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Found 554176 cases in entire database

Case Details (Sorted by Vaccination Date)

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VAERS ID:451821 (history)  Vaccinated:2012-02-21
Age:43.0  Onset:2012-02-21, Days after vaccination: 0
Gender:Female  Submitted:2012-03-14, Days after onset: 21
Location:Foreign  Entered:2012-03-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0074656A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC39033CC IMLA
Administered by: Other     Purchased by: Other
Symptoms: Aggression, Agitation, Asthenia, Fatigue, Feeling abnormal, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling, Local reaction, Mood altered
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of aggression in a 43-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of BOOSTRIX (unknown route and application site). At an unspecified time after vaccination with BOOSTRIX, the subject experienced severe local reaction at injection site. At the time of reporting, on 28 February 2012, the outcome of thee vent was unspecified. Written follow-up information was received on 08 March 2012 from physician. On 21 February 2012 the subject received booster dose of BOOSTRIX (intramuscular, left deltoid). The subject had no underlying or concurrent medical conditions or other risk factors and received no concomitant medication. On 21 February 2012, within hours of vaccination with BOOSTRIX, the subject experienced swelling injection site, injection site redness, injection site pain and injection site-itchy. After treatment with cortisone (Cortisone salbe) and cooling the events resolved. Only small injection site induration was still palpable on 27 February. Additionally the subject experienced mood changes with tiredness, weakness, aggression and excitable, the subject felt like someone else. The events were still present on 25 February 2012, then the events completely resolved. This case was assessed as medically serious by GSK. Latest the time of reporting, on 05 March 2012, all events were resolved.

VAERS ID:452203 (history)  Vaccinated:2012-02-21
Age:0.2  Onset:2012-02-21, Days after vaccination: 0
Gender:Unknown  Submitted:2012-03-19, Days after onset: 26
Location:Foreign  Entered:2012-03-21, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2012066886
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME)SANOFI PASTEURC3575AA0IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This is a spontaneous report from a contactable reporter received from the Medicines and Healthcare Regulatory Authority under reference GB-MHRA-ADR 21532368. A 2-month-old patient of unspecified gender received a dose of PREVENAR 13 intramuscularly on 21Feb2012 and a dose of PEDIACEL intramuscularly on 21Feb2012. On 21Feb2012 the patient experienced left leg became red and hot from the thigh to the ankle and the right leg had a slight reaction, described as 3-4cm. The patient recovered from the events on an unspecified date. The reporter considered the events to be serious and they were medically significant. The MHRA considered the events to be serious for an unspecified reason. No follow-up attempts possible. No further information expected.

VAERS ID:452449 (history)  Vaccinated:2012-02-21
Age:13.0  Onset:2012-02-21, Days after vaccination: 0
Gender:Male  Submitted:2012-03-26, Days after onset: 33
Location:Foreign  Entered:2012-03-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 21Feb2012, 38.5Deg. C
CDC Split Type: B0790812A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB870AJ UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Decreased appetite, Fatigue, Oropharyngeal pain, Pruritus, Pyrexia, Rash, Somnolence, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority (# AT-BASGAGES-120502) and described the occurrence of groggy in a 13-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline), FSME IMMUN (non-gsk). No relevant medical history and no concomitant medications were reported. Previous vaccination included ENGERIX B (GlaxoSmithKline) and FSME IMMUN (non-gsk) given on unspecified dates. On 21 February 2012, the subject received unspecified dose of ENGERIX B (unknown route of administration, unknown site of injection) and unspecified dose of FSME IMMUN (unknown route of administration, unknown site of injection). On 21 February 2012, less than one day after vaccination with ENGERIX B and FSME IMMUN, the subject experienced groggy, tiredness, throat pain, small itching efflorescences on upper part of the body, faintness, fever (up to 38.5 Deg. C), lassitude, stomach pain and inappetence. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 2 March 2012, small itching efflorescences on upper part of the body were resolved and ambulant investigation at pediatric hospital was performed. On 13 March 2012, the other events were resolved. Follow-up information received on 26 March 2012: The subject experienced small itching efflorescences on upper part of the body on 25 February 2012 instead of on 21 February 2012.

VAERS ID:452648 (history)  Vaccinated:2012-02-21
Age:0.2  Onset:2012-02-21, Days after vaccination: 0
Gender:Male  Submitted:2012-03-27, Days after onset: 34
Location:Foreign  Entered:2012-03-29, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: 2012075380
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME)SANOFI PASTEUR  UNUN
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic shock, Angioedema, Bronchospasm, Cardio-respiratory arrest, Convulsion
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Convulsions (narrow), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This is a spontaneous report from a physician (contactable only through Health Authority) received through a foreign Health Authority. Registry case number ES-AGEMED-190046439. A 2-month-old male patient received a dose of PREVENAR 13, a dose of NEISVAC-C, and a dose of PENTAVAC, all on 21Feb2012. Relevant medical history and concomitant medications were not reported. The patient experienced cardio-respiratory arrest, anaphylactic shock with angioedema and bronchospasm, and convulsions on 21Feb2012. The reporter considered the events life-threatening. The patient recovered from cardio-respiratory arrest on an unknown date. The patient was recovering from the event of anaphylactic shock and recovering from the convulsions 12 hours after the event.

VAERS ID:453001 (history)  Vaccinated:2012-02-21
Age:0.2  Onset:2012-02-21, Days after vaccination: 0
Gender:Female  Submitted:2012-04-04, Days after onset: 42
Location:Foreign  Entered:2012-04-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 21Feb2012, 37.1degC
CDC Split Type: B0793228A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMRL
UNK: PNEUMO (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  IMLL
Administered by: Other     Purchased by: Other
Symptoms: Crying, Hypotonia, Injection site pain, Loss of consciousness, Pallor, Presyncope, Screaming, Vaccination complication
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a physician via regulatory authority (NL-LRB-135401) and described the occurrence of vasovagal reaction in a 8-week-old female subject who was vaccinated with SYNFLORIX (GlaxoSmithKline), INFANRIX. Concomitant medication was not reported. The subject had no known medical history and no known past drug therapy. On 21 February 2012, the subject received unspecified dose of SYNFLORIX (intramuscular, left upper thigh), unspecified dose of INFANRIX (intramuscular, right upper thigh). Lot numbers not provided. On 21 February 2012, during vaccination with INFANRIX and SYNFLORIX, the subject started crying. Immediately after, the subject experienced injection site pain and within minutes after vaccination, the baby started screaming for 1 hour until feeding. After feeding, she fell asleep and approximately 4 hours later, she was woken up for the next feeding. During changing her diaper, approximately 6 hours after vaccination, the subject turned pale and limp. She was unconscious for a short period. This event reoccurred for 6 to 10 times during changing the diaper and feeding (approximately 0.5 to 1 hour). This case was assessed as medically serious by GSK. General practitioner was contacted. The diagnosis was vasovagal reaction to vaccination. At the time the physician was visited, the baby was bright and the paleness had disappeared. No pyrexia (temperature 37.1 deg C). The legs were very painful legs upon touching. On 21 February 2012, the events were resolved. The regulatory authority reported that the events were probably related to vaccination with SYNFLORIX and INFANRIX. No further information was available.

VAERS ID:453955 (history)  Vaccinated:2012-02-21
Age:2.0  Onset:2012-02-27, Days after vaccination: 6
Gender:Female  Submitted:2012-04-18, Days after onset: 50
Location:Foreign  Entered:2012-04-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Mycoplasma test, Mar2012, positive; Platelet count, 02Mar2012, 20x10^9/L; Platelet count, 04Mar2012, 8x10^9/L; Platelet count, 28Mar2012, 119x10^9/L
CDC Split Type: B0795979A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER201104027 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Autoimmune thrombocytopenia, Bronchitis, Mycoplasma infection, Mycoplasma test positive, Petechiae, Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician via Sales Representative and described the occurrence of immune thrombocytopenic purpura in a 25-month-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline) and haemophilus influenza type b vaccine (non-gsk). On 21 February 2012, the subject received an unspecified dose of FLUARIX (administration site and route unknown, batch number not provided) and an unspecified dose of Haemophilus influenza type b vaccine (Non-GSK) (unknown). On 27 February 2012, 6 days after vaccination with FLUARIX and Haemophilus influenza type b vaccine (Non-GSK), the subject experienced petechiae without fever. The subject was hospitalised on 5 March 2012. On 2 March 2012, platelet count was 20 x 10^9/L, 8 on 4 March 2012 and 119 on 28 March 2012. Mycoplasma test was positive. The final diagnosis was immune thrombocytopenic purpura, mycoplasma infection and bronchitis. On 26 March 2012, immune thrombocytopenic purpura and bronchitis were resolved. On 28 March 2012, mycoplasma infection was resolved. The physician considered the events were unrelated to vaccination with FLUARIX and Haemophilus influenza type b vaccine (Non-GSK).

VAERS ID:454050 (history)  Vaccinated:2012-02-21
Age:4.0  Onset:2012-02-22, Days after vaccination: 1
Gender:Unknown  Submitted:2012-04-19, Days after onset: 56
Location:Foreign  Entered:2012-04-20, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201203850
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC3546A IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site extravasation, Injection site haematoma, Injection site inflammation, Injection site oedema, Injection site pain, Injection site reaction, Injection site urticaria, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case received from the Health Authorities in a foreign country on 11 April 2012 under the reference number 2012/0094 (HA''s number PLURPLOCR20120320004). A 04-year-old patient, with no reported medical history and concomitant therapy, had received an intramuscular dose of TRIPACEL (batch number C3546AE) in the right arm on 21 February 2012. On 22 February 2012, the patient experienced intense reaction at the injection site exceeding the nearest joint with oedema, erythema, urticarial erythema, pain and bruising on the right arm. The patient also developed urticaria with the largest itchy urticaria on the trunk and upper limbs. Urticaria was less intense on lower limbs. The patient was treated with ZYRTEC, Calcium, FENISTILL locally and generally, and compresses on the arm. On 24 February 2012, urticaria and inflammatory infiltration of the whole vaccinated arm resolved. The patient recovered. The case was assessed as serious due to other medical important condition. The Health Authorities coded injection site reaction, injection site oedema, injection site erythema, injection site urticaria, injection site pain, injection site bruising and urticaria.

VAERS ID:455548 (history)  Vaccinated:2012-02-21
Age:53.0  Onset:0000-00-00
Gender:Female  Submitted:2012-05-14
Location:Foreign  Entered:2012-05-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Intervertebral disc protrusion
Diagnostic Lab Data:
CDC Split Type: PHHY2012DE037821
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABIPUR)NOVARTIS VACCINES AND DIAGNOSTICS 1SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Condition aggravated, Intervertebral disc protrusion
SMQs:
Write-up: Case number PHHY2012DE037821 is an initial spontaneous report from a physician received on 03 May 2012. This report refers to a 53-year-old female patient whose current condition included disc prolapse and her past drugs and concomitant medications were not provided. She was vaccinated with 2 doses of RABIPUR (batch no: not reported) pre exposure or post exposure prophylaxis: not reported through unspecified route and site on 14 Feb 2012 and on 21 Feb 2012. After the second vaccination on an unspecified date, she was presented with disc herniation. It was also reported that her third dose of basic immunization was left out. The outcome of event was not reported. The physician did not report whether the event was suspected to be related to vaccination with RABIPUR.

VAERS ID:494145 (history)  Vaccinated:2012-02-21
Age:16.0  Onset:2012-11-01, Days after vaccination: 254
Gender:Female  Submitted:2013-06-13, Days after onset: 224
Location:Foreign  Entered:2013-06-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Unk
CDC Split Type: B0898340A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA149BA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Gastrointestinal disorder, Headache, Immediate post-injection reaction, Nausea, Orthostatic intolerance, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of orthostatic dysregulation in a 16-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included 1st and 2nd doses of CERVARIX (GlaxoSmithKline, intramuscular, unknown injection site) given on 21 February 2012, the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site). Immediately after vaccination with CERVARIX, the subject experienced gastrointestinal disorder, was queasy ans had headache. Events persisted until around August 2012. In November 2012, 9 months after vaccination with CERVARIX, the subject experienced frequent episodes of syncope and presented at reporter''s hospital. Diagnostic imaging ruled out symptoms including epilepsy at wards such as department of neurosurgery. Orthostatic dysregulation was diagnosed. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting, the subject was under medical care and was treated with METLINE. At the time of reporting, the orthostatic dysregulation was unresolved. The causal relationship between the orthostatic dysregulation and the vaccination with CERVARIX was unspecified.

VAERS ID:526477 (history)  Vaccinated:2012-02-21
Age:17.0  Onset:2013-08-01, Days after vaccination: 527
Gender:Female  Submitted:2014-03-21, Days after onset: 232
Location:Foreign  Entered:2014-03-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0978386A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Temporal lobe epilepsy
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of temporal lobe epilepsy in a 17-year-old female subject who was vaccinated with CERVARIX, (GlaxoSmithKline). Historic vaccination included HPV vaccine (GlaxoSmithKline); intramuscular; given on 17 August 2011 and an unspecified date. The subject had no past medical history of epileptic predispositions such as febrile convulsion. The subject''s eldest brother was diagnosed with another type of epilepsy. On 21 February 2012, the subject received 3rd dose of CERVARIX (.5 ml, intramuscular; lot number not provided). On 1 August 2013, 17 months after vaccination with CERVARIX, the subject experienced temporal lobe epilepsy. The physician considered the event was clinically significant (or requiring intervention). At the time of reporting the event was unresolved. The physician considered the event was related to vaccination with CERVARIX. General temporal lobe epilepsy starts with onset of unilateral temporal lobe seizures, which progresses to bilateral over a long time. Meanwhile, in this case, epilepsy developed with bilateral temporal lobe seizures. Although her eldest brother was diagnosed with another type of epilepsy, the subject was considered extremely unlikely to have a genetic predisposition of epilepsy. A possibility that the event had been triggered by the vaccination with CERVARIX could not be ruled out.

VAERS ID:527988 (history)  Vaccinated:2012-02-21
Age:0.4  Onset:2012-02-21, Days after vaccination: 0
Gender:Female  Submitted:2014-04-10, Days after onset: 778
Location:Foreign  Entered:2014-04-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Positive aluminium allergy test
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER 1SYRLG
Administered by: Unknown     Purchased by: Unknown
Symptoms: Allergy to metals, Blood aluminium abnormal, Haemorrhage, Insomnia, Nodule, Pain, Pruritus
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Itching nodules and contact allergy to aluminium after vaccination INFANRIX® hexa from the manufacturer GlaxoSmithKline. She is really suffering for more than 2 years, cannot sleep at night from the pain, scratches until she bleeds and her condition is getting worse.

VAERS ID:450082 (history)  Vaccinated:2012-02-22
Age:14.0  Onset:2012-02-22, Days after vaccination: 0
Gender:Female  Submitted:2012-02-22, Days after onset: 0
Location:Ohio  Entered:2012-02-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Skin infection
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1441AA0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1726AA1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Syncope w/in 10 minutes of HPV #2 & Hep A #1. No rxn to HPV #1.

VAERS ID:450136 (history)  Vaccinated:2012-02-22
Age:69.0  Onset:2012-02-22, Days after vaccination: 0
Gender:Female  Submitted:2012-02-23, Days after onset: 1
Location:California  Entered:2012-02-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Benicar HCT 40-25 mg, Levothyroxin 0.1 mg, Premarin 0.3 mg, Klor-Con 10 MEQ ER, Amlodipine 10 mg.
Current Illness: Ear infection recently treated with Ampicillin
Preexisting Conditions: asthma, hypothyroid and low blood pressure HCT
Diagnostic Lab Data: to be determined
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Public
Symptoms: Fatigue, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: High fever, 102.2, and overall ache. Extremely tired.

VAERS ID:450141 (history)  Vaccinated:2012-02-22
Age:1.5  Onset:2012-02-22, Days after vaccination: 0
Gender:Male  Submitted:2012-02-23, Days after onset: 1
Location:Tennessee  Entered:2012-02-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: CBC; BCx; UA; UCx; CXR
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4142AA3UNRL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT4119BA0UNLL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0231AA2UNRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9181732UNRA
Administered by: Private     Purchased by: Private
Symptoms: Blood culture, Chest X-ray, Culture urine, Febrile convulsion, Full blood count, Urine analysis
SMQs:, Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Febrile seizure.

VAERS ID:450180 (history)  Vaccinated:2012-02-22
Age:1.3  Onset:2012-02-23, Days after vaccination: 1
Gender:Male  Submitted:2012-02-23, Days after onset: 0
Location:North Carolina  Entered:2012-02-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Unknown     Purchased by: Private
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fever 103.8.

VAERS ID:450198 (history)  Vaccinated:2012-02-22
Age:30.0  Onset:2012-02-22, Days after vaccination: 0
Gender:Female  Submitted:2012-02-23, Days after onset: 1
Location:Ohio  Entered:2012-02-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Same as listed before~Varicella (no brand name)~1~30.17~Patient
Other Medications: None
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 1SYRLA
Administered by: Public     Purchased by: Private
Symptoms: Dizziness, Injection site haematoma, Injection site swelling, Nausea, Pain in extremity, Pyrexia, Vertigo
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Light headed, fever, swelling and bruising around entire area where shot was given. Severe soreness in entire arm. Vertigo, nausea.

VAERS ID:450200 (history)  Vaccinated:2012-02-22
Age:12.0  Onset:2012-02-22, Days after vaccination: 0
Gender:Female  Submitted:2012-02-23, Days after onset: 1
Location:Texas  Entered:2012-02-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0963AA0IMUN
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM110410SCUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B074BA0IMUN
Administered by: Military     Purchased by: Unknown
Symptoms: Sensation of foreign body
SMQs:, Anaphylactic reaction (broad)
Write-up: Sensation of globus (lump in throat) within 10 minutes of receiving HPV#1, Meningococcal, and TdaP.

VAERS ID:450214 (history)  Vaccinated:2012-02-22
Age:0.2  Onset:2012-02-23, Days after vaccination: 1
Gender:Female  Submitted:2012-02-23, Days after onset: 0
Location:California  Entered:2012-02-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vit D Drops
Current Illness: Cold symptoms x 3d
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1346AA0PO 
Administered by: Private     Purchased by: Private
Symptoms: Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Diarrhea explosive per mom. Started today am.

VAERS ID:450248 (history)  Vaccinated:2012-02-22
Age:0.4  Onset:2012-02-22, Days after vaccination: 0
Gender:Female  Submitted:2012-02-24, Days after onset: 2
Location:Virginia  Entered:2012-02-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Saline nasal spray; Multivitamins; Gripe water
Current Illness: None
Preexisting Conditions: Amoxicillin allergy - rash
Diagnostic Lab Data: Bloodwork & urine specimens obtained at ER.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B323AA1UNRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1475AA1UNLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF611771UNLL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41FB212A1PO 
Administered by: Military     Purchased by: Military
Symptoms: Blood test, Body temperature increased, Dyskinesia, Urine analysis, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 3:00 or 4:00pm 3/22/12 temp 100.8. TYLENOL 0.8mL given every 4-6 hours. At 9:00-10:00pm patient had episode of body & extremities stretching out & body & extremities jerking (once). Mother woke her up. She then vomited once. Mother cleaned her up & took her to ER (10:00-10:20). Pt given PEDIALYTE & TYLENOL dose greater than (.8).

VAERS ID:450282 (history)  Vaccinated:2012-02-22
Age:44.0  Onset:2012-02-23, Days after vaccination: 1
Gender:Female  Submitted:2012-02-24, Days after onset: 1
Location:Georgia  Entered:2012-02-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: fever, nausea~Influenza (Seasonal) (Fluzone)~1~43.00~Patient
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSACS28075DA0IMRA
Administered by: Military     Purchased by: Other
Symptoms: Diarrhoea, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Nausea, diarrhea, fever 101 degrees.

VAERS ID:450285 (history)  Vaccinated:2012-02-22
Age:12.0  Onset:2012-02-23, Days after vaccination: 1
Gender:Male  Submitted:2012-02-24, Days after onset: 1
Location:Pennsylvania  Entered:2012-02-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.YK2207 IN 
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0869AA2SCLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Mother noted large amount of redness, swelling, warmth at site of injection. Took child to ER for evaluation and treatment. Prescribed Keflex, Benadryl and Motrin.

VAERS ID:450290 (history)  Vaccinated:2012-02-22
Age:66.0  Onset:2012-02-23, Days after vaccination: 1
Gender:Female  Submitted:2012-02-24, Days after onset: 1
Location:Nebraska  Entered:2012-02-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown-patient marks that she IS NOT on blood thinners, steroids, bronchial dilator or allergies to eggs or component of the flu vaccine.
Current Illness: None
Preexisting Conditions: None noted
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDN56106 IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1241AA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site rash, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Rash length of upper arm, redness and generalized swelling. No itching, shortness of breath or change in circulation. Instructed to apply ice if lump at injection site, use benadryl or calamine lotion on rash, report to MD if swelling increases or does not get better in next 24 hours or shows generalized symptoms.

VAERS ID:450373 (history)  Vaccinated:2012-02-22
Age:11.0  Onset:2012-02-23, Days after vaccination: 1
Gender:Male  Submitted:2012-02-24, Days after onset: 1
Location:New Hampshire  Entered:2012-02-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4053AA0UNRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Large golf-ball sized local reaction on (R) deltoid pink, warm, tender.

VAERS ID:450309 (history)  Vaccinated:2012-02-22
Age:27.0  Onset:2012-02-22, Days after vaccination: 0
Gender:Female  Submitted:2012-02-25, Days after onset: 3
Location:Illinois  Entered:2012-02-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU3869AA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt seen 2/25/2012-pt stated after vaccine had some redness, pruritis, swelling, pain, and warmth at injection site, had low-grade temperature of 99 last 2 days. Has been taking ibuprofen 800 mg every 8 hours. Today redness, swelling and pain improved slightly. Examined patient-had 5 cm area of erythema, moderate swelling, sl warm to touch. As redness/pain improving, will do watchful waiting-continue ibuprofen, ice pack to area. Pt to f/u at this clinic in 24 hours to re-eval site for worsening erythema or symptoms.

VAERS ID:450376 (history)  Vaccinated:2012-02-22
Age:47.0  Onset:2012-02-24, Days after vaccination: 2
Gender:Female  Submitted:2012-02-24, Days after onset: 0
Location:Virginia  Entered:2012-02-26, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lisinopril; SKELAXIN; VICODIN; NAPROSYN
Current Illness: Injury - (R) shoulder/neck
Preexisting Conditions: Per patient Guillain-Barre
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU3869AA IMRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Local reaction
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 6mm red/raised local reaction.

