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Case Details (Sorted by Age)

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VAERS ID:589175 (history)  Vaccinated:2015-06-09
Age:35.0  Onset:2015-06-09, Days after vaccination: 0
Gender:Female  Submitted:2015-08-09, Days after onset: 61
Location:Nevada  Entered:2015-08-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS5MGSS IMLA
Administered by: Private     Purchased by: Private
Symptoms: Feeling abnormal, Injection site pain, Pain, Pain in extremity
SMQs:, Dementia (broad), Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)
Write-up: Per patient, “On June 9, 2015 I went to your clinic for a Tdap vaccine and now I''m having to forgo physical therapy for this arm. I wanted to inform a Manager that this happened. Maybe the shot was given too high in the arm. It felt funny. Not only the normal pain associated with the vaccine but it felt weird. It hurt if I lay on that side, it hurt when driving. The whole left arm and shoulder area, any movement with that arm causes pain.”

VAERS ID:590182 (history)  Vaccinated:2015-08-03
Age:35.0  Onset:2015-08-03, Days after vaccination: 0
Gender:Female  Submitted:2015-08-06, Days after onset: 3
Location:Wisconsin  Entered:2015-08-11, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.L004658 SCLA
TDAP: TDAP (ADACEL)SANOFI PASTEURU5213BA IMRA
Administered by: Other     Purchased by: Unknown
Symptoms: Asthenia, Dyspnoea, Pain
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad)
Write-up: Body aches, weakness, shortness of breath.

VAERS ID:589720 (history)  Vaccinated:2014-10-01
Age:35.0  Onset:2014-12-09, Days after vaccination: 69
Gender:Female  Submitted:2015-08-12, Days after onset: 245
Location:Unknown  Entered:2015-08-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Venlafaxine; Prenatal vitamins; Vitamin D Omega 3; BENADRYL; Cinnamon; ZOFRAN; Docusate; TUMS; TYLENOL 8 hour; Iron; Fibre, dietary; Trazodone
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Ultrasound scan, Normal, 05/22/14; Ultrasound scan, Normal, 04/08/14
CDC Split Type: 2015052802
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDT56905 SYRUN
TDAP: TDAP (ADACEL)SANOFI PASTEUR  SYRUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Congenital anomaly, Foetal exposure during pregnancy, Right atrial dilatation, Stillbirth
SMQs:, Congenital, familial and genetic disorders (narrow), Pulmonary hypertension (narrow), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: This report from study was reported via Pregnancy Registry (initial receipt 29-Jul-2015) concerns a neonate patient. Concomitant medications, received via the mother in utero, included venlafaxine, prenatal vitamins, Krill oil, diphenhydramine, cinnamon capsules, ondansetron, docusate, TUMS, paracetamol, iron, fibre laxative/supplement and trazodone. The 35-year-old mother had a medical history of high blood pressure (diagnosed in 2010), anemia (diagnosed in 1999), depression (diagnosed in 2001), psoriasis (diagnosed in 2000), Multiple Sclerosis (diagnosed in 2011), indigestion, headache, insomnia and low iron. The mother also consumed coffee (from 03-Mar-2014, oral, 8 oz 3/week), caffeine (soda, from 03-Mar-2014, oral), beer (on 07-Apr-2014), 3 servings a day, oral), and inhaled cigarette smoking (from 03-Mar-2014 to 07-Apr-2014, 2 cigarettes per day, stopped at approximately 5 weeks). The mother had an emergency room visit on 30-Mar-2014 for the cut finger in which she needed stitches and took ibuprofen/diphenhydramine on 30-Mar-2014. (Refer to the mother case: 2015052801). On 01-Oct-2014, the patient received AFLURIA injection (batch number T56905) at 1 shot a day, in utero via the mother. On the same day, the patient also received ADACEL vaccine injection (batch number not provided) at 1 shot a day, in utero via the mother. On 29-Oct-2014, the patient''s mother underwent a glucose tolerance test which was normal. On 08-Nov-2014, the patient''s mother developed a respiratory infection. The patient was born/stillbirth (gestational age at delivery 37.1, birth weight was 2611 grams), and was diagnosed with right atrial enlargement at birth. Medical record confirmation was pending. The outcome was not reported. Reporter comments: The reporter assessed the event as serious (congenital anomaly).

VAERS ID:590378 (history)  Vaccinated:2015-07-24
Age:35.0  Onset:0000-00-00
Gender:Female  Submitted:2015-08-12
Location:Unknown  Entered:2015-08-12
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: WAES1508USA003786
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: 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 the patient''s husband referring to his wife a 35 year old patient. There was no pertinent medical history or drug allergies/drug reactions. On approximately 24-JUL-2015 reported as "two weeks ago", the patient was vaccinated with PROQUAD (Merck), subcutaneous injection (dose, lot# and expiration date not provided). There was no concomitant medication described. The reporter stated that, it was recently confirmed (unspecified date) that the patient was pregnant which was considered as an exposure during pregnancy. Last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. No adverse effects were reported. At the time of the report, the outcome of exposure during pregnancy was unknown. Additional information is not expected as no reporter details were provided.

VAERS ID:590691 (history)  Vaccinated:2015-08-16
Age:35.0  Onset:2015-08-17, Days after vaccination: 1
Gender:Female  Submitted:2015-08-18, Days after onset: 1
Location:Arizona  Entered:2015-08-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin, metforim, Topamax, Synthroid, Singulair
Current Illness: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT)GLAXOSMITHKLINE BIOLOGICALS9525T IM 
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.L007720 IM 
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSXE2DJ IM 
Administered by: Public     Purchased by: Private
Symptoms: Injection site erythema, Mobility decreased, Pain in extremity
SMQs:, Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)
Write-up: Patient called 08/18/2015 stating her arm hurts to the point where she is unable to really move it and starting to look red at injection site. Instructed patient to be seen by doctor.

VAERS ID:590891 (history)  Vaccinated:2015-08-14
Age:35.0  Onset:2015-08-14, Days after vaccination: 0
Gender:Male  Submitted:2015-08-17, Days after onset: 3
Location:New York  Entered:2015-08-18, 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: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT)GLAXOSMITHKLINE BIOLOGICALSDF47X IMLA
Administered by: Other     Purchased by: Private
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Patient complained of numbness of the arm, after administration of FLUARIX QUAD vaccine.

VAERS ID:591169 (history)  Vaccinated:2015-08-11
Age:35.0  Onset:2015-08-13, Days after vaccination: 2
Gender:Female  Submitted:2015-08-13, Days after onset: 0
Location:Ohio  Entered:2015-08-20, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None reported
Preexisting Conditions: No known allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS202010IMLA
Administered by: Public     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: Employee presents to dept. 48 hours after Tdap to report redness around injection site that is slightly raised. No pain or illness symptoms.

VAERS ID:591330 (history)  Vaccinated:2015-08-04
Age:35.0  Onset:2015-08-04, Days after vaccination: 0
Gender:Male  Submitted:2015-08-18, Days after onset: 14
Location:Kentucky  Entered:2015-08-21, 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: Aspirin; atorvastatin; cetirizine; clopidogrel; losartan; meloxicam; metformin; methocarbamol; nortriptyline; omeprazole; ropinirole; sertraline
Current Illness: Diabetes; morbid obesity; GERD; hyperlipidemia; CAD; headache; lumbar spinal stenosis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU5213BA1UNLA
Administered by: Other     Purchased by: Other
Symptoms: Dyspnoea, Hypersensitivity, Pruritus generalised, Rash generalised, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 8/6/2015 pt presents today with widespread hives/itching that he states started on Tues evening after his visit to clinic, where he received a Tdap. States rash started on his scalp, is now on his body, arms, legs. Has been taking BENADRYL 25 mg bid with some relief but cont to itch. Denies SOA, wheezing, chest tightness. 8/7/2015 ED PLAN: switch from BENADRYL to ATARAX: 25-50 mg 3 times a day. Also take prednisone 60 mg a day until rash is gone and then taper it off by 20 mg a day over a week. Add ZANTAC 300 mg a day if still having hives, and rub itching areas with 1% hydrocortisone cream whenever needed, instead of scratching. Ok to use Aveeno anti-itch products as well. Meds given in ED that day: 1253 epi 0.3mg IM given in Right deltoid and prednisone 60mg, BENADRYL 25mg and PEPCID 40mg po given. 1405 epi 0.3mg IM in left deltoid tolerated well. Patient was also seen that evening by local ED for difficulty breathing. 8/10/2015, PC visit. Rash and itching went away yesterday, but resumed today. Continue prednisone 60 mg x 1 wk, then start decreasing by 10 mg every 4 days continue hydroxyzine and ranitidine. 8/19/2015 ADDENDUM spoke with patient Allergic reaction has subsided, last dose of prednisone was yesterday 8/18. Allergy Consult appointment for 9-20-2015. Diphenhydramine 25 mg BID, dexamethasone 8 mg once, prednisone 60mg x 3, 40mgx3, 20mgx3.

VAERS ID:594307 (history)  Vaccinated:0000-00-00
Age:35.0  Onset:0000-00-00
Gender:Female  Submitted:2015-08-31
Location:North Carolina  Entered:2015-08-31
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: Immunodeficiency
Preexisting Conditions: Spienectomy
Diagnostic Lab Data:
CDC Split Type: WAES1508USA006856
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a physician via a company representative referring to a 35 year old non-pregnant female patient. The patient had underwent a splenectomy prior and was immunocompromised currently. Drug reactions/allergies were not reported. On an unknown date, the prescribing physician recommended ZOSTAVAX to the patient because the patient was immunocompromised. On an unknown date the patient was vaccinated with 1 vial regular dose of ZOSTAVAX (dose frequency, lot # and expiration date were not reported) in an unknown pharmacy (inappropriate schedule of drug administrating, medication error). On an unknown date in August 2015 "last week", the patient had a reaction from the elbow to the shoulder on an unspecified arm. The affected area was red, warm, swollen and "tender to the touch". On an unknown date, the patient sought medical attention and prednisone (manufacturer unknown) and an unspecified antibiotic were given as treatment. The outcome of the events was unknown. The relatedness of erythema, feeling hot pain in extremity and peripheral swelling to ZOSTAVAX was unknown. Additional information has been requested.

VAERS ID:594551 (history)  Vaccinated:2015-08-29
Age:35.0  Onset:2015-08-29, Days after vaccination: 0
Gender:Male  Submitted:2015-09-01, Days after onset: 3
Location:Virginia  Entered:2015-09-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRUN
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRUN
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Fever, redness and tenderness to injection site.

VAERS ID:594193 (history)  Vaccinated:2015-07-27
Age:35.0  Onset:0000-00-00
Gender:Female  Submitted:2015-09-08
Location:Washington  Entered:2015-09-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol, ibuprofen
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: Positive HCG test 1 Sep 2015
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV42746IMLA
Administered by: Military     Purchased by: Military
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Inadvertent administration of anthrax vaccination with subsequent discovery of pregnancy.

VAERS ID:595815 (history)  Vaccinated:2015-08-19
Age:35.0  Onset:2015-08-20, Days after vaccination: 1
Gender:Female  Submitted:2015-09-09, Days after onset: 20
Location:Georgia  Entered:2015-09-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No routine medications; TUBERSOL
Current Illness: (R) ear congestion on exam - not ill
Preexisting Conditions: Migraines; 7/30/15 reports local reaction - finger to insect bite - signif. edema
Diagnostic Lab Data: No
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU5082BA0IDUN
Administered by: Other     Purchased by: Public
Symptoms: Drug administered at inappropriate site, Incorrect route of drug administration, Injection site pruritus, Pyrexia, Tuberculin test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: MENACTRA administered by ID route inadvertently in (R) forearm approximately 9 AM. MENACTRA IM (L) deltoid; TB skin test ID left forearm - called Sanofi - advised to observe in 48 hours - awakened at 2 AM on 8/20/15 with fever 101, itchy (R) forearm at admin. site.

VAERS ID:595820 (history)  Vaccinated:2015-08-27
Age:35.0  Onset:0000-00-00
Gender:Female  Submitted:2015-08-31
Location:Washington  Entered:2015-09-09, 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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS3N53A IMLA
Administered by: Private     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness, hot to touch, swelling around injection site.

VAERS ID:594792 (history)  Vaccinated:2015-09-09
Age:35.0  Onset:2015-09-09, Days after vaccination: 0
Gender:Female  Submitted:2015-09-10, Days after onset: 1
Location:New York  Entered:2015-09-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergies
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED  UNAR
Administered by: Other     Purchased by: Private
Symptoms: Chills, Dry throat, Headache, Heart rate increased, Ocular hyperaemia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Glaucoma (broad)
Write-up: Got on 9/9 dry throat, eyes bloodshot that night chills, headache, fast HR-started at 2pm-mild sx 2 yrs ago w/ flu shot. 9/10-still have sx but more mild.

VAERS ID:595049 (history)  Vaccinated:2015-09-09
Age:35.0  Onset:2015-09-10, Days after vaccination: 1
Gender:Female  Submitted:2015-09-14, Days after onset: 4
Location:Missouri  Entered:2015-09-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Private     Purchased by: Other
Symptoms: Injection site nodule
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Patient called HD informing nurse she had received flu shot at apt on Wednesday and noticed raised knot type area near injection site.

VAERS ID:595181 (history)  Vaccinated:2015-09-03
Age:35.0  Onset:2015-09-10, Days after vaccination: 7
Gender:Female  Submitted:2015-09-14, Days after onset: 4
Location:Arkansas  Entered:2015-09-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prefer OB (prenatal vitamin) and Ferrous Sulfate 325 mg
Current Illness: No
Preexisting Conditions: Pregnant
Diagnostic Lab Data: None (at doctor''s office for a pregnancy visit anyway and spoke with doctor who said this was a known reaction to the Tdap vaccine and that her arm would get better)
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSB54KE0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Mobility decreased, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Parkinson-like events (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Severe muscle pain that progressed to difficulty moving arm.

VAERS ID:595424 (history)  Vaccinated:2015-09-12
Age:35.0  Onset:0000-00-00
Gender:Female  Submitted:2015-09-15
Location:Indiana  Entered:2015-09-15
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) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS157021 IMLA
Administered by: Other     Purchased by: Public
Symptoms: Vaccination site erythema
SMQs:
Write-up: Red area surrounding site of vaccination.

VAERS ID:596051 (history)  Vaccinated:2015-09-01
Age:35.0  Onset:2015-09-12, Days after vaccination: 11
Gender:Female  Submitted:2015-09-17, Days after onset: 5
Location:Texas  Entered:2015-09-17
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:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS4T4GJ IM 
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.L005298 SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, 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: Itching, redness, swelling and pain around injection site.

VAERS ID:596650 (history)  Vaccinated:2015-09-11
Age:35.0  Onset:2015-09-12, Days after vaccination: 1
Gender:Male  Submitted:2015-09-22, Days after onset: 10
Location:Michigan  Entered:2015-09-22
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: Sulfa, Penicillin (some forms)
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEUR  IMLA
Administered by: Other     Purchased by: Other
Symptoms: Fatigue, Injection site bruising, Injection site pain, Lymphadenopathy, Rash
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fatigue lasting 2 days. Rash on injected arm, extending to upper torso, chest, back and lower neck. Swollen glands in neck. Bruise-like pain at injection site for 4 days when touched, with no pain when untouched.

VAERS ID:596651 (history)  Vaccinated:2015-09-17
Age:35.0  Onset:2015-09-17, Days after vaccination: 0
Gender:Female  Submitted:2015-09-21, Days after onset: 4
Location:South Carolina  Entered:2015-09-22, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDU546061IMUN
Administered by: Other     Purchased by: Private
Symptoms: Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling at injection site.

VAERS ID:596880 (history)  Vaccinated:2015-09-21
Age:35.0  Onset:2015-09-21, Days after vaccination: 0
Gender:Female  Submitted:2015-09-22, Days after onset: 1
Location:Ohio  Entered:2015-09-22
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) (NO BRAND NAME)UNKNOWN MANUFACTURER 1SCLA
Administered by: Other     Purchased by: Other
Symptoms: Impaired driving ability, Injection site pain, Injection site swelling, Injection site warmth, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Severe swelling after nurse injected flu shot through my tattoo. I asked of that was okay to do and she said yes. It''s very hot and sore and very swollen at site and in a pretty wide area around. It''s sore in my shoulder and down to elbow making it hard to drive today. Saw nurse at work and was instructed to ice the area and take Tylenol for the pain.

VAERS ID:596890 (history)  Vaccinated:2015-09-18
Age:35.0  Onset:2015-09-18, Days after vaccination: 0
Gender:Female  Submitted:2015-09-23, Days after onset: 5
Location:Hawaii  Entered:2015-09-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Prescribed and starting taking same day amoxicillin 500mg. 3x day for 10 days for sinus infection.
Current Illness: Sinus infection
Preexisting Conditions: Latex, bee venom, lexofloxacin, Zithromax z-pack.
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 1  
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER 1  
Administered by: Unknown     Purchased by: Private
Symptoms: Arthralgia, Fatigue, Headache, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Myalgia, Nausea, Pain in extremity, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)
Write-up: Swelling and redness at injection sight the size off the vaccine fluid injection. Over the next 12 hours swelling continued to increase at injection site (IS) to the size of 2inches also starting to get low grade heat radiating at (IS). Slight muscle aches all over body. Over the next 12 hours muscle pain increases especially in whole back. (IS) starting to be painful to the touch and difficult to use arm without moderate pain. Over the next 12 hours swelling at (IS) increased to 3inches heat radiating and extreme pain with limited to no movement. Body pain increased to extreme muscle and joint pain all over whole body. Extreme fatigue, nausea, headache and slight blurred vision. These symptoms continued for 12 hours. Over the next 12 hours swelling at (IS) increased in size to 4inches in diameter with heat radiating and limited movement ability.

VAERS ID:597065 (history)  Vaccinated:0000-00-00
Age:35.0  Onset:0000-00-00
Gender:Unknown  Submitted:0000-00-00
Location:New Mexico  Entered:2015-09-23
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
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1575101 IMUN
Administered by: Unknown     Purchased by: Private
Symptoms: Muscle spasms, Pain in extremity
SMQs:, Dystonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Parent reported severe cramping, stabbing pain from shoulder to fingertips approximately 1 hour after receiving flu shot.

VAERS ID:597115 (history)  Vaccinated:2015-09-23
Age:35.0  Onset:2015-09-23, Days after vaccination: 0
Gender:Male  Submitted:2015-09-24, Days after onset: 1
Location:Oregon  Entered:2015-09-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0SYRLA
Administered by: Public     Purchased by: Private
Symptoms: Hyperhidrosis, Pyrexia, Seizure, Tremor, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Shaking, body seizing up, sweating, fever, throwing up all night.

VAERS ID:597116 (history)  Vaccinated:2015-09-23
Age:35.0  Onset:2015-09-24, Days after vaccination: 1
Gender:Female  Submitted:2015-09-24, Days after onset: 0
Location:Arkansas  Entered:2015-09-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No Illness at time of vaccination.
Preexisting Conditions: Milk allergy, allergic asthma at time of vaccination.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Public     Purchased by: Private
Symptoms: Dizziness, Feeling abnormal
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Vestibular disorders (broad)
Write-up: Sudden and unexplained dizziness when moving. Can be explained as a sort of "floaty" feeling.

VAERS ID:598143 (history)  Vaccinated:2015-09-22
Age:35.0  Onset:2015-09-24, Days after vaccination: 2
Gender:Male  Submitted:2015-09-24, Days after onset: 0
Location:New York  Entered:2015-09-24
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: Erythromycin
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS912LU1UNLA
Administered by: Public     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Warmth, redness, tender around injection site. Ibuprofen/cool compress.

VAERS ID:597413 (history)  Vaccinated:2015-09-17
Age:35.0  Onset:2015-09-17, Days after vaccination: 0
Gender:Female  Submitted:2015-09-25, Days after onset: 8
Location:Minnesota  Entered:2015-09-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: nflamed site, fever, fatigue, swollen arm - entire, visibly swollen~Influenza (Seasonal) (no brand name)~UN~28.50~Patient|Inflam
Other Medications: Enbrel 25 mg 1x/week taken on previous Fri; methotrexate 5.5 1x/week taken on previous Fri, Nasacort AQ; Astelin; Singulair; Tramadol; Nabumetone; Viorelle; Folic Acid; Dulera 250; Dovonex cream; Nizoral shampoo; melatonin 1mg nightly; nort
Current Illness: None
Preexisting Conditions: Allergies: Many allergies (pollens, animals, feathers, seafood, fish). Pre-existing conditions: psoriatic arthritis, asthma, psoriasis, allergies. No known birth defects.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  SCLA
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER 0SCRA
Administered by: Private     Purchased by: Private
Symptoms: Adverse reaction, Fatigue, Injection site discolouration, Injection site inflammation, Injection site nodule, Injection site pruritus, Injection site warmth, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Injection site became inflamed and under the skin a knot could be felt. Site was inflamed, hot, and itchy. Additionally had a fever, fatigue, and am experiencing an adverse reaction to certain smells (raw and cooked meat in particular). The size of the inflamed site grew until Tuesday, 9/22/2015. I had to miss work on Monday, 9/21/2015 because I felt so ill. As of 9/25 when this report is being submitted, the knot is still visible and site still inflamed but now a dull purple instead of bright red.

