A DREAM STATE. CLIENT FANNED WITH BOOKS FOR COOLER AIR AND CIRCULATION. HAD CLIENT STAY ON FLOOR FOR ABOUT 7 MINUTES AND SLOWLY SIT UP FOR ABOUT 5 MINUTES UNTIL CLIENT VERBALIZED THAT SYMPTOMS WERE GONE. MOM AND CLIENT ADVISED ON HAVING SOMETHING TO EAT AFTER LEAVING HEALTH DEPARTMENT
Age: 23.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Red, itchy rash on trunk, shest, and upper back
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose normal, Oxygen saturation normal, Syncope
Clinical narrative: Patient had syncope ~ 10 min after receiving the vaccine. At the same time was watching her sibling having blood drawn.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: 7/29/09 TDaP placed in Travel Clinic. Approx. 4 hrs later client began to feel "ache-y" and inj. site begab to swell and become painful. Temp. 101 degrees. Used Tylenol for fever and cold pak for swelling. 7/30 fever consistant and swelling in left deltoid ^, con't Tylenol and cold packs. 8/1 fever gone and swelling decreasing. Client stated "felt normal" by 8/2/09. Swelling cont. to decrease slowly each day.
Age: 19.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Patient received Tdap on 07-31-09. Presented first on 08/03/2009 with fever 99.8 and local site erythema, induration and mild soft tissue swelling. Fever was reported higher by the dorm advisor 2 nights later. Local ice, ibuprofen 400 mg  every 4 hours advised.  Seen again on 08/06/09 still with local reaction.  Added local itching when touching the arm. (Tdap/Adacel by Sanofipasteur)  Received PPD skin test 0n July 29 and read on the 31,2009
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Injection site erythema, Neuralgia
Clinical narrative: Patient reported that she received Zoster vaccine and developed redness around the site of injection.  She reported that three weeks after receiving the vaccine she developed back pain and was seen and evaluated by a doctor for this.  She never broke out in a rash, but had nerve pain in the back.  She was diagnosed with the Shingles and was given Valtrex for one month and tyelenol with codeine for pain relief.  She has been on the Valtrex for one week at this time and is still in pain.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Myalgia, Nausea, Pyrexia, Respiratory rate increased
Clinical narrative: Child received Menactra 8/6/2009am. At 2am on 8/7/2009 became suddenly ill with a high fever, chills, rapid breathing, and bad nausea. Family gave ibuprofen and symptoms improved. Complained of soreness of deltoid muscle on 8/6/2009 evening and used ibuprofen.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Dizziness, Headache, Heart rate increased
Clinical narrative: First, dizziness and diarrhea.  Later, chills, rapid heart beat, fever, aches and pains. On the 6th, diarrhea, head ache.  On 7th diarrhea feeling better.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: First, dizziness and diarrhea.  Later, chills, rapid heart beat, fever, aches and pains. On the 6th, diarrhea, head ache.  On 7th diarrhea feeling better.
Age: 55.0
Sex: U
Vaccine: PNC
Symptoms: Spinal compression fracture
Clinical narrative: subject in pneumococcal vaccine trial, with severe COPD, was hospitalized for thoracic spine compression fracture (T8). Vaccination took place on 1/2/2008. According to the physician the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request.
Age: 54.0
Sex: U
Vaccine: PNC
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized for COPD exacerbation. Vaccination took place on 3/31/2008. According to the physician the relationship is 'Unlikely'. We would be happy to forward the Study's SAE reporting form upon request.
Age: 66.0
Sex: U
Vaccine: PNC
Symptoms: Pneumonia
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD was hospitalized for pneumonia. Vaccination took place on 10/13/2008. According to the physician the relationship is 'Unlikely'. We would be happy to forward Study's SAE reporting form upon request.
Age: 0.5
Sex: M
Vaccine: DTPPHIB, HEP, PNC, RV5
Symptoms: Body temperature increased, Injection site erythema
Clinical narrative: Received 6 mo immunizations on 7/28/09, mother called on 7/29/09 due to temp of 100.9 and red area on right thigh at site of injection.
Age: 55.0
Sex: U
Vaccine: PNC
Symptoms: Pneumonia
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD was hospitalized for community-acquired pneumonia. Vaccination took place on 1/15/2009. According to the physician the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Recieved Prevnar on 7/28/09, on 7/30/09 was seen in this office due to erythema around injection site, area continuuing to spread and is hot and tender. Afebrile
Age: 54.0
Sex: U
Vaccine: PNC
Symptoms: Pneumonia
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD was hospitalized for community-acquired pneumonia. Vaccination took place 4/14/2009. According to the physician the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request.
