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Case Details (Sorted by Age)

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VAERS ID:606635 (history)  Vaccinated:2015-10-30
Age:29.0  Onset:2015-10-30, Days after vaccination: 0
Gender:Female  Submitted:2015-11-02, Days after onset: 3
Location:New Mexico  Entered:2015-11-02
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: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT)GLAXOSMITHKLINE BIOLOGICALS45ER70IMRA
Administered by: Other     Purchased by: Public
Symptoms: Contusion, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Client vaccinated between 0900 & 1130 on Fri., 10/30/2015. Swelling, bruising and puffiness was verbalized that late afternoon. On Mon., 11/2/15 bruising, soreness and no swelling reported. Client has no other complaints.

VAERS ID:606668 (history)  Vaccinated:2015-11-02
Age:29.0  Onset:2015-11-02, Days after vaccination: 0
Gender:Female  Submitted:2015-11-03, Days after onset: 1
Location:North Carolina  Entered:2015-11-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Carmese
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Public
Symptoms: Erythema, Pruritus, Rash, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Left side of face began to swell, itch, and become red (rash like). From the bottom of chin to cheek bone including lips. 24 hours after shot Face is red with itching and rash has spread to full length of back.

VAERS ID:606724 (history)  Vaccinated:2015-05-27
Age:29.0  Onset:2015-05-27, Days after vaccination: 0
Gender:Female  Submitted:2015-10-23, Days after onset: 149
Location:Unknown  Entered:2015-11-03, 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: None
Diagnostic Lab Data: TB skin test
CDC Split Type: 2015051473
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDT57105 IMAR
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS  IMAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Expired product administered, Tuberculin test
SMQs:, Medication errors (narrow)
Write-up: This non-serious medically confirmed spontaneous report (initial receipt 27-MAY-2015) concerns a 29 year-old non-pregnant female patient. The patient had medical history of screening for pulmonary TB, vaccine against tetanus and flue vaccine. On 27-MAY-2015, the patient received one dose of expired AFLURIA (batch number T57105) via the intramuscular route. On the same day, the patient also received BOOSTRIX (batch number not provided) on another arm, and TB skin test (batch number not provided) on the same arm as the AFLURIA injection. The outcome was not provided. Reporters comments: The reporter insisted that no patient harm occurred.

VAERS ID:607061 (history)  Vaccinated:2015-10-11
Age:29.0  Onset:2015-10-14, Days after vaccination: 3
Gender:Female  Submitted:2015-11-03, Days after onset: 20
Location:Missouri  Entered:2015-11-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Elmiron; Sprintec; Prozac; Amitriptyline
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: I have been on steroids since I noticed that something was not right and have been attending Physical Therapy twice a weak and it is still not resolving.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMRA
Administered by: Public     Purchased by: Other
Symptoms: Drug administered at inappropriate site, Injection site pain, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Medication errors (narrow)
Write-up: Flu shot was injected to high on my shoulder so I have had horrible pain trying to move the arm at the shoulder it was injected into.

VAERS ID:607183 (history)  Vaccinated:2015-10-14
Age:29.0  Onset:2015-10-14, Days after vaccination: 0
Gender:Male  Submitted:2015-10-16, Days after onset: 2
Location:North Carolina  Entered:2015-11-03, Days after submission: 18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No medications
Current Illness: None
Preexisting Conditions: ADVIL
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDU551060IMLA
Administered by: Other     Purchased by: Other
Symptoms: Fatigue, Nausea, Rash
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Nausea, Torso rash, and fatigue.

VAERS ID:607159 (history)  Vaccinated:2015-10-23
Age:29.0  Onset:2015-10-23, Days after vaccination: 0
Gender:Female  Submitted:2015-11-04, Days after onset: 12
Location:Washington  Entered:2015-11-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Celexa, Klonopin, Motrin
Current Illness: Depression, tendonosis in both feet
Preexisting Conditions: Septra
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT)GLAXOSMITHKLINE BIOLOGICALS497KX0IMLA
Administered by: Military     Purchased by: Military
Symptoms: Injection site pain, Musculoskeletal stiffness, Tendonitis
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Tendinopathies and ligament disorders (narrow)
Write-up: Severe pain and stiffness in shoulder where injection was given, doctor diagnosed tendonitis in left shoulder, SIRVA.

VAERS ID:607585 (history)  Vaccinated:2015-11-03
Age:29.0  Onset:2015-11-03, Days after vaccination: 0
Gender:Female  Submitted:2015-11-05, Days after onset: 2
Location:Maryland  Entered:2015-11-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Slight cold.
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI482AA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Body temperature fluctuation, Chills, Hyperhidrosis, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)
Write-up: Nausea and large swings in body temperature, from shivering to sweating, between 7 pm and 10 pm. Took paracetamol around 9. Shivering and nausea started again around 2 am, vomited at 3 am. Body temperature returned to normal.

VAERS ID:608077 (history)  Vaccinated:2015-10-21
Age:29.0  Onset:2015-10-21, Days after vaccination: 0
Gender:Female  Submitted:2015-11-06, Days after onset: 16
Location:D.C.  Entered:2015-11-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMETHIA
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS5GF930IMLA
Administered by: Other     Purchased by: Other
Symptoms: Pain
SMQs:
Write-up: C/O pain 3/10 achy to sharp increases with movement, no radiation (L) deltoid after vaccine placed on 10/21/15 at 11:10 am. Pain from 10/21 - 10/25 and then 11/1/15 to present. No redness, swelling at injection site.

VAERS ID:608133 (history)  Vaccinated:2015-10-21
Age:29.0  Onset:2015-10-22, Days after vaccination: 1
Gender:Male  Submitted:2015-11-06, Days after onset: 15
Location:New Mexico  Entered:2015-11-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Not that I know of. Not that was listed on patient''s prescription profile at our pharmacy.
Current Illness: No
Preexisting Conditions: Allergic to amoxicillin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1579250IMLA
Administered by: Public     Purchased by: Other
Symptoms: Mobility decreased, Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Parkinson-like events (broad), Tendinopathies and ligament disorders (broad)
Write-up: Patient reported this to pharmacist (vaccine administer) on 11/6/15 at approx. 3:42pm. The day after receiving his vaccine, he had to go to the urgent care because he could not move his arm. He stated the problems (pain and movement issues) radiated to the shoulder. Doctor treated him with steroids. He currently still has problems with the arm and is seeking physical therapy.

VAERS ID:608553 (history)  Vaccinated:2015-11-03
Age:29.0  Onset:2015-11-03, Days after vaccination: 0
Gender:Male  Submitted:2015-11-09, Days after onset: 6
Location:Illinois  Entered:2015-11-09
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 DIAGNOSTICS1518101 IMLA
Administered by: Other     Purchased by: Private
Symptoms: Oropharyngeal pain, Pain, Pharyngeal oedema
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: Flu shot given 11-3-15, called 11/7/15 and said he was sore and his throat was sore and swollen. Took BENADRYL.

VAERS ID:609130 (history)  Vaccinated:2015-11-10
Age:29.0  Onset:2015-11-10, Days after vaccination: 0
Gender:Female  Submitted:2015-11-10, Days after onset: 0
Location:Illinois  Entered:2015-11-12, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT)GLAXOSMITHKLINE BIOLOGICALSNR9522IMLA
Administered by: Other     Purchased by: Private
Symptoms: Dizziness, Hyperhidrosis, Paraesthesia, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Light headed, sweaty (beaded on face), tingly across chest, arms, felt swollen in face/cheeks. Ambulance called and tended to pt. Pt walked out on own power. AAA x 3. No visual changes in arm.

VAERS ID:609738 (history)  Vaccinated:2015-11-15
Age:29.0  Onset:2015-11-15, Days after vaccination: 0
Gender:Male  Submitted:2015-11-16, Days after onset: 1
Location:Pennsylvania  Entered:2015-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None present.
Preexisting Conditions: None reported.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDU56106 IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.L017997 SCLA
Administered by: Military     Purchased by: Military
Symptoms: Injection site pain, Rash
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Sore Arm at injection site. Rash on Shoulder, Torso, and Neck.

VAERS ID:609987 (history)  Vaccinated:2015-11-13
Age:29.0  Onset:2015-11-13, Days after vaccination: 0
Gender:Female  Submitted:2015-11-16, Days after onset: 3
Location:Pennsylvania  Entered:2015-11-17, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Hives~Influenza (Seasonal) (Fluarix)~UN~0.00~Patient
Other Medications:
Current Illness: None
Preexisting Conditions: PCN; codeine; clindamycin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS4A5K3 UNRA
Administered by: Private     Purchased by: Unknown
Symptoms: Dizziness, Dyspnoea, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Vaccine at approximately 1530. Hives, dizzy, lightheaded, intermittent SOB by 1600.

VAERS ID:610248 (history)  Vaccinated:2015-11-09
Age:29.0  Onset:2015-11-11, Days after vaccination: 2
Gender:Female  Submitted:2015-11-17, Days after onset: 6
Location:South Carolina  Entered:2015-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: Chest x-rays, cardiac monitor, etc.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS    
Administered by: Public     Purchased by: Other
Symptoms: Blood test, Cardiac monitoring, Chest X-ray, Dizziness, Dyspnoea, Hypersensitivity, Hypoaesthesia, Muscular weakness, Oropharyngeal pain, Paraesthesia, Paralysis, Respiratory tract congestion, Throat irritation, Wheezing
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Sore, itchy burning throat, chest caving in, SOB, losing oxygen, wheezing. Went to urgent care where they prescribed albuterol, Proair inhaler, 5 days of prednisone and cheratussin cough suppressant. Went home still unable to breath after a breathing treatment. Went to bed and woke up Thursday 11/12/2015 with paralysis and paresthesia. Went to the hospital. They did a chest x-ray, blood work and hooked me up to the cardiac monitor. Told me I was obviously having a severe allergic reaction to the Fluvirin injection and sent me home. 8 days later I am still experiencing muscle weakness, face numbness, tingly limbs, severe chest congestion, light headeness, dizziness, SOB, paresthesia and paralysis. Went to the neurologist today for them to tell me to wait it out and see if the symptoms progress into Guillain-Barré syndrome and that it is very possible that I have Miller Fisher Syndrome.

