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Case Details (Sorted by Vaccination Date)

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VAERS ID:474139 (history)  Vaccinated:2012-11-14
Age:51.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Male  Submitted:2012-11-14, Days after onset: 0
Location:Maryland  Entered:2012-11-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: facial tingling, itch~Rabies (RabAvert)~1~51.75~Patient|facial tingling, itch, warmness~Rabies (RabAvert)~2~51.75~Patient
Other Medications: Flomax
Current Illness: Today was the third and final shot of the rabies series vaccination. During each of the three shots, I experienced tingling and itchiness of cheek muscles proceeding to the lips approximately 15 minutes after shot administration. The second shot''s reaction (10/29/2012) was the worst of the series with the side effects lasting four hours. During the first (10/22/2012) and third shots, the effects lasted about 15 and 60 minutes respectively.
Preexisting Conditions:
Diagnostic Lab Data: n/a
CDC 'Split Type':
Vaccination
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Dose
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Site
RAB: RABIES (RABAVERT)NOVARTIS VACCINES AND DIAGNOSTICS 2SCLA
Administered by: Other     Purchased by: Other
Symptoms: Paraesthesia, Pruritus
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (broad)
Write-up: Today was the third and final shot of the rabies series vaccination. During each of the three shots, I experienced tingling and itchiness of cheek muscles proceeding to the lips approximately 15 minutes after shot administration. The second shot''s reaction (10/29/2012) was the worst of the series with the side effects lasting four hours. During the first (10/22/2012) and third shots, the effects lasted about 15 and 60 minutes respectively.

VAERS ID:474140 (history)  Vaccinated:2012-11-14
Age:13.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Male  Submitted:2012-11-14, Days after onset: 0
Location:Georga  Entered:2012-11-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: New PT
Diagnostic Lab Data: BP WNL
CDC 'Split Type':
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FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AJ20250IN 
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB646AA1IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0629AE0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4273AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B085CA0IMRA
Administered by: Private     Purchased by: Public
Symptoms: Syncope, Wart excision
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: PT had an episode of syncope post vaccinations and wart removal. PT was assessed and monitored, vitals stable in care to mother to home.

VAERS ID:474146 (history)  Vaccinated:2012-11-14
Age:11.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-11-14, Days after onset: 0
Location:Oklahoma  Entered:2012-11-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: No
Preexisting Conditions: HS Purpura
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
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Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0629AE0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4275AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3976AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Headache, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: PATIENT RECEIVED TDAP, MCV4 AND HPV VACCINE TODAY. AFTER GIVING THE LAST VACCINE WHICH WAS HPV AT 11:16 AM PATIENT PASSED OUT. SHE WAS STILL SEATED IN CHAIR AT TIME. I CAUGHT PATIENT WHEN SHE WAS STARTING TO LEAN OVER AND LAID HER BACK ON MY LAP. WE APPLIED COOL DAMP CLOTHES TO HER FACE AND NECK. SHE CAME BACK AROUND WITHIN THE NEX MINUTE. WE SAT HER BACK UP IN CHAIR AND SHE WENT OUT AGAIN. WE THEN MOVED HER ONTO THE EXAM TABLE TO LIE DOWN. AFTER SHE CAME BACK AROUND WITHIN THE NEXT MINUTE SHE DENIED ANY NAUSEA. SHE SAID HER HEAD HURT A LITTLE BIT. O2 SAT WAS 99% HER BP WAS 119/57 AND PULSE WAS 88. BP REPEATED AND WAS 110/59. STATED SHE WANTED TO TRY AND SIT UP. AT 11:33 WE SAT HER UP AND SHE DRANK SOME WATER. AT 11:34 HER BP WAS 108/67 AND PULSE 93. AT 11:39 HER BP WAS 101/53 AND PULSE 82. SHE SAID SHE WANTED TO LAY BACK AGAIN. I RECHECKED HER BP AT 1145 AND IT WAS 102/56 AND PULSE 82. AT 1154 SHE SAT UP ON EDGE OF EXAM TABLE AND SAID "SHE FEELS BETTER" COLOR WAS GOOD AT THIS TIME ALSO. AT THIS TIME WE HAD HER TO STAND UP AND SHE SAID SHE FELT FINE. HAD HER TAKE A FEW STEPS AND SHE SAID SHE WAS FINE. HER GAIT WAS GOOD. AT 11:58 SHE SAID SHE "FEELS BETTER" AND WALKED OUT OF CLINIC WITH HER MOTHER.

VAERS ID:474247 (history)  Vaccinated:2012-11-14
Age:78.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Male  Submitted:2012-11-15, Days after onset: 1
Location:Florida  Entered:2012-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: PATIENT RETURNED TO CLINIC. PATIENT COMPLAINED OF METALLIC TASTE AND ZERO NUMBNESS.
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
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VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H012576 SCRA
Administered by: Military     Purchased by: Military
Symptoms: Dysgeusia
SMQs:, Taste and smell disorders (narrow)
Write-up: PATIENT RETURNED TO CLINIC 4:04 PM. PATIENT COMPLAINED OF METALLIC TASTE AND ZERO NUMBNESS.

VAERS ID:474250 (history)  Vaccinated:2012-11-14
Age:30.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-11-15, Days after onset: 1
Location:Colorado  Entered:2012-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Allergies to cefprozil, cefazolin
Diagnostic Lab Data: none
CDC 'Split Type':
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FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA711BA IMLA
Administered by: Unknown     Purchased by: Other
Symptoms: Chills, Diarrhoea, Fatigue, Nausea
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Diarrhea, nausea. Chills later on that night. Fatigue.

VAERS ID:474268 (history)  Vaccinated:2012-11-14
Age:16.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-11-15, Days after onset: 1
Location:North Dakota  Entered:2012-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: broke out in chicken pox~Varicella (no brand name)~1~1.08~Patient
Other Medications: Received Mantoux at visit/ Prozac, trazadone, Ativan, albuterol
Current Illness: None
Preexisting Conditions: Allergies (pollen), Asthma, anxiety
Diagnostic Lab Data: None
CDC 'Split Type': ND1226
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0106492IMLA
Administered by: Private     Purchased by: Private
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient received Gardasil (#3) and a TB test. Within a minute of receiving, patient fainted while sitting. Blood Pressure was 84/43 and pulse 45 initially. Five minutes later BP was 115/61, pulse 53. By this time patient was feeling better and drinking juice. Thirty minutes after patient fainted her vitals were normal at 121/70 and pulse 60. She stated her mother also has fainted with shots.

VAERS ID:474288 (history)  Vaccinated:2012-11-14
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2012-11-15
Location:Michigan  Entered:2012-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB646BA IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.H010123 IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM11081 IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H013638 SCLA
Administered by: Public     Purchased by: Public
Symptoms: Maternal exposure during pregnancy, No adverse event
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: No signs or symptoms of an adverse event noted. Vaccines were given per mothers request. After administration the patient informed us that she was pregnant.

VAERS ID:474296 (history)  Vaccinated:2012-11-14
Age:60.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Male  Submitted:2012-11-15, Days after onset: 1
Location:California  Entered:2012-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
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FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDPS1108 IMLA
Administered by: Other     Purchased by: Private
Symptoms: Cough, Dizziness, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad)
Write-up: Patient stated approximately two hours after injection he developed a cough, difficulty breathing, and dizziness. Patient reported he went to the emergency room, and has been admitted.

VAERS ID:474298 (history)  Vaccinated:2012-11-14
Age:11.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-11-15, Days after onset: 1
Location:California  Entered:2012-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Advil; Desmopressin
Current Illness: Right sided abdominal pain
Preexisting Conditions: Austism Spectrum Disorder, Migraines (takes Tylenol), nocturnal enuresis on Desmopressin
Diagnostic Lab Data: Referred to neurology.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
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FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA695BA2IMLL
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0129680IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4285AA0IMRA
Administered by: Unknown     Purchased by: Other
Symptoms: Loss of consciousness, Neurological examination, Pallor, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Received MCV4, HPV4, then FLUARIX, mom noticed was shaking whole body, then fainted (loc for about 2 mintues), went to car, was shaking/pale, then 7:30pm started shaking again; shaking throughout day and night. Went to MD office on 11/15/12, was seen to have intermittent episodes of brief (few seconds) fine tremors in various locations not all at once (head, shoulders, left foot, arms). Normal neuro exam otherwise.

VAERS ID:474299 (history)  Vaccinated:2012-11-14
Age:54.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Male  Submitted:2012-11-15, Days after onset: 1
Location:Wisconsin  Entered:2012-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol (PROVENTIL) 90 MCG/ACT inhaler Inhale 2 puffs every 4 hours as needed for shortness of breath; AMOXICILLIN PO use as directed when noting blood in sputum with coughing; aspirin 81 MG chew tab Take 1 tab by mouth one time d
Current Illness: No
Preexisting Conditions: Avandia, Glucophage, tape, Tylenol
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS120630110IMLA
Administered by: Other     Purchased by: Private
Symptoms: Abdominal pain, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: Itching, rash, abdominal pain.

VAERS ID:474302 (history)  Vaccinated:2012-11-14
Age:11.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-11-15, Days after onset: 1
Location:California  Entered:2012-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE PER FATHER
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE SENT TO EMERGENCY ROOM
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0022AE0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4074BA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B085BA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: PATIENT GIVEN HPV, MCV AND TDAP VACCINES. AFTER THE TDAP VACCINE SHE FAINTED, PROVIDER NOTIFIED. PT RESPONDED WITH AMNONIA INHALANT, 911 AND AMBULANCE CALLED. TAKEN TO ER VIA AMBULANCE.

VAERS ID:474486 (history)  Vaccinated:2012-11-14
Age:10.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-11-14, Days after onset: 0
Location:Florida  Entered:2012-11-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: After reaction Hydroxyzine
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AH2192B0IN 
Administered by: Private     Purchased by: Public
Symptoms: Pruritus generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Had nasal FLUMIST started itching about 1/2 hour later all over. No known allergies to eggs.

VAERS ID:474527 (history)  Vaccinated:2012-11-14
Age:72.0  Onset:2012-11-15, Days after vaccination: 1
Gender:Female  Submitted:2012-11-15, Days after onset: 0
Location:Massachusetts  Entered:2012-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: High blood pressure; underactive thyroid
Diagnostic Lab Data: No
CDC 'Split Type':
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FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12272P IMRA
Administered by: Other     Purchased by: Other
Symptoms: Breast pain, Cellulitis, Erythema
SMQs:, Anaphylactic reaction (broad), Lipodystrophy (broad), Hypersensitivity (broad)
Write-up: Day after vaccination, 2 red areas - painful areas under (R) & (L) breast areas more so on right side saw MD, diagnosed as cellulitis, possibly triggered by vaccine.

VAERS ID:474534 (history)  Vaccinated:2012-11-14
Age:2.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Male  Submitted:2012-11-15, Days after onset: 1
Location:Illinois  Entered:2012-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Resolving cold
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
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Manufacturer
Lot
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FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AJ21600IN 
Administered by: Private     Purchased by: Private
Symptoms: Eye movement disorder, Feeling cold, Pyrexia, Somnolence, Swelling face, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: After 1 hour, developed chills, rising fever up to 104 degrees. Facial swelling, unresponsiveness with eyes rolling & somnolent appearance. Taken to urgent care - emergency room.

VAERS ID:476856 (history)  Vaccinated:2012-11-14
Age:  Onset:0000-00-00
Gender:Male  Submitted:2012-11-14
Location:Kansas  Entered:2012-11-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC523088AA1SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.G0074592SCLA
Administered by: Other     Purchased by: Public
Symptoms: Wrong technique in drug usage process
SMQs:
Write-up: Reconstituted varicella vaccine w/Tdap & gave injection. Contacted dr & he stated child should be fine with on consequence.

VAERS ID:474412 (history)  Vaccinated:2012-11-14
Age:30.0  Onset:2012-11-15, Days after vaccination: 1
Gender:Female  Submitted:2012-11-16, Days after onset: 1
Location:Connecticut  Entered:2012-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Allergy to sulfa drugs, no other conditions
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
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FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1222020IMLA
Administered by: Public     Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Hives on scalp started in the morning. got worse through out the day with treatment of Benadryl, severe all over the body hives when I woke up in the morning on 11/16/12, went to ER, given treatment of prednosone, and Pepcid.

VAERS ID:474456 (history)  Vaccinated:2012-11-14
Age:53.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-11-16, Days after onset: 2
Location:New Mexico  Entered:2012-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None noted
Preexisting Conditions: Codeine allergy
Diagnostic Lab Data:
CDC 'Split Type':
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Dose
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VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H013938 SCRA
Administered by: Other     Purchased by: Private
Symptoms: Headache, Injection site erythema, Injection site inflammation, Pruritus, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: 1st 24 hours-slight fever, itching, headache. Thereafter-red inflammed area at shot location x 48 hours.

VAERS ID:474560 (history)  Vaccinated:2012-11-14
Age:24.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-11-16, Days after onset: 2
Location:New York  Entered:2012-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: No
CDC 'Split Type':
Vaccination
Manufacturer
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Dose
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DPP: DIPHTHERIA TOXOID + PERTUSSIS + IPV (QUATRO VIRELON)NOVARTIS VACCINES AND DIAGNOSTICS  UNLA
Administered by: Unknown     Purchased by: Private
Symptoms: Hyperaesthesia, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Pain immediately after injection, Pain and swelling for 2 days with redness at the site and sensitivity to touch. Taken Tylenol for pain and swelling but no affect. Pain and swelling has gotten worse the past 2 days, not better.

VAERS ID:474592 (history)  Vaccinated:2012-11-14
Age:73.0  Onset:0000-00-00
Gender:Female  Submitted:2012-11-16
Location:Maine  Entered:2012-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Aspirin daily; TRICOR; Lisinopril/HCTZ; Ca++/mg+; Fish oil; glucosamine; multivit.; Vit B, C, D3, E
Current Illness: Was here for yearly CPE
Preexisting Conditions: NKDA; Dyslipidemia; hypertension; fatigue; osteoarthritis; urge incont. - urine; varicose veins; Vit D deficiency
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH759AB IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H012972 IMLA
Administered by: Private     Purchased by: Other
Symptoms: Feeling abnormal, Headache, Pain, Rash erythematous, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Hypersensitivity (narrow)
Write-up: The morning after receiving vacc. she reports feeling "achy, lousy and headachy" - which resolved later in the day. At the end of the day she noticed a bright red, itchy rash on left arm. Comes to office on day 3. Treatment: Antibiotic cephalexin 500mg 1 cap. every 12 hrs x 5days, cool compresses. Watch for worsening s/s.

VAERS ID:474627 (history)  Vaccinated:2012-11-14
Age:42.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-11-16, Days after onset: 2
Location:North Carolina  Entered:2012-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Clonazepam .5 mg at bedtime for RLS; Hctz 20 mg in the AM; Estradiol 1mg at bedtime
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
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Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 19IMRA
Administered by: Unknown     Purchased by: Other
Symptoms: Abdominal pain upper, Back pain, Burning sensation, Chills, Eye irritation, Headache, Neck pain, Oedema peripheral, Pain, Pyrexia, Skin warm, Vaccination complication
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Corneal disorders (broad), Arthritis (broad)
Write-up: Chills initially. 24 hours after the shot: fever 101, severe body pain, headache, stomach pain, neck and back pain, severe eye burning and body felt to be on fire. Arm was very swollen and feverish. This continued 48 hours after the shot. Saw a doctor at Urgent Care today who diagnosed as a reaction to the shot.

VAERS ID:477017 (history)  Vaccinated:2012-11-14
Age:87.0  Onset:2012-11-15, Days after vaccination: 1
Gender:Female  Submitted:2012-11-16, Days after onset: 1
Location:Pennsylvania  Entered:2012-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
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VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H0130230UNRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pt. received ZOSTAVAX on 11-14-12. Niece called 11-16-12 to report/ask about rxn. Woke up at 2 or 3 AM with an itchy, red area at injection site.

VAERS ID:477019 (history)  Vaccinated:2012-11-14
Age:65.0  Onset:2012-11-15, Days after vaccination: 1
Gender:Female  Submitted:2012-11-16, Days after onset: 1
Location:Maine  Entered:2012-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
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Dose
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Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H0126500IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4421AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Erythema, Fatigue, Headache, Pain, Pyrexia, Skin warm
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad)
Write-up: Chills, fever, headache, fatigue, painful, sore, red, hot to touch.

VAERS ID:477024 (history)  Vaccinated:2012-11-14
Age:14.0  Onset:2012-11-15, Days after vaccination: 1
Gender:Female  Submitted:2012-11-16, Days after onset: 1
Location:Maryland  Entered:2012-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
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Dose
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HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB586BA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1561AA0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA110820IMLA
Administered by: Private     Purchased by: Public
Symptoms: Cellulitis, Erythema, Pain in extremity, Skin warm, Tenderness
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: (L) arm pain with area & erythema area tender upon palpation & warm. Diag. cellulitis s/p vaccine admin.

VAERS ID:477028 (history)  Vaccinated:2012-11-14
Age:62.0  Onset:2012-11-15, Days after vaccination: 1
Gender:Female  Submitted:2012-11-15, Days after onset: 0
Location:Iowa  Entered:2012-11-16, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: CITRACAL; OMEGA 3; CO Q 10; Vit K
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
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Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H0133990UNRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B099AA UNLA
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Injection site erythema, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pt. received vaccine on 11-14-12. That evening her arm was sore. The next AM it was fine. Then today, 11-15-12, after work her arm was sore again and area of injection was red. ROCEPHIN 1 gram was given to pt at 5:43 PM (for cellulitis (R) arm).

VAERS ID:474630 (history)  Vaccinated:2012-11-14
Age:1.8  Onset:2012-11-16, Days after vaccination: 2
Gender:Female  Submitted:2012-11-17, Days after onset: 1
Location:Arizona  Entered:2012-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol & ibuprofen
Current Illness: Fever, runny nose, pneumonia, viral illness
Preexisting Conditions:
Diagnostic Lab Data: Haven''t seen the doctor yet, going in the morning. Was told by on call dr to place cold/warm compresses on it every 20 min for 2 hours and call in the morning.
CDC 'Split Type':
Vaccination
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FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMLL
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMLL
Administered by: Private     Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Baseball size welt/hive 1/4 inch away from vaccine site, getting larger as the day goes on.

VAERS ID:474652 (history)  Vaccinated:2012-11-14
Age:57.0  Onset:2012-11-15, Days after vaccination: 1
Gender:Female  Submitted:2012-11-18, Days after onset: 3
Location:Oregon  Entered:2012-11-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nopal Cactus 1000mg; Aleve Allergy Relief 25mg; Meno-Ease herbal supplement; Enteric Coated Aspirin 325 mg
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: I had both the influenza and pneumonia injections in my left arm. This was a first for me getting the pneumonia. By the location of the swelling, I suspect the influenza shot is the one that caused the problems for me.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS66521011510 IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.000064739000IMLA
Administered by: Other     Purchased by: Other
Symptoms: Chills, Erythema, Pain, Pain in extremity, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Began noticing extreme soreness first. Then below the injections redness started first in a couple spots, then enlarged. Afternoon progressed to chills and fever and aches throughout my body. I ended up in bed for most of the next 48 hours. Finally now the evening of 11/17/12 I''m feeling better, though my arm is still very sore. I''ve taken Theraflu, Nyquil, Aleve, Aspirin, Flexeril...

VAERS ID:474657 (history)  Vaccinated:2012-11-14
Age:32.0  Onset:2012-11-15, Days after vaccination: 1
Gender:Female  Submitted:2012-11-18, Days after onset: 3
Location:Ohio  Entered:2012-11-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Multi-vitamin, Zoloft 50mg, oral-contraceptive
Current Illness: None
Preexisting Conditions: Had pneumonia/empyema 2x in early 2012
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
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PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H016283  LA
Administered by: Private     Purchased by: Public
Symptoms: Headache, Injection site erythema, Injection site pain, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Woke up in AM with sore/red spot at injection site, throughout the day pain escalated, along with headache. Took Ibuprofen. Following morning (11/16/2012) whole upper arm was very painful and sore, redness had spread to whole upper arm. Also experienced low grade fever, and nausea, and headache. Visit to Doctor to rule out infection. Redness continued to spread down arm for a few days, as pain diminished.

VAERS ID:477061 (history)  Vaccinated:2012-11-14
Age:71.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-11-18, Days after onset: 4
Location:Florida  Entered:2012-11-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: DM; HPTN
Diagnostic Lab Data: None
CDC 'Split Type':
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Manufacturer
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VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H0139460SYRRA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Erythema, tenderness, swelling at injection site.

VAERS ID:474797 (history)  Vaccinated:2012-11-14
Age:55.0  Onset:2012-11-16, Days after vaccination: 2
Gender:Male  Submitted:2012-11-19, Days after onset: 3
Location:California  Entered:2012-11-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Nut and seed allergies, asthma, spinal disk degenerative disease
Diagnostic Lab Data: None yet but I will now seek medical help
CDC 'Split Type':
Vaccination
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FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEUR  IDLA
Administered by: Public     Purchased by: Other
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Pain of skin
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Note: intradermal flu vaccine given. Pain in injection arm and loss of mobility in at shoulder joint worsening with time up to and including today. Pain is deep in shoulder joint, not just surface/skin pain. I will now seek medical help.

VAERS ID:474831 (history)  Vaccinated:2012-11-14
Age:3.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-11-14, Days after onset: 0
Location:Unknown  Entered:2012-11-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Allergies and asthma including daily use of a 1-FLOVENT twice daily scheduled, 2-daily FLONASE and 3-albuterol emergency inhaler if needed. Premature at birth.
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
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Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AJ2025 IN 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Contraindication to vaccination
SMQs:
Write-up: Public Health Nurse went to local program to administer flu vaccine to children at a flu shot clinic. School nurse gave each parent a IZ consent form and IZ questionnaire to fill out in advance of flu shot clinic visit. Parent of this child wrote down that child did not have asthma on the questionnaire. During flu shot clinic at the program, a child was inadvertently given a single 0.2 ml dose of intranasal MedImmune - lot # AJ 2025 - FLUMIST flu vaccine instead of injectable flu vaccine. This is contraindicated as asthma sufferers are to be given only injectable flu vaccine. PHN contacted parent to request that family watch child for an increased risk of wheezing after the administration of the vaccine. PHN explained that any wheezing or difficulty breathing should be addressed by physician. If severe, child should be taken to the nearest emergency room. Parent said that they would monitor the child closely.

