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Case Details (Sorted by Vaccination Date)

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VAERS ID: 265504 (history)  
Form: Version 1.0  
Age: 33.0  
Gender: Female  
Location: Arkansas  
Vaccinated:2006-10-27
Onset:2006-10-27
   Days after vaccination:0
Submitted: 2006-10-27
   Days after onset:0
Entered: 2006-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0908R / 1 RA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Sulfa Latex
Allergies:
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Pt in office for Varicella vaccine. Approx. 20 min later pt called c/o "lump" in throat and generally feeling bad. Instructed pt to take Benadryl and see MD ASAP. MD office was closed so pt went to the local ambulance service and was transported to the nearest ER facility. Pt was reportedly given Benedryl in the ambulance and was stable upon arrival. After being evaluated and observed in ER pt was released to home.


VAERS ID: 265507 (history)  
Form: Version 1.0  
Age: 47.0  
Gender: Female  
Location: Tennessee  
Vaccinated:2006-10-27
Onset:2006-10-27
   Days after vaccination:0
Submitted: 2006-10-27
   Days after onset:0
Entered: 2006-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2274AA / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dizziness, Dyspnoea, Tremor, Vision blurred
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNKOWN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Approximately ten minutes after receiving the vaccine the patient came back to pharmacy stating that she felt dizzy. She sat down and then when asked how she felt she says she has a history of seizures and felt like she was about to have a seizure. She complained of blurred vision, shortness of breath, tremor. EMS arrived shortly after to assist patient and take her to ER. Patient also stated she has history of diabetes. She stated she checked blood sugar prior to arriving to pharmacy and said it was okay.


VAERS ID: 265540 (history)  
Form: Version 1.0  
Age: 0.59  
Gender: Female  
Location: Nebraska  
Vaccinated:2006-10-27
Onset:0000-00-00
Submitted: 2006-10-27
Entered: 2006-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B053BA / 3 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE826AA / 3 LL / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U1780AA / 3 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08655B / 3 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Medication error
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Meningococcal mixed with Hib conjugate et administered IM to pt instead of Diluent mixed with Hib.


VAERS ID: 265604 (history)  
Form: Version 1.0  
Age: 3.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2006-10-27
Onset:2006-10-28
   Days after vaccination:1
Submitted: 2006-10-30
   Days after onset:2
Entered: 2006-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0794F / 1 LL / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Rash, Viral infection
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My daughter got chickenpox within one day after reciving vericella vaccine.


VAERS ID: 265606 (history)  
Form: Version 1.0  
Age: 40.0  
Gender: Female  
Location: South Dakota  
Vaccinated:2006-10-27
Onset:2006-10-28
   Days after vaccination:1
Submitted: 2006-10-30
   Days after onset:2
Entered: 2006-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA213BA / 1 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Discomfort, Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Local Skin Reaction~Influenza (Seasonal) (Fluarix)~1~0.00~In Patient
Other Medications:
Current Illness:
Preexisting Conditions: NKA
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Employee complained of redness, swelling, warmth and discomfort around injection site. Area red, warm to touch and uncomfortable to touch on exam.


VAERS ID: 265671 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2006-10-27
Onset:2006-10-28
   Days after vaccination:1
Submitted: 2006-10-31
   Days after onset:3
Entered: 2006-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2244AA / UNK LA / -
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 0817F / UNK RL / -

Administered by: Private       Purchased by: Public
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 2in X 1 1/2 in red, firm, warm area at injection site right leg.


VAERS ID: 265707 (history)  
Form: Version 1.0  
Age: 1.1  
Gender: Male  
Location: Texas  
Vaccinated:2006-10-27
Onset:2006-10-30
   Days after vaccination:3
Submitted: 2006-10-31
   Days after onset:1
Entered: 2006-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2192AA / 1 RL / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 0823F / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08682D / 4 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blister
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: colic-11/05, congestion-11/05, allergic dermititis-04/05, ge reflux-11/05
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pts mom states that child has fluid filled blisters appearing all over body. Confirmed by hospital staff. Started 10/30/06.


VAERS ID: 265774 (history)  
Form: Version 1.0  
Age: 48.0  
Gender: Female  
Location: Michigan  
Vaccinated:2006-10-27
Onset:2006-10-27
   Days after vaccination:0
Submitted: 2006-10-30
   Days after onset:3
Entered: 2006-11-01
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 71033 / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Erythema, Feeling hot, Oedema
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)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Erythema, Edema, warmth to touch. 10/20/06 10x7 in size. Treatment with Levaquin 500mg 1tab x 10 day, Claritin 10 mg daily.


VAERS ID: 265807 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Female  
Location: Missouri  
Vaccinated:2006-10-27
Onset:2006-10-29
   Days after vaccination:2
Submitted: 2006-10-31
   Days after onset:2
Entered: 2006-11-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B035AA / 5 LL / -
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR K2275AA / 2 RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR 20001 / 4 LL / -
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 0971F / 2 RL / -

Administered by: Private       Purchased by: Unknown
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 10/27/2006 at 4 year well check administered Dtap, Polio, ProQuad, Flu-mom advised Sunday following injection sites red and hot and developed a rash- seen at urgent care.


VAERS ID: 265817 (history)  
Form: Version 1.0  
Age: 75.0  
Gender: Female  
Location: Michigan  
Vaccinated:2006-10-27
Onset:2006-10-27
   Days after vaccination:0
Submitted: 2006-10-31
   Days after onset:4
Entered: 2006-11-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1008P / 2 LA / -

Administered by: Private       Purchased by: Other
Symptoms: Chills, Erythema, Myalgia, Nausea, Somnolence
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: allergy to Celebrex, Bactrim and Tetanus, CAD (coronary artery disease).
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Soreness in left arm-red and swollen, nausea, chills, slept 10-12 hours, 12 by 6 cm erythema left deltoid.


VAERS ID: 265819 (history)  
Form: Version 1.0  
Age: 38.0  
Gender: Female  
Location: Florida  
Vaccinated:2006-10-27
Onset:2006-10-27
   Days after vaccination:0
Submitted: 2006-10-31
   Days after onset:4
Entered: 2006-11-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0486F / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Chills, Hyperhidrosis, Injection site erythema, Injection site pain, Malaise, Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: CBC; BMP: LFT; Amylase; Lipase
CDC Split Type:

Write-up: The patient comes in today with complaints of fever, chills, sweating, vomiting, nausea. She states the symptoms began two days ago. She thinks they are related to a Pneumovax injection she received the day before. She states that she had been having a flare of her asthma and came into the office and was given Medrol Dose-pack, Singulair, and a Pneumovax. The following day, she started feeling badly with a fever going up to 104 early this morning, headache, nausea, and vomiting. She has body aches. She feels horrible. She feels like a truck has hit her. She is not coughing. Coincidentally, her breathing is very well controlled. She has used her inhaler once since then. Has really felt ok. She has had no sore throat, no nasal congestion. No urinary frequency, no constipation, no diarrhea. She has a slight amount of abdominal pain. She is very sore where she was given the injection and she has a lot of redness. She has never had a reaction like this to any kind of immunization. She is keeping fluids down and she is urinating but not as much as usual. She has not eaten for two days because she feels so nauseous.


VAERS ID: 265857 (history)  
Form: Version 1.0  
Age: 1.0  
Gender: Female  
Location: Vermont  
Vaccinated:2006-10-27
Onset:2006-10-28
   Days after vaccination:1
Submitted: 2006-10-30
   Days after onset:2
Entered: 2006-11-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U217UEA / 1 RL / -
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 1091F / 1 LA / -

Administered by: Private       Purchased by: Public
Symptoms: Injection site rash
SMQs:, Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Allergy Testing
CDC Split Type:

Write-up: Rash around inj site and on buttocks. Treated with Benadryl.


VAERS ID: 265880 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Male  
Location: New Mexico  
Vaccinated:2006-10-27
Onset:2006-10-29
   Days after vaccination:2
Submitted: 2006-11-02
   Days after onset:4
Entered: 2006-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2627AA / 5 LA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Y0991 / 4 RA / SC
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 0815F / 1 RL / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Medication error, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: ASTHMA
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Left arm where site of injection with redness, hard, hot to the touch, swelling, pain and itching DUE TO THE DAPTACEL GIVEN.


VAERS ID: 266021 (history)  
Form: Version 1.0  
Age: 28.0  
Gender: Male  
Location: Arkansas  
Vaccinated:2006-10-27
Onset:2006-11-01
   Days after vaccination:5
Submitted: 2006-11-03
   Days after onset:2
Entered: 2006-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2213AA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: ulcerative colitis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Developed generalized hives, but very few in number. Initially pruritic, but this resolved with use of steroid cream (over the counter), no wheezing, no respiratory symptoms.


VAERS ID: 266022 (history)  
Form: Version 1.0  
Age: 18.0  
Gender: Male  
Location: Georgia  
Vaccinated:2006-10-27
Onset:2006-11-01
   Days after vaccination:5
Submitted: 2006-10-27
   Days after onset:5
Entered: 2006-11-03
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U1908AA / 1 LA / -
TDAP: TDAP (ADACEL) / SANOFI PASTEUR AC52B002AA / 1 RA / -

Administered by: Private       Purchased by: Other
Symptoms: Erythema, Injection site swelling
SMQs:, Anaphylactic reaction (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)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Raised, red area- 7 1/2 x 5 cm. Patient advised to take ADVIL and ice are. Patient to follow-up if worsens.


VAERS ID: 266067 (history)  
Form: Version 1.0  
Age: 73.0  
Gender: Male  
Location: Minnesota  
Vaccinated:2006-10-27
Onset:2006-10-28
   Days after vaccination:1
Submitted: 2006-10-30
   Days after onset:2
Entered: 2006-11-06
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 2 RA / IM

Administered by: Public       Purchased by: Private
Symptoms: 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)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Allergies, codien, sulfa, Aleve, Ibuprofen, Fedine.
Allergies:
Diagnostic Lab Data: Examined
CDC Split Type:

Write-up: Pneumovax booster triggered generalized swelling and intense itching, Prednisone PO and clinic exam only.


VAERS ID: 266130 (history)  
Form: Version 1.0  
Age: 54.0  
Gender: Female  
Location: Missouri  
Vaccinated:2006-10-27
Onset:2006-10-27
   Days after vaccination:0
Submitted: 2006-11-06
   Days after onset:10
Entered: 2006-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA204BA / 3 LA / IM

Administered by: Military       Purchased by: Other
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: none
Preexisting Conditions: breast cancer
Allergies:
Diagnostic Lab Data: ***Several employees and community members have had gastroenteritis**** Unrelated to the Influenza vaccine
CDC Split Type:

Write-up: Employee received vaccine on 10/27/06 after having a bone scan with contrast. She reports becoming extremely ill 3 hours after administration of the vaccine. Began vomiting and was examined in ED--received IV fluids and Magnesium. Her PCP examined employee and states the illness may have been caused by the Influenza vaccine.


VAERS ID: 266329 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Female  
Location: Missouri  
Vaccinated:2006-10-27
Onset:2006-10-27
   Days after vaccination:0
Submitted: 2006-10-30
   Days after onset:3
Entered: 2006-11-08
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B042BA / 5 RA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Y1030 / 4 RA / SC
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 0954R / 3 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Oedema
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)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 6-7cm redness and edema over left deltoid. 2-3cm erythematous macules on left tricep.


VAERS ID: 266393 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Male  
Location: Michigan  
Vaccinated:2006-10-27
Onset:2006-10-29
   Days after vaccination:2
Submitted: 2006-10-31
   Days after onset:2
Entered: 2006-11-09
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2178AA / UNK LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U1922AB / UNK LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B009BA / UNK RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Erythema, Headache, Swelling, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Headache, vomited x 1, swollen and red right arm.


VAERS ID: 266409 (history)  
Form: Version 1.0  
Age: 83.0  
Gender: Female  
Location: Kansas  
Vaccinated:2006-10-27
Onset:2006-10-28
   Days after vaccination:1
Submitted: 2006-10-30
   Days after onset:2
Entered: 2006-11-09
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1049P / UNK LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: None Stated


VAERS ID: 266416 (history)  
Form: Version 1.0  
Age: 57.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2006-10-27
Onset:2006-10-29
   Days after vaccination:2
Submitted: 2006-11-09
   Days after onset:11
Entered: 2006-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 71639 / UNK RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Asthenia, Dyspnoea, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Pain, Paraesthesia, Respiratory failure
SMQs:, Anaphylactic reaction (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), Parkinson-like events (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (narrow), Cardiomyopathy (broad), Demyelination (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Flovent, Xopenex, Singulair
Current Illness:
Preexisting Conditions: Allergic rhinitis, asthma, allergic PCN, Codeine, Avelox.
Allergies:
Diagnostic Lab Data: LABS: EMG/NCS reported by neurologist as WNL (no report included). MRI of complete spine revealed degenerative changes with multilevel spinal stenosis & small disc protrusions at C3-4, T9-10 & T11-12.
CDC Split Type:

Write-up: Aching in legs, weakness, numbness, shortness of breath, admitted to hospital 10/31/06. 11/21/06 Received medical records from hospital which reveal patient admitted 10/31/06 for progressive generalized weakness which began 10/29 associated with paresthesias & progressive gait disorder. Patient admitted for further w/u to exclude cord compression. There was no obvious muscle weakness on exam of 11/1 & it was felt that patient had quickly resolved GBS. She was D/C at that time. Patient was readmittted on 11/2/06 with dx of GBS & respiratory failure. Noted to have phrenic nerve involvement requiring bipap support after being seen with SOB. Treated with plasma exchange x 5 & improved well. D/C to home 11/7/06 PMH: asthma, obesity, HTN, osteoporosis, restless leg syndrome. Final DX: GBS w/respiratory failure, resolving./ss


VAERS ID: 266519 (history)  
Form: Version 1.0  
Age: 32.0  
Gender: Female  
Location: California  
Vaccinated:2006-10-27
Onset:2006-10-27
   Days after vaccination:0
Submitted: 2006-11-10
   Days after onset:14
Entered: 2006-11-13
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2240AA / UNK LA / -

Administered by: Other       Purchased by: Private
Symptoms: Medication error
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Flu vaccine leaked out the side of the syringe (BD integra) where the needle attaches. Vaccine dripped down her arm and got on her face. 0.3 ml (adjusted dose) was then readministered.