VAERS ID:597585 (history)  Vaccinated:2015-09-25
Age:35.0  Onset:2015-09-25, Days after vaccination: 0
Gender:Male  Submitted:2015-09-25, Days after onset: 0
Location:Georgia  Entered:2015-09-28, 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: For #19
Current Illness: None
Preexisting Conditions: Ulcerative colitis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDU56106 UNLA
Administered by: Military     Purchased by: Military
Symptoms: Blood glucose decreased, Immediate post-injection reaction, Malaise, Peripheral swelling, Presyncope, Upper extremity mass
SMQs:, Cardiac failure (broad), Angioedema (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (narrow)
Write-up: Pt''s deltoid immediately swelled 1/2 in x 2 in circle raised lump. Pt stated he did not feel well and had a vasovagal response. EMS came. His blood sugar was 66. Other vitals 118/72, HR= 84, PO: 98%.

VAERS ID:598002 (history)  Vaccinated:2015-09-28
Age:35.0  Onset:2015-09-29, Days after vaccination: 1
Gender:Female  Submitted:2015-09-30, Days after onset: 1
Location:Colorado  Entered:2015-09-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: body rash~Influenza (Seasonal) (no brand name)~UN~33.00~Patient
Other Medications:
Current Illness: None
Preexisting Conditions: Grass, dust, pollen, dander, smoke, adhesive (Previous childhood allergy to: milk, eggs, wheat)
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS157102 IMLA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 24 hours after injection – swelling. 48 hours after injection – continued swelling, redness, heat, persistent itching. Took Zyrtec and applied ice pack.

VAERS ID:598218 (history)  Vaccinated:2015-09-30
Age:35.0  Onset:2015-09-30, Days after vaccination: 0
Gender:Female  Submitted:2015-09-30, Days after onset: 0
Location:California  Entered:2015-10-01, 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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS99LN20IMLA
Administered by: Private     Purchased by: Private
Symptoms: Chest pain, Dysphagia, Feeling hot, Palpitations, Pruritus, Rash generalised
SMQs:, Anaphylactic reaction (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 (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Heart racing, itchy and hot feeling on throat trouble swallowing. Chest pain when taking a deep breath, body rash.

VAERS ID:598296 (history)  Vaccinated:2015-10-01
Age:35.0  Onset:2015-10-01, Days after vaccination: 0
Gender:Female  Submitted:2015-10-01, Days after onset: 0
Location:New York  Entered:2015-10-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hydrocortisone tabs; FLORINET tabs
Current Illness: None
Preexisting Conditions: Addisons Disease
Diagnostic Lab Data: This time but allergy tested recommended
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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FLUR3: INFLUENZA (SEASONAL) (FLUBLOK)PROTEIN SCIENCES CORPORATION550653F0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Dyspnoea, Erythema, Immediate post-injection reaction, Rash, Skin warm
SMQs:, Anaphylactic reaction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Immediately after flu vaccination adm., rashes B/L UE were visible, skin red and warm on chest, no resp distress noted. Resp are even and labored.

VAERS ID:598617 (history)  Vaccinated:2015-10-05
Age:35.0  Onset:2015-10-05, Days after vaccination: 0
Gender:Male  Submitted:2015-10-05, Days after onset: 0
Location:Virginia  Entered:2015-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: HIV
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.K0113171SCRA
Administered by: Military     Purchased by: Military
Symptoms: Unevaluable event
SMQs:
Write-up: Patient given live vaccine (MMR) while he is HIV positive.

VAERS ID:598661 (history)  Vaccinated:2015-09-24
Age:35.0  Onset:2015-09-24, Days after vaccination: 0
Gender:Female  Submitted:2015-10-05, Days after onset: 11
Location:Texas  Entered:2015-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR    
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Extremely hot around injection site. Pain, swelling, redness. The swelling and redness expanded over the course of 7 days so that the entire upper arm was affected, then started to recede. Itchiness and soreness in the muscles and bones followed for the next 5 days. Currently, there is a patch about 4 inches long near the injection site where new, raised and itchy bumps have formed.

VAERS ID:600912 (history)  Vaccinated:2015-10-05
Age:35.0  Onset:2015-10-05, Days after vaccination: 0
Gender:Male  Submitted:2015-10-06, Days after onset: 1
Location:Michigan  Entered:2015-10-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Loratidine
Current Illness: No
Preexisting Conditions: Seasonal allergies
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS 0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Chills, Decreased appetite, Fatigue, Influenza like illness, Nausea, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Flu like symptoms: chills, fever, aches, fatigue, nausea, loss of appetite.

VAERS ID:601140 (history)  Vaccinated:2015-10-05
Age:35.0  Onset:2015-10-05, Days after vaccination: 0
Gender:Female  Submitted:2015-10-07, Days after onset: 2
Location:Ohio  Entered:2015-10-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None known
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURUI431AB IM 
Administered by: Public     Purchased by: Private
Symptoms: Nausea, Pain, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Approximately 1 hour after vaccination, patient felt nauseous, had some vomiting, body aches in upper body (arms and neck, etc). No reaction at site of injection noted. Symptoms resolved within 48 hours.

VAERS ID:601521 (history)  Vaccinated:2015-09-29
Age:35.0  Onset:2015-09-29, Days after vaccination: 0
Gender:Male  Submitted:2015-10-07, Days after onset: 8
Location:Unknown  Entered:2015-10-08, 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: DAYQUIL; ZYRTEC
Current Illness: Oropharyngeal pain, pre-existing
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: US2015139863
Vaccination
Manufacturer
Lot
Dose
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FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT)GLAXOSMITHKLINE BIOLOGICALS  UNLA
Administered by: Other     Purchased by: Other
Symptoms: Headache, Nasopharyngitis, Rhinorrhoea, Sneezing
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: This case was reported by a consumer via call center representative and described the occurrence of cold in a 35-year-old male patient who received FLULAVAL quadrivalent. Concurrent medical conditions included sore throat (pre-existing). Concomitant products included DAYQUIL and ZYRTEC. On 29th September 2015, the patient received FLULAVAL quadrivalent. On 29th September 2015, 2 hrs after receiving FLULAVAL quadrivalent, the patient experienced cold, headache, runny nose and sneezing. On an unknown date, the outcome of the cold, headache, runny nose and sneezing were recovering/resolving. The reporter considered the cold, headache, runny nose and sneezing to be possibly related to FLULAVAL quadrivalent. Additional details were provided as follows: On 29th September 2015, at 9.30, the patient received FLULAVAL quadrivalent batch number and expiry date unknown in left arm. The patient experienced severe cold, headache, runny nose and sneezing.

VAERS ID:601553 (history)  Vaccinated:2015-10-06
Age:35.0  Onset:2015-10-06, Days after vaccination: 0
Gender:Female  Submitted:2015-10-08, Days after onset: 2
Location:Georgia  Entered:2015-10-08
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
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1514801 IMRA
Administered by: Other     Purchased by: Private
Symptoms: Headache, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Patient claims that she has had severe headache and soreness at injection site for 2 days.

VAERS ID:601717 (history)  Vaccinated:2015-09-01
Age:35.0  Onset:2015-09-02, Days after vaccination: 1
Gender:Female  Submitted:2015-10-09, Days after onset: 37
Location:Minnesota  Entered:2015-10-09
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) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS 1IMRA
Administered by: Public     Purchased by: Private
Symptoms: Erythema, Musculoskeletal pain, Neck pain, Pruritus, Skin swelling, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Red swollen, itchy skin and shoulder and neck pain.

VAERS ID:601853 (history)  Vaccinated:2015-10-09
Age:35.0  Onset:2015-10-10, Days after vaccination: 1
Gender:Female  Submitted:2015-10-11, Days after onset: 1
Location:North Carolina  Entered:2015-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid, Paxil, Colac, iron, vit B12, Buspar, vit D, melatonin, probiotic
Current Illness: No
Preexisting Conditions: Allergy: Lexapro, sulfa; Medical: thyroid disease, anxiety, bulging disc, vitamin deficiency
Diagnostic Lab Data: None: Unknown results of steroid treatment. First day of steroid treatment complete.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Other
Symptoms: Erythema, Eyelid oedema, Lip swelling, Pruritus, Swelling, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Swollen eye lids, swollen lips, red itchy hives on neck, face, lips, arms, butt, vaginal area. Treated with Benadryl 50 mg every 8 hours, did not get better, more swelling and hives persisted, forced to seek help 10/11/2015 at urgent care center, received a cortisone shot and week worth of steroids. Continue with Benadryl 50mg every 8 hours.

VAERS ID:601922 (history)  Vaccinated:2015-09-15
Age:35.0  Onset:2015-09-15, Days after vaccination: 0
Gender:Female  Submitted:2015-10-12, Days after onset: 27
Location:Washington  Entered:2015-10-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Other
Symptoms: Hypoaesthesia, Muscular weakness, Pain, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: Severe worsening pain with movement of any kind of my right arm. Intermittent numbness and tingling, extreme weakness of right arm.

VAERS ID:601997 (history)  Vaccinated:2015-10-12
Age:35.0  Onset:2015-10-12, Days after vaccination: 0
Gender:Female  Submitted:2015-10-12, Days after onset: 0
Location:Texas  Entered:2015-10-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ceterizine
Current Illness: Laryngitis
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDU58407 IM 
TDAP: TDAP (ADACEL)SANOFI PASTEURU5278AA IM 
Administered by: Public     Purchased by: Private
Symptoms: Conjunctivitis, Eye discharge, Eye pain, Ocular discomfort, Photophobia
SMQs:, Severe cutaneous adverse reactions (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (broad)
Write-up: Severe conjunctivitis, drainage, eye pressure, and pain as well as light sensitivity.

VAERS ID:602159 (history)  Vaccinated:2015-10-07
Age:35.0  Onset:2015-10-08, Days after vaccination: 1
Gender:Female  Submitted:2015-10-12, Days after onset: 4
Location:Maryland  Entered:2015-10-13, 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: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDU54506 UNLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.K0078260UNLA
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis
SMQs:
Write-up: Cellulitis.

VAERS ID:602269 (history)  Vaccinated:2015-09-29
Age:35.0  Onset:2015-10-01, Days after vaccination: 2
Gender:Female  Submitted:2015-10-13, Days after onset: 12
Location:Colorado  Entered:2015-10-13
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
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS397A70IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site pain, Muscle twitching, Muscular weakness, Neck pain
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad)
Write-up: Left deltoid pain radiating into shoulder and neck. Arm weakness and muscle twitching. Referral to Occ. Med. thru work comp.

VAERS ID:602404 (history)  Vaccinated:2015-10-06
Age:35.0  Onset:2015-10-11, Days after vaccination: 5
Gender:Female  Submitted:2015-10-14, Days after onset: 3
Location:Georgia  Entered:2015-10-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: KEPPRA; LAMICTAL; SEROQUEL; COGENTIN; LOPRESSOR; ASA; INVEGA SUSTENNA
Current Illness: None known
Preexisting Conditions: Seizures; schizophrenia
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT)GLAXOSMITHKLINE BIOLOGICALSH33J2 IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Disorientation, Dizziness, Headache, Hyperventilation, Pain in extremity, Pyrexia, Respiratory rate increased, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Per mom sore arm x 2 days - had flu vaccine 10/6/15 - started running low grade fever 10/11/15, vomited, headache, dizzy, disoriented. On the 13th breathing fast and heavy - called 911. EMS came, checked her out and appeared to be ok. Still running low grade fever. Seems to be feeling better. Mom just wanted us to know - states was wondering if anyone else called with those complaints - states she may just have virus. Advised to see PMD for further eval.

VAERS ID:602838 (history)  Vaccinated:2015-10-12
Age:35.0  Onset:2015-10-14, Days after vaccination: 2
Gender:Female  Submitted:2015-10-16, Days after onset: 2
Location:Pennsylvania  Entered:2015-10-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Claritin 10 mg daily
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.L0120380UNLA
Administered by: Public     Purchased by: Private
Symptoms: Coagulation time shortened, Gingival bleeding, Haemorrhage, Injection site erythema, Injection site rash, Injection site warmth, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Gingival disorders (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt. had red, raised heated rash and welt at sight of injection. Pt. was unable to run or jog. Pt. developed bleeding gums and increased bleeding, decreased clot time starting 10/2015.

VAERS ID:603254 (history)  Vaccinated:2015-10-13
Age:35.0  Onset:2015-10-13, Days after vaccination: 0
Gender:Female  Submitted:2015-10-15, Days after onset: 2
Location:Minnesota  Entered:2015-10-19, 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: LEXAPRO; SYMBICORT
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURUI445AA IMRA
Administered by: Private     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling, redness about 2", hot to the touch, hard lump, pain at inj. site. TX: BENADRYL.

VAERS ID:603860 (history)  Vaccinated:2015-10-20
Age:35.0  Onset:2015-10-21, Days after vaccination: 1
Gender:Female  Submitted:2015-10-21, Days after onset: 0
Location:Ohio  Entered:2015-10-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid, Atorvastatin, Spironolactone, loratidine, calcium + vitamin D, magnesium, Sprintec
Current Illness: No
Preexisting Conditions: Seasonal allergies; high cholesterol; hypothyroidism
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: It may have begun earlier but I didn''t notice until the above day and time. I have a warm, red welt at the injection site.

VAERS ID:603866 (history)  Vaccinated:2015-10-12
Age:35.0  Onset:2015-10-15, Days after vaccination: 3
Gender:Female  Submitted:2015-10-21, Days after onset: 6
Location:Virginia  Entered:2015-10-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxin and a birth control pill
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Military     Purchased by: Other
Symptoms: Arthralgia, Joint swelling, Lymphadenopathy
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Lots of swelling in all joints accompained with pain in all joints, swollen lymph node. On 10/21/2015 (6 days later) only mild joint pain remains.

VAERS ID:604039 (history)  Vaccinated:2015-10-12
Age:35.0  Onset:2015-10-12, Days after vaccination: 0
Gender:Female  Submitted:2015-10-21, Days after onset: 9
Location:Michigan  Entered:2015-10-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid, Minestrin (birth control), Multi Vit, Vit D
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS 0IMLA
Administered by: Unknown     Purchased by: Other
Symptoms: Feeling cold, Hypoaesthesia, Hypoaesthesia oral, Injection site hypoaesthesia, Injection site paraesthesia, Injection site reaction, Paraesthesia, Paraesthesia oral
SMQs:, Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad)
Write-up: Injection site was left deltoid. The numbness started, tingling, and cool feeling traveled from the injection site into my neck and corner of my lower lip and tongue. These side effects were very prominent the first 48 hours, then lessened. But even today, the corner of my left lower lip is still tingling.

VAERS ID:604192 (history)  Vaccinated:2015-10-21
Age:35.0  Onset:2015-10-21, Days after vaccination: 0
Gender:Female  Submitted:2015-10-22, Days after onset: 1
Location:West Virginia  Entered:2015-10-22
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: Asthma; Hypertension; GERD; Obesity
Diagnostic Lab Data: Pt was given DEPO MEDROL 120 mg IM, PO Loratidine, P.O. Prednisone, ZANTAC
CDC Split Type:
Vaccination
Manufacturer
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Dose
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Site
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURU5321FA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Chills, Pruritus, Rash pruritic, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Hx of allergy to penicillin and TESSALON PERLES. Started itching, chills swelling one hr. after shot. Has itchy rash on arms and neck feels swollen.

VAERS ID:604355 (history)  Vaccinated:2015-10-05
Age:35.0  Onset:2015-10-06, Days after vaccination: 1
Gender:Female  Submitted:2015-10-21, Days after onset: 15
Location:West Virginia  Entered:2015-10-22, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSL94EX IMRA
Administered by: Other     Purchased by: Private
Symptoms: Injected limb mobility decreased
SMQs:
Write-up: Patient states rec''vd influenza vaccine Monday Oct 5. No pain at admin. noted. Next day (Tues Oct 6) arm "unable to bend - use arm). Symptoms increased. To see private physician today.

VAERS ID:604527 (history)  Vaccinated:2015-10-21
Age:35.0  Onset:2015-10-21, Days after vaccination: 0
Gender:Female  Submitted:2015-10-23, Days after onset: 2
Location:Colorado  Entered:2015-10-23
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: Environmental Allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT)GLAXOSMITHKLINE BIOLOGICALS 0SYRLA
Administered by: Public     Purchased by: Private
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Heart rate increased, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Vomiting, nausea, diarrhea, shivering, fatigue, headache, increased heart rate.

VAERS ID:604569 (history)  Vaccinated:2015-10-22
Age:35.0  Onset:2015-10-22, Days after vaccination: 0
Gender:Female  Submitted:2015-10-24, Days after onset: 2
Location:West Virginia  Entered:2015-10-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zoloft 25 mg daily; Vitamin D 5000 iu daily
Current Illness: No
Preexisting Conditions: Depression, Vit D deficiency, NKA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMRA
Administered by: Public     Purchased by: Other
Symptoms: Gait disturbance, Immediate post-injection reaction, Impaired work ability, Injection site pain, Myalgia, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)
Write-up: Very sore at site of injection immediately. Body aches began around 9 pm and progressively intensified until muscles of legs, back, arms, buttocks, and feet became very tender and painful. Patient worked night shift at hospital and had difficulty walking and working due to pain. At 7:30 am on 10/23/15, took 400 mg of ibuprofen, 500 mg of Vit C, 5000 iu of vitamin D, and Zoloft 25 mg, and then went to sleep. Muscle aches had disappeared upon awakening at noon on 10/23/15.

VAERS ID:604710 (history)  Vaccinated:2015-10-15
Age:35.0  Onset:2015-10-22, Days after vaccination: 7
Gender:Female  Submitted:2015-10-26, Days after onset: 4
Location:New York  Entered:2015-10-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT)GLAXOSMITHKLINE BIOLOGICALS2F5P4 IMLA
Administered by: Other     Purchased by: Private
Symptoms: Chills, Hyperhidrosis, Nasopharyngitis, Pain, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Patient had body rash above torso and was breaking out in sweats and chills on 10/22. Patient said she felt a minor cold 2 days after vaccination. A couple of days later had a rash which she saw a Dr. and they prescribed a steroid. On 10/22, went to hospital for treatment for fever, rash, body aches.

VAERS ID:604716 (history)  Vaccinated:2015-10-21
Age:35.0  Onset:2015-10-22, Days after vaccination: 1
Gender:Female  Submitted:2015-10-26, Days after onset: 4
Location:Iowa  Entered:2015-10-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS15177010IMLA
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Fatigue, Headache, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Tired/Weak, Swollen Fingers, Headache.

VAERS ID:605046 (history)  Vaccinated:2014-10-24
Age:35.0  Onset:2014-10-25, Days after vaccination: 1
Gender:Female  Submitted:2015-10-18, Days after onset: 358
Location:Pennsylvania  Entered:2015-10-27, 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: Gabapentin; Lamictal; CYMBALTA
Current Illness: None
Preexisting Conditions: Endometriosis; Chronic sinusitis; Seasonal allergies
Diagnostic Lab Data: MRS - Brain, lumbar and C-spine, (L) shoulder, (L) brachial plexus, xray (L) shoulder, SSEP, EMG
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS14132010IMLA
Administered by: Other     Purchased by: Other
Symptoms: Brachial plexus injury, Electromyogram, Hypoaesthesia, Mobility decreased, Musculoskeletal stiffness, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Pain, Somatosensory evoked potentials, X-ray limb
SMQs:, Peripheral neuropathy (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Vaccine administered on 10/24/14. Approx 12 hours later unable to move neck or lift feel left arm. Pain ongoing since vaccine. Seen by neurologist, pain management, ortho.

VAERS ID:605510 (history)  Vaccinated:2013-01-09
Age:35.0  Onset:2013-01-11, Days after vaccination: 2
Gender:Male  Submitted:2015-10-28, Days after onset: 1019
Location:Michigan  Entered:2015-10-28
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
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Public     Purchased by: Private
Symptoms: Herpes zoster
SMQs:
Write-up: Shingles.

VAERS ID:605512 (history)  Vaccinated:2015-10-21
Age:35.0  Onset:2015-10-22, Days after vaccination: 1
Gender:Female  Submitted:2015-10-28, Days after onset: 6
Location:New Jersey  Entered:2015-10-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: NO
Diagnostic Lab Data: Labwork was performed and those documents are available in her chart at the Drs office
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT)GLAXOSMITHKLINE BIOLOGICALS37CC41IMLA
Administered by: Private     Purchased by: Other
Symptoms: Chills, Discomfort, Laboratory test, Pyrexia, Vaccination site swelling, Vaccination site warmth
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient was seen on 10/21/15 for an office visit and flu shot. On Thursday 10/22/15 patient starting to experience fever and chills. On 10/23/15 around 5 PM she was at a store and felt the fever and chills again. Also she experienced like her chest neck and shoulders were being crushed. During these episodes the left shoulder area where the vaccine was administered was hot to the touch and swollen about the size of a half dollar. When she woke up on Saturday 10/24/15 she experienced another episode and at that point she went to the ER. She was given saline through IV and labwork was performed. No Medications were given to her.

VAERS ID:605634 (history)  Vaccinated:2015-10-28
Age:35.0  Onset:2015-10-28, Days after vaccination: 0
Gender:Male  Submitted:2015-10-28, Days after onset: 0
Location:Michigan  Entered:2015-10-28
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: Ashthma, allergies (seasonal and pet dander)
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
Administered by: Other     Purchased by: Private
Symptoms: Headache
SMQs:
Write-up: Headache- moderate intensity, lasting for about 6 hrs until 11PM. No other symptoms. No treatment taken; spontaneously resolved without sequelae.