VAERS ID:474982 (history)  Vaccinated:2012-11-14
Age:6.0  Onset:2012-11-15, Days after vaccination: 1
Gender:Male  Submitted:2012-11-15, Days after onset: 0
Location:Ohio  Entered:2012-11-19, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
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Manufacturer
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FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AJ2157 IN 
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Facial redness & swelling.

VAERS ID:474985 (history)  Vaccinated:2012-11-14
Age:38.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-11-19, Days after onset: 5
Location:Idaho  Entered:2012-11-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH719AC0SYRLA
Administered by: Other     Purchased by: Private
Symptoms: Flushing, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: 30 min after injection pt. c/o facial flushing & itching on legs & arms. Denies SOB, nausea or lightheadedness. BENADRYL 50 mg po given. 1 hour after BENADRYL pt. stated she was feeling better. Pt instructed to go to ER if sx worsen.

VAERS ID:477048 (history)  Vaccinated:2012-11-14
Age:4.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-11-19, Days after onset: 5
Location:New Jersey  Entered:2012-11-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
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Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B146AA4IMLL
Administered by: Private     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)
Write-up: Left thigh began swelling and becoming red at the site of vaccine injection several hours after receiving. Seemed much more swollen and red today (11/16/12).

VAERS ID:478331 (history)  Vaccinated:2012-11-14
Age:0.5  Onset:0000-00-00
Gender:Male  Submitted:2012-11-19
Location:Unknown  Entered:2012-11-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA006895
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Interchange of vaccine products, No adverse event
SMQs:
Write-up: This spontaneous report as received from a consumer refers to a 6 months old female patient. The patient was vaccinated with dose 1 of ACTHIB (lot #, dose and route not reported) at 2 months of age (approximately in July 2012). She then switched providers and was vaccinated a first dose of LIQUID PEDVAXHIB (lot #, dose and route not reported) at 4 months (approximately in September 2012) and was vaccinated with a second dose of LIQUID PEDVAXHIB (lot #, dose and route not reported) at 6 months on 14-NOV-2012. The patient''s mother was reporting that she was concerned about the dosing regimen and was worried her daughter had been given too much of the vaccine. She did not mention an AE. Additional information is not expected.

VAERS ID:474999 (history)  Vaccinated:2012-11-14
Age:0.4  Onset:2012-11-15, Days after vaccination: 1
Gender:Male  Submitted:2012-11-20, Days after onset: 5
Location:New Jersey  Entered:2012-11-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: CT Brain - Showed absence of corpus callosum
CDC 'Split Type':
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DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4230AA1IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9182421IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0055AE1PO 
Administered by: Private     Purchased by: Public
Symptoms: Computerised tomogram abnormal, Computerised tomogram head, Congenital central nervous system anomaly, Eye movement disorder, Gaze palsy
SMQs:, Congenital, familial and genetic disorders (narrow), Ocular motility disorders (narrow)
Write-up: 45 sec. episode of rolling of eyeballs. Taken to hospital. Flickering movements of both eyes lasting approx. 15 min. Discharged home on Phenobarbital.

VAERS ID:475241 (history)  Vaccinated:2012-11-14
Age:74.0  Onset:2012-11-15, Days after vaccination: 1
Gender:Male  Submitted:2012-11-16, Days after onset: 1
Location:Arizona  Entered:2012-11-20, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NORVASC; Atenolol; Lovastatin; Hydroxychloroquine; ASA
Current Illness: None
Preexisting Conditions: Heart condition
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
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Dose
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Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4524AA SYRRA
Administered by: Other     Purchased by: Private
Symptoms: Face oedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Shot given 11/14/12 at 3:00 pm, awoke 11/15/12 at 6:00 am with extreme edema of the face. Took 25 mg of BENADRYL 11/15/12 & slept. Still swollen 11/16/12. Spouse reports better 11/16/12.

VAERS ID:475244 (history)  Vaccinated:2012-11-14
Age:34.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-11-16, Days after onset: 2
Location:Alabama  Entered:2012-11-20, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None
Preexisting Conditions: Asthma
Diagnostic Lab Data: Unknown
CDC 'Split Type':
Vaccination
Manufacturer
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Dose
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Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA711BA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Cold sweat, Dizziness, Pallor, Peripheral coldness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Pt participated in health screening, flu vaccination. While being counseled and soon after vaccination, pt became "dizzy". She was pale, cool & clammy. VS 70/40 BP P 76. Pt conscious & obeyed verbal commands. Pt had donated plasma in AM & drank little since pt left. Cool compress to head & neck. Remained conscious & oriented.

VAERS ID:477360 (history)  Vaccinated:2012-11-14
Age:46.0  Onset:2012-11-20, Days after vaccination: 6
Gender:Female  Submitted:2012-11-20, Days after onset: 0
Location:New York  Entered:2012-11-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hydrochlorothiazide; PROTONIX; VASOTEC; LIBRAX; ALESSE
Current Illness: Animal Bite
Preexisting Conditions: HBP; IBBS
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4170AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Vaccine administered on 11/14/12 at 943A to left deltoid. 11/20/12 Red, hard, circular area noted around vaccine administration site with pruritus.

VAERS ID:477367 (history)  Vaccinated:2012-11-14
Age:54.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-11-20, Days after onset: 6
Location:California  Entered:2012-11-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Thyroid; Blood pressure
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H012072 UNLA
Administered by: Other     Purchased by: Other
Symptoms: Hypoaesthesia, Injection site pain, Peripheral coldness
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Pain in arm of inj. site and numb fingers & also cold fingers of same arm after injection (occurred few hrs after vaccine until 11/20/12 current).

VAERS ID:475098 (history)  Vaccinated:2012-11-14
Age:61.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-11-21, Days after onset: 7
Location:Utah  Entered:2012-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H0130210SCLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient reported redness, swelling, itchiness, hard to touch tissue, and burning in arm that vaccine was administered and for 3 days after. She self administered Benadryl, she says that helped with the swelling and is not having any complications currently.

VAERS ID:478483 (history)  Vaccinated:2012-11-14
Age:  Onset:2012-11-14, Days after vaccination: 0
Gender:Unknown  Submitted:2012-11-21, Days after onset: 7
Location:Unknown  Entered:2012-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA008056
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: This spontaneous report as received from a Pharmacy Student refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX on 14-NOV-2012, which expired on 20-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse event was reported. Additional information has been requested.

VAERS ID:475135 (history)  Vaccinated:2012-11-14
Age:12.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-11-24, Days after onset: 10
Location:Michigan  Entered:2012-11-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Novolog insulin
Current Illness: None
Preexisting Conditions: PCN, Diabetic
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRAR
Administered by: Private     Purchased by: Other
Symptoms: Decreased appetite, Injection site pain, Pyrexia, Somnolence, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Appetite gone, fever, sleepy, sore arm site of injection, vomiting.

VAERS ID:478609 (history)  Vaccinated:2012-11-14
Age:67.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-11-25, Days after onset: 11
Location:Unknown  Entered:2012-11-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Omeprazole; FLONASE
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA007053
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1314AA1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Injection site swelling, Oedema peripheral, Pain in extremity
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)
Write-up: This spontaneous report as received from a nurse refers to a 67 years old patient. The patient did not have any drug reactions/allergies. The patient was vaccinated with the first dose of PNEUMOVAX 23 (0.5 ml, Intramuscular, lot # were unknown) in 2009 and the second dose of PNEUMOVAX 23 (0.5 ml, Intramuscular, lot # 671555/1314AA, expiration date was 05-MAY-2013) on 14-NOV-2012. No other co-suspects were reported. Concomitant medications included omeprazole and FLONASE. On 14-NOV-2012 the patient experienced swelling at the injection site after receiving PNEUMOVAX 23 and swelling was moving down toward her right armpit and down to elbow along with pain and redness. Ibuprofen and BENADYRL were given for adverse event. The outcome of event was unknown. The patient had sought unspecified medical attention. Additional information has been requested.

VAERS ID:477531 (history)  Vaccinated:2012-11-14
Age:62.0  Onset:2012-11-15, Days after vaccination: 1
Gender:Female  Submitted:2012-11-23, Days after onset: 8
Location:Massachusetts  Entered:2012-11-26, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Metoprolol; DIOVAN; LEXAPRO; Triamterene/HCTZ; ASA 81mg qd; MIRAPEX; Ibuprofen PRN
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH747AA IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4335AA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Dyspnoea, Fatigue, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth, Malaise, Pain
SMQs:, Anaphylactic reaction (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)
Write-up: Received Tdap vaccine IM (L) deltoid 11/14/12 lump at injection site on 11/15/2012 and not feeling well. Felt achy, short of breath and tired. Small red area at injection site 11/19/12. 11/20/12 Increased redness, swelling, warmth and pain at injection site. Seen emergency room for IV antibiotics.

VAERS ID:478601 (history)  Vaccinated:2012-11-14
Age:  Onset:2012-11-14, Days after vaccination: 0
Gender:Unknown  Submitted:2012-11-26, Days after onset: 12
Location:Unknown  Entered:2012-11-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA006957
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1160AA SCUN
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: Initial information has been received from a registered pharmacist concerning a patient with unspecified age, gender, pertinent medical and drug reactions/allergies, who on 14-NOV-2012, was vaccinated subcutaneously with ZOSTAVAX (lot 1160AA exp date 18-OCT-2012) expired vaccine (dose was not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effect was reported. No treatment information and lab diagnostic studies performed were reported. Additional information has been requested.

VAERS ID:475381 (history)  Vaccinated:2012-11-14
Age:46.0  Onset:2012-11-15, Days after vaccination: 1
Gender:Male  Submitted:2012-11-27, Days after onset: 12
Location:New Hampshire  Entered:2012-11-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None reported
Current Illness: None reported
Preexisting Conditions: None reported
Diagnostic Lab Data: Patient contacted MD. Clinician has left several follow up messages to see outcome. Pt has not returned calls to date.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12053011IMLA
Administered by: Other     Purchased by: Private
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Rash developed in the middle of pts back. By days end the rash had spread across the back with some spots on shoulders and arms. No other symptoms.

VAERS ID:475388 (history)  Vaccinated:2012-11-14
Age:0.2  Onset:2012-11-18, Days after vaccination: 4
Gender:Male  Submitted:2012-11-27, Days after onset: 9
Location:Texas  Entered:2012-11-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: N/a
Diagnostic Lab Data: CBC, urinalysis, etc
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER    
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER    
PER: PERTUSSIS (NO BRAND NAME)EMERGENT BIOSOLUTIONS    
RVX: ROTAVIRUS (NO BRAND NAME)UNKNOWN MANUFACTURER 0PO 
Administered by: Unknown     Purchased by: Other
Symptoms: Bacterial test negative, Diarrhoea, Full blood count, Urine analysis
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Diarrhea every 2-4 hours. Taken to doctor 3 times. Labs were negative for bacteria. Reason for diarrhea could not be explained.

VAERS ID:475506 (history)  Vaccinated:2012-11-14
Age:69.0  Onset:2012-11-15, Days after vaccination: 1
Gender:Female  Submitted:2012-11-28, Days after onset: 13
Location:New York  Entered:2012-11-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lipitor, calcitrate, vitamin D
Current Illness: No
Preexisting Conditions: Allergy to megese
Diagnostic Lab Data: My doctor told me to put a steroid cream on it and use cold compresses. This has not helped.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Private
Symptoms: Feeling hot, Injection site erythema, Pain, Skin swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: BRIGHT RED 6 INCH CIRCLE AROUND PUNCTURE. VERY HOT. PAINFUL. SKIN RAISED.

VAERS ID:475517 (history)  Vaccinated:2012-11-14
Age:0.5  Onset:2012-11-14, Days after vaccination: 0
Gender:Male  Submitted:2012-11-28, Days after onset: 14
Location:Montana  Entered:2012-11-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B090AA0IMRL
Administered by: Unknown     Purchased by: Private
Symptoms: Wrong drug administered
SMQs:
Write-up: Patient was given Tdap (Boostrix) and should have recieved Dtap (Infanrix).

VAERS ID:475656 (history)  Vaccinated:2012-11-14
Age:62.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-11-25, Days after onset: 11
Location:Wisconsin  Entered:2012-11-28, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4531EA0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Chest pain, Myalgia, Nausea, Pruritus
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Had flu vaccine 11/14/12 at 7pm. Later that evening, experienced facial / scalp itching followed by onset of nausea & muscle pain. 11/15/12 = nausea & muscle pain continued, and chest pain.

VAERS ID:477578 (history)  Vaccinated:2012-11-14
Age:48.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-11-19, Days after onset: 5
Location:Mississippi  Entered:2012-11-28, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Sulfa allergy
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV3093IMAR
Administered by: Other     Purchased by: Unknown
Symptoms: Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Headache - severe & low grade fever within 24 hrs had experienced same symptoms with anthrax #3, but was much worse with anthrax #4 vaccination. Resolved by day 2 post injection.

VAERS ID:477595 (history)  Vaccinated:2012-11-14
Age:12.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-11-21, Days after onset: 7
Location:New Hampshire  Entered:2012-11-28, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Amox allergy
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AJ2160 IN 
HPV4: HPV (GARDASIL)MERCK & CO. INC.0131AE1UNRA
Administered by: Private     Purchased by: Unknown
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Vomited 2 x, 2 minutes after vaccine was given.

VAERS ID:475832 (history)  Vaccinated:2012-11-14
Age:43.0  Onset:2012-11-15, Days after vaccination: 1
Gender:Female  Submitted:2012-11-29, Days after onset: 14
Location:Pennsylvania  Entered:2012-11-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED07049221A SYRLA
Administered by: Other     Purchased by: Private
Symptoms: Axillary pain, Mobility decreased, Oedema peripheral, Throat irritation
SMQs:, Cardiac failure (broad), Angioedema (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient awoke next morning with scratchy throat, pain under arm & swelling under armpit. No visible reaction at injection site. Doctor visit after 2 days - pain decreased arm motility returned. Patient given KEFLEX 500 mg 1 QID & ZYRTEC 1 daily.

VAERS ID:475732 (history)  Vaccinated:2012-11-14
Age:26.0  Onset:2012-11-26, Days after vaccination: 12
Gender:Male  Submitted:2012-11-30, Days after onset: 4
Location:Oklahoma  Entered:2012-11-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cephalexin 500mg, ibuprofen 200mg
Current Illness: No, just sore arm
Preexisting Conditions: No
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRLA
Administered by: Unknown     Purchased by: Private
Symptoms: Asthenia, Injection site erythema, Injection site rash, Injection site swelling, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Horrible rash where the shot was given, red and elevated from the skin, three mosquito bite like dots inside the round rash. Mosquito bite like dots all over my back, neck and ears. My body feels very weak.

VAERS ID:476114 (history)  Vaccinated:2012-11-14
Age:38.0  Onset:2012-11-15, Days after vaccination: 1
Gender:Female  Submitted:2012-12-03, Days after onset: 18
Location:Washington  Entered:2012-12-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV3095IMLA
Administered by: Military     Purchased by: Military
Symptoms: Injection site mass, Injection site pain, Injection site rash, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Member states pain heat and hard lump at injection site. Rash developed on left arm and remained for two weeks plus left arm pain.

VAERS ID:476180 (history)  Vaccinated:2012-11-14
Age:6.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-11-14, Days after onset: 0
Location:Idaho  Entered:2012-12-03, Days after submission: 19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': ID12020
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0142711SCUN
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site mass
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 3cm x 3cm redness at injection site with 5 1/2 cm x 5 1/2 cm lump underneath redness - observe - F/U if worsening. May give BENADRYL.

VAERS ID:476266 (history)  Vaccinated:2012-11-14
Age:63.0  Onset:2012-11-20, Days after vaccination: 6
Gender:Female  Submitted:2012-12-03, Days after onset: 13
Location:California  Entered:2012-12-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1439AA0SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Herpes zoster
SMQs:
Write-up: Developed Herpes zoster. Pt was part of varicella exposure at work. Had (+) h/o varicella dz, negative titer. VARIVAX vaccine given pt. developed Herpes Zoster.

VAERS ID:479536 (history)  Vaccinated:2012-11-14
Age:  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-12-03, Days after onset: 19
Location:Unknown  Entered:2012-12-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA011339
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0385AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 14-NOV-2012 at 12:45, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:479596 (history)  Vaccinated:2012-11-14
Age:  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-12-03, Days after onset: 19
Location:Unknown  Entered:2012-12-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA011338
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0385AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 14-NOV-2012 at 12:45, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:479610 (history)  Vaccinated:2012-11-14
Age:  Onset:2012-11-14, Days after vaccination: 0
Gender:Male  Submitted:2012-12-03, Days after onset: 19
Location:Unknown  Entered:2012-12-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA011340
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0385AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 14-NOV-2012 at 13:46, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:476484 (history)  Vaccinated:2012-11-14
Age:18.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-11-15, Days after onset: 1
Location:Michigan  Entered:2012-12-04, Days after submission: 19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None per patient
Current Illness: None per patient
Preexisting Conditions: Epilepsy
Diagnostic Lab Data: None performed
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB523AA0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1745AA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4274AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B088AA IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0109581SCRA
Administered by: Public     Purchased by: Private
Symptoms: Lip swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Client received vaccines at clinic. Client left the clinic showing no signs of swelling. Approx 3-3.5 hours later client noticed swelling on right side of lips. The swelling progressed to left side. Client went to the ER. Per her report she received BENADRYL & "a steroid."

VAERS ID:476489 (history)  Vaccinated:2012-11-14
Age:38.0  Onset:2012-11-19, Days after vaccination: 5
Gender:Female  Submitted:2012-11-20, Days after onset: 1
Location:Massachusetts  Entered:2012-12-04, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PROAIR; ZOLOFT; GEODAN; Gabapentin; Catapres
Current Illness:
Preexisting Conditions: GERD; Mild Asthma
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H01623820SCRA
Administered by: Private     Purchased by: Private
Symptoms: Axillary pain, Lymphadenopathy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Fever, axillary pain and adenopathy.

VAERS ID:479724 (history)  Vaccinated:2012-11-14
Age:  Onset:2012-11-14, Days after vaccination: 0
Gender:Male  Submitted:2012-12-04, Days after onset: 20
Location:Unknown  Entered:2012-12-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA011341
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0385AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 14-NOV-2012 at 22:41, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:477496 (history)  Vaccinated:2012-11-14
Age:70.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-12-10, Days after onset: 26
Location:Illinois  Entered:2012-12-11, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: CLL
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH745AD IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4313AA0IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Chills, Hyperhidrosis, Injection site erythema, Injection site haematoma, Injection site nodule, Injection site pruritus
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: 12/10/12 Pt reports: Right upper arm, reddened x 10 days, knot & bruise at injection site. Left upper arm, large bruise, reddened x 14 days, knot & bruise at injection site; itchy front of left upper arm for 4 weeks. Eve of 11-14-12 chills & sweat x 1.

VAERS ID:477554 (history)  Vaccinated:2012-11-14
Age:41.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-11-14, Days after onset: 0
Location:Colorado  Entered:2012-12-11, Days after submission: 27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDP50908B IMRA
Administered by: Public     Purchased by: Private
Symptoms: Hypoaesthesia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: C/o tingling down arm 10 minutes after vaccine given to patient states she has numbness & tingling down Rt arm to fingertips.

VAERS ID:478012 (history)  Vaccinated:2012-11-14
Age:36.0  Onset:2012-11-16, Days after vaccination: 2
Gender:Female  Submitted:2012-12-13, Days after onset: 27
Location:California  Entered:2012-12-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED12275P  RA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3989AA  LA
Administered by: Public     Purchased by: Other
Symptoms: Incorrect dose administered, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Pt stated she developed rash and itching two days after vaccination and forgot to mention to the nurse she had "tetanus shot" previously after delivery on 7/13/12 and developed rash and itching few days afterwards.

VAERS ID:478240 (history)  Vaccinated:2012-11-14
Age:66.0  Onset:2012-11-15, Days after vaccination: 1
Gender:Female  Submitted:2012-12-10, Days after onset: 25
Location:Oregon  Entered:2012-12-14, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Sore swollen arm~Tetanus Toxoid, adsorbed (no brand name)~UN~0.00~Patient
Other Medications: ALEVE for arthritis
Current Illness:
Preexisting Conditions: DILAUDID; Penicillin
Diagnostic Lab Data:
CDC 'Split Type': OR201220
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHBB260AB0IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH1354 SCLA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4393BA0IMLA
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF)BERNA BIOTECH, LTD30022010PO 
Administered by: Public     Purchased by: Private
Symptoms: Pruritus generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Noted anal itching the night after 1st dose. Continued through all 4 pills. Itching continued in anal area, on (L) palm of hand, (L) sole of foot, and along spine called 12/7/12. Still having the itching but is better. 12/11/12 Most itching has stopped.

VAERS ID:480264 (history)  Vaccinated:2012-11-14
Age:72.0  Onset:2012-11-16, Days after vaccination: 2
Gender:Female  Submitted:2012-12-14, Days after onset: 28
Location:Unknown  Entered:2012-12-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin D (unspecified); omega-3 marine triglycerides; flaxseed; calcium (unspecified); BENADRYL; red yeast
Current Illness: Unknown
Preexisting Conditions: Sulfa
Diagnostic Lab Data:
CDC 'Split Type': WAES1212USA003659
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H013945 SCUN
Administered by: Other     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)
Write-up: This spontaneous report as received from a other health professional refers to a 72 years old female patient. The patient was vaccinated with ZOSTAVAX on 14-NOV-2012. No other co-suspects were reported. Concomitant medications included vitamin D (unspecified), omega-3 marine triglycerides, flaxseed, calcium (unspecified), BENADRYL and red yeast. On 16-NOV-2012 the patient experienced redness, 3 days after onset of therapy and injection site swelling. Patient was treated with Prednisone for events redness and injection site swelling. The outcome of redness and injection site swelling is recovered. The relatedness for redness and injection site swelling is unknown for ZOSTAVAX. No further information was provided.