VAERS ID: 266821 (history)  
Form: Version 1.0  
Age: 68.0  
Gender: Female  
Location: Louisiana  
Vaccinated:2006-10-27
Onset:2006-10-27
   Days after vaccination:0
Submitted: 2006-11-01
   Days after onset:5
Entered: 2006-11-15
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0577R / 2 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Blood culture, Chills, Erythema, Injection site cellulitis, Lymphocyte count increased, Monocyte count normal, Neutrophil count increased, Oedema peripheral, Pain in extremity, Pyrexia, Ultrasound Doppler normal, White blood cell count increased, White blood cell disorder
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PMH: Hypertension, Cerebrovascular accident, congestive heart failure and osteoporosis.
Allergies:
Diagnostic Lab Data: WBC 12.2, neutrophils 86.8, total lymphs 12.1, mono 0.7 Venouss doppler US left upper extremity: normal phasic flow without evidence of deep venous thrombosis. Normal study. Blood culture:no growth after 5 days.
CDC Split Type: LA061101

Write-up: Chills, fever 104, swelling in arm, pain, pt called back to report pneumonia shot was given at 10:00am and symptoms started at 4:00pm. Pt went to ER and was admitted. Diagnosis unk. 01/09/07-records received and reviewed for DOS 10/28-10/28/06. DC DX: cellulitis left upper extremity. Developed fever and redness spreading down her arm almost to wrist area. In ER treated with Vancomycin IV, but developed "red man syndrome". Changed to IV Levaquin. PMH: Hypertension, Cerebrovascular accident, congestive heart failure and osteoporosis. PE: Erythema remaining in her left upper extremity extends through the antecubital area and down towards wrist, she does not have any erythema in the actual injection site. Follow-up: Spoke with pt on 11/1/06 and patient was home from hospital and on antibiotics. She stated that her arm still appeared red and told her to call the doctors office. Spoke with pt on 11/8/06 and she stated that she did not call the doctor back on 11/1/06, however she finished her antibiotics and has had no problems since. The arm has no discoloration of any kind and she feels fine.


VAERS ID: 267033 (history)  
Form: Version 1.0  
Age: 18.0  
Gender: Male  
Location: Florida  
Vaccinated:2006-10-27
Onset:2006-11-08
   Days after vaccination:12
Submitted: 2006-11-16
   Days after onset:8
Entered: 2006-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2175GA / 4 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Asthenia, CSF test abnormal, Guillain-Barre syndrome, Hypoaesthesia
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: Nodular cystic allergies. PMH: URI approx 4 wks prior to this admit.
Allergies:
Diagnostic Lab Data: Increased protein in CSF LABS: Chem & CBC were WNL. CK was 342. Serum IgG 1940, albumin 5.0. CSF revealed protein 85, glucose 54, Albumin 59.6, IgG 13.5, c/s neg. Blood c/s neg. MRI of L-spine was WNL. CT of brain was WNL. CXR was WNL.
CDC Split Type:

Write-up: Developed Guillain Barre Syndrome about 1 week after receiving flu vaccine. Had strep pharyngitis about 6 weeks before onset of Guillain Barre. Experienced peripheral numbness and about 1 week prior to requiring hospitalization for weakness on 11/08/2006. 5/11/07 Received medical records from hospital which reveal patient experienced LE numbness, difficulty walking & went to ER. Neuro consult done. LP done was abnormal & combined w/LE areflexia, ataxia, paresis of LEs admitted 11/8/06-11/18/06 for GBS. Tx w/plasmapheresis x 5 w/good results. Continued to have some weakness of toes & numbness of LEs but was minimal at D/C to home w/PT. FINAL DX: Guillain Barre syndrome, s/p plasmapheresis.


VAERS ID: 267103 (history)  
Form: Version 1.0  
Age: 32.0  
Gender: Female  
Location: Indiana  
Vaccinated:2006-10-27
Onset:2006-10-28
   Days after vaccination:1
Submitted: 2006-10-30
   Days after onset:2
Entered: 2006-11-17
   Days after submission:18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2192AA / 1 RA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0743F / 1 RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Contusion, Pain, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: X-ray of right arm-negative
CDC Split Type:

Write-up: Treated in hospital for Right arm pain, fever of 101.0. Small bruise at injection site. 10-30-06 Patient complains of arm pain and swelling. Stated it is not any worse.


VAERS ID: 267105 (history)  
Form: Version 1.0  
Age: 8.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2006-10-27
Onset:2006-10-28
   Days after vaccination:1
Submitted: 2006-11-10
   Days after onset:13
Entered: 2006-11-17
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500439P / 1 NS / IN

Administered by: Private       Purchased by: Public
Symptoms: Chest pain, Decreased appetite, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: Constipation
Preexisting Conditions: Allergic to bees. Asthma.
Allergies:
Diagnostic Lab Data: CXR neg. O2 saturation 98%.
CDC Split Type:

Write-up: Patient getting squeezing in chest. Not able to bet in a deep breath. No couth. Getting DOE. No temp elevation. O2 sat 98%. CXR neg. Albuterol inhaler provided relief and prescription given for albuterol MDI. 11/20/06 Received medical records from provider which reveal patient in good health but with AM stomach aches even on non school days. Peppermint candy relieves. Poor appetite. Received FluMist on 10/27 & became ill on 10/28 with squeezing in chest & SOB. Treated w/albuterol MDI. CXR was WNL.


VAERS ID: 267117 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Maine  
Vaccinated:2006-10-27
Onset:2006-10-27
   Days after vaccination:0
Submitted: 2006-10-31
   Days after onset:4
Entered: 2006-11-17
   Days after submission:17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA208BA / 1 LA / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Paraesthesia, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 7:55 a.m. Client received a flu shot in left deltoid. Gave her a sheet on (What you need to known 2006-07 Influenza vaccines. instructed her to stay around people for the next 30 minutes in case of an allergic reaction. 8:10 a.m. Client came back to office complaining that her throat feels tight and has tingling in her hands. Client states" My throat started feeling different when I got back to class but it kept getting worse. My throat has a fullness to it now it is getting worse." 8:15 a.m. Epi-pen 0.3 mg administered to RIGHT THIGH LOT#5EM436 expires 03/07. 2 Puffs from Albuterol inhaler and Benadryl (50mg) given. Person name called ambulance service and client''s husband. Blood pressure 140/80, pulse 90. 8:25 a.m. Ambulance Service arrived and transported to hospital emergency room.


VAERS ID: 267309 (history)  
Form: Version 1.0  
Age: 51.0  
Gender: Female  
Location: Michigan  
Vaccinated:2006-10-27
Onset:2006-11-08
   Days after vaccination:12
Submitted: 2006-11-15
   Days after onset:7
Entered: 2006-11-20
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA220AA / 7+ LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Bone pain, Malaise, Myalgia, Pain, Urticaria
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Actose, Lotrel
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received vaccine 10/27/06 on 11/08 c/o severe muscle aches and bone pain generalized. Experienced pain when touching face. Difficulty to move, felt bad for approx 30 hours took no meds. Pain gradually diminished on 11/10/06 developed hives on arm and torso, takes Benadryl and hives gone on 11/11/06, cannot identify anything new or used that would cause hives.


VAERS ID: 268013 (history)  
Form: Version 1.0  
Age: 59.0  
Gender: Female  
Location: Michigan  
Vaccinated:2006-10-27
Onset:2006-10-27
   Days after vaccination:0
Submitted: 2006-11-27
   Days after onset:31
Entered: 2006-11-30
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0485F / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic shock, Hypersensitivity, Hypotension, Injection site oedema, Respiratory rate decreased
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Proventil, Zyrtec, Singulair, Crestor
Current Illness:
Preexisting Conditions: CONCURRENT CONDITIONS: Bronchitis asthmatic, cholesterol high
Allergies:
Diagnostic Lab Data: Blood Pressure 10/27/06 60/35
CDC Split Type: WAES0611USA05678

Write-up: Information has been received from a health professional concerning a 59 year old female with asthmatic bronchitis and high cholesterol and no allergies, who on 27-Oct-2006 was vaccinated IM with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot#651374/0485F). Concomitant therapy included montelukast sodium, albuterol sulfate (PROVENTIL) inhaler, rosuvastatin calicum (CRESTOR) and cetirizine hydrochloride (ZYRTEC). On 27-Oct-2006 the patient experienced arm swelling, decreased blood pressure (60/35) and a decrease in breathing rate. The patient called the office complaining of injection site right arm edema and was referred to the emergency room. On 28-Oct-2006 early in the morning, the patient went to the emergency room and was diagnosed with anaphylactic shock in association with an allergic reaction. That day, the patient was sent home from the emergency room with prednisone and ranitidine hydrochloride (ZANTAC). On 17-Nov-2006, the patient recovered. It was also reported that the patient received a dose of pneumococcal 23 polysaccharide vaccine in November 2000 and was well tolerated. No product quality complaint was involved. A lot check will be performed. Anaphylactic shock was considered to be immediately life-threatening and disabling. Additional information has been requested.


VAERS ID: 268141 (history)  
Form: Version 1.0  
Age: 56.0  
Gender: Female  
Location: Connecticut  
Vaccinated:2006-10-27
Onset:2006-10-27
   Days after vaccination:0
Submitted: 2006-12-03
   Days after onset:37
Entered: 2006-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Discomfort, Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: zyrtec,naproxen,prevacid,folgard,glucosamin/chondroitin,calcium, magnesium, centrum silver,vitamins c,d,e,b complex
Current Illness: none
Preexisting Conditions: seanonal allergies, osteopenia
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Within 24 hrs of vaccination, there was significant discomfort in the shoulder and clavicle area on side of injection. The lymph nodes in the area above the clavicle were felt as hard round lumps and tender to the touch. Discomfort continued for 5 days with swelling of nodes slowly decreasing over that time. Acetaminophen and Naproxen were used to control discomfort with questionable success.


VAERS ID: 268177 (history)  
Form: Version 1.0  
Age: 57.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2006-10-27
Onset:2006-10-27
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:18
Entered: 2006-12-04
   Days after submission:20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 69897 / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid, Hyzaar
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Redness, swelling from just above elbow to shoulder. Site was hot to the touch. From injection site to below left ear ached. Lasted approx 3 days for aching, redness, and heat stayed over 10 days.


VAERS ID: 268178 (history)  
Form: Version 1.0  
Age: 65.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2006-10-27
Onset:2006-10-27
   Days after vaccination:0
Submitted: 2006-11-13
   Days after onset:17
Entered: 2006-12-04
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 69897 / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Injection site erythema, Injection site hypersensitivity, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lopressor, Hyzaar, Lasix, Potassium
Current Illness:
Preexisting Conditions: High Blood pressure.
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Area around injection was red and itched. Lasted for 4 days. Itching started about 10 min after injection was given.


VAERS ID: 268179 (history)  
Form: Version 1.0  
Age: 29.0  
Gender: Male  
Location: South Carolina  
Vaccinated:2006-10-27
Onset:2006-10-27
   Days after vaccination:0
Submitted: 2006-11-13
   Days after onset:17
Entered: 2006-12-04
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 69897 / 1 RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Piltiazem, lisinopril.
Current Illness: NONE
Preexisting Conditions: Hypertension, Allergic to Ceclor and Hydrocodone.
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Red, warm, sore area around the shot. About 4in x 3in.


VAERS ID: 268180 (history)  
Form: Version 1.0  
Age: 24.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2006-10-27
Onset:2006-10-28
   Days after vaccination:1
Submitted: 2006-11-13
   Days after onset:16
Entered: 2006-12-04
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 69897 / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Pruritus
SMQs:, Anaphylactic reaction (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)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: My arm was red, and puffy where the vaccine was given. My arm itched also.


VAERS ID: 268181 (history)  
Form: Version 1.0  
Age: 47.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2006-10-27
Onset:2006-10-27
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:18
Entered: 2006-12-04
   Days after submission:20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 69897 / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Large red area surrounding location of vaccine, swollen, hot to touch, soreness, lasted about 4 days.