Age: 56.0
Sex: U
Vaccine: PPV
Symptoms: Large intestine perforation, Peritonitis, Respiratory failure, Small intestinal obstruction
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD was hospitalized for small bowel obstruction with perforated cecum and peritonitis/Ventilator-dependent respiratory failure. Vaccination took place 1/31/2008. According to the physician the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request.
Age: 1.0
Sex: M
Vaccine: MMR, PPV, VARCEL
Symptoms: Decreased appetite, Diarrhoea, Injection site rash, Pyrexia, Rash
Clinical narrative: High fever ranging from 101.5-104 degrees fahrenheit, mild rash across back and neck and at point of injection sight, decreased appetite, severe drowsiness, diahrrea. All symptoms lasted 5 days and began in the evening of day 7 after the vaccine was administered. Took son to the E.R. on day 3 after temp reached 104. The nurse practitioner diagnosed him with adverse reaction to MMR vaccine and diahrrea. I am not sure how accurate that is considering he recieved 3 vaccines at once and all the information said rash and fever are possible. Fever broke on day 5. Gave children's motrin for fever and Pedialyte for diarrhea.
Age: 1.0
Sex: M
Vaccine: MMR, PPV, VARCEL
Symptoms: Somnolence
Clinical narrative: High fever ranging from 101.5-104 degrees fahrenheit, mild rash across back and neck and at point of injection sight, decreased appetite, severe drowsiness, diahrrea. All symptoms lasted 5 days and began in the evening of day 7 after the vaccine was administered. Took son to the E.R. on day 3 after temp reached 104. The nurse practitioner diagnosed him with adverse reaction to MMR vaccine and diahrrea. I am not sure how accurate that is considering he recieved 3 vaccines at once and all the information said rash and fever are possible. Fever broke on day 5. Gave children's motrin for fever and Pedialyte for diarrhea.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Cold sweat, Depressed level of consciousness, Dizziness, Hyperhidrosis, Hypotonia
Clinical narrative: Patient received Tdap.  Approximately 5-8 minutes after receiving the vaccine, patient told mother she could not see or hear and she was dizzy.  She became limp and mother lowered patient to the floor.  Patient was pale, clammy and sweaty. Pupils were fixed and dilated.  She was slow to respond.  BP: 104/80, R: 24-28, P: 120-130.  Patient fully recovered within 30 min.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Pallor, Pupil fixed
Clinical narrative: Patient received Tdap.  Approximately 5-8 minutes after receiving the vaccine, patient told mother she could not see or hear and she was dizzy.  She became limp and mother lowered patient to the floor.  Patient was pale, clammy and sweaty. Pupils were fixed and dilated.  She was slow to respond.  BP: 104/80, R: 24-28, P: 120-130.  Patient fully recovered within 30 min.
Age: 56.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Pain, Pain in extremity, Pyrexia
Clinical narrative: 12 hours after injection, arm became extremely painful, pt unable to move arm  due to pain. Achy from head to toe. Fever. These symptoms began to improve on 8/6/09- 3 days after the injection. He missed at least 2 days of work.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Blister
Clinical narrative: Received Smallpox vaccine on 13JUL2009, on 6AUG2009 I had 2 Blisters pop up. I had Immunizations verifiy that the smallpox spread.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 6.5cmX6.0cm erythematous induration on left lateral thigh, non-tender to touch slightly warm.  Treated with clindamycin.  Recheck in three days.
Sex: F
Vaccine: TDAP
Symptoms: Chills, Diarrhoea, Headache, Pain, Pyrexia
Clinical narrative: 24 hours after receiving Tdap client developed body aches, chills, fever of 102.2, headache, diarrhea.  Symptoms lasted about 9 hrs.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site cellulitis, Urticaria
Clinical narrative: Cellulitis around injection site.  Hives day after injection.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Fatigue, Headache, Nausea
Clinical narrative: Fever 102.5, headache, chills, nausea, body aches, joint pain, fatigue, 2 days
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Fever 102.5, headache, chills, nausea, body aches, joint pain, fatigue, 2 days
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: pt said she had a reaction, it was the size of a golf ball at the site of inj. and the size of grapefruit with big whelps outside the inj. point.  She said it was really hot, red and stung and felt like pins being put in.  She said she went to the doctor.  She said that she still had red around the inj. site and has blisters and it is still the size of a golf ball or bigger.  She notified the store on 8-5-09 in the evening.  She said the doctor gave her a double dose of penicillin in the hip, steroids for 10 days and benadryl.  She said she was also on augmentin now.