VAERS ID:478543 (history)  Vaccinated:2012-11-14
Age:49.0  Onset:2012-11-16, Days after vaccination: 2
Gender:Female  Submitted:2012-12-17, Days after onset: 31
Location:Illinois  Entered:2012-12-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA733AA IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Deafness unilateral
SMQs:, Hearing impairment (narrow)
Write-up: Patient has experienced hearing loss to the right ear.

VAERS ID:478580 (history)  Vaccinated:2012-11-14
Age:61.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-12-18, Days after onset: 34
Location:New Jersey  Entered:2012-12-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: CLARINEX; Vitamins (unspecified); Omega-3 marine triglycerides; Glucosamine
Current Illness: Drug hypersensitivity
Preexisting Conditions: Sulfa hypersensitivity
Diagnostic Lab Data: 11/17/2012, Blood test, Normal
CDC 'Split Type': WAES1212USA003786
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED  UNUN
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test normal, Burning sensation, Chest discomfort, Chills, Cough, Rash erythematous, Rash pruritic, Skin warm, Tremor, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: This spontaneous report as received from a consumer refers to a 61-year-old female patient who is allergic to sulfa. Patient had no pertinent medical history. On 14-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and dose were not reported) subdermally. On the same day she also received Influenza Virus Vaccine (manufacturer unknown) (lot number, expiry date, dose and route were not reported). Concomitant medications included CLARINEX, vitamins (unspecified) Over-The-Counter (OTC), fish oil and glucosamine. On 14-NOV-2012, the patient went for swimming as usual and about 2-3 hours she started to experience wheezing, tightness in her chest, trembling, coughing and as well as chills. The symptoms lasted the entire night until the next morning. On 15-NOV-2012, the events wheezing, tightness in her chest, trembling, coughing and chills were resolved. The patient went swimming again 2 days later and the symptoms reappeared about 2-3 hours later. The patient attempted swimming on 2 more occasions and the exact thing appeared. On 03-DEC-2012, the patient went to the allergist and was prescribed VENTOLIN though she had no asthma. The patient reported that every time she went for swimming the same symptoms reappeared. She used VENTOLIN as directed and it only helped a little bit and very temporally. On 07-DEC-2012, about an hour ago of reporting, 08:30 MT (meridian time) the patient noticed a red rash that resembled a sun burn around the front part of her waist. The patient stated that the rash was not raised and was itching and burning and was also hot to touch. Blood work was done on 17-NOV-2012, everything came back normal. The outcome of the reported events were unknown. Patient did not seek medical attention and said she called the doctor and had an appointment on Monday. Additional information has been requested.

VAERS ID:478591 (history)  Vaccinated:2012-11-14
Age:59.0  Onset:2012-11-24, Days after vaccination: 10
Gender:Male  Submitted:2012-12-18, Days after onset: 24
Location:Florida  Entered:2012-12-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Diagnostic Lab Data: Patient had MRI 11/29/12 and Lumbar Puncture to evaluate CSF completed 12/1/12
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA740AA IMLA
Administered by: Other     Purchased by: Other
Symptoms: CSF test, Dysarthria, Dysphagia, Lumbar puncture, Nuclear magnetic resonance imaging, Paraesthesia, Speech disorder, Swollen tongue, VIIth nerve paralysis
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (narrow)
Write-up: Patient presented to ED with left facial droop, slurred speech, difficulty swallowing, speaking, tongue swelling, tingling in hands and feet.

VAERS ID:480374 (history)  Vaccinated:2012-11-14
Age:  Onset:2012-11-14, Days after vaccination: 0
Gender:Unknown  Submitted:2012-12-19, Days after onset: 35
Location:Unknown  Entered:2012-12-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1212USA005858
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 18-JUN-2012, the patient was vaccinated with a first dose of VAQTA 25 U Injection (lot #, dose and route not reported). On 14-NOV-2012, the patient received a second dose of VAQTA 25 U Injection. No other co-suspects were reported. No concomitant medications were reported. The patient received two doses of VAQTA less than 6 months apart. No adverse effects. No additional information provided. Additional information is not expected.

VAERS ID:480442 (history)  Vaccinated:2012-11-14
Age:64.0  Onset:2012-11-21, Days after vaccination: 7
Gender:Female  Submitted:2012-12-20, Days after onset: 29
Location:Unknown  Entered:2012-12-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1212USA006404
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Fatigue, Oedema mouth
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow)
Write-up: This spontaneous report as received via a field representative from a physician refers to a 64 years old female patient. The patient was vaccinated with VAQTA (dose and lot number unknown, intramuscular) on 14-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On 21-NOV-2012 the patient experienced fatigue and swelling of the roof of the mouth which lasted for 10 days, 8 days after onset of therapy. It was further reported that the patient had come from another practice and it was noticed in her records that there were recommendations for her to receive VAQTA in 2/2010 and 8/2010, but the physician had no confirmation that the vaccine was actually administered. No treatment information was reported. The outcome of swelling of the roof of the mouth and fatigue was reported as recovered/resolved. The reporters relatedness for fatigue and swelling roof mouth is unknown for VAQTA. Additional information has been requested.

VAERS ID:479120 (history)  Vaccinated:2012-11-14
Age:91.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-11-18, Days after onset: 4
Location:Indiana  Entered:2012-12-24, Days after submission: 36
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Upon req.
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12064051IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC528B094CD1IMLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site pruritus, Injection site warmth
SMQs:
Write-up: Patient rec. FLUVIRIN in (R) arm on 11/14/12 states arm feels warm, itchy. Has felt this way once rec. shot & still feels this way. Not getting any worse. Also, rec. BOOSTRIX in (L) arm that day - no issues.

VAERS ID:479257 (history)  Vaccinated:2012-11-14
Age:  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-12-26, Days after onset: 42
Location:Ohio  Entered:2012-12-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS123121 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Axillary pain, Back pain, Blood pressure increased, Dizziness, Headache, Hypersensitivity, Malaise, Oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Hypersensitivity to flu vaccine - joints, back and (R) armpit edema/pain malaise, dizziness, headache, elevated blood pressure.

VAERS ID:479772 (history)  Vaccinated:2012-11-14
Age:45.0  Onset:2012-11-22, Days after vaccination: 8
Gender:Male  Submitted:2012-12-28, Days after onset: 36
Location:Missouri  Entered:2012-12-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Glimperide once daily for diabetes control.
Current Illness: No
Preexisting Conditions: Diabetes type 2
Diagnostic Lab Data: Looking into testing... don''t know what to do for it. Advice??
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 1IMLA
Administered by: Other     Purchased by: Private
Symptoms: Injected limb mobility decreased, Injection site pain, Periarthritis
SMQs:, Extravasation events (injections, infusions and implants) (broad), Arthritis (narrow)
Write-up: Frozen shoulder, lack of mobility in left arm... can''t stretch it over my head any more... when stretching, pain radiates through shoulder and down to my elbow and lasts several minutes.

VAERS ID:479795 (history)  Vaccinated:2012-11-14
Age:49.0  Onset:2012-11-15, Days after vaccination: 1
Gender:Female  Submitted:2012-12-30, Days after onset: 45
Location:Ohio  Entered:2012-12-30
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Armour Thyroid
Current Illness: None
Preexisting Conditions: Allergies to aspirins, Allergies to pollens, Hypothyroid
Diagnostic Lab Data: Blood tests, more to be run.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEURUH714AB0IDRA
Administered by: Public     Purchased by: Other
Symptoms: Abdominal discomfort, Blood test, Condition aggravated, Fatigue, Nausea, Palpitations, Pyrexia, Thyroid disorder
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypothyroidism (broad), Hyperthyroidism (broad)
Write-up: Began with low fevers and extremely upset stomach and severe nausea that lasted for 3 days. Then turned to extreme fatigue and heart racing, and now my thyroid is crashing after being stable for past 15 years.

VAERS ID:480141 (history)  Vaccinated:2012-11-14
Age:  Onset:2012-11-14, Days after vaccination: 0
Gender:Unknown  Submitted:2013-01-02, Days after onset: 49
Location:West Virginia  Entered:2013-01-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1212USA009357
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.H015623 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 14-NOV-2012 was vaccinated with an improperly stored dose of PROQUAD (merck) (dose and route unknown), Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient outcome was unknown. Additional information is not expected. This is one of several reports from the same source.

VAERS ID:481821 (history)  Vaccinated:2012-11-14
Age:  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2013-01-17, Days after onset: 64
Location:Unknown  Entered:2013-01-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1301USA007536
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (Lot # not reported) on 09-SEP-2011, second dose of GARDASIL (Lot # not reported) on 14-NOV-2012 and third dose of GARDASIL (Lot # not reported) on 14-JAN-2013. The nurse stated that even though the patient did not adhere to the GARDASIL recommended schedule she had not shown any symptoms of adverse reactions. Additional information has been requested.

VAERS ID:482113 (history)  Vaccinated:2012-11-14
Age:11.0  Onset:2012-11-15, Days after vaccination: 1
Gender:Female  Submitted:2013-01-22, Days after onset: 68
Location:New Jersey  Entered:2013-01-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: N/A
Preexisting Conditions: History of Psoriasis
Diagnostic Lab Data: Motrin as needed; cool compresses to site as needed.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4268AA IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4383AA IMLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Red circle around area of injection (left deltoid). Measure about 2 1/2 inches long by 7cm x 6.5cm - area erythematous; tender to the touch & mildly swollen.

VAERS ID:482306 (history)  Vaccinated:2012-11-14
Age:68.0  Onset:2012-11-15, Days after vaccination: 1
Gender:Female  Submitted:0000-00-00
Location:Unknown  Entered:2013-01-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Bloodwork
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Blood test, Generalised erythema, Pain in extremity, Pruritus generalised, Rash, Rash erythematous, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: A day after receiving the shingles vaccine Pt experienced hot, and painful arm. Around Dec 6th Pt went into see her doctor complaining of a red rash on her stomach. Pt was given Ceftriaxone 1g in the right buttock. Pt. was given LEVAQUIN 500 mg for 5 days. The following day was worse, and went back to the doctor where she was given prednisone. Pt was also given a Rx for a cream for the itching. On Dec 10th Pt. seen CNA, patient was red & itchy from head to toe.

VAERS ID:485132 (history)  Vaccinated:2012-11-14
Age:  Onset:2012-11-19, Days after vaccination: 5
Gender:Male  Submitted:2012-11-21, Days after onset: 2
Location:Wisconsin  Entered:2013-02-20, Days after submission: 91
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: INFLUENZA TEST, 11/19/12
CDC 'Split Type': 2012SE88965
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Other     Purchased by: Other
Symptoms: Influenza, Influenza virus test positive
SMQs:
Write-up: A report has been received from a Pharmacist concerning, male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 14-Nov-2012. The patient experienced POSITIVE INFLUENZA TEST which started on 19-Nov-2012. The outcome of the event of POSITIVE INFLUENZA TEST is unknown. The report was considered to be non-serious. Laboratory values are available.

VAERS ID:485208 (history)  Vaccinated:2012-11-14
Age:3.0  Onset:2012-11-16, Days after vaccination: 2
Gender:Male  Submitted:2012-11-19, Days after onset: 3
Location:Unknown  Entered:2013-02-20, Days after submission: 93
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': 2012SE87783
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AJ2024 IN 
Administered by: Other     Purchased by: Other
Symptoms: Ear disorder, Hyperaesthesia, Irritability, Pyrexia, Rhinorrhoea
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad)
Write-up: A consumer report has been received. The report concerns a 3 year old, Male consumer, who had been receiving Nasal FLUMIST. FLUMIST started on 14-Nov-2012. The patient experienced SENSITIVE EARS, FUSSY, FEVER 103F and RUNNY NOSE which started on 16-Nov-2012. The outcome of the event of SENSITIVE EARS, FUSSY, FEVER 103F and RUNNY NOSE is unknown. The report was considered to be non-serious.

VAERS ID:488827 (history)  Vaccinated:2012-11-14
Age:85.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Michigan  Entered:2013-04-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H0130230UNLA
Administered by: Public     Purchased by: Public
Symptoms: Abnormal behaviour, Atrial fibrillation, Crying, Depressed mood, Hypothyroidism, Injection site swelling, Injection site warmth, Malaise, Vaccination complication
SMQs:, Supraventricular tachyarrhythmias (narrow), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypothyroidism (narrow), Depression (excl suicide and self injury) (narrow)
Write-up: I received the ZOSTAVAX vaccine at the office on November 14, 2012. At first a slight swelling of the left arm (site of injection area) was noted a gradually warmth was felt over a 6-12 hr period. A few days (just before a scheduled appointment with my primary physician I noticed I seemed a little saddened not so obviously so, but I felt "down". At the doctor''s office while awaiting his entrance I shook my head at the nurse''s question of how I felt that I did not feel "well". Dr''s entrance was enough to make me completely silent, looking downward and tearing up very profusely - there was no reason for this behavior and he sat close to me and asked what was the problem - he had never in 17 years ever experienced this person - nor had I ever behaved so unusually. I was finally able to utter that I didn''t feel well that I was sad over what I didn''t know. He advised me to go home lie down and breathe deeply and whole forcibly and to return the next day. At home I began reading over the information sheet that was supplied me at the health clinic as I was vaccinated and realized that I had had a reaction to the vaccination. When I saw Dr and related what I believed had happened he questioned me further and we both agreed that I do seem very sensitive to many medications - ie penicillin, vancomycin, DEMEROL and a host of others. The extra rest and deep breathing and explosive exhalation did aide me but intuitively the understanding of possible reaction to the vaccine seemed the correct answer. I have been diagnosed with atrial fibrillation and have had thyroid cancer with complete recovery but naturally am hypothyroid and require medication for that loss. I believe this "note" will have answered questions # 7, 18, 19 and 21. A year before November 2012 I had a very light case of the shingles which did not produce the "usual" painful after effects that I understand is very common and usual and can last for years. I have no other recollections of the adverse reaction of a "melt down" as I had with the vaccination and have not had any repeat performance since. I don''t feel any further after affects and believe this was just one of those strange occurrences. Dr did not have to prescribe any medication at the time of the occurrence and we are both content to know it was just one of those occurrences - no need to test or prescribe further. If there is further need for information just keep me informed.

VAERS ID:489120 (history)  Vaccinated:2012-11-14
Age:48.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2013-03-15, Days after onset: 120
Location:Unknown  Entered:2013-04-12, Days after submission: 28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Allergies: PCN, FIORINAL, MECLOMEN, Cortisone
Diagnostic Lab Data: 11/21/12, ER visit; 12/19/12, pathology, Urticaria vs Serum Sickness; 01/07/13, clinical lab; 01/22/2013, MRI, Lumbar; 01/25/13, clinical lab, DX 686.9; 01/29/13, Bacterial infection; 03/18/13, EMG; MRI of left thigh to be scheduled
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS  SYRUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Back pain, Bacterial infection, Bacterial test positive, Disorientation, Dizziness, Electromyogram, Eye pain, Gait disturbance, Headache, Intervertebral disc protrusion, Muscle spasms, Nuclear magnetic resonance imaging spinal, Pain in extremity, Pathology test, Rash, Sleep disorder
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: 11/14/12 I was given the flu vaccine by a nurse at my corporate office approximately 30 minutes from my office -off site-. After returning to my office, I became weak, disoriented and immediately went to my desk and sat in my chair. Upon sitting, my back seized up, spasms, then severe cramps -much like back labor- and then sharp, shooting pain ran from the right to the left side of my back. Immediately following those pains traveled down my left leg thigh then went to the right. This lasted for about half an hour. I left work and went home, took muscle relaxers and slept on and off for the next couple days. However, the sharp, shooting pain continued and woke me from my sleep throughout the day and night. I suffered a headache similar to a spinal headache. My eyes were also sore and hurt, no drops even touched those symptoms. I also suffered from lightheadedness. There has been no medication, treatment that has touched my pain or even managed my condition. I have a rash on my left that developed two or three days after receiving the vaccine. This rash goes into remission and will redevelop. I''ve not had any of these symptoms prior to the flu shot, all of this has occurred because of the flu shot. My main symptoms and/or complaints are the pain in my leg and my back. It is documented that I have three bulging discs that have developed since the vaccine; L3. 4. 5. There are days when I struggle to walk because the pain in my left leg is debilitating; however, it is intermittent.

VAERS ID:492902 (history)  Vaccinated:2012-11-14
Age:12.0  Onset:0000-00-00
Gender:Male  Submitted:2013-05-28
Location:Florida  Entered:2013-05-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1305USA011697
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER 1IMRA
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC. 0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMRA
Administered by: Private     Purchased by: Public
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported) and PEDVAXHIB (Lot number, expiry date, route and dose were not reported). Certified medical assistant reported that both vaccines were exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reports. Follow-up received. Certified medical assistant stated other 104 children received GARDASIL and other 18 children received PEDVAXHIB. Follow up information has been received from the certified medical assistant regarding a 12 years old, male patient with no pertinent medical history reported. On 14-NOV-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). Other suspect therapies included the first dose of PEDVAXHIB (lot number and expiration date not reported) administered on 14-NOV-2012 (intramuscular on the left arm, dose not reported). Concomitant therapies included the second dose of Hep A vaccine (manufacturer unknown) (intramuscular on the right arm, second dose) on 14-NOV-2012. It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.

VAERS ID:495356 (history)  Vaccinated:2012-11-14
Age:  Onset:2012-11-27, Days after vaccination: 13
Gender:Female  Submitted:2013-06-26, Days after onset: 210
Location:California  Entered:2013-06-28, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVITRA
Current Illness:
Preexisting Conditions: The subject had relevant medical history of elevated Troponin (start date 26 November 2012) and chest pressure (start date 14 November 2012).
Diagnostic Lab Data: ECG was normal on 26 November 2012 and 29 November 2012.
CDC 'Split Type': 201306828
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEUR   LA
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chest discomfort, Electrocardiogram normal, Injection site pruritus, Troponin increased, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow)
Write-up: Initial report was received 17 January 2013 with follow-up information received on 05 June 2013. This report was initially received by a company representative, however was not received by the Global Pharmacovigilance Department until 05 June 2013. A female subject (age and date of birth not reported) had received ACAM2000, Typhoid (manufacturer unknown), Anthrax (other manufacturer), Hepatitis A (other manufacturer) vaccines on 14 November 2012 and 13 days later on 27 November 2012, she developed possible myopericarditis of mild severity. The subject had relevant medical history of elevated troponin (start date 26 November 2012) and chest pressure (start date 14 November 2012). According to the investigator, "otherwise healthy subject with exercise associated mild chest pressure with onset date of vaccine and continuing 14 days." Concomitant therapies consisted of "LEVITRA" as an "oral contraceptive" beginning 20 November 2012. On 26 November 2012, rapid Troponin and preliminary ECG were normal, however, lab troponin was 0.11 ng/mL (mild) and the subject was referred for care. Follow-up troponin on 29 November 2012 was normal (less than 0.10 ng/mL) and ECG report was normal. During this office visit, the subject reported her last episode of chest pressure occurred on 28 November 2012. The subject also experienced a nonserious event of mild itching and burning at the smallpox vaccine site (left arm) beginning 16 November 2012 (listed as ongoing at the time of the report, stop date not reported). Outcome for the event of possible myopericarditis was recovered on 29 November 2012. According to the investigator, the event of possible myopericarditis was probably related to the study product.

VAERS ID:516811 (history)  Vaccinated:2012-11-14
Age:85.0  Onset:2013-11-17, Days after vaccination: 368
Gender:Female  Submitted:2013-12-17, Days after onset: 30
Location:Vermont  Entered:2013-12-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxine, nifedipine XL, Diovan-hct, Aleve, docusate, aspirin, senna, occuvite preservation oral
Current Illness: No
Preexisting Conditions: Hypothyroidism, hypertension
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.J007211 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster, Papule
SMQs:
Write-up: Herpes zoster rash which fully erupted on 11/17/13; there were a few skin papules present the day after vaccine.

VAERS ID:521567 (history)  Vaccinated:2012-11-14
Age:69.0  Onset:2013-12-30, Days after vaccination: 411
Gender:Female  Submitted:2014-02-03, Days after onset: 35
Location:Virginia  Entered:2014-02-03
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATIVAN; ACTOS; BENICAR; CRESTOR; LEXAPRO; LANTUS
Current Illness: Drug hypersensitivity; Blood cholesterol increased; Hypertension; Diabetes mellitus
Preexisting Conditions: Erythromycin, Drug hypersensitivity
Diagnostic Lab Data:
CDC 'Split Type': WAES1401USA014476
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SYRAR
Administered by: Other     Purchased by: Other
Symptoms: Mobility decreased, Pain, Rash
SMQs:, Anaphylactic reaction (broad), Parkinson-like events (broad), Hypersensitivity (narrow)
Write-up: This spontaneous report was received from a 70 year old female patient with diabetes, high blood pressure, high cholesterol and erythromycin allergy who was reporting on herself. On 12-NOV-2012 the patient was vaccinated with a dose of ZOSTAVAX injection (route, strength, lot number and expiration date not provided). Concomitant therapies included ATIVAN, ACTOS, BENICAR, CRESTOR, LEXAPRO and LANTUS. On 30-DEC-2013 the patient developed a rash and pain after receiving the ZOSTAVAX vaccine. The patient reported that this rash developed on her neck, right shoulder, right arm and all the way down to her right hand and thumb. The patient then reported that on 30-DEC-2013 she has lost almost all of the mobility in her right hand and right arm. The patient reported that she can''t lift any thing with her right arm. The patient saw the doctor. The outcome of events was not reported. The relatedness between vaccination with ZOSTAVAX and events was not reported. Upon internal review the event of patient''s decreased mobility was considered to be disabling. Additional information has been requested.