VAERS ID:610373 (history)  Vaccinated:2015-06-01
Age:29.0  Onset:2015-08-21, Days after vaccination: 81
Gender:Female  Submitted:2015-11-17, Days after onset: 88
Location:Texas  Entered:2015-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: 08/21/2015, Hepatitis B antibody, Negative (0.3) unknown
CDC Split Type: US2015GSK136762
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS24JP32UNRA
Administered by: Other     Purchased by: Other
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration
SMQs:, Medication errors (narrow)
Write-up: This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 30-year-old female patient who received ENGERIX B adult (batch number 54RS5, expiry date 11th October 2016). This case was associated with a product complaint. Co-suspect products included ENGERIX B adult (batch number 995J5, expiry date 6th February 2017) and ENGERIX B adult (batch number 24JP3, expiry date 10th July 2017). On 3rd November 2014, the patient received the 1st dose of ENGERIX B adult. On 4th December 2014, the patient received the 2nd dose of ENGERIX B adult. On 1st June 2015, the patient received the 3rd dose of ENGERIX B adult. On 1st June 2015, not applicable after receiving ENGERIX B adult and ENGERIX B adult, not applicable after receiving ENGERIX B adult and ENGERIX B adult and an unknown time after receiving ENGERIX B adult, the patient experienced drug dose administration interval too long. On 21st August 2015, the patient experienced therapy non-responder. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the therapy non-responder, drug dose administration interval too long and pharmaceutical product complaint were unknown. The reporter considered the therapy non-responder to be possible related to ENGERIX B adult, ENGERIX B adult and ENGERIX B adult. Additional details provided were as follows: This case was previously reported to manufacturer. This case was one of the seven reports reported by an occupational nurse for patients tested negative for Hepatitis B titres following vaccination with ENGERIX B (see cases US2015GSK136757, US2015GSK136758, US2015GSK136759, US2015GSK136760, US2015GSK136761 and US2015GSK136763). The caller reported that, they had their laboratory equipment recalibrated and the tests were rerun and results were same or even lower titres. All of the seven patients were new hires at the company and so the reporter was following them. This case concerned to the 7th patient. On 4th December 2015, the patient received the 2nd dose of ENGERIX B adult. On 1st June 2015, the patient received the 3rd dose, which led to lengthening of the vaccination schedule. On 21st August 2015, 291 days after receiving 1st dose of ENGERIX B adult, 260 days after receiving 2nd dose of ENGERIX B adult and 81 days after receiving 3rd dose of ENGERIX B adult, the patient underwent test for Hepatitis B antibodies and it was found to be negative (0.3), causing the patient to be a non-responder to the therapy.

VAERS ID:610574 (history)  Vaccinated:0000-00-00
Age:29.0  Onset:0000-00-00
Gender:Female  Submitted:2015-11-09
Location:Virginia  Entered:2015-11-18, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Fatigue, Influenza like illness, Nausea, Pain, Respiratory tract congestion
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Flu-like s/s.. Fatigue, nausea, congestion, body aches.

VAERS ID:610563 (history)  Vaccinated:2015-11-17
Age:29.0  Onset:2015-11-17, Days after vaccination: 0
Gender:Female  Submitted:2015-11-18, Days after onset: 1
Location:Ohio  Entered:2015-11-19, 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) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS15174010IMRA
Administered by: Public     Purchased by: Private
Symptoms: Hypersensitivity, Pruritus
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt had flu vaccine on 11/17/2015. Stated no allergies and never had flu vaccine previously. Presented to clinic on 11/18/15 stated started to have severe itching 2 hours after vaccine. No other symptoms on exam - no hives or edema/swelling. Appears to allergic reaction from flu vaccine.

VAERS ID:610982 (history)  Vaccinated:2014-10-13
Age:29.0  Onset:2014-10-13, Days after vaccination: 0
Gender:Female  Submitted:2015-10-05, Days after onset: 357
Location:Unknown  Entered:2015-11-19, Days after submission: 45
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: 2014SA142394
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEURUT4993AA IDLA
Administered by: Other     Purchased by: Other
Symptoms: Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Initial report received from healthcare professional on 14 October 2014. A 29-year-old female patient, whose medical history was reported as unknown and concomitant medication were not reported, had received intradermal a dose of FLUZONE ID, (batch number: UT4993AA, expiry date: not reported) (dose in series not reported) in left arm on 13-Oct-2014. On 13-Oct-2014, patient experienced, swollen in left hand. Illness at the time of vaccination was reported as unknown. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as not recovered. Documents held by sender: none.

VAERS ID:611003 (history)  Vaccinated:2015-11-19
Age:29.0  Onset:2015-11-19, Days after vaccination: 0
Gender:Female  Submitted:2015-11-20, Days after onset: 1
Location:Indiana  Entered:2015-11-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Humalog; Tekturna; Amoxicillin; Multivitamin
Current Illness: None reported
Preexisting Conditions: Type 1 DM, Allergic to Sulfa drugs
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURK170610IMLA
Administered by: Public     Purchased by: Private
Symptoms: Asthenia, Chills, Depressed level of consciousness, Dizziness, Pyrexia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Client reports that a few hours after receiving the Typhoid vaccine she started to feel dizzy and like she was going to "pass out". She also reports feeling feverish with chills. Client reports that she stayed at a store for over 2 hours because she felt too dizzy and weak to walk to her car. Client did not know if she was running a fever because she did not have a thermometer available to check her temp.

VAERS ID:611279 (history)  Vaccinated:2015-09-15
Age:29.0  Onset:0000-00-00
Gender:Female  Submitted:2015-11-23
Location:Unknown  Entered:2015-11-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS173539   
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)
Write-up: Pt c/o pain in the arm since receiving a flu shot. Initially, she was seen in the office for this 9/28/2015 and again 11/23/2015 because the arm still hurts.

VAERS ID:611617 (history)  Vaccinated:2015-11-02
Age:29.0  Onset:2015-11-04, Days after vaccination: 2
Gender:Female  Submitted:2015-11-24, Days after onset: 20
Location:Texas  Entered:2015-11-24
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: Relevant - unknown, lab results - normal
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI482AB0UNLA
Administered by: Public     Purchased by: Private
Symptoms: Back pain, Dizziness, Fatigue, Laboratory test normal, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad)
Write-up: Blurry vision, dizziness, fatigue, back pain.

VAERS ID:612318 (history)  Vaccinated:2015-11-16
Age:29.0  Onset:2015-11-18, Days after vaccination: 2
Gender:Female  Submitted:2015-11-19, Days after onset: 1
Location:Pennsylvania  Entered:2015-11-30, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRUN
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt had 7 cm x 7 cm red raised area (L) upper arm at injection site. There was a 8 cm x 6 cm red raised area underside of (L) upper arm.

VAERS ID:612262 (history)  Vaccinated:2015-11-30
Age:29.0  Onset:2015-11-30, Days after vaccination: 0
Gender:Female  Submitted:2015-12-01, Days after onset: 1
Location:Georgia  Entered:2015-12-01
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED10949211A IMLA
Administered by: Other     Purchased by: Private
Symptoms: Rash, Throat irritation
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Rash and patient described "weird feeling" in throat.

VAERS ID:613290 (history)  Vaccinated:2015-12-05
Age:29.0  Onset:2015-12-05, Days after vaccination: 0
Gender:Male  Submitted:2015-12-05, Days after onset: 0
Location:Michigan  Entered:2015-12-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: None~Influenza (Seasonal) (no brand name)~UN~0.00~Patient
Other Medications:
Current Illness: None
Preexisting Conditions: None listed on questionnaire filled out by patient before receiving vaccination.
Diagnostic Lab Data: Waiting for patient to update us on adverse event
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1578021IMLA
Administered by: Public     Purchased by: Private
Symptoms: Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)
Write-up: Patient was vaccinated in LEFT arm. Shortly after vaccination, patient''s RIGHT arm started to shake uncontrollably. Patient called me (immunizing pharmacist) around 6 PM and I recommended patient go to Emergency Room immediately.

VAERS ID:613402 (history)  Vaccinated:2015-12-03
Age:29.0  Onset:2015-12-04, Days after vaccination: 1
Gender:Male  Submitted:2015-12-07, Days after onset: 3
Location:New Jersey  Entered:2015-12-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No taking other medications
Current Illness: Pt Denies any cold or flu like SX at time of administration
Preexisting Conditions: HX of HSV1, NKDA, no other significant HX
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.FJ21591IN 
Administered by: Military     Purchased by: Military
Symptoms: Burning sensation, Rash erythematous, Rash vesicular
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: PT had a vesicular, moist, erythemic rash directly below the left nostril from nare to vermilian border complained of burning sensation.

VAERS ID:614104 (history)  Vaccinated:2015-11-09
Age:29.0  Onset:0000-00-00
Gender:Male  Submitted:2015-12-09
Location:Florida  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: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDU569071IMLA
Administered by: Other     Purchased by: Other
Symptoms: Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Tendinopathies and ligament disorders (broad)
Write-up: Pain in shoulder.