VAERS ID: 268801 (history)  
Form: Version 1.0  
Age: 19.0  
Gender: Female  
Location: Michigan  
Vaccinated:2006-10-27
Onset:2006-11-10
   Days after vaccination:14
Submitted: 2006-12-05
   Days after onset:25
Entered: 2006-12-12
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0638R / 1 LA / SC

Administered by: Other       Purchased by: Other
Symptoms: Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 10/23/06 varicella titer prior to vaccination negative
CDC Split Type:

Write-up: 11/13/06 Patient seen rash on body since 11-10-06, nauseated raised bumps on back , head, stomach, axillary region, right side of face. Itchy. Temp 98.0, Pulse 80 rate 14. Diagnosed chicken pox post varicella vaccine admin. Prescribed Acyclovin 800 mg 4 times a day for 5 days. Chickenpox precautions. 10/28/06-Varicella zoster IGM/IGG negative


VAERS ID: 268816 (history)  
Form: Version 1.0  
Age: 24.0  
Gender: Female  
Location: Unknown  
Vaccinated:2006-10-27
Onset:2006-10-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2006-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1047P / UNK LA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cellulitis, Dyspnoea, Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction, Pyrexia, White blood cell count increased
SMQs:, Anaphylactic reaction (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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Concomitant drugs not reported.
Current Illness:
Preexisting Conditions: Splenectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: CVOX200600722

Write-up: A report was received from a healthcare professional concerning a 24 year old female. the vaccinee has a history of splenectomy and penicillin allergy and had no concomitant medications. On 10/27/06 the vaccinee was administered influenza virus vaccine (brand unspecified) at and unspecified site and Pneumovax 23 0.5 ml SC in her left arm. On the evening of 10/27/06 the vaccinee developed a cellulitis like reaction at the injection site. Her left arm became red, swollen and sore and she developed a fever. On 10/28/06 the vaccinee developed shortness of breath, was hospitalized, and diagnosed with cellulitis of the left arm. The vaccinee was treated with an unspecified antibiotic through a PICC line. her white cell count was 46.2 )no units provided) and blood cultures were neg. An MRI of the upper left arm was also performed (no results were provided). The vaccinee was hospitalized for 5 days, and by 11/14/06 she had fully recovered. The reporter considered the events to be serious, immediately life threatening and medically significant (OMIC). The vaccinee had been vaccinated with Pneumovax 23 five years ago with no reported reactions. Further information has been requested.


VAERS ID: 268964 (history)  
Form: Version 1.0  
Age: 47.0  
Gender: Male  
Location: Illinois  
Vaccinated:2006-10-27
Onset:2006-10-30
   Days after vaccination:3
Submitted: 2006-12-15
   Days after onset:46
Entered: 2006-12-18
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2274AA / UNK LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Myalgia, Skin burning sensation
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Receive flu shot 10/17/06. 10/28 and 10/29 soreness at injection site Right deltoid. 10/30 noted burning sensation Left arm, left shoulder, left forearm onto L chest-continued thru today. Some days intermittent some days worse then others. To Employee Health-Emergency department to rule out cardiac, PCP


VAERS ID: 269114 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2006-10-27
Onset:2006-10-27
   Days after vaccination:0
Submitted: 2007-03-23
   Days after onset:147
Entered: 2006-12-18
   Days after submission:94
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Headache, Influenza like illness
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0611USA01507

Write-up: Information has been received from a nurse concerning a female patient who on approximately 27 Oct 2006 was vaccinated with a dose of varicella zoster virus vaccine live. On approximately 27 Oct 2006, the patient experienced a headache and flu-like symptoms. Unspecified medical attention was sought and the patient recovered after one day. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2006. Information has been received from a registered nurse concerning a female patient who on approximately 27-OCT-2006 was vaccinated with a dose of ZOSTAVAX (Merck). On approximately 27-OCT-2006, the patient experienced a headache and flu-like symptoms. Unspecified medical attention was sought and the patient recovered after one day. A product quality complaint was not involved. Additional information has been received from the nurse who reported that she was "clear as th whom this is referring to." Additional information was received from the registered nurse who reported that the patient stated that she never expected to feel head achy and "like she was coming down with the flu." In a follow-up telephone call with the patient months later, she reported no ill effects and hardly remembered the previous conversation. No further information is expected.


VAERS ID: 269118 (history)  
Form: Version 1.0  
Age: 62.0  
Gender: Male  
Location: Texas  
Vaccinated:2006-10-27
Onset:2006-10-30
   Days after vaccination:3
Submitted: 2006-12-14
   Days after onset:45
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0981F / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Hypersensitivity, Rash
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Drug hypersensitivity
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0611USA01613

Write-up: Information has been received from a health professional concerning a 62 year old male with an erythromycin allergy an no other medical history who on 27-OCT-2006 was vaccinated with a dose of ZOSTAVAX (lot # 652936/0981F). On 30-OCT-2006, the patient developed a red rash on his right flank and right lateral ribs. The physician diagnosed this as a possible drug allergy and prescribed prednisone as treatment. No diagnostic laboratory tests were performed. At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been requested.


VAERS ID: 269272 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Male  
Location: Alaska  
Vaccinated:2006-10-27
Onset:2006-10-28
   Days after vaccination:1
Submitted: 2006-10-31
   Days after onset:3
Entered: 2006-12-18
   Days after submission:48
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B033AA / 5 LA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Y0991 / 4 LA / SC
MMR: MEASLES + MUMPS + RUBELLA (VIRIVAC) / MERCK & CO. INC. 0094F / 2 RA / SC

Administered by: Public       Purchased by: Unknown
Symptoms: Erythema, Feeling hot, Pain
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: 10/28/2006 client complained of pain on left arm where shot was given. Site noted red, hot to touch. 10/29/06 swelling got worse from collar bone to wrist with increased redness. Mom brought child to ER. Dr. ordered Benadryl. 10/31 talked to clients father he reports redness and swelling on left is down.


VAERS ID: 271846 (history)  
Form: Version 1.0  
Age: 1.0  
Gender: Female  
Location: Georgia  
Vaccinated:2006-10-27
Onset:2006-10-29
   Days after vaccination:2
Submitted: 2007-01-30
   Days after onset:93
Entered: 2007-02-06
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0889R / 3 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08658F / 4 RL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0495F / 1 LA / SC

Administered by: Private       Purchased by: Public
Symptoms: Rash papular
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient broke out with a papular rash 2 days after receiving varicella vaccine. Mom stated this after child received MMR on 1/30/07


VAERS ID: 272584 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2006-10-27
Onset:2006-10-27
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:110
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / UNK AR / IM

Administered by: Private       Purchased by: Other
Symptoms: Injection site haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA04679

Write-up: Information has been received from a registered nurse concerning an approximately 23 year old female who was vaccinated with HPV vaccine (yeast). The registered nurse reported that she had another nurse had given "numerous" Gardasil vaccinations. Subsequently this patient experienced a "trickle of blood down her arm she the needle withdrawn". The nurse further commented that there was "nothing wrong with the patient, she didn''t even notice" and, "there was no blood in the syringe when the plunger was pulled back before injecting the patient". Bleeding resolved and the patient was sent home. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 2/14/2007. Information has been received from a registered nurse concerning an approximately 23 year old female (patient 1 of 4) with no known drug allergies, who on 27-OCT-2006 was vaccinated IM into the deltoid area with a dose of GARDASIL (lot# 653938/0954F). The registered nurse reported that she and another nurse had given "numerous" GARDASIL vaccinations. Subsequently this patient experienced a "trickle of blood down her arm when the needle withdrawn". The bleeding only lasted a few seconds. The nurse further commented that there was "nothing wrong with the patient, she didn''t even notice" and "there was no blood in the syringe when the plunger was pulled back before injecting the patient". Pressure was applied and a bandaid. Bleeding resolved and the patient was sent home. Additional information is not expected.


VAERS ID: 275944 (history)  
Form: Version 1.0  
Age: 32.0  
Gender: Female  
Location: California  
Vaccinated:2006-10-27
Onset:2006-10-28
   Days after vaccination:1
Submitted: 2006-10-30
   Days after onset:2
Entered: 2007-04-10
   Days after submission:161
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA216AA / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Swollen site, hot day after itchy a few days after and hot. Treated with heating pad to site, Tylenol for pain, with some improvement.


VAERS ID: 265521 (history)  
Form: Version 1.0  
Age: 59.0  
Gender: Female  
Location: Missouri  
Vaccinated:2006-10-28
Onset:2006-10-28
   Days after vaccination:0
Submitted: 2006-10-28
   Days after onset:0
Entered: 2006-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Joint stiffness, Pain, Shoulder pain
SMQs:, Rhabdomyolysis/myopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: vitamins
Current Illness: none
Preexisting Conditions: scoliosis, fibromyalgia, arthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Intense pain shooting through entire arm, sometimes into shoulder, sometimes into back at upper shoulder blade area, arm and hand weakness. Unrelieved by medications, ice applied several times, heat alleviated only slightly. Joint stiffness and weakness in shoulder, arm and hand. I received flu shot 12 hours ago and it''s no better. Began about 5 minutes after receiving shot - just after reaching my car in the parking lot. 3 Advil tablets every 4 hours have not helped. It''s the weekend and I live alone. I have no money for emergency room care. I''m really scared of this. I called "ask a nurse" but they didn''t know what to have me do other than ice, heat and pain meds. They don''t help at all.


VAERS ID: 265616 (history)  
Form: Version 1.0  
Age: 64.0  
Gender: Female  
Location: Illinois  
Vaccinated:2006-10-28
Onset:2006-10-29
   Days after vaccination:1
Submitted: 2006-10-30
   Days after onset:1
Entered: 2006-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2243AA / 7+ LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Arthralgia, Diarrhoea, Dysphagia, Musculoskeletal pain, Oedema peripheral
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid
Current Illness: None
Preexisting Conditions: Allergy to Codiene
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: The day after receiving the flu shot, patient states she developed sudden onset of diarrhea, shorly after joint pain in shoulders, knees, ankles and arches of feet. No pain in hips or elbows. Also had trouble swallowing for few hours, resolved now. C/O significant swelling in hands, unable to make fist. Joint pain and swelling still persist today.


VAERS ID: 265875 (history)  
Form: Version 1.0  
Age: 29.0  
Gender: Male  
Location: Kansas  
Vaccinated:2006-10-28
Onset:2006-10-28
   Days after vaccination:0
Submitted: 2006-11-02
   Days after onset:5
Entered: 2006-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / MASS. PUB HLTH BIOL LAB TD154 / 1 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Facial palsy, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Burn
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt. was being treated for a second degree burn and was given an Adult Td vaccination in the left deltoid. He reported at his next follow up appointment that about 4-6 hours after his initial visit he developed weakness in the right side of his face which has persisted--4 days. He indeed has findings consistent with right sided facial weakness (Bell''s Palsy).


VAERS ID: 266125 (history)  
Form: Version 1.0  
Age: 54.0  
Gender: Female  
Location: Virginia  
Vaccinated:2006-10-28
Onset:2006-10-29
   Days after vaccination:1
Submitted: 2006-11-06
   Days after onset:8
Entered: 2006-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U22133A / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Erythema, Eye swelling, Pruritus, Rash maculo-papular
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Approximately 27 hours after the shot patient developed splotchy face, continued over the next few hours to develop into redness and itching over entire face. Went to bed, then woke in the morning with eyes swollen shut due to swelling.


VAERS ID: 266131 (history)  
Form: Version 1.0  
Age: 59.0  
Gender: Female  
Location: Arizona  
Vaccinated:2006-10-28
Onset:2006-10-30
   Days after vaccination:2
Submitted: 2006-11-06
   Days after onset:7
Entered: 2006-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 71356 / 1 LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0619F / 1 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Erythema, Malaise, Pain, 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)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt came into the office 2 days later, with reddness, swelling, and a very painful arm, not feeling good. Pt was given Vicodin and taken off work for 2 days.


VAERS ID: 266356 (history)  
Form: Version 1.0  
Age: 43.0  
Gender: Female  
Location: Washington  
Vaccinated:2006-10-28
Onset:2006-10-29
   Days after vaccination:1
Submitted: 2006-10-31
   Days after onset:2
Entered: 2006-11-08
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 LA / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Contusion, Erythema, Injection site induration, Injection site warmth, Pain, Pruritus
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Respiratory infection
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient was given "booster dose" pneumovax. Prior vaccination about 8 years ago; approx next day arm bruised size of quarter swelling (softball size)-induration, redness, heat and pain. Still lump, itchy six days later. I have left messages to retrieve this info - never received response. This was not given at this clinic, but at medical clinic.


VAERS ID: 266438 (history)  
Form: Version 1.0  
Age: 48.0  
Gender: Female  
Location: Illinois  
Vaccinated:2006-10-28
Onset:2006-10-29
   Days after vaccination:1
Submitted: 2006-11-09
   Days after onset:11
Entered: 2006-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 70741 / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cellulitis, Injection site reaction
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Cellulitis at site- placed on Omnicef 300mg BID


VAERS ID: 266508 (history)  
Form: Version 1.0  
Age: 60.0  
Gender: Female  
Location: Virginia  
Vaccinated:2006-10-28
Onset:2006-10-29
   Days after vaccination:1
Submitted: 2006-11-12
   Days after onset:14
Entered: 2006-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0722F / 1 LA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: glucophage byetta flonase HCTZ
Current Illness: none
Preexisting Conditions: mild diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received vaccination on 10/28/06. On 10/29/06, noticed area around injection was very red, warm to touch, swollen (hard lump), and sore. Noticed red area around injection site was spreading. Returned to doctor on 10/31. Took prescribed antibiotics (ceflix 250 BID 3 days). Returned to doctor for follow-up on 11/7/06...injection site was healed.