VAERS ID:474293 (history)  Vaccinated:2012-11-15
Age:15.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Male  Submitted:2012-11-15, Days after onset: 0
Location:Pennsylvania  Entered:2012-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: Blood sugar 92
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH13542 SCLA
TD: TD ADSORBED (DITANRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B080AA IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0260AE1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Blood glucose normal, Dizziness, Muscle tightness, Presyncope
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Vasovagal episode - on administration of VZV, Tdap and Polio immunizations had sudden feeling of lightheadedness and tensing of muscles. Blood pressure was 83/41 automatic, 90/52 manual, pulse 60, Resps 20, O2 saturation 100% and blood sugar 92.

VAERS ID:474295 (history)  Vaccinated:2012-11-15
Age:21.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-11-15, Days after onset: 0
Location:Maryland  Entered:2012-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
JEV1: JAPANESE ENCEPHALITIS (IXIARO)INTERCELL AGJEV11C83E1IMRA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Eye movement disorder, Loss of consciousness, Pain in extremity, Urinary incontinence
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Within 15 seconds of receiving the vaccination pt c/o severe pain in arm and stated she felt like she was going to pass out. Loc for 10-15 seconds. Rapid eye movement observed and pt had loss of bladder control.

VAERS ID:476871 (history)  Vaccinated:2012-11-15
Age:64.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-11-15, Days after onset: 0
Location:Washington  Entered:2012-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: DM; Hyperlipidemia; DA
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H0109161UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4421AA0UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Vaccine given at 0824 on 11/15/12 in (R) deltoid at about 10 am pt started getting sore arm & redness at site at about 3pm pt presented back to clinic with painful, swollen (R) deltoid, limited ROM (90 degrees abduction). Treated with ice/TYLENOL good relief of pain still limited ROM VSS: 131/95 T-99.6 P 100. Sent home with ice pack, TYLENOL, MOTRIN.

VAERS ID:476937 (history)  Vaccinated:2012-11-15
Age:4.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-11-15, Days after onset: 0
Location:Iowa  Entered:2012-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MIRALAX PRN
Current Illness: None reported
Preexisting Conditions: Syndactyly; Polydactyly
Diagnostic Lab Data: HR; BP; Pulse ox
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B221BC0IMLA
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.H0157851SCRA
Administered by: Private     Purchased by: Private
Symptoms: Eyelid oedema, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow)
Write-up: 30 minutes after receiving immunizations patient developed severe hives, puffy eyes, itching. Patient returned to clinic received BENADRYL, ORAPRED, monitoring of HR, BP and pulse ox. No respiratory involvement. ARNP also consulted & allergist. Patient monitored in clinic for 2 hours.

VAERS ID:474414 (history)  Vaccinated:2012-11-15
Age:21.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Male  Submitted:2012-11-16, Days after onset: 1
Location:Texas  Entered:2012-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM110821IMLA
Administered by: Public     Purchased by: Private
Symptoms: Discomfort, Erythema, Paraesthesia, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Client given Menveo vaccine in left deltoid on yesterday. Today has Approx. 4inchX5inch Swollen, Red, Warm to touch, with discomfort 6 on scale 1-10. Left hand tingling.

VAERS ID:474579 (history)  Vaccinated:2012-11-15
Age:0.2  Onset:2012-11-15, Days after vaccination: 0
Gender:Male  Submitted:2012-11-16, Days after onset: 1
Location:California  Entered:2012-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: None.
Diagnostic Lab Data: Calling mom to find out how baby is doing, 24 hours after receiving the vaccination, infant is doing ok.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4049AA0IMRL
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC52BA1IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH573AA0IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH13400UNLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0182AE0PO 
Administered by: Other     Purchased by: Public
Symptoms: No adverse event, Wrong drug administered
SMQs:
Write-up: No adverse events. Inadvertantly given Pentacel, IPV, HIB.

VAERS ID:474581 (history)  Vaccinated:2012-11-15
Age:82.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-11-16, Days after onset: 1
Location:Illinois  Entered:2012-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Benezepril 10mg, Paxil 10mg
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER21041962 IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.4739 IMRA
Administered by: Public     Purchased by: Public
Symptoms: Axillary pain, Chills, Pain
SMQs:
Write-up: Got chills, soreness not so much at injection site, which is considered normal, but very sore underneath upper arm. Painful to raise right arm.

VAERS ID:474594 (history)  Vaccinated:2012-11-15
Age:2.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Female  Submitted:2012-11-16, Days after onset: 0
Location:Indiana  Entered:2012-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH719AA3IMRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 8 1/2 x 7 cm swelling, pain right upper arm.

VAERS ID:474625 (history)  Vaccinated:2012-11-15
Age:34.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-11-16, Days after onset: 1
Location:California  Entered:2012-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Prilosec, Tramadol, Augmentin, Motrin, Tylenol and employee does not remember the name of a nausea medication she takes as needed for migraines
Current Illness: None
Preexisting Conditions: History of intestinal reaction when ingesting eggs
Diagnostic Lab Data: Prescribed prednisone and Benadryl by ER physician.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH712AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Oropharyngeal discomfort, Pruritus
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad)
Write-up: Employee states she had "discomfort swallowing and itching to chest and face".

VAERS ID:477009 (history)  Vaccinated:2012-11-15
Age:0.7  Onset:2012-11-16, Days after vaccination: 1
Gender:Female  Submitted:2012-11-16, Days after onset: 0
Location:California  Entered:2012-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: At clinic child initially floppy, sleepy, started to become alert then shook briefly & tightened hands
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4223AA1UNLL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0293AE2UNRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHF709961UNRL
Administered by: Public     Purchased by: Public
Symptoms: Dyskinesia, Hyporesponsive to stimuli, Hypotonia, Somnolence, Tremor
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dyskinesia (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Early in day after vaccines child''s eyes were droopy, mother put child in bed, child''s eyes slightly open but not responding as normal - ie no smiles when grandmother walked in after mother left room grandmother saw baby trembling for approximately 2-3 minutes.

VAERS ID:474635 (history)  Vaccinated:2012-11-15
Age:67.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Female  Submitted:2012-11-17, Days after onset: 1
Location:Tennessee  Entered:2012-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDPS0608 IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1418AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness, swelling, and pain at injection site.

VAERS ID:474642 (history)  Vaccinated:2012-11-15
Age:11.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Female  Submitted:2012-11-17, Days after onset: 1
Location:Connecticut  Entered:2012-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Reaction~Influenza (Seasonal) (no brand name)~UN~0.00~Patient
Other Medications: None
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Red, swollen, hot to the touch area around injection site. Large part of upper arm affected. Sore and tender.

VAERS ID:474644 (history)  Vaccinated:2012-11-15
Age:5.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Male  Submitted:2012-11-17, Days after onset: 1
Location:Utah  Entered:2012-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: seizure~Hib (no brand name)~4~2.50~Patient|seizure~Hep A (no brand name)~1~2.50~Sibling
Other Medications: None
Current Illness: None
Preexisting Conditions: Peanut allergies
Diagnostic Lab Data: Unknown at this time since I am going to be taking him to the E.R (waiting for a ride at this time.)
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER 4UNRA
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER 3UNRA
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site warmth, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: He had a bad fever upon waking on 11/16/2012 AND his arm where he was injected was VERY hot to the touch. I assumed it would go away, but its still hot, minus the fever now. I believe he ALSO had a seizure and fever after one of his other shots he got when he was 2 yrs old & took an ambulance ride to the E.R..although I never reported THAT incident. I will be taking him to the E.R today to have his arm looked at for the shot he got 2 days ago.

VAERS ID:474645 (history)  Vaccinated:2012-11-15
Age:63.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-11-17, Days after onset: 2
Location:California  Entered:2012-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: No symptoms until 4 hours after vaccination per pt
Preexisting Conditions: Penicillin
Diagnostic Lab Data: Patient''s primary care physician is to follow up with patient 11/16/12
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDP50608 IMLA
Administered by: Other     Purchased by: Private
Symptoms: Dysphagia, Throat irritation
SMQs:, Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad)
Write-up: Patient had trouble swallowing and itchy throat but was fine after 2 hours.

VAERS ID:477011 (history)  Vaccinated:2012-11-15
Age:69.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Female  Submitted:2012-11-17, Days after onset: 1
Location:Florida  Entered:2012-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Tetracycline
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0567AE SCLA
Administered by: Other     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Redness, itchiness and very warm at injection site.

VAERS ID:474655 (history)  Vaccinated:2012-11-15
Age:4.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Male  Submitted:2012-11-18, Days after onset: 2
Location:Texas  Entered:2012-11-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER    
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Private
Symptoms: Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: High fever (102 by 10:30 AM up to 104 by 11:30 AM). Patient vomited at 3:00 PM. Administered Tylenol and was able to reduce fever. Fever returns to as high as 104 when medicine wears off and he has vomited 3 times between 11/15/2012 and this morning 11/18/2012. He has not fully recovered yet.

VAERS ID:474751 (history)  Vaccinated:2012-11-15
Age:56.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Female  Submitted:2012-11-18, Days after onset: 2
Location:Rhode Island  Entered:2012-11-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Singulair; Azelastine eye drops; Azelastine nasal spray; Fluticasone Proprionate nasal spray
Current Illness: None
Preexisting Conditions: Allergies to sulfa drugs, dust, mites, mold, tobacco, pollen; Von Willebrand''s Disease
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS665210115 IMLA
Administered by: Other     Purchased by: Private
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Dyspnoea, Fatigue, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow)
Write-up: Muscle aches in chest, some difficulty breathing, progressed next day to fatigue, fever, weakness, diarrhea, loss of appetite for 48 hours.

VAERS ID:474766 (history)  Vaccinated:2012-11-15
Age:4.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Male  Submitted:2012-11-19, Days after onset: 4
Location:New York  Entered:2012-11-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B213BA0IMRA
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH759AA IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0648AE1SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0155591SCRA
Administered by: Other     Purchased by: Other
Symptoms: Abdominal discomfort, Anaphylactic reaction, Eyelid oedema, Lacrimation increased, Lip swelling, Swollen tongue, Tachycardia, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Lacrimal disorders (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow)
Write-up: 5-10 minutes developed anaphylaxis: Eye wateriness, puffiness. Abdominal discomfort. Hives. Swollen lips/tongue. Tachycardia. Given epinephrine and BENADRYL.

VAERS ID:474842 (history)  Vaccinated:2012-11-15
Age:16.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Female  Submitted:2012-11-19, Days after onset: 3
Location:Michigan  Entered:2012-11-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin
Current Illness: Obesity
Preexisting Conditions: Allergic rhinitis; urticaria; hyperinsulinism; fatty liver; dyslipidemia
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH721AD IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM120130IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Lip swelling, Oedema peripheral, Swollen tongue
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Patient experienced swelling and redness of (L) arm beginning about 12 hours after vaccination; she also experienced some lip and tongue swelling within a few days.

VAERS ID:474926 (history)  Vaccinated:2012-11-15
Age:20.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Male  Submitted:2012-11-19, Days after onset: 4
Location:Michigan  Entered:2012-11-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Tramadol
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: Abnormal EEG; Normal CT brain and labs
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH719AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4327AA0IMRA
Administered by: Unknown     Purchased by: Private
Symptoms: Computerised tomogram head, Computerised tomogram normal, Convulsion, Electroencephalogram abnormal, Laboratory test normal
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Seizure.

VAERS ID:474931 (history)  Vaccinated:2012-11-15
Age:3.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Female  Submitted:0000-00-00
Location:Pennsylvania  Entered:2012-11-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Ultrasound (L) UE 11/18/12 - negative
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH745AA2IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Ultrasound scan normal
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Received flu shot 11/15/12. Began with (L) arm swelling, erythema & warmth 11/16/12 --$g put on KEFLEX. Redness continued to spread 11/17/12 & changed to BACTRIM. Admitted to hospital 11/17/12 for IV antibiotics & SOLUMEDROL. Unclear if infectious or allergic reaction. Allergy felt it was non infectious & just upper extremity swelling secondary to immunization.

VAERS ID:474932 (history)  Vaccinated:2012-11-15
Age:29.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Male  Submitted:2012-11-19, Days after onset: 3
Location:Virginia  Entered:2012-11-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: ACID REFLUX
Diagnostic Lab Data: NONE
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED06449211A IMLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site haematoma, Injection site swelling
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: EXCESSIVE INJECTION SITE BRUISING (APPROXIMATELY 4 INCHES IN DIAMETER WITH NOTICEABLE SWELLING).

VAERS ID:477040 (history)  Vaccinated:2012-11-15
Age:67.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Female  Submitted:2012-11-19, Days after onset: 3
Location:California  Entered:2012-11-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Pt. had allergic rx to ROCEPHIN injection
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H0125180SCUN
Administered by: Other     Purchased by: Private
Symptoms: Administration site infection, Injection site erythema, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Administered site had redness, itchiness, swollen from the next day she got infection.

VAERS ID:474964 (history)  Vaccinated:2012-11-15
Age:0.3  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-11-20, Days after onset: 5
Location:Kansas  Entered:2012-11-20
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: CSF had WBC of 21 with RBC of 54. Blood, urine and CSF cultures were negative. MRI showed findings consistent with HIE involving cerebral hemispheres but sparing basal ganglia, cerebellum, brainstem and medial temporal lobes. EEG showed signs of severe encephalopathy.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B370BA0IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH624A10IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF92473 IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0277AE0PO 
Administered by: Public     Purchased by: Unknown
Symptoms: Blood culture negative, CSF culture negative, CSF white blood cell count increased, Convulsion, Culture urine negative, Dyskinesia, Electroencephalogram abnormal, Gaze palsy, Hypoxic-ischaemic encephalopathy, Nuclear magnetic resonance imaging brain abnormal, Opisthotonus, Posture abnormal, Red blood cells CSF positive, Status epilepticus
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Ischaemic cerebrovascular conditions (narrow), Convulsions (narrow), Dyskinesia (narrow), Dystonia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: Mother noticed pt to have head turning to the left and rhythmic kicking movements @ 5:30 p.m. which were self resolved. Throughout that night she had 2 more episodes consisting of arm raising, back arching, leg kicking and leftward gaze. She was taken to her PCP on 11/16 found to be seizing, sent to local ED for stabilization of status epilepticus.

VAERS ID:474968 (history)  Vaccinated:2012-11-15
Age:2.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Male  Submitted:2012-11-20, Days after onset: 4
Location:Wisconsin  Entered:2012-11-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4531BA IM 
Administered by: Unknown     Purchased by: Other
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: awoke with redness, swelling in am, by later in day redness and swelling had grown to 2 inches in diameter, warm to touch. seen in urgent care, given cephalexin for cellulitis

VAERS ID:475251 (history)  Vaccinated:2012-11-15
Age:26.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-11-16, Days after onset: 1
Location:Illinois  Entered:2012-11-20, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None stated
Current Illness: None stated
Preexisting Conditions: None stated
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH716AC IMLA
Administered by: Public     Purchased by: Public
Symptoms: Chills, Diarrhoea, Injection site erythema, Injection site pain, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Injection site moderate tenderness. Injection site moderate erythema. Mild fever with chills. Vomiting - onset at 2 hours- diarrhea onset at 2 hours lasting $g 12 hours.

VAERS ID:475086 (history)  Vaccinated:2012-11-15
Age:48.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-11-21, Days after onset: 6
Location:Utah  Entered:2012-11-21
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: This will have to come from the hospital and my Doctor who did not order this for me post-op. This was a hospital protocol and PNEUMOVAX 23 was suggested due to my asthma. I am an RN, but not for this hospital. The nurse did not give me a V
Current Illness: Post operative patient
Preexisting Conditions: Allergies to Septra, NSAIDS Diagnoses: Asthma, Hashimoto''s Disease
Diagnostic Lab Data: CT scan with Contrast of surgical site, no indication of surgical problems. Blood Cultures Day 2 and Day 3, negative to 72 hrs. Chest Xray day 4, normal. Urinalysis negative Day 2, negative to 72 hours.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC. 0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Blood culture negative, Chest X-ray normal, Computerised tomogram normal, Nausea, Pyrexia, Respiratory distress, Urine analysis normal, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: Nausea Vomiting Day 1, fever started 11:30 PM, Hives began Day 3, Respiratory Distress night of Day 3, Nausea now subsiding, Hives and Respiratory distress are still going on.

VAERS ID:475092 (history)  Vaccinated:2012-11-15
Age:53.0  Onset:2012-11-18, Days after vaccination: 3
Gender:Female  Submitted:2012-11-21, Days after onset: 3
Location:Nevada  Entered:2012-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxine
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Private
Symptoms: Dizziness, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Woke up very dizzy, headache, fever. Lasted two days.

VAERS ID:475102 (history)  Vaccinated:2012-11-15
Age:51.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-11-21, Days after onset: 6
Location:Nevada  Entered:2012-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Motrin
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: EKG
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA691BA1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Electrocardiogram, Heart rate increased, Sinus tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow)
Write-up: Stated rapid heart rate, sinus tachycardia 105/min.

VAERS ID:475152 (history)  Vaccinated:2012-11-15
Age:4.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Male  Submitted:2012-11-21, Days after onset: 6
Location:Pennsylvania  Entered:2012-11-21
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis; Asthma; Cleft palate; Cerebral ventricle dilatation
Preexisting Conditions: Brain neoplasm; 06/09/2009, influenza virus vaccine (unspecified), No reaction on previous exposure to drug; 06/09/2009, M-M-R II, No reaction on previous exposure to drug, The patient received influenza virus vaccine (unspecified) (Manufacturer by Sanofi) in the past with no problems.; 06/09/2009, VARIVAX, No reaction on previous exposure to drug, The patient received VARIVAX, M-M-R II and influenza virus vaccine (unspecified) (Manufacturer by Sanofi) in the past with no problems.
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA007452
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR  UNUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.H0119071UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0131821SCUN
Administered by: Other     Purchased by: Other
Symptoms: Abnormal behaviour, Anaphylactic reaction, Breath sounds abnormal, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypersensitivity (narrow)
Write-up: This spontaneous report as received from a healthcare worker (also reported as office administrator) refers to a 4 years old male patient with cerebral ventricular shunt, cleft palate, asthma and prophylaxis and a medical history of history of brain tumor and no drug reactions or allergies. On 09-JUN-2009, dose 1 M-M-R II (dose, route and lot # not reported) and on 15-NOV-2012, dose 2 M-M-R II (lot # H011907 exp: 03-JUL-2014) (dose and route not reported). Other suspect therapies included, on 09-JUN-2009, the patient was vaccinated subcutaneously with dose 1 VARIVAX (Merck) (dose and lot # not reported). On 15-NOV-2012, the patient was vaccinated subcutaneously with dose 2 VARIVAX (Merck) (lot # H013182 exp: 05-JUL-2014) (dose not reported), and on 15-NOV-2012 influenza virus vaccine (unspecified) (Manufacturer by Sanofi). No concomitant medications were reported. The office administrator stated that on 15-NOV-2012, a patient had an anaphylaxis reaction. The patient''s mother and patient left the office and was in the parking lot when the patient''s mother called to say the patient was not acting correct. The patient was brought back into the office and had multiple episodes of vomiting, broke out in urticaria, and experienced diminished breath sounds bilateral. The patient was sent to the emergency room by ambulance. The patient received VARIVAX (Merck), M-M-R II and influenza virus vaccine (unspecified) (Manufacturer by Sanofi) in the past with no problems. The patient ate eggs on the morning of 15-NOV-2012 with no problems. The patient was put on treatment with intramuscular EPIPEN; BENADRYL; nebulizer of albuterol and supplemental oxygen. The outcome of anaphylaxis reaction was reported as recovered/resolved on 15-NOV-2012. The relatedness for all adverse events was unknown for M-M-R II, influenza virus vaccine (unspecified) and VARIVAX (Merck). All events were considered to be disabling and life threatening and medically significant by the reporter. Additional information has been requested.

VAERS ID:475153 (history)  Vaccinated:2012-11-15
Age:4.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Female  Submitted:2012-11-20, Days after onset: 4
Location:Texas  Entered:2012-11-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: 5 days of fever; headache
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4154BA3IMRA
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH752AA2IMRA
HIBV: HIB (ACTHIB)SANOFI PASTEURUH576AA2IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH133013IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0288AE1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0120431SCLA
Administered by: Public     Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:
Write-up: None stated.

VAERS ID:475192 (history)  Vaccinated:2012-11-15
Age:68.0  Onset:2012-11-20, Days after vaccination: 5
Gender:Female  Submitted:2012-11-21, Days after onset: 1
Location:Nevada  Entered:2012-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pancreatic cancer
Preexisting Conditions:
Diagnostic Lab Data: Nonspecific skin erupt neg; Drug allergy
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETHG150751IMLA
Administered by: Private     Purchased by: Private
Symptoms: Drug hypersensitivity, Injection site erythema, Injection site pain
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: 6cm x 8cm red, erythematous skin over (L) deltoid area where PREVNAR given. Min. tender to palpation. No skin breakdown.

VAERS ID:475197 (history)  Vaccinated:2012-11-15
Age:16.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-11-19, Days after onset: 4
Location:Texas  Entered:2012-11-21, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Syncope~Influenza (Seasonal) (Fluzone)~1~15.00~Patient|Syncope~HPV (Gardasil)~1~15.00~Patient
Other Medications:
Current Illness: Conjunctivitis
Preexisting Conditions: None known drug allergies
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH752AA1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0106641IMRA
Administered by: Private     Purchased by: Public
Symptoms: Convulsion, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Syncopal episode, convulsions (rule out seizure disorder). Patient was sent to ER via ambulance.