VAERS ID:614330 (history)  Vaccinated:2015-12-10
Age:29.0  Onset:2015-12-10, Days after vaccination: 0
Gender:Female  Submitted:2015-12-10, Days after onset: 0
Location:Mississippi  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: None reported
Preexisting Conditions: Allergy to bees. NKDA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT)GLAXOSMITHKLINE BIOLOGICALS7HZ7315IMLA
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURU1093AA1IMRA
Administered by: Military     Purchased by: Military
Symptoms: Hypoaesthesia, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Numbness and swelling on R side of face. No other anaphylaxis associated symptoms.

VAERS ID:614572 (history)  Vaccinated:2015-12-09
Age:29.0  Onset:2015-12-12, Days after vaccination: 3
Gender:Female  Submitted:2015-12-12, Days after onset: 0
Location:Ohio  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: Clonazepam, Omeprazole, Topiramate, Hydroxyzine, Quetiapine, Norco
Current Illness: None
Preexisting Conditions: Penicillin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU5292AA IM 
Administered by: Other     Purchased by: Unknown
Symptoms: Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: "Golf-ball size" swollen area at site of injection on right arm.

VAERS ID:615932 (history)  Vaccinated:2015-09-23
Age:29.0  Onset:2015-09-23, Days after vaccination: 0
Gender:Female  Submitted:2015-11-23, Days after onset: 61
Location:Unknown  Entered:2015-12-18, Days after submission: 25
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: PHEH2015US019570
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS173539 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2015US019570, is an initial spontaneous report received from a health care professional (HCP) on 30 Sep 2015. This report refers to a 29 year old female patient. Historical conditions and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173539) intramuscularly at a dose of 0.5 ml on 23 Sep 2015. The HCP reported that the FLUCELVAX which was stored at room temperature for 24 hours was administered to employees. No adverse event was reported following the medication error.

VAERS ID:616042 (history)  Vaccinated:2015-10-07
Age:29.0  Onset:2015-10-07, Days after vaccination: 0
Gender:Female  Submitted:2015-12-22, Days after onset: 76
Location:New York  Entered:2015-12-22
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: Allergic to penicillin
Diagnostic Lab Data: Awaiting appointment with Dermatologist.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED 0IDRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site discolouration, Injection site mass, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: The shot produces a large painful lump under the skin. The lump is smaller but the skin is discolored and it''s 3 months later. It looks/feels like a scar or bruise.

VAERS ID:617696 (history)  Vaccinated:2015-09-30
Age:29.0  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 10/05/15, Hep B Core AB, (-); Hep B Surf. AB, (-); Hep B Surf. AG, (-); HIV Ag/Ab, (-); Hep C AB, (-)
CDC Split Type: NJ1508
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 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:617734 (history)  Vaccinated:2016-01-04
Age:29.0  Onset:0000-00-00
Gender:Female  Submitted:2016-01-06
Location:Minnesota  Entered:2016-01-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSED2EN UNRA
Administered by: Private     Purchased by: Other
Symptoms: Exposure during pregnancy, Incorrect product storage
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Medication errors (narrow)
Write-up: The Tdap injections were stored in a refrigerator which the temperature gauge malfunctioned. The temp lowered to 10 degrees for unknown amount of time.

VAERS ID:617795 (history)  Vaccinated:2015-10-29
Age:29.0  Onset:2015-10-30, Days after vaccination: 1
Gender:Female  Submitted:2016-01-06, Days after onset: 68
Location:Nebraska  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: Wellbutrin; Inderal
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Normal blood work and normal EMG
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS32N270IMLA
Administered by: Public     Purchased by: Other
Symptoms: Blood test normal, Electromyogram normal, Hypoaesthesia, Limb discomfort, Muscular weakness, Neuropathy peripheral, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: Legs and arms: rapid onset over 5 days numbness, tingling, weakness and heaviness. Dx: Neuropathy.

VAERS ID:618012 (history)  Vaccinated:2015-11-25
Age:29.0  Onset:2015-11-30, Days after vaccination: 5
Gender:Female  Submitted:2016-01-07, Days after onset: 38
Location:Kansas  Entered:2016-01-08, 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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS9Z429 UNLA
Administered by: Other     Purchased by: Other
Symptoms: Drug administered at inappropriate site
SMQs:, Medication errors (narrow)
Write-up: Pt. was told by doctor the vaccine was given in her rotator cuff. She has had injections, oral medications, and 6 months of physical therapy.

VAERS ID:618059 (history)  Vaccinated:2014-11-30
Age:29.0  Onset:2014-11-30, Days after vaccination: 0
Gender:Male  Submitted:2015-11-16, Days after onset: 351
Location:Unknown  Entered:2016-01-08, Days after submission: 53
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: PHEH2014US023971
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS14584P IMLA
Administered by: Other     Purchased by: Other
Symptoms: Needle issue, Syringe issue, Underdose
SMQs:, Medication errors (broad)
Write-up: Case number PHEH2014US023971, is an initial spontaneous report received from a pharmacist on 01DEC2014, with a follow-up report received from the pharmacist on 17DEC2014, with a follow up report received from the pharmacist on 19JAN2015, with the follow-up information received from Quality Assurance Department (reference number: 343532) on 27FEB2015. This report refers to a 29 year old male patient. Historical condition and concomitant medication were not reported. His previous vaccinations (unspecified) were well tolerated. He was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: 14584P, expiration date: 30APR2015) intramuscularly in left arm on 30NOV2014 at 08:45 PM. It was reported that during administration the plunger of the FLUVIRIN pre-filled syringe (PFS) got stuck and could not be fully depressed. As a result the patient received a partial dose. No adverse event was reported following these administration errors (vaccine under dose and syringe issue). The complaint was raised for a stuck plunger for FLUVIRIN batch 14584P. No same was available for analysis. No root cause was identified during either the Catalent or BD investigation. The most probable root cause is that the needle, not provided by was plugged, although with no sample available for analysis it is difficult to determine the exact nature of the defect. THe root cause has therefore been determined as supplier/material defective due to a blocked needle. Follow up report received from the pharmacist on 17DEC2014: Updated vaccine expiration date. Follow up report received from a pharmacist on 19JAN2015: Updated vaccination details (vaccination history, site and time of vaccination). Follow-up information received from the Quality Assurance Department (reference number: 343532) on 27 FEB 2015: Updated FLUVIRIN 2014/2015 vaccine batch review report.

VAERS ID:618084 (history)  Vaccinated:2014-11-17
Age:29.0  Onset:2014-11-17, Days after vaccination: 0
Gender:Female  Submitted:2015-11-16, Days after onset: 364
Location:Unknown  Entered:2016-01-08, Days after submission: 53
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: PHEH2014US024295
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS14511P IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2014US024295, is an initial spontaneous report received from a nurse on 02DEC2014, with a follow up report received from the nurse on 19JAN2015. This report refers to a 29 years old female patient. Her previous vaccinations (unspecified) were well tolerated. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: 14511P, expiry date: MAR2015) intramuscularly at a dose of 0.5 ml in left deltoid on 17NOV2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. Patient did not experience any adverse event. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow up report received from the nurse on 19JAN2015: Updated vaccination history, recent vaccination site and reporter''s statement.

VAERS ID:618277 (history)  Vaccinated:2015-12-30
Age:29.0  Onset:2015-12-31, Days after vaccination: 1
Gender:Female  Submitted:2016-01-02, Days after onset: 2
Location:Arizona  Entered:2016-01-11, 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: 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.L0233850SCUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.L0252100SCUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Possible reaction to Varicella injection. Site of injection is red, hard to the touch, warm to the touch, itchy and redness is spreading.

VAERS ID:618705 (history)  Vaccinated:2015-12-27
Age:29.0  Onset:2015-12-28, Days after vaccination: 1
Gender:Male  Submitted:2016-01-13, Days after onset: 16
Location:Texas  Entered:2016-01-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications taken
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: MRI and X-rays taken at local hospital and orthopedic doctor''s office, respectively. Conclusion: the technician at the clinic gave the vaccine too high and the needle hit soft tissue, rendering my husband unable to use his arm properly and causing him to miss work.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER 0SYRRA
Administered by: Public     Purchased by: Private
Symptoms: Activities of daily living impaired, Drug administered at inappropriate site, Fatigue, Injection site pain, Mobility decreased, Musculoskeletal disorder, Nausea, Nuclear magnetic resonance imaging, Pyrexia, Soft tissue injury, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Muscle ache at injection spot, fatigue, nausea, high-grade fever (102 degrees), inability to move arm.

VAERS ID:619505 (history)  Vaccinated:0000-00-00
Age:29.0  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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: US2015GSK184211
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic reaction, Angioedema, Cough, Dyspnoea, Enlarged uvula, Lip swelling, Mouth swelling, Pruritus, Rash, Swelling, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported in a literature article and described the occurrence of anaphylaxis in a 29-year-old female subject who received Flu seasonal TIV Dresden. This case refers to patient 13 in the literature article. On an unknown date, 8 hrs after receiving Flu seasonal TIV Dresden, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included pruritus, angioedema with serious criteria of GSK medically significant, cough, swelling, generalized urticaria, rash and shortness of breath. The subject was treated with antihistamine, H2 blocker and steroid (unspecified). The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included pruritus (recovered/resolved), angioedema (recovered/resolved), cough (recovered/resolved), swelling (recovered/resolved), generalized urticaria (recovered/resolved), rash (recovered/resolved) and shortness of breath (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, pruritus, angioedema, cough, swelling, generalized urticaria, rash and shortness of breath 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 29-year-old female patient who had received an unspecified trivalent influenza vaccine (manufacturer unknown). The patient was a female. 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). The following day, 8 hours after the vaccination, the patient developed angioedema, lips, uvula and mouth swelling, generalized urticaria, pruritus, rash, shortness of breath and cough. This was classified as anaphylaxis by the emergency department doctor. According to the authors the case was considered as Brighton level 1 and setting of initial evaluation was emergency department. The patient was treated by oral antihistamine, oral H2-blocker and oral steroids. At the time of reporting the outcome of the events was recovered. The patient was referred to primary care physician. This 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:619516 (history)  Vaccinated:2015-09-29
Age:29.0  Onset:2015-09-29, Days after vaccination: 0
Gender:Male  Submitted:2016-01-18, Days after onset: 111
Location:Pennsylvania  Entered:2016-01-18
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: Sulfa
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX)NOVARTIS VACCINES AND DIAGNOSTICS1732530IMLA
Administered by: Public     Purchased by: Other
Symptoms: Abdominal pain, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: I ate eggs for dinner and about 30 minutes later I had abdominal pain. Not long after that I started vomiting. Now, every time I eat eggs I have abdominal pain with or without vomiting.