VAERS ID: 266598 (history)  
Form: Version 1.0  
Age: 29.0  
Gender: Female  
Location: Iowa  
Vaccinated:2006-10-28
Onset:2006-10-29
   Days after vaccination:1
Submitted: 2006-11-07
   Days after onset:9
Entered: 2006-11-13
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / AVENTIS PASTEUR U2242AA / UNK UN / -

Administered by: Private       Purchased by: Unknown
Symptoms: Headache, Influenza like illness, Leukopenia, Malaise, Myalgia, Rhinorrhoea, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Norolog insulin
Current Illness: NONE
Preexisting Conditions: Type I Diabetes Mellitus.
Allergies:
Diagnostic Lab Data: CBC revealed leukopenia, consistent with Flu like illnesses.
CDC Split Type:

Write-up: Severe muscle aches, vomiting, headaches, runny nose, general malaise which started abruptly the day after receiving her flu vaccine.


VAERS ID: 267181 (history)  
Form: Version 1.0  
Age: 66.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2006-10-28
Onset:2006-10-29
   Days after vaccination:1
Submitted: 2006-11-19
   Days after onset:21
Entered: 2006-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA234AA / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Epistaxis, Petechiae, Platelet count decreased, Thrombosis
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Aspirin: 81 mg Premarin Centrum Silver
Current Illness: none
Preexisting Conditions: Retinal Detachment (Right eye)
Allergies:
Diagnostic Lab Data: Platelet count: 1,100 (improved to 70,000 with treatment) LABS: Admit labs: Hgb 13.6, plts 1000, fibrogen 356, DDimer 0.57, PT 12.9, INR 0.97, PTT 27 & smear showed marked thrombocytopenia. D/C labs: plts 70,000. US of abd 11/2 revealed spleen size WNL.
CDC Split Type:

Write-up: ITP: petechial rash all over body, including over site of vaccine administration; blood clot in mouth, epistaxis, platelet count of 1100, events started 18 hours after administration of influenza vaccine (fluarix); symptoms improved with administration of steroids and IVIG in hospital, patient was discharged 6 days after admission with increased platelet count to 70,000 after treatment and had no further bleeding/petechiae after administration to hospital and treatment. 1/9/07 Received medical records from hospital which reveal patient admitted 10/31/06-11/6/06 with bleeding. Had red bumps on legs, arms, trunk & back for 2 days prior to admit after received flu shot on day bumps began. Also had a bloody nose & saw PCP who obtained labs which revealed plts of 1100 & patient sent for admit. Exam in ER revealed positive blood clot in left buccal mucosa, positive petechiae in upper palate, under tongue, bilateral extremities & back. Slight tender cervical LAD. Received steroids & IVIG in ER after heme consult. Slowly improved & d/c to home on tapering steroids & heme clinic follow up. FINAL DX: Idiopathic thrombocytopenia.


VAERS ID: 267849 (history)  
Form: Version 1.0  
Age: 64.0  
Gender: Male  
Location: Unknown  
Vaccinated:2006-10-28
Onset:2006-10-28
   Days after vaccination:0
Submitted: 2006-11-01
   Days after onset:4
Entered: 2006-11-27
   Days after submission:26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2246AA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Confusional state, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Has had flu shots in past with no problems. History of Rheumatic fever 1946.
Allergies:
Diagnostic Lab Data: All labs within normal limits.
CDC Split Type:

Write-up: After 10 hours after receiving Influezea vaccine, patient complained of confusion and Temp of 103. Treated in ER with Tylenol and observation. Regained coherence and normal temp within 3 hours.


VAERS ID: 268203 (history)  
Form: Version 1.0  
Age: 42.0  
Gender: Male  
Location: Indiana  
Vaccinated:2006-10-28
Onset:2006-11-07
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2006-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / UNK LA / IM

Administered by: Public       Purchased by: Other
Symptoms:
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: EMG scheduled for 12/04/06 12/14/06 Received EMG report which reveals abnormal study showing acute & ongoing C7-8 radiculopathy or lower brachial plexopathy.
CDC Split Type:

Write-up: Left acute brachial plexus neuritis, evaluated by neurologist. 12/14/06 Received medical records from neurologist which reveal patient eval showed decreased strength & grip in left arm/hand. Tx w/steroids & pain meds & scheduled for EMG on 12/4. No EMG report included. T/C to neuro office to request EMG report.


VAERS ID: 268205 (history)  
Form: Version 1.0  
Age: 63.0  
Gender: Female  
Location: Missouri  
Vaccinated:2006-10-28
Onset:2006-10-30
   Days after vaccination:2
Submitted: 2006-12-04
   Days after onset:35
Entered: 2006-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / AVENTIS PASTEUR V71642 / UNK LA / IM
TD: TETANUS DIPHTHERIA (NO BRAND NAME) / AVENTIS PASTEUR U1847BA / UNK RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Joint range of motion decreased, Pain, Shoulder pain
SMQs:, Rhabdomyolysis/myopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE PMH: dyspnea, +TB skine test, gastritis, DJD, carpal tunnel, hypercholesterolemia
Allergies:
Diagnostic Lab Data: blood work result (to be provided by doctor''s office, doctor''s office has been requested). LABS: CRP elevated at 28.34, WBC 8.0. Elevated triglycerides, cholesterol & A1C Hgb. CXR was WNL.
CDC Split Type:

Write-up: Deep, aching pain in upper right arm and shoulder developed on 10/30/2006. I took Naproxen and TRAMADOL. I reported this to PCP through fax and telephone message. I saw PA name reported on 11/4/2006. She prescribed Ibuprofen and Lido Derm Patches and ordered blood work. These medications did not help. PA name reported prescribed MEDROL Pak after blood work results and ordered referral to neurologist. MEDROL Pak gave me TY-relief only, after 6 days of use pain became acute, I am now using 2nd Dose Pak and seeing neurologist on 12/07. I am unable to lift anything with this arm. I feel severe pain when I move this arm or while I am in bed. 12/14/06 Received medical records from provider which reveal patient seen 10/28/06 with dyspnea & + TB skin test, gastritis, DJD, carpal tunnel & high cholesterol. Records included Lot numbers missing from report. Next seen on 11/4/06 with pain on palpation over right shoulder, no swelling or redness noted but ROM & grip strength of right arm/hand was decreased. Referred to neuro & given steroids to start after labs done. 1/16/07 Received records from neurologist which reveal patient seen 12/7/06 for pain of right shoulder & arm subsequent to tetanus vax 10/28/06. Neuro exam was WNL with some mild difficulty raising arm above head. It was felt that the problem was frozen shoulder or adhesive capsulitis due to the pain rather than any true muscle or nerve involvement. She was referred for intensive PT to be continued for 4-6 weeks then was to return for further evaluation.


VAERS ID: 270543 (history)  
Form: Version 1.0  
Age: 75.0  
Gender: Female  
Location: Arizona  
Vaccinated:2006-10-28
Onset:2006-11-01
   Days after vaccination:4
Submitted: 2007-01-10
   Days after onset:70
Entered: 2007-01-16
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2213AA / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Right arm muscle, shot given. Mild at first. It settled in the muscle on the underside of the arm. Became very painful. Especially 1st thing in am. Went to doctor 12-13-06. Prescribed Ibuprofen 800 mg, didn''t help. Prescribed Sanindoc 200 mg, did not help December 22 December 28 Methocarban 500 mg no help and then Hydrocol Apap 5 500 mg. On 1/2/07 went to orthopedic physician. X-rays showed nothing. Gave me a cortisone shot. It worked and pain went away. Will see him again 1/30/07. He could not tell me if the flu shot was to blame. I called the above service and asked what was in my shot. Have not heard back still would like to know. Do I get another shot next fall?


VAERS ID: 287055 (history)  
Form: Version 1.0  
Age: 60.0  
Gender: Female  
Location: Unknown  
Vaccinated:2006-10-28
Onset:2006-10-29
   Days after vaccination:1
Submitted: 2007-07-30
   Days after onset:274
Entered: 2007-08-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Pain in extremity, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0611USA01342

Write-up: Information has been received from a physician concerning a female in her 60''s with pertinent medical history and drug reactions/allergies reported as unspecified who on 28-OCT-2006 was vaccinated with Pneumovax for the protection of chronic obstructive pulmonary disease (COPD). Concomitant medication was reported as unspecified. On 29-OCT-2006, the patient experienced pruritis. On an unspecified date, the patient sought medical attention. At the time of the report, the patient was recovering from the pruritis. Follow up information indicated that the patient had a sore and red arm that resolved without specific treatment. No further information was available. Additional information is not expected.


VAERS ID: 327744 (history)  
Form: Version 1.0  
Age: 80.0  
Gender: Female  
Location: New Mexico  
Vaccinated:2006-10-28
Onset:2008-06-16
   Days after vaccination:597
Submitted: 2008-09-24
   Days after onset:100
Entered: 2008-10-08
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 1012F / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Herpes zoster, Rash erythematous, Rash vesicular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: (therapy unspecified); FOSAMAX PLUS D; DICLOFENAC; SYNTHROID; LISINOPRIL
Current Illness: Hyperlipidaemia; Hypothyroidism; Hypertension; Osteoarthritis; Asthma; Renal insufficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806USA03771

Write-up: Information has been received from a registered nurse concerning an 82 year old female with hypothyroidism, hypertension, osteoarthritis and renal insufficiency and a history of hyperlipidaemia and asthma who on 28-OCT-2006 was vaccinated with 0.65 ml ZOSTAVAX vaccine (Oka/Merck) (lot number 652946/1012F) by subcutaneous injection (injection site not reported). Concomitant therapy included LISINOPROL (manufacturer unknown), FELOPIDINE, DICLOFENAC, ALENDRONATE SODIUM D, MSD, and SYNTHOROID. On 16-JUN-2008 the patient developed a shingles outbreak. At the time of reporting, the patient was experiencing an erythematous rash with vesicios which extends from her abdomen to back on her right side. Unspecified medical attention was sought. The patient''s shingles outbreak persisted. Additional information has been requested.


VAERS ID: 266865 (history)  
Form: Version 1.0  
Age: 9.0  
Gender: Female  
Location: Foreign  
Vaccinated:2006-10-28
Onset:2006-10-28
   Days after vaccination:0
Submitted: 2006-11-15
   Days after onset:18
Entered: 2006-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LA / -

Administered by: Other       Purchased by: Other
Symptoms: Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0446351A

Write-up: This case was reported by a physician and described the occurrence of vasovagal syncope in a 9 year old female subject who was vaccinated with Hep B vaccine (Engerix B) for prophylaxis. On 10/28/06 the subject received 3rd dose of Engerix B unk. On 10/28/06, 90 seconds after vaccination with Engerix B, the subject experienced vasovagal syncope. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the event was resolved. The physician considered the event was almost certainly related to vaccination with Engerix B.


VAERS ID: 268078 (history)  
Form: Version 1.0  
Age: 19.0  
Gender: Female  
Location: Foreign  
Vaccinated:2006-10-28
Onset:2006-10-29
   Days after vaccination:1
Submitted: 2006-11-28
   Days after onset:30
Entered: 2006-12-01
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1079P / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Hypokinesia, Myalgia, Pyrexia, Rash
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0611USA06200

Write-up: Information has been received from a health authority concerning a 19 year old female who on 10/28/06 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (lot 650887/1079R, NB16020), IM. On 10/29/06, one day post vaccination, the pt experienced a severe skin rash 10cm plus a febrile illness and pain and immobility in the right deltoid muscle. At the time of the report, the pt was recovering. The reporter considered the pts experience to be an other medical event (OMIC). Other business partners numbers included E200606167. No further information is available.


VAERS ID: 341450 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Female  
Location: Foreign  
Vaccinated:2006-10-28
Onset:2009-02-24
   Days after vaccination:850
Submitted: 2009-03-10
   Days after onset:13
Entered: 2009-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA115A / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal mass, Barium enema, Enema administration, Intussusception, Laparotomy, Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, Feb2009, intussuscept; Ultrasound abdomen, Feb2009, intussuscept
CDC Split Type: B0562576A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 32-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given on 16 September 2006. On 28 October 2006, the subject received 2nd dose of ROTARIX (oral). On 24 February 2009, 2 years after vaccination with ROTARIX, the subject experienced vomiting, abdominal distention and abdominal mass. The subject was hospitalised. Abdominal ultrasound and x-ray confirmed diagnosis of intussusception. The subject had a Barium reduction which failed and the intussusception was reduced by laparotomy. At the time of reporting the events were improved.