VAERS ID:477343 (history)  Vaccinated:2012-11-15
Age:0.4  Onset:2012-11-18, Days after vaccination: 3
Gender:Female  Submitted:2012-11-20, Days after onset: 2
Location:Washington  Entered:2012-11-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B351BA1IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH614AA1IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHF657331IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 1PO 
Administered by: Private     Purchased by: Private
Symptoms: Diarrhoea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Vomiting, diarrhea (moderately severe) 3d after vaccine managed conservatively.

VAERS ID:477348 (history)  Vaccinated:2012-11-15
Age:59.0  Onset:0000-00-00
Gender:Female  Submitted:2012-11-21
Location:Georga  Entered:2012-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Losartan/HCTZ; FLEXERIL; ALLEGRA'' NAPROSYN
Current Illness: None
Preexisting Conditions: HTN; Allergies
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4137AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Swelling, redness, achiness.

VAERS ID:477369 (history)  Vaccinated:2012-11-15
Age:14.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Male  Submitted:2012-11-21, Days after onset: 5
Location:New Jersey  Entered:2012-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA007495
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Ageusia
SMQs:, Taste and smell disorders (narrow)
Write-up: This spontaneous report as received from a physician refers to a 14 years old male patient with no drug reactions or allergies and no pertinent medical history. On 15-NOV-2012, the patient was vaccinated with dose 1 GARDASIL (dose, route and lot # not provided). Other suspect therapies included on 15-NOV-2012 Influenza Virus Vaccine (manufacturer unknown). No concomitant medications were reported. The physician stated that on 15-NOV-2012, a patient, who was administered his first dose of GARDASIL as well as Influenza Virus Vaccine (manufacturer unknown), developed loss of taste on 16-NOV-2012. No treatment has been prescribed at the time of the report. The patient sought medical attention by physician office visit. No treatment for the adverse event was given. Laboratory and diagnostics were not performed. The outcome of loss of taste was reported as not recovered/not resolved. The relatedness for loss of taste was unknown for GARDASIL and Influenza Virus Vaccine (manufacturer unknown). Additional information has been requested.

VAERS ID:477371 (history)  Vaccinated:2012-11-15
Age:  Onset:2012-11-15, Days after vaccination: 0
Gender:Unknown  Submitted:2012-11-21, Days after onset: 6
Location:Utah  Entered:2012-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA007121
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Private     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with dose 1, .5 ml GARDASIL on 19-APR-2012 and with dose 2 on 15-NOV-2012. No adverse event was reported. No other co-suspects were reported. No concomitant medications were reported. Additional information has been requested.

VAERS ID:478402 (history)  Vaccinated:2012-11-15
Age:1.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Unknown  Submitted:2012-11-22, Days after onset: 7
Location:Colorado  Entered:2012-11-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA008349
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  UNUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: This spontaneous report was received from a physician regarding a 12 months old infant. The physician reported that an unspecified 12 month old infant was vaccinated with a dose of PNEUMOVAX23 (lot#, expiry, route and dose not reported) on 15-NOV-2012. On the same day on 15-NOV-2012, the patient was concomitantly vaccinated with a dose of M-M-R II (lot# and expiry not reported), VARIVAX (lot# and expiry not reported) and ROTATEQ (Oral) (lot# and expiry not reported). No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is 1 of 2 reports regarding the same patient. Additional information is not expected.

VAERS ID:478531 (history)  Vaccinated:2012-11-15
Age:62.0  Onset:0000-00-00
Gender:Female  Submitted:2012-11-22
Location:Unknown  Entered:2012-11-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ABILIFY; AMITIZA, Atorvastatin; Lorazepam; Levothyroxine sodium; Mirtazapine; Omeprazole; Pinaverium bromide; Zolpidem tartrate
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA008089
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H013399 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Contusion, Injection site pain, Injection site swelling, Local reaction
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This spontaneous report as received from a physician refers to a female patient of currently 62 years old. The patient has may medical issues. On 15-NOV-2012, the patient was vaccinated with a single 0.5 cc dose of intramuscular PNEUMOVAX 23 (lot#H013399; exp date: 07-MAR-2014). Concomitant therapy includes ABILIFY, AMITIZA, atorvastatin, lorazepam, levothyroxine, mirtazapine, omeprazole, Pinaverium Bromide, SENOKOT and zolpidem tartrate. On November 2012, the patient experienced swelling, tenderness and paim at injection site and seek medical attention. The patient Doctor stated that she had a rather severe local reaction above and a bruised area. The patient was treated with glucocorticoid, antibiotic. It was reported that the patient was all better in November 2012. The relatedness of the event with PNEUMOVAX 23 was unknown. No further information provided. Additional information has been requested.

VAERS ID:475125 (history)  Vaccinated:2012-11-15
Age:3.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Female  Submitted:2012-11-23, Days after onset: 7
Location:Washington  Entered:2012-11-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4154BA IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Erythema, pain, and 1.5" swelling at injection site.

VAERS ID:477516 (history)  Vaccinated:2012-11-15
Age:1.1  Onset:2012-11-16, Days after vaccination: 1
Gender:Female  Submitted:2012-11-23, Days after onset: 7
Location:Minnesota  Entered:2012-11-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0628AE0IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1744AA2IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0643AE0IMRL
Administered by: Private     Purchased by: Other
Symptoms: Injection site mass, Injection site rash
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Patient developed a rash on bilateral legs and a lump at injection site on left thigh. Grandmother will continue to monitor & RTC with worsening of symptoms. Is returning in 2 weeks for recheck.

VAERS ID:475173 (history)  Vaccinated:2012-11-15
Age:42.0  Onset:2012-11-17, Days after vaccination: 2
Gender:Male  Submitted:2012-11-26, Days after onset: 9
Location:Unknown  Entered:2012-11-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': PHHY2012US105247
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS  SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Lip swelling, Oedema peripheral, Pruritus generalised, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Case number PHHY2012US105247 is an initial spontaneous report received from a pharmacist on 19 Nov 2012: This report refers to a 42-years-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: not reported) on 15 Nov 2012. After vaccination on the next day, he complained that, he woke up in the middle of the night with hives and itching all over trunk, arms and legs. He was treated with BENADRYL. On 17 Nov 2012, he also experienced lips and hands swelled up. The outcome and causality of the events was not reported.

VAERS ID:475466 (history)  Vaccinated:2012-11-15
Age:53.0  Onset:0000-00-00
Gender:Female  Submitted:2012-11-24
Location:Iowa  Entered:2012-11-26, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED07549221A UNRA
Administered by: Other     Purchased by: Unknown
Symptoms: Insomnia, Pain, Tenderness
SMQs:
Write-up: Patient describes localized tenderness/pain around deltoid area of arm. States she has difficulty sleeping and wonders if it is nerve pain.

VAERS ID:477499 (history)  Vaccinated:2012-11-15
Age:76.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Female  Submitted:2012-11-23, Days after onset: 7
Location:Rhode Island  Entered:2012-11-26, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: High Blood Pressure
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
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Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4311AA0SYRRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Day after vaccine was administered arm surrounding injection was red & swollen, and itchy.

VAERS ID:477547 (history)  Vaccinated:2012-11-15
Age:59.0  Onset:2012-11-18, Days after vaccination: 3
Gender:Female  Submitted:2012-11-20, Days after onset: 2
Location:D.C.  Entered:2012-11-26, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PMR on Prednisone pills 15mg qd -$g 4 mg qd.
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS123003 IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Rash on inner calves of both legs appeared Sunday morning, after Thursday afternoon vaccination.

VAERS ID:475380 (history)  Vaccinated:2012-11-15
Age:52.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Female  Submitted:2012-11-27, Days after onset: 11
Location:Indiana  Entered:2012-11-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH745AD IMRA
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB260AB IMLA
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURH14521 IMLA
JEV1: JAPANESE ENCEPHALITIS (IXIARO)INTERCELL AGJEV11C83E IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0496AE IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B099CA IMLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG15411 IMLA
Administered by: Public     Purchased by: Private
Symptoms: Induration, Inflammation, Vulvovaginal pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Vulva inflammation with severe, incredible pain. Pt stated that her vulva became rock hard a couple days after the vaccination.

VAERS ID:475382 (history)  Vaccinated:2012-11-15
Age:27.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-11-27, Days after onset: 12
Location:South Carolina  Entered:2012-11-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Diagnosis: Cellulitis; course of antibiotics
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
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Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA727CA3IMRA
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC047AA0IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0217AE0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Cellulitis, Erythema, Mobility decreased, Pain, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Parkinson-like events (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Red, hot to touch, swollen, range of motion limited by pain.

VAERS ID:475398 (history)  Vaccinated:2012-11-15
Age:66.0  Onset:2012-11-18, Days after vaccination: 3
Gender:Female  Submitted:2012-11-27, Days after onset: 9
Location:California  Entered:2012-11-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: 50 mg Losartan Potassium; 360 mg Verapamil; 500 mg Cinnamon
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
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Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.616AE0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Back pain, Blister, Hypoaesthesia, Myalgia, Pain, Pain in extremity, Paraesthesia, Pyrexia, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Aching upper right side of back/r.arm,1 1/19 fluid-filled blisters right arm/shoulder, tingling, 11/20 stinging, 11/22 burning pain, numbness in r. hand thumb/11/22-11/25 swelling above right clavicle, sharp shooting pain started 11/25, fever 100.5 11/19, 99.9 11/20, extreme muscle soreness in right arm, burning and sharp pains, and muscle soreness still ongoing.

VAERS ID:475544 (history)  Vaccinated:2012-11-15
Age:61.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Male  Submitted:2012-11-23, Days after onset: 7
Location:Massachusetts  Entered:2012-11-27, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Hypothyroidism
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204701 IMLA
Administered by: Other     Purchased by: Private
Symptoms: Injected limb mobility decreased, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad)
Write-up: In 24 hours after immunization, patient experienced unusual muscle pain. He complained that he could not raise his arm, the pain radiated from shoulder to the elbow & lasted 10 days.

VAERS ID:475650 (history)  Vaccinated:2012-11-15
Age:59.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-11-20, Days after onset: 5
Location:California  Entered:2012-11-28, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SYNTHROID; Temazepam; Lorazepam; PREMARIN Vag .5
Current Illness: Thyroid Autoimmune
Preexisting Conditions: Hashimoto''s Thyroid; Menopause
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNLA
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Chills, Diarrhoea, Nausea, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Fever (101 plus), chills, body aches, severe diarrhea in a.m. morning after Flu shot, weakness, nausea with no vomiting x 2 days. Could not retain even H2O x 2 days.

VAERS ID:475652 (history)  Vaccinated:2012-11-15
Age:60.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-11-17, Days after onset: 2
Location:Florida  Entered:2012-11-28, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1207101 IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H013581 UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Induration, Oedema, Swelling
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), Hypersensitivity (broad)
Write-up: Flu shot given on 11-15-12 at 9 am. Noted edema, erythema and induration few h after at arm. 4+ h after still redness and swelling but better.

VAERS ID:475654 (history)  Vaccinated:2012-11-15
Age:28.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Male  Submitted:2012-11-15, Days after onset: 0
Location:New York  Entered:2012-11-28, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Hx asthma
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12244P0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Dyspnoea, Nausea, Wheezing
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (broad)
Write-up: Administered Flu shot approx 9:15am by 9:30am pt was dizzy & nauseated - SOB, sent to ED developed slight wheezing treated with O2 & fluids, VALIUM & ZOFRAN. Improved after 2 hours - treated & released to home.

VAERS ID:475705 (history)  Vaccinated:2012-11-15
Age:1.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Male  Submitted:2012-11-28, Days after onset: 13
Location:Minnesota  Entered:2012-11-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4485EA0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0496AE0SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0149010SCRL
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness and swelling at injection site lasting 2 weeks.

VAERS ID:477556 (history)  Vaccinated:2012-11-15
Age:6.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-11-28, Days after onset: 13
Location:California  Entered:2012-11-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA007492
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0109150IMUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: Initial information was received from a registered nurse concerning a 6 years old female patient with an unspecified pertinent medical history or drug reactions/allergies who on 15-NOV-2012, the patient was vaccinated with intramuscularly with the first 0.5ml dose of GARDASIL (indication and lot were not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse reactions were reported. No treatment information was reported. The patient''s outcome was unknown. Additional information has been requested.

VAERS ID:477576 (history)  Vaccinated:2012-11-15
Age:40.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Female  Submitted:2012-11-16, Days after onset: 0
Location:Pennsylvania  Entered:2012-11-28, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H014196 UNLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Pain in extremity, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Much redness, swelling, and pain left upper arm. Improved after 24 hrs.

VAERS ID:477583 (history)  Vaccinated:2012-11-15
Age:62.0  Onset:2012-11-17, Days after vaccination: 2
Gender:Female  Submitted:2012-11-19, Days after onset: 2
Location:Arizona  Entered:2012-11-28, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H013022 SCAR
Administered by: Other     Purchased by: Other
Symptoms: Burning sensation, Injection site induration, Injection site rash, Injection site swelling, Pain
SMQs:, Peripheral neuropathy (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Patient described injection site area as hard, raised, swelling 1/2 inch. Area was approximately 6 inches by 4 inches. Patient experienced painful, burning sensation. Patient did go to Urgent Care.

VAERS ID:477588 (history)  Vaccinated:2012-11-15
Age:60.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-11-20, Days after onset: 5
Location:Wyoming  Entered:2012-11-28, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Aspirin; Levothyroxine; Lisinopril; Metformin; Oxybutynin; PRAVACHOL
Current Illness: None
Preexisting Conditions: DM Type II; Hypothyroidism; Dyslipidemia
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4395AA0IMRA
Administered by: Other     Purchased by: Unknown
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Rash on shoulder, upper back, upper chest about 1 hour after injection. Dexamethasone 4 mg and KENALOG 40mg, BENADRYL 25mg.

VAERS ID:478705 (history)  Vaccinated:2012-11-15
Age:63.0  Onset:0000-00-00
Gender:Male  Submitted:2012-11-28
Location:Florida  Entered:2012-11-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Losartan potassium; omeprazole
Current Illness: Gastrooesophageal reflux disease; Hypertension
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA008410
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H013399 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This spontaneous report as received from a physician via office manager regarding approximately a 63 years old male patient. Patient''s current conditions included hypertension and GERD (gastric esophageal reflux disease). Patient had no drug reactions or allergies. On 15-NOV-2012, the patient was vaccinated with a dose of PNEUMOVAX 23 (Lot number was reported as H013399 and expiry date was 07-MAR-2014) 0.5 cubic centimeter (cc) once intramuscularly. Dose number was not reported. Concomitant medications included losartan potassium 50 milligrams (mg) and omeprazole 20 mg. Approximately on an unspecified date in November 2012, the patient experienced swelling, tenderness and pain at the site of injection. The physician also stated that the patient had redness at the site, the size of an orange. No diagnostic studies were performed. The patient sought medical attention (consulted office). No treatment was given. The physician also stated that the patient was all better now. The outcome of all the reported events was recovering. Additional information has been requested.

VAERS ID:475733 (history)  Vaccinated:2012-11-15
Age:37.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Male  Submitted:2012-11-30, Days after onset: 15
Location:Unknown  Entered:2012-11-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
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FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDP59708 IMLA
Administered by: Military     Purchased by: Military
Symptoms: Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: NAUSEA AND VOMITING APROX. 4 HOURS AFTER VACCINATION THAT LASTED THROUGH THE NIGHT. FULL RECOVERY MADE IN 24 HOURS. PROMETHAZINE ADMINISTERED.

VAERS ID:476100 (history)  Vaccinated:2012-11-15
Age:1.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Male  Submitted:2012-12-03, Days after onset: 17
Location:Michigan  Entered:2012-12-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4545AA0IMLL
HEPA: HEP A (VAQTA)MERCK & CO. INC.0669AE0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0643AE0SCRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9181333IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0133980SCLL
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Rash that had a sudden onset. It was present at his chin, trunk, & leg which included redness but no associated fever.

VAERS ID:476280 (history)  Vaccinated:2012-11-15
Age:64.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-11-29, Days after onset: 14
Location:Virginia  Entered:2012-12-04, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown as of 2/2012 --$g PRILOSEC; Vitamin D; Calcium; Acidophilus; Aspirin; TYLENOL arthritis
Current Illness: None
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH753AA UNAR
Administered by: Private     Purchased by: Private
Symptoms: Back pain, Cardiac function test normal
SMQs:, Retroperitoneal fibrosis (broad)
Write-up: Patient received flu vaccine on 11/15/12. Few hours later developed mid back pain requiring trip to Emergency Room where she was admitted to the hospital, cardiac work up (-). Pain resolved the following day.

VAERS ID:476307 (history)  Vaccinated:2012-11-15
Age:58.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-12-04, Days after onset: 19
Location:Utah  Entered:2012-12-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Mobic, Simvastatin
Current Illness: None
Preexisting Conditions: Penicillin allergy, osteoarthritis
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDP592070IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pain in left arm (where injection was given) radiating down to elbow. Becomes severe when moving arm up or over to the right side. Severe at night. Became worse the next day and continues with no relief. No relief from anti-inflammatories (ibuprofen, Mobic).

VAERS ID:479733 (history)  Vaccinated:2012-11-15
Age:  Onset:2012-11-15, Days after vaccination: 0
Gender:Unknown  Submitted:2012-12-04, Days after onset: 19
Location:Ohio  Entered:2012-12-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1212USA000925
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0156AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report as received from an office manager refers to a patient of unknown age. The patient was vaccinated with lot # (669631/0156AA) an unspecified dose of M-M-R II on 15-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. The patient was administered a dose of MMRII that had been exposed to 5 temperature excursions to a high temperature of 55 degrees Fahrenheit for an unsupportable cumulative total of 8.5 hours (Excursion dates 27-JUL-2012 for 1.5 hours; 08-SEP-2012 for 3 hours; 09-SEP-2012 for 4 hours). No adverse effect was reported. No treatment information was reported. No further information is available. This case is linked to case MARRS # 1211USA011055, 1211USA012758 and 1212USA000924 (same reporter). Additional information is not expected.

VAERS ID:476392 (history)  Vaccinated:2012-11-15
Age:17.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-12-05, Days after onset: 20
Location:Unknown  Entered:2012-12-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None.
Current Illness: None.
Preexisting Conditions: Amoxicillin.
Diagnostic Lab Data: CBC, ESR, CRP
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM110411IMLA
Administered by: Military     Purchased by: Military
Symptoms: C-reactive protein, Full blood count, Musculoskeletal pain, Red blood cell sedimentation rate, Tenderness
SMQs:, Rhabdomyolysis/myopathy (broad)
Write-up: Superficial shoulder pain and tenderness.

VAERS ID:479823 (history)  Vaccinated:2012-11-15
Age:  Onset:2012-11-15, Days after vaccination: 0
Gender:Unknown  Submitted:2012-12-06, Days after onset: 21
Location:Unknown  Entered:2012-12-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1212USA001745
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0257AA2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: This spontaneous report as received from a nurse refers to a patient of unknown age and gender who on 15-NOV-2012 was vaccinated with a third dose of ROTATEQ after the vaccine expired (lot number reported as 0257AA, expiration date: 28-OCT-2012) (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. No adverse reaction reported. Additional information is not expected.

VAERS ID:476919 (history)  Vaccinated:2012-11-15
Age:85.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Male  Submitted:2012-12-07, Days after onset: 21
Location:Unknown  Entered:2012-12-07
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FLOMAX
Current Illness: Glaucoma; Hypertension; Blood cholesterol increased; Prostatism
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1212USA001242
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H013847 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis
SMQs:
Write-up: This spontaneous report as received from a physician assistant refers to a 85 years old male patient with high cholesterol, high blood pressure and glaucoma and prostate issue. The patient was vaccinated intramuscularly with 0.5 ml PNEUMOVAX 23 (lot# reported as H013847, exp 15-MAR-2014) on 15-NOV-2012. Concomitant medications included: FLOMAX, unspecified cholesterol med and unspecified blood pressure medicine. On 16-NOV-2012 the patient experienced cellulitis in the same left arm (hospitalization and life threatening). The patient sought medical attention. The patient was admitted at least for one day in Hospital and KEFLEX was given for the treatment. The outcome of the adverse event was unknown. Additional information has been requested.

VAERS ID:479833 (history)  Vaccinated:2012-11-15
Age:  Onset:2012-11-15, Days after vaccination: 0
Gender:Unknown  Submitted:2012-12-07, Days after onset: 22
Location:Unknown  Entered:2012-12-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA010092
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0614AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. On 15-NOV-2012, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number reported as 0614AA), that had expired on 27-SEP-2012. Concomitant medications were not reported. No adverse event was reported. Additional information has been requested.

VAERS ID:477568 (history)  Vaccinated:2012-11-15
Age:45.0  Onset:2012-12-06, Days after vaccination: 21
Gender:Female  Submitted:2012-12-11, Days after onset: 5
Location:Wisconsin  Entered:2012-12-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin D; SYNTHROID; Lisinopril; ASA; SIMCOR; Fluoxetine
Current Illness: None
Preexisting Conditions: Allergy to BIAXIN; Sea scallops; Diabetic-diet-controlled; SYNTHROID for thyroid; Anxiety
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0110740SCLA
Administered by: Private     Purchased by: Private
Symptoms: Blister, Rash erythematous, Rash pruritic, Scab
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: On 12-6-12 patient noted an itchy, red skin eruption on (L) lateral chest wall (armpit area). On 12-7-12 employee developed a similar skin eruption on buttock, abdomen and neck. Some eruptions were fluid-filled. On 12-10-12 areas were scabbed over. No treatment.