VAERS ID:620730 (history)  Vaccinated:2016-01-22
Age:29.0  Onset:2016-01-22, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Pennsylvania  Entered:2016-01-25
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSZ9Z4Y IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Local injection site rxns (swelling, redness, sore arm).

VAERS ID:620761 (history)  Vaccinated:2016-01-21
Age:29.0  Onset:2016-01-21, Days after vaccination: 0
Gender:Male  Submitted:2016-01-25, Days after onset: 4
Location:Washington  Entered:2016-01-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MVI; Fish oil; Zinc; Magnesium; vit B12; Amino acid complex; Creatine; Glucosamine; Co Q10; CLA; ASA
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU5241AA IMLA
Administered by: Public     Purchased by: Public
Symptoms: Chest discomfort, Cold sweat, Hallucination, Heart rate increased, Pain
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)
Write-up: Pt stated today (01/25/16 at 1430) that after his Tdap administration on 01/21/16 at 1500, he went home and at about 1900 that evening he started having cold sweats, body aches, pressure in his chest, and hallucinations. Pt didn''t go to the ER, urgent care and came into the clinic this afternoon for blood draw and to report reaction. Pt also had rapid heart beat.

VAERS ID:620909 (history)  Vaccinated:2015-12-09
Age:29.0  Onset:2015-12-14, Days after vaccination: 5
Gender:Female  Submitted:2016-01-26, Days after onset: 43
Location:Massachusetts  Entered:2016-01-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT)GLAXOSMITHKLINE BIOLOGICALS7994K2IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS92N9B IMRA
Administered by: Private     Purchased by: Other
Symptoms: Injection site pain, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Right shoulder pain- worse some days than others. Relieved with 2-3 ibuprofen each morning. Pain at 90 degree forward motion. Provider suggested continuing ibuprofen and abstraining from physical activity requiring related movements.

VAERS ID:622227 (history)  Vaccinated:2015-10-20
Age:29.0  Onset:2015-10-21, Days after vaccination: 1
Gender:Female  Submitted:2016-02-10, Days after onset: 112
Location:Georgia  Entered:2016-02-10
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: None performed to date.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS 0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Musculoskeletal stiffness
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: Shoulder was sore the day after injection. Instead of getting better shoulder became progressively more sore. It has now been 4 months since injection and shoulder is stiff and painful to the touch. Range of motion is decreased, particularly when attempting to reach upward with the arm.

VAERS ID:622235 (history)  Vaccinated:2016-02-03
Age:29.0  Onset:2016-02-03, Days after vaccination: 0
Gender:Female  Submitted:2016-02-10, Days after onset: 7
Location:Oklahoma  Entered:2016-02-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: swelling, itching~Influenza (Seasonal) (no brand name)~1~18.00~Patient
Other Medications: Ergocalciferol 1.25mg PO Q day, levothyroxine 25mcg PO Q AM
Current Illness: None reported
Preexisting Conditions: Allergies: Ceclor, codeine, Bactrim, iodine, Keflex, morphine, shellfish, toradol, ultracet.
Diagnostic Lab Data: No diagnostic or laboratory test performed.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.K0118021SCLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt reports that site was sore and started itching. A short time after it started itching, the pt noted that the injection site was swollen, red, hot to the touch, and was "hard as a rock". Pt treated symptoms with Benadryl PO, Benadryl topical, and hydrocortisone topical at home. Pt reports that site is less swollen today and that it is bruised, but no longer reddened.

VAERS ID:622336 (history)  Vaccinated:2016-02-09
Age:29.0  Onset:2016-02-10, Days after vaccination: 1
Gender:Male  Submitted:2016-02-11, Days after onset: 1
Location:Unknown  Entered:2016-02-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None known
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Military     Purchased by: Other
Symptoms: Erythema, Peripheral swelling, Pruritus
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: Erythema and swelling of left upper arm with itching.

VAERS ID:622379 (history)  Vaccinated:2014-10-28
Age:29.0  Onset:2014-10-28, Days after vaccination: 0
Gender:Female  Submitted:2015-11-16, Days after onset: 384
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: PHEH2014US025148
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, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2014US025148, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 29 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 28 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.

VAERS ID:622426 (history)  Vaccinated:2015-01-09
Age:29.0  Onset:2015-01-09, Days after vaccination: 0
Gender:Female  Submitted:2015-11-16, Days after onset: 311
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: PHEH2015US001040
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS13443P IMUN
Administered by: Other     Purchased by: Other
Symptoms: Expired product administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2015US001040 is an initial spontaneous report received from a nurse on 09 Jan 2015. This report refers to a 29 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13443P, expiry date: not reported) intramuscularly on 09 Jan 2015. It was reported that the vaccine administered was expired. No adverse events were reported following the maladministration.

VAERS ID:622435 (history)  Vaccinated:2014-10-23
Age:29.0  Onset:2014-10-23, Days after vaccination: 0
Gender:Female  Submitted:2015-11-16, Days after onset: 389
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: PHEH2014US025335
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS145701 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2014US025335, is an initial spontaneous report received from a medical assistant on 16 Dec 2014. This report refers to a 29 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015), at a dose of 0.5 ml intramuscularly in the left deltoid on 23 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this administration error (incorrect storage of drug).

VAERS ID:622753 (history)  Vaccinated:2015-10-15
Age:29.0  Onset:2015-10-15, Days after vaccination: 0
Gender:Female  Submitted:2015-11-16, Days after onset: 32
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: PHEH2015US021584
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1516401 IMUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Product physical issue
SMQs:
Write-up: Case number PHEH2015US021584, is an initial spontaneous report received from healthcare professional on 21 Oct 2015. This report refers to a 29 year old female patient. Historical condition and concomitant medication were not provided. The patient was vaccinated with FLUVIRIN (batch number: 1516401) intramuscularly on 15 Oct 2015. It was reported that during vaccination vial leakage was observed from the point where diaphragm and metal meet. Further there was no harm caused to patient and no medical attention was required. No adverse event was reported following this event.

VAERS ID:622875 (history)  Vaccinated:2015-10-21
Age:29.0  Onset:2015-10-21, Days after vaccination: 0
Gender:Female  Submitted:2015-11-16, Days after onset: 26
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: PHEH2015US022365
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1515101 SCUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site reaction
SMQs:
Write-up: Case number PHEH2015US022365, is an initial spontaneous report received from nurse on 29 Oct 2015. This report refers to a 29 year old female patient. Historical condition and concomitant medication were unknown. The patient was vaccinated with FLUVIRIN (batch number: 1515101) at a dose of 0.5ml subcutaneously on 21 Oct 2015. On the same day after vaccination patient had an injection site reaction. Outcome of the events was reported as unknown. Events were reported to be non-serious and causality of the events was not reported.

VAERS ID:624959 (history)  Vaccinated:2016-02-10
Age:29.0  Onset:0000-00-00
Gender:Female  Submitted:2016-02-12
Location:Mississippi  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:
Current Illness: None
Preexisting Conditions: None known of
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (IMOVAX)SANOFI PASTEURK11112UNLA
Administered by: Public     Purchased by: Private
Symptoms: No adverse event
SMQs:
Write-up: Pt was to get rabies series of 3. 1st vaccine given, 2nd vaccine given 7 days later, 3rd vaccine given 14 days after 1st dose. Should have been 21 days. Give 4th dose at 28 days, no adverse reaction.

VAERS ID:622714 (history)  Vaccinated:2016-02-12
Age:29.0  Onset:2016-02-13, Days after vaccination: 1
Gender:Female  Submitted:2016-02-14, Days after onset: 1
Location:North Carolina  Entered:2016-02-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  IMRA
Administered by: Unknown     Purchased by: Private
Symptoms: Chills, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 101.3 fever, body chills, aches.

VAERS ID:625128 (history)  Vaccinated:2016-01-07
Age:29.0  Onset:2016-01-07, Days after vaccination: 0
Gender:Female  Submitted:2016-02-15, Days after onset: 39
Location:Unknown  Entered:2016-02-15
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: WAES1602USA005154
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
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 as received from a nurse refers to a 29 year old female patient. No concurrent conditions, medical history or allergy/drug reactions were reported. The patient had come for pre-natal care and reported that on 07-JAN-2016, she had been vaccinated with VARIVAX (Merck) (dosing details, route, expiration and lot# were not reported). No concomitant medication was reported. She was 9 weeks and one day pregnant as of 08-FEB-2016. The LMP and EDD was not known. The pregnancy outcome was pending. No adverse effect was reported. There were no product quality complaints (PQC) involved. Additional information has been requested.