VAERS ID: 265744 (history)  
Form: Version 1.0  
Age: 2.0  
Gender: Male  
Location: Maryland  
Vaccinated:2006-10-29
Onset:2006-10-29
   Days after vaccination:0
Submitted: 2006-11-01
   Days after onset:3
Entered: 2006-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No.
Preexisting Conditions: No.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My son broke out in hives on his face, arms, legs and back.


VAERS ID: 266595 (history)  
Form: Version 1.0  
Age: 29.0  
Gender: Female  
Location: Illinois  
Vaccinated:2006-10-29
Onset:2006-10-29
   Days after vaccination:0
Submitted: 2006-11-02
   Days after onset:4
Entered: 2006-11-13
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MU: MUMPS (MUMPSVAX II) / MERCK & CO. INC. 0409F / UNK LA / SC

Administered by: Other       Purchased by: Private
Symptoms: Pharyngeal oedema, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Hives, swelling of throat, Epi Pen.


VAERS ID: 268373 (history)  
Form: Version 1.0  
Age: 68.0  
Gender: Female  
Location: Michigan  
Vaccinated:2006-10-29
Onset:2006-10-29
   Days after vaccination:0
Submitted: 2006-12-05
   Days after onset:37
Entered: 2006-12-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2213AA / 2 LA / IM

Administered by: Unknown       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)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: No
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Immediate redness and swelling at the injection site.


VAERS ID: 271460 (history)  
Form: Version 1.0  
Age: 1.0  
Gender: Female  
Location: Texas  
Vaccinated:2006-10-29
Onset:2006-10-29
   Days after vaccination:0
Submitted: 2006-10-29
   Days after onset:0
Entered: 2007-01-29
   Days after submission:92
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2552AA / 4 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0984F / 3 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08646D / 4 RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Rash, Tenderness, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: Food allergies-pork, beef, milk, nuts
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: After administration developed rash, wheezing, tender, given Epinephrine, Dreadron, Albuterol, Benadryl


VAERS ID: 287047 (history)  
Form: Version 1.0  
Age: 44.0  
Gender: Male  
Location: Unknown  
Vaccinated:2006-10-29
Onset:2006-10-29
   Days after vaccination:0
Submitted: 2007-07-30
   Days after onset:274
Entered: 2007-08-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Injection site rash, Injection site reaction, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0611USA00585

Write-up: Information has been received from a pharmacist concerning a 44 year old male with no past medical history who on 29-OCT-2006 was vaccinated IM with a first dose of Pneumovax 23 as part of a church immunization program. There was no concomitant medications. On 29-OCT-2006 the patient developed local injection site reactions that progressed over the next 48 hours. On approximately 29-OCT-2006 the patient developed a 4 and a half inch, round rash at the injection site and the are was swollen and painful. The patient was going to see his physician on 31-OCT-2006. At the time of the report, the patient had not recovered. Additional information has been requested.


VAERS ID: 287053 (history)  
Form: Version 1.0  
Age: 63.0  
Gender: Female  
Location: Unknown  
Vaccinated:2006-10-29
Onset:2006-10-31
   Days after vaccination:2
Submitted: 2007-07-30
   Days after onset:271
Entered: 2007-08-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: albuterol; DUONEB; LIPITOR; furosemide; gabapentin; NOVOLIN; PREVACID; REGLAN; TOPROL XL TABLETS; potassium (unspecified); AMBIEN
Current Illness: Diabetes; Chronic obstructive pulmonary disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0611USA00726

Write-up: Information has been received from a registered pharmacist concerning a 63 year old female with diabetes and chronic obstructive pulmonary disease with no drug allergies who on 29-OCT-2006 was vaccinated with a dose of Pneumovax 23. Concomitant therapy included LIPITOR, NOVOLIN, AMBIEN, DUONEB, albuterol, REGLAN, potassium (unspecified), TOPROL XL TABLETS, furosemide, gabapentin, and PREVACID. On 31-OCT-2006 the patient experienced fever. At the time of the report, the patient was considered to be not recovered. Unspecified medical attention was sought. Additional information has been requested.


VAERS ID: 268398 (history)  
Form: Version 1.0  
Age: 1.98  
Gender: Male  
Location: Foreign  
Vaccinated:2006-10-29
Onset:2006-10-29
   Days after vaccination:0
Submitted: 2006-12-04
   Days after onset:36
Entered: 2006-12-06
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR Z0354 / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site erythema, Injection site infection, Injection site nodule, Injection site oedema, Injection site warmth, Lymphadenitis, Lymphadenopathy, Pyrexia, White blood cell count increased
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)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab results showed WBC at 15.8x10^9/L with N 615 and L 39%.
CDC Split Type: 200603234

Write-up: Case received from a healthcare professional abroad on 24 November 2006 under the local reference number Hib 271106-CN-2006. A 02-year-old male patient with no medical history, experienced soft tissue infection of right upper arm and lymphadenitis, a few hours after receiving his 1st intramuscular dose of Haemophilus Influenzae type B Conjugate Vaccine (Act-Hib), batch number Z0354-2, in the right deltoid. 7 to 8 hours post-vaccination, the patient experienced fever at 100.4-102.2 degrees F and, later "in the afternoon" he presented with redness, swelling and "hotness" in local area. Right axillary lymph node swelling was noted and injection site nodule was also reported. He was hospitalized on unspecified dates. The patient received ANTIPYRETICS and PENICILLIN G SODIUM and the patient''s temperature went to normal on 31 October 2006. Lab results showed WBC at 15.8 X 10^9/L with N 61% and L 39%. The patient recovered on 10 November 2006.


VAERS ID: 272718 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2006-10-29
Onset:2006-10-29
   Days after vaccination:0
Submitted: 2007-02-19
   Days after onset:113
Entered: 2007-02-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0444F / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood pressure decreased, Bronchospasm, Dizziness, Dyspnoea, Glasgow coma scale, Heart rate decreased, Oxygen supplementation, Pallor, Palpitations, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Phobic anxiety
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: blood pressure 29Oct06 110/67 mmHg Comment: sitting BP, physical examination 29Oct06 Comment: Pulse rate 55, Glasgow come scale 29Oct06 Comment: 15/15
CDC Split Type: WAES0612AUS00040

Write-up: Information has been received from a physician concerning a 17 year old female who on 29-OCT-2006 was vaccinated with Gardasil (lot No 654672/0444F, batch no NE01680, Expiry date 23-FEB-2009) on her left deltoid muscle. The patient is needle phobic and had nothing to eat on 29-OCT-2006 until the patient received vaccination on 12:02pm. On 29-OCT-2006 the patient experienced syncope and bronchospasm. Four minutes after injection, the patient had syncope. The symptoms included light headedness, pallor, feeling like fainting and palpitation. The patient had no chest pain but had bronchospasm with dyspnoea. The patient''s sitting blood pressure was 110/67 mmHg and pulse rate was 55. Glasgow Coma Score was 15/15. The patient had oxygen mask. The patient was not hospitalized. The physician considered her diagnosis as phobia, syncope vs drug reaction. Subsequently the patient recovered from syncope and bronchospasm. The physician considered syncope and bronchospasm were related to therapy with Gardasil and asked the patient to reconsider about continuing the next dose of Gardasil. Syncope and bronchospasm were considered to be life threatening by the reporting physician. Additional information is not expected.


VAERS ID: 301415 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2006-10-29
Onset:2006-11-01
   Days after vaccination:3
Submitted: 2008-01-02
   Days after onset:427
Entered: 2008-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Antinuclear antibody negative, Blood creatine phosphokinase increased, Blood immunoglobulin G normal, Dermatomyositis, Eosinophilia, Erythema, Erythema of eyelid, Full blood count normal, Neutrophil count increased, Rash papular
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Eosinophilic pneumonia (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Antinuclear antibody, Dec2006, negative; complete blood count, Apr2007, normal; creatine phosphokinase, Dec2006, increased; creatine phosphokinase, Feb2007, increased; creatine phosphokinase, Apr2007, normal; IgG, 2007 negative; neutrophil count, Dec2006, increased; neutrophil count, Feb2007, increased; neutrophil count, Apr2007, normal
CDC Split Type: B0500897A

Write-up: This case was reported by a dermatologist and described the occurrence of possible dermatomyositis in a 3-month-old male subject who was vaccinated with combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (Infanrixquinta, GlaxoSmithKline), pneumococcal vaccine and unspecified (Prevenar) for prophylaxis. Concurrent medical conditions were unspecified. In September 2006, the subject received his first dose of Infanrixquinta and Prevenar. On 29 October 2006, he received his second dose of Infanrixquinta (unknown) and of Prevenar (unknown). On 01 November 2006, three days after the second vaccination with Infanrixquinta and Prevenar, the subject experienced liliaceae erythema of eyelid, red face, not filtrated papules on chest. There was no hospitalization. In December 2006, blood tests revealed and increase in creatine phosphokinase and in hypereosinophilia (values not provided). Antinuclear antibody test was negative. Diagnosis of myopathy and trichinosis were evoked. In February 2007, neutrophils count and creatine phosphokinase level still increased but increase in creatine phosphokinase was more important than the increase in neutrophils count. In April 2007, creatine phosphokinase level and complete blood count (including neutrophils count) were normal. Within unspecified time after onset, the events were resolved and did not recur thereafter. Recently, diagnosis of trichinosis was ruled out because IgG test was negative. This case was assessed as medically serious by GSK. Causality assessment was unknown.


VAERS ID: 265991 (history)  
Form: Version 1.0  
Age: 30.0  
Gender: Male  
Location: Florida  
Vaccinated:2006-10-30
Onset:2006-11-02
   Days after vaccination:3
Submitted: 2006-11-03
   Days after onset:1
Entered: 2006-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / UNK LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 1 RA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bronchoscopy abnormal, Candidiasis, Cellulitis, Condition aggravated, Cough, Cystic fibrosis lung, Diarrhoea, Electrolyte imbalance, Erythema, Fatigue, Hypokalaemia, Hypomagnesaemia, Induration, Injection site oedema, Injection site pain, Injection site swelling, Malaise, Mobility decreased, Oedema peripheral, Pain in extremity, Pyrexia, Renal failure, Skin warm, Sputum purulent, Vaccination complication, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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), Congenital, familial and genetic disorders (narrow), Pseudomembranous colitis (broad), Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PMH: cystic fibrosis w/multiple exacerbations. Recently on multi antibiotics for prior pseudamonas infection & MRSA in sputum. Recurrent sinusitis s/p multi sinus surgeries. GERD. Right elbow arthritis.
Allergies:
Diagnostic Lab Data: LABS: bronchoscopy revealed + pseudomonas & staph aureus.
CDC Split Type:

Write-up: On Monday, October 30, the patient received a pneumococcal vaccine and over a period of 48 hours he developed a progressive swelling and extreme tenderness over the site of the injection on the left arm. On November 2 he was seen by M.D. and patch of 7 x 8 cm of erythema and induration that on the previous day had been quite small had enlarged and spread to the medial aspect of the arm. The patient had significant induration and the overlying skin was warm and despite the fact that the patient had been trying to use cold compress to obtain relief he was quite uncomfortable. The patient also had a temperature that was documented to 101.5. It should be noted that all these reactions occurred while the patient was receiving linezolid. 11/28/06 Received medical records from hospital which reveal patient admitted 10/16/-10/30/06 w/Dx: excerbation of cystic fibrosis of increased cough, production of purulent sputum, increased fatigue, renal dysfunction, vomiting/diarrhea & general malaise. Also had lost approx 20# over past 2-3 mo. Received IV antibiotics. Consults by pulm & ID. Improved significantly. Was given flu & pneumo on day of d/c to home. D/C DX: acute exacerbation of cystic fibrosis, improved; renal insufficiency, resolved; & electrolye imbalance, treated. Patient was readmitted to hospital approx 48 hours after receiving vax w/severely swollen arm w/pain, limited mobility, fever, redness, induration & edema extending from lower deltoid to elbow. Admitted 11/2/06 & d/c 11/5/06. Treated with IV antibiotics. Developed & was treated for candida. Improved significantly & was d/c to home on continued oral antibiotics. D/C DX: severe reaction to pneumococcal vax w/cellulitis & sterile vaccine reaction; cystic fibrosis, stable; recovering from recent CF exacerbation; chronic hypokalemia & hypomagnasemia; & candidiasis. Patient was febrile on 2NOV06


VAERS ID: 266165 (history)  
Form: Version 1.0  
Age: 9.0  
Gender: Female  
Location: Maryland  
Vaccinated:2006-10-30
Onset:2006-10-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2006-11-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500438 / 1 NS / IN

Administered by: Other       Purchased by: Public
Symptoms: Dizziness, Headache
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: 10/31/06 complained of bouts of dizziness and head hurting to mother. 11/3/06 Mother called to report.


VAERS ID: 266645 (history)  
Form: Version 1.0  
Age: 25.0  
Gender: Female  
Location: Virginia  
Vaccinated:2006-10-30
Onset:2006-10-31
   Days after vaccination:1
Submitted: 2006-11-13
   Days after onset:13
Entered: 2006-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 71826 / 3 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site erythema, Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cymbalta, Yasmin
Current Illness: None
Preexisting Conditions: Topical steroid allergy; diagnosed w/anxiety disorder
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: The patient was vaccinated 10/30/6. The following day she presented to employee health witha 3" x 3" reddened hardened area at the site of injection.