VAERS ID:605756 (history)  Vaccinated:2015-10-23
Age:35.0  Onset:2015-10-23, Days after vaccination: 0
Gender:Female  Submitted:2015-10-29, Days after onset: 6
Location:North Dakota  Entered:2015-10-29
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
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURUI431AD IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Type III immune complex mediated reaction
SMQs:, Hypersensitivity (narrow)
Write-up: Type III Hypersensitivity Reaction.

VAERS ID:605761 (history)  Vaccinated:2015-10-26
Age:35.0  Onset:2015-10-28, Days after vaccination: 2
Gender:Female  Submitted:2015-10-29, Days after onset: 1
Location:Virginia  Entered:2015-10-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: No
Preexisting Conditions: NK
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI446AB14IMRA
Administered by: Private     Purchased by: Private
Symptoms: 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: Injection site swollen, warm to touch 3 X 3 Painful.

VAERS ID:606367 (history)  Vaccinated:2015-10-30
Age:35.0  Onset:2015-10-30, Days after vaccination: 0
Gender:Female  Submitted:2015-11-01, Days after onset: 2
Location:Illinois  Entered:2015-11-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lyrica, Armour thyroid, Yaz, Trazodone, Topamax, Imitrex
Current Illness: No
Preexisting Conditions: Hypothyroid, Pinched occipital nerc
Diagnostic Lab Data: Physical exam
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSH52990IMLA
Administered by: Military     Purchased by: Unknown
Symptoms: Migraine, Musculoskeletal stiffness, Neuralgia
SMQs:, Peripheral neuropathy (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad)
Write-up: Burning nerve pain (occipital nerve), migraine, stiff neck, stiff arm (spread all the way to halfway down forearm), stiff trapezius muscle. Symptoms started out relatively mild (0840 10/30/15) and then became intense (0700 10/31/15). Got even worse through 10/31/15 until received treatment. As of 11/01/15, symptoms present in a moderate state but managed with Methocarbamol, Tylenol with codeine, and Prednisone.

VAERS ID:606614 (history)  Vaccinated:2015-10-15
Age:35.0  Onset:2015-10-17, Days after vaccination: 2
Gender:Female  Submitted:2015-10-21, Days after onset: 4
Location:Alabama  Entered:2015-11-02, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth control
Current Illness: None
Preexisting Conditions: Endometriosis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDU58107 IMLA
Administered by: Other     Purchased by: Private
Symptoms: Pain, Skin tightness
SMQs:
Write-up: Soreness and tightness day 1. Pain on day 3-4. Been on steroid for 4 days, will continue for 3 more days and then reevaluated.

VAERS ID:606907 (history)  Vaccinated:2015-10-06
Age:35.0  Onset:0000-00-00
Gender:Male  Submitted:2015-10-15
Location:Maine  Entered:2015-11-03, Days after submission: 19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Acyclovir
Current Illness: None
Preexisting Conditions: ADHD
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS15162010IMLA
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS24JP32IMRA
Administered by: Other     Purchased by: Private
Symptoms: Nerve injury
SMQs:, Accidents and injuries (narrow)
Write-up: 10/15/15 pt. reports doctor visit for nerve damage and possible shoulder impingement secondary to FLUVIRIN injection being given too low on the arm (left).

VAERS ID:607045 (history)  Vaccinated:2015-11-01
Age:35.0  Onset:2015-11-02, Days after vaccination: 1
Gender:Female  Submitted:2015-11-03, Days after onset: 1
Location:Michigan  Entered:2015-11-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Valium; Estrace; Microzide; Norco
Current Illness: Unsure
Preexisting Conditions: Allergies to tramadol, Aleve, and amoxicillin
Diagnostic Lab Data: WBC 15.6; lactic acid 2.2
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU5309BA1IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.14420 SCRA
Administered by: Public     Purchased by: Other
Symptoms: Blood lactic acid decreased, Pyrexia, Tachycardia, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Tachycardia and fever of 102.

VAERS ID:607108 (history)  Vaccinated:2015-10-06
Age:35.0  Onset:2015-11-04, Days after vaccination: 29
Gender:Female  Submitted:2015-11-04, Days after onset: 0
Location:Texas  Entered:2015-11-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prozac 10MG qd, Naproxen 500mg q12 hrs prn/headache
Current Illness: No illnesses noted.
Preexisting Conditions: Pre DM, Hyperlipidemia, Onycomycosis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI450AB IMLA
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSHZ9Z91IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.K0161531SCLA
Administered by: Public     Purchased by: Public
Symptoms: Maternal exposure before pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Patient received a live virus vaccine (MMR) on 10/6/15. She presented today for a pregnancy test which was positive. Had signed consent not pregnant and agreed to not become pregnant within 4 weeks of vaccination. Based on LMP, probable conception was the day after receiving the MMR vaccine. Report is precautionary.

VAERS ID:607371 (history)  Vaccinated:0000-00-00
Age:35.0  Onset:2015-06-04
Gender:Female  Submitted:2015-11-04, Days after onset: 153
Location:Maryland  Entered:2015-11-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Rifampin
Current Illness: Product used for unknown indication
Preexisting Conditions:
Diagnostic Lab Data: 06/04/2015, Measles antibody, Negative rubella
CDC Split Type: WAES1510USA014433
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC. 1SCUN
Administered by: Other     Purchased by: Other
Symptoms: Measles antibody negative
SMQs:
Write-up: Information was received from a registered nurse concerning a 35 year old female patient, who received 2 doses of MMR II (each doses on a separate unspecified date in 2009) (albumin status, dosage, and route of administration not provided). On 04-JUN-2015, the patient had MMR titers drawn and the titers showed that the patient was negative rubella. The patient received a dose of MMR II (lot #K011188, expiration date 12-AUG-2016) on 16-JUN-2015, and an additional dose of MMR II (lot #L003856, expiration date 05-FEB-2017) (albumin status, dosages and route of administration not provided) on 15-SEP-2015, because of the negative rubella titer. The outcome of the negative rubella titer and the causality was not reported. No further information was provided. Additional information has been requested.

VAERS ID:607984 (history)  Vaccinated:2015-10-22
Age:35.0  Onset:2015-10-22, Days after vaccination: 0
Gender:Female  Submitted:2015-11-02, Days after onset: 11
Location:Massachusetts  Entered:2015-11-06, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: HTN; Hyperlipidemia
Diagnostic Lab Data: BP 131/85; Resp 16; Oxygen saturation at 100%; no temperature
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS5GF431IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Erythema, Feeling hot, Flushing, Injection site erythema
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: States received flu vaccine around 10 AM and approx 3 hours later (1:00 pm) developed flushing, hot feeling to neck. Went to ED for evaluation: noted flushing to upper chest and under neck. (L) upper arm erythema approx 4-5 cm diameter. No wheals or other rash. Denies prior h/o allergy or reaction to flu shot or eggs.

VAERS ID:608166 (history)  Vaccinated:2015-10-26
Age:35.0  Onset:2015-10-28, Days after vaccination: 2
Gender:Female  Submitted:2015-11-07, Days after onset: 10
Location:Arizona  Entered:2015-11-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Not related, but Paxil and birth control
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMRA
Administered by: Private     Purchased by: Other
Symptoms: Impaired work ability, Mobility decreased, Nerve injury, Neuralgia, Pain, Pain in extremity, Sleep disorder
SMQs:, Peripheral neuropathy (narrow), Parkinson-like events (broad), Accidents and injuries (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Excruciating arm pain with sharp shooting pains radiating my entire arm, could not move my arm, recovery time about 4 days, pain had gotten worse from day of vaccination, doc stated nerve damage/pain, doc gave me Gabapentin, Lidocaine patches and Hydrocodone + Acetaminophen to ease the pain as could not sleep, pain was so bad, missed 2 days of work

VAERS ID:608363 (history)  Vaccinated:2015-10-13
Age:35.0  Onset:2015-10-15, Days after vaccination: 2
Gender:Male  Submitted:2015-11-09, Days after onset: 25
Location:Michigan  Entered:2015-11-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Clindamycin
Current Illness: Patient denies
Preexisting Conditions: Acne, Right arm tattoo. NKDA
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURUI463AB0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Area of redness, tenderness at injection site started 1-2 days after injection; symptoms reported to office on 11/02/2015. Pt examined by physician on 11/02/2015, Dx: Papule. Rx: Cephalexin. Advised to return if sx worsen or don''t improve. Follow-up call to pt done 11/09/2015: sx improved, pt did not take antibiotic.

VAERS ID:608665 (history)  Vaccinated:2015-11-09
Age:35.0  Onset:2015-11-09, Days after vaccination: 0
Gender:Female  Submitted:2015-11-10, Days after onset: 1
Location:Connecticut  Entered:2015-11-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUR3: INFLUENZA (SEASONAL) (FLUBLOK)PROTEIN SCIENCES CORPORATION550603F0IMRA
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Injection site pain, Injection site pruritus, Injection site swelling, Mobility decreased, Nausea, Urticaria
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Night of vaccine: nausea, silver dollar size welt on arm, swollen/painful/itchy site of injection, trouble raising arm, red dot in middle of welt.

VAERS ID:609013 (history)  Vaccinated:2015-11-04
Age:35.0  Onset:2015-11-04, Days after vaccination: 0
Gender:Female  Submitted:2015-11-11, Days after onset: 7
Location:Maryland  Entered:2015-11-11
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: Hypothyroid
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Unknown
Symptoms: Blister, Burning sensation, Erythema, Injection site swelling, Injection site urticaria, Peripheral swelling, Pruritus, Skin exfoliation
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Started as hive where shot was given, then, over course of 2 days, the entire arm and hand grew to twice its original size. The effects were swelling, itching and a burn-type feeling in the arm. The look and feel of the reaction resembled a 2nd degree burn - there was swelling, blisters, redness, and when that subsided, the skin started pealing.

VAERS ID:609019 (history)  Vaccinated:2015-11-06
Age:35.0  Onset:2015-11-06, Days after vaccination: 0
Gender:Male  Submitted:2015-11-11, Days after onset: 5
Location:Connecticut  Entered:2015-11-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Insulin
Current Illness:
Preexisting Conditions: IDDM
Diagnostic Lab Data: CBC, BMP
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.K0148331IMRA
Administered by: Public     Purchased by: Other
Symptoms: Full blood count, Metabolic function test, Speech disorder, Swelling face, Swollen tongue
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), 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), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Right sided facial swelling, tongue swelling and difficulty talking.

VAERS ID:609021 (history)  Vaccinated:2015-10-29
Age:35.0  Onset:2015-10-29, Days after vaccination: 0
Gender:Female  Submitted:2015-11-11, Days after onset: 13
Location:Louisiana  Entered:2015-11-11
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: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURUI445AC IMRA
Administered by: Unknown     Purchased by: Private
Symptoms: Dyspnoea, Paraesthesia oral, Pruritus, Swelling face
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Facial swelling, lips tingling, shortness of breath, itching.

VAERS ID:609334 (history)  Vaccinated:2015-11-10
Age:35.0  Onset:2015-11-10, Days after vaccination: 0
Gender:Female  Submitted:2015-11-12, Days after onset: 2
Location:California  Entered:2015-11-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Rash~Influenza (Seasonal) (Fluzone)~~34.58~Patient
Other Medications: None disclosed.
Current Illness: None disclosed or noted.
Preexisting Conditions: None disclosed or noted.
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURU5319AA IMLA
Administered by: Private     Purchased by: Other
Symptoms: Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Rash/Hives. Benadryl given in ER and discharge prescription of Benadryl and Prednisone (times 3 days) give.

VAERS ID:609513 (history)  Vaccinated:0000-00-00
Age:35.0  Onset:2015-10-27
Gender:Female  Submitted:2015-11-12, Days after onset: 16
Location:Unknown  Entered:2015-11-12
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: US2015GSK159505
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT)GLAXOSMITHKLINE BIOLOGICALSH33J2 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Mobility decreased, Pain in extremity
SMQs:, Parkinson-like events (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a nurse via call center representative and described the occurrence of mobility decreased in a 35-year-old female patient who received FLULAVAL quadrivalent (batch number H33J2, expiry date May 2016). In 2015, the patient received FLULAVAL quadrivalent .5 ml. On 27th October 2015, an unknown time after receiving FLULAVAL quadrivalent, the patient experienced mobility decreased and pain in arm. On an unknown date, the outcome of the mobility decreased and pain in arm were unknown. It was unknown if the reporter considered the mobility decreased and pain in arm to be related to FLULAVAL quadrivalent. Additional details provided were as follows: The healthcare professional reported that, there were 2 patients (for other patient see case US2015GSK159506) who received FLULAVAL quadrivalent and experienced the events. These reports could be a duplicate of a previous cases reported. However, according to the patient identifiers provided in both these case, no duplicate reports has been identified. An unspecified time after vaccination the patient in this concerned case experienced left arm pain and also the patient was unable to lift the left arm since 27th October 2015. The patient received physical therapy as a treatment.

VAERS ID:609755 (history)  Vaccinated:2015-10-01
Age:35.0  Onset:2015-10-02, Days after vaccination: 1
Gender:Female  Submitted:2015-11-15, Days after onset: 44
Location:Virginia  Entered:2015-11-16, 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: No
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS157901 IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Impaired work ability, Injection site pain, Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)
Write-up: Pain around the rotating left shoulder. Missed work the first two days after the shot. Patient has been using the adhesive tape to wrap around the upper arm to give support. Complaint still pain even a mark after or up to today date.

VAERS ID:609775 (history)  Vaccinated:2015-11-12
Age:35.0  Onset:2015-11-14, Days after vaccination: 2
Gender:Female  Submitted:2015-11-16, Days after onset: 2
Location:North Dakota  Entered:2015-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None Reported
Preexisting Conditions: None Reported
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV427A5IMRA
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF)BERNA BIOTECH, LTD300300212PO 
Administered by: Military     Purchased by: Military
Symptoms: Rash, Somnolence
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Pt states she is experiencing rash on chest. Pt states she feels drowsy after taking oral typhoid capsules.

VAERS ID:609823 (history)  Vaccinated:2015-10-21
Age:35.0  Onset:2015-10-21, Days after vaccination: 0
Gender:Female  Submitted:2015-11-16, Days after onset: 26
Location:Illinois  Entered:2015-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Oral Cefdinir
Current Illness: Sinus infection
Preexisting Conditions: None
Diagnostic Lab Data: Blood test, x-rays
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.L0013110IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Blood test, Chills, Fatigue, Hyperhidrosis, Malaise, Mobility decreased, Nausea, Pain in extremity, Pyrexia, Rash, X-ray
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Arm so painful it was immobilized. Rash spreading into armpit like fingers; General feeling of unwell, very tired, nausea, chills, sweats, 104 degree fever.

VAERS ID:610131 (history)  Vaccinated:2015-10-13
Age:35.0  Onset:2015-10-13, Days after vaccination: 0
Gender:Female  Submitted:2015-10-30, Days after onset: 17
Location:Virginia  Entered:2015-11-17, Days after submission: 18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None listed
Current Illness: Denies illness
Preexisting Conditions: NEOSPORIN; PCN; SEPTRA; Hx Scleroderma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDU546062IMLA
Administered by: Other     Purchased by: Other
Symptoms: Blister, Rash erythematous, Rash generalised
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Rash - face, neck, trunk, buttocks, groin, hands, and feet. Red raised with some blistering between fingers and toes.

VAERS ID:610174 (history)  Vaccinated:2015-11-02
Age:35.0  Onset:2015-11-02, Days after vaccination: 0
Gender:Female  Submitted:2015-11-10, Days after onset: 8
Location:Texas  Entered:2015-11-17, 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:
Current Illness: Type 2 DM; Pregnancy
Preexisting Conditions: Ciprofloxacin
Diagnostic Lab Data: Neuro exam and physical exam no abnormal findings
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4714AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Hypoaesthesia, Neurological examination normal, Pain, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Pain, numbness and tingling in arm starting evening after Tdap vaccine, tingling in fingers persisting for 2 days and intermittently recurring.

VAERS ID:610954 (history)  Vaccinated:2014-11-27
Age:35.0  Onset:2014-11-28, Days after vaccination: 1
Gender:Female  Submitted:2015-10-05, Days after onset: 310
Location:Minnesota  Entered:2015-11-19, Days after submission: 45
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Egg allergy
Preexisting Conditions: UNK
Diagnostic Lab Data: Body temperature, 104 degree C
CDC Split Type: 2014SA172330
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURUI245AB IMAR
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea, Lymphadenopathy, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Initial report received from a Healthcare professional on 10 December 2014. This case is a part of 3 cluster cases and this case is linked to case 2014SA172329 and 2014SA172324. A patient, whose medical history and concomitant medications was not reported, had received a intramuscular dose of FLUZONE QIV (Batch number UI245AB, expiry date 30 Jun 2014) in the deltoid, on an unspecified date. On an unspecified date after vaccination the patient had experienced fever. The patient''s illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were reported as unknown. The patient required ER visit. At the time of this report, the patient was recovered within 8 hours of onset of event. List of documents held by sender: none. Follow-up information received from nurse on 07 April 2015. A 35-year-old female patient, whose medical history was reported as an egg allergy, had received a dose of FLUZONE QIV on 27 November 2014. On 28 November 2014, one day after vaccination patient had experienced high fever (104 degree celsius), swollen arm pit glands, vomiting and loose stools. It was reported that, patient was healthy at the time of vaccination but patient''s children was sick at home and patient''s sister had a site reaction to injection. Patient had no vaccine within 4 weeks prior to vaccination, laboratory data and other medications. Patient was vaccinated at hospital and vaccine purchased from hospital funds. It was reported that, patient did not required emergency room. The patient had recovered from all events on an unspecified date. List of documents held by sender: none.

VAERS ID:611410 (history)  Vaccinated:2015-11-19
Age:35.0  Onset:2015-11-20, Days after vaccination: 1
Gender:Female  Submitted:2015-11-24, Days after onset: 4
Location:Georgia  Entered:2015-11-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Opana ER 15 mg
Current Illness: N/A
Preexisting Conditions: History of migraines
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS15724P0IMLA
Administered by: Other     Purchased by: Military
Symptoms: Condition aggravated, Migraine
SMQs:
Write-up: Patient had a recurrence of migraines.

VAERS ID:611910 (history)  Vaccinated:0000-00-00
Age:35.0  Onset:0000-00-00
Gender:Female  Submitted:2015-11-24
Location:Unknown  Entered:2015-11-24
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: WAES1511USA006148
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 3UNUN
Administered by: Other     Purchased by: Other
Symptoms: Extra dose administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: This spontaneous report as received from a 35 year old female pharmacy student regarding herself. No medical history and concurrent conditions were reported. On an unknown date approximately in September 2015 (also reported as 2 months ago) the patient was vaccinated with GARDASIL dose 4 (Extra dose administered) (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with GARDASIL was unknown. The outcome of the events was unknown. There was no product quality complaint reported. Additional information has been requested.

VAERS ID:611731 (history)  Vaccinated:2015-11-13
Age:35.0  Onset:2015-11-14, Days after vaccination: 1
Gender:Female  Submitted:2015-11-16, Days after onset: 2
Location:Virginia  Entered:2015-11-25, 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: None
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.L0052901SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Fatigue, Flushing, Injection site erythema
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Red circle at injection site. BENADRYL, Ibuprofen, ice, ZYRTEC. Fatigue, face flushed.

VAERS ID:611738 (history)  Vaccinated:2015-11-24
Age:35.0  Onset:2015-11-24, Days after vaccination: 0
Gender:Male  Submitted:2015-11-25, Days after onset: 1
Location:California  Entered:2015-11-25
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) (FLUZONE)SANOFI PASTEURUI431AE0UNRA
Administered by: Private     Purchased by: Private
Symptoms: Immediate post-injection reaction, Mass
SMQs:, Hypersensitivity (narrow)
Write-up: Immediately after administration pt had palpable lump from about 1" in diameter and visible to the eye.

VAERS ID:612048 (history)  Vaccinated:2015-11-13
Age:35.0  Onset:2015-11-13, Days after vaccination: 0
Gender:Female  Submitted:2015-11-25, Days after onset: 12
Location:D.C.  Entered:2015-11-25
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: Chronic bronchitis
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRAR
Administered by: Unknown     Purchased by: Public
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Several hours post vaccines patient felt slight pain in arm around site of injections. Returned 1 week later with similar complaints. 2nd complaints 2 weeks later.

VAERS ID:611954 (history)  Vaccinated:2015-11-25
Age:35.0  Onset:2015-11-26, Days after vaccination: 1
Gender:Male  Submitted:2015-11-29, Days after onset: 3
Location:Unknown  Entered:2015-11-29
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: N/a
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV427A IMRA
Administered by: Military     Purchased by: Military
Symptoms: Injection site erythema, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Redness on site and itching.