VAERS ID:450368 (history)  Vaccinated:2012-02-22
Age:49.0  Onset:2012-02-24, Days after vaccination: 2
Gender:Female  Submitted:2012-02-24, Days after onset: 0
Location:North Carolina  Entered:2012-02-27, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: cetirizine; fluticasone; B12; vit D; VICTOZA
Current Illness: None
Preexisting Conditions: Hyperlipidemia; DMII controlled
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT427AA IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0812AA IMLA
Administered by: Private     Purchased by: Other
Symptoms: Erythema, Oedema peripheral, Pain, Pain in extremity
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: On 2/24/12 at 10:00 am Pt was given vaccines on 2/22/12. Was given a call at the clinic that pt''s arm was hurting to lift red, swollen, and painful. I had the pt come into be seen by another physician here at the clinic. Pt was evaluated and placed on clindamycin.

VAERS ID:450522 (history)  Vaccinated:2012-02-22
Age:11.0  Onset:2012-02-22, Days after vaccination: 0
Gender:Female  Submitted:2012-02-24, Days after onset: 2
Location:Georgia  Entered:2012-02-27, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Environmental allergies dx: Dec 2011
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0664Z0UNRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0567AA2UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA101260UNLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B074BA0UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0830AA1UNLA
Administered by: Public     Purchased by: Public
Symptoms: Cough, Eye swelling, Odynophagia, Swelling face, Throat irritation
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Itchy throat, needing to cough & swallowing would hurt chest. Face & eyes swollen. Took OTC BENADRYL as directed (1) tab. All within an hour of receiving injections. Went to ER - they gave a shot of BENADRYL in (R) hip & steroid in the left hip. Vaccines given around 4:40 pm. At ER at 6:30.

VAERS ID:450566 (history)  Vaccinated:2012-02-22
Age:29.0  Onset:2012-02-23, Days after vaccination: 1
Gender:Male  Submitted:2012-02-27, Days after onset: 4
Location:Pennsylvania  Entered:2012-02-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB538AA IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0703AA SCRA
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU3870AA IMLA
Administered by: Public     Purchased by: Private
Symptoms: Rash erythematous, Rash pruritic, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Itching red rash and wheals over upper extremities and face.

VAERS ID:450568 (history)  Vaccinated:2012-02-22
Age:23.0  Onset:2012-02-22, Days after vaccination: 0
Gender:Female  Submitted:2012-02-27, Days after onset: 5
Location:Pennsylvania  Entered:2012-02-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1106AA IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0703AA SCRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4015AA IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0868AA SCLA
Administered by: Public     Purchased by: Public
Symptoms: Pyrexia, Rash generalised, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fever, followed by diffuse itching rash over whole body.

VAERS ID:450593 (history)  Vaccinated:2012-02-22
Age:39.0  Onset:2012-02-24, Days after vaccination: 2
Gender:Female  Submitted:2012-02-25, Days after onset: 1
Location:Pennsylvania  Entered:2012-02-27, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4137AA UNRA
Administered by: Public     Purchased by: Unknown
Symptoms: Axillary pain, Hypoaesthesia, Sensation of heaviness
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Pt. received Tdap 2-22-12. States (R) axilla pain with arm "heaviness & numbness" since 2-24-12. Called & spoke with center coordinator, 2-25-12. Came in clinic 2-26-12 BP 180/110 sent to ER.

VAERS ID:450712 (history)  Vaccinated:2012-02-22
Age:68.0  Onset:2012-02-22, Days after vaccination: 0
Gender:Female  Submitted:2012-02-23, Days after onset: 1
Location:Unknown  Entered:2012-02-28, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lidocaine 5%; Enoxaparin sodium; Levothyroxine sodium; Acetaminophen; Fluticasone; Bupropion SR; Simvastatin; Albuterol; SENOKOT; Docusate sodium
Current Illness:
Preexisting Conditions: The patient has no known drug allergies. The patient denies alcohol and tobacco use. Patient has normal liver and kidney function.
Diagnostic Lab Data: The patient has a PMH significant for depression, bipolar disorder, Coronary artery disease, hypertension, hyperlipidemia, hypothyroidism, and anemia.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1723AA SYRRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: The patient got a PNEUMOVAX shot in her right upper arm and developed a 4-5 cm raised erythematous patch which decreased over 24 hours. She has since been discharged.

VAERS ID:450745 (history)  Vaccinated:2012-02-22
Age:11.0  Onset:2012-02-24, Days after vaccination: 2
Gender:Female  Submitted:2012-02-27, Days after onset: 3
Location:Alabama  Entered:2012-02-28, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA101260IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURUH104AA4IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0868AA1SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling, redness of left arm shoulder to elbow.

VAERS ID:450764 (history)  Vaccinated:2012-02-22
Age:78.0  Onset:2012-02-23, Days after vaccination: 1
Gender:Female  Submitted:2012-02-28, Days after onset: 5
Location:California  Entered:2012-02-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: High BP
Diagnostic Lab Data: Had blood work by PMD and was told pain is due to rheumatoid arthritis.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURERUNK IMRA
Administered by: Private     Purchased by: Other
Symptoms: Blood test abnormal, Injection site pain, Pain, Rheumatoid arthritis
SMQs:, Extravasation events (injections, infusions and implants) (broad), Arthritis (narrow)
Write-up: Persistent throbbing pain on R arm (where received the shot) radiating to L arm and down to hips.

VAERS ID:450789 (history)  Vaccinated:2012-02-22
Age:24.0  Onset:0000-00-00
Gender:Male  Submitted:0000-00-00
Location:Illinois  Entered:2012-02-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TTOX: TETANUS TOXOID (NO BRAND NAME)UNKNOWN MANUFACTURER04136BA1UNLA
Administered by: Military     Purchased by: Military
Symptoms: Unevaluable event
SMQs:
Write-up: None stated.

VAERS ID:450794 (history)  Vaccinated:2012-02-22
Age:11.0  Onset:2012-02-22, Days after vaccination: 0
Gender:Male  Submitted:2012-02-28, Days after onset: 6
Location:Michigan  Entered:2012-02-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ROBITUSSIN per ED note
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data: Went to Emergency Dept
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.97251061IMLA
Administered by: Private     Purchased by: Private
Symptoms: Face oedema, Lip swelling, Ocular hyperaemia, Rash generalised
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Glaucoma (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: He had lip swelling, facial edema & entire body rash. He also had eye redness.

VAERS ID:450835 (history)  Vaccinated:2012-02-22
Age:58.0  Onset:2012-02-25, Days after vaccination: 3
Gender:Female  Submitted:2012-02-29, Days after onset: 4
Location:Texas  Entered:2012-02-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Premarin, Zoloft, Zyrtec, sublingual allergy therapy
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4030AA0IMRA
Administered by: Private     Purchased by: Other
Symptoms: Arthralgia, Chills, Malaise, Night sweats, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Generalized joint pain, fever of 100.5 WITH Aleve and Tylenol on board, malaise. Chills and night sweats into Sunday, 2/26/2012 with resolution of all symptoms except malaise.

VAERS ID:450874 (history)  Vaccinated:2012-02-22
Age:23.0  Onset:2012-02-23, Days after vaccination: 1
Gender:Male  Submitted:2012-03-01, Days after onset: 7
Location:North Carolina  Entered:2012-03-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Valtrex 500mg daily for herpes esophagitis, Sucralfate- last dose 1 week ago
Current Illness: Incidental finding of neutropenia when patient presented to ED.
Preexisting Conditions: herpes esophagitis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV3052  
SMALL: SMALLPOX (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Military     Purchased by: Unknown
Symptoms: Chills, Cough, Diarrhoea, Headache, Malaise, Nausea, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fever to 103.3F, body aches, malaise, nausea, intermittent headaches, chills, mild cough, diarrhea.

VAERS ID:450906 (history)  Vaccinated:2012-02-22
Age:38.0  Onset:2012-02-28, Days after vaccination: 6
Gender:Female  Submitted:2012-03-01, Days after onset: 2
Location:Georgia  Entered:2012-03-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NO PAST MEDICAL PROBLEMS, ALLERGIES, MEDICAL CONDITIONS.
Diagnostic Lab Data: DIAGNOSED AS LOCAL ALLERGIC REACTION. PLACED ON TRIAMCINOLONE 0.5% CREAM.
CDC Split Type:
Vaccination
Manufacturer
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Site
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUH140AA0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site rash
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: PATIENT NOTES RED, PRURITIC RASH TO SITE OF YELLOW FEVER VACCINE. DENIES SYSTEMIC REACTION, WHEEZING, SHORTNESS OF BREATH. RASH IS LOCALIZED.

VAERS ID:451099 (history)  Vaccinated:2012-02-22
Age:12.0  Onset:2012-02-22, Days after vaccination: 0
Gender:Male  Submitted:2012-02-22, Days after onset: 0
Location:Oregon  Entered:2012-03-05, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: OR201210
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH498AC0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B074BA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1217AA1SCRA
Administered by: Public     Purchased by: Private
Symptoms: Posture abnormal, Staring, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)
Write-up: Phone call from mother, stated client''s father told her after receiving shots today, pt got into car, began to shake, arms extended out, and eyes open and staring. Episode lasted 30 seconds. Father reported patient doesn''t remember what happened and was alert after episode. Client hadn''t eaten prior to immunizations and he "had been worked up for past couple days about getting immunizations" per mother. I advised mother to follow up with her PCP if she is concerned.

VAERS ID:451112 (history)  Vaccinated:2012-02-22
Age:20.0  Onset:2012-03-04, Days after vaccination: 11
Gender:Male  Submitted:2012-03-05, Days after onset: 1
Location:California  Entered:2012-03-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: patient examination
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A0 LA
Administered by: Military     Purchased by: Military
Symptoms: Eschar, Scab, Vaccination complication
SMQs:
Write-up: Secondary inoculation approx 1/2" inferior to the patients left lower lip from the vermilion border. Eschar appears to be healing at the same stage as the primary vaccine. Patient first noticed sore, self applied pro activ cream (thinking it was acne) then the following morning sore was scabbed and appeared healing normally.

VAERS ID:451189 (history)  Vaccinated:2012-02-22
Age:19.0  Onset:2012-03-01, Days after vaccination: 8
Gender:Male  Submitted:2012-03-06, Days after onset: 5
Location:Puerto Rico  Entered:2012-03-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NO OTHER MEDICATIONS
Current Illness: NONW
Preexisting Conditions: NO SYSTEMIC ILLNESSES, NO ALLERGIES
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1272AA0IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site papule, Injection site pruritus, Injection site vesicles, Vaccination site pain, Vaccination site swelling
SMQs:
Write-up: ITCH IN VACCINE SITE, THEN SWELLING AND PAIN WITH DEVELOPMENT OF PAPULES AND VESICLES IN AREA ON 3/4/12.

VAERS ID:451215 (history)  Vaccinated:2012-02-22
Age:60.0  Onset:2012-02-23, Days after vaccination: 1
Gender:Female  Submitted:2012-03-07, Days after onset: 13
Location:Michigan  Entered:2012-03-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3922AA0IMLA
Administered by: Public     Purchased by: Other
Symptoms: Erythema, Inflammation, Pain, Pruritus, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 2/23/12 pt had pain & inflammation, area 4 cm x 4 cm red & raised, pt went to PCP 2/24/12, antibiotic KEFLEX 500 mg QID & BROLENE ointment. 2/24/12 itching noted.

VAERS ID:451316 (history)  Vaccinated:2012-02-22
Age:66.0  Onset:2012-02-22, Days after vaccination: 0
Gender:Male  Submitted:2012-03-08, Days after onset: 15
Location:North Carolina  Entered:2012-03-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Simvastatin; Nexium; Synthroid
Current Illness: No
Preexisting Conditions: Hypercholesterolemia, Hypothyroidism; GERD
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B073B IM 
Administered by: Unknown     Purchased by: Private
Symptoms: Dizziness, Motion sickness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Patient c/o dizziness, motion sickness- BP was normal and symptoms lessened a few hours later but still lingered 2 days later.

VAERS ID:451370 (history)  Vaccinated:2012-02-22
Age:33.0  Onset:2012-03-07, Days after vaccination: 14
Gender:Male  Submitted:2012-03-09, Days after onset: 2
Location:Maine  Entered:2012-03-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZOLOFT
Current Illness: None
Preexisting Conditions: None; allergy to PCN
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.081320SCRA
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Erythema, Feeling hot, Hypersensitivity, Induration, Injection site pain, Pruritus generalised
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 2 weeks following injection noted generalized itching for one hour followed by redness. Soreness to injection site - increased in soreness & redness over next 2 days. 3 cm firm induration erythema & heat noted. Without adenopathy. T-98. Advised BENADRYL at bedtime & corticosteroid cream. Cellulitis vs delayed allergic reaction.

VAERS ID:451397 (history)  Vaccinated:2012-02-22
Age:39.0  Onset:2012-02-23, Days after vaccination: 1
Gender:Female  Submitted:2012-03-09, Days after onset: 15
Location:Minnesota  Entered:2012-03-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Omega 3, multi vitamin, Vitamin D, 81 MG aspirin
Current Illness: None
Preexisting Conditions: Allergic to Amoxicillin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU4308BA SYR 
Administered by: Public     Purchased by: Other
Symptoms: Mobility decreased, Musculoskeletal pain, Neuralgia, Pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Parkinson-like events (broad), Tendinopathies and ligament disorders (broad)
Write-up: I experienced intense pain (left arm) in the middle of the night after the injection. The intense pain did subside after 2 days. Since that time it is still very painful in the left shoulder area with limited mobility. I also experience shooting nerve pain down the arm into elbow and fingers, up my shoulder into neck and through the middle of my back on left side. I have been taking ibuprofen which really doesn''t seem to do anything to relieve pain. I did see my physician at the two week mark and he suggested an EMG and prescribed Vicodin as needed for sleep which I have not needed. I may pursue EMG at a later time also looking into some physical therapy.

VAERS ID:452093 (history)  Vaccinated:2012-02-22
Age:73.0  Onset:2012-02-22, Days after vaccination: 0
Gender:Female  Submitted:2012-03-19, Days after onset: 25
Location:Utah  Entered:2012-03-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: EKG, Blood work
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1165AA0SCRA
Administered by: Public     Purchased by: Private
Symptoms: Asthenia, Blood pressure increased, Blood test, Body temperature increased, Dyspnoea, Electrocardiogram normal, Heart rate increased, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Weakness, Pain in left arm, increased BP, difficulty breathing, increased HR, admitted to ER, increased temp., EKG and monitored for 6 hrs with no could not find any cause for symptoms.

VAERS ID:452153 (history)  Vaccinated:2012-02-22
Age:23.0  Onset:2012-03-12, Days after vaccination: 19
Gender:Female  Submitted:2012-03-20, Days after onset: 8
Location:Maryland  Entered:2012-03-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Hx of eczema
Preexisting Conditions: Seasonal allergies; Allergy to cats and some soaps
Diagnostic Lab Data: 3/15/12: lesions on thigh and vulva tested positive for orthopox virus (per LRN).
CDC Split Type:
Vaccination
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Site
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEUR   UN
Administered by: Military     Purchased by: Military
Symptoms: Dysuria, Orthopoxvirus test positive, Pain, Paraesthesia, Pruritus, Pyrexia, Skin irritation, Skin lesion, Vulval disorder, Vulvovaginal pruritus
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 23 y/o female who had intimate contact with primary vaccinee (vaccination date of 2/22/12) on 2/26, 2/29, 3/3 and 3/8. During at least one of these encounters the vaccination site dressing came dislodged/off. On 3/11/12 she developed fever, body aches, and vaginal pruritis. On 3/12/12 the pt developed itchy lesions of her thigh and vulva. The pt scratched all of lesions and irritated areas. Additionally, she applied TEMOVATE cream to her vaginal area. She developed a lesion on her back on 3/13/12. Lesion to thigh and vulva tested positive for orthopox virus (per LRN) 3/15/12. Pt used tampons to manage menses 3/12-3/15. Pt was treated with VIG on 3/17/12. Symptoms: Dysuria, Disturbance of skin sensation.

VAERS ID:452181 (history)  Vaccinated:2012-02-22
Age:71.0  Onset:2012-02-28, Days after vaccination: 6
Gender:Male  Submitted:2012-03-20, Days after onset: 20
Location:Alabama  Entered:2012-03-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Has polyneuropathy. Stem cell transplant for P.O.E.M.S Syndrome June 2008
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
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Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4305BA0IDRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Red area, 2 inch circumference on lateral aspect and 4 inches down from shoulder.

VAERS ID:452451 (history)  Vaccinated:2012-02-22
Age:16.0  Onset:2012-02-24, Days after vaccination: 2
Gender:Male  Submitted:2012-02-24, Days after onset: 0
Location:Texas  Entered:2012-03-26, Days after submission: 30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
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Dose
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MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR04098AB0UNRA
Administered by: Private     Purchased by: Unknown
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Rash on body.

VAERS ID:452645 (history)  Vaccinated:2012-02-22
Age:88.0  Onset:2012-02-23, Days after vaccination: 1
Gender:Male  Submitted:2012-03-28, Days after onset: 33
Location:California  Entered:2012-03-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: COUMADIN
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1203USA02585
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1268AA SCUN
Administered by: Other     Purchased by: Other
Symptoms: Cerebrovascular accident, Injected limb mobility decreased, Mobility decreased, Pain in extremity, Wheelchair user
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a physician concerning an 88 year old male patient who on 22-FEB-2012, was vaccinated with ZOSTAVAX (Merck), 0.65 ml, SC (lot number 671142/1268AA, exp 05-NOV-2012). Concomitant therapy included COUMADIN. It was reported that the patient suffered from a stroke on 23-FEB-2012 ("the day after receiving ZOSTAVAX (Merck)"). The patient called into the healthcare professional''s office complaining of his left arm hurting, and the office just thought that it was due to injection site pain, since the vaccine was administered on his left arm. The patients wife told the healthcare professional''s office that he couldn''t lift the arm, the healthcare professional office then received a second call where the patient explained that he was not able to move his left leg. The patient came into the office after that call and had to be wheeled into the office they did not send him to the hospital. On an unknown date, the patient recovered. It was reported that therapy with ZOSTAVAX (Merck) was not reintroduced. Upon internal review, stroke was determined to be an other important medical event. Additional information is not expected.

VAERS ID:452878 (history)  Vaccinated:2012-02-22
Age:35.0  Onset:2012-03-03, Days after vaccination: 10
Gender:Female  Submitted:2012-03-22, Days after onset: 18
Location:New York  Entered:2012-04-03, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Repeating Rubeola titer (qualitative)
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1293AA0SCUN
Administered by: Private     Purchased by: Other
Symptoms: Eye pain, Immediate post-injection reaction, Measles antibody, Pyrexia, Rash, Vision blurred
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: 10 days post vaccine experienced bilateral ocular pain, some blurriness in vision for 5-7 days. Experienced "chest rash"/fever immediately post vaccine - resolved.

VAERS ID:453529 (history)  Vaccinated:2012-02-22
Age:70.0  Onset:2012-02-24, Days after vaccination: 2
Gender:Male  Submitted:2012-03-01, Days after onset: 6
Location:Washington  Entered:2012-04-12, Days after submission: 41
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None known
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1268AA0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site vesicles
SMQs:
Write-up: Received ZOSTAVAX vaccine 2-22-12 at pharmacy. Wife called pharmacy 2-24-12 and reported a 5 inch blister at vaccine site, which she thought was shingles.

VAERS ID:454163 (history)  Vaccinated:2012-02-22
Age:16.0  Onset:2012-03-13, Days after vaccination: 20
Gender:Female  Submitted:2012-04-17, Days after onset: 35
Location:Florida  Entered:2012-04-23, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: (?) Whitehead or daughter nipple (lt) breast
Preexisting Conditions: None
Diagnostic Lab Data: EKG & CXR pending; CBC; CMP normal; TSH, T3 pending
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB539CA0UNLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1229AA0UNLA
Administered by: Private     Purchased by: Public
Symptoms: Dyspnoea, Full blood count normal, Metabolic function test normal, Vision blurred
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)
Write-up: (1) Hard to breath. (2) Vision is foggy but she cans still see.

VAERS ID:457474 (history)  Vaccinated:2012-02-22
Age:14.0  Onset:0000-00-00
Gender:Female  Submitted:2012-06-14
Location:New Hampshire  Entered:2012-06-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: 12/21/2011~HPV (Gardasil)~1~14.00~Patient
Other Medications: Microgestin Fe
Current Illness: No
Preexisting Conditions: Sweet potato allergy; Menorrhagia; Acne
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0840AA1IMLA
Administered by: Private     Purchased by: Public
Symptoms: Syncope, Vaccine positive rechallenge
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Mom called today (6/14/12) and reported that pt fainted 3 wks after GARDASIL #2. Episode approx 3 min. Occurred when pt got out of bed in am. Also reporting today same thing occurred after GARDASIL #1.

VAERS ID:459938 (history)  Vaccinated:2012-02-22
Age:54.0  Onset:2012-02-22, Days after vaccination: 0
Gender:Male  Submitted:2012-06-22, Days after onset: 120
Location:Texas  Entered:2012-07-20, Days after submission: 28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No acute illness; Back pain
Preexisting Conditions: Hepatitis C; Allergic rhinitis; Hypertension; Hyperlipidemia; H/O drug abuse
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1169AA1SYRLA
Administered by: Other     Purchased by: Other
Symptoms: Burning sensation, Chills, Feeling hot, Impaired driving ability, Malaise
SMQs:, Peripheral neuropathy (broad)
Write-up: Day #2: Pt reports that he had reaction to PNEUMOVAX shot yesterday. Has chills and then felt hot. Has resolved now. Day #3 Pt calls and states that he still feels ill post pneumococcal immunization. Wife reports that after shot he could not drive home without driving off of road. When he arrived home he had chills and then turned up. Went to ER where he received steroid injections. Treatment: Methylprednisolone.

VAERS ID:462797 (history)  Vaccinated:2012-02-22
Age:5.0  Onset:2012-02-22, Days after vaccination: 0
Gender:Female  Submitted:2012-02-27, Days after onset: 5
Location:Unknown  Entered:2012-08-17, Days after submission: 171
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: MEDI0015033
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.YL2068 IN 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: A non-serious spontaneous report of patient received expired FLUMIST was received from a health professional concerning a five-year-old female. Neither the patient''s medical history nor concomitant medications were reported. The product expired on 12-Feb-2012. On 22-Feb-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.