VAERS ID: 267727 (history)  
Form: Version 1.0  
Age: 79.0  
Gender: Female  
Location: Unknown  
Vaccinated:2006-10-30
Onset:2006-11-14
   Days after vaccination:15
Submitted: 2006-11-22
   Days after onset:8
Entered: 2006-11-27
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN
TD: TD ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER YD162 / UNK UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1052F / UNK RA / SC

Administered by: Other       Purchased by: Other
Symptoms: Central nervous system lesion, Encephalitis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0611USA04571

Write-up: Information has been received from an office manager concerning a 79 year old female who on 10/30/06 was vaccinated SC in the right arm with a 0.5ml dose of varicella virus vaccine live (lot 654693/1052F). Concomitant therapy that day included a dose of Pneumococcal 23v polysaccharide vaccine and a dose of Diphtheria toxoid/tetanus toxoid. The vaccinations occurred during an immigration physical exam. On approx 11/14/06 the pt developed encephalitis and brain lesions and was hospitalized. The pts encephalitis and brain lesion persisted. There was no product quality complaint. The reporter considered the events to be other important medical events and life threatening. Additional information has been requested.


VAERS ID: 277664 (history)  
Form: Version 1.0  
Age: 22.0  
Gender: Female  
Location: Ohio  
Vaccinated:2006-10-30
Onset:2006-10-31
   Days after vaccination:1
Submitted: 2007-04-30
   Days after onset:180
Entered: 2007-05-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0689F / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Antinuclear antibody, Arthralgia, C-reactive protein increased, Joint swelling, Red blood cell sedimentation rate increased, Rheumatoid factor negative
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Doxycycline, Hormonal contraceptives
Current Illness: Acne
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: erythrocyte - elevated, serum C-reactive - elevated, serum ANA - pending, serum rheumatoid factor - negative
CDC Split Type: WAES0704USA05875

Write-up: Information has been received from a physician concerning his daughter, a 23 year old female with no drug reactions or allergies with acne who on 31-AUG-2006 was vaccinated intramuscularly with the first 0.5 ml dose of Gardasil (Lot # 653736/0689F). Concomitant therapy included hormonal contraceptives (unspecified) and doxycycline. On 30-OCT-2006, the patient was vaccinated, intramuscularly with the second 0.5 ml dose of Gardasil. On approximately 31-OCT-2006, "two months after the first dose", the patient experienced arthralgia, with progressive pain in her knees, and wrists, and left wrist swelling. On 26-FEB-2007, the patient was vaccinated, intramuscularly with the third 0.5 ml dose of Gardasil. The patient sought unspecified medical attention. Laboratory evaluation revealed elevated sedimentation rate (sed rate), elevated C-reactive protein, negative rheumatoid factor, and antinuclear antibodies (ANA) pending. The physician reported that he believed the pain was causing the patient significant disability as she could not participate in former activities. The patient was treated with ADVIL. At the time of the report, the patient had not recovered. The physician considered the patient''s arthralgia with progressive pain in her knees and wrists and left wrist swelling to be disabling. Additional information has been requested.


VAERS ID: 283482 (history)  
Form: Version 1.0  
Age: 49.0  
Gender: Female  
Location: Illinois  
Vaccinated:2006-10-30
Onset:2006-10-30
   Days after vaccination:0
Submitted: 2007-05-30
   Days after onset:211
Entered: 2007-06-04
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1025F / 1 UN / SC

Administered by: Public       Purchased by: Private
Symptoms: Injection site bruising, Injection site discomfort, Injection site erythema, 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)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0611USA00558

Write-up: Information has been received from a health professional concerning a 49 year old female, who denied having any allergies or medical history, who on 30-OCT-2006 was vaccinated once with a first 0.5 ml subcutaneous dose in the left upper arm of MMR (Lot# 654687/1025F). There was no concomitant medication. Illness at the time of vaccination was denied. Immediately after vaccination, on 30-OCT-2006 the patient experienced redness, swelling, bruising, warmth, and discomfort at the injection site on the left upper arm. The patient had not experienced systemic symptoms. An ice compress was applied to the site but the patient had not noticed improvement at the time of the report. There was no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow-up information from a health professional indicated that the patient recovered on 31-OCT-2006. Additional information is not expected.


VAERS ID: 282745 (history)  
Form: Version 1.0  
Age: 26.0  
Gender: Female  
Location: Kansas  
Vaccinated:2006-10-30
Onset:2006-11-16
   Days after vaccination:17
Submitted: 2007-06-22
   Days after onset:217
Entered: 2007-06-25
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood corticotrophin normal, Drug exposure during pregnancy, Pre-eclampsia, Ultrasound scan normal
SMQs:, Hypertension (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: vitamins (unspecified)
Current Illness: Pregnancy NOS (LMP = 9/28/2006); Sulfonamide allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: ultrasound 11/16/06 - normal, ACTH stimulation 01/16/07 - negative
CDC Split Type: WAES0611USA04683

Write-up: Information has been received through the Merck pregnancy registry and from a 26 year old female with a sulfonamide allergy who on 30-OCT-2006 was vaccinated with the first dose of Gardasil (Lot#653735/0688F). Concomitant therapy included prenatal vitamins. On 16-NOV-2006 the patient had an ultrasound which confirmed she was pregnant. No adverse event was noted. Additional information received from a pediatrician indicated that on 04-JUN-2007 the patient gave birth by c-section due to pre-eclampsia to a 4lb 4oz female. The patient was 35.6 weeks from LMP. On 16-JAN-2007, laboratory diagnostic studies included tetra-screening at 16 weeks and was reported to be normal. The infant was reported to be normal. Upon internal review, pre-eclampsia was considered to an other important medical event. Additional information is not expected.


VAERS ID: 282830 (history)  
Form: Version 1.0  
Age: 35.0  
Gender: Female  
Location: California  
Vaccinated:2006-10-30
Onset:2006-10-30
   Days after vaccination:0
Submitted: 2007-06-25
   Days after onset:237
Entered: 2007-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 71216 / 4 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dizziness, Influenza like illness, Malaise
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient felt very sick the evening the vaccine was given. She felt dizzy,severe flu like symptoms.


VAERS ID: 287049 (history)  
Form: Version 1.0  
Age: 57.0  
Gender: Female  
Location: Oregon  
Vaccinated:2006-10-30
Onset:2006-10-30
   Days after vaccination:0
Submitted: 2007-07-30
   Days after onset:272
Entered: 2007-08-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1007P / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRINE; ESTRING; FLOVENT; ATROVENT; CLARITIN; ACIPHEX; vitamins (unspecified); ACCOLATE; AMBIEN
Current Illness: Penicillin allergy; Allergic reaction to antibiotics; Drug hypersensitivity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0611USA00648

Write-up: Information has been received from a physician concerning a 57 year old female with penicillin allergy, allergic reaction to antibiotics ("e-mycin", azithromycin, clindomycin), drug allergy to indomethacin and drug allergy to codeine who on 30-OCT-2006 was vaccinated subcutaneously with a 0.5 mL dose of Pneumovax 23 (Lot# 651319/1007P). Concomitant therapy included ATROVENT, ACCOLATE, CLARITIN, ACIPHEX, ESTRING, vitamins (unspecified), ASPIRINE, AMBIEN and FLOVENT. The physician reported that on 30-OCT-2006 the patient had fever, chills, muscle aches, localized swelling, redness and tenderness at injection site (right upper arm) approximately 4-5 hours post-injection. The patient was treated with BENADRYL and TYLENOL. At the time of the report, the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.


VAERS ID: 287056 (history)  
Form: Version 1.0  
Age: 77.0  
Gender: Male  
Location: Illinois  
Vaccinated:2006-10-30
Onset:2006-10-31
   Days after vaccination:1
Submitted: 2007-07-30
   Days after onset:271
Entered: 2007-08-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0618F / UNK UN / SC

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), 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)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0611USA01345

Write-up: Information has been received from a certified medical assistant (C.M.A.) concerning a 77 year old male with pertinent medical history and drug reactions/allergies unspecified who on 30-OCT-2006 was vaccinated with Pneumovax 23 (lot # 651400/0618F) 0.5 ml subcutaneously. Concomitant medication was unspecified. On 31-OCT-2006, the patient developed redness, swelling and fever at the injection site that moved down to his forearm. The patient medical attention. No diagnostic studies were performed. The event did not improve. At the time of reporting, the patient had not recovered. Additional information has been received from an other at the physician''s office. On an unspecified date, the patient recovered. No additional information is expected.


VAERS ID: 287146 (history)  
Form: Version 1.0  
Age: 79.0  
Gender: Female  
Location: Indiana  
Vaccinated:2006-10-30
Onset:2006-10-31
   Days after vaccination:1
Submitted: 2007-07-30
   Days after onset:271
Entered: 2007-08-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0618F / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0611USA04645

Write-up: Information has been received from a certified medical assistant (C.M.A.) concerning a 79 year old female who on 30-OCT-2006 was vaccinated with Pneumovax 23 (lot # 651400/0618F) 0.5 ml subcutaneously. On 31-OCT-2006, the patient experienced redness and raised area the size of silver dollar at the injection site. The patient sought medical attention. The outcome of the event was not reported. Additional information has been received from an other unspecified. No diagnostic tests were performed. On an unspecified date, the patient recovered. No further information is expected.


VAERS ID: 287162 (history)  
Form: Version 1.0  
Age: 35.0  
Gender: Female  
Location: Unknown  
Vaccinated:2006-10-30
Onset:2006-10-31
   Days after vaccination:1
Submitted: 2007-07-30
   Days after onset:271
Entered: 2007-08-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Computerised tomogram abnormal, Injection site cellulitis, Injection site pain, Injection site swelling, Oedema, Vaccine positive rechallenge
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)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Sickle cell crisis, Sickle cell anaemia; Hospitalisation; Sickle-cell beta thalassemia; Non-smoker
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: computed axial 10/31?/06 - positive for diffuse subcutaneous edema in right thigh
CDC Split Type: WAES0611USA04670

Write-up: This report was received from GlaxoSmithKline and was assigned manufacturer report A0626767A. This was originally reported by a pharmacist concerning a 35 year old hospitalized female with sickle cell beta thalassemia and in sickle cell pain crisis at the time of the vaccination. It was reported that the patient had a history of cellulitis following prior receipt of concomitant administration of influenza virus split virion 3v vaccine inactivated and pneumococcal 23v polysaccharide vaccine (date unknown). It was reported that the patient had received multiple unspecified concurrent medications. On 30-OCT-2006, the patient was vaccinated with pneumococcal 23c polysaccharide vaccine (lot # not reported) IM in the right thigh at 9:00 AM. On 30-OCT-2006, at 9:00 AM, the patient concomitantly received a dose of influenza virus split virion 3v vaccine inactivated (Fluarix) IM in the right thigh. At the time of the concomitant administration of pneumococcal 23v polysaccharide vaccine and influenza virus split virion 3v vaccine inactivated (Fluarix), 30-OCT-2006, the patient was hospitalized for sickle cell anemia. On 31-OCT-2006, 1 day after vaccination with pneumococcal 23v polysaccharide vaccine and influenza virus split virion 3v vaccine (Fluarix), the patient developed injection site cellulitis. The reporter did not specify at which site of injection the cellulitis occurred. The patient''s hospitalization was extended as a result of the injection site cellulitis. The patient was treated with intravenous and oral clindamycin. At the time of this report, the patient had not recovered from the event. The pharmacist reported that she "does not know if the injection site cellulitis was due to the pneumococcal 23v polysaccharide vaccine or the influenza virus split virion 3v vaccine inactivated (Fluarix)". Additional information was received from the pharmacist who reported that on 31-OCT-2006, the patient developed pain and swelling at the injection site, presenting as cellulitis. A computed tomography (CT) scan was positive for diffuse subcutaneous edema in the right thigh. The patient was treated with clindamycin IV and orally. On 10-NOV-2006, the patient recovered. The pharmacist considered the injection site cellulitis to be disabling. The pharmacist considered the injection site cellulitis to be an Other Important Medical Event. Follow-up information was received from the PharmD. The patient had no history of smoking and rarely drank alcohol. In October 2004, the patient received both the flu vaccine and "pneumonia" vaccine. The patient had no documented reaction. According to the reporter, it was unknown if the patient had experienced any adverse events following previous vaccination with the flu vaccine or Pneumococcal 23v polysaccharide vaccine. On 30-OCT-2006, the patient received the received the first dose of pneumococcal 23v polysaccharide vaccine intramuscularly in the right thigh. The patient experienced injection site swelling and injection site pain on 31-OCT-2006. The patient was diagnosed with injection site cellulitis. A biopsy was not performed. The event resolved on 10-NOV-2006. The pharmacist considered the events were possibly related to vaccination with pneumococcal 23v polysaccharide vaccine and influenza virion 3v vaccine inactivated. No additional information is expected.


VAERS ID: 290403 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Female  
Location: North Carolina  
Vaccinated:2006-10-30
Onset:2006-10-30
   Days after vaccination:0
Submitted: 2006-11-01
   Days after onset:2
Entered: 2007-09-12
   Days after submission:314
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN

Administered by: Public       Purchased by: Public
Symptoms: Rash, Viral rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Unclear, maybe URI
Preexisting Conditions: Milk protein allergy, GERD
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Fine flesh colored papules on upper neck and trunk/back began within hours of receiving vaccine. Not urticarial. Could also be consistent with viral exanthem.