VAERS ID:612093 (history)  Vaccinated:2015-11-06
Age:35.0  Onset:2015-11-09, Days after vaccination: 3
Gender:Female  Submitted:2015-11-30, Days after onset: 21
Location:Maryland  Entered:2015-11-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamin, Zyrtec
Current Illness: None
Preexisting Conditions: 6 weeks pregnant
Diagnostic Lab Data: Ultrasound on 11/18/15 and 11/25/15
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDU556060IMLA
Administered by: Private     Purchased by: Other
Symptoms: Exposure during pregnancy, Foetal heart rate abnormal, Ultrasound antenatal screen abnormal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)
Write-up: I was 5 weeks, 6 days pregnant at the time of the flu shot vaccination. I had an ultrasound on 11/18/15 which demonstrated growth of only 6 weeks and 2 days, no fetal heartbeat. Ultrasound on 11/25/15 confirmed previous findings.

VAERS ID:612165 (history)  Vaccinated:2015-10-17
Age:35.0  Onset:2015-10-18, Days after vaccination: 1
Gender:Female  Submitted:2015-11-28, Days after onset: 41
Location:Ohio  Entered:2015-11-30, 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:
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data: Require an MRI and PT
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDU548061SYRLA
Administered by: Other     Purchased by: Other
Symptoms: Bursitis, Drug administered at inappropriate site, Pain
SMQs:, Medication errors (narrow)
Write-up: Injected in shoulder instead of arm (per pt) resulted in bursitis. Treated with prednisone. Pain came back after she stopped prednisone. Pt have pain when she moves her arm around.

VAERS ID:612895 (history)  Vaccinated:0000-00-00
Age:35.0  Onset:0000-00-00
Gender:Female  Submitted:2015-12-02
Location:New Jersey  Entered:2015-12-02
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) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS43E97 IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypersensitivity, Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Redness/pain/swelling ecchymosis around injection site/area warm to touch. Dx: Allergic rx at doctor.

VAERS ID:613188 (history)  Vaccinated:2015-11-30
Age:35.0  Onset:0000-00-00
Gender:Female  Submitted:2015-12-03
Location:Michigan  Entered:2015-12-04, 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: CLARITIN; Albuterol
Current Illness: None
Preexisting Conditions: Allergies
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1571040IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Hivrs around injection site.

VAERS ID:613335 (history)  Vaccinated:2015-12-02
Age:35.0  Onset:2015-12-02, Days after vaccination: 0
Gender:Female  Submitted:2015-12-03, Days after onset: 1
Location:Pennsylvania  Entered:2015-12-04, 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: ORTHO-CYCLEN; Rizatriptan
Current Illness:
Preexisting Conditions: Adhesive tape allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU5049AA0IMLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURK03310IMLA
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUI106AA0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Oropharyngeal pain, Swollen tongue
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Received immunizations at approx. 845 am 12/2/15. Pt called at 11:30 am saying she felt like she had a sore throat and her tongue was swelling. Advised to call 911 and go to ER. She received SOLUMEDROL, BENADRYL and PEPCID at ER. Sent home with EPIPEN and to follow up with PCP.

VAERS ID:614062 (history)  Vaccinated:2015-12-08
Age:35.0  Onset:2015-12-09, Days after vaccination: 1
Gender:Female  Submitted:2015-12-09, Days after onset: 0
Location:Maryland  Entered:2015-12-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.L0282771SCRA
Administered by: Unknown     Purchased by: Other
Symptoms: Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Rash. She was evaluated in the ED. Diagnosis was hives. She was given Pepcid, Prednisone and Benadryl.

VAERS ID:614252 (history)  Vaccinated:2015-12-02
Age:35.0  Onset:2015-12-03, Days after vaccination: 1
Gender:Female  Submitted:2015-12-10, Days after onset: 7
Location:Idaho  Entered:2015-12-10
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: Hypothyroid, allergy to Norco
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU5213BA IMRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site cellulitis, Wound
SMQs:, Accidents and injuries (broad)
Write-up: Message received from PA at urgent care facility. Pt presented Thursday 12/3 for cellulitis. Spoke with nurse at clinic. Reported patient had "softball-sized" cellulitis at the injection site of her Tdap injection from 12/2. Pt given antibiotics and instructed to return to urgent care on 12/5 for reevaluation of wound.

VAERS ID:614462 (history)  Vaccinated:2015-12-02
Age:35.0  Onset:2015-12-02, Days after vaccination: 0
Gender:Female  Submitted:2015-12-04, Days after onset: 2
Location:Montana  Entered:2015-12-11, 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: AMBIEN; omeprazole; probiotics; Ibuprofen; TYLENOL
Current Illness: Recovering from viral illness
Preexisting Conditions: Latex allergy; joint pain; elevated CRP
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI506AB IMRA
Administered by: Public     Purchased by: Private
Symptoms: Erythema, Malaise, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pain within first 2 hours, redness and swelling after that. Systemic feelings of malaise started approx 24 hours after vaccine.

VAERS ID:614558 (history)  Vaccinated:2015-10-27
Age:35.0  Onset:2015-10-27, Days after vaccination: 0
Gender:Female  Submitted:2015-12-12, Days after onset: 46
Location:Illinois  Entered:2015-12-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS23FM4 IMRA
Administered by: Private     Purchased by: Other
Symptoms: Injected limb mobility decreased, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Right shoulder pain, reduced ROM, still have pain today.

VAERS ID:614680 (history)  Vaccinated:2014-09-19
Age:35.0  Onset:2014-09-20, Days after vaccination: 1
Gender:Male  Submitted:2015-12-14, Days after onset: 450
Location:California  Entered:2015-12-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol HFA MDI PRN (unknown if patient taking at time of apparent adverse event.
Current Illness: None known.
Preexisting Conditions: Childhood EIB, Insomnia, Headaches, IBS
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV387A1IMLA
Administered by: Military     Purchased by: Military
Symptoms: Chest pain, Dyspnoea, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: On 19 September 2014 he received his second dose of Anthrax and the following day (20 September) he noted onset of myalgias and developed chest pain and shortness of breath while running. He denies rhinoconjunctival, lip/tongue/oral/laryngeal, cutaneous and GI symptoms. He denies any adverse vaccine reactions prior to or since this episode. He has not received further doses of Anthrax.

VAERS ID:615652 (history)  Vaccinated:2015-11-19
Age:35.0  Onset:2015-11-30, Days after vaccination: 11
Gender:Male  Submitted:2015-12-19, Days after onset: 19
Location:Texas  Entered:2015-12-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 16 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: EMG and Nerve conduction tests confirmed; Lumbar puncture and Brain and total spine MRI also performed
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI496AB IMLA
Administered by: Other     Purchased by: Other
Symptoms: Electromyogram, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture, Nerve conduction studies, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Plasmapheresis
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)
Write-up: Guillain Barre Syndrome requiring IVIG and plasmapheresis treatment.

VAERS ID:615664 (history)  Vaccinated:2015-11-24
Age:35.0  Onset:2015-11-24, Days after vaccination: 0
Gender:Male  Submitted:2015-12-19, Days after onset: 25
Location:California  Entered:2015-12-19
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
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDU568070IMLA
Administered by: Other     Purchased by: Military
Symptoms: Vaccination site pain
SMQs:
Write-up: Patient denies constantly aching at the vaccinated site. Denies any swelling or bruising. Patient has tried to massage it but the pain has not improved. Patient called in to pharmacy 12/19/2015 5:30pm to report to me that he had experienced pain ever since he received the vaccination. I advised the patient take Ibuprofen/Tylenol to help with the pain and for him to follow-up with his PCP. I also advised him to call me back if condition worsen or if he has any other questions.

VAERS ID:615675 (history)  Vaccinated:2015-10-17
Age:35.0  Onset:2015-10-18, Days after vaccination: 1
Gender:Female  Submitted:2015-12-20, Days after onset: 63
Location:California  Entered:2015-12-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol given following onset of aches and shakiness, none immediately prior, prednisone w/in the previous 90 days
Current Illness: Recently recovered from a cold, and had taken prednisone in the preceeding 90 days for a UTI
Preexisting Conditions: Allergic to Keflex, Latex, Iodine, Nickel, Sulfa
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
Administered by: Military     Purchased by: Military
Symptoms: Arthralgia, Chills, Musculoskeletal stiffness, Myalgia, Nasopharyngitis, Nausea, Pain, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)
Write-up: Achy, shakes/shivering, nausea, muscle aches, joint aches, stiff neck, follwed the next day by severe cold type symptoms.

VAERS ID:615775 (history)  Vaccinated:2015-11-09
Age:35.0  Onset:2015-11-09, Days after vaccination: 0
Gender:Female  Submitted:2015-12-10, Days after onset: 31
Location:Arizona  Entered:2015-12-21, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURUI516AA2IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Flu shot given high on upper right arm, close to shoulder. Rt shoulder pain.

VAERS ID:616726 (history)  Vaccinated:2015-12-08
Age:35.0  Onset:2015-12-08, Days after vaccination: 0
Gender:Male  Submitted:2015-12-29, Days after onset: 21
Location:Michigan  Entered:2015-12-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None known
Current Illness: NONE
Preexisting Conditions: OPIOIDS- MORPHINE, AND PENICILLINS
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1578040IMLA
Administered by: Other     Purchased by: Other
Symptoms: Deafness unilateral, Paraesthesia, Respiratory distress, Trismus
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Dystonia (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Hearing impairment (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Tingling in hands and feet as well as face. Hearing loss in right ear and a locked jaw for 48 hours after receiving vaccine. Also, patient reports distressed breathing.

VAERS ID:617282 (history)  Vaccinated:2014-02-28
Age:35.0  Onset:2014-02-28, Days after vaccination: 0
Gender:Unknown  Submitted:2015-12-30, Days after onset: 670
Location:Unknown  Entered:2015-12-30
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: WAES1512USA009892
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0425AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Expired product administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: This spontaneous report was received from a pharmacist referring to 35 year old patient of unknown gender. The patient''s concurrent conditions and medical history were not provided. On 28-FEB-2014 the patient was vaccinated with an expired dose of MMR II lot # 0425AE expiration date 27-FEB-2014 (route and dose were not provided). There was no concomitant medication described. It was unknown if the patient sought medical attention. No adverse effects were reported. No product quality complain was involved. Additional information has been requested.

VAERS ID:617023 (history)  Vaccinated:1999-02-10
Age:35.0  Onset:1999-08-16, Days after vaccination: 187
Gender:Female  Submitted:2016-01-02, Days after onset: 5983
Location:Iowa  Entered:2016-01-02
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations: BODILY ITCHING SEVERE PLUS RASH AT INJECTION SITE~Hep B (no brand name)~2~25.92~Patient
Other Medications: MULTIVITAMIN; ONE PER DAY. IBUPROFEN; PRN
Current Illness: NONE/ DATE AND TIME OF VACCINATIONS IS APPROXIMATE
Preexisting Conditions: ENDOMETRIOSIS, PMS
Diagnostic Lab Data: ULTRASOUNDS ON 08/17/1999 AND EXTENSIVE ULTRASOUNDS, CT SCANS, MRI''S EXAMINATIONS, AND HEALTH CARE PROVIDER CARE SINCE THAT TIME NOW AS CONTINUOUS. 6 MONTHS OF ANTICOAGULANT THERAPY AFTER DISCHARGE FROM HOSPITAL IN 1999. LAST VACCINATION OF SERIES OF 3 WAS APPX 3 WEEKS BEFORE PORTAL VEIN THROMBOSIS WAS DIAGNOSED BY ULTRASOUND AND CT SCANS. THE RELEVANT CONNECTION BETWEEN THE SERIES OF 3 HEPATITIS B VACCINATIONS AND THE PORTAL VEIN THROMBOSIS IS NOT KNOWN BY PATIENT AS FAR AS FACTUAL AND POSSIBLE IN HAPPENING.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER 2SYRRA
Administered by: Public     Purchased by: Other
Symptoms: Computerised tomogram abnormal, Nuclear magnetic resonance imaging, Portal vein thrombosis, Ultrasound scan abnormal
SMQs:, Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow)
Write-up: SYMPTOMS AND SECONDARY ILLNESSES LEADING UP TO PORTAL VEIN THROMBOSIS WHICH WAS DECIDED FINAL DIAGNOSIS AFTER SERIES OF THREE VACCINATIONS FOR HEPATITIS B. I DO NOT HAVE ACTUAL KNOWLEDGE IF VACCINATIONS AND FINAL DIAGNOSIS CAN HAVE A POSSIBILITY OF BEING CONNECTED TO EACH OTHER AS CAUSE AND EFFECT.

VAERS ID:617055 (history)  Vaccinated:2015-09-30
Age:35.0  Onset:2015-10-02, Days after vaccination: 2
Gender:Female  Submitted:2015-12-30, Days after onset: 89
Location:Pennsylvania  Entered:2016-01-03, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS173906 IMLA
Administered by: Other     Purchased by: Unknown
Symptoms: Pain, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)
Write-up: Left arm pain - worse when arm is lifred in the air or rotated. Saw my doctor 12/15/15 was given a steroid pack/pain patch.

VAERS ID:617638 (history)  Vaccinated:2015-09-30
Age:35.0  Onset:0000-00-00
Gender:Unknown  Submitted:2016-01-06
Location:New Jersey  Entered:2016-01-06
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: Collected 10/5/15, Hep B Core AB, (-); Hep B Surf. AB (+); Hep B Surf, AG, (-); HIV Ag/Ab, (-); Hep C AB, (-)
CDC Split Type: NJ1538
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED11049221A IMAR
Administered by: Other     Purchased by: Private
Symptoms: HIV antibody negative, HIV antigen negative, Hepatitis B core antibody negative, Hepatitis B surface antibody positive, Hepatitis B surface antigen negative, Hepatitis C antibody negative, Incorrect product storage, Multiple use of single-use product, Underdose, Wrong technique in product usage process
SMQs:, Liver infections (narrow), Medication errors (narrow)
Write-up: On 9/30, DOH was notified by an out-of-state health services company that a nurse had reused syringes for multiple persons earlier that day at an employee influenza vaccination clinic where the health services company had been contracted. The nurse contracted by the health services company brought three multiple-dose vials of vaccine that were intended for another event (and stored in her personal fridge without temp monitoring). The nurse reported using two syringes she found among her supplies to administer vaccine to 67 employees of the business. She reported wiping the syringes with alcohol and using a new needle for each of the 67 persons. Only 2 multiple dose vials of vaccine (10 doses/vial) were used for 67 adult participants. Participants were offered blood-borne pathogen testing (hep B, hep C, HIV), hepatitis B vaccine, and flu vaccine.

VAERS ID:617714 (history)  Vaccinated:2015-09-30
Age:35.0  Onset:0000-00-00
Gender:Male  Submitted:2016-01-05
Location:New Jersey  Entered:2016-01-06, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Collected 10/05/15, Hep B Core AB, -; Hep B Surf. AB, +; Hep B Surf/ AG, -; HIV Ag/Ab, -; Hep C AB, -
CDC Split Type: NJ1530
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED11049221A IMAR
Administered by: Other     Purchased by: Private
Symptoms: HIV antibody negative, HIV antigen negative, Hepatitis B core antibody negative, Hepatitis B surface antibody negative, Hepatitis B surface antigen negative, Hepatitis C antibody negative, Incorrect product storage, Multiple use of single-use product, Underdose, Wrong technique in product usage process
SMQs:, Medication errors (narrow)
Write-up: On 9/30, DOH was notified by an health services company that a nurse had reused syringes for multiple persons earlier that day at am employee influenza vaccination clinic where the health services company had been contracted. The nurse contracted by the health services company brought three multiple-dose vials of vaccine that were intended for another event (and stored in her personal fridge without temp monitoring). The nurse reported using two syringes she found among her supplies to administer vaccine to 67 employees of the business. She reported wiping the syringes with alcohol and using a new needle for each of the 67 persons. Only 2 multiple dose vials of vaccine (10 doses/vial) were used for 67 adult participants. Participants were offered blood borne pathogen testing (hep N, hep C, HIV), hepatitis B vaccine, and flu vaccine.

VAERS ID:617720 (history)  Vaccinated:2015-09-30
Age:35.0  Onset:0000-00-00
Gender:Unknown  Submitted:2016-01-05
Location:New Jersey  Entered:2016-01-06, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Collected 10/4/15, Hep B Core AB, (-); Hep B Surf. AB, (+); Hep B Surf. AG, (-); HIV Ag/Ab, (-); Hep C AB, (-); Hep C RNA, (-)
CDC Split Type: NJ1511
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED11049221A IMAR
Administered by: Other     Purchased by: Private
Symptoms: HIV antibody negative, HIV antigen negative, Hepatitis B core antibody negative, Hepatitis B surface antibody positive, Hepatitis B surface antigen negative, Hepatitis C RNA negative, Hepatitis C antibody negative, Incorrect product storage, Multiple use of single-use product, Underdose, Wrong technique in product usage process
SMQs:, Liver infections (narrow), Medication errors (narrow)
Write-up: On 9/30, DOH was notified by an out-of-state health services company that a nurse had reused syringes for multiple persons earlier that day at an employee influenza vaccination clinic where the health services company had been contracted. The nurse contracted by the health services company brought three multiple-dose vials of vaccine that were intended for another event (and stored in her personal fridge without temp monitoring). The nurse reported using two syringes she found among her supplies to administer vaccine to 67 employees of the business. She reported wiping the syringes with alcohol and using a new needle for each of the 67 persons. Only 2 multiple dose vials of vaccine (10 doses/vial) were used for 67 adult participants. Participants were offered blood-borne pathogen testing (hep B, hep C, HIV), hepatitis B vaccine, and flu vaccine.

VAERS ID:617738 (history)  Vaccinated:2015-10-07
Age:35.0  Onset:2015-10-07, Days after vaccination: 0
Gender:Female  Submitted:2015-10-13, Days after onset: 6
Location:Illinois  Entered:2016-01-06, Days after submission: 85
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
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSC92E70SYRLA
Administered by: Other     Purchased by: Public
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Employee c/o fever, itchiness, redness and swelling at injection site.

VAERS ID:618169 (history)  Vaccinated:2016-01-08
Age:35.0  Onset:2016-01-08, Days after vaccination: 0
Gender:Female  Submitted:2016-01-11, Days after onset: 3
Location:California  Entered:2016-01-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMRA
Administered by: Public     Purchased by: Private
Symptoms: Apathy, Arthralgia, Confusional state, Dry eye, Fatigue, Headache, Lymphadenopathy, Musculoskeletal pain, Musculoskeletal stiffness, Neck pain
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Corneal disorders (broad), Depression (excl suicide and self injury) (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Neck pain, head pain, face stiffness, tiredness, confusion, dry eyes, joint pain, pain in shoulder, swelling of glands, apathy.

VAERS ID:618914 (history)  Vaccinated:2015-10-12
Age:35.0  Onset:2015-10-27, Days after vaccination: 15
Gender:Male  Submitted:2016-01-14, Days after onset: 79
Location:Georgia  Entered:2016-01-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 15 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: NO
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS1412401 SYRLA
Administered by: Other     Purchased by: Other
Symptoms: Skin irritation, Urinary retention, Urinary tract disorder
SMQs:, Anticholinergic syndrome (broad)
Write-up: I felt my skin was irritating while coming back from work at evening on 10/27. Next day started some urination problem and on 10/28, I was not able to pass urine at all.

VAERS ID:619511 (history)  Vaccinated:0000-00-00
Age:35.0  Onset:0000-00-00
Gender:Female  Submitted:2016-01-18
Location:Unknown  Entered:2016-01-18
Life Threatening? Yes
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: Food allergy; Rubber sensitivity; Drug hypersensitivity
Diagnostic Lab Data:
CDC Split Type: US2015GSK184196
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic reaction, Dyspnoea, Pruritus generalised, Swollen tongue, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported in a literature article and described the occurrence of anaphylaxis in a 35-year-old female subject who received Flu seasonal TIV Dresden. This case refers to patient 32 in the literature article. Concurrent medical conditions included shellfish allergy, latex allergy, penicillin allergy, allergic reaction to antibiotics and allergic reaction to antibiotics. On an unknown date, several minutes after receiving Flu seasonal TIV Dresden, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included generalized pruritus, swollen tongue, shortness of breath and throat tightness. The subject was treated with epinephrine, antihistamine, antihistamine and albuterol. The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included generalized pruritus (recovered/resolved), swollen tongue (recovered/resolved), shortness of breath (recovered/resolved) and throat tightness (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, generalized pruritus, swollen tongue, shortness of breath and throat tightness may have been caused by Flu seasonal TIV Dresden. Additional information was provided: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 35-year-old female patient who had received an unspecified trivalent influenza vaccine (manufacturer unknown). The patient was a female. The subject''s medical history included atopic disease with shellfish, latex, amoxicillin, ciprofloxacin and gentamicin allergies. No further information on the patient''s concurrent medical conditions, medical or family history, or concomitant medication was provided. On an unspecified date, between the 1st of January of 2009 and the 31st of December of 2011, the patient received an unspecified dose of an unspecified trivalent influenza vaccine (dosage unknown; administration route and site unspecified; batch number not provided). On an unspecified date, within less than 30 minutes after the vaccination, the patient developed generalized pruritus, tongue swelling, shortness of breath and throat closure. This was classified as anaphylaxis by the family practice doctor. According to the authors the case was considered as Brighton level 2 and setting of initial evaluation was clinic. The patient was treated by epinephrine, parenteral antihistamine, intravenous therapy and albuterol. At the time of reporting the outcome orf the events was recovered. The event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case is 1 of the 28 valid cases reported in the same literature article.