VAERS ID:464279 (history)  Vaccinated:2012-02-22
Age:0.5  Onset:2012-09-01, Days after vaccination: 192
Gender:Male  Submitted:2012-09-06, Days after onset: 5
Location:California  Entered:2012-09-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.AHAVB586CA IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1769AA SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1907AA SCLL
Administered by: Unknown     Purchased by: Private
Symptoms: Blister, Pyrexia, Rash pruritic, Scab
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Complains of rash x 2 days. Started as a few spots on face and has been progressive. Now all over trunk, extremities, face. Minimally pruritic. New spots continue to emerge and old spots are filling with fluid/crusting. Has low grade fever first day of illness. He has been in daycare in the past month. Also received 12 month IZs (including varicella) 10 days ago. 10 days post vaccine administration, patient developed rash. Minimally pruritic. New spots continue to emerge and old spots are filling with fluid/crusting. Has low grade fever first day of illness.

VAERS ID:469385 (history)  Vaccinated:2012-02-22
Age:11.0  Onset:2012-02-22, Days after vaccination: 0
Gender:Female  Submitted:2012-10-12, Days after onset: 232
Location:Florida  Entered:2012-10-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: ALLERGIC RHINITIS
Diagnostic Lab Data: PATIENT WAS NOT TAKEN DOCTOR OR HOSPITAL
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH476AD0IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB513AA0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1229AA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4025AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3540AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Headache, Nausea, Pain, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: MOM STATES PATIENT HAD GENERALIZED BODYACHES, HEADACHE, NAUSEA AND VOMITING, FEVER UP TO 103F.

VAERS ID:479654 (history)  Vaccinated:2012-02-22
Age:41.0  Onset:2012-02-25, Days after vaccination: 3
Gender:Female  Submitted:2012-11-05, Days after onset: 254
Location:Oklahoma  Entered:2012-12-03, Days after submission: 28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma
Preexisting Conditions: There was no history of adverse events following previous vaccinations.
Diagnostic Lab Data: UNK
CDC Split Type: A0968469A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  IMAR
Administered by: Public     Purchased by: Private
Symptoms: Faeces pale, Feeling abnormal, Gastrointestinal disorder, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Dementia (broad), Biliary system related investigations, signs and symptoms (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a healthcare professional (also the mother of the subject) and described the occurrence of gastrointestinal symptoms in a 41-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included asthma. On the afternoon of 22 February 2012 the subject received 1st dose of TWINRIX in an unknown arm. On the evening of 25 February 2012, 3 days after vaccination with TWINRIX, the subject experienced systemic events of gastrointestinal symptom, feces pale, muscle pain and feeling physically bad. At the time of the reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with TWINRIX. The nurse/mother was trying to determine if her daughter should receive the second dose of TWINRIX in the vaccination series. She noted that it was not known who administered the vaccine, but stated that she believed probably a nurse or a medical assistant and not a physician.

VAERS ID:486692 (history)  Vaccinated:2012-02-22
Age:1.3  Onset:2012-03-28, Days after vaccination: 35
Gender:Male  Submitted:2013-03-04, Days after onset: 341
Location:New York  Entered:2013-03-12, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Sonogram-fluid collection (L) thigh c/w abscesses
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1475AA3IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9181723IMLL
Administered by: Private     Purchased by: Private
Symptoms: Abscess limb, Oedema peripheral, Ultrasound scan abnormal
SMQs:, Cardiac failure (broad), Angioedema (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Child received Hib & PREVNAR at 15 mnth visit on 2/22/2012. Had small rings, then on 3/28/12, seen for (L) thigh swelling. Sono done on 3/28 c/w with abscess, sent to ER -$g surgery evaluation.

VAERS ID:520154 (history)  Vaccinated:2012-02-22
Age:  Onset:2012-02-22, Days after vaccination: 0
Gender:Unknown  Submitted:2014-01-22, Days after onset: 700
Location:Unknown  Entered:2014-01-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA008555
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1267AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 16-JAN-2012 at 7:30 and on 17-JAN-2012 at 7:30, ZOSTAVAX (Lot # 671141/1267AA) was exposed to -8 degrees C for an estimated total time out of range of 14 hours. On 22-FEB-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671141/1267AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.

VAERS ID:525450 (history)  Vaccinated:2012-02-22
Age:20.0  Onset:2012-02-22, Days after vaccination: 0
Gender:Female  Submitted:2014-03-10, Days after onset: 746
Location:Unknown  Entered:2014-03-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Drug hypersensitivity, diphenhydramine; Drug hypersensitivity; Hypertension; Heart rate irregular; Depression; Migraine; Asthma
Preexisting Conditions: Anaemia, childhood; Diphenhydramine hydrochloride, Drug hypersensitivity; Penicillin, Drug hypersensitivity
Diagnostic Lab Data: 03/06/2012, Human chorionic gonadotropin, positive; 02/22/2012, Pregnancy test, negative
CDC Split Type: WAES1203USA01156
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1261AA2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, Pregnancy test negative
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a nurse, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female patient with asthma, migraines, depression, irregular heartbeat, high blood pressure, penicillin allergy and diphenhydramine allergy and a childhood history of anemia who on 29-SEP-2009 was vaccinated IM with her first dose of GARDASIL (lot # 663452/0671Y, expiration date 18-SEP-2011). On 07-DEC-2009, the patient was vaccinated IM with her second dose of GARDASIL (lot # 661952/1129X, expiration date 12-MAR-2011). On 22-FEB-2012, the patient was vaccinated IM with her third dose of 0.5 ml GARDASIL (lot # 670049/1261AA, expiration date 11-NOV-2013). There was no concomitant medication. A pregnancy test was done on 22-FEB-2012 before the patient received dose 3 and it was negative. On 06-MAR-2012, the patient had a positive urine pregnancy test. Her last menstrual period (LMP) was on 03-FEB-2012, and delivery date (EDD) was on 09-NOV-2012. The patient had sought medical attention by office visit. No treatment was given to the patient. A phone call was placed to the registered nurse who indicated the baby was born at 40 weeks gestational age. No complications during pregnancy. On 11-FEB-2014, the baby was seen at a facility and was diagnosed with flu (MARRS case no 1403USA004648). The R.N. also noted in the baby''s chart that the baby was experiencing behavior problems and was scheduled for an autism review once the baby reaches 18 months of age. Significant information. This case is related to MARRS case no 1403USA004648 (parent-child link). Additional information has been requested.

VAERS ID:525452 (history)  Vaccinated:2012-02-22
Age:1.3  Onset:2014-02-11, Days after vaccination: 720
Gender:Unknown  Submitted:2014-03-10, Days after onset: 26
Location:Unknown  Entered:2014-03-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1403USA004648
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1261AA2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abnormal behaviour, Foetal exposure during pregnancy, Influenza
SMQs:, Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from a nurse, for GARDASIL, a Pregnancy Registry product, concerning an approximately 15 months old child from a 20 year old female patient with asthma, migraines, depression, irregular heartbeat, high blood pressure, penicillin allergy and diphenhydramine allergy and a childhood history of anemia who on 22-FEB-2012 was vaccinated IM with her third dose of GARDASIL (lot # 670049/1261AA, EXP 11-NOV-2013). There was no concomitant medication. A pregnancy test was done on 22-FEB-2012 before the patient received dose 3 and it was negative. On 06-MAR-2012, the patient had a positive urine pregnancy test (MARRS case no. 1203USA01156). Her last menstrual period (LMP) was on 03-FEB-2012, and delivery date (EDD) was on 09-NOV-2012. The patient had sought medical attention by office visit. No treatment was given to the patient. On 11-FEB-2014, the baby was seen and was diagnosed with flu. The R.N. also noted in the baby''s chart that the baby was experiencing behavior problems and was scheduled for an autism review once the baby reaches 18 months of age. The outcome of the events was unknown. This case is related to MARRS case no. 1203USA01156 (parent-child link). Additional information has been requested.

VAERS ID:571135 (history)  Vaccinated:2012-02-22
Age:2.0  Onset:2012-04-13, Days after vaccination: 51
Gender:Male  Submitted:2015-03-24, Days after onset: 1075
Location:New York  Entered:2015-03-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Fever and Febrile Seizure
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Public
Symptoms: Febrile convulsion, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fever and febrile seizure.

VAERS ID:582417 (history)  Vaccinated:2012-02-22
Age:60.0  Onset:2012-03-12, Days after vaccination: 19
Gender:Male  Submitted:2012-05-07, Days after onset: 56
Location:California  Entered:2015-06-17, Days after submission: 1136
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pt tolerated vaccine well per nurse note. 3 weeks later presents to ER c/o of multiple symptoms. Patient reports left arm pain and neck pain, multiple joint pain and BLE edema, ever since receiving vaccine
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1255AA1UNLA
Administered by: Other     Purchased by: Other
Symptoms: Acute kidney injury, Arthralgia, Myalgia, Neck pain, Oedema peripheral, Pain in extremity, Rash
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Tumour lysis syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Myalgia. skin rash, acute renal failure & BLE edema. Acetaminophen.

VAERS ID:451130 (history)  Vaccinated:2012-02-22
Age:18.0  Onset:2012-02-22, Days after vaccination: 0
Gender:Female  Submitted:2012-03-05, Days after onset: 12
Location:Foreign  Entered:2012-03-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood test, 22Feb2012, No abnormality; Electrocardiogram, 22Feb2012, No abnormality
CDC Split Type: B0784013A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA149CA IMAR
Administered by: Other     Purchased by: Other
Symptoms: Blood test normal, Convulsion, Electrocardiogram normal, Immediate post-injection reaction, Shock, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a pharmacist and described the occurrence of syncope in a 18-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 22 February 2012, in the morning, the subject received unspecified dose of CERVARIX (0.5 ml, intramuscular, unknown deltoid). On 22 February 2012, when she stood up immediately after vaccination with CERVARIX, the subject experienced syncope. After that, the subject was brought to the hospital with her guardian in ambulance. The subject''s condition improved after she was treated in an emergency department and she went back home. The pharmacist considered the event was clinically significant (or requiring intervention). At the time of reporting the event was improved. The pharmacist considered the event was related to vaccination with CERVARIX. Follow-up information was received on 29 February 2012: On 22 February 2012, when she stood up immediately after vaccination with CERVARIX, the subject also experienced convulsion and shock. The subject was treated with drip infusion of SOLU-CORTEF. No abnormality was found in electrocardiography or blood test. On 22 February 2012, the events were resolved.

VAERS ID:451171 (history)  Vaccinated:2012-02-22
Age:52.0  Onset:2012-02-22, Days after vaccination: 0
Gender:Female  Submitted:2012-03-06, Days after onset: 13
Location:Foreign  Entered:2012-03-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Chest x-ray, Feb2012, unknown; Electrocardiogram, Feb2012, unknown; Ultrasound chest, Feb2012, unknown
CDC Split Type: D0074645A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB913AH UNUN
Administered by: Other     Purchased by: Other
Symptoms: Chest X-ray, Chest pain, Electrocardiogram, Hypersensitivity, Injection site swelling, Local swelling, Neuralgia, Pleurisy, Pleuritic pain, Pyrexia, Ultrasound chest
SMQs:, Angioedema (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician via a sales representative and described the occurrence of prolonged very severe thoracic pain syndrome (chest pain syndrome) in a 52-year-old female subject who was vaccinated with ENGERIX-B adult (GlaxoSmithKline). On 22 February 2012 the subject received an unspecified dose of ENGERIX-B adult (1 ml, unknown). Approximately two hours post vaccination with ENGERIX-B adult, on 22 February 2012, the subject experienced allergic reaction. Initially anaphylaxis was suspected. This case was assessed as medically serious by GSK criteria. At the time of reporting the outcome of the events was unspecified. Follow-up information was received on 29 February 2012 from the sales representative. The subject did not experience anaphylaxis but prolonged very severe thoracic pain syndrome (chest pain syndrome). The subject was hospitalised for an unknown period of time. At the time of follow-up reporting the outcome of the events was unspecified. On 29 February 2012 the same case was reported by a regulatory authority (# DE-PEI-PEI2012006350). Previous vaccinations included ENGERIX-B adult (GlaxoSmithKline), given in August 2003 and in October 2003. Post vaccination with the second dose of ENGERIX-B adult in October 2003, on an unknown date in 2003, the subject experienced local swelling (injection site swelling). Otherwise past medical history was not provided. On 22 February 2012 the subject received the third dose of ENGERIX-B adult (1 ml, intramuscular, left deltoid). Less than one day post vaccination with ENGERIX-B adult, on 22 February 2012, the subject experienced fever, pleuritis and pleuritic pain right or, by differential diagnosis, neuropathic chest pain right. The subject was hospitalised for an unknown period of time. The events were confirmed by thoracic x-ray, ultrasonography of chest and electrocardiogram (EEG) (results not specified). By differential diagnosis pulmonary embolism and pneumonia have been excluded. At the time of reporting, on 23 February 2012, the events were unresolved. Follow-up information from the reporting physician was still pending.

VAERS ID:451266 (history)  Vaccinated:2012-02-22
Age:14.0  Onset:2012-02-22, Days after vaccination: 0
Gender:Male  Submitted:2012-03-07, Days after onset: 14
Location:Foreign  Entered:2012-03-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood test, normal; Computerized axial tomography, negative; Lumbar puncture, lymphocytic plei
CDC Split Type: B0786139A
Vaccination
Manufacturer
Lot
Dose
Route
Site
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURERVNS1K04B IMUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37B063AE IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test normal, Computerised tomogram normal, Lumbar puncture abnormal, Meningitis viral, Pleocytosis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: This case was reported by a physician via a regulatory authority (# 159996) and described the occurrence of viral meningitis in a 14-year-old male and subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), NEISVAC-C. On 22 February 2012, the subject unspecified dose of BOOSTRIX (intramuscular, unknown site of injection) and unspecified dose of NEISVAC-C (intramuscular, unknown site of injection). On 22 February 2012, less than one day after vaccination with BOOSTRIX and NEISVAC-C, the subject experienced viral meningitis. The subject was hospitalised. Results for blood tests were normal and for computerized axial tomography were negative. A lumbar puncture was also performed and the results were as follows: lymphocytic pleocytosis (60 cells). The subject was treated with SOLDESAM. On 28 February 2012, the event was resolved. The regulatory authority reported that the event was possibly related to vaccination with BOOSTRIX and NEISVAC-C.

VAERS ID:452298 (history)  Vaccinated:2012-02-22
Age:10.0  Onset:2012-02-22, Days after vaccination: 0
Gender:Male  Submitted:2012-03-22, Days after onset: 28
Location:Foreign  Entered:2012-03-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 22Feb2012, more than 39deg.; Body temperature, 24Feb2012, 38.7deg.C
CDC Split Type: B0784613A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB537AB UNUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Chills, Delirium, Fatigue, Feeling cold, Headache, Hyperhidrosis, Hypotonia, Irritability, Malaise, Nausea, Paramnesia, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of cold feeling in a 10-year-old male subject who was vaccinated with HAVRIX JUNIOR (GlaxoSmithKline). On 22 February 2012, the subject received unspecified dose of HAVRIX JUNIOR (unknown route of administration). On 22 February 2012, less than one day after vaccination with HAVRIX JUNIOR, the subject experienced cold feeling, fever, malaise, nausea, headache and huffiness. At the time of reporting the outcome of the events was unspecified. Follow-up information received on 12 March 2012: On 22 February 2012, at midday, the subject received 1st dose of HAVRIX JUNIOR (intramuscular, unknown deltoid). On 22 February 2012, at 07:00 PM, 7 hours after vaccination with HAVRIX JUNIOR, the subject experienced cold feeling, delirium, sweating, fever (more than 39 Deg. C), chills, fever dreams and excessive imagination (fantasy). The same day the subject experienced malaise and huffiness. On 23 February 2012, 1 day after vaccination with HAVRIX JUNIOR, the subject was exhausted but afebrile. On 24 February 2012, 2 days after vaccination with HAVRIX JUNIOR, the subject experienced nausea, headache and floppy. The subject experienced fever again (38.7 Deg. C). On 25 February 2012, 3 days after vaccination with HAVRIX JUNIOR, the subject experienced weakness, no fever. At an unspecified date in February 2012, less than 1 month after vaccination with HAVRIX JUNIOR, the subject experienced nausea again and vomited once. This case was assessed as medically serious by GSK. The subject was treated with MEXALEN and homeopathic medication. On 01 March 2012, all the events were resolved.

VAERS ID:452857 (history)  Vaccinated:2012-02-22
Age:7.0  Onset:2012-02-23, Days after vaccination: 1
Gender:Unknown  Submitted:2012-04-02, Days after onset: 38
Location:Foreign  Entered:2012-04-03, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: not reported
Diagnostic Lab Data: not reported
CDC Split Type: 201203331
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURC3568AB IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug administered to patient of inappropriate age, Erythema, Joint warmth, Rash morbilliform, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Arthritis (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case of misuse, i.e. inappropriate age at vaccine administration, received from the Health Authorities through the local affiliate in a foreign country on 22 March 2012 under the reference number PL-URPL-OCR-20120314003 (local reference number 2012/0083). A 07-year-old patient (gender not specified), with no reported medical history, had received an intramuscular dose of TRIPACEL, batch number C3568AB, on 22 February 2012. TRIPACEL is indicated for children < 7 years old, however the misuse was not reported by the HAs. On 23 February 2012, i.e. the following day post-vaccination, the patient experienced urticaria and morbilliform rash as well as erythema (10 x 30 cm in diameter) including the forearm and the shoulder joint associated with warmth. There was no injection site reaction. The Health Authorities coded "erythema ", "urticaria" and "rash morbilliform". The patient recovered on an unspecified date. The case was reported as serious, i.e. as a medically important condition. Documents held by sender: none.

VAERS ID:453176 (history)  Vaccinated:2012-02-22
Age:13.0  Onset:2012-02-22, Days after vaccination: 0
Gender:Female  Submitted:2012-04-06, Days after onset: 43
Location:Foreign  Entered:2012-04-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergic Rhinitis
Preexisting Conditions: Asthma
Diagnostic Lab Data: Blood pressure, 22Feb2012, 90/55mmHg; Blood pressure, 22Feb2012, 95/61mmHg; Blood pressure, 22Feb2012, 83/47mmHg; Blood pressure, 22Feb2012, 91/56mmHg; Oxygen saturation, 22Feb2012, 98%; Pulse rate, 22Feb2012, 77bpm; Pulse rate, 22Feb2012, 72bpm; Pulse rate, 22Feb2012, 46bpm; Pulse rate, 22Feb2012, 67bpm
CDC Split Type: B0784443A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA149BA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure decreased, Feeling abnormal, Heart rate decreased, Pallor, Presyncope
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of vagal reaction in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 22 February 2012, the subject received unspecified dose of CERVARIX (0.5 ml, intramuscular, unknown injection site, batch number not provided). On 22 February 2012, 7 minutes after vaccination with CERVARIX, the subject experienced feels poorly, facial pallor and decreased pulse rate. The blood pressure was 83/47 mmHg, oxygen saturation as measured using pulse oximetry (SpO2) was 98% and the pulse rate lowered to 46 bpm. The subject was placed at bed rest with the lower extremities elevated. The blood pressure and the pulse rate recovered to 90/55 mmHg and 67 bpm, respectively ten minutes later. At the time of reporting the events were improved. The physician considered the events were related to vaccination with CERVARIX. Follow-up information received on 2 March 2012: On 22 February 2012, 7 minutes after vaccination with CERVARIX, the subject also experienced decreased blood pressure. At the time of reporting the events were improved. Follow up information received on 28 March 2012 (case upgraded to serious): The subject''s medical history included asthma. Concurrent medical conditions included allergic rhinitis. On 22 February 2012 (at 17:20), the subject received 3rd dose of CERVARIX (0.5 ml, intramuscular, left upper arm). On 22 February 2012 (around 17:27), 7 minutes after vaccination with CERVARIX, the subject complained of feeling poorly; she was sitting on a chair, but she experienced facial pallor with the blood pressure of 83/47 mmHg, pulse rate of 46 beats per minute and oxygen saturation measured by pulse oximetry (SPO2) of 98%. It was diagnosed that the event was vagal reflex by the intramuscular vaccination of CERVARIX and the subject was laid down with the lower extremities raised by putting a mat under them The physician considered the events were clinically significant (or requiring intervention). On 22 February 2012 (at 17:40), the feeling poorly improved gradually with the blood pressure of 90/55 mmHg, pulse rate of 67 beats per minute and oxygen saturation of 98%. On 22 February 2012 (at 17:52), the feeling poorly continued improving, the blood pressure was 95/61 mmHg and pulse rate was 7 beats per minute in a sitting position, and no subjective symptom in particular was noticed any more. On 22 February 2012 (at 18:00), no feeling poorly was noted even in a standing position. It was considered that vasovagal reflex improved because the complexion of the facial surface became almost normal and the blood pressure and pulse rate were stable at 91/56 mmHg and 77 beats per minute, respectively, then the patient was allowed to go back to her home.

VAERS ID:454049 (history)  Vaccinated:2012-02-22
Age:5.0  Onset:2012-02-22, Days after vaccination: 0
Gender:Unknown  Submitted:2012-04-19, Days after onset: 56
Location:Foreign  Entered:2012-04-20, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Not reported
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 201203853
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC3568A IMUN
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURE5985 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Bone pain, Cough, Injection site rash, Injection site reaction, Muscular weakness, Nasopharyngitis, Pyrexia, Rash papular, Urticaria
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Osteonecrosis (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Initial report received from the Health Authorities in a foreign country on 11 April 2012 under the reference number PL-URPL-OCR-20120320005. A 05-year-old patient (unspecified gender), with no reported medical history and concomitant medications, had received an intramuscular dose of TRIPACEL (batch number C3568AB) and an intramuscular dose of IMOVAX POLIO (batch number E5985-1) on 22 February 2012. On the same day, post-vaccination, the patient experienced injection site reaction (diameter more than 10 cm), fever at 38.9 C. Then in the night he presented with pain in bone and joint, papular rash, cough, catarrh and urticaria. Two days post-vaccination, the patient also experienced muscle weakness. The patient recovered from all events on an unspecified date. The case was assessed as serious due to other medical important condition. The Health Authorities coded injection site reaction, fever, pain, injection site rash, cough, catarrh, muscle weakness and urticaria.