VAERS ID:622933 (history)  Vaccinated:2016-01-04
Age:29.0  Onset:2016-01-04, Days after vaccination: 0
Gender:Female  Submitted:2016-02-16, Days after onset: 43
Location:Georgia  Entered:2016-02-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Meloxicam; GRALISE; ACCU-CHECK AVIVA PLUS METER; ACCU-CHECK AVIVA PLUS test strips; Lancets, ultra thin; Trazodone; NASONEX; Azelastine; Tizanidine; Paroxetine
Current Illness: Strep; Pyelonephritis
Preexisting Conditions: Hx: pancreatic CA; Absence of spleen; Lupus. Allergy: KEFLEX; PCN; Clindamycin
Diagnostic Lab Data: Patient was hospitalized for strep/pyelonephritis while s/s from vaccination present.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURUI503AA IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.L0122150IMRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Pyelonephritis, Pyrexia, Streptococcal infection
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: PNEUMOVAX 23 to (R) deltoid - edema, redness, pain, induration at injection site. Patient was hospitalized a few days after immunization for strep and pyelonephritis, treated with steroids and vancomycin. Had 103 fever. At 6 wks out induration at site still present.

VAERS ID:625450 (history)  Vaccinated:2015-09-08
Age:29.0  Onset:2015-09-11, Days after vaccination: 3
Gender:Female  Submitted:2016-02-18, Days after onset: 160
Location:West Virginia  Entered:2016-02-18
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
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema multiforme, Oedema, Pruritus, Rash, Urticaria
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Skin rash, rash, erythema multiforme, urticarial pruritus and edema.

VAERS ID:623491 (history)  Vaccinated:2016-02-18
Age:29.0  Onset:2016-02-22, Days after vaccination: 4
Gender:Male  Submitted:2016-02-23, Days after onset: 1
Location:Michigan  Entered:2016-02-23
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: Tamsulosin, oxybutynin, ibuprofen, acetaminophen/oxycodone, cephalexin
Current Illness: Large staghorn right renal calculus
Preexisting Conditions: Latex, Nickel, sulfadiazine
Diagnostic Lab Data: Ultrasound of upper extremity
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURUT5362AA IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.K008410 IMRA
Administered by: Public     Purchased by: Private
Symptoms: Injection site infection, Injection site reaction, Soft tissue infection, Ultrasound scan
SMQs:
Write-up: Right deltoid skin and soft tissue infection with likely extension into the muscle following influenza and pneumococcal vaccines.

VAERS ID:623756 (history)  Vaccinated:2013-09-28
Age:29.0  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: 2015SE84970
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 drug exposure during pregnancy in a 29 year old, female subject. The patient''s medical and concomitant history was not provided at the time of reporting. The patient received FLUMIST quadrivalent (intranasal) on 28-Sep-2013. The patient experienced drug exposure during pregnancy on an unknown date. The outcome of the pregnancy was reported to be a healthy baby. The investigator assessed the event of drug exposure during pregnancy to be non-serious.

VAERS ID:625744 (history)  Vaccinated:2016-02-20
Age:29.0  Onset:2016-02-20, Days after vaccination: 0
Gender:Female  Submitted:2016-02-24, Days after onset: 4
Location:Washington  Entered:2016-02-24
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: Allergy to penicillins
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSZ9Z4Y IMLA
Administered by: Other     Purchased by: Private
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: About 5 minutes after administering the BOOSTRIX Tdap shot, the patient fainted (syncope). The patient was able to recover in less than a minute.

VAERS ID:623735 (history)  Vaccinated:2016-02-20
Age:29.0  Onset:2016-02-21, Days after vaccination: 1
Gender:Female  Submitted:2016-02-25, Days after onset: 4
Location:Indiana  Entered:2016-02-25
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: suicide~Influenza (H1N1) (H1N1 (MONOVALENT) (UNKNOWN))~5~26.25~Patient
Other Medications: Levofloxacin 750 mg.
Current Illness: phamonia was diagnosed with also a ten day 750 mg antibiotic pill prescribe. I did not request the vaccination as it also is well known to containg embryotic sexual tissue cells, and that goes against my moral faith and growth structure continual belief system. they may or may not deny that any injection was on record although missing from order date.
Preexisting Conditions: Spots on skin, med allergies Haldol and ryspridol.
Diagnostic Lab Data: Shot was disgustion. Sometime after blood was pulled. Shot was administered through same as blood pull line into the blood stream. Embryotic rape violation sexual vaccination shoot is or is not actually recorded by the hospital. She had really short hair dyed bad blonde from brunette and poor mousy blue eyes with glasses. She said something like if I''m so against lesbians I deserved it, because I''d asked for them to leave the room if I had to change into a gown. She was at the date thinner and meaning still nothing good to me.
CDC Split Type:
Vaccination
Manufacturer
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Dose
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Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 2SYRAR
Administered by: Public     Purchased by: Public
Symptoms: Feeling abnormal, Incorrect route of drug administration, Pathological doubt, Retching, Seizure, Shock, Skeletal injury, Skin disorder, Swelling, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Medication errors (narrow), Hypoglycaemia (broad)
Write-up: Swelling of the torso and enlarging movement of the rib bones. Intense sun tanning and shock to the skin particularly of the face and neck. Violent seizuring, dry heaving and vomiting, moral doubt in self, more skin and rib damage, more shock to the original quality of the eyes and facial features, feelings of vicious intended rape, a consequence of feeling that I have violated my faith.

VAERS ID:625623 (history)  Vaccinated:2016-03-04
Age:29.0  Onset:2016-03-05, Days after vaccination: 1
Gender:Female  Submitted:2016-03-05, Days after onset: 0
Location:California  Entered:2016-03-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatals
Current Illness: No
Preexisting Conditions: Pregnant
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: Arthralgia, Back pain, Nausea, Neck pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fever. Severe hip, back and neck pain. Headache. Nausea.

VAERS ID:625645 (history)  Vaccinated:2016-03-05
Age:29.0  Onset:2016-03-05, Days after vaccination: 0
Gender:Female  Submitted:2016-03-07, Days after onset: 2
Location:North Carolina  Entered:2016-03-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Protonix 40 mg daily
Current Illness: None
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH 0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Dizziness, Respiration abnormal, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypersensitivity (broad), Respiratory failure (broad)
Write-up: Light headed, weakness, and mild feeling as if breathing was becoming affected. No shortness of breath, but a little tightness in throat area.

VAERS ID:627622 (history)  Vaccinated:2016-03-13
Age:29.0  Onset:2016-03-14, Days after vaccination: 1
Gender:Male  Submitted:2016-03-16, Days after onset: 2
Location:Wisconsin  Entered:2016-03-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: Temperature of 103.2
CDC Split Type:
Vaccination
Manufacturer
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Dose
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Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4714AA1IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.K0162941IMRA
Administered by: Other     Purchased by: Private
Symptoms: Dizziness, Injection site infection, Injection site rash, Mobility decreased, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Day 1:arm pained him to point he couldn''t raise or use it. He felt dizzy also. Day 2:rash formed at injection. fever. arm in sling. Starting Cephalexin for suspected infection of injection site. Day 3:rash larger. fever of 103.2. Rash in shape of deltoid muscle, not circular.

VAERS ID:627696 (history)  Vaccinated:2016-01-08
Age:29.0  Onset:2016-01-08, Days after vaccination: 0
Gender:Unknown  Submitted:2016-03-16, Days after onset: 67
Location:Unknown  Entered:2016-03-16
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: WAES1603USA007625
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.L01296312UNUN
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 certified medical assistant and refers to a 29 year old patient of unknown gender. The patient''s medical history and concurrent conditions were not reported. On 08-JAN-2016, the patient was vaccinated with the third dose of RECOMBIVAX HB, lot number L029631, expiration date 14-AUG-2017, (dose, anatomical location and route were not reported) that experienced temperature excursion. There was no concomitant medication reported. No adverse event was reported. This is one of several reports from the same source. Additional information has been requested.

VAERS ID:627627 (history)  Vaccinated:2016-03-14
Age:29.0  Onset:2016-03-15, Days after vaccination: 1
Gender:Male  Submitted:2016-03-17, Days after onset: 2
Location:Massachusetts  Entered:2016-03-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamin
Current Illness: None
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
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Dose
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Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM150321IMLA
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Induration, Tenderness
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Induration, erythema, tenderness just below the injection site. Monitoring symptoms, no treatment indicated.

VAERS ID:627839 (history)  Vaccinated:2015-03-25
Age:29.0  Onset:2015-03-28, Days after vaccination: 3
Gender:Male  Submitted:2016-03-18, Days after onset: 356
Location:Alabama  Entered:2016-03-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Abnormal Autonomic Testing: Tilt table test is abnormal, Qsweat test abnormal. Low testosterone, High ferritin (acute phase reactant), and positive anti smooth muscle antibody.
CDC Split Type:
Vaccination
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FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDAS174100IMRA
Administered by: Other     Purchased by: Private
Symptoms: Autonomic nervous system imbalance, Blood testosterone decreased, Dry eye, Dry mouth, Erectile dysfunction, Food intolerance, Gastrointestinal motility disorder, Hypoaesthesia, Hypotension, Malabsorption, Muscular weakness, Orthostatic intolerance, Palpitations, Panic attack, Paraesthesia, Serum ferritin increased, Smooth muscle antibody positive, Sweat test abnormal, Tachycardia, Tilt table test positive, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal obstruction (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Corneal disorders (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Noninfectious diarrhoea (broad)
Write-up: Autonomic dysfunction - orthostatic intolerance, dry eyes, dry mouth, palpitations, tachycardia, malabsorption (loss of documented 40 lbs), gastrointestinal motility dysfunction, low blood pressure, new food intolerance, muscle weakness, erectile dysfunction, low testosterone, sweating dysfunction, panic attacks and numbness/tingling of extremities.