VAERS ID:621315 (history)  Vaccinated:2011-11-22
Age:35.0  Onset:2012-07-18, Days after vaccination: 239
Gender:Female  Submitted:2016-01-29, Days after onset: 1290
Location:New York  Entered:2016-01-29
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: 2011, Myomectomy
Diagnostic Lab Data: 11/22/2011, Pregnancy test, Negative; 12/10/2011, Pregnancy test, negative, comment: positive; 12/10/2011, Pregnancy test, positive, Comment: negative
CDC Split Type: WAES1112USA01614
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Caesarean section, Exposure during pregnancy, Pregnancy test positive, Premature delivery
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a 35 year old female patient with no drug reactions/allergies and no pertinent medical history for VARIVAX (Merck), a Pregnancy Registry product, who on 22-NOV-2011, was vaccinated with the first dose of VARIVAX (Merck) (route not reported). There was no concomitant medication. The same day, on 22-NOV-2011, a pregnancy test at the doctor''s office was negative. The patient ovulated on 26-NOV-2011. A home pregnancy test on 10-DEC-2011 was positive. The patient repeated the home test and it was again negative. The patient telephoned the doctor and would see her on 13-DEC-2011. At the time of the report, the patient outcome was unknown. The last menstrual period was 12-NOV-2011. Estimated delivery date would be 18-AUG-2012. Follow-up information was received from the nurse practitioner on 25-JAN-2016. It was reported that the patient had undergone scheduled C-section (Caesarean section) (medically significant) at 35-36 weeks (premature delivery) of pregnancy and delivered a male infant weighing 3130 grams and 18 3/4 inches in length. The APGAR score was reported as 9/9 at 5 mins. No information was provided regarding the health status of the infant or congenital anomalies. The reason for the patient''s scheduled C-section and she reported that the patient had a history of a Myomectomy in 2011 prior to vaccination. The outcome of the events caesarean section and the premature baby was reported as recovered. The relatedness of the events "scheduled C-section" and "premature delivery" with the suspect product VARIVAX (Merck) was unknown. Upon internal review the term "scheduled C-section" and "premature delivery" was considered as medically significant. The case was linked to another case via same parent child link. Additional information is not expected as no further information was not available. Events and narrative updated.

VAERS ID:621401 (history)  Vaccinated:2016-01-28
Age:35.0  Onset:2016-01-28, Days after vaccination: 0
Gender:Male  Submitted:2016-01-31, Days after onset: 3
Location:Indiana  Entered:2016-01-31
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
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER 0SYRLA
Administered by: Public     Purchased by: Private
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fatigue at first onset, body aches by afternoon, chills by early evening, fever. Second day, continued fatigue, body aches, fever, but with a headache. After letting my immune system fight it off naturally with no progress...I opted for Tylenol which decreased symptoms almost immediately.

VAERS ID:621736 (history)  Vaccinated:2014-11-11
Age:35.0  Onset:2014-11-11, Days after vaccination: 0
Gender:Female  Submitted:2015-11-16, Days after onset: 370
Location:Unknown  Entered:2016-02-02, Days after submission: 78
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: PHEH2014US025000
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS145701 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2014US02500, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 35 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 11 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The events reported after the maladministration.

VAERS ID:621899 (history)  Vaccinated:2016-02-02
Age:35.0  Onset:2016-02-03, Days after vaccination: 1
Gender:Male  Submitted:2016-02-04, Days after onset: 1
Location:Tennessee  Entered:2016-02-04
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
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Migraine with aura, Nausea, Photophobia, Vomiting
SMQs:, Acute pancreatitis (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad)
Write-up: Migraine with severe aura, photophobia and photophobia plus severe nausea and vomiting. Lasted all day. No prior history of migraine.

VAERS ID:621942 (history)  Vaccinated:2015-11-19
Age:35.0  Onset:2015-11-22, Days after vaccination: 3
Gender:Female  Submitted:2016-02-04, Days after onset: 74
Location:California  Entered:2016-02-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Not sure
Preexisting Conditions: Epilepsy, Chronic Migraines, TMJ problems, latex allergy, Vicodin allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Public     Purchased by: Other
Symptoms: Asthenia, Dehydration, Ear infection, Facial pain, Gingival cyst, Gingivitis, Influenza, Injection site swelling, Migraine, Musculoskeletal stiffness, Myalgia, Pain, Sinusitis, Swelling, Tooth abscess, Tooth infection, Toothache, Vaccination complication
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal neoplasms (narrow), Oropharyngeal infections (narrow), Gingival disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Flu symptoms, severe migraine from morning to night for both days more severe than usual chronic pain, muscle pain (arms, legs chest/shoulder area) arm swelling at the site of injection, weakness, excruciating toothache, facial pain, swelling, stiff neck. Infection in tooth, gums, sinus, and ear followed shortly after immunization. Complained to doctor staff, was told it was probably a reaction to the doses of two immunizations that I received. That it may have just been "too much for me" Treatment at emergency dentist of Amoxicillin in month of November. Again in December; Amox again, even though I explain to all docs that I am already resistant to two unknown (I forgot) types of antibiotics...then to ER for facial swelling and severe pain, migraine, infections, dehydration; diagnosed w/all but migraine and prescribed clindamycin. Infection not gone. To this day 02/04/2016 I have a reoccurring cyst in my gums, tooth abscess, persistent sinus infection and swelling which won''t go away. My children have all caught the flu despite their own flu shots..(physicians) are not readily willing test or confirm the presence of MRSA. We are given antibiotics without bloodwork or nasal swabs to confirm anything. My 8 yr old daughter now has a lung infection with severe chest pain, diarrhea, dehydration, stomach pain, missing school. Her older brother (13 yrs) has type one diabetes with a fever of high as 103 degrees last weekend which got better with close monitoring and medicine, no doctor visit or ER, oldest son (15yrs) was very sick for one week in January, did not get treated or diagnosed, had the flu. Youngest son 10 yrs old had all flu symptoms with difficulty breathing, taken to doctor, given antibiotics as well as Pepto Bismol for throat, Tylenol and Motrin for severe fever of 104, Benadryl for sinusitis, it seems to have gone. Whatever has happened with the virus or whatever this is, our family can''t seem to shake it and are all worsening, passing it back and forth and missing school, activities and going to a lot of doctor visits. I''m not understanding why blood testing is becoming a thing of the past nowadays to rule out more serious deficiency or autoimmune disorders which would make these occurrences more easily treated with knowledge of resistance.

VAERS ID:621968 (history)  Vaccinated:2016-02-04
Age:35.0  Onset:2016-02-04, Days after vaccination: 0
Gender:Female  Submitted:2016-02-04, Days after onset: 0
Location:Michigan  Entered:2016-02-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RITALIN; PARAFON FORTE; NORCO
Current Illness: None
Preexisting Conditions: ADHD; PPD
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI440AC IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Hives, lightheaded no oral swelling no SOB. Pt allergic to BENADRYL and oral prednisone given 40mg KENALOG IM and pt states lightheaded resolved and hives stopped progressing pt instructed to go to ED for problems.

VAERS ID:622007 (history)  Vaccinated:2015-11-09
Age:35.0  Onset:2015-11-26, Days after vaccination: 17
Gender:Female  Submitted:2016-02-06, Days after onset: 72
Location:Florida  Entered:2016-02-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Cat Scans; TC scans; Spinal Tap; Blood work
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI432AA1UNRA
Administered by: Private     Purchased by: Other
Symptoms: Blood test, Computerised tomogram, Guillain-Barre syndrome, Laboratory test normal, Lumbar puncture, Peripheral coldness, Sensory disturbance, Tenderness, VIIth nerve paralysis
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Demyelination (narrow), Hearing impairment (broad)
Write-up: Prior to 11/26 I noticed a strange sensation in my legs put not pain. More just sore to the touch and nerve sensors were off and my legs were always VERY cold for about a week prior to 11/26. Then in 11/26 Woke up and noticed that most of my face was paralyzed. I could not smile, or close my lips all the way or close my eyes all the way. I went to the hospital where they did all kinds of tests to rule out Bells Palsy. All the tests came back negative but my face slowly got worse and now it was affecting both sides of my face. Could not blink or smile etc. No other symptoms. After 1 week, the symptoms started to go away and I was diagnosed with a rare case of Guillain Barre Syndrome.

VAERS ID:622276 (history)  Vaccinated:2015-06-03
Age:35.0  Onset:2015-06-03, Days after vaccination: 0
Gender:Male  Submitted:2016-01-25, Days after onset: 236
Location:Georgia  Entered:2016-02-10, Days after submission: 16
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Bupropion HCL; Sertraline HCL
Current Illness:
Preexisting Conditions: Depression; Anxiety
Diagnostic Lab Data: MRI; Ultrasound; manual tests in office
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU5189AA IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Asthenia, Joint range of motion decreased, Laboratory test, Nuclear magnetic resonance imaging, Pain, Ultrasound scan
SMQs:, Guillain-Barre syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Excruciating pain - approx 2 weeks. Weakness - ongoing. Reduced range of motion - ongoing. Chronic pain - ongoing.

VAERS ID:622593 (history)  Vaccinated:2015-09-08
Age:35.0  Onset:2015-09-08, Days after vaccination: 0
Gender:Male  Submitted:2015-11-16, Days after onset: 69
Location:Unknown  Entered:2016-02-11, Days after submission: 87
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: PHEH2015US017650
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS157103 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2015US017650, is an initial spontaneous report received from a nurse on 09 Sep 2015. This report refers to a male patient of unspecified age. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157103) intramuscularly at a dose of 0.5 ml on 08 Sep 2015. It was reported that before administration the FLUVIRIN prefilled syringe was stored at 33.2 degrees Fahrenheit. No adverse event was reported following this maladministration. Follow-up report received from a nurse on 27 Oct 2015. Updated patient height and weight.

VAERS ID:622650 (history)  Vaccinated:2016-02-04
Age:35.0  Onset:2016-02-09, Days after vaccination: 5
Gender:Female  Submitted:2016-02-09, Days after onset: 0
Location:Unknown  Entered:2016-02-11, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NKDA, possible allergy to pine trees - "rash"
Diagnostic Lab Data: No laboratory tests required at this time.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURUS292AA IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Musculoskeletal stiffness, Skin lesion
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: The patient reports that on 02/04/2016 when she was being treated for a left palm laceration she received a tetanus booster from the office staff upon orders of Dr. She states that within the last 1-2 days she noticed a hot, red patch spreading out from the injection site at the right deltoid. She reported that it was accompanied by a sensation of muscle stiffness in the right arm. She noted additional well-demarcated patches of red, raised skin of a smaller size spreading distally from the central lesion. She states that someone told her to try applying cortisone but this did not help with the problem. She denies difficulty speaking, tightness in the throat, chest pain, shortness of breath, or difficulty breathing. Examination reveals a large irregularly shaped raised erythematous lesion with maximum dimensions of 10 cm x 7 cm. There is no visible dimpling or injection site wound. There are 4 smaller patches better individually demarcated traveling distally down the arm to just above the elbow. They are also raised. All of these lesions are hot to the touch compared to the surrounding skin. There is no crusting, flaking, induration, exudate, or drainage. Dr. also examined the patient and we question whether or not his may be a case of erysipelas versus some sort of adverse reaction to a vaccine component or preservative. There is no indication that the patient is having an anaphylactic reaction or other life-threatening event. Possible infection spreading distally from infection site. Our POC is to treat with KEFLEX 500 mg p.o. b.i.d. x10 days. Prescription written for 20 capsules, 0 refills. Safer medication use was discussed with the patient. I discussed signs and symptoms of anaphylaxis with the patient and she was advised to seek emergent medical attention if they occur. Plan to recheck in our office in 72 hours otherwise.

VAERS ID:622667 (history)  Vaccinated:2015-09-08
Age:35.0  Onset:2015-09-08, Days after vaccination: 0
Gender:Male  Submitted:2015-11-16, Days after onset: 69
Location:Unknown  Entered:2016-02-11, Days after submission: 87
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: PHEH2015US017651
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS157103 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2015US017651 is an initial spontaneous report received from a nurse on 08 SEP 2015. This report refers to a male patient whose age was not reported. Past medical history and concomitant medications were not reported. His vaccination history included administration of FLUVIRIN (batch number: not reported) for twice on an unknown dates which were tolerated. The patient was vaccinated with 0.5 ml of FLUVIRIN 2015/2016 (batch number: 157103) pre-filled syringe (PFS) intramuscularly into left deltoid on 08 SEP 2015 at 14:30 hours. It was reported that the patient received vaccine which was out of temperature range at 33.2 degree Fahrenheit on 08 SEP 2015. The event was reported as non-serious. No adverse events were reported following the inadvertent administration. Follow-up information received from a nurse on 27 OCT 2015: Patient''s demographics (height and weight), vaccination history, time of vaccination, site of vaccination and other clinically relevant information updated in the narrative.

VAERS ID:622533 (history)  Vaccinated:2016-02-10
Age:35.0  Onset:2016-02-11, Days after vaccination: 1
Gender:Female  Submitted:2016-02-12, Days after onset: 1
Location:Pennsylvania  Entered:2016-02-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metoprolol 50mg/day; Glyburide 5mg/day; Prenatal vitamin
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  IMLA
Administered by: Private     Purchased by: Other
Symptoms: Chills, Headache, Influenza, Nausea, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Flu symptoms. Headache, nausea, fever, chills, aches. Treated as if it were the actual flu (liquids and Tylenol).

VAERS ID:622901 (history)  Vaccinated:2015-10-08
Age:35.0  Onset:2015-10-08, Days after vaccination: 0
Gender:Female  Submitted:2015-11-16, Days after onset: 39
Location:Unknown  Entered:2016-02-12, Days after submission: 88
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: PHEH2015US020587
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1412701 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Expired product administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2015US020587 is an initial spontaneous report received from a nurse on 13 Oct 2015. This report refers to a 35 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with an expired dose of FLUVIRIN (batch number: 1412701) at a dose of 0.5 ml, intramuscularly on 08 Oct 2015. No adverse event was reported following this medication error (expired vaccine used).

VAERS ID:623049 (history)  Vaccinated:2015-12-04
Age:35.0  Onset:2015-12-04, Days after vaccination: 0
Gender:Female  Submitted:2016-01-22, Days after onset: 49
Location:Arizona  Entered:2016-02-18, 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 reported
Current Illness:
Preexisting Conditions: None reported
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU5319AA IMRA
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.K0207550SCRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4765AA IMLA
Administered by: Public     Purchased by: Private
Symptoms: No adverse event, Wrong drug administered
SMQs:, Medication errors (narrow)
Write-up: Patient was administered PROQUAD vaccine (MMRV) instead of MMR vaccine. No s/s or tx noted/given.

VAERS ID:623263 (history)  Vaccinated:2016-02-22
Age:35.0  Onset:2016-02-22, Days after vaccination: 0
Gender:Female  Submitted:2016-02-22, Days after onset: 0
Location:New York  Entered:2016-02-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Currently on Remecaide and Asocal
Current Illness: Denies any symptoms prior to getting the vaccine
Preexisting Conditions: Severe Colitis
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURUI496AA IMLA
Administered by: Public     Purchased by: Other
Symptoms: Dysgeusia
SMQs:, Taste and smell disorders (narrow)
Write-up: Metallic taste in her mouth. No treatment given except to continue to monitor. No SOB or difficulty breathing at present.

VAERS ID:623407 (history)  Vaccinated:2015-11-07
Age:35.0  Onset:2015-11-07, Days after vaccination: 0
Gender:Male  Submitted:2016-01-10, Days after onset: 64
Location:North Dakota  Entered:2016-02-23, Days after submission: 44
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
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDU566064IMLA
Administered by: Military     Purchased by: Military
Symptoms: Discomfort, Injection site pain, Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)
Write-up: Intense pain upon initial vaccination. Subsequent pain and discomfort for approx 10 weeks following vaccination. All pain in shoulder area (deltoid).

VAERS ID:623634 (history)  Vaccinated:2015-01-01
Age:35.0  Onset:2015-03-01, Days after vaccination: 59
Gender:Female  Submitted:2016-02-23, Days after onset: 359
Location:California  Entered:2016-02-24, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: USEmergentBioSolutions16A
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSUNKNOWN3UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Information received from an Investigator in a vaccine pregnancy registry. A 35 year old female (gravida 1 para 0) received dose 4 of BioThrax vaccine in JAN2015 (at 4 weeks 0 days estimated gestational age (EGA)). The female was determined to be pregnant in JAN2015, 10 days after vaccination. She sent a study referral (generated from active case finding efforts) in FEB2016 which indicated that she had a miscarriage in MAR2015 (5 weeks + 3 days EGA). Treatments included: oxycodone hcl / acetaminophen, promethazine and acetaminophen. No further information is expected. The subject was not eligible for entry in the registry; the Investigator forwarded the information to the vaccine manufacturer.

VAERS ID:623740 (history)  Vaccinated:2013-10-22
Age:35.0  Onset:0000-00-00
Gender:Female  Submitted:2015-07-01
Location:Unknown  Entered:2016-02-24, Days after submission: 238
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: 2015SE65204
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: A report has been received from a Study Investigator concerning a 35 year old, female subject, Weight: 124.0 pounds, enrolled in study MA-VA-MEDI3250-1115; A Postmarketing Safety Study of Q/LAV in Subjects 2 Through 49 Years of Age. The patient''s medical and concurrent history was not provided at the time of reporting. FLUMSIT (intranasal) started on 22-Oct-2013 for influenza. The patient experienced pregnancy. Action taken with FLUMIST was unknown at the time of reporting. The outcome of pregnancy was abnormal outcome. The investigator assessed the event of pregnancy to be non-serious.

VAERS ID:623883 (history)  Vaccinated:2015-11-23
Age:35.0  Onset:2015-11-24, Days after vaccination: 1
Gender:Unknown  Submitted:0000-00-00
Location:New York  Entered:2016-02-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1515001 UNUN
TDAP: TDAP (ADACEL)SANOFI PASTEURU5235AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Rash on back of neck, legs and redness of ears little on face. Patient took BENADRYL and its reducing rash.

VAERS ID:623997 (history)  Vaccinated:2015-11-03
Age:35.0  Onset:2015-11-03, Days after vaccination: 0
Gender:Female  Submitted:2016-02-26, Days after onset: 115
Location:Virginia  Entered:2016-02-26
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: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI443AA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Nausea, Nervousness, Throat tightness
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Hypoglycaemia (broad)
Write-up: Within in the hour of flu vaccination, patient reported feeling nauseous, shaky and throat feeling tight. Administration nurse gave 50mg im Benadryl in vaccination arm. Ambulance was called and patient was transported to ER. I attempted to contact the patient on numerous occasions for follow up. She did not respond to my calls.

VAERS ID:624214 (history)  Vaccinated:2015-09-23
Age:35.0  Onset:2015-09-28, Days after vaccination: 5
Gender:Female  Submitted:2016-02-26, Days after onset: 151
Location:Hawaii  Entered:2016-02-26
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 8 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: CSF with total protein of 83. WBC of ZERO. Glucose of 52. Negative MRI.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT)GLAXOSMITHKLINE BIOLOGICALS7AJ5J1IMRL
Administered by: Military     Purchased by: Military
Symptoms: CSF glucose normal, CSF protein increased, CSF white blood cell count negative, Guillain-Barre syndrome, Immunoglobulin therapy, Nuclear magnetic resonance imaging normal
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)
Write-up: Guillain Barre with 30 day hospitalization. Diagnosed with lumbar puncture and CSF findings. Treated with IVIG x5 doses. Inpatient and outpatient rehabilitation.

VAERS ID:624307 (history)  Vaccinated:2016-02-18
Age:35.0  Onset:2016-02-18, Days after vaccination: 0
Gender:Female  Submitted:2016-02-29, Days after onset: 11
Location:Nebraska  Entered:2016-02-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Januvia; glipizide; Lantus; Humalog; diclofenac
Current Illness: No
Preexisting Conditions: Diabetes, hypertension
Diagnostic Lab Data: EMG pending
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  SCLA
Administered by: Unknown     Purchased by: Other
Symptoms: Electromyogram, Hypoaesthesia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Numbness, tingling in arm.

VAERS ID:624583 (history)  Vaccinated:2015-10-01
Age:35.0  Onset:2015-10-01, Days after vaccination: 0
Gender:Female  Submitted:2016-03-01, Days after onset: 152
Location:Maryland  Entered:2016-03-01
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: Tylenol 3, Cipro, Flagyl
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED 0IMRA
Administered by: Other     Purchased by: Private
Symptoms: Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging abnormal, Pain, Rotator cuff syndrome
SMQs:, Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (narrow)
Write-up: Onset of pain injection, limited range of motion in right shoulder, pain when doing any movement. MRI results show two tears in my roator cuff resulting from the flu shot. Did cortisone shot and still doing 2-3 times a week of Physical therapy.

VAERS ID:625279 (history)  Vaccinated:2015-10-16
Age:35.0  Onset:2015-11-28, Days after vaccination: 43
Gender:Male  Submitted:2016-03-03, Days after onset: 96
Location:Wisconsin  Entered:2016-03-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: MRI is normal. I''ve been seeing neurologist every month since. With no improvements, and not able to return to work.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDU55906 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea, Dizziness, Impaired work ability, Malaise, Neurological symptom, Nuclear magnetic resonance imaging normal, Post procedural complication, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow)
Write-up: Got extremely sick, uncontrolled puking, diarrhea. Admitted to the hospital. 2 weeks later. On Dec. 11 I woke up with dizziness, and many neurological symptoms. I have not worked since Dec. 15th. My Neurologist diagnosed with a post infectious phenomenon. Directly relates it to the flu vaccine. Still suffer to this day.