VAERS ID:454242 (history)  Vaccinated:2012-02-22
Age:16.0  Onset:2012-03-01, Days after vaccination: 8
Gender:Female  Submitted:2012-04-24, Days after onset: 53
Location:Foreign  Entered:2012-04-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Nasopharyngitis
Preexisting Conditions: Infantile Asthma
Diagnostic Lab Data: Platelet count, 01Mar2012, 70000cells/mm3; Platelet count, 05Mar2012, 80000cells/mm3; Platelet count, 15Mar2012, 70000Cells/mm3
CDC Split Type: B0787575A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Idiopathic thrombocytopenic purpura, Nasopharyngitis, Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a pharmacist and described the occurrence of idiopathic thrombocytopenic purpura in a 16-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included infantile asthma. Concurrent medical conditions included nasopharyngitis. Concurrent vaccination included CERVARIX; GlaxoSmithKline; intramuscular; unknown given on an unspecified date. Concurrent medications included Unknown (Unknown drug). On 22 February 2012, the subject received 3rd dose of CERVARIX (intramuscular, unknown arm, lot number not provided). On 1 March 2012, 8 days after vaccination with CERVARIX, the subject experienced platelets decreased. Blood investigation showed platelet count was at 70000 cells/mm^3. On 5 March 2012, platelet count was at 80000 cells/mm^3. At the time of reporting, the event was improved. Follow up information received on 16 March 2012: In March 2012, less than one month after vaccination with CERVARIX, the subject experienced common cold. On 15 March 2012, the subject visited the reporting physician''s hospital again, and Platelet count was decreased again (70000 cells/mm3). The cause of the symptom was considered to be unknown and she was referred to another Hospital. Follow-up information received on 17 April 2012: The case was upgraded to serious. On 1 March 2012, 8 days after vaccination with CERVARIX, the subject experienced idiopathic thrombocytopenic purpura. This case was assessed as medically serious by GSK.

VAERS ID:454327 (history)  Vaccinated:2012-02-22
Age:43.0  Onset:2012-02-23, Days after vaccination: 1
Gender:Female  Submitted:2012-04-24, Days after onset: 60
Location:Foreign  Entered:2012-04-25, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2012NL032441
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM10104 SYRRA
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis staphylococcal, Culture positive, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Case number PHHY2012NL032441 is an initial spontaneous report received from nurse via foreign Health Authority (NL-LRB-135458) on 16 Apr 2012: This report refers to an adult female patient. She had no past medical history or family history. She did not use any co medication. She was vaccinated with MENVEO (batch number: M10104) into the right upper arm on 22 Feb 2012. On 23 Feb2012, she experienced cellulitis along with painful, swollen and red upper arm. Reportedly, she was hospitalized three to four days later with signs of cellulitis. She was treated intravenously with an undetermined antibiotic. She was also treated with ice packs and some unspecified medications. Approximately one week after vaccine administration she was discharged from hospital. Later microbiological culture was performed which showed the presence of a unspecified staphylococcus, "it concerned staphylococcus cellulitis". Physical findings and investigations were not available at the time of this report. The patient recovered on an unknown date. Duration of the event was reported to be one week. Causality was assessed as possible due to temporal association and location of the event at the site of administration.

VAERS ID:455714 (history)  Vaccinated:2012-02-22
Age:4.0  Onset:2012-02-22, Days after vaccination: 0
Gender:Unknown  Submitted:2012-05-16, Days after onset: 83
Location:Foreign  Entered:2012-05-17, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: not reported
Diagnostic Lab Data: not reported
CDC Split Type: 201204845
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURC3568AB IMAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Injection site reaction, Oedema, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case received from the Health Authorities through the local affiliate in a foreign country on 08 May 2012 under the reference number PL-URPL-OCR-20120405003 (local reference number 2012/0132). A 05-year-old patient (gender not specified), with no reported medical history, had received an intramuscular dose of TRIPACEL, batch number C3568AB, in the arm, on 22 February 2012. On 22 February 2012, post-vaccination, the patient experienced an intensified reaction at the injection site (more than 10 cm in diameter). On 22 February 2012, the patient developed oedema and redness of almost the whole arm with itching. There was no pain. The patient''s oedema appeared in the night of 22-23 February 2012. The patient was in a good general condition with body temperature at 36.6 degrees C. At the time of the report, the patient''s oedema and redness were smaller. The Health Authorities coded "injection site reaction" and "swelling arm". The patient recovered on an unspecified date. This case was assessed as serious by the HAs, i.e. as an important medical condition. Documents held by sender: none.

VAERS ID:471223 (history)  Vaccinated:2012-02-22
Age:0.4  Onset:2012-02-22, Days after vaccination: 0
Gender:Female  Submitted:2012-10-23, Days after onset: 243
Location:Foreign  Entered:2012-10-24, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient received first vaccination with ACT-HIB and DI-TE-KI-POL at three months (15-Dec-2011), without any AE. On 03-Feb-2012 it was noted in the patient''s medical records that she had a cold with some cough, and had been febrile for a few days. Her throat was red, and she had a streptococcus A infection.
Diagnostic Lab Data:
CDC Split Type: E201207090
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPIPV: DTP + IPV (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNUN
HIBV: HIB (ACTHIB)SANOFI PASTEUR 1SYRUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pyrexia, Rash erythematous, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Case received from health care professional via the other company on 15-Oct-2012. Case medically confirmed. A 5-month-old female patient had received an injection of ACT-HIB (batch number not reported, dose 2) and concomitant with DI-TE-KI-POL (batch number not reported, dose 2) on 22-Feb-2012 and later on the same day she developed a red rash, high fever and was unresponsive. It was reported that 6.5 hours post vaccination the girl developed high fever of 40 degrees and a red non-itching rash. The parents thought she was unresponsive for about 30 minutes. An ambulance was called, but upon their arrival the girl was fine, and she was not sent to hospital. The rash was recovered one day later. The patient received first vaccination with ACT-HIB and DI-TE-KI-POL at three months (15 -Dec-2011), without any AE. On 03-Feb-2012 it was noted in the patient''s medical records that she had a cold with some cough, and had been febrile for a few days. Her throat was red, and she had a streptococcus A infection. At the time of reporting, the outcome was recovered. No further information expected. Additional information was received from other company on 18-Oct-2012: Stated in the report: "From the available it cannot be excluded that there is a causal relationship between the vaccination and the reaction "unresponsive to stimuli" and therefore it is assessed as a possible adverse event". No further information expected.

VAERS ID:479819 (history)  Vaccinated:2012-02-22
Age:1.0  Onset:2012-02-22, Days after vaccination: 0
Gender:Male  Submitted:2012-12-27, Days after onset: 309
Location:Foreign  Entered:2012-12-31, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: First dose PREVENAR 13, Crying; First dose INFANRIX HEXA, Crying; Second dose PREVENAR 13, Fever; Second dose PREVENAR, Local reaction; Second dose INFANRIX HEXA, Fever; Second dose INFANRIX HEXA, Drug reaction; Febrile convulsion, occurred when the patient was 3-month-old and was treated with benzodiazepines
Diagnostic Lab Data: 22-FEB-2012, Body temperature, 39 Centigrade
CDC Split Type: 2012327642
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA21FB281B2IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF492412IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Clonus, Gaze palsy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This is a spontaneous report received from the foreign Regulatory Authority. Regulatory Authority report number 186476. A physician (contactable through Regulatory Authority only) referred that a 12-month-old male patient of unspecified ethnicity received the third dose of PREVENAR 13 (lot # F49241 expiration date: 31Mar2014) at 0.5 ml single dose intramuscularly on 22Feb2012 at 09:00 and the third dose of INFANRIX HEXA (lot # A21FB218B expiration date 31Mar2014) at 0.5 ml single dose intramuscularly on 22Feb2012 at 09:00. Medical history included febrile convulsion (occurred when the patient was 3-month-old and was treated with benzodiazepines). Patient''s concomitant medications were not reported. The patient experienced crying when he had received the first dose of PREVENAR 13 and INFANRIX HEXA. He experienced pyrexia and local reaction when he had received the second dose of PREVENAR 13 and INFANRIX HEXA. On 22Feb2012, after third dose vaccinations, he experienced fever (body temperature 39C), clonus at limbs and gaze palsy. The patient was treated with tachipirina and recovered after 5 minutes. The patient was visited at the Emergency room where no other therapy was administered. At the time of reporting the patient recovered from all events.

VAERS ID:487128 (history)  Vaccinated:2012-02-22
Age:14.0  Onset:2012-02-22, Days after vaccination: 0
Gender:Female  Submitted:2013-03-18, Days after onset: 389
Location:Foreign  Entered:2013-03-18
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Epilepsy; Febrile convulsion
Diagnostic Lab Data: Nuclear magnetic resonance ima, normal
CDC Split Type: B0874446A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA149CA2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test normal, Distractibility, Gait disturbance, Malaise, Nuclear magnetic resonance imaging normal, Pain, Rheumatoid factor negative
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician via a regulatory authority (# HPV-1004) and described the occurrence of malaise in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included epilepsy and febrile convulsion. On an unspecified date, the subject received 2nd dose of CERVARIX (intramuscular, administration site unknown). At the time of vaccination, the subject complained of malaise but had no problem. On 22 February 2012, the subject received 3rd dose of CERVARIX (intramuscular, administration site unknown). Less than one day after vaccination with CERVARIX, the subject experienced malaise, gait disturbance and generalized pain (shoulder pain which spread to arms, wrists, back, hip joints and knees). The sites of pain differed from day to day. The pain was as if the internal organs were squeezed out. In May 2012, the pain intensified. The physician considered the events were disabling. Between August and September 2012, although the subject visited several clinics of internal medicine, the values associated with collagen disorder including the rheumatoid arthritis factor on blood tests and magnetic resonance imaging showed no abnormal findings. The subject had difficulty in walking before but had no paralysis. Her intelligence didn''t decrease but she appeared to be distracted. No abnormality was noted in her daily conversation. At the time of reporting, the events were unresolved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:489891 (history)  Vaccinated:2012-02-22
Age:15.0  Onset:2012-03-01, Days after vaccination: 8
Gender:Female  Submitted:2013-04-23, Days after onset: 417
Location:Foreign  Entered:2013-04-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0885042A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA148CB2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Pain in extremity
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a physician and described the occurrence of knee pain in a 16-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Historic vaccination included CERVARIX;GlaxoSmithKline; intramuscular; given on 20 August 2011 and 21 September 2011. On 22 February 2012, the subject received 3rd dose of CERVARIX (intramuscular unknown injection site; lot number not provided). In March 2012, 1 month after vaccination with CERVARIX, the subject experienced knee pain. At the time of reporting the event was unresolved. The physician considered the event was related to vaccination with CERVARIX. Follow-up information received ion 16 April 2013: The case was upgraded to serious by the reporter. In March 2012, 1 month after vaccination with CERVARIX, the subject experienced knee pain, elbow pain and thumb pain. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:450154 (history)  Vaccinated:2012-02-23
Age:40.0  Onset:2012-02-23, Days after vaccination: 0
Gender:Male  Submitted:2012-02-23, Days after onset: 0
Location:Virginia  Entered:2012-02-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4104AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt. deltoid muscle swelled immediately after Tdap injected to approximately 50 mm in diameter. Deltoid muscle was red. Ice was applied. Pt. reported no pain, 50mg oral BENADRYL given. Dr. evaluated pt.

VAERS ID:450205 (history)  Vaccinated:2012-02-23
Age:1.3  Onset:2012-02-23, Days after vaccination: 0
Gender:Female  Submitted:2012-02-23, Days after onset: 0
Location:Tennessee  Entered:2012-02-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU3282DA3IMRL
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSAHIBC260BA0IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETH9163043IMLL
Administered by: Public     Purchased by: Private
Symptoms: Injection site reaction, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 2-3 cm welt that extended up thigh about 5 minutes after injection of HIBERIX & PREVNAR - has received PREVNAR before with no problems. Cold compresses & 6.25 mg BENADRYL.

VAERS ID:450284 (history)  Vaccinated:2012-02-23
Age:0.2  Onset:2012-02-23, Days after vaccination: 0
Gender:Female  Submitted:2012-02-24, Days after onset: 1
Location:Pennsylvania  Entered:2012-02-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamins with Iron
Current Illness: No. Feeding and growing preterm infant.
Preexisting Conditions: Prematurity (ex 25 wks)
Diagnostic Lab Data: Blood culture (pending) CBC w/diff (abnormal) CRP (abnormal) ABG (WNL for pt)
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B323AA0IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH521AA0IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF611770IMRL
Administered by: Public     Purchased by: Other
Symptoms: Apnoea, Blood culture, Blood gases normal, Bradycardia, C-reactive protein abnormal, Differential white blood cell count abnormal, Full blood count abnormal, Oxygen saturation decreased, Tachypnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haematopoietic leukopenia (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Eosinophilic pneumonia (broad), Myelodysplastic syndrome (broad), Respiratory failure (narrow)
Write-up: Infant started to have desaturations and tachypnea, followed within a hour by apnea and bradycardia. Required Oxygen via Nasal Cannula and a sepsis work up.

VAERS ID:450513 (history)  Vaccinated:2012-02-23
Age:4.0  Onset:2012-02-24, Days after vaccination: 1
Gender:Female  Submitted:2012-02-27, Days after onset: 3
Location:North Carolina  Entered:2012-02-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: At different doctor''s office~Pertussis (no brand name)~UN~0.00~Patient
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B184AA IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1406AA1SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0708AA1SCLL
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 10cm area of swelling & erythema on (R) thigh at site of injection.

VAERS ID:450543 (history)  Vaccinated:2012-02-23
Age:18.0  Onset:2012-02-24, Days after vaccination: 1
Gender:Female  Submitted:2012-02-27, Days after onset: 3
Location:Washington  Entered:2012-02-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Levonrgestrel-ethinly Estrad 0.15-30 Mg-Mcg tab -once daily
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3921AA IMLA
Administered by: Unknown     Purchased by: Public
Symptoms: Diarrhoea, Dizziness
SMQs:, Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow)
Write-up: Diarrhea, fever, dizziness.

VAERS ID:450567 (history)  Vaccinated:2012-02-23
Age:13.0  Onset:2012-02-23, Days after vaccination: 0
Gender:Female  Submitted:2012-02-27, Days after onset: 4
Location:North Carolina  Entered:2012-02-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Penicillin Allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB541CA0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1291AA1IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1224AA1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Dizziness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Vaccine was administered and about 3 minutes after administration the patient said she felt dizzy and then had a syncopal episode lasting less than one minute. The patient was already seated but I supported her weight so she did not fall out of the chair. Dr. was immediately notified and came to the exam room. Once the patient was able, she was assisted to the exam table to lay down and Dr. assessed her (pulse, orienteation); patient was oriented and pulse was normal. We kept her in the room for 25 minutes for observation and her condition improved after about 15 minutes, and she was sitting up, drinking water and talking with her siblings and mother.

VAERS ID:450584 (history)  Vaccinated:2012-02-23
Age:11.0  Onset:2012-02-24, Days after vaccination: 1
Gender:Female  Submitted:2012-02-27, Days after onset: 3
Location:Idaho  Entered:2012-02-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH506AB IMRL
TDAP: TDAP (ADACEL)SANOFI PASTEURC3921AA IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1143AA SCLL
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Mom called - pt has red, raised rash around injection site, pt c/o itching notified to use TYLENOL & BENADRYL prn.

VAERS ID:450599 (history)  Vaccinated:2012-02-23
Age:14.0  Onset:2012-02-23, Days after vaccination: 0
Gender:Female  Submitted:2012-02-24, Days after onset: 1
Location:Michigan  Entered:2012-02-27, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: citalopram; ADVAIR
Current Illness: None
Preexisting Conditions: Allergy: ATIVAN; hx of psi pleura nerve sheath tumor right chest wall
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1723AA0SCRA
Administered by: Public     Purchased by: Other
Symptoms: Dizziness, Injection site erythema, Injection site oedema, Nausea, Neck pain, Pain in extremity
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Patient has complaint of pain right arm that radiates to neck. Right upper arm edematous with 7 x 8 in erythema. Also experienced some dizziness & nausea & lightheadedness.

VAERS ID:450600 (history)  Vaccinated:2012-02-23
Age:17.0  Onset:2012-02-23, Days after vaccination: 0
Gender:Male  Submitted:2012-02-27, Days after onset: 4
Location:Wisconsin  Entered:2012-02-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Allergies; PCN; CEFTIN; CEFZIL
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B074AA IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0820AA1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Mother noted left arm redness, swollen, hard, warm to the touch on back of (L) upper arm. First noted pain night of 2/23/2012. As of 2/27/12 redness is gone, but still firm to the touch.

VAERS ID:450650 (history)  Vaccinated:2012-02-23
Age:78.0  Onset:2012-02-25, Days after vaccination: 2
Gender:Male  Submitted:2012-02-28, Days after onset: 3
Location:Massachusetts  Entered:2012-02-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Hypertension; Hyperlipidemia
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)MASS. PUB HLTH BIOL LABA041A IMLA
Administered by: Private     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Physician reports being paged on Sat. 2/25/12 by patient with swelling, redness and warmth at site of injection. On 2/27/12 patient updates office that symptoms have resolved.

VAERS ID:450655 (history)  Vaccinated:2012-02-23
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2012-02-27
Location:Michigan  Entered:2012-02-28, Days after submission: 1
Life Threatening? No
Died? Yes
   Date died: 2012-02-26
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1441AA1IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1495AA2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Death
SMQs:
Write-up: None at time of service. Pt. expired 2-26-12.

VAERS ID:450771 (history)  Vaccinated:2012-02-23
Age:59.0  Onset:0000-00-00
Gender:Female  Submitted:2012-02-28
Location:California  Entered:2012-02-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Thyroid; Acid-reflux
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1600AH SCLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient called this morning complaining that injection site had become swollen, red, and very itchy. The adverse reaction started after injection and lasted several days. Patient reports that the reaction is improving and going away.

VAERS ID:450824 (history)  Vaccinated:2012-02-23
Age:52.0  Onset:2012-02-23, Days after vaccination: 0
Gender:Female  Submitted:2012-02-29, Days after onset: 6
Location:Maryland  Entered:2012-02-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fish oil supplement
Current Illness: Pt denies any illness. But stated that once s/s started, she ignored them since her work place is so cold.
Preexisting Conditions: Allergic to Sulfa. Had similiar s/s after Tdap vaccine as she had after taking Sulfa.
Diagnostic Lab Data: NA
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3941AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Chills, Headache, Heart rate increased, Injection site mass, Injection site pain, Injection site swelling, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fever, chills, headache, nausea, and intermittent rapid heartrate that evening. Also had lump at injection site, with swelling and soreness. Took Motrin/Advil which helped s/s. Symptoms subsided by early afternoon the next day. Feels fine now (2-29-12).

VAERS ID:450884 (history)  Vaccinated:2012-02-23
Age:48.0  Onset:2012-02-25, Days after vaccination: 2
Gender:Female  Submitted:2012-03-01, Days after onset: 5
Location:Texas  Entered:2012-03-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: NKDA - No medical condition
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4304BA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Lip blister
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Rec''vd Tdap 2/23/12 - 2 days later noticed redness, itching 1 in below injection site - on 2-28-12 noticed more redness et itching. Pain only when scratches, area warm to touch. No fever - had blister lower lip - no other problems.

VAERS ID:450908 (history)  Vaccinated:2012-02-23
Age:22.0  Onset:2012-02-23, Days after vaccination: 0
Gender:Male  Submitted:2012-03-01, Days after onset: 7
Location:Oregon  Entered:2012-03-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: none
Preexisting Conditions: N/A
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TTOX: TETANUS TOXOID (NO BRAND NAME)SANOFI PASTEURU3989AA5IMLA
Administered by: Other     Purchased by: Private
Symptoms: Body temperature increased, Chills
SMQs:, Neuroleptic malignant syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Mild, chills and low temp.

VAERS ID:450950 (history)  Vaccinated:2012-02-23
Age:20.0  Onset:2012-02-24, Days after vaccination: 1
Gender:Female  Submitted:0000-00-00
Location:Oregon  Entered:2012-03-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB493AA1IMUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.1778Y0IMUN
Administered by: Other     Purchased by: Unknown
Symptoms: Otitis media, VIIth nerve paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)
Write-up: Patient was diagnosed with OM & Bell''s palsy on 2/24/12 at ER.

VAERS ID:450968 (history)  Vaccinated:2012-02-23
Age:15.0  Onset:2012-02-23, Days after vaccination: 0
Gender:Female  Submitted:2012-03-02, Days after onset: 8
Location:Florida  Entered:2012-03-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FIORICET pen; Albuterol neb PRN
Current Illness: Migraine; Allergic rhinitis
Preexisting Conditions: Peanuts; Asthma; Allergic rhinitis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1561AA2UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0420AA1UNLA
Administered by: Private     Purchased by: Private
Symptoms: Anaphylactic reaction, Face oedema, Immediate post-injection reaction, Lip oedema, Pharyngeal oedema, Pyrexia, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Immediate anaphylaxis after varicella administration. Facial/pharynx/lip edema, urticaria to face and trunk, vomited x1. Epi 0.5cc SC, albuterol neb with Epi, DECADRON 8mg IM, DEPO MEDROL 80mg IM within 3 mins of vaccine administration. Oral steroid and antihistamines x7 days. Reported fever night after vaccine.

VAERS ID:451030 (history)  Vaccinated:2012-02-23
Age:38.0  Onset:2012-02-23, Days after vaccination: 0
Gender:Female  Submitted:2012-02-29, Days after onset: 6
Location:Illinois  Entered:2012-03-02, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Asthma; High blood pressure
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1102101 IMUN
Administered by: Other     Purchased by: Unknown
Symptoms: Condition aggravated, Erythema, Fatigue, Headache, Hypertension, Oropharyngeal pain, Paraesthesia, Pyrexia, Skin warm
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypertension (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: About 45 min to 1 hour after shot, she had low grade fever & her hands were red, warm, & little tingly. Next morning, she had headache, sore throat & her BP was high. Two hour later, she was ok (only headache & tired).

VAERS ID:451077 (history)  Vaccinated:2012-02-23
Age:33.0  Onset:2012-02-23, Days after vaccination: 0
Gender:Female  Submitted:2012-02-27, Days after onset: 4
Location:Minnesota  Entered:2012-03-05, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Hx of Acute myelocytic leukemia 2003 - in remission
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3989AA UNLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Induration, Local reaction, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Localized reaction - with erythema, (7 x 10 cm) induration & itching started within hours of vaccination.