VAERS ID:628411 (history)  Vaccinated:2016-03-15
Age:29.0  Onset:2016-03-15, Days after vaccination: 0
Gender:Female  Submitted:2016-03-21, Days after onset: 6
Location:Pennsylvania  Entered:2016-03-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRLA
Administered by: Unknown     Purchased by: Other
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Influenza like illness, Nausea, Pain, Pain in extremity, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Sore arm, fever, nauseousness, diarrhea, dizziness, flu like aches and pains, chills, extremely weak.

VAERS ID:629381 (history)  Vaccinated:2015-07-15
Age:29.0  Onset:2015-07-30, Days after vaccination: 15
Gender:Female  Submitted:2016-03-28, Days after onset: 242
Location:Nebraska  Entered:2016-03-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: IMOGAM
Current Illness:
Preexisting Conditions: Comments: None
Diagnostic Lab Data:
CDC Split Type: USSA2015SA177876
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (IMOVAX)SANOFI PASTEURK1057, K17290IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood test normal, Headache, Inappropriate schedule of drug administration
SMQs:, Medication errors (narrow)
Write-up: Initial unsolicited misuse report received from a physician ion 04-Nov-2015. This case involves an 29-year-old female patient who was vaccinated with an intramuscular first dose of Imovax (batch number: K1057, K1729, site of administration was not reported) and an intramuscular first dose of Imogam (batch number: L1050-2, expiry date: 23-Jan-2017 and site of administration was not reported) on 15-Jul-2015. The patient was possibly vaccinated with RABAVERT on an unspecified date. It was reported that the patient had no illness at the time of vaccination, no known allergies and no medical conditions. Patient had no vaccination within 4 weeks of vaccination and concomitant medications were not reported. On 30-Jul-2015, 15 days after vaccination, the patient experienced daily headaches in parietal area. The patient was noncompliant with receiving the post exposure vaccines, had received 3 after receiving the second vaccine. Patient required an ER visit on 15-Jul-2015. It was a case of inappropriate schedule of vaccine administered. Laboratory investigation include blood tests which was within normal limits and did not had any studies to evaluate the headaches. It was reported that corrective treatment include over the counter medications to relieve headaches. The outcome of the event was reported as not recovered. Documents held by sender: none.

VAERS ID:630165 (history)  Vaccinated:2011-09-01
Age:29.0  Onset:0000-00-00
Gender:Male  Submitted:2016-04-04
Location:Florida  Entered:2016-04-04
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: auto immune disease~HPV (Gardasil)~1~31.00~Patient
Other Medications: none
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data: Auto-immune disease of the hypoparathyroid
CDC Split Type:
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Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  SYRUN
Administered by: Private     Purchased by: Private
Symptoms: Autoimmune hypothyroidism, Burning sensation, Pain, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypothyroidism (narrow)
Write-up: The night of my shot I experienced extreme burning in my whole body, as well as pain and tingling. This lasted for 2 days.

VAERS ID:630368 (history)  Vaccinated:2016-04-01
Age:29.0  Onset:2016-04-01, Days after vaccination: 0
Gender:Female  Submitted:2016-04-05, Days after onset: 4
Location:Puerto Rico  Entered:2016-04-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI443AC1IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.L0144200IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSZ9Z4Y0IMLA
Administered by: Private     Purchased by: Public
Symptoms: Headache, Oedema peripheral, Pain, Pyrexia
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient specifies that she felt fever, headaches, body aches and edema on right arm.

VAERS ID:630988 (history)  Vaccinated:2016-03-11
Age:29.0  Onset:2016-03-11, Days after vaccination: 0
Gender:Male  Submitted:2016-04-08, Days after onset: 27
Location:Virginia  Entered:2016-04-12, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSHZ9Z9 UNRA
Administered by: Military     Purchased by: Public
Symptoms: Blood pressure increased, Erythema, Hyperhidrosis, Joint range of motion decreased, Local reaction, Oedema peripheral, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: 29 yo male employee who received 3rd TWINRIX on Friday 3/11/2016. Sat evening 3/12/2016 he c/o bilateral ankle edema, redness and tenderness to touch (entire ankle L$gR). Sunday there was no change or addition of any other symptom. No fever, rash, ha, increase in swelling or limitation in ROM. Monday 3/14/2016 he went to medical where nurse called Immunization Healthcare Branch to discuss possible vaccine reaction. Based on her statements then of sudden onset ankle swelling and sweating and elevated BP at 156/90 I advised these were not common side effect to TWINRIX and suggested he see MD there - they recommended he see his PCP or go to ER. He called his HCP and went. BP 156-90 Temp 98.3F HR 90 RR20. Pt''s ankle appeared mildly edematous. Color was within normal limits. Pt. was sweating. Since he rode his bike to work this am I could not determine if this was medical or from exercise. Dr. suggested that the pt. be seen by his primary care MD or outpatient facility. I followed up with him 3/15/2016 to clarify symptom complaints: description of his ankles, and more details on the sweating. He states he is a big man (like Hoss Cartwright) and sweats a lot normally and suggested his bp up after riding his bike to work. His reports his BP was normal at medical facility. Today 3/16/2016 his redness and swelling are gone. He is on day 3 of 5 steroid dose (60 mg/day). Your reaction was discussed with Dr. of vaccine safety and allergist. While reported vaccine side effects do list swelling, redness, joint pain and sweating as reported post vaccine side effects to TWINRIX thereby suggesting a temporal association to the vaccine (timing of reaction <24 hours after vaccine administration); the localized reaction does not support an allergic reaction to the vaccine or it''s ingredients (ankles only). Reactions typically include more than one site (unless a local injection site reaction). You said your vaccine site was okay.

VAERS ID:632674 (history)  Vaccinated:2016-04-18
Age:29.0  Onset:2016-04-21, Days after vaccination: 3
Gender:Female  Submitted:2016-04-21, Days after onset: 0
Location:New York  Entered:2016-04-22, 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: Open wound R hand
Preexisting Conditions: NKA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU5378AA1IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt received Tdap administred 4/18/16, IM L deltoid. She called on 4/21/16 at 11:32 am to report 2x2 circle redness at site, warm to touch, slight swelling and achy.

VAERS ID:632743 (history)  Vaccinated:2010-07-28
Age:29.0  Onset:2010-07-28, Days after vaccination: 0
Gender:Female  Submitted:2010-07-29, Days after onset: 1
Location:Florida  Entered:2016-04-25, Days after submission: 2097
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Alprazolam; ORTHO TRI-CYCLEN LO; Sertraline; Trazodone
Current Illness: h/o depression and panic d/o NOS
Preexisting Conditions: history of acute respiratory failure/ARDS 3/2010- severe shortness of breath and tachycardia. intubated. Etiology was never quite discovered. Denies any respiratory complaints. Was on inhalers for a short period of time but now is doing well without them.
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
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Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB703AA1UNLA
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Dyspnoea, Erythema, Hyperhidrosis, Hypersensitivity, Pyrexia, Rash, Tremor, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Per various notes in chart: Comments: pt states she has started to develop a reaction from her second hep B injection. She has a rash and a fever of 102.4 she will come to walk in for eval. She is not having any problems breathing, sob, swelling in throat etc. Patient came to team II and reported that she had her second dose of Hepatitis B today (her at 0851) and started to feel dizzy at 1100 then her face started turning red and developed a rash on her jaw area. Will send to walk in clinic as provider has no available appts this time of day. Pt of Dr, no avail appts presents to walk in with c/o having an allergic reaction to her second Hep B vaccine, which was given here this morning at 9am, since then she has been lightheaded, dizzy, sweats, face getting red, and shaky. 29 year old female pt recd her 2nd immunization for hep B in the series and shortly thereafter developed hives, dizziness, mild shortness of breath. The hives have resolved and the only remaining finding is some mild erythema of the cheeks and submandibular area. Lung fields are clear bilaterally.

VAERS ID:632913 (history)  Vaccinated:0000-00-00
Age:29.0  Onset:0000-00-00
Gender:Female  Submitted:2016-04-25
Location:Unknown  Entered:2016-04-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature (date unknown): Fever (increased)
CDC Split Type: WAES1603USA014225
Vaccination
Manufacturer
Lot
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Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This spontaneous report was received from a medical assistant referring to a 29 years old female patient. The patient''s medical history and concurrent conditions were not reported. On an unspecified date in 2008, the patient was vaccinated with hepatitis B vaccine (manufacturer unspecified) (dose number, dose, frequency, lot number, expiration date, frequency and route were not reported). Concomitant medications were not provided. On an unknown date, the patient experienced pyrexia and rash but she did not seek medical attention at that time and no treatment was given for the adverse events. No product quality complaint (PQC) was involved. At the time of the report, the outcome of pyrexia and rash was reported as recovered on an unspecified date. Additional information is not expected as no contact permission was provided.

VAERS ID:634403 (history)  Vaccinated:2016-05-02
Age:29.0  Onset:2016-05-02, Days after vaccination: 0
Gender:Female  Submitted:2016-05-05, Days after onset: 3
Location:Oklahoma  Entered:2016-05-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABAVERT)NOVARTIS VACCINES AND DIAGNOSTICS586011A1IMLA
Administered by: Military     Purchased by: Military
Symptoms: Skin lesion, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Urticarial lesion, $g 10 measured 30-10mm currently resolving, using hydrocortisone for symptomatic treatment.

VAERS ID:634666 (history)  Vaccinated:2016-05-02
Age:29.0  Onset:2016-05-02, Days after vaccination: 0
Gender:Female  Submitted:2016-05-06, Days after onset: 4
Location:Massachusetts  Entered:2016-05-06
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: Anxiety; Chronic neck pain
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MEN: MENINGOCOCCAL (MENOMUNE)SANOFI PASTEURU5179AA0IMLA
Administered by: Private     Purchased by: Other
Symptoms: Fatigue, Lymphadenopathy, Muscle swelling, Tenderness
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fatigue, left neck muscle swelling, left cervical chain tender lymphadenopathy.