VAERS ID:480168 (history)  Vaccinated:2012-11-15
Age:66.0  Onset:0000-00-00
Gender:Female  Submitted:2012-12-13
Location:New York  Entered:2012-12-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Oxygen
Current Illness: Chronic obstructive pulmonary disease
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1212USA000778
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H013023 SCUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Headache, Injection site cellulitis, Pain, Pyrexia, Skin warm, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: This spontaneous report was received from a registered pharmacist concerning a 66 year old female patient with no drug reactions/allergies. Concomitant condition of the patient included chronic obstructive pulmonary disease. On 15-NOV-2012, the patient was vaccinated with 0.65 milliliter (ml0 ZOSTAVAX (lot number reported as H013023, expiry date: October 2013), subcutaneously. Patient received oxygen concomitantly, unspecified volume per minute. On an unknown date in November 2012, after the receiving the dose of ZOSTAVAX, the patient experienced headache, body ache and a low grade fever of unspecified temperature. She also reported a large red welt (unspecified measurement) which was too hot to touch for which she saw a physician. Patient sought medical attention (office visit). She was diagnosed with cellulitis at injection site and she was prescribed with unspecified antibiotics (manufacturer unknown). The outcome of body ache, low grade fever of unspecified temperature, headache and cellulitis at injection site was unknown. The relatedness for cellulitis at injection site, low grade fever of unspecified temperature, body ache and headache was unknown for ZOSTAVAX. Additional information has been requested.

VAERS ID:478099 (history)  Vaccinated:2012-11-15
Age:49.0  Onset:2012-11-17, Days after vaccination: 2
Gender:Male  Submitted:2012-12-07, Days after onset: 20
Location:Nevada  Entered:2012-12-14, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA736AA6IMLA
Administered by: Private     Purchased by: Private
Symptoms: Pyrexia, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: 11-27-12 - Developed rash 2 days post vaccination also c/o fever at that time - rash worsened covering trunk, arms, legs, back - seen in E.R. 12-6-12 - acute urticaria trunk & arms not hands or feet.

VAERS ID:478186 (history)  Vaccinated:2012-11-15
Age:50.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Female  Submitted:2012-12-14, Days after onset: 28
Location:Maryland  Entered:2012-12-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: 2010, 2011~Influenza (H1N1) (H1N1 (MONOVALENT) (UNKNOWN))~1~48.17~Patient
Other Medications: Lantus, Nature''s Way Vitamin D3 (2,000 IU), and Bell Healthy Blood Pressure Support #26
Current Illness: None
Preexisting Conditions: Type II Diabetes with complications
Diagnostic Lab Data: None taken
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12273P IM 
Administered by: Private     Purchased by: Other
Symptoms: Asthenia, Chest discomfort, Cough, Decreased appetite, Diarrhoea, Dizziness, Fatigue, Headache, Increased upper airway secretion, Musculoskeletal chest pain, Pain, Productive cough, Pyrexia, Respiratory tract congestion, Throat irritation, Vomiting, Wheezing
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow)
Write-up: I started on 11-16-12 with a severe scratchy throat then followed by body aches and pains all over, headache, lightheadedness, dizziness, no appetite, not able to hold anything down but water, extreme fatigue, extreme weakness, chest tightness, congestion, severe coughing spells with sputum, vomiting, diarrhea, wheezing, thick phlegm, rib pain and fever.

VAERS ID:478292 (history)  Vaccinated:2012-11-15
Age:31.0  Onset:2012-11-23, Days after vaccination: 8
Gender:Male  Submitted:2012-12-12, Days after onset: 19
Location:California  Entered:2012-12-17, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject had an allergy to penicillin and had frequent headaches since 1984.
Diagnostic Lab Data: 28 November 2012: Abnormal ECG
CDC 'Split Type': 201211829
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEUR  IDLA
Administered by: Military     Purchased by: Military
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Electrocardiogram abnormal, Headache, Troponin I increased
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: This study case was received from the investigator in a trial on 30 November 2012. A 31-year-old male subject had received the following vaccinations on 15 November 2012: ACAM2000 (lot number and route not reported) in the left arm, anthrax vaccine (manufacturer, lot number, route and site not reported) and FLUMIST (lot number, route and site not reported). Eight days post-vaccination on 23 November 2012, the subject experienced onset of chest pain, chest pressure and shortness of breath that was exacerbated by wearing combat gear. All symptoms are in the middle of chest and are a constant sharp pain. The subject also reported headaches since one day post-vaccination on 16 November 2012. The subject started taking ADVIL for the symptoms on 16 November 2012. The subject was evaluated by the provider before visit two. No ECG or labs were performed and the subject returned to full duty. On 28 November 2012, an ECG was done that was abnormal. Troponin I was increased at 0.13 ng/ml. The subject had an allergy to penicillin and had frequent headaches since 1984. No further information was available at the time of the report. The subject''s outcome was not recovered. According to the investigator, the event of elevated Troponin was considered another important event and possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study''s adjudication committee for assessment. Documents held by sender: None.

VAERS ID:478384 (history)  Vaccinated:2012-11-15
Age:4.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-12-17, Days after onset: 32
Location:Minnesota  Entered:2012-12-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: F/u with MD. MD question if from immunizations or virus?
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH717AA1IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH400AA1IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0232AE0SCLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9172451IMLL
Administered by: Public     Purchased by: Public
Symptoms: Injection site pain, Lymphadenopathy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Fever for 2 days after doses administered and also enlarged lymphoids - bil. size of a quarter at femoral pulse site. Rebound tenderness at site when palpated. Reported at facility on 12-5-12.

VAERS ID:478475 (history)  Vaccinated:2012-11-15
Age:74.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-11-21, Days after onset: 6
Location:Kansas  Entered:2012-12-17, Days after submission: 26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H0130250SCAR
Administered by: Other     Purchased by: Private
Symptoms: Injection site haematoma, Injection site induration, Injection site swelling
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Lots of swelling/bruising/hardening at injection site. Started to improve 11/20/12.

VAERS ID:479006 (history)  Vaccinated:2012-11-15
Age:46.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Male  Submitted:2012-12-21, Days after onset: 35
Location:Massachusetts  Entered:2012-12-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COMPLERA; TRICOR; ASA; Fish Oil; MOTRIN
Current Illness:
Preexisting Conditions: Sleep Apnea; HIV positive; Hypertriglyceridemia; Eczema
Diagnostic Lab Data: Hospital
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4462AA0UNLA
Administered by: Private     Purchased by: Public
Symptoms: Myocarditis
SMQs:, Cardiomyopathy (broad)
Write-up: Myocarditis.

VAERS ID:479152 (history)  Vaccinated:2012-11-15
Age:66.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-12-24, Days after onset: 39
Location:Indiana  Entered:2012-12-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Minocycline, Sertraline
Current Illness: None
Preexisting Conditions: Depression, Rosalea
Diagnostic Lab Data: None.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H0139400SCLA
Administered by: Other     Purchased by: Public
Symptoms: Injection site pruritus, Injection site urticaria, Injection site warmth
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Welt at injection site for about 1 week. Itching at injection site. Warm to touch at injection site.

VAERS ID:479935 (history)  Vaccinated:2012-11-15
Age:  Onset:2012-12-21, Days after vaccination: 36
Gender:Unknown  Submitted:2012-12-28, Days after onset: 7
Location:California  Entered:2012-12-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1212USA009833
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a Licensed Vocational Nurse refers to a patient of unknown age and gender with a medical history and drug allergies not reported, who on 15-NOV-2012, was vaccinated with dose 1 GARDASIL (lot #, dose and route not provided). On 21-DEC-2012, was vaccinated with dose 2 GARDASIL (lot #, dose and route not provided). No other co-suspects were reported. No concomitant medications were reported. The nurse, reported there not was adverse symptoms. Additional information has been requested.

VAERS ID:480145 (history)  Vaccinated:2012-11-15
Age:  Onset:2012-11-15, Days after vaccination: 0
Gender:Unknown  Submitted:2013-01-02, Days after onset: 48
Location:West Virginia  Entered:2013-01-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1301USA000238
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.H015623 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 15-NOV-2012 was vaccinated with an improperly stored (Merck) PROQUAD (dose and route unknown), Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient''s outcome was unknown. This is one of several reports from the same source. Additional information is not expected.

VAERS ID:480518 (history)  Vaccinated:2012-11-15
Age:35.0  Onset:2012-11-17, Days after vaccination: 2
Gender:Female  Submitted:2013-01-08, Days after onset: 52
Location:New Jersey  Entered:2013-01-08
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: Cannot receive X-ray due to pregnancy but condition has never improved.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12065011IMLA
Administered by: Other     Purchased by: Private
Symptoms: Injected limb mobility decreased, Injection site pain, Maternal exposure during pregnancy, Periarthritis
SMQs:, Extravasation events (injections, infusions and implants) (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Arthritis (narrow)
Write-up: Severe pain at and around injection site. Can not move arm. Frozen shoulder.

VAERS ID:481030 (history)  Vaccinated:2012-11-15
Age:78.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Female  Submitted:2013-01-11, Days after onset: 56
Location:California  Entered:2013-01-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lasix; potassium; timolol; warfarin; vit D
Current Illness: None
Preexisting Conditions: PMHX- Meniere''s; IBS; chronic abd pain; vertigo; CVA; DVT Allergy amoxil hives Allergy sensitivities cipro; dicylcomin; codeine; demerol; doxy; erythro; morphine; naproxen; neomycin; patanol
Diagnostic Lab Data: All normal
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH719AA0IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site erythema, Injection site pruritus, Laboratory test normal, Nausea, Viral upper respiratory tract infection
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Itching/redness at site and nausea. Pt request report as she has had persisting itching and recurring viral URI since vaccine. No antibiotics. Pt refuses rx. Only wants dietary supplement.

VAERS ID:481357 (history)  Vaccinated:2012-11-15
Age:33.0  Onset:2012-11-18, Days after vaccination: 3
Gender:Female  Submitted:2012-11-19, Days after onset: 1
Location:New Mexico  Entered:2013-01-15, Days after submission: 57
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUH352AC0SCRA
Administered by: Military     Purchased by: Military
Symptoms: Injection site erythema, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pt received yellow fever vaccine 15 Nov 2012 about 0804 am. Pt received VIS form, informed of adverse reactions, verified not possible pregnancy with disclaimer form. Pt waited read 30 min with no reaction. Pt states later she noticed red area at injection site the size of a small baseball and site was itching. Pt reported no other sx. Dr notified he said no intervention needed but to inform pt to watch for signs of anaphylaxis or other concerns and calling if needed.

VAERS ID:481359 (history)  Vaccinated:2012-11-15
Age:60.0  Onset:2013-01-02, Days after vaccination: 48
Gender:Female  Submitted:2013-01-12, Days after onset: 10
Location:Arizona  Entered:2013-01-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LANTUS; Lisinopril
Current Illness:
Preexisting Conditions: HTN; DM
Diagnostic Lab Data: EMG/NCS; Neurology consult
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEURUT4471AA IDRA
Administered by: Other     Purchased by: Other
Symptoms: Electromyogram, Guillain-Barre syndrome, Nerve conduction studies
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)
Write-up: Developed Guillain Barre Syndrome within few wks after flu vaccine.

VAERS ID:481520 (history)  Vaccinated:2012-11-15
Age:14.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Male  Submitted:2013-01-10, Days after onset: 56
Location:Colorado  Entered:2013-01-16, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Normal
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Private     Purchased by: Other
Symptoms: Asthenia, Listless, Pallor
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Approximately 4 hrs. after receiving vaccine HPV GARDASIL 2nd dose, he became pale and listless. Laid in bed for about 4 hrs., then was fine, I would call this a mild reaction, no headache, no fever, just weakness.

VAERS ID:482151 (history)  Vaccinated:2012-11-15
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2013-01-21
Location:Florida  Entered:2013-01-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1301USA004821
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Maternal exposure during pregnancy, No adverse event
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: This spontaneous prospective pregnancy report was received from a 25 years old female consumer regarding herself. Patient had no pertinent medical history and drug reactions or allergies. On 15-NOV-2012, the patient was vaccinated with her first and only dose of GARDASIL (lot#, dose and route not reported). No concomitant medications were reported. Subsequently on 28-NOV-2012, the patient found out that she was pregnant with an LPM of 28-OCT-2012 and an EDD of 04-AUG-13. She was not going to have the second or third shot until the pregnancy was completed. No treatment was given. No laboratory test were performed. Patient sought medical attention (called the Healthcare professional). No adverse reactions were reported. Initial exposure to GARDASIL was at 2 weeks. Additional information has been requested.

VAERS ID:482500 (history)  Vaccinated:2012-11-15
Age:14.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Female  Submitted:2013-01-24, Days after onset: 69
Location:Unknown  Entered:2013-01-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: 16-NOV-2012: Body temperature: 100 Fahrenheit
CDC 'Split Type': WAES1301USA010839
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Feeling abnormal, Influenza like illness, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad)
Write-up: This spontaneous report was received from a nurse practitioner concerning a 14 years old female patient. The patient was vaccinated intramuscularly with the first dose of 0.5 ml GARDASIL (lot not reported) on 15-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. The patient experienced fever of 100 Fahrenheit, flu-like symptoms and missed 3 days of work after receiving the first dose of GARDASIL. No treatment information was reported. The patient stated that it was the worst she had ever felt. These symptoms occurred a day later after GARDASIL vaccination and recovered within 3 days. The relatedness for the events was unknown for GARDASIL. Additional information is not expected.

VAERS ID:484107 (history)  Vaccinated:2012-11-15
Age:44.0  Onset:0000-00-00
Gender:Female  Submitted:0000-00-00
Location:Iowa  Entered:2013-02-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Evaluated by ortho surgeon dx post injection inflammatory reaction.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH755AB IMLA
Administered by: Public     Purchased by: Private
Symptoms: Inflammation, Injection site pain, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pain at site and pain with use of arm.

VAERS ID:484108 (history)  Vaccinated:2012-11-15
Age:37.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2013-02-07, Days after onset: 84
Location:Wisconsin  Entered:2013-02-12, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Ankylosing Spondylitis
Diagnostic Lab Data: General practitioner diagnosed pain as shoulder bursitis. Prescribed NSAID & exercises. Tests included movement/strength of shoulders.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH734AB IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4422AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: The Flu shot (in right arm) and whooping cough/tetanus shot (left arm) were administered high on the arm. Shot hurt worse than before especially for right arm. That day I could not raise either arm above my head. Saw administering nurse approximately 3 weeks after. Then saw my general practitioner approximately 5 weeks after. She diagnosed me with shoulder bursitis in both shoulders. Right one is the worse one. Treatment included 2 weeks of NSAID (took approximately 4 weeks) & exercises. Pain continues to be present.

VAERS ID:484591 (history)  Vaccinated:2012-11-15
Age:  Onset:2012-11-15, Days after vaccination: 0
Gender:Unknown  Submitted:2013-02-14, Days after onset: 91
Location:Unknown  Entered:2013-02-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1302USA005713
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0234AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report was received from a quality control individual at a medical facility refers to a patient of unknown age. On 15-NOV-2012, the patient was vaccinated with a dose of M-M-R II (lot # 0234AE, exp: 26-JAN-2014) (Dose and route were not reported). No other co-suspects were reported. No concomitant medications were reported. The reported called for a patient who were administered M-M-R II that was exposed to an unsupported temperature excursion (10.1C for 96 hours). No adverse effect reported. This is one of seven reports from the same source. Additional information has been requested.

VAERS ID:484926 (history)  Vaccinated:2012-11-15
Age:31.0  Onset:2013-01-31, Days after vaccination: 77
Gender:Male  Submitted:2013-02-14, Days after onset: 14
Location:Virginia  Entered:2013-02-20, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject has no significant medical history.
Diagnostic Lab Data:
CDC 'Split Type': 201302234
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEUR  IDUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Echocardiogram normal, Electrocardiogram normal, Myocarditis, Troponin I increased
SMQs:, Myocardial infarction (narrow), Cardiomyopathy (broad)
Write-up: This study case was received from the investigator on 05 February 2013. A 31-year-old male subject received an injection of ACAM2000 (lot number not reported), Anthrax (D1, lot not reported, other MFR), and Influenza, live vaccine (intranasal, lot not reported, other manufacturer) on 15 November 2012. The subject had no significant medical history. On 03 December 2012, the subject was diagnosed with Non-specific myocarditis. Diagnostic testing on 29 November 2012 revealed abnormal Troponin I (highest value 00.13); and on 03 December 2012 diagnostic testing included: normal ECG and Echocardiogram. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.

VAERS ID:485293 (history)  Vaccinated:2012-11-15
Age:10.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Male  Submitted:2012-11-16, Days after onset: 0
Location:Unknown  Entered:2013-02-20, Days after submission: 96
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': 2012SE88011
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Other     Purchased by: Other
Symptoms: Oropharyngeal pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)
Write-up: A consumer report has been received. The report concerned a 4 month old, male consumer. On 15-Nov-2012 the patient started receiving nasal FLUMIST. The patient experienced fever and sore throat which started on 16-Nov-2012. Consumer reported that the patient was not sitting upright when he received his dose of FLUMIST. The action taken of FLUMIST was not applicable. The outcome of the event of fever and sore throat was unknown. The report was considered to be non-serious by the reporter.

VAERS ID:485297 (history)  Vaccinated:2012-11-15
Age:4.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-11-16, Days after onset: 1
Location:Unknown  Entered:2013-02-20, Days after submission: 96
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': 2012SE87541
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Other     Purchased by: Other
Symptoms: Incorrect dose administered
SMQs:
Write-up: A consumer report has been received. The report concerns a 4 year old, Female consumer, who had been receiving Nasal FLUMIST. FLUMIST started on 08-Nov-2012. The two children was administered with FLUMIST twice, once at a clinic with mom on 15-Nov-2012 and the other the doctor office with dad on 08-Nov-2012 which started on 15-Nov-2012. The outcome of the event of RECEIVED FLUMIST TWICE is unknown. The report was considered to be non-serious. Corrected report 30-Nov-2012: Coding of event ''received FLUMIST twice'' changed from Intentional drug misuse to Extra dose administered, narrative updated.

VAERS ID:485303 (history)  Vaccinated:2012-11-15
Age:1.7  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-11-15, Days after onset: 0
Location:Texas  Entered:2013-02-20, Days after submission: 97
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': 2012SE87426
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AJ2159 IN 
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age
SMQs:
Write-up: A report has been received from a Health Professional concerning a 1 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced ADMINISTRATION TO A 20 MONTH OLD which started on 15-Nov-2012. The outcome of the event of ADMINISTRATION TO A 20 MONTH OLD is unknown. The report was considered to be non-serious. Corrected report 29-Nov-2012: Key ingredient of FLUMIST corrected from influenza virus vaccine polyvalent to FLUMIST, coding of event ''administration to a 20 month old'' corrected from intentional drug misuse to inappropriate age at vaccine administration, narrative updated.

VAERS ID:485311 (history)  Vaccinated:2012-11-15
Age:5.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Female  Submitted:2012-11-16, Days after onset: 0
Location:Unknown  Entered:2013-02-20, Days after submission: 96
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': 2012SE88009
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: A consumer report has been received. The report concerns a 5 year old, female consumer, who had been receiving FLUMIST. FLUMIST started on 15-Nov-2012. The patient experienced STOMACH PAINS, LOOSE STOOLS, NAUSEA, VOMITING and TIRED which started on 16-Nov-2012. The outcome of the event of STOMACH PAINS, LOOSE STOOLS, NAUSEA and TIRED is unknown. The report was considered to be non-serious by company physician.

VAERS ID:485686 (history)  Vaccinated:2012-11-15
Age:82.0  Onset:0000-00-00
Gender:Male  Submitted:2013-02-27
Location:Colorado  Entered:2013-02-27
Life Threatening? No
Died? Yes
   Date died: 2012-12-13
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1302USA012087
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Cardiac arrest, Death, Multi-organ failure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Tumour lysis syndrome (broad)
Write-up: This spontaneous report as received from a consumer refers to an 82 year old male patient. The patient''s medical history and concurrent conditions were not provided. On 15-NOV-2012 the patient was vaccinated with a dose of ZOSTAVAX. Dose, route and lot number were not provided. No concomitant medications were reported. On an unknown date the patient experienced multi-organ failure and cardiac arrest. The outcome of multi-organ failure and cardiac arrest was reported as fatal. The patient died on 13-DEC-2012 at 1515 (military time) in the hospital. The cause of death was reported as cardiac arrest and multi-organ failure, according to the Death Certificate. No reporter causality was provided. Additional information has been requested.

VAERS ID:490316 (history)  Vaccinated:2012-11-15
Age:39.0  Onset:0000-00-00
Gender:Male  Submitted:2013-04-26
Location:California  Entered:2013-04-29, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: COMPLERA; NEURONTIN; DEPO-TESTOSTERONE
Current Illness:
Preexisting Conditions: HIV
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA730AA UNLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0653AA UNRA
Administered by: Other     Purchased by: Private
Symptoms: Convulsion, Fatigue, Memory impairment, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: On 1/10/13 patient stated neighbor saw patient "having a seizure" 2 days ago. Patient also aware of waking up a "couple times" and wondering how he got on sofa. On 2/21/13 MD reports patient had syncope episodes over last several months (at least 4 times) no numbness, tingling, weakness in extremities. 4/26/13 neurologist reports patient states he is "missing a block of time" usually at night, feels "like is waking up". Patient reports about 20 episodes since episodes first started with a "wave" or "pulse" of light and feeling tired with episodes.

VAERS ID:492525 (history)  Vaccinated:2012-11-15
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-05-24
Location:Florida  Entered:2013-05-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1305USA011683
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.  IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMLA
Administered by: Private     Purchased by: Public
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report as received from a medical assistant refers a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The medical assistant reported that the vaccine was exposed to temperature of 26 F for a total of 135 hours. No adverse effects reported. Follow-up received. Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the medical assistant regarding a 13 years old, female patient with no pertinent medical history reported. On 15-NOV-2012 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). Concomitant medications included Hepatitis A vaccine (manufacturer unknown) (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.