VAERS ID:451190 (history)  Vaccinated:2012-02-23
Age:20.0  Onset:2012-03-06, Days after vaccination: 12
Gender:Male  Submitted:2012-03-06, Days after onset: 0
Location:Washington  Entered:2012-03-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None at this time.
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: No diagnostic testing at this time.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV3051IMRA
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A0 LA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEUR810260IMRA
Administered by: Military     Purchased by: Military
Symptoms: Lymph node pain, Malaise, Pyrexia, Rash papular
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)
Write-up: Patient received smallpox vaccination on left shoulder approximately two weeks before presenting. On the morning of March 6, 2012 he noted a papular rash on his chest, abdomen, neck and back. No rash on arms or hands. Prior to the rash he had typical symptoms associated with smallpox vaccination: axillary lymph node tenderness, intermittent fevers and malaise. Considering mild presentation will defer treatment at this time. Will continue to follow. (Comments provided by Doctor).

VAERS ID:451191 (history)  Vaccinated:2012-02-23
Age:43.0  Onset:2012-03-02, Days after vaccination: 8
Gender:Female  Submitted:2012-03-06, Days after onset: 4
Location:New York  Entered:2012-03-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: none
Preexisting Conditions: Allergies: Codeine, Ibuprofen, Nifedipine, Sulfa
Diagnostic Lab Data: CT cervical spine, Xray shoulder complete, ESR, Comp Metabolic panel, CBC with diff, Troponin, EKG, Ultrasound of extremity
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4030AA0IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Computerised tomogram, Differential white blood cell count, Electrocardiogram, Full blood count, Injection site reaction, Metabolic function test, Neck pain, Neuralgia, Pain in extremity, Red blood cell sedimentation rate, Sleep disorder, Troponin, Ultrasound scan, X-ray limb
SMQs:, Peripheral neuropathy (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Pt received Adacel on 2/23/12, called office on 3/2/12 with "nerve type pain" in arm where she received injection. C/O pain getting worse radiating down arm and into neck. Unable to sleep due to pain. Seen 3/3/12 and 3/5/12 at Emergency room. Treated with Prednisone and "pain meds".

VAERS ID:451202 (history)  Vaccinated:2012-02-23
Age:1.1  Onset:2012-02-28, Days after vaccination: 5
Gender:Female  Submitted:2012-03-06, Days after onset: 7
Location:West Virginia  Entered:2012-03-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Cetirizine (Zyrtec) as needed. This was not given to her on the day of the vaccination.
Current Illness: No reactions at time of vaccination.
Preexisting Conditions: Was seen by allergist at 7 months old (August of 2011) and was given skin test for dander, mold, dust mites. Was told could see allergies in future due to genetics (both parents have allergies), but child did not react positively to any skin tests given.
Diagnostic Lab Data: Blood pressure taken. Temperature. Consult with emergency room doctor. Was taken to Pediatric facility on 2/29 and 3/2 for additional symptoms after emergency room visit. Was given Amoxicillin.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER 0 RL
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0 LL
Administered by: Unknown     Purchased by: Private
Symptoms: Crying, Dermatitis acneiform, Disorientation, Injection site erythema, Injection site rash, Pyrexia, Rash vesicular, Seizure like phenomena, Staring, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Sudden crying, blank staring, seizure like symptoms, spiked fever, disorientation, throwing up multiple times, pimple like rash over belly and back. Child was also seen by Pediatric facility on 2/29 and on 3/2. Developed 4 chicken pox like marks on lower back area after emergency room visit and redness and hard bumps at site where injection was given.

VAERS ID:451212 (history)  Vaccinated:2012-02-23
Age:37.0  Onset:2012-02-24, Days after vaccination: 1
Gender:Female  Submitted:2012-03-07, Days after onset: 12
Location:Texas  Entered:2012-03-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Singulair 10mg, Advair, Xyzal, Nasacort
Current Illness: Denied
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB223DA IMRA
RAB: RABIES (RABAVERT)NOVARTIS VACCINES AND DIAGNOSTICS498011A0IMLA
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUH276AA0SCRA
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient states that the day after yellow fever administration the site became "red, swollen, and itchy". Denies other symptoms. Denies any treatment. On 3/1/2012, the assessed area was red approximately 1 inch in diameter. Pt reports occassional itching. Denies other symptoms.

VAERS ID:451280 (history)  Vaccinated:2012-02-23
Age:60.0  Onset:2012-02-23, Days after vaccination: 0
Gender:Female  Submitted:2012-02-27, Days after onset: 4
Location:New York  Entered:2012-03-08, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1603AA0SCRA
Administered by: Other     Purchased by: Private
Symptoms: Burning sensation, Immediate post-injection reaction, Injection site pain
SMQs:, Peripheral neuropathy (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Immediately following vaccine, patient reported burning at the injection site that felt like it travelled up her right arm (where she received the vaccine), up through her neck and behind her ear. She reported feeling fine about an hour later.

VAERS ID:451451 (history)  Vaccinated:2012-02-23
Age:54.0  Onset:2012-02-23, Days after vaccination: 0
Gender:Female  Submitted:2012-03-08, Days after onset: 14
Location:Georgia  Entered:2012-03-12, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CRESTOR; ASA
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4030AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling at site & redness - was given BENADRYL 25 mg by mouth - pt felt fine was told to take BENADRYL at home also - kept pt in clinic for 45 min and checked on her the next day & swelling had started to go down.

VAERS ID:451496 (history)  Vaccinated:2012-02-23
Age:12.0  Onset:2012-02-24, Days after vaccination: 1
Gender:Male  Submitted:2012-02-28, Days after onset: 4
Location:Louisiana  Entered:2012-03-12, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ALDEX CT 1 PO q 8hrs prn; betamethasone valerate 0.1% topically BID to rash
Current Illness: Rhinitis; Atopic dermatitis
Preexisting Conditions: Infantile seizures; Torticollis
Diagnostic Lab Data: PHs 335; CBC - WBC 7.5, Hgb 13.6, HCT 40.9, MCV 77, MCHC 33.3, MCH 25.5, Mono 14.5; CMP - Na 140, K 4.5, CL 103, CO2 25.4, AST 47, ALT 118, AlKP 384, T. Bil 0.1
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT492AB0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3704AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURU3874BA IMLA
Administered by: Private     Purchased by: Public
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Blood bilirubin decreased, Blood chloride normal, Blood potassium normal, Blood sodium normal, Carbon dioxide normal, Cellulitis, Confusional state, Disorientation, Full blood count normal, Haematocrit normal, Haemoglobin normal, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Laboratory test, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased, Mean cell volume decreased, Metabolic function test, Pain in extremity, Platelet count normal, Sluggishness, White blood cell count, White blood cell count normal
SMQs:, Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Biliary system related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: 2/23/12 Received TDAP & MCV in (L) deltoid. 2/24/12 AM mom reported pain in (L) armat immunization - now going down arm, disorientation, confusion (mild) & sluggish behavior. Mother gave BENADRYL. 2/25/12 mother took child to ER - arm swollen from shoulder to elbow with erythema, increased warmth and intense pain. Treated in ER with doxycycline & TORADOL. Discharged on doxycycline & MOTRIN. Diagnosis: cellulitis.

VAERS ID:451503 (history)  Vaccinated:2012-02-23
Age:70.0  Onset:2012-03-02, Days after vaccination: 8
Gender:Male  Submitted:2012-03-06, Days after onset: 4
Location:California  Entered:2012-03-12, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Public     Purchased by: Private
Symptoms: Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Red spots on my face.

VAERS ID:451764 (history)  Vaccinated:2012-02-23
Age:4.0  Onset:2012-02-24, Days after vaccination: 1
Gender:Male  Submitted:2012-03-06, Days after onset: 11
Location:Arizona  Entered:2012-03-14, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Heart murmur
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4003AA4UNLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURG10833SCUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1119AA1SCUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0978AA1SCUN
Administered by: Private     Purchased by: Private
Symptoms: Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Arm (left) swollen, hot to the touch.

VAERS ID:452371 (history)  Vaccinated:2012-02-23
Age:4.0  Onset:2012-02-26, Days after vaccination: 3
Gender:Female  Submitted:2012-03-23, Days after onset: 25
Location:Wisconsin  Entered:2012-03-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B184AA0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0352AA1SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0339AA1SCLA
Administered by: Unknown     Purchased by: Public
Symptoms: Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Hives on torso followed the next day by rash.

VAERS ID:452402 (history)  Vaccinated:2012-02-23
Age:17.0  Onset:2012-03-06, Days after vaccination: 12
Gender:Female  Submitted:2012-03-19, Days after onset: 12
Location:California  Entered:2012-03-26, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: URI
Preexisting Conditions: Diabetes, Type 1; Celiac Dz
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1048NA0IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0494Z0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSX100610IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4009BA0IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Rash on face, neck, torso. Tx: Anti-histamine.

VAERS ID:452555 (history)  Vaccinated:2012-02-23
Age:59.0  Onset:2012-03-05, Days after vaccination: 11
Gender:Male  Submitted:2012-03-28, Days after onset: 22
Location:California  Entered:2012-03-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 36 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: LP; neuro exam
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4137BA IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Bedridden, Bronchoscopy abnormal, Chronic obstructive pulmonary disease, Computerised tomogram head normal, Dysphagia, Dyspnoea, Electromyogram abnormal, Endotracheal intubation, Gastrointestinal tube insertion, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Increased bronchial secretion, Intensive care, Lumbar puncture abnormal, Mechanical ventilation, Muscular weakness, Nerve conduction studies abnormal, Neurological examination abnormal, Paraesthesia, Pneumonia, Pneumonia aspiration, Respiratory disorder, Respiratory failure, Tracheostomy
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient is a 59 yrs old male with no significant PMH who initially presented to the ER with two days of progressive numbness and tingling which started in his hands and spread to his legs and then unable to get out of bed due to weakness of extremities. Patient was admitted to the hospital. His CT of head was negative. He was seen by neurology and LP studies showed evidence of Guillain-Barre Syndrome. He was started on IVIG. His EMG and nerve conduction was consistent with axonal varient GBS which has poor prognosis. During the hospitalization, he continued to have progressive weakness including his swallowing and respiratory status. He went into respiratory failure with COPD retention and was transferred to ICU. He was intubated. He was started for antibiotics for possible aspiration pneumonia vs hospital-acquired pneumonia. He had bronchoscopy with thick secretions. He had tracheostomy placement on 3/19/12. 3/24: Continues with vent and nebs. Completed all antibiotics. 3/25: Passed swallow evaluation and started on puree diet with nectar thick liquids. 3/26 failed repeat swallow evaluation, NPO. Resumed on tube feeds was placed on TC. 3/27 overnight, placed back on ventilator. States he couldn''t breathe. Doing OK. No complaints. Placed on TC this morning.

VAERS ID:452730 (history)  Vaccinated:2012-02-23
Age:53.0  Onset:2012-02-26, Days after vaccination: 3
Gender:Female  Submitted:2012-03-30, Days after onset: 32
Location:New York  Entered:2012-03-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Varicella titer
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1224AA UNUN
Administered by: Other     Purchased by: Unknown
Symptoms: Antibody test, Blister, Dyspnoea, Erythema, Fatigue, Induration, Nasopharyngitis, Oedema peripheral, Pain in extremity, Pyrexia, Varicella virus test
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: After receiving varicella vaccine - felt feverish, fatigue, cold like symptoms with some shortness of breath. Approximately 10 days later (L) arm became swollen, red, sore to touch, "hard like a ball" and "skin was bubbly".

VAERS ID:453026 (history)  Vaccinated:2012-02-23
Age:62.0  Onset:2012-02-23, Days after vaccination: 0
Gender:Male  Submitted:2012-04-04, Days after onset: 40
Location:California  Entered:2012-04-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Glyburide 5mg 1 twice a day Furosemide 20mg 1 twice a day Spirolactone 50mg daily Lisinopril 20mg daily Omeprazole 40mg twice a day Carbidopa25/Levodopa 100mg tid Carbidopa50/Levodopa 200mg in am
Current Illness: no
Preexisting Conditions: Cirrhosis, HTN, DM type 2, Esophageal varices, peptic ulcer dx. Parkinsons
Diagnostic Lab Data: Hep B antibody neg, antigen neg.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVCO46AA0IMLA
Administered by: Military     Purchased by: Other
Symptoms: Hepatitis B antibody negative, Hepatitis B antigen, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: On 3/23/12 visit pat. reports itching on his back and stomach. Lasted 2 weeks.

VAERS ID:453638 (history)  Vaccinated:2012-02-23
Age:17.0  Onset:2012-02-23, Days after vaccination: 0
Gender:Female  Submitted:2012-04-12, Days after onset: 48
Location:Utah  Entered:2012-04-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data: She has been to ER twice and her pediatrician several times, he did blood work to test for mono and thyroid issues all of which were negative. Her symptoms got worse after 2nd dose that was given on FEB 23, 2012. I did not relate the shot to illness first time until 2nd shot was given and she got worse and worse. DO NOT GIVE THIS SHOT tO ANYMORE YOUNG GIRLS. IT IS CAUSING MAJOR HEALTH PROBLEMS AND DEATH. We as consumers trust that you will give us the extreme possible side effect info prior to shots. WE will be looking for compensation. There have been over 8000 complaints and over 35 deaths. Do something about it. NOW
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1  
Administered by: Unknown     Purchased by: Private
Symptoms: Anxiety, Arthralgia, Dizziness, Dyspnoea, Fatigue, Fear, Gastrointestinal disorder, Headache, Lymphadenopathy, Mononucleosis heterophile test negative, Muscular weakness, Nausea, Thyroid function test normal, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Severe headaches, nausea, dizziness, joints hurt, muscles feel weak, swollen lymph nodes in throat, hard to breathe, extreme fatigue, gastrointestinal problems, shaking, anxiety, afraid to sleep.

VAERS ID:453887 (history)  Vaccinated:2012-02-23
Age:50.0  Onset:2012-02-23, Days after vaccination: 0
Gender:Female  Submitted:2012-04-17, Days after onset: 53
Location:North Carolina  Entered:2012-04-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data: None yet. Still making doctor appts to find out what the problem is.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC018BA IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Cardiac disorder
SMQs:
Write-up: I felt a couple of strong rushes around my heart and it countinued for the next 3 days with it getting less strong each day. And then it happened periodically after that and it is still continuing today. I went to the emergency room due to it escalating on April 12, 2012 and was admitted overnight to check heart.

VAERS ID:453917 (history)  Vaccinated:2012-02-23
Age:29.0  Onset:2012-02-24, Days after vaccination: 1
Gender:Female  Submitted:2012-02-29, Days after onset: 5
Location:Missouri  Entered:2012-04-17, Days after submission: 47
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV3056IMRA
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC018BA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B078AA0IMLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG11241IMRA
Administered by: Military     Purchased by: Military
Symptoms: Local swelling
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 23 Feb 2012 vaccines were given. Patient woke up next morning and around 11:00am noticed swelling in her left clavicle area. No pain noted.

VAERS ID:454068 (history)  Vaccinated:2012-02-23
Age:0.2  Onset:2012-02-24, Days after vaccination: 1
Gender:Male  Submitted:2012-04-20, Days after onset: 55
Location:Michigan  Entered:2012-04-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin D and probiotics
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4022AA0IMLL
Administered by: Private     Purchased by: Other
Symptoms: Crying, Infantile spitting up, Irritability, Lethargy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Extreme fussiness, inconsolable crying, slight fever, spitting up (with no prior spitting up ever), lethargy.

VAERS ID:454461 (history)  Vaccinated:2012-02-23
Age:0.2  Onset:2012-02-24, Days after vaccination: 1
Gender:Female  Submitted:2012-04-26, Days after onset: 61
Location:Missouri  Entered:2012-04-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B305DA0IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1310AA0IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF171550IMRL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41FB207A0PO 
Administered by: Private     Purchased by: Private
Symptoms: Rash, Swelling face, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Mom noticed a few spots on cheek when awakened for feeding. When she put her back to bed at 12:30 am, she had a couple more spots. When she awoke at 4:00am, the side of her face was covered in rash and was swollen. Continued with increasing rash. Was instructed to give dose of Benadryl by Dr on Call. Pt was seen in Urgent Care on 2/25/2012 @ 4:45pm with increasing urticarial rash.

VAERS ID:454978 (history)  Vaccinated:2012-02-23
Age:17.0  Onset:2012-02-27, Days after vaccination: 4
Gender:Female  Submitted:2012-05-04, Days after onset: 66
Location:Unknown  Entered:2012-05-04
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Nuclear magnetic resonance imaging, abnormal, significant, suggestive of intracranial hypertension; Lumbar puncture, abnormal, significant, pressure was up
CDC Split Type: PHEH2012US005261
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM10127B1IMLA
Administered by: Other     Purchased by: Other
Symptoms: CSF pressure increased, Cerebrospinal fluid drainage, Headache, Hypoaesthesia, Intracranial pressure increased, Lumbar puncture abnormal, Neck pain, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia, Vision blurred
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Arthritis (broad), Hypoglycaemia (broad)
Write-up: Case number PHEH2012US005261 is an initial spontaneous report received from a physician on 02 Mar 2012 with a follow up information received on 24 Apr 2012. This report refers to a 17-years-old female patient whose medical history, past drugs, current conditions and concomitant medications were not provided. Her vaccination history included administration of MENACTRA (other manufacturer, batch number: unspecified) on 23 Jun 2008 and it was well tolerated. She was vaccinated with second dose of MENVEO (batch number: M10127B) intramuscularly on the left deltoid on 23 Feb 2012. On 27 Feb 2012, she experienced blurred vision, headache, pain on the right side of neck and numbness on fourth and fifth right fingers and arm. It was reported that subsequently she experienced tingling in her right arm. A history of injury was not reported. Magnetic resonance imaging (MRI) without contrast of brain was negative. It was reported that MRI with and without contrast was performed and the findings were compatible with intracranial hypertension. She was admitted in hospital for spinal tap and the pressure was up. Drainage was performed. The outcome of the event was reported as condition improving causality was assessed as possible to vaccine administration. Follow up received on 24 Apr 2012: Vaccination history added, vaccination date of MENVEO, events, outcome and causality updated.

VAERS ID:458375 (history)  Vaccinated:2012-02-23
Age:0.2  Onset:2012-02-23, Days after vaccination: 0
Gender:Male  Submitted:2012-06-28, Days after onset: 125
Location:Louisiana  Entered:2012-06-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4116AA0IMRL
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC070BA0IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHF046930IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0680AA0PO 
Administered by: Private     Purchased by: Public
Symptoms: Diarrhoea, Irritability, Mucous stools
SMQs:, Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)
Write-up: Diarrhea, mucousy stools and fussiness for three days after vaccine.

VAERS ID:458380 (history)  Vaccinated:2012-02-23
Age:4.0  Onset:2012-02-23, Days after vaccination: 0
Gender:Male  Submitted:2012-06-28, Days after onset: 125
Location:Texas  Entered:2012-06-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Persistent asthma
Diagnostic Lab Data:
CDC Split Type: TX120018PR
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC3944AA4 LL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH13054 RA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0187AA1 LA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9169714 LL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0407AA1 LA
Administered by: Private     Purchased by: Private
Symptoms: Asthma, Condition aggravated, Erythema, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Erythema [illegible word] face and body with hives; spontaneously resolved in less than 1 hour. [illegible word] of asthma. Prescribing antihistamines for allergies.

VAERS ID:462464 (history)  Vaccinated:2012-02-23
Age:3.0  Onset:2012-02-23, Days after vaccination: 0
Gender:Male  Submitted:2012-04-27, Days after onset: 63
Location:Missouri  Entered:2012-08-17, Days after submission: 112
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: MEDI0015051
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.YL2068 IN 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 37-month-old male. Neither the patient''s medical history nor the concomitant medications were reported. The reporter spoke to patient''s mother on 28-Feb-2012, mother did not report any adverse events. She did not want to bring her son in for additional dose of FLUMIST as the expired FLUMIST was his second dose. The product expired on 12-Feb-2012. On 23-Feb-2012, the patient received expired product. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune''s FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age. Additional information was obtained on 27-Apr-2012: the reporter stated that the patient did not experience any late occurring adverse events.

VAERS ID:477480 (history)  Vaccinated:2012-02-23
Age:1.5  Onset:2012-02-24, Days after vaccination: 1
Gender:Female  Submitted:2012-12-10, Days after onset: 290
Location:Arkansas  Entered:2012-12-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZYRTEC
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Hospital allergy department. Intradermal testing positive food tap
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4002AA3IMRL
HEPA: HEP A (VAQTA)MERCK & CO. INC.1416AA0IMLL
Administered by: Private     Purchased by: Private
Symptoms: Skin test positive, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Mild hives 1 day after receiving immunizations. Treated with ZYRTEC and hydrocortisone cream.

VAERS ID:480649 (history)  Vaccinated:2012-02-23
Age:71.0  Onset:2012-12-04, Days after vaccination: 285
Gender:Female  Submitted:2013-01-02, Days after onset: 29
Location:Nebraska  Entered:2013-01-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Mastectomy; 06/2008, Breast cancer; Varicella, as a child
Diagnostic Lab Data: Pain, 8
CDC Split Type: WAES1212USA010880
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1605AA SCRA
Administered by: Other     Purchased by: Other
Symptoms: Blister, Herpes zoster, Pain, Skin lesion
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a pharmacist refers to a 71 years old female patient. The patient''s medical history included chickenpox when was a child, chad carcinoma insitu left breast (June 2008) and chat bilateral mastectomy. On 23-FEB-2012, the patient was vaccinated with ZOSTAVAX (lot # 672476/1605AA), 1 ml, right deltoid, subcutaneously. No other co-suspects were reported. No concomitant medications were reported. The patient did not presented illness at the time of vaccination. The patient was not exposure to chickenpox or herpes zoster. It was noted that the patient did not experienced a rash at the injection site or elsewhere within 42 days of the vaccination. On 04-DEC-2012 in the afternoon, the patient experienced herpes zoster. Blisters started on 16-DEC-2012, and had pain that kept when awake. The patient was seen in the office on 17-DEC-2012 and had stated to breakout with pain along bra line from midline center front to mid line back on the left, 6 cm at greatest, lesions to numerous to count and was diagnosed with herpes zoster the same day. Tried to obtain some fluids but blisters were too small. The pain was level 8 (from 1 to 10). No treatment information was reported. The patient required medical attention. The patient was not performed fluorescent antibody test. Was unable to collected specimen for PCR test. Photo was not taken. At the time of the report, the outcome of herpes zoster was unknown. The relatedness for herpes zoster was unknown for ZOSTAVAX. Additional information has been requested.