VAERS ID:634758 (history)  Vaccinated:2016-05-06
Age:29.0  Onset:2016-05-06, Days after vaccination: 0
Gender:Male  Submitted:2016-05-06, Days after onset: 0
Location:Colorado  Entered:2016-05-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Indomethacin
Current Illness:
Preexisting Conditions: Congenital Dislocation of right elbow; Melrose disease
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSZC5LR1IMLA
Administered by: Other     Purchased by: Private
Symptoms: Hot flush, Hyperhidrosis, Palpitations, Pruritus
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Patient felt a hot flash, sweating, racing heart, itching of upper extremities.

VAERS ID:634959 (history)  Vaccinated:2016-05-09
Age:29.0  Onset:2016-05-09, Days after vaccination: 0
Gender:Female  Submitted:2016-05-09, Days after onset: 0
Location:Ohio  Entered:2016-05-09
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: Fibromyalgia
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Other
Symptoms: Dizziness, Headache, Hyperhidrosis, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypoglycaemia (broad)
Write-up: Nauseous, Sweating, dizziness, severe headache.

VAERS ID:635013 (history)  Vaccinated:2016-05-05
Age:29.0  Onset:2016-05-07, Days after vaccination: 2
Gender:Male  Submitted:2016-05-10, Days after onset: 3
Location:Oregon  Entered:2016-05-10
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
JEV1: JAPANESE ENCEPHALITIS (IXIARO)INTERCELL AGJEV15B82E0IMLA
Administered by: Military     Purchased by: Military
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Rash.

VAERS ID:635229 (history)  Vaccinated:2015-11-12
Age:29.0  Onset:2015-11-12, Days after vaccination: 0
Gender:Female  Submitted:2016-05-11, Days after onset: 180
Location:Colorado  Entered:2016-05-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Zyrtec; Camilla (Oral Contraceptive)
Current Illness: None.
Preexisting Conditions: Seasonal allergies. Excellent health at time of vaccination.
Diagnostic Lab Data: MRI 3/23/2016
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURUI431AE IMRA
Administered by: Private     Purchased by: Other
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site oedema, Injection site pain, Nuclear magnetic resonance imaging abnormal, Oropharyngeal pain
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: 11/12/2015 Received the flu vaccination in my right shoulder and had immediate and persistent pain. Approximately 2-3 weeks later I called my doctor to advise the pain still persisted. I was told to apply hot/cold compresses and call back if it did not resolve. I called again in early January to notify my doctor I was still having severe shoulder pain where at times I couldn''t lift my arm due to pain. 3/1/2016 I saw Dr. for a sore throat and to follow up on the shoulder pain. She offered to send me to get an MRI. 3/23/2016 I had an MRI. I was notified of the results of my MRI showed edema in my shoulder. At this time I still had persistent shoulder pain. The doctor recommended physical therapy and/or to see an orthopedist. 4/21/2016 I saw PA-C for an orthopedic appointment and he noted my shoulder pain and prescribed an anti-inflammatory.

VAERS ID:635415 (history)  Vaccinated:2016-05-12
Age:29.0  Onset:2016-05-12, Days after vaccination: 0
Gender:Male  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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI441AD IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS3Z3X90IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM15069 IMLA
RAB: RABIES (RABAVERT)NOVARTIS VACCINES AND DIAGNOSTICS584011A0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSZ9Z4Y IMLA
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUI267AA0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Pallor
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Approximately 1 min. after receiving the Yellow Fever vaccine, which was the last of 6 vaccines given (Hep A, Flu, MENVEO, Rabies, Tdap. )Pt started to become pale and stated he felt lightheaded. Lowered pt. to supine, applied cool pack to the back of his neck. He never lost consciousness. He was able to speak coherently. Remained supine for 10 min. then sat in a chair for 10 min. His color returned to normal after about 3 min. in the supine position. He drank 8 oz. of water during the 10 min. he sat in a chair. He stated he felt fine and left the office.

VAERS ID:635971 (history)  Vaccinated:2016-04-11
Age:29.0  Onset:2016-04-12, Days after vaccination: 1
Gender:Female  Submitted:2016-04-13, Days after onset: 1
Location:Texas  Entered:2016-05-16, Days after submission: 33
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None.
Preexisting Conditions: None.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0SCRA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Injection site pain, Injection site swelling, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Redness, warmth, painful injection site with swelling. Approximate area 15 cm X 9 cm as of 4/13/16. Injection received on 4/11/16. 4 mg methylprednisolone prescription and 800 mg BACTRIM prescription.

VAERS ID:636057 (history)  Vaccinated:2016-05-16
Age:29.0  Onset:2016-05-17, Days after vaccination: 1
Gender:Female  Submitted:2016-05-18, Days after onset: 1
Location:Maryland  Entered:2016-05-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None reported
Preexisting Conditions: None reported
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.L0368312SCLA
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Induration, Local reaction, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Large local reaction, redness, induration 9cm, warmth.

VAERS ID:636135 (history)  Vaccinated:2015-12-29
Age:29.0  Onset:2015-12-29, Days after vaccination: 0
Gender:Unknown  Submitted:2016-05-18, Days after onset: 140
Location:Georgia  Entered:2016-05-18
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: WAES1605USA008107
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.L038499 IMAR
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 29 year old patient of unknown gender. There was no information about the patient''s concurrent conditions, concomitant therapies or medical history provided. On 29-DEC-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L038499, expiration date: 26-JUN-2017, 1 ml, intramuscularly, in deltoid (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:636355 (history)  Vaccinated:2016-05-04
Age:29.0  Onset:2016-05-04, Days after vaccination: 0
Gender:Female  Submitted:2016-05-20, Days after onset: 16
Location:Unknown  Entered:2016-05-20
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: WAES1605USA003810
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV9: HPV (GARDASIL 9)MERCK & CO. INC.L045711 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, Exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Medication errors (narrow)
Write-up: This spontaneous prospective pregnancy report as received from a registered nurse refers to a 29 year-old female patient who was 28 weeks pregnant. The patient''s medical history and concurrent conditions were not reported. On 04-MAY-2016 the patient was inadvertently vaccinated with GARDASIL 9 (lot # L045711; expiry date: 08-MAY-2017) at a dose of 0.5 ml, once via intramuscular route. The reporter stated that the patient was doing fine. The outcome of the events was unknown. Additional information has been requested.

VAERS ID:636362 (history)  Vaccinated:2014-03-31
Age:29.0  Onset:2014-03-31, Days after vaccination: 0
Gender:Unknown  Submitted:2016-05-20, Days after onset: 781
Location:Georgia  Entered:2016-05-20
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: WAES1605USA008055
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.  IMUN
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 29 year old patient of unknown gender. There was no information about the patient''s concurrent conditions, concomitant therapies or medical history provided. On 31-MAR-2014, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # and expiration date was not reported) 1 ml, intramuscularly (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:636443 (history)  Vaccinated:2016-05-16
Age:29.0  Onset:2016-05-17, Days after vaccination: 1
Gender:Female  Submitted:2016-05-20, Days after onset: 3
Location:Texas  Entered:2016-05-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypothyroidism; Low pnemunoccal levels
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cellulitis, Chills, Haemoptysis, Headache, Hyperaesthesia, Hyperhidrosis, Oropharyngeal pain, Pain, Productive cough, Pyrexia, Walking aid user
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Severe body aches and sensitivity to touch (unable to get out of bed or walk without assistance). Sore throat. Coughing up blood and mucus. Progressing to severe headache (worst ever). Reoccurring fever. Sweating. Chills. Cellulitis on arm near but not on injection site that spreads in size over time. 5/17/2016-5/20/2016 (still dealing with side effects).

VAERS ID:636459 (history)  Vaccinated:2016-05-18
Age:29.0  Onset:2016-05-19, Days after vaccination: 1
Gender:Female  Submitted:2016-05-20, Days after onset: 1
Location:Minnesota  Entered:2016-05-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PT ALSO RECEIVED PPD SAME DAY APLISOL 0.1ML 15 LFA LOT 789289
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.L0124810SCLA
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU5280AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.L0072260SCLA
Administered by: Public     Purchased by: Other
Symptoms: Pyrexia, Rash generalised, Rash pruritic, Varicella post vaccine
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fever of 102 the following morning after receiving vaccine. The following day itchy chicken pox rash started and spread from head to toe- consistent with varicella illness.

VAERS ID:636959 (history)  Vaccinated:2016-05-20
Age:29.0  Onset:2016-05-22, Days after vaccination: 2
Gender:Female  Submitted:2016-05-24, Days after onset: 2
Location:Oklahoma  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: JANUMET, INVOKANA, METOPROLOL, BENAZEPRIL, VERAPAMIL, SIMVASTATIN AND LEVOTHYROXINE. MULTIVITAMIN AND GARCINIA CAMBOGIA.
Current Illness: NONE REPORTED BY PATIENT.
Preexisting Conditions: NONE KNOWN.
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS29Z4Y0IMRA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: REDNESS AROUND INJECTION SITE AND MILD ITCHING. NO PAIN OR SORENESS REPORTED.

VAERS ID:637269 (history)  Vaccinated:2016-05-24
Age:29.0  Onset:2016-05-25, Days after vaccination: 1
Gender:Female  Submitted:2016-05-26, Days after onset: 1
Location:Washington  Entered:2016-05-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.L003188 UNLA
Administered by: Other     Purchased by: Public
Symptoms: Erythema, Musculoskeletal stiffness, Peripheral swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), 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), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Red arm, swollen, and slightly stiff. Pt went to hospital. Prednisone and BENADRYL from urgent care.