VAERS ID:492539 (history)  Vaccinated:2012-11-15
Age:16.0  Onset:0000-00-00
Gender:Male  Submitted:2013-05-24
Location:Florida  Entered:2013-05-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1305USA011685
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER  IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMLA
Administered by: Private     Purchased by: Public
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report as received from a medical assistant refers a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the medical assistant regarding a 16 years old, male patient with no pertinent medical history reported. On 15-NOV-2012 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). Concomitant medications included Hepatitis A Vaccine (manufacturer unknown) (intramuscular in the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. This is an amended report the adverse event codification was updated. Additional information is not expected.

VAERS ID:496622 (history)  Vaccinated:2012-11-15
Age:36.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2013-07-12, Days after onset: 238
Location:Michigan  Entered:2013-07-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4422AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Pt''s LMP 11/5/12 had to Tdap 11/15/12. Pt was early pregnant baby now has hypoplastic Lt heart.

VAERS ID:497570 (history)  Vaccinated:2012-11-15
Age:47.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2013-07-24, Days after onset: 250
Location:New York  Entered:2013-07-24
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Daily multi-vitamin/Vitamin B12 and Calcium supplements.
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: Blood tests performed showed normal results. X-Ray, CT scan/MRI pending as per doctor''s advice.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLUA733BA1IMLA
Administered by: Public     Purchased by: Other
Symptoms: Blood test normal, Computerised tomogram, Cough, Headache, Immediate post-injection reaction, Influenza like illness, Injected limb mobility decreased, Injection site pain, Muscular weakness, Nasopharyngitis, Nuclear magnetic resonance imaging, Pain, Pyrexia, Rhinorrhoea, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Lot of pain at injection site immediately after the IM Flu shot in upper arm. Around 11/25/2012, severe flu like syndrome developed with low grade fever, cough, cold, running nose, body-ache and headache. It lasted for two weeks. Gradual development of intense pain in right shoulder and arm and restriction of movements of right arm and shoulder akin to frozen shoulder from 11/15/2012 until 07/24/2013. Extreme pain and disability and weakness of the arm persists.

VAERS ID:498335 (history)  Vaccinated:2012-11-15
Age:62.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2013-07-31, Days after onset: 257
Location:Wisconsin  Entered:2013-07-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1307USA015215
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H011048 SCLA
Administered by: Private     Purchased by: Private
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown age and gender. The pharmacist reported that unknown number of patients might have received ZOSTAVAX (lot number unspecified) that as improperly stored from 20-MAY-2013 to 05-JUN-2013. No adverse effects reported. It was unknown if the patients had sought medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Follow up information has been received from a health professional refers to a 62 (also reported as 63) year old female patient. On 15-NOV-2012 at 10:03 the patient vaccinated subcutaneously in left arm with a dose of ZOSTAVAX (lot number H011048, exp. date not reported) (dose not reported) which was incorrectly stored. No adverse reactions reported. This is one of several reports from the same source. Additional information is not expected.

VAERS ID:508141 (history)  Vaccinated:2012-11-15
Age:65.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Female  Submitted:2013-10-18, Days after onset: 335
Location:California  Entered:2013-10-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Shingles Vaccine Vitamin supplements, hormone blocker, anti-histamine
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Advised to use anti-histamine.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Other
Symptoms: Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Sub-cutaneous rash, continued spreading and itching.

VAERS ID:511823 (history)  Vaccinated:2012-11-15
Age:28.0  Onset:2012-12-10, Days after vaccination: 25
Gender:Female  Submitted:2013-11-07, Days after onset: 332
Location:Vermont  Entered:2013-11-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamins
Current Illness: Pregnancy
Preexisting Conditions: Pregnancy
Diagnostic Lab Data: Electromyography, Spinal tap
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA715BA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Electromyogram, Exposure during pregnancy, Hypoaesthesia, Lumbar puncture, Paraesthesia, Tremor
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Tingling, numbness and loss of strength involving fingers and toes. Tremors around eyes.

VAERS ID:514927 (history)  Vaccinated:2012-11-15
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2013-11-27
Location:Unknown  Entered:2013-11-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1311USA007036
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMLA
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a healthcare worker, certified medical assistant (C.M.A) refers to a patient of unknown age and gender. In approximately November 2011 reported as about 2 years ago the patient was vaccinated with the first dose of GARDASIL, injection (strength, dose, lot number and expiration date not provided). In approximately November 2012 reported as about 1 year ago the patient was vaccinated with the second dose of GARDASIL injection (strength, dose, lot number and expiration date not provided). On 15-NOV-2013 the patient came to office to receive the 3rd dose of GARDASIL. No adverse effect was reported. Additional information has been requested.

VAERS ID:520420 (history)  Vaccinated:2012-11-15
Age:  Onset:2012-11-15, Days after vaccination: 0
Gender:Unknown  Submitted:2014-01-23, Days after onset: 434
Location:Unknown  Entered:2014-01-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1401USA008624
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H012576 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:
Write-up: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 12-OCT-2012 at 18:00, ZOSTAVAX lot # H012576 was exposed to -8 for an estimated total time out of range of 10 hours 20 min. On 15-NOV-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H012576, exp date 28-SEP-2013) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.

VAERS ID:520424 (history)  Vaccinated:2012-11-15
Age:  Onset:2012-11-15, Days after vaccination: 0
Gender:Unknown  Submitted:2014-01-23, Days after onset: 434
Location:Unknown  Entered:2014-01-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1401USA008625
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H012576 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:
Write-up: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 12-OCT-2012 at 18:00, ZOSTAVAX lot # H012576 was exposed to -8 for an estimated total time out of range of 10 hours 20 min. On 15-NOV-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H0112576, exp date 28-SEP-2013) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.

VAERS ID:475563 (history)  Vaccinated:2012-11-15
Age:83.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-11-27, Days after onset: 12
Location:Foreign  Entered:2012-11-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Warfarin sodium; Atenolol; Sertraline; Lansoprazole
Current Illness: Anxious depressive syndrome; Aphasia; Chronic atrial fibrillation; Hemiparesis of face; Mitral valve disease; Osteoporosis
Preexisting Conditions: Cementoplasty; Cerebral ischemia; Purpura
Diagnostic Lab Data: Chest X-ray, 15Nov2012, see text; Computerized tomography, 15Nov2012, see text; Electrocardiogram, 15Nov2012, atrial fibrillation
CDC 'Split Type': B0846667A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA754AA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Aphasia, Chest X-ray normal, Computerised tomogram abnormal, Condition aggravated, Electrocardiogram abnormal, Hemiparesis, Mobility decreased
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)
Write-up: This case was reported by a physician via a regulatory authority (# 182133) and described the occurrence of exacerbation of hemiparesis in a 83-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject''s medical history included ischemic stroke. Concurrent medical conditions included atrial fibrillation, dysphasia and hemiparesis. Concurrent medications included COUMADIN. On 15 November 2012, the subject received an unspecified dose of FLUARIX (intramuscular, administration site unknown). On 15 November 2012, less than one day after vaccination with FLUARIX, the subject experienced exacerbation of hemiparesis and aphasia. The subject was hospitalised. At the time of reporting, the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with FLUARIX. Follow-up information received on 26 November 2012: The subject''s medical history included cementoplasty in May 2012 and cerebral ischemia. Concurrent medical conditions included anxious depressive syndrome, aphasia, chronic atrial fibrillation, hemiparesis of right face, mitral valve disease and osteoporosis with compression lumbar vertebrae. At the time of reporting, cerebral ischemia, right face hemiparesis and aphasia were improved. Historic medications included prednisolone. Concurrent medications included COUMADIN, atenolol, sertraline and lansoprazole. In May 2012, she had important immune reaction with purpura of the lower limbs as a result of therapy with bisphosphonate immediately suspended. She was treated with prednisone for about 3 weeks. At the time of vaccination, the subject was in good health without hyperthermia. On 15 November 2012, 1 hour after vaccination with FLUARIX, the subject experienced exacerbation of hemiparesis, complete aphasia and unable to get up. The subject was admitted to the neurology department. The computerized tomography showed evidence of large area of hypodensity left due to the ischemic lesion with signs of recent haemorrhage for which it was temporally suspended the OAT. On chest x-ray, there was no evidence of acute injury. The electrocardiogram showed atrial fibrillation as already known. There was no significant alterations for complete blood tests, no fever, no obvious skin reactions. Currently, the neurological deficit was without significant improvements.

VAERS ID:475412 (history)  Vaccinated:2012-11-15
Age:87.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Male  Submitted:2012-11-28, Days after onset: 12
Location:Foreign  Entered:2012-11-28
Life Threatening? No
Died? Yes
   Date died: 2012-11-20
   Days after onset: 4
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211ITA010964
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURERJ8336 IDUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.G009997 SCUN
Administered by: Other     Purchased by: Other
Symptoms: Death, Productive cough, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Case received from Health Authority (case n. 182595) through agency (local case n. IT614/12). Initial report received on 21-NOV-12. Case medically confirmed. An 87 year old male patient was vaccinated on 15-NOV-12 with one dose of INTANZA (batch n. J8336-1) i.d. and concomitantly with one dose of PNEUMOVAX (batch n. G009997) s.c.. On 16-NOV-12 he presented with febrile increase treated with TACHIPIRINA. On 17-NOV-12 and 18-NOV-12, the patient was afebrile. On 19-NOV-12 in the afternoon, there was a febrile increase with productive cough. He was treated with TACHIPIRINA and ceftriaxone i.m. On 20-NOV-12 at 6:15 am the patient died. The case is closed.

VAERS ID:478675 (history)  Vaccinated:2012-11-15
Age:69.0  Onset:2012-11-17, Days after vaccination: 2
Gender:Female  Submitted:2012-11-28, Days after onset: 11
Location:Foreign  Entered:2012-11-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Corticosteroids (unspecified); Diltiazem hydrochloride;NORVASC
Current Illness: Osteoarthritis; Blood cholesterol increased
Preexisting Conditions: Muscle spasms
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA008302
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Blister, Rash vesicular
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (narrow)
Write-up: This spontaneous report as received from a physician refers to a 69 years old female patient. That patient''s medical history included angina like spasm and the current conditions included high cholesterol and osteoarthritis. On 15-NOV-2012, the patient was vaccinated with a dose of, 0.5 milliliter (ml) ZOSTAVAX (lot#, expiry not reported) once subcutaneously. Concomitant medications included topical corticosteroids (unspecified) (corticosteroids (unspecified)), as metal ds, diltiazem hydrochloride and NORVASC. On 17-NOV-2012, the patient experienced blistering rash close to injection site on one side of body that looked like shingles. No diagnostic tests were performed. The patient sought medical attention (went to office). The physician reported that she had plans to treat the patient with VALTREX. The outcome of the event blistering rash close to injection site on one side of body that looked like shingles was unknown. Additional information has been requested.

VAERS ID:475663 (history)  Vaccinated:2012-11-15
Age:10.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Male  Submitted:2012-11-29, Days after onset: 14
Location:Foreign  Entered:2012-11-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Methylphenidate HCl
Current Illness: Attention deficit hyperactivity dis
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': D0077975A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Pain
SMQs:
Write-up: This case was reported by a foreign regulatory authority (# DE-PEI-PEI2012060149) and described the occurrence of general body pain whole left side in 10-year-old male subject who was vaccinated with INFLUSPLIT SSW (GlaxoSmithKline). The case was reported to the foreign regulatory authority (# DE-DCGMA-159445) by a hospital physician. Concurrent medical conditions included attention deficit hyperactivity disorder (ADHS). Concomitant medication included MEDIKINET. On 15 November 2012 the subject received a dose of INFLUSPLIT SSW (0.5 ml, intramuscular, unknown). Immediately post vaccination with INFLUSPLIT SSW, on 15 November 2012, the subject experienced general body pain whole left side which was spontaneously improving. The subject was hospitalised for an unknown period of time. At the time of reporting, on the next day, on 16 November 2012, the event was resolved. No further information will be available.

VAERS ID:476703 (history)  Vaccinated:2012-11-15
Age:12.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-12-05, Days after onset: 20
Location:Foreign  Entered:2012-12-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1212GBR001576
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Pallor, Tachycardia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was received from the health authority in a foreign country on 28-Nov-2012. GB-MHRA-ADR 21928546. This case is medically confirmed. A 12 year old female patient received an injection of GARDASIL (batch number reported as H013055), IM, 0.5mls, site not reported, on 15-Nov-2012. On 15-Nov-2012, five minutes post vaccination, the patient experienced dizziness and became pale for a short while. The same day the patient then had a prolonged episode of tachycardia for over one hour. She also had episodes of whole body shaking. At the time of reporting the patient was recovering. The events were considered to be medically significant by the reporter due to the prolonged period of tachycardia.

VAERS ID:476800 (history)  Vaccinated:2012-11-15
Age:0.6  Onset:2012-11-16, Days after vaccination: 1
Gender:Female  Submitted:2012-12-05, Days after onset: 19
Location:Foreign  Entered:2012-12-06, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': 2012300253
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF635576 SCRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site cellulitis
SMQs:
Write-up: This is a spontaneous report from a contactable physician received from the INFARMED. Regulatory Authority report number PT-INFARMED-N201211-69. A 7-month-old female patient of an unspecified ethnicity received a dose of PREVENAR 13, lot# F635576, via subcutaneous on 15Nov2012 at 1DF single for immunsiation, administered on the right thigh. The patient had no relevant medical history or concomitant medications. No other vaccine was administered concomitantly with PREVENAR 13. On 16Nov2012, the patient cellulitis (2cm diameter) on the right thigh, at the administration site . The event occurred one day after the administration of the vaccine and cause the hospitalization for 2 days. The action taken in response to the event for PREVENAR 13 was not applicable. Therapeutic measures taken as a result of cellulitis on the right thigh included administration of amoxicillin, clavulanic acid. The event resolved approximately two days after onset. At the time of the report the patient was recovered from the event.

VAERS ID:477781 (history)  Vaccinated:2012-11-15
Age:79.0  Onset:2012-11-18, Days after vaccination: 3
Gender:Female  Submitted:2012-12-12, Days after onset: 24
Location:Foreign  Entered:2012-12-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0851341A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA749B SCUN
Administered by: Other     Purchased by: Other
Symptoms: Ascites, Haemodialysis, Pericardial effusion, Pleural effusion, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Systemic lupus erythematosus (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), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad)
Write-up: This case was reported by a physician via a regulatory authority (# 184365) and described the occurrence of pericardic effusion in a 79-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included diabetes mellitus. On 15 November 2012 the subject received unspecified dose of FLUARIX (subcutaneous, unknown injection site). On 18 November 2012, 3 days after vaccination with FLUARIX, the subject experienced pericardic effusion, pleural effusion, ascites and renal failure. The subject was hospitalised. The subject was treated with hemodialysis. At the time of reporting the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with FLUARIX.

VAERS ID:478456 (history)  Vaccinated:2012-11-15
Age:34.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Female  Submitted:2012-12-13, Days after onset: 27
Location:Foreign  Entered:2012-12-17, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': PHHY2012DE113148
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)NOVARTIS VACCINES AND DIAGNOSTICS031011A IMLA
Administered by: Other     Purchased by: Other
Symptoms: Rash generalised, Rash pruritic, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Case number PHHY2012DE113148 is an initial spontaneous report from a physician via health authority (health authority reference number DE-PEI-PEI2012061998) received on 07 Dec 2012. This report refers to a 34-year-old female patient. The patient''s history included vaccination with influenza vaccines INN, which were well tolerated. The patient was vaccinated with OPTAFLU (batch no. 031011A) intramuscularly in her left upper arm on 15 Nov 2012. On 16 Nov 2012, the patient presented with pruritic rash, generalized urticarial exanthema (accented at extremities) lasting intermittently for seven days due to which she was hospitalized. She was treated with FENISTIL 8 mg, prednisolone 100 mg, SDH 250 mg and fexofenadine 180 mg. The outcome of the events was unknown. The events were reported as serious (hospitalization). The causality assessment of the events was reported as suspected.

VAERS ID:478557 (history)  Vaccinated:2012-11-15
Age:0.2  Onset:2012-11-15, Days after vaccination: 0
Gender:Unknown  Submitted:2012-12-17, Days after onset: 32
Location:Foreign  Entered:2012-12-18, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No personal and family medical history reported.
Diagnostic Lab Data:
CDC 'Split Type': 201211927
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER20911003A SCLA
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURERUVA11005 IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURH8097 IMRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anxiety, Crying, Diarrhoea, Mucous stools, Muscle spasms, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow)
Write-up: Case received from the Health Authorities through the local affiliate on 12 December 2012 under the reference number PL-URPL-N1410/2012. A 2-month-old patient (gender not reported), with no reported medical history, had received an intramuscular injection of ACTHIB (batch number H8097-1) in the right thigh concomitantly with an intramuscular injection of EUVAX B (batch number UVA 11005) in the left thigh and a subcutaneous injection of "PIX360326" interpreted as "DTP vaccine" (other manufacturer, batch number 20911003A) in the left arm on 15 November 2012. On 15 November 2012, since vaccination, the patient was anxious, he cried all the night and slept near 45 minutes. He experienced spasm and fever (from 38.0 degrees C to 38.4 degrees C) that persisted during 24 hours. He also developed diarrhea (loose stools with mucus four times). The patient recovered at an unspecified date. This case was reported as serious, i.e. as other medical important condition. The Health Authorities coded: anxiety, persistent crying, loose stools, muscle spasms and fever. Sender''s comment: "fever, persistent crying (atypical, inconsolable) are known reaction, expected after administration of above vaccine. Diarrhea is a reaction expected for EUVAX B and DTP. Anxious, spasm are unexpected and known reactions." Documents held by sender: none.

VAERS ID:478632 (history)  Vaccinated:2012-11-15
Age:13.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Female  Submitted:2012-12-18, Days after onset: 32
Location:Foreign  Entered:2012-12-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0853255A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Feeling hot, Lymphadenopathy, Pain
SMQs:
Write-up: This case was reported by a physician via a regulatory authority (AT-BASGAGES-123461) and described the occurrence of enlarged axillary lymph nodes in a 13-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 15 November 2012, the subject received an unspecified dose of BOOSTRIX (administration site and route unknown, batch number not provided). On 16 November 2012, 1 day after vaccination with BOOSTRIX, the subject experienced enlarged axillary lymph nodes, localized pain and localized feeling of warmth. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting, the events were improved.

VAERS ID:479478 (history)  Vaccinated:2012-11-15
Age:45.0  Onset:0000-00-00
Gender:Male  Submitted:2012-12-21
Location:Foreign  Entered:2012-12-27, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Previous vaccination with Td-IPV vaccine (manufacturer not reported) in 1994 was well tolerated. No infections during the last months.
Diagnostic Lab Data:
CDC 'Split Type': E201210115
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Mobility decreased, Muscular weakness, Paraesthesia, Speech disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow)
Write-up: Case was received from a healthcare professional on 04-Dec-2012. Case is medically confirmed. A 45-year-old male patient received a booster dose of COVAXIS (lot-no. not reported) IM on 15-Nov-2012. Unspecified time later in Nov-2012 (reported as "since two weeks") he complained of generalised muscular weakness and tingling of both hands and feet. He was found to have increased CK value (548, no unit reported). He hardly could climb stairs. No infections during the last months. At the time of reporting the patient had not recovered. A neurological check up was planned. Previous vaccination with Td-IPV vaccine (manufacturer not reported) in 1994 was well tolerated. Follow-up on 17-Dec-2012. Upon new information received via phone from the reporting physician the case was upgraded to serious. First unspecified symptoms occurred about 10 days p.v. The patient was then hospitalized on an unspecified date. He was treated with immunoglobulins for three days. Guillain Barre syndrome was diagnosed. The patient developed also speech disorder. He was discharged, in a not recovered status, on an unspecified date. Plasmapheresis and transfer to rehabilitation clinic were planned.

VAERS ID:479479 (history)  Vaccinated:2012-11-15
Age:0.1  Onset:2012-11-18, Days after vaccination: 3
Gender:Unknown  Submitted:2012-12-21, Days after onset: 33
Location:Foreign  Entered:2012-12-27, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No medical history reported.
Diagnostic Lab Data: Not reported
CDC 'Split Type': 201212176
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER20910001A SCLL
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURERUFA11006 SCRL
HIBV: HIB (ACTHIB)SANOFI PASTEUR49975 SCRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying
SMQs:, Depression (excl suicide and self injury) (broad)
Write-up: Case received from the health Authorities through the local affiliate on 17 December 2012 under the reference number PL-URPL-N1472/2012. A 06-week-old patient (gender not reported), with no reported medical history, had received a subcutaneous injection of ACT-HIB (batch number "49975-1") in the right thigh, concomitantly with a subcutaneous injection of EUVAX B (batch number UFA 11006) in the right thigh and a subcutaneous injection of DTP (other manufacturer, batch number 20910001A) in the left thigh on 15 November 2012. Three days after vaccination, i.e. on 18 November 2012, the patient experienced uncontrollable crying: the mother could not calm the patient. The patient was hospitalized for 2 days. The patient recovered at an unspecified date. The Health Authorities coded: persistent crying. Sender''s comment: "crying (inconsolable, atypical, persistent, without obvious reason) is expected reaction for above vaccines". Documents held by sender: none.

VAERS ID:479558 (history)  Vaccinated:2012-11-15
Age:13.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-12-27, Days after onset: 42
Location:Foreign  Entered:2012-12-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1212IRL009449
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NP008601IMUN
Administered by: Other     Purchased by: Other
Symptoms: Muscular weakness, Pain in extremity, Sensory disturbance
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: This case was received from the health authority in a foreign country on 18-Dec-2012. IMB REF 2012-015695. This case is medically confirmed. The primary reporter is a physician. A 13-year-old female patient, with no reported medical history and no concomitant medication, was vaccinated with a second dose of GARDASIL (batch no. G019345, dose and site of administration not reported) on 15-Nov-2012 and on the same day she experienced soreness/pain in her left arm followed by persistent weakness in her left arm/hand and a funny sensation that evening. The patient was seen by a paediatrician. No corrective treatment was done to date. At the time of reporting the patient had not recovered. The IMB considered this case to be serious as an other medically important condition.