VAERS ID:486149 (history)  Vaccinated:2012-02-23
Age:18.0  Onset:2012-02-23, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Unknown  Entered:2013-03-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRIVORA; Multivitamins
Current Illness:
Preexisting Conditions: No known drug allergies.
Diagnostic Lab Data:
CDC Split Type: BERNA20120248
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF)BERNA BIOTECH, LTD 0PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Erythema, Nausea, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was received from a nurse on 21.Mar.2012. This case concerns a 18-year-old female patient who had received oral Typhoid vaccine (batch no: not reported). The patient had no known drug allergies. Concomitant medication was included TRIVORA and multivitamins. On 23.Feb.2012, the patient took the first capsule of VIVOTIF. On the same day, one hour after vaccine intake, the patient experienced dizziness and nausea. She also developed red and itchy hives on chest. All symptoms resolved within 24 hours. She discontinued the oral vaccination and after having consulted a physician she received injectable Typhoid vaccination on 09.Mar.2012 without problems. This case was considered non-serious.

VAERS ID:494292 (history)  Vaccinated:2012-02-23
Age:19.0  Onset:2012-02-23, Days after vaccination: 0
Gender:Male  Submitted:2013-06-13, Days after onset: 475
Location:California  Entered:2013-06-17, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Occasional chest pain (1999), night palpitations.
Diagnostic Lab Data: Troponin result not available.
CDC Split Type: 201306801
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEUR  IDRA
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Military     Purchased by: Military
Symptoms: Dizziness, Dyspnoea, Electrocardiogram normal, Fatigue, Headache, Myopericarditis, Nausea, Night sweats, Troponin
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This study case was received from the investigator in a trial on 17 January 2013. A 20-year old (age stated on ECG report) male subject had received the following vaccinations on 23 February 2012: ACAM2000 (lot number, right arm and route not reported); anthrax vaccine (Manufacture name, lot number not reported); and Typhoid vaccine (Manufacture name and lot number not reported). At study visit 2 on 28 February 2012 the subject reported he had experienced the same night following the vaccinations on 23 February 2012 mild shortness of breath, worsening headache, lightheadedness, night sweats, nausea and general fatigue. The symptoms worsened over 12 hours but the subject did not seek medical evaluation. The symptoms resolved completely the following day on 24 February 2012. An electrocardiogram on 28 February 2012 was normal and a rapid Troponin was completed as well; however the result was not available as the vial broke during processing. The subject was referred for follow-up care. Assessment: low suspicion myopericarditis. Relevant medical history included occasional chest pain (onset in 1999) and night palpitations (onset date unknown). The subject was reported as recovered on 24 February 2012. According to the Investigator, the events of mild shortness of breath, worsening headache, lightheadedness, night sweats, nausea and general fatigue was considered important events and possibly related. Documents held by sender: None.

VAERS ID:495673 (history)  Vaccinated:2012-02-23
Age:5.0  Onset:2013-06-28, Days after vaccination: 491
Gender:Female  Submitted:2013-07-01, Days after onset: 3
Location:Massachusetts  Entered:2013-07-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Rash
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1247AA1UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Less than 10 spots on body a couple on face for 3 days, low grade temp.

VAERS ID:520160 (history)  Vaccinated:2012-02-23
Age:  Onset:2012-02-23, Days after vaccination: 0
Gender:Unknown  Submitted:2014-01-22, Days after onset: 699
Location:Unknown  Entered:2014-01-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA008554
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1267AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 16-JAN-2012 at 07:30 and on 17-JAN-2012 at 7:30, ZOSTAVAX (Lot # 671141/1267AA) was exposed to -8 degrees C for an estimated total time out of range of 14 hours. On 23-FEB-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot number 671141/1267AA, expiration date 05-NOV-2012) (dose and route administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.

VAERS ID:520945 (history)  Vaccinated:2012-02-23
Age:  Onset:2012-02-23, Days after vaccination: 0
Gender:Unknown  Submitted:2014-01-28, Days after onset: 705
Location:Unknown  Entered:2014-01-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA009191
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0869AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 23-FEB-2012, the patient was administered with a dose VARIVAX (Lot # 670851/0869AA, expiry date 26-JUL-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.

VAERS ID:521089 (history)  Vaccinated:2012-02-23
Age:  Onset:2012-02-23, Days after vaccination: 0
Gender:Unknown  Submitted:2014-01-29, Days after onset: 706
Location:Unknown  Entered:2014-01-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA009192
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0975AA SCUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 23-FEB-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 670799/0975AA, expiry date 17-JUN-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.

VAERS ID:524391 (history)  Vaccinated:2012-02-23
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2014-03-03
Location:Florida  Entered:2014-03-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: 02/23/2012, Papilloma viral infection, Illness at time of Vaccination, Genital bumps, Continuing
Preexisting Conditions:
Diagnostic Lab Data: 02/23/2012, Pregnancy test, Negative; 02/29/2012, Pregnancy test, Positive
CDC Split Type: WAES1203USA00332
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Exposure during pregnancy, Pregnancy test positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a Licensed Practical Nurse concerning an 18 year old female patient who on 23-FEB-2012, before vaccination, presented to the office with "genital bumps" which were diagnosed to be HPV, after she was vaccinated with the first dose of GARDASIL (batch number: 12329AA was an invalid lot number for GARDASIL, expiry 12-NOV-2013, dose and route not reported). On the same day, the patient had a negative pregnancy test. According to the nurse, the patient had a positive pregnancy test on 29-FEB-2012. The last menstrual period was reported as 13-SEP-2012. The patient sought medical attention by visit to the office. Follow up information was received which reported that the patient''s last menstrual period was on 13-SEP-2012 and the estimated delivery date would be on 19-JUN-2012. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.

VAERS ID:577764 (history)  Vaccinated:2012-02-23
Age:2.0  Onset:2012-02-24, Days after vaccination: 1
Gender:Female  Submitted:2015-05-11, Days after onset: 1171
Location:Washington  Entered:2015-05-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Small hole between ventricles of heart
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Aspiration, Muscle spasms, Pyrexia, Respiratory arrest, Seizure
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dystonia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Child had full body single spasms and fast spiking fever for 12 hrs leading up to event. About 30 hrs after shot, child had a seizure. Sitting the seizure she aspirated saliva and stopped breathing. 911 was called and within three minutes she was breathing again.

VAERS ID:450199 (history)  Vaccinated:2012-02-23
Age:3.0  Onset:2012-02-23, Days after vaccination: 0
Gender:Female  Submitted:2012-02-23, Days after onset: 0
Location:Foreign  Entered:2012-02-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURUH521AA0IMLL
Administered by: Military     Purchased by: Military
Symptoms: Crying, Dyskinesia, Opisthotonus, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Dystonia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Patient cried after vaccinated, Pt''s mother picked her up and pt stopped crying, Pt was placed into a stroller. While her brother was about to be vaccinated next, Corpsman and nurse found Pt closing eyes tongue out, slowly sliding out from a stroller by stretching her back, no response to mother''s call. Called 911. Nurse immediately placed Pt in prone position on floor, Pt started spastic motion. Nurse keep calling patient, and pt responded at 3:32. Pt cried and placed on bed, temperature 97.9F. ER corpsman and physician arrived and took Pt to ER @3:40.

VAERS ID:451166 (history)  Vaccinated:2012-02-23
Age:0.2  Onset:2012-02-23, Days after vaccination: 0
Gender:Male  Submitted:2012-03-06, Days after onset: 12
Location:Foreign  Entered:2012-03-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0074695A
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA21CB164A0IMUN
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURERVNS1K04D0IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF610190IMUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSAROLA436AC0PO 
Administered by: Other     Purchased by: Other
Symptoms: Electroencephalogram, Hypotonic-hyporesponsive episode, Laboratory test
SMQs:, Hypotonic-hyporesponsive episode (narrow)
Write-up: This case was reported by a foreign regulatory authority (DE-PEI-PEI2012006911) and described the occurrence of hypotonic-hyporesponsive episode (HHE) in an 8-week-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline) and INFANRIX HEXA (GlaxoSmithKline). Co-suspect vaccinations included PREVENAR 13 (Pfizer Pharma) and NEISVAC-C (Baxter). Past medical history was not provided. The subject has received no previous vaccinations. On 23 February 2012 the subject received the first dose of ROTARIX (1 ml, oral), the first dose of INFANRIX HEXA (0.5 ml, intramuscular, unknown), the first dose of PREVENAR 13 (0.5 ml, intramuscular, unknown) and the first dose of NEISVAC-C (0.5 ml, intramuscular, unknown). Approximately 13 hours post vaccination with ROTARIX, INFANRIX HEXA, PREVENAR 13 and NEISVAC-C, on 23 February 2012 or 24 February 2012, the subject experienced three episodes of hypotonic-hyporesponsive episode (HHE) which lasted 10 - 20 seconds each. The father has the subject in the arms and has stimulated the subject. The subject was hospitalised for an unknown period of time. Examination included electroencephalography (EEG), quantitative electroencephalography (QEEG) and oxygen cardio-respirography (OXY-CRG). By differential diagnosis cerebral hemorrhage and convulsive seizure were excluded. At the time of reporting, on 28 February 2012, the event was resolved. The vaccination courses with ROTARIX, INFANRIX HEXA, PREVENAR 13 and NEISVAC-C were not continued up to now. No further information will be available.

VAERS ID:451263 (history)  Vaccinated:2012-02-23
Age:0.1  Onset:2012-02-27, Days after vaccination: 4
Gender:Male  Submitted:2012-03-07, Days after onset: 9
Location:Foreign  Entered:2012-03-07
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Platelet count, 27Feb2012, 4000uL
CDC Split Type: B0784875A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSAROLA387BB0PO 
Administered by: Other     Purchased by: Other
Symptoms: Platelet count decreased, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of thrombocytopenia in a 1-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject''s medical history was not provided. On 23 February 2012, the subject received 1st dose of ROTARIX (oral). On 27 February 2012, 4 days after vaccination with ROTARIX, the subject experienced severe thrombocytopenia (platelet count: 4000 ?L, low norm: 150000). The physician considered the event was life threatening. At the time of reporting, the outcome of the event was unspecified. The physician considered the event was possibly related to vaccination with ROTARIX. Due to the short-time elapse since the clinical presentation and the treatment carried out, it was not yet possible to establish a prognosis.

VAERS ID:451841 (history)  Vaccinated:2012-02-23
Age:0.7  Onset:2012-03-01, Days after vaccination: 7
Gender:Male  Submitted:2012-03-12, Days after onset: 10
Location:Foreign  Entered:2012-03-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: image and test results (date unknown): diagnosed mycoplasmal pneumonia
CDC Split Type: 2012062523
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Imaging procedure, Mycoplasma test positive, Pneumonia mycoplasmal, Productive cough
SMQs:
Write-up: This is a spontaneous report from a contactable consumer (patients mother) via the call center. A 8-month-old male patient received the second dose of PREVENAR intramuscularly on 23Feb2012 to prevent pneumococcal disease. Past vaccine history included the first dose of PREVENAR on 17Jan2012. Relevant medical history and concomitant medications were not provided. On 01Mar2012, the patient experienced a productive cough. He was taken to see the doctor at the local hospital. He was diagnosed with Mycoplasmal pneumonia according to image and test results. The patient had been stayed in hospital for seven days so far. Outcome was unknown. No follow-up attempts possible. No further information expected.

VAERS ID:452050 (history)  Vaccinated:2012-02-23
Age:29.0  Onset:2012-02-23, Days after vaccination: 0
Gender:Female  Submitted:2012-03-16, Days after onset: 21
Location:Foreign  Entered:2012-03-19, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No relevant patient''s medical history.
Diagnostic Lab Data:
CDC Split Type: E201201692
Vaccination
Manufacturer
Lot
Dose
Route
Site
CHOL: CHOLERA (NO BRAND NAME)UNKNOWN MANUFACTURER 0PO 
JEV1: JAPANESE ENCEPHALITIS (IXIARO)INTERCELL AGJEV10H62B0IMLA
RAB: RABIES (NO BRAND NAME)UNKNOWN MANUFACTURERE04760IMLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURE08780IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Burning sensation, Facial paresis, Headache, Hypersensitivity, Neurological examination, Swollen tongue
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case was received from the Health Authorities on 12-Mar-2012 (reference number PEI2012007339). Case is medically confirmed. A 29-year-old female patient (weight, height not reported) with no relevant medical history received a first dose of TYPHIM VI (batch number E0878-3) and TOLLWUT IMPFSTOFF (batch no. E0476-1) both IM into the left upper arm on 23-Feb-2012. Additionally, on the same day, she received a first dose of IXIARO (MFR Novartis Behring, batch no. JEV10H62B) IM into the left upper arm and p.o. a first dose of DUKORAL (MFR Novartis Behring, batch no. not reported). On 23-Feb-2012, about 1-2 hours post vaccination, the patient developed mild facial paresis and swelling of tongue. Two hours post vaccination, the patient developed burning headache. An allergic reaction was suspected. Examination was performed in an outpatient clinic with neurological consultation. Action taken was not reported. Swelling of tongue resolved within 3 hours. Facial paresis and headache were ongoing at the time of reporting. Allergic reaction was also reported to be ongoing. Outcome with persistent damage was suspected.

VAERS ID:452139 (history)  Vaccinated:2012-02-23
Age:13.0  Onset:2012-03-13, Days after vaccination: 19
Gender:Female  Submitted:2012-03-19, Days after onset: 6
Location:Foreign  Entered:2012-03-20, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: CSF test, 13Mar2012, normal
CDC Split Type: D0074907A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA133BN UNUN
Administered by: Other     Purchased by: Other
Symptoms: CSF test normal, Facial paresis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: This case was reported by a physician and described the occurrence of facial paresis in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 23 February 2012 the subject received an unspecified dose of CERVARIX (0.5 ml, unknown). Approximately 19 days after vaccination with CERVARIX, on 13 March 2012, the subject experienced facial paresis. On 13 March 2012 he subject was hospitalised for two days. Cerebrospinal fluid (CSF) examinations showed no pathologic findings. At the time of reporting the outcome of the event was unspecified. Follow-up information has been requested.

VAERS ID:452140 (history)  Vaccinated:2012-02-23
Age:24.0  Onset:2012-02-23, Days after vaccination: 0
Gender:Female  Submitted:2012-03-19, Days after onset: 24
Location:Foreign  Entered:2012-03-20, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pain in area of blood draw (arm).
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0784280A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB913AC IMLA
Administered by: Other     Purchased by: Other
Symptoms: Facial pain, Oral pain, Pain in extremity, Paraesthesia, Paraesthesia oral, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Glaucoma (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a nurse and described the occurrence of pain-left leg in a 24-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 23 February 2012, the subject received unspecified dose of ENGERIX B (20 mcg, intramuscular, left arm). On 23 February 2012, 2 hours after vaccination with ENGERIX B, the subject experienced pain and pins and needles in her left arm, left leg and around her face and mouth. 5 hours after vaccination with ENGERIX B, the subject went to emergency room. No hospitalisation was necessary. At the time of reporting, the events were unresolved. Follow-up info was received on 02 March 2012: Concurrent medical conditions included pain in area of blood draw (arm). It was thought the pins and needles were related to the vaccination with ENGERIX, however when the subject attended the hospital, it was the site where she had blood drawn that was painful and the problem was musculo-skeletal. Follow-up information received on 9 March 2012 by a physician via a regulatory authority (# 2012-010101): Historic vaccination included hepatitis A vaccine inactivated (manufacturer unspecified, unknown route injection site) given on an unspecified date. In February 2012, less than 1 week after vaccination with ENGERIX B, the subject experienced a possible muscle sprain in the left shoulder in addition to the initial reported events. The injection site was clear of erythema and induration. The reported stated that the injection puncture wound was not visible. The subject also experienced pain in the left shoulder with altered sensation in finger of hand. The regulatory authority reported that the events were clinically significant (or requiring intervention). The subject was treated with ibuprofen. On 24 February 2012, pins and needles were resolved. At the time of reporting the subject had no further facial or lower limb symptoms. Muscle sprain, shoulder pain and altered sensation in finger of hand were unresolved. The regulatory authority reported that the events were unrelated to vaccination with ENGERIX B but to an ergonomic problem.

VAERS ID:452456 (history)  Vaccinated:2012-02-23
Age:0.1  Onset:2012-02-23, Days after vaccination: 0
Gender:Unknown  Submitted:2012-03-26, Days after onset: 31
Location:Foreign  Entered:2012-03-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0790781A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER20910001C IMUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURERUVA10012 IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEURG9586 IMUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSAROLA411BB PO 
Administered by: Other     Purchased by: Other
Symptoms: Apnoea, Crying
SMQs:, Acute central respiratory depression (narrow), Depression (excl suicide and self injury) (broad), Respiratory failure (narrow)
Write-up: This case was reported by a physician via a regulatory authority (PL-URPL-OCR-20120314002) and described the occurrence of apnea in a 1-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline), DTP (a or w not known), ACTHIB (non-gsk) and hepatitis B vaccine (non-gsk). On 23 February 2012, the subject received unspecified dose of ROTARIX (oral), unspecified dose of DTP (a or w not known) vaccine (non-GSK) (intramuscular, unknown site of injection), unspecified dose of ACTHIB (intramuscular, unknown site of injection) and unspecified dose of Hepatitis B vaccine (Non-GSK) (intramuscularly, unknown site of injection). On 23 February 2012 at 1:00 PM, less than one day after vaccination with ACTHIB, DTP (a or w not known) vaccine (non-GSK), Hepatitis B vaccine (Non-GSK) and ROTARIX, the subject experienced continuous crying uncontrollable with period of apnea lasting 10-15 seconds. At 4:00 PM, the subject was hospitalised. The regulatory authority reported that the events were clinically significant (or requiring intervention). The subject was treated with paracetamol. After administration of paracetamol, the subject became calm. At the time of reporting, the events were resolved. No further information could be obtained from the regulatory authority since all available information have been provided. Therefore, this case has been closed.

VAERS ID:452519 (history)  Vaccinated:2012-02-23
Age:13.0  Onset:2012-02-23, Days after vaccination: 0
Gender:Female  Submitted:2012-03-27, Days after onset: 32
Location:Foreign  Entered:2012-03-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Fear
Preexisting Conditions: Hyperventilation
Diagnostic Lab Data: Blood pressure, 23Feb2012, 90/50mmHg
CDC Split Type: B0785895A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure decreased, Clonic convulsion, Fall, Headache, Loss of consciousness, Muscle twitching, Pallor, Syncope, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of syncope in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 23 February 2012, the subject received the 1st dose of CERVARIX (intramuscular, unknown shoulder, batch number not provided). On 23 February 2012, 15 minutes after vaccination with CERVARIX, the subject experienced syncope. The subject had particularly no sick feeling and was not scared at the time of vaccination. After the vaccination, the patient sat down on a chair and was followed. Approximately 15 minutes later, the patient suddenly suffered from syncope. Then, the patient became conscious immediately and had no problems, and thus was sent home. The physician considered the event was clinically significant (or requiring intervention). On 23 February 2012, the event was resolved. The physician considered the event was related to vaccination with CERVARIX. Additional information received on 21 March 2012. The subject had a past medical history of hyperventilation syndrome. On 23 February 2012, the subject received the intramuscular vaccination of CERVARIX in the left shoulder after she was given explanation on the vaccination. It seemed that she had slight fear during the explanation before the vaccination, but she did not cry or act violently in particular, and the vaccination was completed. When she was sitting in a sofa, taking a rest, approximately 15 minutes after the vaccination, clonic convulsion-like twitching of the whole body and ill complexion were suddenly noted and she lost consciousness completely for 2 to 3 minutes. Decreased blood pressure was noted, but the symptoms improved only with being placed at bed rest. The subject had no painful/emotional stimulus before the onset of the event, no sweat or warmth feeling before the event. She had a menstrual period. It seemed that the subject had fear of pain and syncope during the explanation on the vaccination. The event developed suddenly. The subject fell sideways as if she were slipping from a sofa. Her movement was clonic and lasted for several seconds. She was pale and she lost consciousness for 2 to 3 minutes. Her respiratory pattern was normal. Blood pressure was 90/50 mmHg. She experienced twitching in the face, arms and legs. There was no tongue biting. The subject did not receive any medical treatment and did not undergo any special test. The event resolved while the subject was in the supine position. After the subject recovered from loss of consciousness, she experienced headache. The subject did not remember anything regarding loss of consciousness, her vision suddenly became dark. The event did not recur.

VAERS ID:454261 (history)  Vaccinated:2012-02-23
Age:0.4  Onset:2012-02-23, Days after vaccination: 0
Gender:Unknown  Submitted:2012-04-20, Days after onset: 56
Location:Foreign  Entered:2012-04-24, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: not reported
CDC Split Type: 201203855
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER20910001D SCUN
HIBV: HIB (ACTHIB)SANOFI PASTEURG9952 IMUN
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURG0120 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Apnoea, Crying, Hypotonic-hyporesponsive episode, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case received from the Health Authorities in a foreign country on 11 April 2012 under the reference number 2012/0096 (HA''s number PLURPLOCR20120320007). A 04-month-old patient, with no reported medical history and concomitant therapy, had received an intramuscular dose of IMOVAX POLIO (batch number G0120-4, site of administration not reported), an intramuscular dose of ACTHIB (batch number G9952-1, site of administration not reported) and a subcutaneous dose of DTP (other manufacturer, batch number 20910001D, site of administration not reported) on 23 February 2012. On 23 February 2012, the patient experienced fever at 38-38.4 degrees C, uncontrollable crying and hypotonic-hyporesponsive episode with apnea. The patient was admitted to hospital in good condition on an unspecified date. The patient did not have respiratory disturbances. The patient was admitted to the allergological unit for further observation. Saturation rate was 98% and pulse rate was 163 beats/minute. The patient was hospitalized for 3 days and was discharged upon the patient''s mother request. The patient recovered on an unspecified date. The Health Authorities coded fever, crying uncontrollable and hypotonic-hyporesponsive episode.

VAERS ID:483986 (history)  Vaccinated:2012-02-23
Age:0.2  Onset:2012-03-01, Days after vaccination: 7
Gender:Female  Submitted:2013-02-11, Days after onset: 347
Location:Foreign  Entered:2013-02-11
Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Abdominal X-ray, Handles distenti
CDC Split Type: B0865673A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSQROLA350BA0PO 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal X-ray, Cardio-respiratory arrest, Death, Hypovolaemic shock, Intussusception, Multi-organ failure, X-ray abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Gastrointestinal obstruction (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a health professional and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 23 February 2012, the subject received 1st dose of ROTARIX (oral). At an unspecified time after vaccination with ROTARIX, the subject experienced intussusception, cardiorespiratory arrest, hypovolemic shock and multiple organ dysfunction. The subject was hospitalised and the regulatory authority reported that the events were clinically significant (or requiring intervention). An abdominal X-ray confirmed intussusception and showed handles distention. The subject died from cardiorespiratory arrest, hypovolemic shock, intussusception and multiple organ dysfunction. It was unknown whether an autopsy was performed. This report is one of 800 cases received as part of a line-listing, each containing minimal information. No further information was expected. Case was closed.