VAERS ID:637695 (history)  Vaccinated:2016-05-27
Age:29.0  Onset:2016-05-27, Days after vaccination: 0
Gender:Female  Submitted:2016-06-01, Days after onset: 5
Location:Georgia  Entered:2016-06-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.L0282731SCLA
Administered by: Other     Purchased by: Private
Symptoms: Asthenia, Dizziness, Hypotension, Nausea, Vertigo, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow)
Write-up: Employee states that within 15-20 minutes after receiving the vaccine, she began experiencing dizziness. The next day she experienced nausea, vomiting, vertigo and weakness and low blood pressure. These symptoms continued for approx. 3 days.

VAERS ID:637778 (history)  Vaccinated:0000-00-00
Age:29.0  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:
Diagnostic Lab Data:
CDC Split Type: 2015057127
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Angioedema, Cough, Dyspnoea, Enlarged uvula, Lip swelling, Mouth swelling, Pruritus, Rash, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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 29 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 no history of atopy. On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received influenza virus vaccine (manufacturer and batch number not reported), which was administered one day before the reaction. On an unspecified date, 8 hours after vaccination, the patient experienced anaphylaxis. The symptoms included angioedema, swelling on lips, uvula and mouth, generalised urticarial, pruritus, rash, shortness of breath and cough. The case met Brighton Collaboration case definition of anaphylaxis criteria level 1. She received treatment with oral antihistamines and oral H2 blockers and oral steroids. The outcome was recovered and the patient was referred to PCP (primary care physician). Reporter''s comments: The attributed trigger was vaccine.

VAERS ID:639349 (history)  Vaccinated:2014-08-25
Age:29.0  Onset:2014-08-25, Days after vaccination: 0
Gender:Female  Submitted:2016-05-25, Days after onset: 639
Location:Kentucky  Entered:2016-06-01, 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: No reported illness
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSB457F1UNLA
Administered by: Private     Purchased by: Private
Symptoms: Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: Pt reports weakness in left arm after TWINRIX injection that lasted 2 days. This shot was given 8/25/2014 and was just reported today.

VAERS ID:637844 (history)  Vaccinated:2015-10-09
Age:29.0  Onset:2015-10-09, Days after vaccination: 0
Gender:Male  Submitted:2016-05-09, Days after onset: 213
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: 2015055524
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDT51608 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)
Write-up: This spontaneous case was initially received on 03-Nov-2015. The case report was received from a(n) Health Professional and concerns a(n) 29 years old male patient. Weight: 240 pounds, Height: 74 inches. The patient received AFLURIA on 09-Oct-2015, Batch no: T51608, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 09-Oct-2015, the patient received an IM dose of expired AFLURIA.

VAERS ID:637950 (history)  Vaccinated:0000-00-00
Age:29.0  Onset:0000-00-00
Gender:Female  Submitted:2016-05-09
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: 2016059214
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site nerve damage
SMQs:
Write-up: This medically confirmed health authority report (initial receipt 23-NOV -2016) concerns a 29 year old female patient. On an unspecified date, the patient received influenza seasonal vaccine (manufacturer and batch number not reported). On an unspecified date, the patient reported that the injection hit the nerve. The outcome was not reported. Linked case: 2016059213 (same patient). Case correction 08-MAR-2016: LLT for AE 1"injection hit nerve" re-coded to "injection site nerve damage", case downgraded to non serious.

VAERS ID:638068 (history)  Vaccinated:2015-10-06
Age:29.0  Onset:2015-10-06, Days after vaccination: 0
Gender:Female  Submitted:2016-05-09, Days after onset: 216
Location:Florida  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: 2016059220
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED  IMRA
Administered by: Other     Purchased by: Private
Symptoms: Hypersensitivity, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 29 years old female patient. The patient had no known illnesses. She gave birth exactly one month prior to vaccination. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient had no medical history and no known illnesses. She gave birth exactly 1 month prior to vaccination. The patient received AFLURIA on 06-Oct-2015 - unknown stop date, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml, Site: right arm. No additional drugs suspected. On 06-Oct-2015, 1 week 0 days after starting / treatment with AFLURIA the patient experienced Allergic reaction, Hivers covering face, chest and arms. Event treatment: Diphenhydramine eased the symptoms. Reporter''s assessment: The health authority assessed the events as non-serious.

VAERS ID:638295 (history)  Vaccinated:2015-09-01
Age:29.0  Onset:2015-09-01, Days after vaccination: 0
Gender:Female  Submitted:2016-05-09, Days after onset: 251
Location:Unknown  Entered:2016-06-02, Days after submission: 24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnant: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2015053764
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDT53909 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Expired product administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: This spontaneous medically confirmed (initial receipt 01-Sep-2015) concerns a 29-year-old female patient. On 01-Sep-2015, the patient inadvertently received an intramuscular dose of expired AFLURIA (batch number T53909, expiry date: 30-Jun-2015) 0.5 mL once via intramuscular route of administration. No adverse reaction occurred after the administration. The outcome was reported as recovered. Reporter's outcome: The reporter assessed the event as non-serious and reported the term ''Medication error''. Additional information was received from the reporter on 01-Dec-2015: The reporter assessed the event as unrelated to AFLURIA.

VAERS ID:639222 (history)  Vaccinated:2014-10-02
Age:29.0  Onset:2015-01-23, Days after vaccination: 113
Gender:Female  Submitted:2016-06-02, Days after onset: 495
Location:New Jersey  Entered:2016-06-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: 2013, Cervical dysplasia; 2013, Papilloma viral infection; Drug hypersensitivity
Preexisting Conditions: 05/02/2010, LUTERA, 1 tab, po, daily; amoxicillin, Drug hypersensitivity
Diagnostic Lab Data: On an unknown date, the patient had normal PAP Smears (Smear Cervix). In 2013, history of low-grade squamous intraepithelial lesion (LSIL) or higher Pap/Biopsy (BX): high grade squamous intraepithelial lesion with HPV DNA+. On 23-JAN-2015, PAP Smears showed high grade lesion and a cone biopsy showed CIN3; the margins were free. In addition, final cytologic diagnosis was interpreted as high grade squamous intraepithelial lesion.
CDC Split Type: WAES1605USA005698
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0670Y2IMLA
Administered by: Other     Purchased by: Other
Symptoms: Biopsy cervix abnormal, Cervical dysplasia, Cytology abnormal, Expired product administered, Human papilloma virus test positive, Smear cervix abnormal, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Reproductive premalignant disorders (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Uterine and fallopian tube malignant tumours (broad), Uterine and fallopian tube tumours of unspecified malignancy (broad), Medication errors (narrow)
Write-up: This spontaneous report as received from a physician via medical records refers to a 29 year old female patient. Patient''s medical history included normal PAP Smears (Smear Cervix) (on an unspecified date). Her concurrent conditions included an allergy to amoxicillin and a high grade squamous intraepithelial lesion with Human Papilloma Virus Infection (HPV) DNA+ diagnosed in 2013. Historical drugs included LUTERA. Patient''s last menstrual period was on 31-DEC-2014. On 12-JUN-2014, the patient was vaccinated with a first dose of expired GARDASIL (lot # 1702X exp 08-SEP-2011). Then on 14-AUG-2014, the patient was vaccinated with a second dose of expired GARDASIL (lot # 0053X exp. 28-JUL-2010). Finally, on 02-OCT-2014, the patient was vaccinated with the third dose of expired GARDASIL (lot # 0670Y exp. 20-JUN-2010). All doses were administered intramuscularly, in the left deltoid, with a dose of 0.5ml. A PAP smear test and a cone biopsy, performed on 23-JAN-2015 showed a high grade lesion (HSIL) and cervical intraepithelial neoplasm (CIN3) with free margins, respectively. The diagnoses was interpreted as high grade squamous intraepithelial lesion (cervical dysplasia); from moderate to severe dysplasia (CIN 2-3). This was considered as a vaccination failure. At the reporting time, the outcome of the cervical dysplasia was unknown. The causality between the events and therapy with GARDASIL was not stated. No product quality complaint was reported (PQC). The physician stated that he understood that the patient was not virginal at the time that the patient received the vaccine but he thought that maybe the lot numbers could be checked just to make sure about another unexpected outcomes associated with those batches. All available medical records will be provided upon request. Additional information has been requested.

VAERS ID:638802 (history)  Vaccinated:2016-01-31
Age:29.0  Onset:2016-01-31, Days after vaccination: 0
Gender:Unknown  Submitted:2016-06-04, Days after onset: 124
Location:Georgia  Entered:2016-06-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1605USA008087
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.L038499 IMLA
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 29-year-old patient of unknown gender. The patient''s medical history and concurrent conditions were not reported. On 31-JAN-2016, the patient was vaccinated with an improperly stored dose of hepatitis B vaccine (recombinant) (manufacturer unknown)(left deltoid, route of administration: intramuscularly, dose number not reported, lot number: L038499, expiry date: 26-JUN-2017). Concomitant therapy was not reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.

VAERS ID:638610 (history)  Vaccinated:2016-01-29
Age:29.0  Onset:2016-01-29, Days after vaccination: 0
Gender:Unknown  Submitted:2016-06-10, Days after onset: 132
Location:Georgia  Entered:2016-06-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1605USA008082
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.L038499 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 and refers to a 29 year old patient of unknown gender. There was no information about the patient''s concurrent conditions, concomitant therapies or medical history provided. On 29-JAN-2016, the patient was vaccinated with the improperly stored dose of RECOMBIVAX HB (1 ml, intramuscularly in right deltoid, lot # L038499, expiration date 26-JUN-2017). 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.

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