VAERS ID:626993 (history)  Vaccinated:2016-02-23
Age:35.0  Onset:2016-02-24, Days after vaccination: 1
Gender:Female  Submitted:2016-03-08, Days after onset: 13
Location:Virginia  Entered:2016-03-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CIPRO; PENLAC; DIFLUCAN
Current Illness: Unknown
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type: WAES1602USA011746
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.L040178 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This spontaneous report as received from a nurse referring to a 35 year old female patient with asthma. Patient was not pregnant and had no drug reaction or allergies. On 23-FEB-2016, the patient was intramuscularly vaccinated with dose PNEUMOVAX23 (dose and frequency were not reported, lot # L040178 with expiration date: 18-AUG-2017). Concomitant therapies included CIPRO, PENLAC and DIFLUCAN. On 24-FEB-2016, the patient developed swelling and redness at the site PNEUMOVAX23 injection. The patient was not recovered. No treatment was given for adverse event. Lab diagnostic studies were not performed. The patient sought medical attention. A lot check was requested. Causality assessment was not reported. Additional information has been requested.

VAERS ID:628685 (history)  Vaccinated:2015-04-03
Age:35.0  Onset:2015-04-03, Days after vaccination: 0
Gender:Female  Submitted:2016-03-22, Days after onset: 354
Location:Maryland  Entered:2016-03-22
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No medications
Current Illness: No.
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TETANUS DIPHTHERIA (TENIVAC)SANOFI PASTEURU4669AA3IMLA
Administered by: Public     Purchased by: Private
Symptoms: Autoimmune disorder, Blood test, Borrelia test positive, Headache, Immediate post-injection reaction, Injection site pain, Lyme disease, Muscle spasms, Nuclear magnetic resonance imaging, Pain, Peripheral swelling, Skin warm, Swelling, Tendon rupture, X-ray
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Dystonia (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (narrow)
Write-up: Immediately the shot hurt. The arm swelled up and was hot to the touch. Headache started the following day and has not gone away since. Entire body hurts and has muscle cramping and spasms that need to be controlled by muscle relaxers. Physicians believe there is now an autoimmune disorder from the reaction to the tetanus vaccine and my tendons are now susceptible to tearing, my posterior tibial tendon is now torn and needs surgery. I have had blood work, MRI''s, Xrays. I now have Lyme disease and several courses of antibiotics have not been successful in treating it. I still test positive for multiple strains. They are putting me in the infectious disease unit to do IV antibiotics now. I have to take HCTZ for weird parts of my body that suddenly swell.

VAERS ID:628957 (history)  Vaccinated:2015-11-13
Age:35.0  Onset:2015-11-14, Days after vaccination: 1
Gender:Female  Submitted:2016-03-23, Days after onset: 129
Location:California  Entered:2016-03-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: None
Diagnostic Lab Data: MRI
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS15752P1IMRA
Administered by: Other     Purchased by: Other
Symptoms: Mobility decreased, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Tendonitis, Weight bearing difficulty
SMQs:, Parkinson-like events (broad), Tendinopathies and ligament disorders (narrow)
Write-up: Pt. states her armpit to elbow was sore. She states this was still present 6weeks later when she seeked medical attention. She now has loss of flexibility in that arm and is unable to lift heavy thing. States that and MRI shows inflammation of tendons.

VAERS ID:629226 (history)  Vaccinated:2016-03-22
Age:35.0  Onset:2016-03-23, Days after vaccination: 1
Gender:Male  Submitted:2016-03-25, Days after onset: 2
Location:Unknown  Entered:2016-03-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Redness and swelling to injection site. PT stated also having pain
Preexisting Conditions: N/a
Diagnostic Lab Data: N/a
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV4494 IM 
Administered by: Military     Purchased by: Military
Symptoms: Injection site erythema, Injection site swelling, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness and swelling to injection site.

VAERS ID:630144 (history)  Vaccinated:2016-04-01
Age:35.0  Onset:2016-04-01, Days after vaccination: 0
Gender:Male  Submitted:2016-04-02, Days after onset: 1
Location:Louisiana  Entered:2016-04-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lisinopril 10mg, loratidine
Current Illness: No
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Other
Symptoms: Fatigue, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: I was unusually fatigued for the rest of the day after getting the vaccine on 04/01/2016. The following day, 04/02/2016, I had muscle aches from the time I got up in the morning. Aches got worse until I took two ibuprofen around 12 PM. Now it is about 4 PM and the only ache remaining is in my upper back/shoulders.

VAERS ID:630708 (history)  Vaccinated:2016-04-08
Age:35.0  Onset:2016-04-08, Days after vaccination: 0
Gender:Male  Submitted:2016-04-08, Days after onset: 0
Location:South Dakota  Entered:2016-04-08
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
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV427A4IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.K0219521SCLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURK17063IMRA
Administered by: Military     Purchased by: Military
Symptoms: Flushing, Nausea, Pruritus, Throat irritation
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: NAUSEA, ITCHY THROAT, FLUSH FACE, ITCHY LEGS.

VAERS ID:630710 (history)  Vaccinated:2016-03-08
Age:35.0  Onset:2016-04-08, Days after vaccination: 31
Gender:Female  Submitted:2016-04-08, Days after onset: 0
Location:Illinois  Entered:2016-04-08
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: Sulfa
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALST54GG2IMRA
Administered by: Public     Purchased by: Private
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Patient complains of pain in her right shoulder. Pain starts at elbow and radiates to her neck. Says it started sooner after receiving vaccine. Had no trouble with the two previous vaccines. Denies any other symptoms.

VAERS ID:630748 (history)  Vaccinated:2011-06-23
Age:35.0  Onset:2011-06-23, Days after vaccination: 0
Gender:Female  Submitted:2016-03-31, Days after onset: 1743
Location:Tennessee  Entered:2016-04-08, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Available upon request
Current Illness:
Preexisting Conditions: Allergic to penicillin, irritable bowel syndrome
Diagnostic Lab Data: Allergic to: nuts and seeds, penicillin, pollen, animal hair and dander, Johnson grass, Russian olive, bee sting, wasp sting, flying insect sting.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS 0UNAR
TTOX: TETANUS TOXOID (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNAR
Administered by: Public     Purchased by: Private
Symptoms: Allergy to animal, Allergy to arthropod sting, Drug hypersensitivity, Food allergy, Pain, Seasonal allergy, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Conjunctival disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Sore, puffy.

VAERS ID:630777 (history)  Vaccinated:2016-03-15
Age:35.0  Onset:2016-03-15, Days after vaccination: 0
Gender:Female  Submitted:2016-04-08, Days after onset: 24
Location:Missouri  Entered:2016-04-08
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
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS45SJ21IMLA
Administered by: Public     Purchased by: Private
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: States had pain at site of injection (left deltoid) immediately after shot; gradually worsened to "excruciating pain", not able to use arm normally, not able to raise arm, by 4/8/2016; to PCP for evaluation, Dx possible bursitis or allergic reaction; started on Prednisone PO. To check back with PCP on 4/11/2016.

VAERS ID:631290 (history)  Vaccinated:2016-04-08
Age:35.0  Onset:2016-04-09, Days after vaccination: 1
Gender:Female  Submitted:2016-04-13, Days after onset: 4
Location:Rhode Island  Entered:2016-04-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol inhaler, clindamycin-benzoyl peroxide gel, escitalopram oxalate 10mg daily, ferrous sulfate, Flovent, fluticasone, lorazepam 0.5mg, multivitamin daily, omeprazole 20mg daily, ranitidine 150mg daily
Current Illness: None
Preexisting Conditions: Allergies: Macrobid, Paxil, Ciprofloxacin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.L003227 IMLA
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, Chills, Dizziness, Injection site pain, Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Pt reports day after receiving vaccine she had joint pain, dizziness, pain at injection site. No fever, but did have chills. Hives on arm at site of injection.

VAERS ID:632836 (history)  Vaccinated:2016-03-25
Age:35.0  Onset:2016-03-25, Days after vaccination: 0
Gender:Female  Submitted:2016-04-25, Days after onset: 31
Location:New York  Entered:2016-04-25
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
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.L0242640SCRA
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU5251AA1IMLA
Administered by: Public     Purchased by: Private
Symptoms: Erythema, Injection site mass, Pain in extremity, Peripheral swelling
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), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt. returned today 4-25-16 for MMR #2 - She stated that after her last MMR her arm swelled to size of a "football" was red and painful. She went to her primary MD on 3/28/16 where he treated her w/Diphenhydramine and Ibuprofen and inst. her to ice it. RN noted that there is still a walnut sized lump at inj site. No other s/s.

VAERS ID:633119 (history)  Vaccinated:2016-04-25
Age:35.0  Onset:2016-04-26, Days after vaccination: 1
Gender:Male  Submitted:2016-04-27, Days after onset: 1
Location:Georgia  Entered:2016-04-27
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
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUI123AA1SCRA
Administered by: Military     Purchased by: Military
Symptoms: Arthralgia, Chills, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Subjective fever, myalgia, arthralgia, and chills.

VAERS ID:633701 (history)  Vaccinated:2015-10-21
Age:35.0  Onset:2015-10-21, Days after vaccination: 0
Gender:Female  Submitted:2016-04-23, Days after onset: 185
Location:Minnesota  Entered:2016-04-29, 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: None
Current Illness: None
Preexisting Conditions: Crohn''s
Diagnostic Lab Data: MRI
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT)GLAXOSMITHKLINE BIOLOGICALSGB7490IMLA
Administered by: Other     Purchased by: Private
Symptoms: Bursitis, Drug administered at inappropriate site, Nuclear magnetic resonance imaging abnormal, Pain
SMQs:, Medication errors (narrow)
Write-up: After flu shot, patient experienced severe pain and inflammation of bursa sac on arm where flu shot administered. Pt''s physician said caused by inappropriate placement of flu shot injection. Inflammation shown on MRI. Pt has been in physical therapy since 10/21/15 immunization and has seen some improvement, but not 100%.

VAERS ID:633786 (history)  Vaccinated:2016-04-26
Age:35.0  Onset:2016-04-28, Days after vaccination: 2
Gender:Female  Submitted:2016-04-29, Days after onset: 1
Location:Alabama  Entered:2016-04-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Aripiprazole 5mg, Vyvanse 40mg, fluoxetine 20mg
Current Illness: No. However, when patient presented to the pharmacy 3 days later with the rash, she said she had gotten sun burn a few days before receiving the vaccine.
Preexisting Conditions: NKDA. Patient has been diagnosed with depression and adult ADD.
Diagnostic Lab Data: Patient was given a steroid shot at the urgent care that she visited and was prescribed ibuprofen 800mg 3x/day for 5 days to treat the rash.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS9Y57K IMLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Patient reported having no reaction the day that the vaccine was administered. However, the morning after administration, she developed a circular red rash around the injection site. The next day (4/29/16) she presented to the pharmacy after going to urgent care because the rash had gotten bigger and was slightly swollen. Patient denied fever, itching, or swelling of any other body parts (symptoms were localized to injection site area). Rash was about 3" in diameter.

VAERS ID:633902 (history)  Vaccinated:2016-04-21
Age:35.0  Onset:2016-04-22, Days after vaccination: 1
Gender:Female  Submitted:2016-05-02, Days after onset: 10
Location:Massachusetts  Entered:2016-05-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Escitalopram Oxalate
Current Illness: None
Preexisting Conditions: Mood disorder
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.L0386690IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURU5378AA IMRA
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Mobility decreased
SMQs:, Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Redness, warmth, swelling at injection site, limited mobility of arm.

VAERS ID:633949 (history)  Vaccinated:2016-04-16
Age:35.0  Onset:2016-04-17, Days after vaccination: 1
Gender:Male  Submitted:2016-04-28, Days after onset: 11
Location:South Carolina  Entered:2016-05-02, Days after submission: 4
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: NKDA; WD male
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV439A3UNUN
JEV1: JAPANESE ENCEPHALITIS (IXIARO)INTERCELL AGJEV14J74E0UNUN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURK17061UNUN
Administered by: Other     Purchased by: Military
Symptoms: Ear pain, Myringotomy
SMQs:, Hearing impairment (broad)
Write-up: Pt received below vaccines and reported to general medicine c/o significant bilateral ear pain and was referred to EENT who performed a myringotomy and pending required tympanostomy tube placement.

VAERS ID:633966 (history)  Vaccinated:2016-04-27
Age:35.0  Onset:2016-04-28, Days after vaccination: 1
Gender:Female  Submitted:2016-05-02, Days after onset: 4
Location:Kansas  Entered:2016-05-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEXAPRO
Current Illness: None
Preexisting Conditions: Depression
Diagnostic Lab Data: Did not seek medical treatment
CDC Split Type:
Vaccination
Manufacturer
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Dose
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PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.M005287 IMUN
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness and swelling at the injection site, followed by itching.

VAERS ID:634461 (history)  Vaccinated:2015-01-20
Age:35.0  Onset:2015-02-01, Days after vaccination: 12
Gender:Female  Submitted:2016-04-27, Days after onset: 450
Location:Arizona  Entered:2016-05-05, Days after submission: 8
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 16 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Parotitis swollen gland
Preexisting Conditions: Rheumatoid Arthritis
Diagnostic Lab Data: Lumbar puncture
CDC Split Type:
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FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1453010UNAR
Administered by: Private     Purchased by: Unknown
Symptoms: Guillain-Barre syndrome, Lumbar puncture, Plasmapheresis, Sensory loss
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)
Write-up: Guillain-Barre. Loss of feeling all over body. Plasma treatment and therapy.

VAERS ID:634474 (history)  Vaccinated:2016-05-04
Age:35.0  Onset:2016-05-05, Days after vaccination: 1
Gender:Female  Submitted:2016-05-05, Days after onset: 0
Location:Massachusetts  Entered:2016-05-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unk
Current Illness: Unk
Preexisting Conditions: Allergies: Lisinopril
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.L040053 IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Cellulitis, Erythema, Peripheral swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient received pneumococcal polysaccharide PPV23 on 5/4/16. She reported swelling and redness of left arm. Came to the urgent care dept on 5/5/16 diagnosed with cellulitis and given PO antibiotics and NSAIDS.

VAERS ID:634685 (history)  Vaccinated:2016-04-19
Age:35.0  Onset:2016-04-20, Days after vaccination: 1
Gender:Male  Submitted:2016-05-03, Days after onset: 13
Location:Virginia  Entered:2016-05-06, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: ~Anthrax (no brand name)~6~0.00~Patient|~Anthrax (no brand name)~5~0.00~Patient
Other Medications: Ibuprofen; CLARITIN
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV554A6IMRA
Administered by: Private     Purchased by: Public
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Vaccination 4/19/16. On 4/20 c/o pain/swelling rt. shoulder area, no SOB/sx. No numbness, weakness. 4/21 - unscheduled visit to Dr. - Increased rt. shoulder pain, swelling decreased ROM rt. shoulder - MEDROL DOSE PAK given 4/24/16 - Called, arm improved.

VAERS ID:634771 (history)  Vaccinated:2016-04-25
Age:35.0  Onset:0000-00-00
Gender:Male  Submitted:2016-05-08
Location:New York  Entered:2016-05-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Pt received all these vaccinations from her primary care doctor.
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Influenza like illness, Influenza virus test positive, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient received her MMR on April 25 from her primary care doctor. Then on May 5th, she developed flu like symptoms and rash on May 7th. Tested positive flu today. Unclear if rash is from MMR. Seen in urgent care today. Pt will follow up with her primary care doctor tomorrow.

VAERS ID:635001 (history)  Vaccinated:2014-09-13
Age:35.0  Onset:2014-12-23, Days after vaccination: 101
Gender:Female  Submitted:2016-04-22, Days after onset: 485
Location:Georgia  Entered:2016-05-10, Days after submission: 18
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 13 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI271AB UNRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Fatigue, Guillain-Barre syndrome, Hypoaesthesia, Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Shoulder pain and weakness started a few weeks after administering soon followed by feet numbness and fatigue. Guillain Barre diagnosed 12/27/2014.

VAERS ID:635064 (history)  Vaccinated:2015-08-11
Age:35.0  Onset:2015-08-12, Days after vaccination: 1
Gender:Male  Submitted:2016-05-10, Days after onset: 272
Location:Missouri  Entered:2016-05-10
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV427A UNUN
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Local reaction, Peripheral swelling, Pruritus, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Upper arm is swollen, red, tender, and is a little itchy. No systemic symptoms. Local reaction only. Swelling down to his elbow.

VAERS ID:635180 (history)  Vaccinated:2007-07-09
Age:35.0  Onset:0000-00-00
Gender:Male  Submitted:2016-05-10
Location:Florida  Entered:2016-05-11, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: 11 Jul 2007, HEPATITIS B (Merck, #0691U)
Current Illness: None
Preexisting Conditions: Intermittent episodes of acute lower back pain since 2001
Diagnostic Lab Data: 07 APR 2016, SERUM, Iron Panel, Iron, 163.3 mcg/dL, Iron Binding Capacity Unsaturated, 104.6 mcg/dL, Iron Binding Capacity Total, 267.9 mcg/mL, Iron/Total Iron Binding Capacity, 61.0%, Ferritin, 43.9 ng/mL; 07 Apr 201, BLOOD, CBC w/ diff, WBC, 5.3x10(3)/mcL, RBC, 4.06x10(6), Hemoglobin, 13.1 g/dL, Hematocrit, 37.7%, MCV, 92.9 fL, MCH, 32.3 pg, MCHC, 34.7 g/dL, Platelets, 197x10(3), RDW CV, 12.50%, MPV, 11.0 fL, Neutrophils, 67.9%, Lymphocytes, 23.2%, Monocytes, 7.50%, Eosinophils, 0.80%, Basophils, 0.40%, Granulocytes Immature, 0.20%, ABS Neutrophils, 3.6x10(3)/mcL, ABS Lymphocytes, 1.2x10(3)/mcL, ABS Monocytes, 0.4x10(3)/mcL, ABS Eosinophils, 0.0x10(3)/mcL, ABS Basophils, 0.0x10(3)/mcL; 04 Dec 2015, SERUM, Hepatitis A+B+C Virus Profile, He
CDC Split Type:
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ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1056UNUN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEUR  IMUN
Administered by: Military     Purchased by: Military
Symptoms: Activities of daily living impaired, Alanine aminotransferase normal, Arthralgia, Aspartate aminotransferase normal, Asthenia, Basophil count normal, Basophil percentage decreased, Blood 25-hydroxycholecalciferol, Blood albumin normal, Blood alkaline phosphatase normal, Blood calcium normal, Blood chloride normal, Blood cortisol normal, Blood creatine phosphokinase normal, Blood creatinine normal, Blood glucose normal, Blood iron normal, Blood phosphorus normal, Blood potassium normal, Blood sodium normal, Blood urea normal, C-reactive protein normal, Chest X-ray normal, Continuous positive airway pressure, Differential white blood cell count, Eosinophil count normal, Eosinophil percentage decreased, Fatigue, Glomerular filtration rate decreased, Glycosylated haemoglobin normal, Granulocytes abnormal, Haematocrit decreased, Haemoglobin decreased, Hepatitis A antibody negative, Hepatitis B core antibody negative, Hepatitis B surface antibody positive, Hepatitis B surface antigen negative, Hepatitis C antibody negative, Hypogonadism, Insomnia, Intervertebral disc degeneration, Iron binding capacity total decreased, Iron binding capacity total normal, Limb discomfort, Lymphocyte count, Lymphocyte count normal, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume normal, Mean platelet volume increased, Metabolic function test normal, Monocyte count normal, Monocyte percentage, Myalgia, Neutrophil count decreased, Neutrophil percentage, Nuclear magnetic resonance imaging spinal abnormal, Pain in extremity, Platelet count normal, Poor quality sleep, Red blood cell count decreased, Red cell distribution width normal, Renal function test, Reticulocyte count normal, Reticulocyte haemoglobin equivalent, Reticulocyte percentage normal, Serum ferritin normal, Sex hormone binding globulin, Sleep apnoea syndrome, Somnolence, Vitamin D, White blood cell count decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Liver infections (narrow), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Fertility disorders (narrow), Chronic kidney disease (broad), Arthritis (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: 44-year-old (currently) M who noted a significant change in his health, primarily muscle pain and fatigue, within 3 weeks of receiving his 7th anthrax vaccine in Jul 2007. Prior to Jul 2007 vaccine receipt, patient was in his usual state of excellent health, typically running 6 miles/day and bicycling 200 miles/week. Patient had completed a 1/2 marathon earlier in 2007 and reports he was in the "best shape ever". Onset of patient''s symptoms occurred shortly after he moved in Jul 2007. On his second day at his new job, he received his 7th anthrax vaccine. Within 1 month of vaccine receipt, patient could not even run 2 miles due to lower extremity pain and significant post-exercise fatigue. During the next 12 months, patient''s symptoms continued and were intense. Because of lower extremity muscle and joint pain, "heaviness" in lower extremity muscles, and inability to recover following exercise, patient discontinued running for 9 months. During this period, the pain patient experienced was in the large muscles of his lower extremities, as well as in his hip and knee joints. It was dull, aching pain with pain intensity of 7/10 using a pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). Pain was constant and did not migrate but affected all lower extremity large muscles and joints simultaneously. Patient had difficulty going to sleep because pain seemed worse at bedtime. He tried a variety of treatments including anti-inflammatories, moist heat, massage, compression sleeves, and topical analgesics. Nothing he tried relieved his pain. The pain improved the most when patient changed from prolonged sitting to getting up and walking, or after walking, sitting to rest. He also noted moderate benefit with compression sleeves on calves. Patient denies experiencing numbness and tingling in his lower extremities. Patient describes his concomitant fatigue as feeling of inadequate energy to perform activities and the sensation of exhaustion. At times, he struggled to stay awake. If his baseline energy level was 100%, during his first year post-symptom onset, he rates his energy level as 30-40%. He would awaken feeling unrefreshed and this feeling would continue through the day; on rare occasions the fatigue would worsen during the day. He could tell when he needed to rest and recover, but even though he would significantly reduce or stop activities, he would experience a period of increased fatigue lasting from weeks to up to several months. During this period, patient typically was able to sleep 6-7 hours/night. If he did not get at least 6 hours of sleep, he felt worse the following morning. He would take brief naps on the weekend, otherwise he did not nap. He denies a history of associated symptoms of fevers, sore throat, swollen glands, headaches, cognitive changes, and dizziness or passing out. In 2008, patient began running again. He gradually increased his pace and distance. He "pushed through" the pain and fatigue. He would stop running when his legs became too heavy, and he would take time to recover from post-exercise malaise. He was able to continue this pattern for 3 - 6 months at a time and then would reach a point where "he knew it was doing more harm than good". At that point, he would take 2 - 4 weeks off and then gradually start over again. Patient reports his symptoms of lower extremity muscle and joint pain, lower extremity heaviness, and generalized fatigue have waxed and waned through the years since 2008. His symptoms have never completely resolved. The character of his symptoms has not changed significantly except for intensity. At his best, his lower extremity pain intensity was rated as 3-4/10 and his energy level increased to about 70% of his baseline. Patient has learned to balance his activities and rest. Patient received subsequent anthrax vaccines without exacerbation of his symptoms, and denies worsening of symptoms in temporal association to other vaccines. Denies history of large local vaccinati

VAERS ID:635417 (history)  Vaccinated:2016-05-10
Age:35.0  Onset:2016-05-12, Days after vaccination: 2
Gender:Female  Submitted:2016-05-12, Days after onset: 0
Location:Illinois  Entered:2016-05-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FLONASE, SINGULAIR, ZANTAC, PRENTATAL VITAMINS, PHENTERMINE. PATIENT HAD CHILD IN FEBRUARY 2016
Current Illness: NONE, NO FEVER. PATIENT NOT ON ANY ANTIBIOTICS
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE. PATIENT GIVEN ANTIBIOTIC. TOLD TO ICE THE AREA AND TAKE BENADRYL.
CDC Split Type:
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PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHM733320IMLA
Administered by: Other     Purchased by: Private
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Injection site warmth, Limb discomfort
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: SWELLING AT SIGHT OF IMMUNIZATION. REDNESS AND HEAT. PATIENT SAID ARM FELT HEAVY. PATIENT FELT HOT.