VAERS ID:525630 (history)  Vaccinated:2012-02-23
Age:9.0  Onset:2012-04-23, Days after vaccination: 60
Gender:Female  Submitted:2014-03-12, Days after onset: 688
Location:Foreign  Entered:2014-03-12
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 60 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1403BRA005302
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Atrophy, Complex regional pain syndrome, Decreased appetite, Depression, Muscular dystrophy, Pain
SMQs:, Congenital, familial and genetic disorders (narrow), Depression (excl suicide and self injury) (narrow)
Write-up: This spontaneous report as received from a Physician, who sent an email to Global Medical Affairs, refers to his niece a 9 year old female patient. On unspecified dates the patient was vaccinated with GARDASIL dose 1 and 2, 0.5 mL, intramuscular. On 23-FEB-2012 the patient was vaccinated GARDASIL dose 3, 0.5 mL, intramuscular - UAE. On 23-APR-2012, 61 days after onset of therapy the patient begin to present several symptoms, which were diagnosed later, by a rheumatologist, as Complex Regional Pain Syndrome (hospitalization and disability). Approximately on June 2012, the patient experienced surgical procedure to insert a electrical stimulation device on patient''s spinal cord (medically significant). On an unknown date the patient experienced depression and anorexia. The outcome of complex regional pain syndrome, anorexia and depression was reported as not recovered/not resolved. The reporter considered complex regional pain syndrome, anorexia and depression to be related to GARDASIL. Additional information has been requested. Following there is a copy of the message sent by the reporter to Merck: "This is my niece''s case. She was 9 yo when received the third dose of GARDASIL in Feb 23, 2012 (she was living there on that time). Two months later the last shot, she started to have some neurological symptoms, such as allodynia and severe pain in left foot. It was initially considered as a muscle strain and treated with foot immobilization and medicines. The clinical signs did not improve and, in fact, started to get more severe. She came here, a rheumatologist has given her a diagnosis of Complex Regional Pain Syndrome (CRPS). The diagnosis was also confirmed in Hospital and some months later as well. In mid-2012 she has undergone a surgical procedure because of untreatable pain even using high doses of opioid drugs. This procedure inserted an equipment in the spinal cord in order to make an electrical stimulation. Pain was partially controlled after this procedure. A few months later, she spent two months in a specialized hospital to treat the CRPS with intensive physiotherapy. Unfortunately, the treatment was not able to stop the disease progression, and pain started to get worse again even using the electro stimulator equipment. A muscular dystrophy in the left lower limb has progressively become evident (atrophy of the left foot, which twisted internally). According to the orthopedists, this situation has low chances to be reverted. I''ve read something about this Syndrome and, when the disease is not well controlled, the dystrophy is the natural course of it. Meanwhile, she developed a severe depression and anorexia. In fact, I''m very concerned about the outcome. Currently, she has been treated with a specialized team on chronic pain and children psychiatry. Sadly we haven''t seen any significant improvement since she started the treatment in 2012. In fact, as a physician, I''m not so helpful of seeing her getting better. In spite of all efforts in defining the reasons for the CRPS, no evident etiological factor was found. Vaccine has been always refused by her physicians as the reason for her CRPS. But now, they are strongly considering this possibility since there is no reasonable explanation for the disease after a comprehensive investigation. You know better than me how enthusiastic I am in terms of HPV vaccination. We have wonderful results, those that we recently published. We had no severe adverse events in our cohort. I always refused all negative media reports about GARDASIL, such as Guillain-Barre, neurological dysfunctions, depression, CRPS, and so on. But, to be honest, I''ve started to be concerned about vaccine safety after the report of a couple of cases of CRPS supposedly related to GARDASIL. This came in the same time my own niece has been fighting against a weird disease with no evident etiological factor. So, I''m strongly considering that my niece''s disease can be a severe adverse event related to GARDASIL. I k

VAERS ID:557088 (history)  Vaccinated:2012-02-23
Age:14.0  Onset:2013-04-01, Days after vaccination: 403
Gender:Female  Submitted:2014-11-10, Days after onset: 588
Location:Foreign  Entered:2014-11-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1411JPN003697
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Chest pain, Motor dysfunction, Pain, Swelling, Visual impairment
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a physician via Agency on 06-NOV-2014 and refers to a 14 year old female patient. There were no special notes (including underlying disease, allergy, vaccination/disease within the recent one month, past adverse reaction history, growth status). Family history was not reported. On 10-NOV-2011, the patient was intramuscularly vaccinated with the first dose of GARDASIL (lot #, dose, anatomical location were not reported). Although pain and swelling were noted after vaccination, symptoms improved over time. On 23-FEB-2012, the patient was intramuscularly vaccinated with the second dose of GARDASIL (lot #, dose, anatomical location were not reported). Other concomitant medications were not reported. Severe pain was noted after the second dose of GARDASIL. In around April 2012, the patient developed various symptoms including chest pain, abnormal vision, pain and decreased motor function. On an unspecified date, the symptoms were resolving with steroid pulse therapy. In around Summer of 2014, the symptoms recurred. As of the time of the report on 06-NOV-2014, the patient had not recovered from various symptoms (chest pain, abnormal vision, pain and decreased motor function). The reporting physician considered various symptoms (chest pain, abnormal vision, pain and decreased motor function) as serious due to possible disability (medically significant). The reporting physician felt that the causal relationship of various symptoms (chest pain, abnormal vision, pain and decreased motor function) to GARDASIL was unknown with no other causative factor. Additional information has been requested.

VAERS ID:450307 (history)  Vaccinated:2012-02-24
Age:0.6  Onset:2012-02-24, Days after vaccination: 0
Gender:Male  Submitted:2012-02-25, Days after onset: 1
Location:California  Entered:2012-02-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no.
Preexisting Conditions: none.
Diagnostic Lab Data: None yet. Hoping it does not get to that point.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER   LL
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER    
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)UNKNOWN MANUFACTURER    
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER    
RVX: ROTAVIRUS (NO BRAND NAME)UNKNOWN MANUFACTURER   LL
Administered by: Private     Purchased by: Private
Symptoms: Chills, Crying, Decreased appetite, Hypotonia, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: 3pm shots administered. 6pm dinner time - no appetite. 10:45pm crying, no appetite, vomited once, had shivers, limp in the knees, cried until nursed to sleep. It''s currently 11:45pm so I hope this is the end of these reactions to the vaccines.

VAERS ID:450310 (history)  Vaccinated:2012-02-24
Age:53.0  Onset:2012-02-24, Days after vaccination: 0
Gender:Female  Submitted:2012-02-25, Days after onset: 1
Location:Virginia  Entered:2012-02-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: A cold
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0SYRRA
Administered by: Unknown     Purchased by: Private
Symptoms: Dizziness, Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: Was visiting a friend. Ate dinner, had 2 drinks. Was standing around talking. Felt dizzy, walked to bedroom, asked if I could lie down, passed out cold on floor. From dizziness to collapse, about 2 minutes.

VAERS ID:450367 (history)  Vaccinated:2012-02-24
Age:4.0  Onset:2012-02-26, Days after vaccination: 2
Gender:Male  Submitted:2012-02-27, Days after onset: 1
Location:California  Entered:2012-02-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: NO
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B140CA4IMRL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT499AB3IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURE02043IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0600AA1SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0607AA1SCLL
Administered by: Military     Purchased by: Military
Symptoms: Injection site erythema, Injection site haematoma, Injection site swelling, Injection site warmth
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient has a round 6.5cm diameter size bruise with red/pink outer limit outline, slightly raised warm to touch (WNL) on his right thigh. Patient denies itching and pain.

VAERS ID:450395 (history)  Vaccinated:2012-02-24
Age:2.0  Onset:2012-02-25, Days after vaccination: 1
Gender:Male  Submitted:2012-02-25, Days after onset: 0
Location:New York  Entered:2012-02-27, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4144AA3UNLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1004AA0UNLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH171552UNRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0975AA0UNRL
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site swelling, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: (L) leg local large induration & rash, red, swollen leg after 24 hr of PENTACEL. (-) fever, (-) swg approx. 16cm x 12cm. (R) leg local rxn 4-5 cm x 4-5 cm at PREVNAR-13 site.

VAERS ID:450447 (history)  Vaccinated:2012-02-24
Age:0.2  Onset:2012-02-24, Days after vaccination: 0
Gender:Female  Submitted:2012-02-24, Days after onset: 0
Location:Louisiana  Entered:2012-02-27, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Not indicated
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4143AA0IMRL
HPV4: HPV (GARDASIL)MERCK & CO. INC.1317AA0IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF227220IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1393AA0PO 
Administered by: Private     Purchased by: Public
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
SMQs:, Medication errors (narrow)
Write-up: Pt accidentally received HPV (GARDASIL) instead of Hep B vaccine. Dr. notified, counseled pt father, answered all questions. Spoke with CDC instructed to watch for s/s of local reaction. None noted. Manufacturer notified.

VAERS ID:450535 (history)  Vaccinated:2012-02-24
Age:4.0  Onset:2012-02-24, Days after vaccination: 0
Gender:Female  Submitted:2012-02-27, Days after onset: 3
Location:New Jersey  Entered:2012-02-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: Asthma, allergies, food allergy - cashews
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC3082AA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH13053IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0952AA1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1063AA1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Right arm redness, swelling, pain - progressed over 48h to include entire right upper arm then started to decrease.

VAERS ID:450571 (history)  Vaccinated:2012-02-24
Age:11.0  Onset:2012-02-24, Days after vaccination: 0
Gender:Female  Submitted:2012-02-27, Days after onset: 3
Location:New Mexico  Entered:2012-02-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE PER MOTHER
Preexisting Conditions: NONE PER MOTHER
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1497AA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4077BA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4009AA0IMRA
Administered by: Military     Purchased by: Military
Symptoms: Injection site erythema, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: PATIENT NOTICED ITCHING ON RIGHT ARM AT INJECTION SITE THE EVENING OF RECIEVING HER VACCINES. SHE RECIEVED TdaP AND MCV4 IN THE RIGHT ARM AND GARDISIL VACCINE IN THE LEFT ARM. MOTHER NOTED REDESS AT SITE. MOTHER NOTED AS DAYS WENT ON THAT THE REDNESS SPREAD. MOTHER DID NO INTERVENTIONS FOR CHILD. MOTHER REPORTED TO THE IMMUNIZATIONS CLINIC 27 FEB 2012 AT APPROXIMATELY 12 PM. I SAW CHILD''S REDNESS ON THE RIGHT ARM. MOTHER HAD MARKED THE RASH FROM EARLIER TIME TO NOTE THAT THE REDNESS WAS INCREASING. CHILD PRESENTED WITH NO OTHER S/SX OTHER THAN ITCHING AT SITE. I REPORTED THE INFORMATION TO THE PEDIATRICS CLINIC IMMEDIATELY. THE CHILD WAS THEN SEEN BY A PEDIATRICIAN. THE PEDIATRICIAN SENT THE CHILD HOME WITH HOME CARE. NO MEDICATIONS PRESCRIBED.

VAERS ID:450572 (history)  Vaccinated:2012-02-24
Age:1.5  Onset:2012-02-25, Days after vaccination: 1
Gender:Female  Submitted:2012-02-27, Days after onset: 2
Location:California  Entered:2012-02-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: runny nose
Preexisting Conditions: previous complex seizure 9/9/11 tibial torsion 9/14/10
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4003AA3IMLL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4184BD1IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH523AA3IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHF611773IMRL
Administered by: Private     Purchased by: Private
Symptoms: Condition aggravated, Convulsion, Moaning, Postictal state, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Parents heard baby moaning, went into room and found baby seizing and febrile, seizure last appx 5 min with 20 min post ictal period, did not call 911, grandfather who is a doctor examined baby in the morning.

VAERS ID:450656 (history)  Vaccinated:2012-02-24
Age:5.0  Onset:2012-02-25, Days after vaccination: 1
Gender:Female  Submitted:2012-02-28, Days after onset: 3
Location:Indiana  Entered:2012-02-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B184BA UNLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1374AA1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1149AA1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Erythema, Induration, Pain, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Aching pain, swelling, warmth & erythema. Onset 2/25/12 - no relieving factors i e: cold compresses TYLENOL/ibup. Seen in office 3d after vaccine given Rx KEFLEX to cover cellulitis, induration marked with pen on 2/25/12 as instructed by on call nurse area 2/27/12 progressed - .5in.

VAERS ID:450696 (history)  Vaccinated:2012-02-24
Age:0.4  Onset:2012-02-25, Days after vaccination: 1
Gender:Male  Submitted:2012-02-28, Days after onset: 3
Location:Kansas  Entered:2012-02-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: MRI - NL; CT - NL; spinal tap NL; EEG - NL
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B315AA1IMUN
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1531AA1IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF227201IMUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1303AA1PO 
Administered by: Private     Purchased by: Private
Symptoms: Computerised tomogram normal, Convulsion, Electroencephalogram normal, Lumbar puncture normal, Nuclear magnetic resonance imaging normal
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Cluster of seizures.

VAERS ID:450752 (history)  Vaccinated:2012-02-24
Age:1.1  Onset:2012-02-27, Days after vaccination: 3
Gender:Female  Submitted:2012-02-28, Days after onset: 1
Location:Florida  Entered:2012-02-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER    
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Private
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Palpable rash over entire body.

VAERS ID:450754 (history)  Vaccinated:2012-02-24
Age:74.0  Onset:2012-02-25, Days after vaccination: 1
Gender:Female  Submitted:2012-02-28, Days after onset: 3
Location:Tennessee  Entered:2012-02-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: soreness, redness at injection site~Influenza (Seasonal) (no brand name)~~0.00~Patient
Other Medications: sertraline, tekturna, losartan, pantoprazole, metformin, Januvia, hctz, lisinopril, glyburide
Current Illness: no
Preexisting Conditions: high blood pressure type 2 diabetes glaucoma no allergies
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1601AA0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Patient reports experiencing soreness at injection site as well as a red area around the injection site about the size of a dollar bill folded in half. Patient also report heat in the area of redness.

VAERS ID:450761 (history)  Vaccinated:2012-02-24
Age:59.0  Onset:2012-02-25, Days after vaccination: 1
Gender:Female  Submitted:2012-02-28, Days after onset: 3
Location:Ohio  Entered:2012-02-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: REGLAN; Sulfa
Diagnostic Lab Data: Referred to FMD no tx
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1602AA SCLA
Administered by: Public     Purchased by: Other
Symptoms: Arthralgia, Erythema, Headache, Lethargy, Rash
SMQs:, Anaphylactic reaction (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: ZOSTAVAX SQ 2/24/12 --$g presented to occupational health cc: raised area 4 cm diameter center 6" x 4" width area of erythema. C/O HA lethargic joint aches.

VAERS ID:450833 (history)  Vaccinated:2012-02-24
Age:60.0  Onset:2012-02-27, Days after vaccination: 3
Gender:Female  Submitted:2012-02-29, Days after onset: 2
Location:Ohio  Entered:2012-02-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Diovan, Simvastatin, Synthroid, Singulair, Advair
Current Illness: Sciatica
Preexisting Conditions: Known allergies: Tetracycline, PCN, codeine
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B078AA0IMRA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0730AA0SCRA
Administered by: Public     Purchased by: Private
Symptoms: Herpes zoster, Pain, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Awoke in AM with pimple like area noted on right rib cage. Pain started shortly thereafter and a few more bumps appeared. Seen by MD 2/28/12 diagnosed with shingles. MD added he did not feel vaccine contributed to outbreak. Prescribed anti-viral medication, pain med. Additional area of rash developed on right upper arm early 2/29/12.

VAERS ID:450865 (history)  Vaccinated:2012-02-24
Age:5.0  Onset:2012-02-24, Days after vaccination: 0
Gender:Male  Submitted:2012-02-27, Days after onset: 3
Location:New Mexico  Entered:2012-03-01, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: RAD - stable- intermittent
Preexisting Conditions: RAD - intermittent
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4118AA IMLL
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Left thigh redness and swelling, pain.

VAERS ID:450878 (history)  Vaccinated:2012-02-24
Age:68.0  Onset:2012-02-24, Days after vaccination: 0
Gender:Female  Submitted:2012-03-01, Days after onset: 6
Location:Illinois  Entered:2012-03-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: atenolol 50mg q day, levothyroxine 150mcg q day
Current Illness: no
Preexisting Conditions: hypertension, hypothyroidism
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1723AA IMLA
Administered by: Public     Purchased by: Private
Symptoms: Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Severe upper arm pain and swelling.

VAERS ID:450885 (history)  Vaccinated:2012-02-24
Age:15.0  Onset:2012-02-24, Days after vaccination: 0
Gender:Female  Submitted:2012-03-01, Days after onset: 6
Location:Oregon  Entered:2012-03-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1397AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Headache, Malaise, Tinnitus
SMQs:, Hearing impairment (narrow)
Write-up: Patient c/o headache, tinnitus, and "not feeling well" x24 hrs after vaccine.

VAERS ID:450921 (history)  Vaccinated:2012-02-24
Age:4.0  Onset:2012-02-24, Days after vaccination: 0
Gender:Male  Submitted:2012-02-27, Days after onset: 3
Location:Georgia  Entered:2012-03-01, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B196BA0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1375AA1SCLA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9181730IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1250AA1SCRA
Administered by: Military     Purchased by: Military
Symptoms: Injection site erythema, Injection site rash
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: After receiving vaccines pt developed local red rash at each injection site. Pt denied itching or burning at site. Pt was treated with BENADRYL 25mg PO and observed for 30 minutes. Rash subsided.

VAERS ID:450964 (history)  Vaccinated:2012-02-24
Age:41.0  Onset:2012-02-24, Days after vaccination: 0
Gender:Female  Submitted:2012-02-29, Days after onset: 5
Location:Massachusetts  Entered:2012-03-02, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: EXCEDRIN migraine
Current Illness: None
Preexisting Conditions: NKA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1219AA1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Blister, Cellulitis, Erythema, Oedema, Pyrexia
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Edema. Blisters. Erythema. Fever. Treated in ER 48 hours after injection. Diagnosis - cellulitis Rx Prednisone, KEFLEX.

VAERS ID:451005 (history)  Vaccinated:2012-02-24
Age:70.0  Onset:2012-02-25, Days after vaccination: 1
Gender:Female  Submitted:2012-03-04, Days after onset: 8
Location:Virginia  Entered:2012-03-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0SYRLA
Administered by: Other     Purchased by: Other
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)
Write-up: Onset of pain in the opposite arm (right arm) from the injection site, where I had pain from singles that I had some 7 years ago. Scale of pain is like having shingles again, (8 out of 10). No blisters present to date with this episode.

VAERS ID:451078 (history)  Vaccinated:2012-02-24
Age:29.0  Onset:2012-02-24, Days after vaccination: 0
Gender:Female  Submitted:2012-02-27, Days after onset: 3
Location:Kentucky  Entered:2012-03-05, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: CBC nl
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1002AA1SCUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Full blood count normal
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Pt received MMR #2 2/24/12 - reports dizziness developed w/i 1h - has lasted ever since. PE - normal 2/27/12.

VAERS ID:451081 (history)  Vaccinated:2012-02-24
Age:4.0  Onset:2012-02-25, Days after vaccination: 1
Gender:Female  Submitted:2012-03-05, Days after onset: 9
Location:Arkansas  Entered:2012-03-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: cefdinir; loratadine; albuterol; FLOVENT
Current Illness:
Preexisting Conditions: Asthma
Diagnostic Lab Data: Rapid strep; UA; flu A/B; urine cx; resp. cx; CBC - r/o illness.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B178DA0IMLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB539DA1IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1600Z1SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1209AA SCLL
Administered by: Private     Purchased by: Public
Symptoms: Abdominal pain, Cough, Culture, Culture urine, Full blood count, Headache, Influenza A virus test, Influenza B virus test, Respiratory tract congestion, Rhinorrhoea, Streptococcus test, Urine analysis, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Runny nose, cough, congestion, abdominal pain, HA, vomiting.. Began day after vaccinations. Lasted 2 days.

VAERS ID:451095 (history)  Vaccinated:2012-02-24
Age:71.0  Onset:2012-02-25, Days after vaccination: 1
Gender:Female  Submitted:2012-03-05, Days after onset: 9
Location:Iowa  Entered:2012-03-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: No known drug allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0693AA0SCRA
Administered by: Other     Purchased by: Unknown
Symptoms: Diarrhoea, Headache, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Approximately 9 hours after vaccine - patient reported having diarrhea x 1. Approximately 15 hours after vaccine - patient reported having vomiting x 1. Approximately 20 hours after vaccine - patient reported having headache lasting approximately 2 hours then patient able to resume normal activities.

VAERS ID:451109 (history)  Vaccinated:2012-02-24
Age:1.0  Onset:2012-02-27, Days after vaccination: 3
Gender:Male  Submitted:2012-03-05, Days after onset: 7
Location:California  Entered:2012-03-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER  IDLL
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  IMRL
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  IMRL
Administered by: Unknown     Purchased by: Other
Symptoms: Asthenia, Decreased appetite, Pyrexia, Rash, Rash erythematous, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: High Fevers 105 degrees, shaking, Weak, Loss of appetite. On day 4 of fevers, broke out in rash. Tiny red dots on trunk of body treated around the clock with fever reducing medications in order to keep fever less than 104-105 degrees.

VAERS ID:451252 (history)  Vaccinated:2012-02-24
Age:5.0  Onset:2012-02-25, Days after vaccination: 1
Gender:Female  Submitted:2012-03-07, Days after onset: 11
Location:Massachusetts  Entered:2012-03-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEUR 4IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1394Z1SCRA
Administered by: Private     Purchased by: Unknown
Symptoms: Hypersensitivity, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Skin lesion
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 2/27/12 - pt. seen in office. ? Cellulitis ? allergic reaction 9cm x 9cm, erythema with lesions near center at injection site. Warm, swollen. Pt given KEFLEX 250 - 1 tsp. TID x 7D.

VAERS ID:451270 (history)  Vaccinated:2012-02-24
Age:31.0  Onset:2012-02-26, Days after vaccination: 2
Gender:Male  Submitted:2012-02-29, Days after onset: 3
Location:North Carolina  Entered:2012-03-08, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UTI
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC40098A IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Feeling hot, Induration, Oedema, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)
Write-up: Initial induration, tenderness - 48 hours marked induration, erythema, warmth & superficial edema.