VAERS ID: 296779 (history)  
Form: Version 1.0  
Age: 6.0  
Gender: Male  
Location: New Hampshire  
Vaccinated:2006-10-30
Onset:2007-08-02
   Days after vaccination:276
Submitted: 2007-10-06
   Days after onset:65
Entered: 2007-10-12
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 0465F / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Rash, Varicella
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZYRTEC
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0708USA01034

Write-up: Information has been received from a registered nurse concerning a 6-year-old male with no pertinent medical history and no drug reactions/allergies who on 30-OCT-2006 was vaccinated SC with a 0.5mL dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # 653465/0465F). Concomitant therapy included ZYRTEC. It was noted that the patient was vaccinated with Varivax (MSD) on 03-APR-2002 (lot number not reported). The patient developed a skin rash on the lower extremity on 02-AUG-2007 which spread to the entire body. The rash presented as dew drops on rose petals consistent with varicella. On 03-AUG-2007 the patient was diagnosed with chickenpox by the physician. No other details were provided. There were no lab diagnostic studies performed. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.


VAERS ID: 299487 (history)  
Form: Version 1.0  
Age: 66.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2006-10-30
Onset:2006-10-30
   Days after vaccination:0
Submitted: 2006-12-07
   Days after onset:38
Entered: 2007-11-14
   Days after submission:342
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2197A / UNK UN / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Dysgeusia, Headache
SMQs:, Taste and smell disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nexium, Zantac
Current Illness:
Preexisting Conditions: The patient had no illnesses at the time of the vaccination on 30 October 2006. He has a history of allergy to dye and Celebrex. He has a history of Reflux disease.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200602892

Write-up: A 66-year-old male patient, with an allergy to dyes, and Celebrex; and who has reflux disease, had received a right deltoid, intra-muscular injection of FLUZONE SV "2006-2007" USP, lot number U2187AA, on 30 October 2006. Within one hour post-immunization, the patient experienced a strong metallic taste in his mouth. The next day, the metallic taste continued and he complained of a headache. He had no other complaints. Per the reporter, a 23 gauge, 1 inch needle was used for the injection. The patient did not seek medical attention, and no diagnostic tests or laboratory work were performed. At the time of this report, the patient had not recovered. Follow-up information received on 06 December 2006 from a health care professional. The patient recovered.


VAERS ID: 299500 (history)  
Form: Version 1.0  
Age: 53.0  
Gender: Female  
Location: Nevada  
Vaccinated:2006-10-30
Onset:2006-10-30
   Days after vaccination:0
Submitted: 2007-07-31
   Days after onset:273
Entered: 2007-11-14
   Days after submission:106
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2193A / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dysgeusia
SMQs:, Taste and smell disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Claritin, pseudopherine, bio-identical hormone replacement
Current Illness:
Preexisting Conditions: The patient had a history of albuterol use "four years ago".
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200702050

Write-up: Initial report received on 04 June 2007 from a health care professional. A 53-year-old female patient, with no illness at the time of vaccination, had received a left deltoid injection of Fluzone SV 2006-2007, lot number not reported, on an unspecified date. On an unspecified date post-immunization, the patient experienced a metallic taste in her mouth. Medications included Claritin, "pseudopherine", and bio-identical hormone replacement. No further follow-up was required after the vaccination. At the time of this report, recovery status was not reported. Follow-up information received on 30 July 2007 from a health care professional. The date of vaccination was 30 October 2006, and the adverse event onset was 30 October 2006, four hours post-immunization. The Fluzone lot number was U2193AA, and Fluzone was administered intramuscularly in the left deltoid. Per the reporter, the duration of the event was 36-40 hours, and the patient recovered. The reporter in this case is the same as in cases 2006-02707 and 2007-02049.


VAERS ID: 302512 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Male  
Location: Ohio  
Vaccinated:2006-10-30
Onset:2007-07-23
   Days after vaccination:266
Submitted: 2008-07-03
   Days after onset:346
Entered: 2008-01-09
   Days after submission:175
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 0301F / 1 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Exposure to communicable disease, Skin lesion, Varicella post vaccine
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~Varicella (no brand name)~1~10.00~Sibling
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA03365

Write-up: Information has been received from a registered nurse concerning a 5 year old white male who on 29-Aug-2002 and 30-Oct-2006 was vaccinated with his first and second doses of PROQUAD (lot #653355/0301F) in the left deltoid. On 23-Jul-2007 the patient developed varicella via exposure from his brother characterized by 2 lesions on the abdomen and 1 lesion on the upper leg. Medical attention was sought and the patient was treated with ZOVIRAX 400mg TID for 5 days. On 30-Aug-2007 the patient recovered. The reporter considered the patient''s experience to be an other important medical event since medication was prescribed. This is one of several reports from the same source. Additional information is not expected. Follow-up information from the reporting registered nurse indicated that the patient received the first dose of varicella virus vaccine live (oka/Merck) not measeles virus vaccine live (enders-Edmonston) (+) mumps virus live (Jeryl Lynn) (+) rubella virus live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) on 29-Aug-2002. The patient developed 7 lesions on his abdomen and 1 lesion on his upper leg and the patient''s brother (WAES#0789USA63364) was the first brother to experience the lesion on the mid right abdomen. The reporter stated there was no mention of an exposure to VZV WILD TYPE STRAIN virus in the patient''s chart. The patient recovered. It was noted that there were no reocurrences of the event. This is one of several reports from the same source.


VAERS ID: 327518 (history)  
Form: Version 1.0  
Age: 8.0  
Gender: Male  
Location: Alabama  
Vaccinated:2006-10-30
Onset:2006-10-30
   Days after vaccination:0
Submitted: 2008-09-05
   Days after onset:675
Entered: 2008-09-24
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Military       Purchased by: Other
Symptoms: Allergy test negative, Eczema, Inappropriate schedule of drug administration, Skin lesion, Skin reaction
SMQs:, Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamin
Current Illness: Unknown
Preexisting Conditions: The subject has no history of allergies. The subject experienced the same events following administration of Aventis''s flu shot (1st flu shot given to the subject). He had over 300 lesions at that time.
Allergies:
Diagnostic Lab Data: Unspecified allergy testing came back negative, including a test for egg allergy.
CDC Split Type: A0739853A

Write-up: This Case was reported by the mother of a consumer and described the occurrence of skin reactions (dermatological reaction) in an 8-year-old male subject who was vaccinated with influenza virus vaccine (flu vaccine, Glaxosmithkline). A physician or other health care professional has not verified this report. Concurrent medications included multivitamins. On 30 October 2006, in the afternoon, the subject received unspecified dose of flu vaccine at .25ml in an unknown arm. Two to four weeks after vaccination with flu vaccine, the subject developed what the mother referred to as a Dermatological reaction (skin reactions). A systemic reaction. He developed lesions (described as a nummular) on his hand, wrist, arms and the back of the ankles. It had been called eczema as well as some other Unidentifiable term (spongia). The condition responds to steroids, but when they are stopped the symptoms return. The subject has also been treated with Mupirocin and this worsened the lesions. The child has reportedly seen several dermatologists as well as allergists. He was tested for everything and it all comes back negative. The first flu vaccine the subject ever received was by Aventis and he ended up with over 300 lesions. At the time of reporting the outcome of the events was was unspecified. This was also considered to be a medication error as Glaxosmithkline flu vaccine in not indicated for use in pediatric subjects. These events occurred again in this subject in 2007 following vaccination with a Glaxosmithkline flu vaccine. Refer to case number A0739862A for details surrounding the second report.


VAERS ID: 348393 (history)  
Form: Version 1.0  
Age: 10.0  
Gender: Male  
Location: Georgia  
Vaccinated:2006-10-30
Onset:2006-10-31
   Days after vaccination:1
Submitted: 2009-05-27
   Days after onset:938
Entered: 2009-06-02
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U188OCA / 6 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Activities of daily living impaired, Asthenia, Dysphagia, Grip strength, Heart rate abnormal, Insomnia, Nervous system disorder, Pain in extremity, Pharyngitis streptococcal, Pyrexia, Restless legs syndrome, Sweat test abnormal
SMQs:, Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Oropharyngeal infections (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amoxil 800mg
Current Illness: Strep throat
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Diminished grip tilt test- autonomic nerve damage sweat test- autonomic nerve damage.
CDC Split Type:

Write-up: Patient given a TB vaccine while he had a fever of 104 and a case of Strep throat. He began to have neurological problems about 24 hours later. (Trouble swallowing, weakness and a pain in limbs, inability to sleep + heart rate issues). There was no treatment other than IV iron for the restless leg syndrome he developed. He missed 7 weeks of school. His problems resolved over a period of 6 months.


VAERS ID: 380241 (history)  
Form: Version 1.0  
Age: 28.0  
Gender: Female  
Location: Florida  
Vaccinated:2006-10-30
Onset:0000-00-00
Submitted: 2010-01-07
Entered: 2010-01-27
   Days after submission:20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LA / UN
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 AR / UN

Administered by: Public       Purchased by: Public
Symptoms: Injection site haemorrhage, Pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Insomnia. It was unknown if adverse events were reported with previous vaccinations.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0760078A

Write-up: This case was reported by a consumer and described the occurrence of exacerbation of insomnia in a 28-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline), HAVRIX. A physician or other health care professional has not verified this report. The subject''s medical history included insomnia. Previous and/or concurrent vaccination included HAVRIX; GlaxoSmithKline; unknown; unknown arm given on 30 October 2006. Concurrent medications included Unknown. On 30 October 2006, 30 November 2006 and 30 April 2007 the subject received 1st dose, 2nd dose and 3rd dose of Engerix B (unknown, unknown arm). On 30 April 2007 the subject received 2nd dose of Havrix (unknown, unknown arm). In May or June 2007, at an unspecified time after vaccination with Engerix B and Havrix, the subject experienced exacerbation of insomnia. On 30 October 2006 and 30 November 2006 after vaccination with Engerix B, the subject experienced injection hurt going in. On 30 April 2007, after vaccination with Engerix B, the subject experienced injection hurt going in and injection site hemorrhage. The subject reported she has history of insomnia for years and reported that after her last dose of Havrix and Engerix B vaccines, she experienced a worsening of her insomnia. She did not know the brand names of the hepatitis A and hepatitis B vaccines, but when she consulted the Department of Health regarding this event, they referred her to GSK for information, thus she assumes they were GSK brands. She was vaccinated for prevention since her family member has a liver transplant due to hepatitis B virus. She noticed a worsening of her insomnia in either May or June 2007, a after her last doses of Havrix or Engerix B vaccines that were given 30 April 2007. She has seen her doctor for medication for her insomnia but she has not discussed with her doctor that the worsening of insomnia might be due to the vaccines. She only recently began to suspect the vaccines. Subject stated the worsening of insomnia has been disabling since cannot work but it has not been physically disabling. She has not been hospitalized for treatment. The subject also reported events with Engerix B, of injections hurt, especially the last dose, with the last dose, blood spurted out of the injection site. She thought this was due to the nurse being distracted as they were discussing politics at the time of the injection. The blood spurted out was just treated by covering the injection with a bandage. Both these events has resolved on unknown dates. At the time of reporting the outcome of exacerbation of insomnia was unresolved; injection hurt going in and injection site hemorrhage resolved on an unknown date.


VAERS ID: 437345 (history)  
Form: Version 1.0  
Age: 34.0  
Gender: Female  
Location: Virginia  
Vaccinated:2006-10-30
Onset:2006-10-30
   Days after vaccination:0
Submitted: 2011-10-07
   Days after onset:1802
Entered: 2011-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 RA / IM

Administered by: Public       Purchased by: Private
Symptoms: Ankylosing spondylitis, Back pain, Cell marker, Colitis ulcerative, Full blood count, Iritis, Metabolic function test, Musculoskeletal stiffness, Oropharyngeal pain, Pain, Pain in extremity, Pulmonary congestion, Pyrexia, Red blood cell sedimentation rate, Rhinorrhoea
SMQs:, Cardiac failure (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Gastrointestinal ulceration (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Ischaemic colitis (broad), Ocular infections (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: ASTHMA, ULCERATIVE COLITIS IN REMISSION
Allergies:
Diagnostic Lab Data: CBC, COMPMET, HLAB27, SED RATE
CDC Split Type:

Write-up: SORE ARM AFTER INJECTION, PAIN WORSENED BY EVENING AND WAS UNABLE TO LIFT ARM WITHOUT SEVERE PAIN. BY NEXT DAY SORE THROAT, RUNNY NOSE AND FEVER. BY THE END OF THE WEEK ALL THE ABOVE PLUS STIFF NECK/BACK AND CHEST CONGESTION. THIS CONTINUED FOR ABOUT TWO MONTHS. WITH IN A FEW WEEKS OF GETTING THE FLU SHOT, CAME SEVERE BACK PAIN THAT RADIATED TO MY FEET, THEN ULCERATIVE COLITIS FLARE UP. NEXT CAME IRITIS TO THE POINT I''D WAKE UP IN THE MORNING UNABLE TO SEE. MONTHS LATER I WAS DIAGNOSED WITH ANKYLOSING SPONDYLITIS AND AM TAKING MEDICATION.