VAERS ID:636034 (history)  Vaccinated:2016-03-15
Age:35.0  Onset:2016-05-01, Days after vaccination: 47
Gender:Male  Submitted:2016-05-17, Days after onset: 16
Location:Pennsylvania  Entered:2016-05-17
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:
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YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUH866AA0SCLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site pain, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: 5-1-16 noticed left tricep sore. Bilateral legs tingling sensation intermittently. Feels as if "rain hitting" legs.

VAERS ID:636541 (history)  Vaccinated:2013-02-27
Age:35.0  Onset:2013-02-27, Days after vaccination: 0
Gender:Male  Submitted:2015-03-27, Days after onset: 757
Location:Unknown  Entered:2016-05-20, Days after submission: 420
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: PHEH2014US004303
Vaccination
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MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA12098 IMUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Product preparation error
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2014US004303 is an initial spontaneous report received from a pharmacist on 27 Feb 2014. This report refers to a 35-year-old male patient. Past medical history and concomitant medications was not reported. He was inadvertently administered only Men A lyophilized conjugate component of MENVEO (batch number: A12098), reconstituted with a sterile diluent instead of MenCYW-135 liquid component, intramuscularly on 27 Feb 2013. Reported stated that, the patient is a physician, who will be traveling. No adverse reaction was reported following this administration error.

VAERS ID:637285 (history)  Vaccinated:2016-02-22
Age:35.0  Onset:2016-02-22, Days after vaccination: 0
Gender:Unknown  Submitted:2016-05-21, Days after onset: 88
Location:Georgia  Entered:2016-05-21
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: WAES1605USA008096
Vaccination
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HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.L035881 IMRA
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: This spontaneous report was received from a back office lead referring to a 35-year-old patient of unknown gender. There was no information about the patient''s concurrent conditions, concomitant therapies or medical history provided. On 22-FEB-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L035881, expiration date: 26-JUN-2017, 1 ml, intramuscularly, in right deltoid (a dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.

VAERS ID:636729 (history)  Vaccinated:2015-11-06
Age:35.0  Onset:2015-11-06, Days after vaccination: 0
Gender:Female  Submitted:2016-05-24, Days after onset: 199
Location:Michigan  Entered:2016-05-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Food-based organic multivitamin
Current Illness: None.
Preexisting Conditions: None.
Diagnostic Lab Data:
CDC Split Type:
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FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Private
Symptoms: Abdominal pain, Dry eye, Erythema, Eye pruritus, Fatigue, Gingival discolouration, Lymphadenopathy, Nasal congestion, Nausea, Ocular hyperaemia, Pain, Pyrexia, Somnolence
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gingival disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad)
Write-up: Flu shot: face redness, whites of both eyes bright red, fever, fatigue, body soreness, extreme abdominal pain lasting through the night, nasal congestion, dry itchy eyes, sleepiness, nausea, bright purple red gums, swollen lymph nodes.

VAERS ID:637310 (history)  Vaccinated:2016-05-23
Age:35.0  Onset:2016-05-24, Days after vaccination: 1
Gender:Female  Submitted:2016-05-27, Days after onset: 3
Location:Florida  Entered:2016-05-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data:
CDC Split Type:
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TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS73D7R IMLA
Administered by: Private     Purchased by: Other
Symptoms: Injection site erythema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pt Developed redness and warmth to the injection site.

VAERS ID:637772 (history)  Vaccinated:0000-00-00
Age:35.0  Onset:0000-00-00
Gender:Female  Submitted:2016-05-12
Location:Unknown  Entered:2016-06-01, Days after submission: 20
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: Shellfish allergy; Latex allergy; Amoxicillin; Ciprofloxacin and gentamycin allergy
Diagnostic Lab Data:
CDC Split Type: 2015057136
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FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Dyspnoea, Pruritus generalised, Swollen tongue, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 35 year old female patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had history atopy: other (shell fish, latex, amoxicillin, ciprofloxacin and gentamycin). On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, in less than 30 minutes after vaccination, the patient experienced anaphylaxis. The symptoms included generalized pruritus, swelling (tongue), shortness of breath (SOB) and throat closure. The case met Brighton Collaboration case definition of anaphylaxis criteria level 2. She received treatment with epinephrine, parenteral antihistamine, IVT (intravenous transfusion) and bronchodilator (albuterol). The outcome was recovered. Reporter''s comments: The attributed trigger was vaccine. ***Case correction (12-Jan-2016): Upgraded all events to serious.

VAERS ID:637801 (history)  Vaccinated:2015-10-08
Age:35.0  Onset:2015-10-08, Days after vaccination: 0
Gender:Female  Submitted:2016-05-09, Days after onset: 214
Location:Wisconsin  Entered:2016-06-01, Days after submission: 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: 2016059749
Vaccination
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FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDU55406 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage
SMQs:, Medication errors (narrow)
Write-up: This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 36 year-old female patient. On 08-Oct-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5mL for the prevention of influenza. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion as 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.

VAERS ID:637820 (history)  Vaccinated:2015-10-07
Age:35.0  Onset:2015-10-07, Days after vaccination: 0
Gender:Female  Submitted:2016-05-09, Days after onset: 215
Location:Wisconsin  Entered:2016-06-01, Days after submission: 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: 2016059744
Vaccination
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FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDU55406 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage
SMQs:, Medication errors (narrow)
Write-up: This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 35 year-old female patient. On 07-Oct-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5mL via the intramuscular route. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.

VAERS ID:637751 (history)  Vaccinated:2016-05-24
Age:35.0  Onset:2016-05-24, Days after vaccination: 0
Gender:Female  Submitted:2016-06-02, Days after onset: 9
Location:California  Entered:2016-06-02
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: 28 weeks pregnant
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Military     Purchased by: Military
Symptoms: Exposure during pregnancy, Fatigue, Nausea, Pain, Pain in extremity, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Nausea and vomiting, extreme fatigue, soreness, achy legs and feet.

VAERS ID:637869 (history)  Vaccinated:2015-11-04
Age:35.0  Onset:2015-11-04, Days after vaccination: 0
Gender:Female  Submitted:2016-05-09, Days after onset: 186
Location:Unknown  Entered:2016-06-02, Days after submission: 24
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: 2016057886
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDU58908 IMAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site pain, Muscle haemorrhage
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad)
Write-up: This spontaneous case was initially received on 25-Nov-2015. The case report was received from a Health Professional and concerns a 35 year old female patient. The patient received AFLURIA on 04-Nov-2015 - 4-November-2015, Batch no: U58908, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 04-Nov-2015, 1 day after starting treatment with AFLURIA the patient experienced Arm pain near injection site/Pain in context of arm. On an unknown date, after starting treatment with AFLURIA the patient experienced Intramuscular hematoma. Pharmacist suggested that the patient try oral ibuprofen. Reporter''s assessment: Non serious.

VAERS ID:637969 (history)  Vaccinated:2015-10-30
Age:35.0  Onset:2015-10-30, Days after vaccination: 0
Gender:Female  Submitted:2016-05-09, Days after onset: 192
Location:Unknown  Entered:2016-06-02, Days after submission: 24
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: 2015055517
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDU56306 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Incorrect product storage
SMQs:, Medication errors (narrow)
Write-up: This spontaneous case was initially received on 02-NOV-2015. The case report was received from a(n) Health Professional and concerns a(n) 35 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 30-OCT-2015 - 30-OCT-2015, Batch no: U56306, Route of administration: Intramuscular, Dose: no information provided. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: The AFLURIA vaccine shipment was received at the pharmacy on 26-OCT-2015. The pharmacy thought it may be frozen so segregated it in the refrigerator so it would not be dispensed. On an unknown date, the patient was administered with one vaccine from quarantined syringes (temperature excursion occurred - frozen) (non serious outcome: Unknown), (non serious, outcome: unknown) Action taken: not provided Event treatment: Referred to the PCP (primary care physician) and recommended repeat vaccination per CDC. Rechallenge/Dechallenge information not provided. For relevant tests results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter''s assessment: The Health Professional considered the event(s) Administered one vaccine from quarantined syringes, Temperature excursion occurred - frozen as non-serious and causality of unlikely in relation to AFLURIA.

VAERS ID:638118 (history)  Vaccinated:2015-09-30
Age:35.0  Onset:2015-09-30, Days after vaccination: 0
Gender:Male  Submitted:2016-05-09, Days after onset: 222
Location:New Jersey  Entered:2016-06-02, Days after submission: 24
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: 10/5/2015: Hepatitis B core antibody, Negative; Hepatitis B surface antibody, Positive; Hepatitis B, surface antigen, Negative; Hepatitis C antibody, Negative; HIV antibody, Negative; HIV antigen, Negative
CDC Split Type: 2016059408
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED11049221A IMUN
Administered by: Other     Purchased by: Private
Symptoms: HIV antibody negative, Hepatitis B core antibody negative, Hepatitis B surface antibody positive, Hepatitis B surface antigen negative, Hepatitis C antibody negative, Incorrect dose administered, Incorrect product storage, Multiple use of single-use product
SMQs:, Liver infections (narrow), Medication errors (narrow)
Write-up: This medically confirmed health authority report (initial receipt 22-FEB-2016) concerns a 35-year-old male patient. On 30-SEP-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for anther event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccine (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (batch number: 11049221A) in the arm. The patient was offered blood pathogen testing, (hep B, hep C, HIV), hepatitis B vaccine and flu vaccine. On 05-OCT-2015, the patient underwent Laboratory tests which showed positive results for Hepatitis B surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antique and hepatitis C antibody. The outcome was unknown. Reporter''s comments: The health authority assessed the events as non-serious.

VAERS ID:639262 (history)  Vaccinated:2016-04-08
Age:35.0  Onset:2016-04-08, Days after vaccination: 0
Gender:Female  Submitted:2016-06-02, Days after onset: 55
Location:Iowa  Entered:2016-06-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: XANAX; Nabumetone; Cyclobenzaprine
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.L0449170IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.L0242681IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.L0412040SCRA
Administered by: Public     Purchased by: Other
Symptoms: Asthenia, Body temperature increased, Nausea, Pain, Rash
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Temp, weakness, nausea, fluid filled rash to neckline around ears, body aches rash systemic.

VAERS ID:638290 (history)  Vaccinated:2015-10-26
Age:35.0  Onset:2015-12-07, Days after vaccination: 42
Gender:Female  Submitted:2016-06-07, Days after onset: 182
Location:California  Entered:2016-06-07
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:
Diagnostic Lab Data: Cortisone shots to bursa, possible rotator cuff injury, shoulder impingement, Physical Therapy
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER   LA
Administered by: Public     Purchased by: Other
Symptoms: Injected limb mobility decreased, Injection site pain, Rotator cuff syndrome
SMQs:, Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (narrow)
Write-up: Upper left arm pain and immobility.

VAERS ID:638416 (history)  Vaccinated:2016-06-06
Age:35.0  Onset:2016-06-07, Days after vaccination: 1
Gender:Female  Submitted:2016-06-08, Days after onset: 1
Location:Colorado  Entered:2016-06-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 6 prior doses were given in childhood
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURL146216IMLA
Administered by: Other     Purchased by: Other
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Nausea, Pain, 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), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt. reported to PCP (& Occupational Health clinic) body aches, chills, low-grade fever (38 C), nausea; pain, redness and swelling at the site of injection. PCP recommended (via telephone consult) to take Advil and OTC antihistamine.

VAERS ID:638491 (history)  Vaccinated:2016-03-25
Age:35.0  Onset:2016-03-25, Days after vaccination: 0
Gender:Unknown  Submitted:2016-06-09, Days after onset: 76
Location:Georgia  Entered:2016-06-09
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: WAES1605USA008076
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.042846 UNLA
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: This spontaneous report was received from a back office lead and refers to a 35 year old patient of unknown gender. There was no information about the patient''s concurrent conditions, concomitant therapies or medical history provided. On 25-MAR-2016, the patient was vaccinated with the improperly stored dose of RECOMBIVAX HB (1 ml, in left deltoid, lot # reported as 042846 (verified to be non valid), expiration date 15-SEP-2017; route was not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.

VAERS ID:638966 (history)  Vaccinated:2016-05-11
Age:35.0  Onset:2016-05-11, Days after vaccination: 0
Gender:Female  Submitted:2016-06-13, Days after onset: 33
Location:Texas  Entered:2016-06-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Neuropathy, Latex allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI450AE IMRA
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS4AN45 IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.L034730 SCRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSTX43X IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.L043622 SCLA
Administered by: Public     Purchased by: Public
Symptoms: Condition aggravated, Facial paralysis, Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hearing impairment (broad)
Write-up: Pain on the upper left arm, and redness on injection site. Later that day patient c/o minor numbness on the lower left arm and weakness on the left arm with soreness. Patient states that injection site swelled approximately the size of an egg. Patient states had a history of Bell''s Palsy in the past, patient experienced Bell''s Palsy again and decided to go to the hospital, was given an allergy cocktail in the ER.

VAERS ID:639718 (history)  Vaccinated:2016-06-14
Age:35.0  Onset:2016-06-15, Days after vaccination: 1
Gender:Female  Submitted:2016-06-16, Days after onset: 1
Location:Illinois  Entered:2016-06-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: wellbutrin synthroid multi-vitamin
Current Illness: none known
Preexisting Conditions: none known
Diagnostic Lab Data: will follow up with primary care physician
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
Administered by: Private     Purchased by: Private
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Pain, Pain in extremity, Tenderness
SMQs:, Rhabdomyolysis/myopathy (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Deep, excruciating pain from shoulder to tips of fingers. Could not touch or move arm due to stiffness and pain.

VAERS ID:639829 (history)  Vaccinated:2012-02-05
Age:35.0  Onset:2012-02-05, Days after vaccination: 0
Gender:Male  Submitted:2012-08-22, Days after onset: 198
Location:Unknown  Entered:2016-06-16, Days after submission: 1394
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: PHEH2012US011315
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong technique in product usage process
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2012US011315 is an initial spontaneous report received from a nurse on 01 Jun 2012 and a follow up received from a healthcare professional on 19 Jun 2012: This case refers to a patient of 35-year-old male. He was previously vaccinated with MENVEO which was tolerated well. On 05 Feb 2012 he was vaccinated only with Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: unknown), intramuscularly, without reconstituting with Men A component. It was reported that, later she was received the correct dose of MENVEO. No adverse event was reported following this administration error. Follow up information received from a healthcare professional on 19 Jun 2012: updated patient demographics, vaccination history, and confirmed that no adverse event happened following vaccination.

VAERS ID:639726 (history)  Vaccinated:2016-06-03
Age:35.0  Onset:2016-06-04, Days after vaccination: 1
Gender:Female  Submitted:2016-06-17, Days after onset: 13
Location:Unknown  Entered:2016-06-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Divalproex sodium, Zyrtec, Rizatriptan
Current Illness: NONE.
Preexisting Conditions: Penicillin, Keflex, Duricef, Sulfa
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDU562060IMLA
Administered by: Military     Purchased by: Military
Symptoms: Rash, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Erythematous rash on bilateral forearms. Rash still present on 17Jun2016 @ 2:30 PM with no progression.

VAERS ID:640866 (history)  Vaccinated:2016-06-15
Age:35.0  Onset:2016-06-16, Days after vaccination: 1
Gender:Female  Submitted:2016-06-17, Days after onset: 1
Location:North Carolina  Entered:2016-06-17
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
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.L0482090IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.M0007600SCRA
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Induration, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pruritus, induration, cellulitis. Antibiotics started 6/17/16.

VAERS ID:640532 (history)  Vaccinated:2016-06-20
Age:35.0  Onset:2016-06-21, Days after vaccination: 1
Gender:Female  Submitted:2016-06-23, Days after onset: 2
Location:Mississippi  Entered:2016-06-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Medrol Dose Pack on 6/13/2016 and Motrin 800mg (ten days supply) on 6/13/2016
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: n/a
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU5318AA1IMLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient had a red, swollen, slightly warm to the touch area around the injection site. Patient presented to the pharmacy 6/23/16 to show pharmacist her arm. Her arm was still somewhat red, and warm to the touch.

VAERS ID:641635 (history)  Vaccinated:2016-06-29
Age:35.0  Onset:2016-06-30, Days after vaccination: 1
Gender:Male  Submitted:2016-07-01, Days after onset: 1
Location:Florida  Entered:2016-07-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: NO
Preexisting Conditions: No
Diagnostic Lab Data: NO
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS2BA47 IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU5392AA IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.L017406 IMRA
Administered by: Other     Purchased by: Private
Symptoms: Injection site rash
SMQs:, Hypersensitivity (narrow)
Write-up: Patient developed rash originating from injection site.