VAERS ID:482420 (history)  Vaccinated:2012-11-15
Age:0.6  Onset:2012-11-21, Days after vaccination: 6
Gender:Unknown  Submitted:2013-01-17, Days after onset: 57
Location:Foreign  Entered:2013-01-24, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 09-AUG-2012, PREVENAR 13, Batch G06048; 09-OCT-2012, PREVENAR 13, Batch G06048; 09-OCT-2012, INFANRIX HEXA
Diagnostic Lab Data:
CDC 'Split Type': 2013014508
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF9583342IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Agranulocytosis, Exanthema subitum, Immunosuppression, Infection, Pyrexia
SMQs:, Agranulocytosis (narrow), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: This is a spontaneous report from a contactable physician through a Pfizer sales representative. A 10-months-old baby of an unspecified ethnicity received the third dose of PREVENAR 13 (Batch F958334, expiration date Sep2014) intramuscular on 15Nov2012. The patient medical history was not reported. The patient''s concomitant medications were not reported. The first dose of PREVENAR 13 was administered on 09Aug2012, the second dose was administered on 09Oct2012 (Batch G06048, expiration date Jan2015). The vaccine was administered into the left thigh. The patient has also vaccination history included INFANRIX HEXA, the third dose (the last dose) was administered on 09Oct2012. The baby was brought to the pediatrician on 21Nov2012 because he had a fever. It was sent to the hospital where was hospitalized from 21Nov2012 to 29Nov2012. At the hospital it was made a diagnosis of agranulocytosis vs. parainfectious and exanthema subitum; also "affection" of PREVENAR 13 was mentioned. The patient was subsequently examined as outpatient on 04Dec2012 and 11Dec2012 and status post exanthema subitum and IgA immunosuppression were stated. The patient was hospitalized again from 01Jan2013 to 03Jan2013 due to agranulocytosis and ongoing infection. At the time of the report the patient was not recovered. The patient received pharmacotherapy treatment for agranulocytosis, infection and exanthema subitum. Follow-up attempts completed. No further information expected.

VAERS ID:482449 (history)  Vaccinated:2012-11-15
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2013-01-24
Location:Foreign  Entered:2013-01-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0860583A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC119CD IMUN
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALSA69CD055A IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Asthenia, Back pain, Dizziness, Gait disturbance, Hepatitis B antibody negative, Muscular weakness, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: This case was reported by a physician and described the occurrence of muscle weakness in a 22-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline) and PRIORIX (GlaxoSmithKline). On 15 November 2012 the subject received an unspecified dose of ENGERIX B (20 mcg, intramuscular, Batch number AHBVC119CD) and unspecified dose of PRIORIX (1 injection, intramuscular, Batch number reported as A69FD055A. Following lot number review this was corrected to A69CD055A). In November 2012, less than one week after vaccination with ENGERIX B and PRIORIX, the subject experienced muscle weakness, weakness, dizziness, abdominal pain, limb pain, back pain and walking difficulty. On 19 November 2012 the subject was hospitalised due to the events. The physician stated that this was not an allergic reaction. On 22 November 2012 the patient was discharged from hospital and the muscle weakness, weakness, dizziness, abdominal pain, limb pain, back pain and walking difficulty were resolved. It was also reported the patient''s blood levels were checked and there were no surface antibodies identified for Hepatitis B. The physician stated the patient was unable to attend nursing school as she has not gained protection against Hepatitis B. The patient had ''gained immunity'' to measles and rubella but it was unknown if the patient had ''gained immunity'' to mumps.

VAERS ID:483450 (history)  Vaccinated:2012-11-15
Age:16.0  Onset:2012-11-17, Days after vaccination: 2
Gender:Male  Submitted:2013-02-04, Days after onset: 79
Location:Foreign  Entered:2013-02-05, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The data concerning the patient''s previous reactions to vaccinations were not known.
Diagnostic Lab Data: On an unspecified date, lab results showed: SE: 25, CRP: 20, CK: 295, Tr: 153, AST: 40 and Eosinophils: 20 (no units provided). Hemoculture and urinoculture tests were negative. Stool bacteriology and parasitology tests were negative. Adenovirus and Rota virus tests were negative. Lab results on the discharge day: CRP: 6.4, AST: 57, Eo: 8, TR: 124 and CK: 311 (no units reported).
CDC 'Split Type': 201301041
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEUR  IMAR
TD: TD ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Adenovirus test, Aspartate aminotransferase increased, Bacterial test negative, Blood creatine phosphokinase increased, Blood culture negative, C-reactive protein increased, Culture urine negative, Enterocolitis, Eosinophil percentage increased, Injection site pain, Myalgia, Parasite stool test negative, Pyrexia, Rotavirus test negative
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Extravasation events (injections, infusions and implants) (broad), Ischaemic colitis (broad), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (broad)
Write-up: Case received from the Health Authorities through a distributor on 22 January 2013. A 16-year-old male patient, with no reported medical history, was hospitalized two days after receiving his intramuscular dose of IMOVAX POLIO (batch number not reported) in the arm, concomitantly with his dose of diphtheria and tetanus vaccine (other manufacturer, batch number and route of administration not reported) in the arm, on 15 November 2012. Data concerning previous reactions to vaccination were not known. The patient was hospitalized due to thigh fever (40 degrees C), pain on the injection site of both arms and myalgia. High temperature was present for 12 hours and then went down to normal values due to therapy with antipyretics. During the hospitalization, he developed enterocolitis of unknown etiology and stayed in the hospital for 12 days. It was reported that according to the information received from the Agency''s AE report, duration of symptoms was 3 days. On an unspecified date, lab results showed: SE: 25, CRP: 20, CK: 295, Tr: 153, AST: 40 and Eosinophils: 20 (no units provided). Hemoculture and urinoculture tests were negative. Stool. bacteriology and parasitology tests were negative. Adenovirus and Rota virus tests were negative. Lab results on the discharge day: CRP: 6.4, AST: 57, Eo: 8, TR: 124 and CK: 311 (no units reported). The final outcome was "recovering/resolving". According to the reporter, the causality of drug to reaction was possible. Documents held by sender: none.

VAERS ID:483768 (history)  Vaccinated:2012-11-15
Age:63.0  Onset:2012-11-28, Days after vaccination: 13
Gender:Male  Submitted:2013-02-07, Days after onset: 71
Location:Foreign  Entered:2013-02-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0865139A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA750AA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Gait disturbance, Guillain-Barre syndrome, Immunoglobulin therapy, Paraesthesia
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow)
Write-up: This case was reported by a physician via a regulatory authority (# 190782) and described the occurrence of suspected Guillain Barre Syndrome in a 63-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 15 November 2012, the subject received an unspecified dose of FLUARIX (0.5 ml, intramuscular, unknown injection site). On 28 November 2012, 13 days after vaccination with FLUARIX, the subject experienced paresthesia and walking difficulty. A Guillain Barre Syndrome was suspected. This case was assessed as medically serious by GSK. The subject was treated with normal immunoglobulin. At the time of reporting, the event were improved. The regulatory authority reported that the events were possibly related to vaccination with FLUARIX.

VAERS ID:484650 (history)  Vaccinated:2012-11-15
Age:0.2  Onset:0000-00-00
Gender:Male  Submitted:2013-02-14
Location:Foreign  Entered:2013-02-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient medical history and concomitant medication was not reported.
Diagnostic Lab Data: Laboratory details were not reported.
CDC 'Split Type': 201301788
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME)SANOFI PASTEUR1453059 UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Feeling hot, Hypotonic-hyporesponsive episode, Laboratory test, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (narrow), Hypersensitivity (broad)
Write-up: This initial case report is part of a batch of reports associated with several products that was received on 04 February 2013 by the Sanofi Pasteur affiliate in a foreign country who received the report from the Foreign Ministry of Health. A male patient, whose medical history and concomitant therapies were not reported, had received his 1st dose of IPV (mfr unk), PENTA, VORH and Pneumo 10 vaccine, "The lot number is reported as "1453059" but it is not mentioned which vaccine this batch number refers to", (route and anatomical site of administration not reported) on 05 November 2012. On an unspecified date post-vaccination the patient experienced Pain; Redness; Heating; Hypotonic hyporesponsive episode; Fever more than or equal to 39.5C. The patient''s outcome was recovered ("cure") without sequelae. The action regarding next vaccinations is reported as: contraindication with scheme change. The resolution was reported as "indefined". The case was assessed as serious by the Ministry of Health. The patient was hospitalized. Documents held by sender: None.

VAERS ID:485088 (history)  Vaccinated:2012-11-15
Age:5.0  Onset:2012-11-26, Days after vaccination: 11
Gender:Male  Submitted:2012-12-03, Days after onset: 7
Location:Foreign  Entered:2013-02-20, Days after submission: 79
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness: Common cold
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': 2012SE91482
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AF2105 IN 
Administered by: Other     Purchased by: Other
Symptoms: Henoch-Schonlein purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Vasculitis (narrow), Hypersensitivity (narrow)
Write-up: A report has been received from a physician concerning a five year-old male patient. The patient''s medical history, concomitant medications were not reported. The patient''s concurrent disease was reported as common cold. On 15-Nov-2012 the patient received nasal FLUENZ. On 26-Nov-2012 the patient was diagnosed with Henoch-Schonlein purpura. Leukosis had been excluded. At the time of reporting the event was ongoing. The case has been assessed as serious due to medical importance by company physician. According to the reporter there was a causal relationship between the suspect drug of FLUENZ and the event of Henoch-Schonlein purpura.

VAERS ID:485397 (history)  Vaccinated:2012-11-15
Age:14.0  Onset:2012-12-17, Days after vaccination: 32
Gender:Female  Submitted:2013-02-25, Days after onset: 70
Location:Foreign  Entered:2013-02-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Febrile convulsion, The patient had a medical history of febrile convulsion at the age of 2-3 years.
Diagnostic Lab Data: On 17-Dec-2012, she was unresponsive until the ambulance arrived after about 5 minutes. When lying blood pressure was 110/75, after standing about 2 minutes blood pressure was 105/85-90 with significant increased heart rate. She was afebrile, hemoglobin was 124, WBC in normal range, CRP less than 1, glucose, creatinine and electrolytes were without remarks. ECG was normal.
CDC 'Split Type': WAES1302SWE008780
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0053420UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood creatinine normal, Blood electrolytes normal, Blood glucose normal, C-reactive protein normal, Dizziness, Electrocardiogram normal, Fatigue, Haemoglobin normal, Headache, Heart rate increased, Infection, Nausea, Pyrexia, Syncope, Unresponsive to stimuli, White blood cell count normal
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Initial case was reported as serious by health care professional via the Health Authority on 12-Feb-2013 under the reference 130126. Case medically confirmed. A 14-year-old female patient (weight and height not reported) with a medical history of febrile convulsion at the age of 2-3 years, had received the first dose of GARDASIL (batch number H005342) via not reported route and site of administration on 15-Nov-2012. After vaccination she had headache and several infectious episodes. The patient also developed nausea on an unspecified date. On 17-Dec-2012, she sought emergency as she woke up in the morning with headache. She took a pill of ALVEDON and then, on her way to school, she fainted. She was unresponsive until the ambulance arrived after about 5 minutes. When lying blood pressure was 110/75, after standing about 2 minutes blood pressure was 105/85-90 with significant increased heart rate. She felt a little dizzy. She was afebrile, hemoglobin was 124, WBC in normal range, CRP less than 1, glucose, creatinine and electrolytes were without remarks. ECG was normal. She was monitored in the clinic during the day where she was perking up and behaved adequately. It appeared that she had a week-long episode until a week ago with high fever when she raved and since that she had been rather tired. The patient possibly fainted due to the previous infection episodes and due to heavy periods, but epileptic seizures could not be ruled out. No concomitant medication was reported. At the time of reporting, the patient had recovered within an unspecified timeframe. According to the Health Authority, the events were possibly related to the vaccination. No further information expected. Upon medical review, the manufacturer coded the adverse event "epileptic seizure" which was mentioned in the narrative but not coded by HA.

VAERS ID:485676 (history)  Vaccinated:2012-11-15
Age:76.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2013-02-26, Days after onset: 103
Location:Foreign  Entered:2013-02-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Limb pain; Loss of muscular force; Paresthesia
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0870268A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA750AA SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Guillain-Barre syndrome, Peripheral sensorimotor neuropathy
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)
Write-up: This case was reported by a consumer via a regulatory authority (# 193639) and described the occurrence of sensorimotor polyneuropathy in a 76-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included 4 limbs pain, reduction in force of four limbs and paresthesia. On 15 November 2012, the subject received unspecified dose of FLUARIX (unknown route and injection site). On 15 November 2012, 1 day after vaccination with FLUARIX, the subject experienced sensorimotor polyneuropathy Guillain Barre like. The subject was hospitalised. At the time of reporting the event was improved.

VAERS ID:485770 (history)  Vaccinated:2012-11-15
Age:0.3  Onset:2012-11-30, Days after vaccination: 15
Gender:Male  Submitted:2013-02-27, Days after onset: 89
Location:Foreign  Entered:2013-02-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0869598A
Vaccination
Manufacturer
Lot
Dose
Route
Site
BCG: BCG (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
DTAPIPV: DTAP + IPV (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  UNUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSAROLA431AA1PO 
Administered by: Other     Purchased by: Other
Symptoms: Eczema, Haematochezia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), Hypersensitivity (narrow)
Write-up: This female subject was enrolled in a prophylactic post-marketing surveillance open study. On 09 October 2012 and 15 November 2012, she received the 1st and 2nd dose of ROTARIX (PO). On 30 November 2012, 15 days after the 2nd dose of ROTARIX, this three-month-old subject developed eczema. The event was clinically significant (or requiring intervention). The subject was treated with petrolatum. The event resolved on 14 December 2012. The investigator considered that there was no reasonable possibility that the eczema may have been caused by ROTARIX and that the event was possibly due to [other contributing factors]. Investigator comments: This case is sent in response to MHRA inspection. 09 October 2012: A subject was vaccinated with the first dose of ROTARIX (oral). Lot number: AROLA429BA. 01 November 2012: The patient experienced bloody stool. 15 November 2012: The subject was vaccinated with the second dose of ROTARIX. Lot number: AROLA431AA. 30 November 2012: Eczema developed. Treatment with PROPETO was performed for the adverse event.

VAERS ID:495674 (history)  Vaccinated:2012-11-15
Age:66.0  Onset:2012-12-09, Days after vaccination: 24
Gender:Male  Submitted:2013-07-02, Days after onset: 204
Location:Foreign  Entered:2013-07-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EXFORGE; FLUDEX; ZESTRIL; KARDEGIC; XATRAL
Current Illness: Type 2 diabetes mellitus; Hypertension; Renal failure chronic; Arteritis; Gout
Preexisting Conditions:
Diagnostic Lab Data: Blood creatinine, High, 210 umol/l
CDC 'Split Type': PHHY2013FR066867
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)NOVARTIS VACCINES AND DIAGNOSTICS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Biopsy, Blood creatinine increased, Cardiac failure, Eczema, Eosinophil count increased, Eosinophilia, Prurigo, Viral infection
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (narrow), Retroperitoneal fibrosis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad)
Write-up: Case number PHHY2013FR066867, is an initial spontaneous report received from an other-health care professional via a foreign Health Authority (HA number: RN20130652) on 24 Jun 2013. This report refers to a 68-years-old male patient. Concurrent condition of the patient included non-insulin-dependent diabetes mellitus, hypertension, chronic renal insufficiency, arteritis and gout. Concomitant medication included ZESTRIL, KARDEGIC and XATRAL. The patient received EXFORGE for an unknown indication since an unknown start date and dose, FLUDEX for an unknown indication since an unknown start date and dose orally. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) intramuscularly on 15 Nov 2012. On 19 Dec 2012, the patient consulted dermatologist for eczematous reaction which evolved over 10 days. Etiologic hypothesis included virosis for which a treatment with DIPROSONE and an unspecified anti-histaminic (manufacturer unknown) was introduced. During monitoring consult on 27 Dec 2012 and 11 Jan 2013, persistence of the eruption was noted with aggravation of cardiac decompensation, requiring hospitalization on 11 Jan 2013. At entrance, the patient presented with eczematous reaction of the lower limb and forearms with an aspect of prurigo at trunk level. Biological workup showed hypereosinophilia at 1.34G/L with normal hepatic workup, blood creatinine at 210mcmol/L. The biopsy performed was not conclusive. At a dermatological level, eczema outcome was favorable under dermoval treatment. Etiological investigation did not find any treatment modification for several months but a vaccination against flu 3 weeks before the eruption appearance. In absence of other etiological argument, the clinicians concluded that it was a possible eczema-like toxicoderma-type reaction secondary to vaccination. Nevertheless, EXFORGE and FLUDEX were discontinued. The event outcome was reported as complete recovery. The foreign health authority only coded Reaction eczematous as a serious event (hospitalization) and assessed as unlikely related to the suspected drugs EXFORGE and FLUDEX and influenza vaccine.

VAERS ID:501603 (history)  Vaccinated:2012-11-15
Age:26.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Female  Submitted:2013-09-06, Days after onset: 294
Location:Foreign  Entered:2013-09-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELOTROXIN; lamotrigine; KALEORID; CENTYL; GESTONETTE
Current Illness: Unknown
Preexisting Conditions: Epilepsy; Hypothyroidism
Diagnostic Lab Data:
CDC 'Split Type': WAES1309DNK001380
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Condition aggravated, Convulsion, Dizziness, Epilepsy, Malaise, Rash
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: Case received from consumer via the Health Authorities in a foreign country on 26-Aug-2013 under the reference number 22219015 and EFO6616. Case not medically confirmed. A 26 year old female patient (weight 120 kg and height 175 cm) had received an injection of GARDASIL (dose 1, batch number not reported, site and route of administration not reported) on 15-Nov-2012 and later on, the same day, she developed increased frequency of seizures. Concomitant drugs at the time of vaccination: ELTROXIN, Lamotrigin, KALEORID, CENTYL, GESTONETTE. The patient is suffering from epilepsy and prior to vaccination she had only one attack every 12 months. After the first vaccination (15-Nov-2012) with GARDASIL, she developed her first epileptic seizure since several months back. This time worse than ever. On 19-Nov-2012 (HA reported 19-Nov-2013, presumably type wrong) she developed malaise and again seizures. Now more than 6 months later, the seizure is still not under complete control and the patient is on sick leave. The patient was unsure whether she should receive the second vaccination. She then chose to receive it (GARDASIL, dose 2, batch number not reported, site and route of administration not reported, vaccination date unspecified in 2013) in order to clarify whether the seizure was worsening because of the vaccine (and according to patient it could actually be worse). Subsequently, she got rashes and dizziness as well as several attacks (even though she had experienced it previously). After the third vaccination (GARDASIL, dose 3, batch number not reported, site and route of administration not reported, vaccination date not reported) the symptom was not quite as bad. The patient has received the following treatment for the side effect: Epilepsy medication (product name not reported). The patient had not been hospitalised because of adverse reaction. The HA has requested medical confirmation and reply is awaited. HA has reported rechallenged. The patient thinks that the adverse events are related to vaccination but no one takes her seriously. The patient has a history of hypothyroidism and epilepsy. At the time of reporting, the outcome was recovering for increased frequency for seizures and unknown for dizziness, rash and malaise.

VAERS ID:503513 (history)  Vaccinated:2012-11-15
Age:3.0  Onset:2013-03-02, Days after vaccination: 107
Gender:Unknown  Submitted:2013-04-15, Days after onset: 43
Location:Foreign  Entered:2013-09-20, Days after submission: 158
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Influenza B quick test, positive
CDC 'Split Type': 2013SE25507
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AF2105 IN 
Administered by: Other     Purchased by: Other
Symptoms: Influenza, Influenza B virus test positive
SMQs:
Write-up: A report received from a physician via Regulatory Authority (PEI) described a 3-year-old child of unknown gender. Medical history and concomitant medications were not reported. On 12-Nov-2012 the patient received vaccination with nasal FLUENZ (lot number AF2105). On 02-Mar-2013, despite the vaccination the patient developed influenza B confirmed by influenza B quick testing method. Outcome of the influenza infection was not reported and further information is not expected. The company physician assessed the infection to be serious as an important medical event.

VAERS ID:474628 (history)  Vaccinated:2012-11-16
Age:60.0  Onset:2012-11-16, Days after vaccination: 0
Gender:Female  Submitted:2012-11-16, Days after onset: 0
Location:Arkansas  Entered:2012-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: The patient stated that she was well, and had been well prior to the vaccine administration. She reported no recent illness, use of antibiotics, or any other medication used for cold or flu symptoms in the past few weeks.
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.HO139440SCRA
Administered by: Other     Purchased by: Private
Symptoms: Respiratory distress, Tonic convulsion, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad)
Write-up: Unresponsiveness, respiratory distress, tonic seizure activity, unsure if patient lost consciousness.

VAERS ID:477013 (history)  Vaccinated:2012-11-16
Age:0.2  Onset:2012-11-16, Days after vaccination: 0
Gender:Male  Submitted:2012-11-16, Days after onset: 0
Location:South Carolina  Entered:2012-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4298AA0IMRL
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC189AA0IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG150740IMLL
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Local reaction, Screaming
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Four hours after receiving vaccines patient started screaming for 20 minutes, local reaction - redness & swelling at site.

VAERS ID:475839 (history)  Vaccinated:2012-11-16
Age:60.0  Onset:2012-11-26, Days after vaccination: 10
Gender:Female  Submitted:2012-11-30, Days after onset: 4
Location:California  Entered:2012-11-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Flu symptoms~Influenza (Seasonal) (no brand name)~~52.00~Patient
Other Medications: Multivitamin, Caltrate, fish oil, ASA 82 mg
Current Illness: No
Preexisting Conditions: None. Typically very healthy
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
Administered by: Public     Purchased by: Other
Symptoms: Chills, Malaise, Nausea, Pyrexia,