VAERS ID: 446464 (history)  
Form: Version 1.0  
Age: 46.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2006-10-30
Onset:0000-00-00
Submitted: 2011-12-29
Entered: 2011-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK AR / IM
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK AR / IM

Administered by: Military       Purchased by: Unknown
Symptoms: Lymphadenopathy, Nodule, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: unknown
Preexisting Conditions: unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received both Tdap and influenza (inactive) vaccine in same arm on 10/30/2006. Reports that arm was swollen and had palpable knot for 1 month after receiving vaccine, and lymph nodes underneath arm were swollen for 6 months following vaccination. Patient has since received her annual influenza vaccines without complication.


VAERS ID: 267287 (history)  
Form: Version 1.0  
Age: 75.0  
Gender: Female  
Location: Foreign  
Vaccinated:2006-10-30
Onset:2006-10-30
   Days after vaccination:0
Submitted: 2006-11-17
   Days after onset:18
Entered: 2006-11-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Medication error
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PNEUMOVAX II (PNEUMOCOCCAL VACCINE), Unknown, 00-May-2004/00-May-2004 MIRTAZAPINE (MIRTAZAPINE), 45 mg 1x per 1 day, 26-Sep-2006/UNK
Current Illness:
Preexisting Conditions: Depression
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBWYE380531OCT06

Write-up: Follow up information was received upgrading this case to serious. Other information was received regarding pt demographics, concomitant medication, adverse event details, outcome and reporter causality. This case was considered medically important (OMIC). Information regarding Prevnar was received from a healthcare professional regarding a 75 year old female pt who was administered Prevnar instead of flue jab. The pt received a dose on 10/30/06. The pts concurrent illness included depression. Indication for Prevnar was not provided. Product was administered on 10/30/06. Dose regimen was 1 dose 1 time per day IN. Concomitant therapy included Pneumovax and Mirtazapine. Staff brought Prevnar to the GP who thought it was a flu vaccine and the pt was administered Prevnar instead of Flu jab (wrong drug administered) on 10/30/06. At the time of the report, no adverse event had occurred and the reporter considered the event recovered on 10/30/06. The reporter stated that the adverse event was related to Prevnar and that this event could have been avoided if the component of the vaccine, Pneumococcus, was clearly printed on the label, similar to other vaccines. No additional information was available at the time of this report.


VAERS ID: 267784 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Male  
Location: Foreign  
Vaccinated:2006-10-30
Onset:2006-10-31
   Days after vaccination:1
Submitted: 2006-11-27
   Days after onset:27
Entered: 2006-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS ALUA195AB / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Cellulitis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature 31Oct2006 40.0 Deg C
CDC Split Type: B0445397A

Write-up: This case was reported by a physician and described the occurrence of cellulitis in a 4-year-old male subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On 30 October 2006, the subject received unspecified dose of Fluarix (intramuscular, unknown arm). On 31 October 2006, 1 day after vaccination with Fluarix, the subject experienced cellulitis and fever. The subject was hospitalized for 4 days. On 3 November 2006, the events were resolved. The physician considered the events were almost certainly related to vaccination with Fluarix. He also specified there was no problem in injection route, site and storage of vaccine. In the follow-up received on 23 November 2006, it was reported that the cellulitis spread from the injection site to the chest. the fever''s value was 40 Deg. C. During hospitalization, the patient was treated with antibiotics. It was also confirmed that he left the hospital after 4 days of treatment. In the follow-up received on 24 November 2006, it was mentioned that the subject didn''t have any medical history. There was no concomitant medication or vaccination. The injection site was the left arm.


VAERS ID: 269474 (history)  
Form: Version 1.0  
Age: 0.24  
Gender: Male  
Location: Foreign  
Vaccinated:2006-10-30
Onset:2006-10-30
   Days after vaccination:0
Submitted: 2006-12-19
   Days after onset:50
Entered: 2006-12-21
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER KMP0058 / UNK - / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR Y9608 / UNK - / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER KMP0058 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Blood urine, Heart rate increased, Hypotonia, Injection site reaction, Leukocytosis, Pain, Pyrexia, Skin discolouration, Stupor, Tenderness
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Uncomplicated pregnancy, born at expected time. Birth weight 4100g. Has previously been healthy and well, except for a simple cold. Has tow elder siblings. Lives with mother and father. At the hospital he was examined and was found to have a good tonus. Capillary response under 3 second. Normal overall response. Seems to strain once in a while, as if he needs to defecate. Normally he defecates 2-3 times per day, but there are days with none. No defecation previously this day. He is breast fed every 4 hours, also during the AE. Mother had on 30 Oct 2006 noticed blood in urine. Temperature of 39.3 degrees Celsius. The fontanel is levelled and not tense. No conjunctivitis of the eyes. The pupils are quite small, especially when straining. No otitis in ears. The oral cavity has no redness. Lung status is overall vesicular and without rale. Heart status is normal function without bruit. Abdomen is soft and not tender. No fillings. No enlarged organs, free non tender kidneys and normal bowel sound. A rectal examination showed a quite tense sphincter. No tumors. Normal coloured faeces without blood or mucus on the glove. Skin has no marmorations or petechiae. No suspicion of intussusception at the point of admission. Genital examination showed no signs of epi or hypospadias. Testicles in scrotum. Can support his weight on his legs and holds his head.
Allergies:
Diagnostic Lab Data: Urine test negative. Leukocyte count was marginally elevated. CRP 1.5, temperature decreased from 39.3 degrees Celsius at admission to 38.1 in the morning. Normal acid base equilibrium.
CDC Split Type: E200606645

Write-up: Initial case was reported as serious on 08 Dec 2006. It was reported that a 2 month old boy was vaccinated with ActHib, batch number Y9608-1 IM, site of administration not reported and concomitant DTP/Polio vaccine batch number KMP0058 on the 30 Oct 2006. Back at home after vaccination, and 15 minutes after breast feeding, the boy suddenly had a hyporesponsive episode when he was flaccid. The episode lasted 2 minutes and during this time he turned grey and was apneic. His mother listened to his heart and could hear it was beating fast (anamnetically judged as 170 bpm). The episode faded spontaneously and the child was taken to the hospital. At the hospital the boy was awake and complaining and seemed to be suffering from pain. He was found to have fever with a temperature of 39.3 degrees Celsius at admission, which decreased to 38.1 in the morning. Mother has on 30 Oct 2006 noticed blood in urine. He was slightly tender at the injection site in the morning of 31 Oct 2006. At arrival to the hospital (30 Oct 2006) he was examined and was found to have a good tonus. Normal overall response (see patient history comments). He was admitted for observation over night. He was given panodil (paracetamol, mfr nor rep, 175 mg, single doe in the evening, route not rep, and thereafter 125mg suppositories, every six hours) leading to lowered temperature in the morning. Results in blood tests showed marginally elevated leukocyte count. CRP was 1.5 (unit not rep). Normal acid base equilibrium. He was recovered in the morning and seemed to be a happy child with normal spontaneous movements. Nothing abnormal noted at examination before discharge. It is reported that the events correspond very well to a reaction caused by the vaccination. The reporter notes that the hyporesponsive episode and apnea, leading to the coding of life threatening reaction, are not medically confirmed, as these events happened at home. The outcome is recovered. Case is closed.


VAERS ID: 270304 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Male  
Location: Foreign  
Vaccinated:2006-10-30
Onset:2006-10-31
   Days after vaccination:1
Submitted: 2007-01-08
   Days after onset:69
Entered: 2007-01-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Bronchitis asthmatic
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0701USA00323

Write-up: Information has been received from a pediatrician via Health Authority concerning an 11 year old male with a history of bronchial asthma who on 30-Oct-2006 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot# not reported) IM into the upper arm. Concomitant therapy, also given on 30-Oct-2006, included influenza virus split 3v vaccine inactivated (INFLUSPLIT) (lot #not reported) IM into the other arm (side not reported). On 31-Oct-2006, the patient experienced intense redness, swelling and pain upper arm, elbow and forearm (pneumococcal 23v polysaccharide vaccination, the influenza vaccine was definitely given on the other side and is not suspected. The boy was treated with ibuprofen (3 x 20 mg per os) and local dressing with ethacridinlactate (RIVANOL). At the time of reporting, the patient had not yet fully recovered (date of report unknown), but the reporter assumed that the boy will fully recover. The reporting physician felt that the redness, swelling arm, pain in arm and injection site reaction were serious (Other Important Medical Events). The case is closed. Other business partner numbers included: E2006-07038. No further information is available.


VAERS ID: 271353 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Foreign  
Vaccinated:2006-10-30
Onset:2006-10-30
   Days after vaccination:0
Submitted: 2007-01-26
   Days after onset:88
Entered: 2007-01-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abortion induced, Pregnancy, Pregnancy test positive, Ultrasound antenatal screen normal
SMQs:, Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Pregnancy
Allergies:
Diagnostic Lab Data: Ultrasound no anomaly 22Dec06, Bata human chorionic gonadotropin (unsp) 30Oct06 pregnant.
CDC Split Type: WAES0701USA04331

Write-up: Information has been received from a health professional concerning a 21 year old female, with one healthy child, who was vaccinated with a first dose of MMR II vaccine, before her first pregnancy. On 30-Oct-2006 the patient was vaccinated with a second intramuscular dose MMR II. Her last menstrual period dated back to 08-Oct-2006. The patient was unaware of her pregnancy at the time of vaccination. It was noted that both reporting physicians advised her to terminate her pregnancy. It was reported that the patient decided to terminate her pregnancy. No anomaly was shown on the ultrasound, however the pregnancy was terminated as a precaution on 22-Dec-2006. The case is closed. Decided to terminate her pregnancy was considered to be an other important medical event. Other business partner numbers included: E2007-07047 and 6296.


VAERS ID: 620110 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2006-10-30
Onset:2006-11-01
   Days after vaccination:2
Submitted: 2015-12-23
   Days after onset:3339
Entered: 2015-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Arthralgia, Cognitive disorder, Constipation, Decreased appetite, Disturbance in attention, Dizziness postural, Dyskinesia, Dysuria, Eating disorder, Fatigue, Headache, Hypersensitivity, Hyperventilation, Loss of personal independence in daily activities, Lymphadenopathy, Memory impairment, Menstruation irregular, Muscular weakness, Nausea, Pain, Palpitations, Photophobia, Pyrexia, Skin disorder, Sleep disorder, Syncope, Tilt table test normal, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dyskinesia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Tilt table test was normal.
CDC Split Type: WAES1512DNK011469

Write-up: Information has been received from SPMSD (manufacturer control # DK-1577272925-2015001276) on 22-DEC-2015. Case received from a physician via HA on 18-Dec-2015 under the reference number DK-DKMA-WBS-0002058 and DK-DKMA-ADR 23278858. A 17-year-old female adolescent patient received GARDASIL, (batch number unknown, Dose 1) via intramuscular route on 30-Oct-2006, GARDASIL, (batch number unknown, Dose 2) via intramuscular route on 25-Jun-2007, GARDASIL, (batch number unknown, Dose 3) via intramuscular route on 15-Aug-2007, GARDASIL, (batch number unknown, Dose 4) via intramuscular route on 30-Jan-2008. The patient experienced Abdominal pain / pain in stomach in NOV-2006, Headache / severe headache in NOV-2006, Cognitive disorder on an unknown date, Skin disorder / skin problems on an unknown date, Syncope / fainting attack in NOV-2006, Dizziness on standing up on an unknown date, Palpitation on an unknown date, Nausea in NOV-2006, Voiding difficulty on an unknown date, Menses irregular on an unknown date, Hyperventilation on an unknown date, Sleep disorder on an unknown date, Involuntary muscle movement on an unknown date, Limb weakness on an unknown date, Joint pain on an unknown date, Light sensitive on an unknown date, Constipation on an unknown date, Visual disturbance in NOV-2006, Pain in NOV-2006, Fever in NOV-2006, Swollen lymph nodes in NOV-2006, extreme tiredness in NOV-2006, has no appetite for food in NOV-2006, Memory impaired in NOV-2006, Concentration impaired in NOV-2006, allergies on an unknown date, problems with food on an unknown date and patient has been without school for 1 year in 2015. The patient informs that she in the month of November, shortly after 1st vaccine, developed pain, fever, swollen lymph nodes, extreme tiredness, pain in stomach, nausea, has no appetite for food, concentration impaired, memory impaired, severe headache, visual disturbance, fainting attacks. Later, she developed problems with food, allergies and skins problems. Subsequently the other reported symptoms developed. Consequently, the patient has been without school for 1 year. In 2015 the patient was about to start higher education, but had to stop - and lives now at home with the family. Tilt table was normal. Unknown whether there are other vaccines or medications. At the time of reporting, the patient had recovered from syncope/fainting attack on Nov-2006, the outcome was unknown for the reactions menses irregular, pain, fever, Swollen lymph nodes, extreme tiredness, has no appetite for food, Memory impaired, concentration impaired, allergies, problems with food, and patient has been without school for 1 year. The patient had not recovered from the other reactions.


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