VAERS ID:641697 (history)  Vaccinated:0000-00-00
Age:35.0  Onset:0000-00-00
Gender:Female  Submitted:2016-07-05
Location:Georgia  Entered:2016-07-05
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: Medical History/Concurrent Conditions: Allergic reaction to antibiotics; Drug allergy; Latex allergy; Shellfish allergy
Diagnostic Lab Data:
CDC Split Type: USSA2016SA117968
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Dyspnoea, Pruritus generalised, Swollen tongue, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Initial unsolicited report received from the literature on 21 June 2016. This case was linked to 2016SA117942, 2016SA117944, 2016SA117945, 2016SA117946, 2016SA117947, 2016SA117948, 2016SA117949, 2016SA117950, 2016SA117951, 2016SA117952, 2016SA117953, 2016SA117954, 2016SA117955, 2016SA117956, 2016SA117957, 2016SA117958, 2016SA117959, 2016SA117960, 2016SA117961, 2016SA117962, 2016SA117963, 2016SA117964, 2016SA117965, 2016SA117966, 2016SA117967, 2016SA117969. (Same literature). The following is verbatim from the article: Background: Anaphylaxis is a potentially life-threatening allergic reaction. The risk of anaphylaxis after vaccination has not been well described in adults or with newer vaccines in children. Objective: We sought to estimate the incidence of anaphylaxis after vaccines and describe the demographic and clinical characteristics of confirmed cases of anaphylaxis. Methods: Using health care data from the Vaccine Safety Datalink, we determined rates of anaphylaxis after vaccination in children and adults. We first identified all patients with a vaccination record from January 2009 through December 2011 and used diagnostic and procedure codes to identify potential anaphylaxis cases. Medical records of potential cases were reviewed. Confirmed cases met the Brighton Collaboration definition for anaphylaxis and had to be determined to be vaccine triggered. We calculated the incidence of anaphylaxis after all vaccines combined and for selected individual vaccines. Results: We identified 33 confirmed vaccine-triggered anaphylaxis cases that occurred after 25,173,965 vaccine doses. The rate of anaphylaxis was 1.31 (95 percent CI, 0.90-1.84) per million vaccine doses. The incidence did not vary significantly by age, and there was a non-significant female predominance. Vaccine-specific rates included 1.35 (95 percent CI, 0.65-2.47) per million doses for inactivated trivalent influenza vaccine (10 cases, 7,434,628 doses given alone) and 1.83 (95 percent CI, 0.22-6.63) per million doses for inactivated monovalent influenza vaccine (2 cases, 1,090,279 doses given alone). The onset of symptoms among cases was within 30 minutes (8 cases), 30 to less than 120 minutes (8 cases), 2 to less than 4 hours (10 cases), 4 to 8 hours (2 cases), the next day (1 case), and not documented (4 cases). Conclusion: Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case involves a 35-year-old female patient who was vaccinated with a dose Trivalent Influenza Vaccine (Manufacturer: unknown, batch number, dose, route and site of administration was not reported) on an unspecified date. The medical history of atopy included other (shellfish, latex, amoxicillin, ciprofloxacin, and gentamicin). Concomitant medications were not reported. On unspecified date, less than 30 minutes following the vaccination, the patient had experienced generalized pruritus, swelling (tongue), Shortness of breath (SOB), throat closure and anaphylaxis. The patient required ER/doctor visit. Laboratory data were not reported. The patient received corrective treatment with epinephrine, parenteral antihistamine, IVT, bronchodilator (albuterol). On an unspecified date, patient was recovered from all the events. Upon internal review the case was considered as serious because of important medical event: Anaphylaxis. List of documents held by sender: none. Sender''s Comments: The reported symptoms are consistent with the diagnosis of anaphylactic reaction. Time to onset is compatible with the role of the vaccine. The patient had allergic history to shellfish, latex, Amoxicillin, Ciprofloxacin and Gentamicin. Additional information including but not limited to the patient''s previous immunization history (i.e., previous immunizations and any adverse events following immunizations), medical history, concomitant medication, vaccine details, an

VAERS ID:642000 (history)  Vaccinated:2016-06-28
Age:35.0  Onset:2016-06-28, Days after vaccination: 0
Gender:Female  Submitted:2016-06-29, Days after onset: 1
Location:New York  Entered:2016-07-05, 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: RIG
Current Illness: None known
Preexisting Conditions: Penicillin; pistachios; latex
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABAVERT)NOVARTIS VACCINES AND DIAGNOSTICS58601AA1IMLA
Administered by: Public     Purchased by: Private
Symptoms: Myalgia, Paraesthesia, Peripheral coldness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Pt came to clinic for day 3 RPtP. Reports muscle aches after day 0 shot. Day 3 RABAVERT shot given (L) deltoid without issue pt. took well. Approx. 2 hrs. later pt. called in to report (L) arm, finger and up to cheek cold, tingling, fell asleep. Advised to call her MD. As of 6/29/16- pt. states has some feeling in (L) arm, Not worse, MD advised to go to ER if gets worse. Pt to receive monitoring at hosp. ER in controlled setting.

VAERS ID:643470 (history)  Vaccinated:0000-00-00
Age:35.0  Onset:0000-00-00
Gender:Female  Submitted:2016-07-15
Location:Maryland  Entered:2016-07-15
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: Medical History/Concurrent Conditions: Allergy to vaccine
Diagnostic Lab Data:
CDC Split Type: USSA2016SA129064
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Allergy to vaccine, Anaphylactic reaction, Similar reaction on previous exposure to drug
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)
Write-up: This case is linked with 2016SA111915 (same patient). Initial unsolicited report received from a consumer (extracted from the medical records) on 30-JUN-2016. This case involves a 35-year-old female patient who was vaccinated with a dose of FLU SHOT (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient had a medical history of allergy to flu vaccine, tuberculin/ppd vaccine, bactrim vaccine, Buspar vaccine, Reglan vaccine and pre-existing physician diagnosed allergies, birth defects, medical conditions and any other vaccination with in four weeks prior to date of vaccination were reported as unknown. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had similar reaction after flu shot and allergy to flu vaccine. It was reported that the patient required ER visit. Lab data and corrective treatment were not reported. The outcome of the event was not reported. Upon medical review, the case was considered as serious due to important medical event: Anaphylactic reaction (similar reaction after flu shot). List of documents held by sender: none. Sender''s Comments: The case is very poorly documented. The patient had a significant allergic history to Bactrim (critical), Buspar (Moderate), Reglan (Moderate) and Tuberculin/PPD (critical). Further information on the symptoms the patient experienced after the flu shot, vaccination details, time to onset, data confirming the diagnosis, allergy testing to identify the culprit allergen, etc. will be needed for complete assessment of this case. Based on the information available, a role of the vaccine cannot be ruled out.

VAERS ID:644587 (history)  Vaccinated:2016-07-07
Age:35.0  Onset:2016-07-08, Days after vaccination: 1
Gender:Male  Submitted:2016-07-23, Days after onset: 15
Location:North Carolina  Entered:2016-07-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamin; Vitamin D3 2000 IU
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Drug administered at inappropriate site, Exposure during pregnancy, Injected limb mobility decreased, Joint stiffness, Pain, Sleep disorder
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow)
Write-up: Tdap vaccine was given less than a finger''s width below the joint space. Have had decreased PROM/AROM especially with L shoulder ABD, flexion, and internal rotation. Unable to sleep on left or right side. Constant aching w/ pain worse at night due to increased joint stiffness. Have been to orthopedist and PT. Have received joint mobs, PROM, and dry needling. Tdap vaccine received because I am 7 months pregnant.

VAERS ID:644649 (history)  Vaccinated:2016-07-15
Age:35.0  Onset:2016-07-18, Days after vaccination: 3
Gender:Female  Submitted:2016-07-25, Days after onset: 7
Location:Georgia  Entered:2016-07-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: n/a
Preexisting Conditions: sulfa/ PCN/ seasonal allergies/ vitiligo
Diagnostic Lab Data: patient referred to orthopedic specialist
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU5476AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Left shoulder pain radiating to elbow, anti-inflammatories prescribed.

VAERS ID:644915 (history)  Vaccinated:2015-10-23
Age:35.0  Onset:2015-10-23, Days after vaccination: 0
Gender:Male  Submitted:0000-00-00
Location:North Carolina  Entered:2016-07-26
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: Allergy to dust mites
Diagnostic Lab Data: CMP, 26 July 2016; CBC with Diff, 26 July 2016; ESR, 26 July 2016
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURER 2UNAR
Administered by: Other     Purchased by: Other
Symptoms: Differential white blood cell count, Full blood count, Injection site urticaria, Metabolic function test, Red blood cell sedimentation rate
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Patient developed hives at the site of his previous allergen vaccines (described as posterior triceps area) that begin within 1-2 days of receiving his third anthrax vaccine received on 23 October 2015.

VAERS ID:645287 (history)  Vaccinated:2016-07-20
Age:35.0  Onset:2016-07-22, Days after vaccination: 2
Gender:Male  Submitted:2016-07-28, Days after onset: 6
Location:Maryland  Entered:2016-07-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Patient was given Menactra 0.1 ml ID in error. Physician ordered PPD 0.1 ml ID
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU5392AA0IDRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Wrong drug administered
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Mild redness.

VAERS ID:645804 (history)  Vaccinated:2016-08-01
Age:35.0  Onset:2016-08-01, Days after vaccination: 0
Gender:Female  Submitted:2016-08-01, Days after onset: 0
Location:Georgia  Entered:2016-08-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.M004893   
Administered by: Public     Purchased by: Public
Symptoms: Circumstance or information capable of leading to medication error, Exposure via direct contact, Eye irrigation
SMQs:, Medication errors (narrow)
Write-up: Administered MMRV to her daughter, daughter moved and part of the vaccine went into mothers right eye. Right eye was irrigated with eye wash. Client instructed to report if develops any s/s and seek medical treatment for s/s.

VAERS ID:646454 (history)  Vaccinated:2016-08-02
Age:35.0  Onset:2016-08-03, Days after vaccination: 1
Gender:Female  Submitted:2016-08-04, Days after onset: 1
Location:New York  Entered:2016-08-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin; Invokana; Pravastatin; Lexapro
Current Illness: No
Preexisting Conditions: Diabetes, high cholesterol
Diagnostic Lab Data:
CDC Split Type: 1981
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC. 0SYRLA
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia, Vomiting
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), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Redness, swelling and warm to touch at injection site. Low grade fever developed during the day and vomiting at night.

VAERS ID:646630 (history)  Vaccinated:2016-07-25
Age:35.0  Onset:2016-07-29, Days after vaccination: 4
Gender:Female  Submitted:2016-08-05, Days after onset: 7
Location:Oregon  Entered:2016-08-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Smoker
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.M018766 IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURU5318AA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Cellulitis, Erythema, Pain, Peripheral swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Red, sore, swelling arm on friday 7/29. Patient slept all day friday. Treated at urgent care for cellulitis on saturday.

VAERS ID:646645 (history)  Vaccinated:2016-08-01
Age:35.0  Onset:2016-08-05, Days after vaccination: 4
Gender:Female  Submitted:2016-08-05, Days after onset: 0
Location:Nebraska  Entered:2016-08-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Trazodone 100mg, Lovastatin 40mg, Sertraline 100mg, Metoprolol tartrate 25mg
Current Illness: No
Preexisting Conditions: Blood clotting disorder
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU5315AA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Area around injection is large, red, and swollen, hot to the touch. Arm is also very sore.

VAERS ID:647139 (history)  Vaccinated:2016-08-01
Age:35.0  Onset:2016-08-06, Days after vaccination: 5
Gender:Female  Submitted:2016-08-09, Days after onset: 3
Location:North Carolina  Entered:2016-08-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PROZAC
Current Illness: None
Preexisting Conditions: Allergies, CIPRO, FLAGYL, BACTRIM, PCN; Depression
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSEG9Y22IMRA
HEPA: HEP A (VAQTA)MERCK & CO. INC.KT54C1IMLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURL01720IMLA
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURU1293AA0SCRA
Administered by: Other     Purchased by: Private
Symptoms: Cellulitis, Erythema, Induration, Local swelling, Pruritus, Skin lesion, Skin warm, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Day 1- Day 5 "Became red swollen and itchy (4cm diameter) since then." It stayed like that until 8/6 when she noted it was warm and tender. She examined it at that time and noted that a 2-3 cm portion had become cellulitic in appearance (raised, hard, bumpy, well demarcated) and then there was spreading macular erythema surrounding the lesion. 8/9/16 called to see if improvement. Left message on vm.

VAERS ID:647364 (history)  Vaccinated:2016-07-28
Age:35.0  Onset:2016-08-01, Days after vaccination: 4
Gender:Female  Submitted:2016-08-11, Days after onset: 10
Location:Florida  Entered:2016-08-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ibuprofen; LINZESS; ESGIC; ZOFRAN; BENADRYL
Current Illness:
Preexisting Conditions: Nerve cluster problem (L) shoulder; MVA x2
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURUI545AA0UNLA
Administered by: Other     Purchased by: Other
Symptoms: Back pain, Hypoaesthesia, Injection site joint movement impairment, Injection site pain, Neck pain, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad)
Write-up: Limited active range of motion initially (L) shoulder. Pain base of (L) neck, (L) trapezius radiating to upper back, pain (L) shoulder, pain (L) upper extremity. Numbness/tingling (L) upper extremity.

VAERS ID:647684 (history)  Vaccinated:2016-08-11
Age:35.0  Onset:2016-08-11, Days after vaccination: 0
Gender:Female  Submitted:2016-08-14, Days after onset: 3
Location:Oregon  Entered:2016-08-14
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: Not that I know of
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Public     Purchased by: Other
Symptoms: Burning sensation, Headache, Photopsia, Pyrexia, Rash macular, Rhinorrhoea
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retinal disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Several rapid flashes of light followed by sever headache that has reduced to a dull ache for going on 4 days now. On the 2nd night 08/13/2016 at 7pm I noticed red blotches on my face. By the morning of 08/14/2016 at 6 am I had them on my stomach. I have had a runny nose for 2 days and a low grade fever of 99.3. The red blotches dont itch but they do burn and especially when I get hot or go outside in warm weather.

VAERS ID:647782 (history)  Vaccinated:2016-06-21
Age:35.0  Onset:2016-06-21, Days after vaccination: 0
Gender:Female  Submitted:2016-08-12, Days after onset: 52
Location:Unknown  Entered:2016-08-15, 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: US2016089389
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS2BA47 IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS7RJ9B IMLA
Administered by: Other     Purchased by: Other
Symptoms: Fatigue, Headache, Influenza like illness, Musculoskeletal stiffness, Visual impairment
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Arthritis (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 35-year-old female patient who received BOOSTRIX (batch number 7RJ9B, expiry date 18th NOVEMBER 2018). Co-suspect products included TWINRIX adult (batch number 2BA47, expiry date 27th SEPTEMBER 2018). On 21st JUNE 2016, the patient received BOOSTRIX (intramuscular) .5 ml and TWINRIX adult (intramuscular) 1 ml. On 21st JUNE 2016, 6 hrs after receiving BOOSTRIX and TWINRIX adult, the patient experienced headache, spots before eyes, influenza-like symptoms, fatigue and stiff neck. On an unknown date, the outcome of the headache, spots before eyes and stiff neck were recovered/resolved and the outcome of the influenza-like symptoms was unknown and the outcome of the fatigue was unchanged. The reporter considered the headache, spots before eyes, influenza-like symptoms , fatigue and stiff neck to be probably related to BOOSTRIX and TWINRIX adult. Additional details were provided as follows: The patient was vaccinated at 8:30 with BOOSTRIX and TWINRIX adult respectively in the left and right deltoid. The call was transferred to medical information. The case was erroneously considered as "Exclude from Pader".

VAERS ID:648062 (history)  Vaccinated:2015-09-15
Age:35.0  Onset:2015-09-16, Days after vaccination: 1
Gender:Female  Submitted:2016-08-17, Days after onset: 336
Location:Massachusetts  Entered:2016-08-17
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: Comments: None
Diagnostic Lab Data:
CDC Split Type: USSA2015SA144963
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURUI440AE IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cellulitis, 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: Initial unsolicited report received from a non health care professional on 17 September 2015. This case is linked to case 2015SA143288 (same reporter) This case involves a (age unknown) female patient who was vaccinated with a [dose not reported] intramuscular [dose series not reported] dose of FLUZONE QIV (batch number UI440AE, expiry date 30-JUN-2016) in "right and left deltoid" on 15 September 2015. Illness at time of vaccination was not applicable and pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as no known allergy (NKA). Concomitant medications were not reported. On 16 September 2015, one day following the vaccination patient had had cellulitis and injection site redness, swelling, pain and warm to touch. Patient required emergency room (ER)/doctor visit. Patient laboratory investigation was not reported. It was reported that, patient treated for cellulitis with ABX (antibiotics). The outcome of event was not recovered. List of documents held by sender: none. Follow up information received non-healthcare professional on 16 November 2015. A 35-year-old female patient received vaccine in left deltoid. Patient did not have any Illness at time of vaccination and pre-existing physician-diagnosed allergies, birth defects and medical conditions was reported as no.

VAERS ID:648193 (history)  Vaccinated:0000-00-00
Age:35.0  Onset:0000-00-00
Gender:Male  Submitted:2016-08-11
Location:Unknown  Entered:2016-08-17, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Back injury (PATIENT HAD LIFTED 100 LB WEIGHT); Herpes zoster (LEFT SIDE OF BACK)
Diagnostic Lab Data:
CDC Split Type: USSA2016SA140381
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abasia, Albumin CSF increased, Antinuclear antibody, C-reactive protein, Electromyogram abnormal, Endotracheal intubation, Full blood count, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Intensive care, Laboratory test, Metabolic function test, Muscular weakness, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Plasmapheresis
SMQs:, Rhabdomyolysis/myopathy (broad), Angioedema (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Respiratory failure (broad)
Write-up: Initial unsolicited report received from the literature on 29-Jul-2016. This case is linked to cases 2016SA140361, 2016SA140962, 2016SA140455, 2016SA140480, 2016SA140494, 2016SA140516, 2016SA140980, 2016SA140990, 2016SA141005, 2016SA141097, 2016SA141105 (same literature). Background: No comparative review of Vaccine Adverse Event Reporting System (VAERS) submissions following pandemic influenza A (H1N1) 2009 and seasonal influenza vaccinations during the pandemic season among one population has been published. Methods: We compared two populations'' adverse event reporting rates. Adverse events (AEs) following vaccination were identified from VAERS for adults aged 17-44 years after pandemic (monovalent influenza [MIV], and seasonal (trivalent inactivated influenza [IIV3], live attenuated influenza [LAIV3]) vaccines. The first population vaccination coverage was provided by the Medical Surveillance System. The second population vaccination coverage was estimated using data from the National 2009 H1N1 Flu Survey and the Behavioral Risk Factor Surveillance System survey. Results: Vaccination coverage was more than four times higher for MIV and more than twenty times higher for LAIV3 in the first population than in the second population. The reporting rate of serious AE reports following MIV in the first population (1.19 per 100,000) was about half that reported by the second population (2.45 per 100,000). Conversely, the rate of serious AE reports following LAIV3 among the first population(1.32 per 100,000) was more than twice that of the second population. Although fewer AEs following MIV in the first population were reported overall, the rate of Guillain-Barre Syndrome (GBS) (4.01 per million) was four times greater than that in the second population. (1.04 per million). Conclusions: Despite higher vaccination coverage in the first population, the rate of serious AEs following MIV was about half that in the second population. The rate of GBS reported following MIV was higher in the first population. This case involves a 35-year-old male patient who was vaccinated with a dose of Monovalent H1N1 Vaccine (batch number, expiry date, route and site of administration not reported) on an unspecified date. Patient''s ongoing history included Herpes Zoster on left side of back The patient''s medical history included Back injury. Concomitant medications were not reported. On an unspecified date, 36 days following the vaccination, the patient developed Atypical GBS" (2)/Guillain-Barre syndrome and experienced ascending numbness, unable to walk and ''weakness all limbs''. Relevant laboratory tests included CSF examination which was remarkable for positive albumin cytologic dissociation and EMG which showed absent P waves in early Guillain Barre Syndrome (GBS). Other testes included CBC, CMP, CRP, ANA, MRI (head), tests involving cervical and thoracic spine. Corrective treatment included plasmapheresis intubated in ICU. It was further reported that the patient suffered relapse on discharge and was re admitted. There was a repeat plasmapheresis followed by course of IVIG with marked positive clinical response. The outcome of events were not reported. Upon medical review, the case was considered as serious due to important medical event: Atypical GBS" (2)/Guillain-Barre syndrome. Documents held by sender: none. Sender''s Comments: Patient had Guillain-Barre syndrome 36 days following MONOVALENT INFLUENZA A (H1N1) 2009 VACCINE. Time to onset is compatible with the vaccine but too long, Guillain-Barre syndrome is usually preceded by upper respiratory tract or gastrointestinal tract infection, influenza infection and vaccination, in this case patient had herpes zoster left side of back a viral infection 4 weeks prior which could be triggering factor and also patient was vaccinated with influenza vaccine which is also one of the triggering factors, patient is also positive for albuminocytologic dissociation in CSF. Detail medical history, past vaccinati

VAERS ID:649209 (history)  Vaccinated:2016-08-18
Age:35.0  Onset:2016-08-19, Days after vaccination: 1
Gender:Male  Submitted:2016-08-24, Days after onset: 5
Location:California  Entered:2016-08-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None known
Current Illness: Cut on heel
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU5468AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Headache, Hypoaesthesia, Injection site erythema, Pain in extremity, Paraesthesia, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fever up to 101 for 3 days, redness at injection site; Then on 8/22/16 fever resolved and headache & left facial numbness/tingling extending into left arm developed and has persisted although somewhat improved. Left arm feels sore although somewhat improved.

VAERS ID:649583 (history)  Vaccinated:2016-08-12
Age:35.0  Onset:2016-08-12, Days after vaccination: 0
Gender:Male  Submitted:2016-08-26, Days after onset: 14
Location:California  Entered:2016-08-26
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
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSLL2F61IMAR
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS16199011IMAR
HEPA: HEP A (VAQTA)MERCK & CO. INC.M0157731IMAR
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage
SMQs:, Medication errors (narrow)
Write-up: None, due to refrigerator temperature excursion on 8/12/2016, manufacture determined based on drop in temperature that the vaccine is not viable and CDC recommended revaccination.

VAERS ID:649682 (history)  Vaccinated:2011-11-08
Age:35.0  Onset:2011-11-11, Days after vaccination: 3
Gender:Male  Submitted:2016-08-20, Days after onset: 1743
Location:Florida  Entered:2016-08-29, Days after submission: 9
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No diagnosis
Preexisting Conditions:
Diagnostic Lab Data: See patient''s medical records
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA638BA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Asthenia, Bruxism, Cardiac flutter, Dizziness, Dyspnoea, Fatigue, Muscle spasms, Musculoskeletal stiffness, Myalgia, Nausea, Pyrexia
SMQs:, Rha