VAERS ID:451277 (history)  Vaccinated:2012-02-24
Age:71.0  Onset:2012-02-25, Days after vaccination: 1
Gender:Unknown  Submitted:0000-00-00
Location:Pennsylvania  Entered:2012-03-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Got shingles shot on 2/24/12. The next day my arm was red and sore and the day after it spread it was red and sore almost to my elbow I slept with ice which they did not tell me to use but I talked to my Dr. & he said to use ice. It took almost a week for it to go away.

VAERS ID:451322 (history)  Vaccinated:2012-02-24
Age:64.0  Onset:2012-03-04, Days after vaccination: 9
Gender:Female  Submitted:2012-03-08, Days after onset: 4
Location:Arizona  Entered:2012-03-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Psoriasis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4308BA1IMLA
Administered by: Public     Purchased by: Private
Symptoms: Erythema, Pain, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Large localized area of redness half-way between shoulder and elbow. Warm to touch, very sore.

VAERS ID:451355 (history)  Vaccinated:2012-02-24
Age:16.0  Onset:2012-02-24, Days after vaccination: 0
Gender:Female  Submitted:2012-02-24, Days after onset: 0
Location:Indiana  Entered:2012-03-09, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VENTOLIN
Current Illness: None
Preexisting Conditions: Asthma; allergies
Diagnostic Lab Data: None, healthy patient w/ controlled asthma, allergies
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH507AA0IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB539CA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4033AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1207AA0SCRA
Administered by: Public     Purchased by: Other
Symptoms: Dizziness, Hyperventilation, Muscle spasms, Pallor
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Anticholinergic syndrome (broad), Dystonia (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Muscle spasm upper extremities. Hyperventilation. Dizziness, paleness.

VAERS ID:451358 (history)  Vaccinated:2012-02-24
Age:4.0  Onset:2012-02-25, Days after vaccination: 1
Gender:Male  Submitted:2012-03-02, Days after onset: 6
Location:Arizona  Entered:2012-03-09, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Chronic otitis media; atopic derm
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4003AA4IMLA
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH471AA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURG10833SCRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0705AA1SCLA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9181730IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0932AA1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Bright red rash at injection site that spread to trunk - itchy.

VAERS ID:451368 (history)  Vaccinated:2012-02-24
Age:1.1  Onset:2012-02-26, Days after vaccination: 2
Gender:Male  Submitted:2012-03-06, Days after onset: 9
Location:Florida  Entered:2012-03-09, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: ENFAMIL-rash; Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1121AA0SCLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9181723IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1575AA0SCRL
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site pustule, Injection site reaction, Injection site warmth, Pallor, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Raised red rash on right thigh/itching. Received VZV vaccine on 2/24/12. No fever - pustule surrounded by 2.5cm dia. area of erythema, blanchable, area hard, warm & non-tender.

VAERS ID:451521 (history)  Vaccinated:2012-02-24
Age:6.0  Onset:2012-02-24, Days after vaccination: 0
Gender:Male  Submitted:2012-03-08, Days after onset: 13
Location:Kentucky  Entered:2012-03-12, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic ITP
Preexisting Conditions: ITP
Diagnostic Lab Data: Chronic ITP - Blood culture: negative
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC3944AA4IMRL
HEPA: HEP A (VAQTA)MERCK & CO. INC.1586AA0IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURG15003IMRL
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4077BA0IMLL
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1170AA0IMLL
Administered by: Other     Purchased by: Public
Symptoms: Blood culture negative, Cellulitis, Condition aggravated, Erythema, Idiopathic thrombocytopenic purpura, Oedema peripheral, Pain in extremity, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Right leg edema, erythema and pain, few hours after vaccines. Fever same day of vaccines. Admitted x 3 days due to cellulitis treated with clindamycin. Pt has chronic ITP refractory to steroids, IVIG and WinRho.

VAERS ID:451544 (history)  Vaccinated:2012-02-24
Age:72.0  Onset:2012-02-25, Days after vaccination: 1
Gender:Female  Submitted:2012-03-12, Days after onset: 15
Location:Wisconsin  Entered:2012-03-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: alprazolam, diazepam, lomotil, felodipine, lisinopril, terbinafine
Current Illness: none
Preexisting Conditions: hypertension, fungal nail infection, irritable bowel syndrome
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1270AA0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Headache, Hypersensitivity, Injection site erythema, Rash erythematous, Rash generalised, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: The patient described a local injection site red reaction after the vaccine, and then a fine red itchy bumpy rash that started on her legs and spread to most of her body over the next week or so. She was seen by Dr. on 3/01 and evaluated. He felt the rash was most likely an allergic reaction to the vaccine. He concurred with the patient''s assesment of the injection site reaction and rash. The patient also reported low-grade headache but no fever or chills or other symptoms. He did not feel the rash was a varicella-type rash. He prescribed OTC diphenhydramine 25-50 mg every 4 hours as needed and cool baths. As of 3/12/12, the patient reports improvement but still a rash on arms.

VAERS ID:451554 (history)  Vaccinated:2012-02-24
Age:4.0  Onset:2012-03-11, Days after vaccination: 16
Gender:Female  Submitted:2012-03-12, Days after onset: 0
Location:Pennsylvania  Entered:2012-03-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1002AA1SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0942M1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Unevaluable event
SMQs:
Write-up: Patient seen in office.

VAERS ID:451555 (history)  Vaccinated:2012-02-24
Age:15.0  Onset:2012-02-24, Days after vaccination: 0
Gender:Female  Submitted:2012-03-12, Days after onset: 16
Location:New Jersey  Entered:2012-03-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1397AA2IMRA
Administered by: Private     Purchased by: Private
Symptoms: Fall, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Fainted and fall down after 5 minutes of vaccination (GARDASIL).

VAERS ID:451739 (history)  Vaccinated:2012-02-24
Age:3.0  Onset:2012-03-05, Days after vaccination: 10
Gender:Female  Submitted:2012-03-14, Days after onset: 8
Location:Indiana  Entered:2012-03-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NO
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1296AA0UNLG
Administered by: Unknown     Purchased by: Unknown
Symptoms: Rash generalised, Rash morbilliform
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient developed a rash on her face and her trunks, the next morning it had spread into a total body rash. It looked like she had the measles all over her body. It lasted for a day, then the next day the trunk faded, the following day the arms improved. When she gets hot, you can still see a little residual on her face and arms/legs.

VAERS ID:452066 (history)  Vaccinated:2012-02-24
Age:17.0  Onset:2012-02-25, Days after vaccination: 1
Gender:Female  Submitted:0000-00-00
Location:North Carolina  Entered:2012-03-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Omeprazole 40mg-q am
Current Illness: Reflux
Preexisting Conditions: Reflux
Diagnostic Lab Data: All test ordered 3-12-12 (see above #7) normal
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB549BA1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1560AA2IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA100600IMRA
Administered by: Private     Purchased by: Private
Symptoms: Antinuclear antibody negative, Arthralgia, Back pain, Borrelia test negative, C-reactive protein normal, Cytomegalovirus test negative, Epstein-Barr virus antibody negative, Epstein-Barr virus test negative, Fatigue, Hypoaesthesia, Lymphadenopathy, Metabolic function test normal, Neck pain, Pain in extremity, Pyrexia, Red blood cell sedimentation rate normal
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 2/29/12 - fever, back pain, neck pain - Tx: NAPROSYN. 3/12/12 - back pain, joint pain, swollen lymph nodes-neck, fatigue. Labs ordered: EBV twice, CMV titre, ANA, CRP, ESR, Lyme titre, CMP. 3/16/12 - phone call from parent: c/o arm pain & numbness - rheumatologist referral made.

VAERS ID:453374 (history)  Vaccinated:2012-02-24
Age:  Onset:0000-00-00
Gender:Unknown  Submitted:0000-00-00
Location:Unknown  Entered:2012-04-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Expired drug administered
SMQs:, Medication errors (narrow)
Write-up: An expired dose of MENACTRA was given to a patient the dose expired on X/XX/2012 and dose was given on X/XX/2012 (next day). We have removed the vaccine from the fridge and the patient will be revaccinated.

VAERS ID:458419 (history)  Vaccinated:2012-02-24
Age:76.0  Onset:2012-02-25, Days after vaccination: 1
Gender:Female  Submitted:2012-03-22, Days after onset: 25
Location:Massachusetts  Entered:2012-06-29, Days after submission: 99
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1603AA0SCRA
Administered by: Public     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Local reaction at site of injection tenderness, redness, swelling. No Rx- resolved less than 1 week.

VAERS ID:461241 (history)  Vaccinated:2012-02-24
Age:77.0  Onset:2012-03-05, Days after vaccination: 10
Gender:Unknown  Submitted:2012-07-30, Days after onset: 146
Location:Unknown  Entered:2012-07-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Gout; Hypertension
Diagnostic Lab Data: 05/17/2012, Ultrasound abdomen, irritated stomach, AO, LBD, GB, liver, pancreas, kidneys and spleen; 05/17/2012, X-ray, Pneumonia deep
CDC Split Type: WAES1206USA01179
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Abdominal pain upper, Axillary pain, Breast pain, Chest X-ray abnormal, Differential white blood cell count, Echocardiogram, Epigastric discomfort, Feeling abnormal, Flank pain, Full blood count, Herpes zoster, Metabolic function test, Muscle strain, Paraesthesia, Platelet count, Pneumonia, Red blood cell sedimentation rate, Scan spleen, Ultrasound Doppler, Ultrasound abdomen abnormal, Ultrasound biliary tract, Ultrasound kidney, Ultrasound liver
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Lipodystrophy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a patient who on 24-FEB-2012 was vaccinated at a local drug store with a dose of ZOSTAVAX (Merck) (lot #, dose and site of administration were not reported). The patient''s intuition told that should not have it. The patient had a call from a friend who had one and she also told to the patient about another friend that also had one. She convinced to the patient to do this. About 10 to 12 days later, (approximately on 05-MAR-2012), the patient began with unbearable pain from under the left armpit, across the breasts and the total abdomen. The patient was wearing a bra or slacks with elastic bands were total torture and still was. On 14-MAR-2012, the patient went to the doctor who the patient had been with for about 15-20 years. The doctor told that had a pulled muscle. The patient knew that was not correct as the patient had been sitting in the rocker and reading all this time because the patient was miserable with pain. (Please note he was no longer the patient''s doctor.). The patient had two sons and they were very concerned. The youngest son said that''s it would find a doctor. On 11-MAY-2012, the patient went to a clinic. That doctor told to the patient she was very concerned about the timing of the shot and when the patient''s pain began. She honestly told to the patient that she was not an expert in the Shingles shot. By that time the patient''s son found a new doctor. On 17-MAY-2012, the patient went to the new doctor. That day the physician examined to the patient and he decided that the patient should have an x-ray. The patient did it. In the afternoon and about 2 hours later, the physician called to the patient to report that it was found pneumonia deep in the chest. The physician said that he could not tell if that was causing the pain. Beside the x-ray the physician ordered the following test: XR-Chest, CBC with Automated Diff and Platelet, Comprehensive Metabolic Panel, ESR, UL Ultrasound Abdomen, Complete (inc. AD, LBD, GB, Liver, Pancreas, Kidney, Spleen, and ECH Echocardiogram (at the time of this report results were not provided). In addition to the pneumonia, the patient also had an irritated stomach and that was another thing that was very painful. The test of the stomach showed that the patient had that. The patient''s life had been hell since receiving the shot. It was reported that the patient was still in pain. People tell to the patient how pain shingles were. Well, the patient would not wish the pain that the patient had had on anyone. The patient just wonder if had Shingles inside body. At the time of the report, the patient''s outcome from abdominal pain upper, epigastric discomfort, feeling abnormal, shingles, muscle strain and pneumonia were not reported. Follow-up information has been received from 77 years old patient with high blood pressure and gout who had been in very good health, very active in a lot of activities. Concomitant medications included felodipine, hydrochlorothiazide (manufacturer unknown), Gabapentin, Probenecide and "Preserve Vision". Patient reported that on an unknown date, he had ultrasound of his abdomen including aorta (AO), "LBD", gall bladder (GB), liver, pancreas, kidneys and spleen (results not provided). It was reported that irritated stomach was found. On unknown date, the patient had done echocardiogram (results not provided). The patient reported that he is going to have MRI and must consult with gastroenterologist doctor. The patient also reported that we still had a lot of pain in his left side and his stomach had pins and needles feeling and was bloated at the end of the day. After four months, "he was really tired of pain". At the time of reported, the outcomes of "stomach had pins and needles feeling" and "bloated at the end of the day" were unknown. The relatedness for the patient''s events was not reported for ZOSTAVAX (Merck). Additional information has been requested.

VAERS ID:483718 (history)  Vaccinated:2012-02-24
Age:  Onset:2012-03-03, Days after vaccination: 8
Gender:Male  Submitted:2013-02-01, Days after onset: 335
Location:California  Entered:2013-02-07, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject had a penicillin allergy and Lasik surgery in July 2011.
Diagnostic Lab Data: 05 March 2012: ECG: Normal
CDC Split Type: 201301151
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEUR  IDUN
Administered by: Military     Purchased by: Military
Symptoms: Chest discomfort, Electrocardiogram normal, Myopericarditis, Troponin normal
SMQs:, Anaphylactic reaction (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This study case was received from the investigator in a trial on 24 January 2013. A male subject (age and date of birth not reported) had received the following vaccinations on 24 February 2012: ACAM2000 (lot number and site not reported) and anthrax vaccine (manufacturer, lot number, route and site not reported). Eight days post-vaccination on 03 March 2012, the subject experienced mild intermittent chest pressure in absence of any other symptoms that was not related to activity. Rapid and lab troponin and ECG were both normal on 05 March 2012. The subject was referred for care due to some suspicion of myopericarditis. The subject had an allergy to penicillin and Lasik surgery in July 2011. No further information was available at the time of the report. The subject''s outcome was not recovered. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study''s adjudication committee for assessment. Documents held by sender: None.

VAERS ID:504013 (history)  Vaccinated:2012-02-24
Age:25.0  Onset:2012-02-24, Days after vaccination: 0
Gender:Female  Submitted:2013-09-24, Days after onset: 577
Location:North Carolina  Entered:2013-09-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLEGRA-D 12 hour
Current Illness: Hypersensitivity, Continuing
Preexisting Conditions:
Diagnostic Lab Data: Pregnancy test, Positive, Home pregnancy test positive; 03/09/2012, Diagnostic, Not yet completed. Reassurance patient GARDASIL exposure
CDC Split Type: WAES1203USA00342
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1668AA0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Exposure during pregnancy, Pregnancy test positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a licensed practical nurse, for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female patient with no drug reactions or allergies and no pertinent medical history who on 24-FEB-2012, was vaccinated with a first dose of GARDASIL 0.5 ml, intramuscular (lot number reported as 1668AA, expiration date 15-AUG-2014). Concomitant therapy included ALLEGRA-D 12 hour. There was no treatment given for receiving the first dose of GARDASIL and being pregnant by the patient. It was reported that the patient was pregnant. On an unknown date, home pregnancy test was performed with positive result. The patient''s last menstrual period was on 31-JAN-2012. Estimated delivery date would be 06-NOV-2012. Follow-up information has been received from a licensed practical nurse for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female patient with a history of one previous pregnancies and one full term deliveries and unknown obstetric history of birth defects or infant complications in previous pregnancies, who on 24-FEB-2012, was vaccinated with a first dose of GARDASIL. Concomitant therapy included ALLEGRA-D 12 hour for the treatment of allergies, and reporter was unsure it was taken afternoon (PM) by the patient. Ultrasound test was scheduled on 09-MAR-2012 to reassurance patient''s GARDASIL exposure. It was not completed at the time of the report. A follow-up information has been received from a nurse, who reported that the patient was no longer with the practice. Additional information is not expected.

VAERS ID:516339 (history)  Vaccinated:2012-02-24
Age:21.0  Onset:0000-00-00
Gender:Female  Submitted:2013-12-12
Location:Georgia  Entered:2013-12-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hormonal contraceptives (unspecified)
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1203USA00043
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0180AA0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from a Registered Nurse and a 21 year old female consumer, as part of a pregnancy registry for GARDASIL, reporting on herself with no pertinent medical history, drug reactions or allergies who on 24-FEB-2012, was vaccinated with the first dose of GARDASIL (lot number 667878/0180AA; dose and route not reported). Concomitant therapy included hormonal contraceptives (unspecified). The registered nurse reported that the patient went in February 2010 for her annual exam; at the tie she was on the pill and had not missed a period so she received GARDASIL. The consumer reported that on 28-FEB-2011 she found out she was pregnant. The consumer estimated that her last menstrual period was in the first week of February (on approximately 01-FEB-2012). The estimated delivery date was on 07-NOV-2012. No lab diagnostic tests were performed. The registered nurse reported that she did not have any information about an OBGYN for the patient. Follow up information received. Case was lost to follow up. Pregnancy outcome was not known. Additional information is not expected.

VAERS ID:532299 (history)  Vaccinated:2012-02-24
Age:71.0  Onset:2012-02-25, Days after vaccination: 1
Gender:Male  Submitted:2012-03-30, Days after onset: 33
Location:Oregon  Entered:2014-05-29, Days after submission: 790
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1072AA1UNRA
Administered by: Other     Purchased by: Other
Symptoms: Injected limb mobility decreased, Local swelling, Pain in extremity
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Swollen right arm, painful, could not lift it. Went to ER got abx.

VAERS ID:574301 (history)  Vaccinated:2012-02-24
Age:24.0  Onset:2012-02-24, Days after vaccination: 0
Gender:Unknown  Submitted:2015-02-27, Days after onset: 1099
Location:Unknown  Entered:2015-04-16, Days after submission: 47
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.  UNUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.K001231 UNUN
Administered by: Public     Purchased by: Unknown
Symptoms: Wrong drug administered
SMQs:, Medication errors (narrow)
Write-up: Client was assessed to need Td, Hep B and Flu from immunization record. When order was written by nurse, MMR was written on order instead of Hep B. Vaccine was administered as order mistakenly written. Client subsequently got needed Hep B once error was discovered before leaving,

VAERS ID:451126 (history)  Vaccinated:2012-02-24
Age:15.0  Onset:2012-02-25, Days after vaccination: 1
Gender:Female  Submitted:2012-03-05, Days after onset: 9
Location:Foreign  Entered:2012-03-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0785327A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA149CA2IMLA
Administered by: Other     Purchased by: Other
Symptoms: Contusion, Fall, Feeling abnormal, Headache, Loss of consciousness, Presyncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of loss of consciousness in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 24 February 2012, the subject received the 3rd dose of CERVARIX (0.5 ml, intramuscular, left deltoid). On 25 February 2012, 1 day after vaccination with CERVARIX, the subject experienced loss of consciousness, vagal reaction, feels poorly, fall, bruise of head, bruising of face and headache. The subject felt poorly during shopping on the next day after the vaccination. She went to a restroom, and fell, while she was waiting for her turn, and hit her head and face. She took a rest for approximately 1 hour in an infirmary of a department store. She visited a department of neurosurgery. On 27 February 2012, the subject visited a department of plastic surgery. She had pain in the head at the time of reporting. The physician considered the events were clinically significant. At the time of reporting the outcome of the events bruising of face and bruising of head was unspecified, the events loss of consciousness, vagal reaction, fall and feeling poorly were resolved and headache was still ongoing. The reporter considered possible that the event was vagal reflex, because it developed when the patient was waiting to use a restroom.

VAERS ID:451337 (history)  Vaccinated:2012-02-24
Age:  Onset:2012-02-24, Days after vaccination: 0
Gender:Female  Submitted:2012-03-08, Days after onset: 13
Location:Foreign  Entered:2012-03-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0784677A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  UNUN
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong technique in drug usage process
SMQs:, Medication errors (narrow)
Write-up: This case was reported by a physician and described the occurrence of wrong technique in drug usage process in an infant female subject who was vaccinated with PRIORIX (GlaxoSmithKline), INFANRIX-POLIO. On 23 February 212, the subject received unspecified dose of PRIORIX TETRA (unknown route and injection site), unspecified doe of INFANRIX (unknown route and injection site). The subject was vaccinated with a single injection of a solution of both vaccines as the physician diluted the powder of PRIORIX TETRA with the solution of INFANRIX. No adverse event was reported. Follow-up information received on 29 February 2012: This case was updated to serious. On 24 February 2012 the subject received unspecified dose of PRIORIX (unknown route and injection site). Unspecified dose of INFANRIX POLIO (unknown route and injection site). The subject was vaccinated with a single injection of a solution of both vaccines as the physician diluted the powder of PRIORIX TETRA with the solution of INFANRIX. The subject was hospitalised.

VAERS ID:451486 (history)  Vaccinated:2012-02-24
Age:0.2  Onset:2012-02-27, Days after vaccination: 3
Gender:Female  Submitted:2012-03-09, Days after onset: 11
Location:Foreign  Entered:2012-03-12, Days after submission: 2
Life Threatening? No
Died? Yes
   Date died: 2012-02-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No medical history (including allergy); No concomitant therapy
Diagnostic Lab Data: Not reported
CDC Split Type: 201202444
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURG13750SCLA
PNC: PNEUMO (PREVNAR)PFIZER/WYETH11G03A0SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Death, Nonspecific reaction, Resuscitation
SMQs:
Write-up: Case received from the Health Authorities on 28 February 2012 under the reference number A201200064 (HA''s number HIB-337, 337-2). A 02-month-old female patient, with no medical history and no concomitant therapy, had received her 1st subcutaneous dose of ACTHIB (batch number G1375) in the left upper arm and her 1st subcutaneous dose of PREVENAR (other manufacturer, batch number 11G03A) in the right upper arm on 24 February 2012 at 02:37pm. The patient''s body temperature before vaccination was 36.8 degrees C. On 27 February 2012 at 09:00am, the patient did not experience any abnormal symptoms. On 27 February 2012 at 10:00am, she developed abnormal symptoms (not specified). She was taken to hospital by ambulance and the physicians began trying to resuscitate the patient. On 27 February 2012 at 0:09pm the patient''s death was confirmed. Physician''s comment: A causal relationship between the vaccines and the patient''s death is not assessable.

VAERS ID:453587 (history)  Vaccinated:2012-02-24
Age:4.0  Onset:2012-02-25, Days after vaccination: 1
Gender:Unknown  Submitted:2012-04-12, Days after onset: 46
Location:Foreign  Entered:2012-04-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0794774A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B132BG IMAR
Administered by: Other     Purchased by: Other
Symp