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Syncope
Clinical narrative: fainted as leaving clinic after receiving Gardasil and varicella- event happened in clinic
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Information has been received from a certified medical assistant concerning an adult female patient who on an unknown date was vaccinated with a dose of (Lot #660717/0224). Subsequently, the patient experienced a sore shoulder which lasted over one week, the patient had no swelling and redness noted. At the time of reporting the patient was recovering. The certified medical assistant reported that the last year they never received any adverse reaction complaints and this year they had already received five complaints. The reporter has requested a lot check. In follow up the medical assistant reported that the patient was vaccinated on 13-OCT-2008. In October 2008, the patient experienced a sore, stiff arm. Subsequently, the patient recovered from the sore, stiff arm. The medical assistant still administered additional patients using lot # 660717/0224X. However, she now administered it in the patients' hips instead of arms. No adverse events have been reported after she changed injection sites. A standard lot check investigation was performed. All in process quality checks for the lot number 660717/0224X was satisfactory. The lot number 660717/0224X met the requirements of the Agency and was released. This is one of several reports provided by the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 67 year old female with asthma, cholesterol high, type 2 diabetes mellitus, arthritis and PENICILLIN allergy and a history of pneumonia who on 24-NOV-2008 was vaccinated with the second dose of PNEUMOVAX, IM (lot# 662662/0979X).  The date of the first vaccination was unknown.  Concomitant therapy included influenza virus vaccine (manufacturer unknown) administered in opposite arm and other unspecified medications.  On 24-NOV-2008 the patient experienced a local reaction including redness, swelling, and warmth to touch.  On 25-NOV-2008 the patient was seen in office and prescribed BENADRYL and IBUPROFEN.  Follow up information has been received from the registered nurse who reported that on 24-NOV-2008, the patient received the first dose of PNEUMOVAX, IM (lot# 662662/0979X) (initially reported as the second dose by the same reporter).  The patient's erythema and swelling at injection site was 4-5cm in diameter.  The patient was treated with ice and "NSAID" (nonsteroidal anti-inflammatory drug).  Subsequently, the patient recovered.  Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from an RN concerning 70 year old female who on 16-Oct-2008 was vaccinated with a first dose of PNEUMOVAX 23 (lot# 659199/1541U) intramuscularly. Concomitant therapy included AMBIEN. The patient experienced redness, tenderness and warmth at the injection site after vaccination. The time to onset of the symptoms was not available. The patient contacted the office by phone and was recommended to apply cold compresses. No lab diagnostic study was performed. The patient subsequently recovered after 1 week. Additional information has been requested.
Age: 0.21
Sex: F
Vaccine: DTAP, IPV, PNC, RV1
Symptoms: Dehydration, Intussusception, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of intussusception in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). There were no reported concomitant medications or relevant medical history. The subject had not experienced adverse events following previous vaccinations. Concurrent vaccination included DAPTACEL (non-gsk) (Sanofi) given on 8 July 2009; PREVNAR (non-gsk) (Wyeth Labs) given on 8 July 2009; IPOL (non-gsk) (Sanofi) given on 8 July 2009. On 8 July 2009 the subject received 1st dose of ROTARIX (1 ml; oral). The lot number was reported as A41OA733A. On 15 July 2009, 7 days after vaccination with ROTARIX, the subject experienced intussusception and "severe" vomiting. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were improved. The healthcare professional considered the events were probably related to vaccination with ROTARIX.  10/2/09 Hospital records, DC summary, received DOS 7/16/09 to 7/17/09. Assessment: Intussusception. Presented to ER with 2 days of increased vomiting, fussiness, and decreased stooling, no wet diapers. Fever, respirations and heart rate elevated. Rash below chin. Abdomen rigid. Symptoms resolved with air enema. Some ascites.    ICD-9 Codes: 560.0 Intussusception, 276.51 Dehydration. Follow-up information received on 21 August 2009 indicated that the events began on 15 July 2009 and resolving by the following day, 16 July 2009. The subject received an enema for treatment and symptoms resolved. In the reporter's opinion, the events were probably related to treatment with ROTARIX. The child did not receive bowel resection.